Jump to:

NYSA TI Single-Page 4

Allegations of Fda Abuses of Authority Hearings Before the

Date: 05 Dec 1995
Length: 177 pages

Jump To Images
nysa_ti_s4 TI14380109-TI14380285


For sale b) the U.S. Govem,nenl Priming Office Sup~ri.tcnd~'nt of Dc.,cumcnL~,. Congressional Sales 0/1ic¢, Washington.


Named Organization
American Bar Association
American Dental Association
American Medical Association (physicians group)
Professional trade group representing American physicians.
Baylor College of Medicine (Located in Houston, Texas)
Biomet Inc.
CBS (Columbia Broadcasting System)
Cleveland Clinic
*Department of Health and Human Services
Department of Health and Human Services (HHS)
Department of Justice (DOJ)
Department of State (DOS)
Environmental Protection Agency (EPA)
Federal Bureau of Investigation (FBI)
Federal Communications Commission (FCC)
Federal District Court
Federal Register (publication)
Food and Drug Administration (FDA)
General Counsel
*Health and Human Services (HHS) (use United States Department of Health and Hum (US)
Health Research Group (An anti-smoking group)
An anti-smoking group
Heritage Foundation
House of Representatives
Internal Revenue Service (IRS)
Justice Department
Mayo Clinic (Located in Rochester, Minnesota)
Has a nicotine dependence center; runs the smoking cessation program at the Mayo Clinic
McDonald's Corp.
Merck (pharmaceutical company)
Ministry of Health (Located in Singapore)
MRI (see Mason Research Institute)
see Mason Research Institute
National Institutes of Health (NIH)
New York Times
Office of Compliance
Office of Special Counsel
Patton, Boggs & Blow
Public Citizen ("PC") (Nonprofit consumer advocate organization founded by Ralph Na)
Public Citizen is a nonprofit consumer advocate-action organization founded in 1971 by Ralph Nader.
Securities and Exchange Commission (SEC)
The Shield (anti-tobacco and alcohol publication of the 1920s)
United States Senate
University of Southern California
USA Today
Wall Street Journal
White House
Winston & Strawn (Tobacco law firm)
Named Person
Aikman, Troy
Alley, Katherine
Alpert, Susan
Andros, Rich
Andros, Richard
Baca, Joe
Bailey, George F.
Barton, Joe
Bell, Mary Jean
Bianchi, Pat
Bianchi, Pat A.
Bianchi, Patricia
Boucher, Rick
Bowen, Thomas
Bowen, William
Bowers, Brent
Brubaker, William
Bryant, John
Burlington, Bruce
Burlington, Donald Bruce
Burr, Richard
Chesemore, Ronald G. (FDA Regulatory Affairs, Associate Commissioner 1994)
Chisler, Pam
Clark, Mike
Coale, John
Coale, John P.
*Coale, Mr. (use Cale, John P.)
Coburn, Tom
Cohen, Bruce, Ph.D. (Epidemiologist, MA Dept. of Public Health)
Cohen, Ralph
Cole, John
Cook, Kay
Cox, Christopher
Crapo, Michael D.
Davis, Dave M.D.
Davis, Jim
Deal, Nathan
Dear, Joe
Deutsch, Peter
Dingell, John (Philip Morris Washington Office)
Dingell, John D.
Dole, Bob
Driscoll, Mike
Dunn, A. William
Eccleston, Bob
Farr, Leonard
Fields, Jack
Foster, Kent R.
Frank, Gloria
Franks, Gary A.
Furse, Elizabeth
German, Mary
Gibbs, Jeff
Gibbs, Jeffrey N.
Gill, Lillian
Gordon, Bart
Gorman, Mary
Greenwood, James C.
Haley, Charles
Hall, Ralph M.
Hampton, Tommy
Hamrick, Kay
Holcombe, Kay
Holston, Sharon
Hooten, Marina
Horowitz, Leon
Hutchison, Kay Barley
Isaacs, John
Jaffe, Richard
Jaffe, Richard A.
Jank, Roland C.
Johnson, John
Kaplan, Sheila
Kelly, Patrick
Kent, John
Kessler, David A., M.D., J.D. (Former FDA Commissioner)
appointed FDA Commissioner by President George Bush in December 1990.
Klink, Ron
Kress, Jack
Levitt, Joseph
Lincoln, Blanche Lambert
Lorenz, Walter
Lowell, Roger
Lowell, Roger L.
Manton, Thomas J.
Markey, Edward J.
Mcdonald, Gabrielle
Mcgarry, J. Michael, III
Medi, Sara
Michaels, Mary
Michaels, Mary K.
Michaels, Paul
Michaels, Paul A.
Michelson, Gary
Michelson, Gary K.
Miller, Dane
Miller, Dane A.
Milliken, Roger
Moorhead, Carlos J.
Morrison, Alan B.
Moss, Ralph
Myers, Dennis
Nader, Ralph (Consumer Activist)
Consumer activist long renowned for a career of exposing corporate deception and wrongdoing that result in human harm.
Nolan, Patrick
Norwood, Charlie
Oxley, Michael G.
Pallone, Frank, Jr.
Palmore, Mary
Parr, Edward J., Jr.
Parr, Ted
Pedersen, Amanda
Pendergast, Mary
Peters, Amanda
Pines, Wayne
Pollard, Colin
Porter, Margaret
Porter, Margaret Jane
Powers, Debra
Raphael, Sally Jesse
Redmond, Geoffrey P.
Redmond, Patricia
Richardson, Bill
Richardson, Glenda
Richter, Kimber
Rush, Bobby L.
Schaefer, Dan
Scheman, Carole
Single, Gregory
Singleton, Greg
Snyder, Sharon
Spiller, Robert
Stearns, Cliff
Steelman, Deborah
Stone, Bob
Stone, Roger
Stupak, Bart
Taylor, Nancy
Thomas, Cheryl Rayner
Thomas, Rich
Thomas, Rick
Thompson, Diane
Thompson, Diane E.
Upton, Fred
Watkins, Bob
Watkins, Robert
Watkins, Robert G.
Waxman, Henry A.
White, Rick
Whitfield, Ed
Willis, Delores
Withers, John
Wolf, Dr. ---
Wolf, Sidney
Wolfe, Sidney M.
Wolfe, Sidney M. D.
Woods, James D., Ph.D. (Building Construction Professor, VA Tech.)
Virginia Polytechnic Institute & State University
Worland, Richard
Wright, Earl
Wright, Grant
Wright, Grant A.
Wright, H. Earl
Yin, Lillian
Young, Frank, M.D. (FDA former commissioner)
Zeller, Mitchell R., J.D. (Former FDA employee)
Assisted with investigation of tobacco companies and nicotine after ABC Day One segment claims of nicotine spiking.
Date Loaded
18 Jul 2005

Document Images

Text Control

Highlight Text:

OCR Text Alignment:

Image Control

Image Rotation:

Image Size:

Page 1: TI14380109
ALLEGATIONS OF FDA ABUSES OF AUTHORITY HEARINGS BEFORE THE SUBCOMMITTEE ON OVERSIGHT _&ND I,WESTIGATIONS OF THE COMMITTEE ON COMMEI~CE HOUSE OF REPRESENTATIVES ONE HUNDRED FOURTH CONGRESS FIRST SESSION JULY 25, NOVEMBER 15, AND DECEMBER 5, 1995 Serial No. 104-51 Printed for the use of the Committee on Commerce 21-558CC U.S. GOVEP.NMENT PRINTING OFFICE WASHINGTON : 1996 For sale b) the U.S. Govem,nenl Priming Office Sup~ri.tcnd~'nt of Dc.,cumcnL~,. Congressional Sales 0/1ic¢, Washington. DC 20402 ISBN 0-16-052316-8
Page 2: TI14380110
O0 0 0 COMMITTEE ON COMMERCE THOMAS J. BLILEY, JR., Virginia, Chmrman CARLOS J. MOORHEAD, California, Vice Chairman W.J. "BILL'I"' TAUZ[N, Louisina JACK FIELDS, Texas MICHAEL G. OXLEY, Ohio MICHAEL BILIRAKIS, Florida DAN SCHAEFER, Colorado JOE BARTON, Texas J. DENNIS IL~STERT, Illinois FRED UPTON, Michigan CLIFF STEARNS, Florida BILL PAXON, New York PAU_L E. GILLMOR, Ohio SCOTT L, KLUG, Wisconsin GARY A. FRANKS, Connecticut JAMES C. GREENWOOD, Pennsylvania MICHAEL D. CRAPO, Idaho CHRISTOPHER COX, California NATHAN DEAL, Georgia RICHARD BURR, North Carolina BRIAN P. BILBRAY, California ED WHITFIELD, Kentucky GREG GANSKEo Iowa DAN FRISA, New York CHARLIE NORWOOD, Geor£;a RICK WHITE, Washington TOM COBURN, Oklahoma JOHN D. DINGELL, Michigan HENRY A. WAXMAN, California EDWARD J. MARKEY, Massachusetts CARDISS COLLINS, Illinois RON WYDEN, Oregon RALPH M. HALL, Texas BILL RICHARDSON, New Mexico JOHN BRYANT, Texas RICK BOUCHER, Virginia THOMAS J. MANTON, New York EDOLPHUS TOWNS, New York GERRY E. STUDDS, Massachusetts FRANK PALLONE, JR., New Jersey SHERROD BROWN, Ohio BLANCHE LAMBERT LINCOLN, Arkansas BART GORDON, Tennessee ELIZABETH PURSE, Oregon PETER DEUTSCH, Florida BOBBY L. RUSH, Rlinois ANNA G. ESHOO, California RON KLINK, Pennsylvania BART STUPAK, Michigan JA~tv.s E. DsanzmAN, Chief of Staff CHARLES L. INOEBRETSON, General Counsel ALAtq J. ROTH, Minority S~aff Director and Chief Counsel SUBCOMMITTEE ON OVER~IGH~ AND INVESTIGATIONS JOE BARTON, Texas, Chairman CHRISTOPHER COX, California Vice Chairman GARY A. FRANKS, Connecticut JAMES C. GREENWOOD, Pennsylvania MICHAEL D. CRAPO, Idaho RICHARD BURR~ North Carolina DAN FRISA0 New York THOMAS J. BLILEY, JB., Virginia, ~Ex 0fficlo~ PETER DEUTSCH, Florida HENRY A. WAXMAN, California ANNA G. ESHO0, California RON KLINK, Pennsylvania ELIZABETH FURSE, Oregon JOHN D. DINGELL, Michigan (Ex Officio) (If) CONTENTS Psgs (llI) Hearings held on: ' July 25, 1995 1 November 15, 1995 ........................................................................................... 79 December 5, 1995 ............................................................................................. 203 Testimony of: 57 Cassagnol, Reginald ......................................................................................... 18 Gorman, Mary ................................................................................................... Jaffe, Richard A., Attorney .............................................................................. 20 48 Jankelson, Roland C., director, Myo-Tronics, Inc .......................................... Kessler, Hon. David A., Commissioner, Food and Dru~ Administration: November 15, 1995, accompanied by: Bruce Burlington, Director, Center for Devices and Radiological Health; Margaret Porter, Chief Counsel; Ronald Chesemore, Associate Commissioner for Regu- latory Affairs; Mitch Zeller, Deputy Associate Commissioner .for Policy; Susan A1part, Director, ODE, CDRH; Diane Thompson, As- sociate Commissioner, Legislative Affairs; Amanda Pedersen, Chief Mediator and Ombudsman; Robert Spiller, Associate Chief Counsel for Enforcement, OGC; Roger Lowell, District Director, Seattle Dis- trict; Richard Andros, Compliance Officer, Seattle District; Grog Singleton, Dental Officer, CDRH; Kay Cook, Associate Chief Cou.n- sol for Medical Devices; and Marina Hooten, Chief, Ethics Branch, Division of Ethics and Program Integrity ..................................... ._. ..... 84 December 5, 1995, accompanied by: Bruce Burlington, Director, Cen- tor for Devices and Radiological Health; Ronald Chesemore, Associ- ate Commissioner, Regulatory Affairs; Diane Thomp~,on., .A~ssociat,e Commissioner, Legislative Affairs; Margaret Porter, ~nxel ~ounseG Mitch Zeller, Deputy Associate Commissioner for Policy; Grog Sin- ~ leton, Dental Officer, CDRH; Joseph Levitt, Deputy Director for olicy, CDRH; Lillian Yin, CDRH; Susan Alpert, Director, ODE,, CDRH; Robert Spiller, Associate Chief Counsel for Enforcemen,~, OGC; Edward J. Parr, Jr., Trial Attorney, OGC; Kay Cook, Assocl. ate Chief Counsel for Medical Devices; Amanda Pedersen, Chief Mediator and Ombudsman; and Tommy Hampton, Special Agent in Charge, Office of Internal Affairs .................................................... 204 26 Michaels,Michaels' ~I:u7 ................................................................................................. 26 61 Michelson, Gary K ............................................................................................ Miller, Dane A., President, Biomet, Inc .......................................................... 53 Niedelman, Steven, Director, Division of Enforcement, Center for Devices and Radiological Health, Food and Drug Ad..,m.inistration ......................... 169 Watldns, Robert G., Kerlan-Jobe Orthopedic wlinic ...................................... 59 Wright H. Earl, Vice President, Inventive Products, Inc ............................. 13 Material s~mitted for the record by: Baker, Hon. Bill, a Representative in Congress from the State of Caiifor- rda, letter dated July 24, 1995 to Susan Alpert, Food and Drug Admin- istration re Sensor Pad, submitted by H. Earl Wright .............................. 18 Food and Drug Administration: Canada Health Protection Branch, memorandum dated Nevember 30, 1995 from W. Freeland, M.D., re Breast Sensor Pad ................... 246 Changes in Labeling Claims for Sensor Pad ........................................... 188
Page 3: TI14380111
Material submitted for the record by--Continued Page Dental Products Panel Meeting Expenditures ........................................ 245 Excer~ from Report to Ministry of Health, Province of Ontario re Dr. _urzynski ......................................................................................... 177 FDA Office of Criminal Investigations, report on responsibilities of OCI investigators ................................................................................... 185 Memorandum dated July 28, 1995 from Compliance Branch re Inven- tive Products, Inc. shipments of Sensor Pad after September 11, 1991 .................................................................................................... ..... 34 Office of Public Affairs, breakdown of number of employees ................. 312 Responses to subcommittee questions dated February 7, 1996 ............ 338 Status of Soap and Water as a Medical Device ...................................... 100 Gregg, Hon. Judd, a Representative in Congress from the State of New Hampshire, letter dated July 25, 1995 to Chairman Joe Barton ............. 7 Myo-Tronics, Inc., letter dated September 10, 1995 from Roland C. Jankelson, responding to question of Hon. Richard Burr .......................... 75 Oversight and Investigations Subcommittee: Canada Health Protection Branch, letter dated May 5, 1994 to Earl Wright from Kent R. Foster re Senso-Touch Sensor Pad, submitted by Hon. Richard Burr ............................................................................ 311 Chronological order of FDA contacts on Sensor Pad, submitted by Hon Richard Burr ................................................................................. 182 Conference call notes dated July 24, 1995 re Inventive Products, Inc. Sensor Pad, submitted by Hon. Richard Burr ............................. 208 Court Order dated January 21, 1986 re Burzynski Cancer Research Institute, submitted by Hon. Tom Coburn .......................................... 119 E-Mall dated May 23, 1995 from Roger Lowell, FDA District Director, Seattle, to Jim Davis, et al. re Myo-Tronics distribution, submitted FbyDA Chairman Barton .............................................................................. 144 letters dated: September 16, 1992 to Grant A. Wright, Inventive Products, from Patricia Bianchi, submitted by Hon. Richard Burr ............ 179 December 7, 1994 to Dr, Robert R. Jankelson, Myo-Trenics, Inc., from Susan Alpert, submitted by Hon. Michael D. Crapo .......... 240 December 20, 1994, document entitled "Update on Pedicle Screws", submitted by Hon. Christopher Cox .............................. 330 FDA memorandum dated July 28, 1995 to Ron Chesemore, Asso- ciate Commissioner, from Roger Lowell, District Director, Se- attle re Myo-Trenics, submitted by Hon. James C. Greenwood . 138 Indictment of Stanislaw R. Burzynski, M.D., Burzynsld Research Institute, by District Court, Houston, TX, submitted by Hon. Henry A. Waxman .......................................................................... 220 Inventive Products, Inc.: Letter dated March 2, 1992 from Grant A. Wright to Delores Willisj submitted by Hon. Richard Burr ....................................... 104 Letter dated August 14, 1992 to Pat Bianshi, FDA, from Grant A. Wright, submitted by Hon. Richard Burr ................................ 210 Legal Times article dated January 13, 1992 entitled "Family Ties . Fore Staffer into Rocusal", submitted by Hon. Christopher Cox ..... 326 Myo-~'ronics case submissions of FDA documents by Chairman Bar- ton: E-Mail dated March 20, 1995 from Pat Bianchi; draft conflict ~ f interest review of Dr. Bertolami's poentiai conflict of interest, ated March 6, 1995; memorandum dated December 9, 1992 from Dr. Singleton; E-Mall dated June 13, 1994 from Dr. Singleton to Rich Andros and others; letter dated December 7, 1994 from Susan Alpert to Dr. Robert Jankelson; and memorandum dated September 25, 1995 from Karen Schifter ............................................ 192 (~v) Material submitted for the record by--Continued Page National Performance Review, fax transmittal and letter dated Au- gust 21, 1994 to David Kessler, from Bob Stone enclosing legal brief from Jeffrey N. Gibbs, attorney for Myo-Tronics, Inc., submit- ted by Chairman Barton ....................................................................... 272 Phone records dated February 1, 1995 of Dr. Yin, FDA, submitted by Hon, Richard Burr ............................................................................ 313 Public Citizen, letter dated December 5, 1995 to Chairman Barton, from Dr. Sidney M. Wolfe, submitted by Hon. Henry A. Waxman ,.. 265 Sensor Pad label from manual on Sensor Pad, submitted by Hon. Richard Burr .......................................................................................... 44 Sofamor Exhibit 1, court order dated October 26, 1995 re orthopedic bone screw products liability litigation, submitted by Hon. Chris- topher Cox .............................................................................................. 111 Scfamor Exhibit 2, index of documents provided to Mitch Zeller, FDA from John Coale, submitted by Hon. Christopher Cox .............. 166 Talk Paper, FDA, dated April 13, 1994 re Sensor Pad, submitted Wbyall Hon. Richard Burr ............................................................................ 308 Street Journal article dated April 12, 1994 re Sensor Pad, submitted by Hon. Richard Burr .......................................................... 305 Thompson, Diane E., Associate Commissioner for Legislative Affairs, FDA, letter dated August 2, 1995 to Chairman Barton, submitted by Hon. Michael D. Crapo ..................................................................... 92
Page 4: TI14380112
ALLEGATIONS OF FDA ABUSES OF AUTHORITY TUESDAY, JULY 25, ~995 HOUSE OF REPP.ESENTATIVES, COMMITTEE ON COMMEROE, SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS, Washington, DC, The subcommittee met, pursuant to notice, in room 2123, Ray. burn House Office Building, it 10:05 a.m., Hon. Joe Barton (chair- man) presiding. . Members present: Representatives Barton, Crapo, Burr, Fnsa, Bliley [ex officio], Wyden, Waxman, and Eshoo. St~f present: Alan Slobodin, majority counsel, Cheryl Rayner Thomas, majority counsel, Reid Stuntz, minority general counsel, and Kay Holcombe, minority professional staff. Mr. BAt~TON. The subcommittee will come to order. Today the subcommittee continues its investigation of the impact of FDA reg. ulation on the safety, health and economic well-being of Americans and the adequacy of the Food, Drug and Cosmetic Act. Our previous hearings have dealt with the systemic problems in the regulatory approach and the priorities of this Agency. Unfortu- nately, we must now turn our attention to allegations of retaliation or appearances of retaliation, discrimination and other acts of mal- feasance that have harmed firms regulated by FDA, as well as their patients. We believe that the witnesses today will tell compelling stories of ill treatment, in some cases, life-threatening treatment by the FDA. The subcommittee wants to thank our witnesses today and notes that the witnesses who represent regulated companies have come forward at great risk to themselves. We applaud their courage and we will do everything in our power to safeguard them from re- prisal. The subcommittee has put a lot of effort to get the FDA's views on this hearing. We have invited Commissioner Kessler to testify with the assistance of three FDA officials of his choosing. He de- clined the opportunity to testify today, but has indicated that he does want to testify at a hearing in the near future. We have made extensive document requests and asked for inter- views with specific FDA employees to get their perspective on the Sensor Pad case that's going to be featured at this hearing, After some delay, we have received the documents just recently. The interviews that we requested have yet to take place.
Page 5: TI14380113
oo ~o o 2 A week ago, staff contacted the Deputy Commissioner and briefed her for over an hour about the cases we will hear about today, We extended an invitation to the FDA to share any docu- ments with the subcommittee that would give their side of the story on any of the cases that we'll be hearing about today. The FDA, to this point, has decided not to engage the subcommittee in a conversation about these allegations and instead has sought to delay these hearings and the fact-finding process. We fully intend to hear from the FDA at a later date, and I want to emphasize that. We will get the information that we have requested. We can do it the easy way, with their cooperation, or we can do it the hard way, but we will get the information. Rather than preview today's testimony, I would like to point out that. these stories are not rare exceptions. One need only to look at the history of the FDA. A former Chief Counsel for the FDA re- cently explained how the FDA never forgets who its enemies are. "If you lose a lawsuit against them, you have an angry FDA which is willing to slit your throat," and I'm quoting. When the FDA loses a case, it has a mind like an elephant. It's just some- thing you've got to understand about the FDA. Once the Agency makes a collective decision, trying to make it let go is almost im- possible. These are 'FDA crusades.' In a real sense, they're vendet- tas. They started a war in 1920 with the diet supplement industry, and it's not over yet." A notable case of retaliation involved RS Medical, a medical de- vice manufacturer that appeared to have raised the ire of the FDA. Aware of the bias against the firm, RS Medical undertook the cost of an experiment that ultimately convinced a Federal District Court of the retaliation practiced by FDA. The firm had a muscle stimulator that required 510(k) approval. They prepared 2 identical applications and submitted them to the FDA simultaneously. One submission was in their name and the other was presented as the work of a consultant. The latter application was approved in less than 3 months. Their application with their name on it took almost 1 year for review and was found not to be approvable. The District Court found the FDA determination to be "unreasonable and arbitrary" and that the $A~4 ency had engaged in "bad faith conduct." RS Medical won nearly 00,000 in attorney fees. As we will see, FDA has investigated allegations of abuse before, but without much effect. The climate of fear and the perception of the FDA unfairness and retaliation remain. Strong words against retaliation are not enough. The Agency has been unable to inves- tigate itself seriously or punish the wrongdoers within its Agency ap_p_r, opriately. History tells us that it is too much to expect this Agency or any a~fency, by itself, to restore its own integrity with any credibility with the public. Accountability for FDA employee conduct must be imposed outside the agencies from the Congress. To the extent that we can, we will try to address some of these issues through legisla- tion~ but I will take action now to instill a level of accountability and provide a recourse for those with legitimate grievances about FDA abuses. Therefore, today I am pleased to announce that, at my sugges- tion, the House Commerce Committee has created an E-Mail ad- dress, called FDAABUSE@HR.HOUSE.GOV. This E-Mail address is now operable. Through this outlet, allegations of FDA abuse c~. be reported to this subcommittee. This will enable us, in a bipar~ - san manner, to establish a comprehensive and responsible means of addressing allegations of FDA abuse. Where it is justified, the subcommittee will investigate and refer matters to the appropriate authorities. Through this effort, we may be able to calculate the extent of the problem of FDA employee misconduct.' But what is beyond calculation is the damage done to millions of patients who were denied access to needed treatments because of the impact of FDA abuses of authority. That is why we must act. The FDA, the Congress, industry and the American pub- lic must work together collegially to put a stop to an adversarial culture. American patients deserve our best efforts. I think this is a very important hearing and I am, as subcommit- tee chairman, absolutely dedicated to investigating the cases that are before us and other cases. We are going to change the culture of the FDA so that it is user-friendly for the American public. With that, I would now recognize the distinguished ranking member of this subcommittee, Mr. Wyden, for an opening state- ment. Mr. WYDEI~. Thank you very much, Mr. Chairman. Mr. Chair- man and colleagues, the Food and Drug Administration has a truly daunting challenge. This Agency must shield consumers from un- safe medical products, while, at the same time, exercising its en- forcement power o.ver regulated industries with prudence and cau- tion. The allegations of Agency retaliation before the subcommittee today are very disturbing to members on both sides of the aisle. The FDA's mission is to protect U.S. consumers from bad medicine and snake oil products, but the FDA's wide-ranging authority should never become a regulatory billy club, cavalierly used by rogue employees driven by a personal grudge. Members on both sides of the aisle share this view. I note that one of our earliest actions this year was a letter signed by both the m~jority and the minority to Dr. Kessler, urging him to investigate all allegations of bullying tactics outside the scope of the Agency's authority and to take actions against FDA staff members involved in retaliatory action. Dr. Kessler, in turn, has responded that he will, in fact, take all appropriate action. Nonetheless, our subcommittee has a continuing oversight re- sponsibility in this area and it is critical that we exercise it. FDA, through its approval process, can literally determine life or death for small entrepreneurial firms in the health care field. Representa- tives of several companies will testify today about FDA actions that they believe constitute heavy-handed punishment. In my view, it is unfortunate that FDA witnesses are not available to respond to the individual complaints which will be made. The subcommittee thus will only get one side of the story. Had the subcommittee waited another couple of weeks when it might have gotten both sides agency representatives could have been present. I am of the view that there is a growing consensus
Page 6: TI14380114
on both sides of the aisle for a comprehensive FDA legislative re- form effort this year. A record built on one-sided accounts does not help our bipartisan cause. Minority staff have reviewed the complaints of the companies in some detail. In each and every case, the conduct of the FDA and the regulated companies is open to question. In several of the cases, the FDA can make a persuasive argument that rigorous en- forcement was necessary. I am equally concerned, however, that some FDA employees will use confrontation when conciliation bet- ter serves the public interest. Does this constitute retaliation in the cases before us today? It Is almost impossible to tell from what we have been given. For ex- ample, in a small number of cases there ap.pears to have been a continuing and stubborn proclivity by companies to sell unapproved products across State lines, even after Federal courts ordered them to stop. Now, the rule of law is basic. When Federal courts tell you to ~top shipping unapproved products, you ought to stop. If you don't et the FDA use its enforcement capability in cases like this, it makes a mockery out of the rule of law. Nobody is going to defend the Agency as a work of bureaucratic perfection, but the applicants in several of these cases discussed today made mistakes that drew FDA enforcers like ants to honey. I believe, Mr, Chairman, we ought to work through these issues on a bipartisan basis, because together [ believe we can make the Agency a better Agency for all of our citizens. I note your 800 num- ber this morning for reports of retaliatory action. It's certainly im- portant to have that service available and maybe together, on a bi- partisan basis, we can agree that there ought to be an 800 number to make sure that unsafe products or products that constitute quackery are reported to us as well. Mr, Chairman, I look forward to working closely with you. Mr. B,~f~TON. I thank the gentleman from Oregon. We would now recognize Mr. Crapo for a 3-minute opening statement. Mr. CIV~PO. Thank you, Mr. Chairman. I appreciate your holding this hearing. The concerns that we've all heard about, the delays in processing of applications at the FDA, have caused many of us to l~elieve that we need major FDA reform. But the concerns that have been raised and the questions raised about retaliation even bring more pressure and more concern to the table to make us need to hold these hearings, and I appreciate your doing that. The gentleman from Oregon has indicated that building a one- sided record is not appropriate. It's my understanding from the Chair that this will not be a one-sided record, that this committee will hear all of the evidence. In fact, our chairman said that we would get the information one way or the other, and I think that it's an appropriate point to make that if there has been retaliation, we need to find it out. If there has not been retaliation, we need to find it out. That's what this committee's investigation is about and I will commit to the gentleman [rom Oregon that I am as interested in making sure that we have the full record and the accurate record 5 as he is and I think that our entire committee is committed to get- ting to the bottom of these facts. One thing that I think that most of us agree to is that we need major FDA reform, and this committee is, I hope, going to develop the groundwork to make it clear that we have the proper record upon which to build the true kinds of reform that will benefit the American public. Thank you. Mr. BARTON..Thank you. Mr. WYD]~N. Would the gentleman just yield very briefly? Mr. CRAPO. Yes. Mr. WYDEN. I want it understood that our concern is the idea of having contemporaneous testimony. For example, I reviewed this morning with Commissioner Kessler and he indicated to me that prior to a July 18 conversation with one of the FDA Commis- sioners, the agency knew of only 1 allegation, the one involving Sensor Pad. I want to work on a bipartisan basis, I have an FDA reform bill and I think Mr. Barton has a lot of constructive ideas. It is very hel ful at every stage of the process that when we have the compa- niesp, we also have the Agency. That's the concern on the part of the minority this morning. Mr. B~TON. Well, if I could respond to that. We have several other opening statements. The distinguished gentleman from Cali- fornia, our distinguished chairman, and Mr. Burr of North Caro- lina. But I want the record to be perfectly clear that this sub- committee and its staff have worked for approximately 2 months leading up to this hearing. We have done everything except sub- poena information and witnesses, and that's a step that we may consider. The chairman and myself were in a conversation with Dr. Kessler yesterday and everything that's going to be discussed today, at least at the staff level, FDA officials have known about. We have attempted to work with them and, for various reasons, they have cooperated ~ery grudgingly. This is not a partisan issue. The public health is at stake, as well as the trust of the American people in the FDA. But Dr. Kessler and his associates will be before the subcommit- tee and we will get the information and we will get it in a biparti- san way and in a very fair way. I want to assure you and the other minority members of that. The Chair would recognize the distinguished gentleman from California for a 3-minute opening statement. Mr. WAxiv~. Thank you, Mr. Chairman. I think it's appropriate that this subcommittee investigate whether the FDA is doing its job, whether it is taking any retaliatory measures against a com- pany that seeks its authorization to market its product. This is what our committee should be doing. But I do believe we should be doing this investigation in a way that gives us all sides to the question and not just one side. We're going to hear from witnesses and we ought to listen carefully to what they have to say. It's important. But in.his respon.se to your letter, Commissioner Kessler expressly stated that retaliatory havior cannot and will not be tolerated at the Food and Drug Ad- ministration.
Page 7: TI14380115
I believe we can take Dr. Kessler at his word and expect the Agency to ensure that this type of behavior or decisionmaking does not ever represent the policy or motives operandi of the FDA. I'm concerned about the cases to be discussed at the hearing this morning, that they may not have been thoroughly investigated. The subcommittee is relying largely on one side of the story and these are re.ports of several companies with claims to have had difficult expermnces with FDA. With respect to 4 of the 5 cases we're going to hear about today, the subcommittee has not even asked for FDA documents or other information that would place the companies' re- ports in context. Without FDA's records related to these allega- tions, how can the subcommittee make a balanced assessment based on both sides of the story? In the one case where documents have been received, they need to be evaluated thoroughly. They need to be analyzed from both the companies' perspectives and the FDA's perspective. I know we're going to have another hearing later to give Dr. Kessler and people at FDA a chance to respond, but no FDA employee has even been interviewed about some of these matters. I think that when we rush into a hearing, we're on shaky ground if we appear to be drawing conclusions based on less than a rigor- ous investigation and one that's fair. There are people who ar.e very much against the FDA. They would like us to end the Agency or cripple it itself and I think that we ought not to lend credence to that sort of thing. What we need to do is not base our policy deci- sions on anecdotes and hyperbole. What we need to do is stay above that type of debate and the best way for us to act is to reach sound conclusions about FDA after listening to all sides of each story, The best way for us to do this is to listen carefully to our wit- nesses today and to listen just as carefully to the FDA when they get a chance to come before us. As I understand it, there were less than 2 or 3 weeks that they had to prepare, that Dr. Kessler said that wasn't enough time and asked for additional time, which I un- derstand he will be given before he comes in. I think it would have been very appropriate to have waited to have aa opportunity so we could hear all sides and get a full per- spective. I am not critical of the fact that we will have to do this in parts, but let's understand today we're hearing only one part, one side. It may be accurate, but there may be another side and a broader context in which to put it. Thank you, Mr. Chairman. Mr. WYDEN. Mr. Chairman. Mr. BARTON. We thank the gentleman from California. Mr. W~re.n~vYDEN. Thank you, Mr. Chairman. Very briefly. I would ask for unanimous consent that Mr. Dingelrs statement be placed into the record after Mr. Waxman's opening statement. Mr. BARTON. Without objection, so ordered. We also have a letter, dated July 25, from Senator Judd Gregg of New Hampshire, that we will also submit for the record and get the appropriate copies. [The prepared statement of Hon. John D. Dingell and letter from Senator Judd Gregg follow:] 7 PREPARED STATEMENT OF HeN. JOHN D. DINGELL, A REPRESENTATIVE IN CONORESS FROM THE STATE OF MICHIGAN Thank you, Mr. Chairman. There is good new~ and bad news about both the sub- stance and procedure for this hearing. First, the procedure: the good news is that this subcommittee is continuing to examine allegations of arbitrary and capricious behavior at FDA, and is continuing to serve as an outlet for such allegations, The bad news is that we have a lot more investigating to do before we can conclude any- thing about the five case studies, that the Committee has not yet requested docu- ments on four of the case studies, and that FDA was only told a week age that four of the five matters wou]d be discussed today. Second, the substance', the good news is that Dr. Kessler recognizes his personal responsibility to address allegations such as these; the bad news is that continued management weakness at FDA creates fer- tile soil for these kind of allegations. It is important that the Subcommittee continue work on allegations of arbitrary and capricious behavior at FDA. The agency is very important, the products it regu- lates are critical to health, and we are a government of laws, not of whims. But it is equally important that this Subcommittee's work be done right. We will join the majority in investing the time and resources to examine all relevant documents and interview all relevant FDA and industry witnesses. It is unfortunate that this hear- ing had to be conducted before that work had been completed. Also, judging from the correspondence, ~ gather there have been procedural glitches and miscommunication between the majority and FDA, perhaps aggravated by tight deadlines that the majority is apparently trying to meet, It is in the interest of all that these matters be worked out so that the Subcommittee's inquiry can proceed fairly and expeditiously. The key substantive issue today is preventing and, where necessary, remedying arbitrary and capricious behavior,,, of which retaiiatmn .... ~s a particularly odious sub- set. As I noted in July 1989, an Agency which is perceived as fair.and .ac,.countable, is far more effective in policing than one which has shown itself to be arbitrary ann capricious." Leaving aside for the moment the merits of the allegations before us today, it appears from this Subcommittee's previous work that there is much room for improvement at FDA. Several reforms are.needed.: stronge.r...mann.gems.hi and management systems; an appeals mechanism that works; a credible in~erna~ inves- tigation capability; better and more effective communication and coordination be. tween FDA headquarters and field office.s; more sunshine; improved professional training; and sufficient resources to put these in place. I thank the witnesses for testifying before us today. When there nre allegations like this, we need to hear them. I also Iool~ forward to Dr. Kessler's appearance be.- fore the Subcommittee at a later date to respond fully and forthrightly to these and any other claims of arbitrary and capricious behavior by FDA. UNITED STATES SENATE, Washington, DC, July 26, 1995, HON. JOE BARTON Chairman, Subcommittee on Oversight and Investigations, Committee on Commerce Washington, DC DEAR JOE: I would like to commend you for your efforts in the House of Rep- resentatives on issues relating to the reform of the Food and Drug Administra.tion (FDA), in particular, the subject of your hearing today: FDA retribution against bio- medical research and manufacturing companies. I know that this is of great concern to you and your colleagues, as it is to those of us in the Senate who are taking a long look at this Agency and itspractices. I think that it is important that this issue be aired publicly. It is obvious fro,re, conversations with Commissioner Kassler at the Labor Committee hearing on April 6, 1995, and subsequent correspondence, that he does not perceive any problems of intimidation or retribution by FDA personnel against companies who openly criticize the agency. Yet the calls and conversations I have with individuals who have direct dealings with the FDA are indisputably clear: there is a real perception that the FDA functions as a policing agency, rather than an agency working to facilitate the health and well-being of American citizens by reviewing biomedical products fairly and efficiently. Personally, I am appalled by the culture of confrontation that appears to exis, t ,at the FDA. I am deeply concerned that this adversarial attitude is doing as much co hurt U.S. innovation and advances in biomedical products as is the burdensome reg-
Page 8: TI14380116
8 tllatory and anticompetitive policies that exist at the FDA. I congratulate your effort to delve into these problems and look forward to reviewing the record of the hearing. Sincerely, JUDD GP, EGG, U.S. Senate. Mr. BARTON. The Chair would recognize the distinguished full committee chairman, Mr. Bliley of Virginia, for an opening state- ment, Chairman BLILEY. Thank you, Mr. Chairman. Mr. Chairman, let me commend you for holding this critically important hearing. I have felt that an investigation into the allegations of unfair, dis- criminatory and retaliatory practices of the FDA is long overdue. This is an Agency that believes it's a law unto itself. Since the in- ception into our inquiry into allegation of FDA abuses, this sub- committee has been stonewalled at nearly every opportunity by the Agency. Document requests have been unduly delayed and incomplete. Interviews with FDA employees in preparation for this hearing, which we requested for the week of July 10, were resisted by the Agency and have not taken place up to now. I well remember the difficulties we had at the beginning of the generic drug investiga- tion back in 1988. This subcommittee voted subpoenas in June of that year. Those directed to the FDA were resisted for over a year, despite the fact that one FDA employee took the Fifth rather than answer the subcommittee's questions about payoffs. To Secretary Bowen's and Commissioner Frank Young's credit, they ultimately removed the principal obstructions from any in- volvement with the investigation. The same offices, Legislative Af- fairs and Chief Counsel, occupied by different individuals, are ap- parently deeply involved in hampering investigations of this Con- gress. Unfortunately, we cannot help but assume that they apparently have the support of Commissioner Kessler. The Commissioner has told us and the world that he will not tolerate any act or threat of retaliation by any FDA employee. He has also emphasized the need for FDA employees to make every effort to avoid even the ap- pearance of unfairness or retaliatory action. We will see what ac- tion he takes in light of the testimony we well hear today. However, I doubt that Dr. Kessler will take the necessary action to transform the core values of this Agency. The reasons for my skepticism are twofold. First, Dr. Kessler has not reformed the bu- reaucracy. In 1990, Dr. Kessler was appointed by President Bush to clean up the Agency in the wake of the generic drug scandal. Let us be clear. The FDA did not uncover nor was it responsible for cleaning up the generic drug industry. Those tasks fell to this sub- committee, under former Chairman Dingell, with the active sup- ~ort of the Republican members, including me and an unusually il~ent and effective office of the U.S. Attorney in Baltimore. t~pon taking office, Dr. Kessler immediately chose the easier road of attacking the regulated industries and, in doing so, gave his bu. reaucrats carte blanche to settle old scores with firms that had mistakenly assumed that the congressional scrutiny and negative publicity about the FDA made it possible to deny the Agency def- erence it expected from its regulated companies. At no time has Dr. Kessler assumed the more difficult and less publicized task of reforming the bureaucracy. His enforcement-ori- ented leadership has turned a blind eye to the abuse of power by his employees and to needs of American patients. Dr. Kessler him- self has led the Agency away from the core mission into areas that are either peripheral to the public health or for which other agen- cies hold a statutory mandate. Fresh orange juice from concentrate is not a public health dan- ger. The delay in approving life-saving drugs and medical devices is a serious public health problem. The second reason I question the Commissioner's resolve to deal with retaliation is because the threat of retaliation is deeply em- bedded in the culture of this Agency. That threat, spoken or unspoken, is used by his bureaucrats to avoid the more difficult task of promulgating clear rules based on sound science and afford- ing firms and individuals subject to those rules the due process of law that every American has a right to under our Constitution. They also use the threat of rewarding friends and punishing en- emies to avoid consistent, sensible and timely reviews of applica- tions for new drugs, devices and food additives. Regardless of the difficulty this sort of reform entails, it was and is Dr. Kessler's job to change the adversarial culture of the FDA. He has failed and simple declaration that such behavior will not be tolerated will be ignored. No further proof is really needed than the FDA response to our requests for the documents and interviews in preparation for this hearing. The message from the Commis- sioner to his bureaucrats is clear: do as I do, not as I say. Well, this committee, this subcommittee has had a long history of getting answers to its questions and though the leadership has changed, the mission will not. We will get answers to our questions and I hope Dr. Kessler will come forward with the answers without any necessary subpoena. But if it has to be subpoenas, then subpoenas it will be. Thank you, Mr. Chairman. Mr. BARTON. We thank the gentleman. Mr, WM~MAN. Mr. Chairman, may I ask a question of the Chair? Just so we have a clear record. Has Dr. Kessler refused to testify before us and are they refusing to give you documents or are they telling you you'll get documents and they haven't responded as quickly as you'd like? Mr. BARTON. In a telephone conversation that I had yesterday morning with Dr. Kessler, he indicated that he would not come today because he did not feel he had adequate time to prepare. So to say he absolutely refused is not correct. He did refuse to come today. Mr. WAXMAN. Today. Mr. BARTON. And with respect to documents, we have received the documents that we've requested for the Sensor Pad. We have not yet been allowed to interview specific FDA employees that we have requested. Some of the witnesses that are here today are going to make some statements that the FDA is well aware of. We have not yet asked for specific documentation on some of those.
Page 9: TI14380117
10 There is one case that we're going to hear about today that has been to three Grand Juries in Texas and the FDA is well aware of that case. Mr. WAXMAN. Mr. Chairman, let me express to you my desire that this subcommittee get all the information we need to conduct this investigation. Mr. BARTON. I can assure you that will be done. Mr. W~. But let me also point out and have in the record a letter to you from Dr. Kessler, saying "I want to appear person- ally before the subcommittee to address these concerns, accom- panied by the appropriate senior Agency officials." I think we ought to give Dr. Kessler a chance to come and we ought to schedule an- other hearing. Mr. BARTON. With all due respect, we have given him that chance. We're going to give him other chances, there's no question about that. Part of the problem that we're having is the traditional tug-of-war between the executive branch and the legislative branch. I think part of the problem is that there are people within the FDA who really do not wish to have some of the internal prob- lems aired. Part of the problem, quite frankly, is that the FDA is trying to wrestle with how to approach this particular committee. Mr. WVDEN. Would the gentleman just yield very briefly? Having lbeen on a few of those tug-of-wars and 15 years on this committee, et me say that I can tell when somebody is not willing to cooper- ate. My view is that Dr. Kessler is very anxious to work with you, Mr. Chairman, in trying to resolve this matter. As he said to me this morning, the situation was that prior to the July 18 conversation, he felt that he was in the dark on 4 of the 5 of the cases that were to be looked at and that's why he asked for a little time. You Imow that I, in particular, am anxious to work with you on FDA reform and make this a bipartisan effort. I think we help our cause every step of the way by having both sides represented. I thank you for yielding. Mr. BARTON. We are going to work this in a bipartisan manner, I can assure you. The chairman has indicated his full support to get to the facts and we are going to get to them. And with all due respect for all the rights of the administration and the minority that are participating, this is not a witch hunt. It is a fact-finding subcommittee and we're going to continue the tradition of Con- ~aceSSman Dingell, who did so well in getting to the bottom of the tso The Chair would now recognize the gentleman from North Caro- lina, Mr. Burr, for a 3-minute opening statement. Mr. BuRr~. Thank you, Mr. Chairman. Let me commend you for holding what may well be the most important hearing this sub- committee will convene this Congress. For those who believe that FDA reform is an overblown concern trumped up by special inter- ests, today's testimony should shake them to the core, as it has me, a member. All of our witnesses have compelling stories of retaliation and other abuses by an agency of their government. The written testi- mony of one witness, Richard Jaffe, an attorney from Houston, 11 Texas, not only horrified me, it terrified me. The abuse of power detailed in his testimony transcends regulatory misconduct. It con- stitutes nothing less than one of the worst abuses of the criminal justice system I've ever witnessed. The target is Mr. Jaffe's client, Dr. Stanislaw Burzynski, a Hous- ton, Texas physician with a doctorate in biochemistry, who mN grated to the United States from Poland in 1970 to work in an en- vironment free of communist interference. In the words of Mr. Jaffe, "Little did he know that America would treat him harsher and more vindictively than the communist bureaucracy." I realize that Mr. Jaffe has only 5 minutes to give his statement, as I do. It will take far longer for a complete detailing of abuses by the FDA and the Department of Justice in this case. I strongly advise the members of the media and interested public to read his statement and supporting exhibits carefully. In his testimony, Mr. Jaffe calls for a complete congressional in- vestigation of this case, and I would hope that we will assume that task. He also asks that the FDA be required to supply answers to certain questions, and I would hope that they would be asked and truthfully answered and supplied. I have several questions that I would have liked to have asked Dr. Kessler myself. Unfortunately, I won't have that opportunity today. It appears that confidential doctor/patient records have beeh subpoenaed by 3 separate Grand Juries, none of whom have in- dicted Dr. Burzynski. Grand Juries are known to be putty in the hands of Federal prosecutors. For one Grand Jury to "no bill" a tar- get is highly unusual. For three Grand Juries to refuse to indict means that the prosecutors, the FDA, its lawyers and the co-con. spirators in the Department of Justice have such a weak case that it's not prosecution, it's persecution. I would hope that we will forward this record and any other in- formation developed in an appropriate way to deal with the miscredence in the Department of Justice. As for the FDA and HHS employees involved, they should be exposed and similarly fired. There is no place in the American criminal justice system for this kind of abuse. Dr. Kessler, who chose not to show up today despite his state- ments to this committee and others that retaliation would not be tolerated, should answer to this committee to explain whether or not he was aware of this retaliation. If so, he should be fired along with all FDA employees who supported these trumped-up criminal charges. The use of Grand Jury proceedings as harassment is not the worst of the malfeasance by the FDA. It appears that the doctor/ patient information obtained by Grand Jury subpoena was used to buy 1 or more FDA employees to contact patients and warn them away from Dr. Burzynski's treatment. If so, it's a basic violation of Rule 6(e), involving the use of confidential doctor/patient informa- tion. These individuals should not only be fired, but prosecuted. I hope we have time to outline the many other abuses by FDA and HHS personnel in this case, all of which stem from the Agem cy's displeasure at having a Federal District Judge restrain Dr. Burzynski's lawful practice of medicine. There is no place in our
Page 10: TI14380118
12 government for this heavy-handed abuse of power. The FDA has transformed itself from regulator to persecutor in this case. The nest of abuse must be cleaned out; not just for the sake of Dr. Burzynski's patients, but for the freedom of all Americans. Mr. Chairman, I would also like to add that I think the case was JfaUSt made by my dear colleague from Oregon, Mr. Wyden, that the ct that Mr. Kessler is so unaware of what I think are obvious abuses, obvious retaliation from the FDA, that he couldn't respond with certainty the notice that we gave him, is, in fact, an Agency that's out of control and not under well management. Thank you and I yield back. Mr. BARTON. I thank the gentleman from North Carolina. All other members of the subcommittee will have 3 legislative days to submit a statement for the record. At this time, we would welcome our first panel to testify. We have Mr. Earl Wright, Ms. Mary Gorman, Mr. Richard Jaffe, and we have Ms. Mary Michaels and her son, Paul. If you all would please come forward. The Chair would like to welcome each of you to testify before the Oversight and Investigations Subcommittee of the Commerce Com- mittee. I think each of you are aware that it's the tradition of the subcommittee to take testimony under oath. Do any of you all have a problem with testifying under oath? [Chorus of nays.] Mr. BARTON. I think you're also aware that you have the right, under the Constitution of the United States and the rules of the House of Representatives, to be advised by counsel during your tes- timony. Do any of you wish to take advantage of that constitutional right? [Chorus of nays.] * Mr. BARTO~. Will you please stand, then, and raise your right hand. [Witnesses sworn.] Mr. BARTON. Be seated. We are going to hear from 4 of you in our first panel. I'm going to give an introduction of each of you and then we'll let you testify. First, we're going to hear from Mr. Earl Wright. Mr. Wright is Vice President of Inventive Products and the co-inventor of the Sensor Pad. For the past 30 years, he has invented, developed and sold new products. He has over 150 patents worldwide, including such prod- ucts as blood serum filters, surgical scrub pumps, and the face pow- der known as Corn Silk. Intellectual Property Owners Foundation selected Mr. Wright as their outstanding inventor of 1989 for the Sensor Pad. Mr. Wright will tell you of his attempt to market the Sensor Pad for the last years and to gain approval for that product from the FDA. We have Ms. Mary Gorman. Ms. Gorman is a resident of Chevy Chase, Maryland. She is a breast cancer survivor. She was fortu- nate to have worked for a health care association and, therefore, had access to the Sensor Pad that Mr. Wright invented. When she used the Sensor Pad, she discovered a tiny lump that had been missed by a mammogram. She will testify to her belief why the Sensor Pad saved her life. 13 We have Mr. Richard Jaffe. He's an attorney in Houston, Texas, His firm represents health care practitioners. He is here testifying on behalf of one of his clients, Dr. Stanislaw Burzynski of the Burzynski Institute. Dr. Burzynski has researched and developed a new theory of cancer and its treatment. His story includes a 13- year history with the Enforcement Division of the FDA, numerous Grand Jury investigations and his patients' records, including cur- rent patient records being seized. Dr. Burzynski was advised not to testify today because he is still under yet another Grand Jury investigation. We have Ms. Mary Michaels and her son, Paul. Ms. Michaels is accompanied by her son, who, at age 4, was diagnosed with a brain tumor. In 1987, he began cancer treatment at the Burzynski Insti- tute. He is now in remission and, in fact, his tumor has shrunk. He continues his therapy at the institute. Ms. Michaels will testify to her son's progress under Dr. Burzynski's care and her fear that she possesses that one day the FDA will prevent her son from being treated. Mr. Wright, we accept your written statement for the record. We are going to ask you to summarize that in 5 minutes. We have a light that will go on and as long as it's green, you may speak, and when it turns red, we would ask you to conclude your testimony. We welcome your testimony. TESTIMONY OF H. EARL WRIGHT, VICE PRESIDENT, INVEN- TIVE PRODUCTS, INC.; MARY GORMAN; RICHARD A~ JAFFE, ATTORNEY; AND MARY MICHAELS, ACCOMPANIED BY PAUL MICHAELS Mr. WRIGHT. Thank you for asking us to testify today, although I must admit that I do so with some fear and trembling. I have put a Sensor Pad before each of you so you could see for yourself what I'm talking about. I won't take the time to read FDA's definition of a medical device, but I think it's easy to see that the Sensor Pad is not invasive, it's not taken internally, does not change any bodily function, nor is it life-sustaining or life-supporting, nor would its malfunction pose a potential unreasonable risk of illness or injury, Mr. BARTON. Mr. Wright, would you please unfold that and hold it up so that the people can see what it is? Mr. Wl~IGHT. Yes. Mr. BARTON. It's basically two pieces of plastic. Mr. WRIGHT. With a lubricant between. What it does is the same as soap and water does when the woman takes a shower, excep~ it's more efficient. The Sensor Pad was never intended to diagnose or treat any disease. It was simply meant to be an aid to breast self-examination (BSE), much like soap and water, which has been recommended for years by medical groups, and even the U.S. Gov- ernment's own literature. And we hope it would encourage women to do the BSE. Its purpose has not changed since its development. Everything we've done as a company has been straightforward and in good faith, hoping that at some point common sense would prevail. We feel our story is a classic example of a government agency making a bureaucratic mountain out of an obvious mole hill.
Page 11: TI14380119
14 It's extremely difficult to summarize a 10-year struggle in 5 min- utes, but I will try. The subcommittee has been provided with the details and the documents to back up my testimony. In 1985, at the recommendation of FDA's Small Business Assistance Division, we filed a 510(k) so a determination could be made as to whether the Sensor Pad would be considered a medical device. We thought we would have approval immediately and we could be to market in a maximum of 90 days. By law, FDA is required to inform you in 90 days whether your product can be 510(k). But for 1~/2 years after filing, we were con- tinually delayed by requests for additional information. Each time started another 90-day period. After waiting that long, as you might guess, we were becoming just a little impatient for some de- cision. We asked our attorney to write an inquiry about the status of our 510(k). Keep in mindwe have supplied all the information that had been requested, including a study which the ODE had ap- proved. They had approved our protocol, the protocol justification, and even the models that we were to use in the study and sug- gested changes in these models, still implying that if we submitted the information they wanted or if we did this study, we would be 510(k). While that study was still underway, however, we received a let- ter that we were not substantially equivalent and would be re- quired to submit a PMA. Was this retaliation for having an attor- ney ask our status? It was certainly a complete 180-degree change by the Agency. Under a PMA, they then began to ask for studies which experts told us could not be done. It was our understanding that we should only be required to run studies to prove claims we make for our product. But at this point, we were asked to prove that we could diagnose breast cancer, a claim we never did want to make and still don't want to make and we will not make. Our only claim is that the Sensor Pad is an aid in BSE and is equivalent to soap and water, which is used for the same purpose. In 1988, after 2 years of stalling, indecision and escalating de- mands by the FDA, we challenged the decision that the Sensor Pad was a medical device and went to the market on the advice of legal counsel. We were extremely well received by the medical commu- nity and the women who used the product. No one expected the Sensor Pad to diagnose any condition, but it was welcomed as an aid in performing BSE. In the 1 year we were on the market, we distributed over 250,000 pads to hospitals and imaging centers. The medical community and the American woman seemed to understand the purpose of the pad, even though the FDA couldn't. On April 18, 1989, the FDA seized over 30,000 pads and related materials in a raid on our company and filed suit in Federal court, declaring it a medical device. While in litigation, on advice of legal counsel, we remained on the market until a final decision was made upholding the FDA's determination. We appealed the lower court's decision, but once the appeals court ruled in favor of FDA, we withdrew from the market volun- tarily. While we were in litigation, however, we learned several 15 months after the fact that ODE had held a meeting at their offices with the minority stockholder in our company without our knowl- edge or approval. We felt this was a violation of ethical conduct on their part and we filed a complaint. How would it be if DuPont's minority stockholder went to FDA, got a meeting and found out the status of one of their drug applica- tions? That was the inference. Howe'~er, we still wanted to work with the FDA to get our prod~ uct to market. So we continued to request a meeting to discuss how this could be achieved. After many months, we were able to ar. range a meeting, which we felt would be the time to sit down and reasonably discuss what needed to be done to go to market. Mr. BARTON. Mr. Wright, could you please--I know you've waited a long time. I hate to cut you off, but we have several other wit- nesses. Could you summarize in about a minute? Mr. WRIGHT. I'll try. Mr. BARTON. Please, sir. Mr. WRIGHT. So we went to this meeting and we were met by the FDA's attorney, a representative of the Justice Department, who immediately took control of the meeting. They threatened us, no matter how or for what you market this product, we will come after you, a direct threat, and other threats and insult and injuries from that day. We filed another complaint that day against the attorney making those threats. The result of that was 6 months later, we received a 305 notice hearing. The 305 is a very serious situation. It's been held over our head for 2V2 years, this 305 hearing. My son, who was going to come with me today, but didn't because he's scared to death. Yet, isn't it amazing? On the 19th, last Tuesday, I re- ceived a letter that the 305 procedure hearing had been dropped, after 2V2 years. Amazing, the timing. And what's even more amazing is that we had a very fine meet- ing at the FDA. We want to still work to get the job done. And I want to say this, too. Dr. Burlington, Dr. Albert, and even Dr. Kessler were not in their current positions when our problems began. I think they are aware of the problems that exist with some of their subordinates and are working to correct these problems, but they've got to get it done. We still want to work with them to get that job done. If we can come up with enough money--I came here today to announce that we were closing the Sensor Pad business, period, because we're out of money and we're out of time. Two-and-a-half million dollars has went through our accounts, with nothing coming in, and 9 years of our patent life have eroded, very valuable property gone. We've also been intimidated. We've lost our will to go. So here we are sitting. The FDA wants one more study, and I can agree that we could do that study now. They finally got it to where we can do it. But how are we supposed to finance it? How are we sup. posed to keep going for another 6 months, another 12 months to get this done? So when I say I came and I planned today originally to say I'm going to close the business, I'm going to tell you I'm going to go home and try to see if we can get together enough funds and
Page 12: TI14380120
16 enough money to keep the business open if the FDA will do what they told me they would do last week. Thank you. I'll be happy to answer any questions. [The prepared statement of H. Earl Wright follows:] PREPARBD STATEMENT OF H. ]~ARL WRIOHTj VICB PRESIDENT, IhWENTIVE PRODUCTS, INC. Mr. Chairman and honorable members, thank you for inviting us to testify today. Although I must admit I do so with some fear and trembling. I have put a Sensor Pad before each of you so you could see for yourself what I am talking about. I won't take time to read FDA's definition of a medical device. But, I think it's easy to see that the Sensor Pad is not invasive; is not taken internally; does not change any bodily function. Nor is it life-supporting or life-sustaining. Nor would its malfunction pose a potential unreasonable risk of illness or injury. The Sensor Pad was never intended to diagnose or treat any disease. It was sim- FolY meant to be an aid to breast self-examination; to make it easier and more com- rtable~much like soap and water which has been recommended foryears by, .med- ical groups and even the government's own literature. And we hoped it womu en- courage women to do BSE. Its purpose has not changed since its development. Everything we have done as a company has been straightforward and in good faith, hoping that at some point common sense would prevail. We feel our story is a classic example of a government agency making a bureaucratic mountain out of an obvious molehill. It's extremely difficult to summarize a 10-year struggle in five minutes, but I'll try. The subcommittee has been provided with details and the docu- ments to back up my testimony. In 1985, at the recommendation of FDA's Small Business Assistance Division, we filed a 510K so a determination could be made as to whether the Sensor Pad would be considered a medical device. We thought we would have approval for market within a maximum of 90 days. By law, FDA is required to inform you in 90 days whether your product can be 510K'd. But, for a year and a half after filing, we were continually delayed by re- quests for additional information (which each time started another 90-day period). A/tot waiting that long, as you might guess, we were becoming just a little, imp.a- tlent for some decision, so we asked our attorney to write and inquire about t~e tus of our 510K. Keep in mind that we had supplied all the information that had been requested, including a study for which ODE had approved our protocol and protocol justifica- tlon~ and even the models to be used--still implying that if we submitted the infor- mation they wanted or "if we did this study," we would be 510I~d. While that study was still underway, however, we received a letter that we were not substantially equivalent and would be required to submit a PMA. Was this re- taliation for having an attorney ask for our status? It was certainly a complete 180- degree turn by the Agency. Under a PMA, they then began to ask for studies which experts told us could not be done. It is our understanding that we should only be required to run studies to prove claims we make for our product. But at this point, we were asked to prove that we could diagnose breast cancer--a claim we never did want to make and still don't want to make. Our only claim is that the Sensor Pad is an aid to BSE and is equivalent to soap and water which is used for the same purpose. In 1988, after two years of stalling, indecision, and escalating demands by the FDA, we challenged the decision that the Sensor Pad was a medical device and went to market. We were extremely well received by the medical community and the women who used the product. No one expected the Sensor Pad to diagnose any con- dition~ but it was welcomed as an aid in performing BSE. In the oneyear we were on the market, we distributed over 250,000 Pads through hospitals and imaging centers. The medical community--and American women-- seemed to understand the purpose of the Pad even if the FDA could not. On April 18, 1989, the FDA seized over 30,000 Pads and related materials at our facilities and filed suit in Federal Court declaring it a medical device. While in gation, on advice of legal counsel we remained on the market until .a final decision was made upholding FDA's determination. We appealed the lower courfs decision, but once the Appeals Court ruled in favor of FDA--and we had had an opportunity to meet with our attorney and review the findings of the court--we made a decision not to appeal further and voluntarily ceased distribution. While we were in litigation, however, we learned--several months after the fact-- that the ODE had held a meeting at their offices with a minority stock holder in 17 our company.., without our knowledge or approval. We felt this was a violation of e _tl~.'cal conduct on their part, and we filed a complaint. l"iowever, we still wanted to work with the FDA to get our product to market, so we continued to request a meeting to discuss how this could be achieved. After many months, we were able to arrange a meeting which we felt would be a time to sit down and reasonably discuss what needed to be done to go to market. We took with us our FDA consultant, our attorney, and a physician who was an expert in radiology and a strong proponent of the Pad since she had actually seen th Pad s ability. However, instead of the productive meeting we had anticipated, we were met by representatives of ~he Justice Department and FDA's attorney who took charge of the meeting with the opening statement, "No matter how or fo~: what you market .... this product, the FDA will come after you." During that. meeting, we were intimidated and threatened. Was this because we filed a complmnt about the minority stockholder meeting? Because of the tone of th/s meeting, we filed another complaint against the FDA attorney who, we felt, had so blatantly threatened us. Then, not six months later~ we received notice of a 305 Hearing. (This was the only answer we ever did receive to that complaint.) That was two-and-a-half years ago. However, it was held over our heads until we received notification just last week in a letter dated July 19~ 1995, that this action had been dropped. Many companies would give up rather than fight this kind of battle for so long There are many times we've wanted to do just that. But, we have kept going fo~ two reasons. First, because we know we have a product that can be of use to every American woman; and secondly, because we continue to feel that it is our right as American citrons to question any part of our government which we feel is not work~ ing in the best interest of the American public. But, frankly, we are tired. And, yes, we are afraid. In fact, my son Grnnt, who is president of our company, did not appear today for fear of further retaliation by the FDA. He is a young man with three young children and he is totally disillu- sioned with our government. I think that is a sad commentary. We feel we have fought a good fight for the past 10 years, But, it has cost us dear. ly. FDA's delaying and retaliatory actions have cost us over $2,5 million, nine years of our patent life, hundreds of potential jobs, and millions of potential sales, But, even worse, it has cost us peace of mind and our faith in what we have always felt was the greatest governmental system anywhere in the world. Today I was to announce the closing of the Sensor Pad business since we seemed no closer to approval of this very simpleproduct than we were when we begnn in 1985. However, in a meeting with the Office of Device Evaluation last weel~ (July 19th), I think we made some real progress toward a solution to our problems, ODE has asked for a small study to address the issue of masking, In other words, does the_ Pa.d mask anything a woman might feel while doing BSE with her bare hand? Studies have been done on models...this new study would be done on human breasts. However, after I0 years, we are financially depleted and will have a difficult tlm~ coming up with the funds to do even a small study. (So, if any of you have access to researe~h funds, I'd be happy to chat with you later.) Do let me say that Dr. Burlington, Dr. Alpert, and even Dr. Kessler, were not in their current positions when our problems began. I think they are aware of the problems that exist with some of their subordinates and are working to correct those problems. We still want to work with them to get the job done. And (if we can come up with enough money to proceed) we think we will be able to provide the small study that addresses what they toll us is their only remaining concern with the Sensor Pad, Hopefully, when th.at study is completed, we will be able to gain approval and pro- ceed to market quickly. Iql be happy to answer any questions you might have. Mr. BARTON. We appreciate you, Mr. Wright, for testifying, I can't speak for anybody but myself, but on behalf of the U.S. Gov- ernment, I want to apologize to you. I think it's inexcusable what your company has had to go through. I have studied the record and I think, off the record, a number of people at the FDA would share in my apology. I don't know how many would on the record, But that's one of the purposes for oversight, is for the people who are represented and elected by the people to keep in check the unelected representatives of our government. So, again, I can only
Page 13: TI14380121
18 speak for myself, but I apologize to you and I hope that this hear- ing will result in a better reception for you and others like you at the FDA. We would now like to hear from Ms. German. Mr, WRIGHT. I would like to have this put in the record. It's a letter from Senator Baker from California. Mr. B,'~RTON. It will be submitted, sir, without objection. [The letter referred to follows:] CONGRESS OF TH~ UNITED STATES, HOUSE OF REPRESENTATIVES, Washington, DC, July 24, 1995 Susan Alpert, M.D. Director of Office of Device Evaluation, F~od and Drug Administration, 9200 Corperate Blvd., HFZ-400, Room ll0G Rockvllle, MD DEAR DR. ALPERT: I write to express my deep concern and dismay over the FDA's delay in approving the Sensor Pad, which is produced by Inventive Products, Inc. This delay of almost ten years seems characteristic of the behavior of the FDA when presentedwith new medical inventions and devices. The Sensor Pad is one of the most promising devices in the battle against breast cancer. As a non-invasive, easy-to-use device, it has the potential to save hundreds of thousands of women's lives. The inventors of the Sensor Pad do not claim that this tool will cure breast cancer, but rather enable women to perform breast self exams more effectively. It requires no high-tech gadgetry, no invasion of the body, and no machinery. It is simple to use and has already saved hundreds of lives. The FDA has a responsibility to the American people to approve products that will facilitate medical improvements and save lives. Our citizens wonder why they are being deprived of new products and life saving medicines. And we all wonder why inventors are leaving the country. Certainly, with nearly 45,000 women dying from breast cancer each year, any product that has the potential of aiding women in conducting self breast exams should be given top priority by the FDA. I am hopeful a clear understanding between Inventive Products and the FDA can be reached and that this device will no longer be stalled by bureaucratic red-tap.e. It is my hope that for the sake of the 180,000 women who will be diagnosed w~th breast cancer this year, the FDA will move forward and aid them in the detection process. Thank you for your attention and action in regard to this matter. I would appre- ciate being apprmsed of your action when a decision is reached. Sincerely, BILL BA.~R, Member of Congress. Mr. BARTON. Ms. German, you may proceed for 5 minutes. TESTIMONY OF MARY GERMAN Ms. GeRMAn. Thank you for this opportunity to speak to this committee on behalf of the Sensor Pad. I received the Sensor Pad while I was working for a health care association here in Washing- ton and after using it for about a year, I found a little lump that was about the size of a pea. When I went to my doctor, she couldn't find it and I had had a mammogram only 4 months before and it was not on the mammogram. So I pulled out the Sensor Pad and she found the lump and she said we'll watch it. Well, we did watch it. It was very little. It was only a centimeter in diameter and we watched it for about a month and then Dr. Katherine Alley, a breast surgeon here in Washington, removed the lump and she said that it was one of the smallest tumors, malignant tumors that she had ever removed. 19 I found this using the Sensor Pad and Dr. Alley and I both be- lieve that this pad may have saved my life. It's been 5 years now since my cancer treatment and I'm feeling great. I feel fine and healthy. I attribute this to the early detection and surgery. The statistics on breast cancer are alarming. One in 8 women will be a victim. There is no sure way to prevent it and there is no cure. Early detection is the name of the game. It's the only hope we can offer the women of the United States. My aunt died of breast cancer. My sister is being treated for it now. I have two daughters and 13 nieces, all of whom are in the high risk category. My feeling is that they should be able to go to the pharmacy or the grocery store and buy this simple device. It's less dangerous to use than hair coloring products or teeth whiten- ing products that are sold over-the-counter. Every woman should be encouraged to perform regular self-ex- aminations and to have mammograms regularly. The Sensor Pad is not a substitute nor was it ever intended to be a substitute for doctor visits and mammograms. It will not prevent breast cancer and it can't cure it. But it can be used as a tool to increase the awareness of the importance of regular breast self-examinations, Just having it by my bedside table makes me more aware to use it and facilitates the exam. I think you all have one in front of you. If you'd just take it and maybe find a speck on the desk and see how it enhances the size of that little speck of dust or bit of crumb that you might feel under it. As a Nation, we are spending lots of money on cancer treatment, The costs of chemotherapy, radiation and bone marrow transplants increase every year. This simple plastic device doesn't cost very much. It's only $10 to $15 and it doesn't wear out, so it doesn't have to be replaced. I'm still using the one I used 6 years ago, Doesn't it make sense to make this simple device available to American women? Some women might find lumps that are not can- cerous and that's the good news. This validates the effectiveness of the device, because it enhances the sensitivity to lumps. Women are justifiably scared of cancer. They want to know if the lumps that they feel are cancerous. Just as every false alarm brings a feeling of relief, every malig- nant lump detected early enough to be removed before it spreads can easily mean a life saved. I really feel that it's time we give American women credit for having the common sense and give them a large share in preserving their own health. Thank you. Mr. BARTON. We thank you and we thank you for personally coming to give your testimony. The Sensor Pad that you received several years ago you still have. Ms. GOP~. Yes. Mr. BARTOhr. Okay. We'd now like to hear from Mr. Richard Jaffe, who is an attorney from Houston, Texas. Again, your state- ment is submitted for the record. We'd ask for you to summarize it in 5 minutes.
Page 14: TI14380122
20 TESTIMONY OF RICHARD A. JAFFE Mr. JAFFS. I come here to talk to you about Dr. Burzynski. In short, Dr. Burzynski is a medical doctor who has a Ph.D. in bio- chemistry and has been treating advanced cancer patients for the last 17 years. He's been working on this treatment for 25 years. I should point out up front that his drug is not approved for interstate marketing by the FDA. However, in 1991, the National Cancer Institute sent a panel of experts to Houston to review a best case series and they determined that in each case of advanced brain cancer, Dr. Burzynski's treatment caused anti-cancer effect. I should also point out there has never been an allegation, con- cern or a whisper that his treatment is, harmful or toxic, unlike many conventional drugs. Dr. Burzynski s dealings with the FDA commenced in 1983. At that point, the FDA commenced a civil ac- tion to try to close the clinic and stop all patients from receiving the medicine. The FDA received basically a partial victory or a complete failure, depending on your perspective. The judge in the case basically said that he can treat anybody he wants in Texas, but he can't ship his medicine in interstate commerce. The FDA viewed that as a failure and told Dr. Burzynski at the time, his attorneys at the time that they have other ways to get him. Let's talk about the other ways. In 1985, the FDA convened a Grand Jury to hear evidence to try to indict Dr. Burzynski. In con- nection with that, they had a raid of his clinic, where they seized 200,000 pieces of paper, including all of his medical records of all patients. It's a little difficult to practice medicine when you don't have medical records. They presented the evidence to the Grand Jury. No indictment. In 1986, they come back, seized another 100,000 documents, no indictment. In 1990, another Grand Jury, either the second or the third. They presented more documents. Dr. Burzynski testified ex- tensively before the Grand Jury. No indictment. 1991 to 1993, FDA investigates Dr. Burzynski. We don't know if evidence was pre- sented to another Grand Jury. In 1994, another Grand Jury, no in- dictment. In 1995, another Grand Jury. This Grand Jury started in March of this year. On March 25, I believe, it was Dr. Burzynski, along with a few of his patients, appeared on the CBS Morning Show. Later that day, the FDA came, another raid, more patient docu- ments, more subpoenas. May, June and July, more witnesses testi- fied before the Grand Jury, more documents. So we've had now 4, 5 or 6 Grand Juries. Let me talk about the subpoena practices. In 1994, a local politi- ,cia~n tes.tifie_s on.Dr. Burzynski's behalf and strongly supports him Demre tl~e Grand Jury, to the dismay of the FDA. A week later the U.S. Attorney's Office subpoenaed his campaign contribution records and intimate to the press that they're doing an independent investigation, alleging some kind of criminal conduct. It turns out there was no such independent investigation and, at that point, the U.S. Attorney on the case was reassigned. In 1995, a well known person in the alternative medical field, a member of the Office of Alternative Health Advisory Committee, writes a let- ter, publishes a letter condemning FDA practices. Two weeks later, 21 he gets a subpoena requesting all documents. In the record, I have set forth all the subpoenas and why I think that that subpoena was a violation of the DOJ guidelines. Most recently, the FDA has now subpoenaed the medical records of every patient who has gone on TV and told their story about Dr, Burzynski. We'll let the committee judge what they think of that. Let me talk about dissemination of false information by the FDA, In 1985, FDA tells anyone who calls inquiring about Dr. Burzynski that he's being criminally investigated. When the judge on the case found out about that, he issued a cease-and-desist and a strong reprimand against that. The FDA now has refined this tactic. In- stead of waiting for people to call up the FDA, what they've done is subpoena all the records from Dr. Burzynski about his business associates and all the researchers around the world, and there are many of them who are researching antineoplastons as therapy. Now what they're doing is systematically contacting everyone who does business with them or who may do business with them and telling about the Grand Jury investigation and subpoenaing documents. I believe that the~re doing this in order to make it more difficult for him to do business. I'd like the following questions to be asked to the FDA. How much money have they spent in the last 10 years to try to put Dr, Burzynski out of business? How many documents can they sub- poena and how many more Grand Juries does he have to go to? And why can't patients who have advanced cancer seek medical treatment of their choice? I have three brief suggestions, which I have outlined in detail in my memo. First, Access to Medical Treatment Act. I think it's a good idea. We have a couple cosponsors here on the legislation, This would directly cover the position of Dr. Burzynski and other innovative practitioners. I think it's an excellent idea and I think you ought to pass it. Two, there needs to be reform of the efficacy requirements of the new drug laws. Specifically, there has to have a risk of--analysis of--a ratio of risk-benefit analysis. There's no reason in the world why things like the Sensor Pad should undergo the same scrutiny in terms of efficacy as toxic drugs where the difference between ef- fectiveness and death are minute dosages. That needs to be changed. Third, there needs to be an oversight committee where the FDA can basically have their actions in the most egregious cases re- viewed publicly and then perhaps corrected. Finally, with Dr, Burzynski's case, we'd request, as alluded to by the gentleman from North Carolina, that the FDA be required to explain why they keep doing this after 10 or 12 years. And I've come here today to talk, but I've also heard some inter- esting comments. I now understand why this is going on. The FDA lost in 1983 and the last 12 years has been an attempt to correct the fact that the judge refused to close them down. We thank the committee for your time and we thank you for your interest in this case. [The prepared statement of Richard A. Jaffe follows. Exhibits A through J are retained in the committee files.]
Page 15: TI14380123
22 PREPARED STATEMENT OF RICHARD A. JAFFE, ESQ. INTRODUCTION My name is Richard Jaffa. ~ am an attorney practicing in Houston, Texas. I rep- resent health practitioners and small companies who work on the cutting edge of medicine, some of whom have been attacked, persecuted and prosecuted by the gov- ernment. I come here today to tell you the story of a doctor's thirteen year struggle with the enforcement divislon of the FDA. The story involves Dr. Stanislaw R. Burzynski, or Dr. B as he is known to his patients. Dr. B is a medical doctor and has a PhD in Biochemistry. For the past twenty-five years, Dr. Burzynski has been researching and developing a new theory of cancer and its treatment• For the past eighteen years, he has been treating ad- vanced cancer patients and, more recently, HIV positive patients, at his clinic in Houston, Texas. The treatment he invented is not approved by the FDA for inter- state marketing, but is under study. Researchers at medical universities around the world use his treatment with much success on advanced cancer patients. Dr. B~Lrzynski began his study of cancer in his native Poland where he partici- pated in a scientificproject to compare the blood of cancerpatiente with that of healthy individuals. He observed that cancer patients had a deficiency of a certain group of medium size peptides. He hypothesized that there might be a causal con- nectfon between this deficienc~ and cancer. Essentially, all of Dr. Burzynski's work since that time has been to 1solute and identify these peptides, understand their mechanism of action, and prove that they constitute an essential part of the body's defense system against cancer. In 1970, Dr. B decided to leave Poland because he wanted to escape the repression and tyranny of a corrupt communist regime. Little did he know that Amer~a would treat him harsher and more vindictively than the communist bureaucracy. From 1970 through 1977 Dr. B. worked as a research scientist at the Baylor Col- lege of Medicine, developing his biochendcal defense theories of cancer and testing the peptides which he had isolated. in 1977, Dr. B decided to start a private medical practice and try helping cancer patients with his treatment. Before doing so, he hired an attorney to advise him whether it was legal for him to treat patients in Texas with his own non-FDA ap- proved treatment.He was advised that under federal and state law it wo'ald be legal to do so. FDA ACTIONS AGAINST DR. BURZ~SK~ In 1983, the enforcement branch of the FDA fried a civil lawsuit in the Houston federal court to close Dr. Burzynski's clinic. FDA Attorneys told the attorney for Dr. Burzynski's patients (who had intervened in the action) that if the judge didn't close the clinic, the FDA had other ways to shut it down. But federal judge Gabrielle McDonald refused to prohibit Dr. B. from treating patients. However, she did issue an injunction prohibiting him from shipping or introducing his medicine in inter- state commerce. The FDA did not appeal Judge McDonald's decision. But since 1983, the FDA has attempted to correct the fact that Judge McDonald refused to close Dr. Burzynski's clinic using the following tactics: I. grand jury investigations: at least four of them in the past 10 years. 2. FDA raids and search and seizure warrants which confiscate Dr, B's medical records, making it more difficult for him to treat patients. 3.grand iury subpoenas on individuals who either speak out on his behalf or work with him mcluding members of the press and other high profile individuals. 4. dissemination of false information to Dr. Burzynski's patients, prospective patients, potential par~- ners and insurance companies.~ Let me explain the FDA enforcement division's application of these tactics. In July, 1985 the FDA raided Dr. I~urzynski's clime, armed with a search and sei- zure warrant and a large truck, and confiscated almost all of Dr. Burzynski's records, in excess of 200,000 pages, including all medical records of every patient Dr. Burzynski had ever treated. A grand jury investigated him for nine months, but no indictments were returned. However, the FDA did make effective use of the grand jury proceedings by widely disseminating the fact that he was a target of a grand jury criminal investigation. Obviously, the FDA disseminated this information to make it more difficult for Dr. ~ During the current grand jury investigation, FDA agents have approached at least one of Dr. Burzynski's terminal cancer patients, advised him that the treatment is not effective and suggested that he receive more established care. See statement of AP attached hereto as Exhibit "A". Burzyr~s. ki to continue his medical practice. When Judge McDonald learned of the agency's actions, she ordered the FDA to cease releasing misleading and inappropri. ate information about Dr. Burzynski. (See Exhibit "B" attached). .Sin~ce. tl~.e~, w..as ..no.o..incr~minatln~ evidence in the 200,000 pages of dooument~ s,e~z~ .~n..~wo, tn,e ~'~A s, uo~na.ea anom~ 1.00,000 p..ages of documents to be pro- ~ucea to tne grand jury, me mIiow~ng year. ~iu~ again, ~nere was no indictment, In 1990, the FDA tried again, asking another ~rand jury to indict him, Dr, Burzynski testified at length before this second (or third) grand jury, along with ~eV- oral other witnesses. But the Government still had no case, and no indictments were returned by this grand jury either• From 1991 through 1993, the FDA continued to spend taxpayer dollars to inves- tigate Dr. I~urzynski. We do not know whether the FDA presented evidence to a grand jury during this period of time. /,n Apri] 1994, the FDA ,co.nv?ne, d,,a ~ (,o.r four~h, or fifth) grand ju~, Numerou~ witnesses were summoneu m msuIy, mclucnng some of Dr, Burzynsld s employees, This grand ~ury did not return any indictments. However, the assistant U,~, After. nay presenting the case was removed for abusive use of subpoenas. (more about that later). On Friday morning March 24, 1995 Dr. B. and a number of his advanced cancer patients who had gone into remission appeared on CBS's '~l'his Morning~. The show was quite positive and very well received. Late that aRernoon, FDA and postal inspector a~ents raided Dr ]~vn~,~ rice. Duri..,n.g the execution of the search warrant,-FDA agents h~r~e-~-a]~"l" Burzynskis employees into a room--including nurses who were administering IV~s to patients--and held them captive until they signed statements revealing their na~nest ad,d~..sses,~, telephone numbers, and social security numbers. The action seamen unbehevame oecause another diwsion of the FDAhad been working coop- er~tively .wi.'th D.r~ B.urzynski on reviewing testing protocols. ~uring me rain, me agents confiscatedoriginal records of fifteen p, atients and re. move.d many boxes, of d.ocumen, ts, inclu~ng a ]i.st of all Dr. Burzynski's patients, The agen~ a~so servea various subpoenas ~or production of documents. However, some of the documents subpoenaed had already been turned over in previous subpoenas, raids, or produced to the FDA as part of submissions for Investigational New Drug Applications. (INDs). . In~.Ap~ri~l~. 1995,..Dr.. Bur~.~. ski tes, tifi~e.d extens, ively before this grand jury (the murm, n~tn or sLx'm), as ma severm ox his employees. Addition~ subpoenas were served. bairn May and June, more of Dr. Burzysnki's employees were subpoenaed to testli~y mrs the grand jury. Additional subpoenas were served. This grand jury was still calling employees of Dr, Burzynski as recently as last week. ABUSIVE SI~POENA TACTICS Let m.e .relate a few examples of the enforcement division's use of grand j_my sub. poenas ~o narass people who work with Dr. Burzynski or express support for him, Harris County Attorney Mike Driscoll is a member of the Board et~Diree~r~ of Dr. Burzynski's Research Institute and a vocal supporter of his work. He testified tb~fo?~ti?e 19~94.~r~and..j.ury an, d strongly suppo..r~.d. Dr. Burzynski, to the dismay of .,no ~A.. an_a_ t#,~. Attorney's Office. In retahation for his testin~ony, the FDA ~nrougn me t~.S. Attorneys office issued a grand jury subpoena on the Harris Goun. .t~ Clerk's office requesting the records of the County Attorney's campaign contrl.bu. tmns for the previous ten years. The subpoena was obviously written to imply that t~here.wa.s, some fin~,ancial, improp~ety.or possible criminal conduct on the par~ of the ~ounzy Aworney. ~ne suopoena round its way to the media which reported that the U.S..Attorney's Office was investigating Driscol/'s campaign finances. The Govern. men~ initially confirmed the report, then denied that there was an independent vestigation. All of the information subpoenaed was contained in public records. Thus it W~ not neces.s .a~y. f.or...the Governm.ent to subpoena these documents at all. But the sub. ~_oena, an.a..the im~al co .nfirma..tion of a..n. investigation did prove embarrassing to the ~ounz~ At-~orn.e~y ~o.r.a sno~ ume, until the media determined the true purpose of ~n?.suvp.oena...~ee r~ewspaper articles attached as Exhibit • nero is, another example: After the FDA's March 1995 raid, ~}r. Ralph Moss, Pub. hsher of The Cancer Chronicles," and a member of the advisory committee of NIH's Office of Alternative Health, published a letter strongly condemning the raid, Short- l~ therea/tor, the Government served Dr. Moss wit~ a subpoena to produce every ,~o~ament he had relating to Dr. Bu~ynski. (Copy of Subpoena attached as Exldbit D.)
Page 16: TI14380124
24 The Department of Justice has strict guidelines which must be followed prior to the issuance of a subpoena to a member of the media. (Copy of Guidelines attached as Exhibit "E"). Basically, the U.S. Attorney's office must receive pro-approval from the Attorney General before issuance, and it must have determined that the infor- mation is critical to the investigation and not obtainabl~ anywhere else• I do not I~lieve that the subpoena complied with these mandatory guidelines. When Dr. Moss informed the Government that he knew about these guidelines and the penalty for violating them, the Government rescinded the subpoena, (See Exhibit "F"). But Dr. Moss learned the lesson given County Attorney Mike Driscoll: there is a price to be paid for speaking out. The most bone chilling act of the enforcement division is that it has recently sub- poenaed Dr. Burzynsld's medical records of all of his patients who have publicly spo- ken out for him, including the three patients who appeared with him on the March 1995 "This Morning" program, as well as the patients who appeared on other na- tional televlsien programs. In our country where freedom of speech is a cornerstone, people suffering from cancer should be able to tell their story without fear of government reprisal. After my presentation, this panel will hear testimony from the family of one of Dr. Burzynski's patients who had the courage to speak cut, and whose medical records have been confiscated by the enforcement division of the FDA. I believe that the enforcement division is subpoenaing the medical records of these patients to send them the same message sent to Dr. Moss and Harris County Attor- ney Mike Driscoll: public support for Dr, Burzynski has a price. I suspect that in the future this message will be repeated to others, but I predict it will be louder. I leave it to this committee to determine whether it is appropriate for the FDA to send this message and employ these methods. FinMly, the enforcement division has improved on its old t~ctic of disseminating inappropriate information to third parties. Back in 1985, and until enjoined by Judge McDonald, the FDA would advise all who inquired that Dr. Burzynski was the target of a grand jury investigation. T~king a more direct approach now, the FDA has subpoenaed from Dr. Burzynski the names and addresses of his business associates, and all university researchers around the world who research and use Dr. Burzynski's treatment. (See Subpoena attached as Exhibit "G", categories 2, 11, and 12). Armed with this information, the FDA is starting to contact these people, advising them of the "criminal investigation", and subpoenaing documents. (See ubpoenas attached as Exhibit H .) I believe that the enforcement division expects that this will make it more difficult for Dr. Burzynski to conduct business, and less likely that other universities wi/l continue with their research on antineoplastons. In fairness, Dr. Burzynski's relationship with the FDA is more complicated and not as ur~dimensionai as the above might suggest. You may have noticed that l have addressed my concerns and complaints to the enforcement division of the FDA. But the FDA is a large institution with many divisions covering different aspects of drug regulation. The FDA's interactions with Dr. Burzynski have not been uni- formly hostile. For example, Dr. Burzynski manufactures his medicine in his own plant. The FDA has or at least has claimed jurisdiction over the manufacturing practices and policies of the plant's operation, Dr. Burzynski's staff has been in regular contact with the part of the FDA which oversees Good Manufacturing Practices (GMP). This division of the FDA makes periodic inspections of the manufacturing facilities and there is a positive and professional relationship in these interactions. In addition this panel should know that by 1994, the regulatory division of the FDA had approved INDs for all of Dr. Burzynsld's treatment. Recently, other INDs have been filed and they are being reviewed by the FDA in a professional and time- ly fashion. It is possible that the drug approval division's positive interactions with Dr. Burzynski has been helped by the fact that in in 1991, the National Cancer Insti- tute sent a panel of experts to review the medical records and scans of seven ad- vanced bra~n cancer patients treated by Dr. Burzynski The panel concluded that in every case, Dr. Burzynski% antineopl~ston treatment caused anti-cancer activity. (A copy of this report is annexed hereto as Exhibit ~I".) The fact that Dr. Burzynski has a good working relationship with these other two branches of the FDA makes the enforcement division's tactics and goals even more unintelli&dble, Before I conclude, I would like to raise a few questions and discuss some possible solutions and recommendations. 25 QUESTIONS I would like to raise the following questions to this committee, 1, How much money has the FDA spent over the past 10 years trying to put Dr. ki out of business~ Bu~zyns " . ' " .... A .... nt the same case to different grand jttrtes? 2. How many ti~, es can. ~e ~_p~__~:~ Juries (and -erha-s as many as sLY) Can So far, there have ~sen at leas~ tour ~ ~-~ j . _ r ~- .... ° do~n this for another I0 years to another four grana ~urles7 they _keep " g ..... ~ *~^usands of documents can the FDA seize from Dr, 3. How many nun~Ireus w Burz ki. How many employees, other scientists, and business associates can the FDA hY~a~aes before someone, somewhere decides to call ~t off?. 4. Why don't incurable p.a~%~el~h~ve the right to take any drug which the patient s/her doctor think aught n p. and hi ............ * ~hould net be in the business of regulating • ! sub~t th~ ~n.e~:[taeer~n~°~°~e~sing the decisions made by patients witll the pracuce oI me~m incurable diseases and their physicians. p~MEDIES I would like to spend a few moments discussing possible solutions to the genora~ problems of FDA abuse and also raise some possible remedial action in this particu- lar case. omisin enerai solution is the legislation now pending bs- The first and most ]~.r .... ~,~ .... *~ x~dical Treatment Act", HR 2019 which • n ess caneu me ~w ~,~ fore this £~o g~,., ......... :~ .... ~ ~ mittee members Cox and Furse ! believe the chairman oz ~m~ ~uuu,,,~ -,.~ re co-s onsorln~. (A copy is attached as Exhibit "J"). Pending before the Senate, ~ an ideP~tical b~ll co-sponsored by majority Leader Bob Dole minority leader Tom D~s~.chle. ~ ......... n ~ocs a lon= way to reestablishing .the legitimate .rlg,hts, This proposes l~a~ e ~ • • • s and would em ower them and their physlcmns to have more conzro~ o~ of patient .... there is a rice to be aid, Hsro rmation, th~ " of in.fo ._'. ~' ~-" ...... ~m seekin~ unconventional or non-FDA approved forms of treatment, Third, I think Can~ess needs to pass legislation creating a permanent o.ver_~ij~t ommission which has the power to investigate egregious cases of abuse by the c ........ -'--- *~-~ ~isiens of t~e FDA on cases like th.e breast cancer ~cnraee~n~u~l~cYe.r%v~n~h~'~ &~ agency has to be forced to act with more co.m.mon s~nse and fairness, especially for small companies that do not have the severs/RUn, dre,d, million dollars it currently takes to bring a drug to market. If common sense can t be found w~thin the agency, it must be brought in from the outeids by Con- gress. As for Dr. Burzynski's situation, we would ask this Committee to launch a Con- gressional investigation into the FDA enforcement division's misconduct and harass- ment and that appropriate action be taken e~ainst those resl~onsible. The investiga- tion ~a not heI Dr. Burzynski, but it might stop the FDA from subjecting other innova~iYve scien~sts to the kind of bureaucratic inquisitions which Dr. Burzynsld has experienced for more than a decade.
Page 17: TI14380125
4~ O0 0 26 I thank this Committee for its time, and we especially appreciate that after so [Exhibits A throtlgn d are remmea in me ~.,~um~= ...... Mr. BARTON. We thank you, Mr. Jaffe, for coming to testify. We'd now like to hear from Ms. Mary Michaels and, if you wish, also from your son, Paul. You need to speak into the microphone and you have 5 minutes. TESTIMONY OF MARY MICHAELS Ms. MICHAELS. Thank you. In November of 1985, our son Paul was diagnosed with an inoperable brain tumor. The diagnosis was verified by a biopsy. There was no treatment available for Paul, al- though some of the doctors suggested radiation. The majority of the doctors felt radiation offered no hope of a cure and that it would cause severe deficits, not the least of which was blindness. So at the age of 4, Paul was sent home to die. Since conventional medicine had nothing to offer us, we tried some unconventional treatments, such as a macrobiotic diet and Laetrile. Neither of these treatments decreased the size of Paul's tumor and, in fact, it continued to grow. In the meantime, we sent Paul's scans and records to different neurosurgeon around the country. One of these was Dr. Patrick Kelly at the Mayo Clinic. He was one of the first doctors using a computer-guided laser in neurosurgery. He wrote back to us with the bad news that he felt that even his technique offered no hope for Paul's recovery, and I'll read just a few lines out of that letter because of the time. He says "I have reviewed the MRI scans on your 5-year-old boy, Paul. I must tell you that it is the largest tumor that I have ever een in this area in anybody ever referred to me for surgery. I am sure, however, that it is not curable by surg~cai means. And the nn~xt, sentence says. "Without surgery, your boy will die." Paul ~r-did receive ~n~ surgery from him or another doctor. In April 1987, we saw Dr. Burzynski on the Sally Jesse Raphael Show. After sending Paul's records to Dr. Burzynski, we were in- formed that Paul was a candidate for antineoplaston therapy and we went to Houston to begin treatment. The first months o~ treat- ment showed no improvement in the size of the tumor. However, Paul seemed to perk up after a couple of weeks on the treatment. He seemed more able to keep up with his brothers and this was what encouraged us to continue antineoplaston therapy. Finally, we did begin to see reductions in the size of the tumor and we were ecstatic. It has been 8 years that Paul has been tak- ing antineoplaston under Dr. Burzynski's care. During this time, Paul has been able to lead a normal life. Doctors have confirmed that he is neurologically normal in every way. He does well at school, He plays in the school orchestra. He's physically strong and active. He mows lawns, trims trees, water skis and bike-rides. His quality of life is very good, but most impor- tantly, Paul's tumor is shrinking. We were told time and time again that this was not possible. Dr. Bruce Cohen at the Cleveland Clinic was delighted with Paul's urogress when we met with him in 1991. He reque_sted~ a fro- zen sliae of Paul's biopsy to test himself to be sure that Paul actu- 27 ally had the type of tumor the reports indicated. Dr. Cohen's find- ings concurred with the actual biopsy report. Dr. Cohen urged us to continue to follow Dr. Burzynski's recommendation for Paul's treatment, and I'll quote just a line or two from his letter. He says, "I am personally not knowledgeable about the antineoplaston therapy Paul is receiving, but I do know that it falls outside of standard care practices followed by pediatric oncologists and neurooncologists in the major children's cancer study groups. However, the therapy being given seems to be working and I would not, under any circumstances, recommend changing the therapy unless Dr. Burzynski first gave his approval." We would like nothing more than to continue Paul's treatment with Dr. Burzynski. It seems in the years that we have been with Dr. Burzynski, there has been one crisis situation after the other concerning the FDA and other government agencies, each threaten- ing that Paul may no longer be able to receive the treatment that is saving his life. Without this treatment, Paul will die and the prognosis given to us when Paul was first diagnosed will come to pass. Paul has been under Dr. Burzynski's treatment for 8 years. There is no other form of chemotherapy available that would reduce the size of Paul's tumor, let alone one that he could be on daily for 8 years and sur. vive the side effects of the chemo itself. Yet, in spite of the fact that, A, Paul is getting better a.nd, that he's been on this treatment for 8 years with minimal side ef- fects, the FDA feels compelled to protect us from this treatment. Our heartfelt desire is that the FDA be prevented from continuing its constant harassment of Dr. Burzynski. The stress that our family goes through each time the FDA starts another investigation is unjustifiable. The FDA has raided Dr. Burzynski's clinic enough times now that they should have been able to prove any legitimate charges they may have had against him. The relentless stress the FDA has put Dr. Burzynski's patients through is unforgivable. The FDA has confiscated Paul's medical records. Some of these records cannot be replaced. I feel this jeopardizes Paurs welfare as he struggles against a life-threatening illness. It also prevents me from showing you his first scan as compared to the most recent scan, which would prove to you that the tumor has shrunk from about three inches in diameter to about the size of a pea. I cannot tell you how stressful these repeated investigations are on our family and Paul in particular, since he's now old enough to understand what is going on. This stress will eventually take its toll. I would hope that some way the FDA could be stopped so that those most vulnerable, the sick, could be protected by their govern- ment. I want to tell you what the FDA's persecution of Dr. Burzynski means to me. If it wasn't for Dr. Burzynski, our son would be dead, If Paul was on another form of chemotherapy, he would look ill and he would be ill. Having cancer isn't really so bad when you're get- ting better and feeling fine as you recover. This is what Dr. Burzynski has given me. He's given Paul back to me, a healthy~ strong son .that I rejoice in watching play and grow. I thank Dr. Burzynski for sparing me having to watch my son die.
Page 18: TI14380126
28 How much of the FDA's tactics can be justified when patients' lives will be lost if Dr. Burzynski becomes unable to treat them? I can tell you that no ideal the FDA could possibly attain by its harassment of Dr. Burzynski is worth my son's life. Thank you. [The prepared statement and attachments of Mary Michaels fol- Iow:] PP~PARED STATEMENT OF MARY MICHAELS In Novomber of 1985, our son, Patti, was diagnosed with an inoperable brain tumor (optic hypothalamic glioma astrocytoma). ,The,.,diagr~osis was, ve.rified by a,bi~ opsy, There was no treatment available for Pare, alm_o_ugn, som,e aoc~o.rs sugges~ea. radiation. The majority of the doctem felt radiation offered no nope of a cure and that it would cause severe deficits, not the least of which was blindness. So at the age of four, Paul was sent home to die. Since conventional medicine had nothing to offer us we tried some unconventional treatments such as a Macrobiotic diet and Laetrile. Neither of these treatments de- creaJed the size of Paul's tumor and in fact, it continued to grow. In the meantime we sent Paul's scans and records to different neuresurgeons around the country. One of these was Dr. Patrick Kelly at the Mayo Clinic. He was one of the first dec- tom-using a computer-guided laser in neurosurgery. He wrote back to us with the bad news that he felt that even his technique offered no hope for Paul's recovery. (See letter.) In April of 1987, we saw Dr. Burzynski on the Sally Jessy Raphael Show. After sending Paul's records to Dr. Bursynski, we were informed that Paul was a can- didate for Antineoplaston therapy and we went to Houston to begin treatment. The first months of treatment showed no improvement in the size of the tumor. However, Paul seemed to perk up after a couple of weeks on the treatment. He seemed to be more able to keep up with his two brothers, and this was what encour- aged us to continue Antineoplaston therapy. Finally, we began to see reductions in the size of the tumor and we were ecstatic. It has been eight ~years that Paul has been taking Antineoplaston under Dr. Burzynski's care. Dunng this time, Paul has been able to lead a normal life. Doctors have-confirmed he is neurologically normal in every way. He does well at school. He plays in the orchestra. He is physically strong and active, mowing lawns, trim- ruing trees, water skiing, and bike riding. His quality of life is very good. But most importantly, Paul is recovering. We were told time and time again that this was no,possible. Dr. Bruce Cohen at the Cleveland Clinic was delighted with Paul's progress when we met with him in 1991. He requested a frozen slide of Paul's biopsy to test him- self to be sure that Paul actually had the type of tumor the reports indicated. Dr. Cohen's findings concurred with the original biopsy report. Dr. Cohen (see letter) recommended we continue to follow Dr. Burzynski's recommendations for Paul's treatment. We would like nothing more than to continue Paul's treatment with Dr. Burzynski. It seems in the years that we have .been with Dr. Burzynski, the,re has been one crisis situation after the other, each threatening that Patti may no ranger be able to receive the treatment from Dr. Burzynski that is saving his life. Without this treatment, Paul will die. The prognosis given to us when Paul was first diag- nosed, will come to pass. Paul has been on Dr. Burzynski's treatment for eight years. There is no other form of chemotherapy available that would reduce the size of Paul's tumor, let _alo.ne one that he could be on daily for eight years and survive the side-effects of the chemo itself. Yet, in spite of the fact that, A.) Paul is getting better, and B.) that he's been en this treatment for eight years with minimal side-effects, the FDA feels compelled to protect us from this treatment. Our heartfelt desire is that the FDA be prevented from continuing its constant harassment of Dr. Burzynski. The stress that our family goes through each time the FDA starts another investigation is un- justifiable, The FDA has raided Dr. Bu~zynski's clinic enough times now that they should have been able to prove any legitimate charges they may have had against him. The relentless stress the FDA has put Dr. Burzynski's patients through is un- forgivable. The FDA has confiscated Paul's medical records. Some of these records cannot be replaced. I feel this jeopardizes Paul's welfare as he struggles against a life-threat- ening illness. 29 I cannot tell you how stressful these repeated investigations are on our family, and Paul in particular, since he is now old enough to understand what is going on, This stress will eventually take its toll. I would hope that some way, the FDA could be stepped, so that those most vulnerable, the sick, could be protected by their gov. ernment. I want to tell you what the FDA's pers~ecution of.D.rx B~urz, ynski means.,to m~e, If it wasn't for Dr Burzynski, our son would be dean ~ ram was on anomer mrm of chemothera~.y, he would look 111. He would be ill. Ha,nng cancer lent really s bad when you re getting bettor and feeling fine as you recover. This is what Dr, Burzynski has given me. He's given Paul back to me. A ,heathy, st, tong so,n that I rejoice in watching play and grow. I thank Dr. Burzynski mr spanng me nawng to watch my son die. How much of the FDA's tactics can be justified when patients llve.s, w~l." 1. be~l~os, t if Dr. Burz ski becomes unable to treat them? I can tell you that no ~dea] t~e could possi~; attain by its harassment of Dr. Burzynski is worth my son~s life. MAYO CLINIC, Rochester, MN, December 9, 1986. MRS. MARY K. MICHAELS 177 Miracle Troy, MI 48084 D~.Aa MI~s. M~ClaA~LS: I have reviewed the MRI scans on your 5-year-old boy Paul. As I am sure you are aware, this is an extremely extensive lesion involving pontine mesencephalic and diencephalic structures. I must tell you it is the largest tumor that I have ever seen in this area in anybody ever referred to me for surgery. I am not too sure exactly what should be done. I showe.d, yo~,u~_ son'.s scans to.,a num- ber of my colleagues here, who feel that it is inoperable. I m not so sure ~naz we couldn't do anything. I am sure, however, that it's not curable by surgical means. Without surgery, your boy will die. However, there is a good chance with an gressive surge~ to remove a significant amount of the tumor that a significant neurolo~c deficit could result. To be sure, I have operated on many deep-seated tu- mors w~th good results. However, there is always the risk that a patient may not do well following an aggressive surgical procedure. ]f you would l~nke to come up here and talk about the possibility of surgery, please call my office and make arrangements for ~,our son to see one of our Pediatric Neu- rologists and myself to discuss the pros anacons of surgery. Sincerely, P.J. KELLY, M.D. THE CLEVELAND CLINIC FOUNDATION, Cleveland, OH, September 25, 1991. GEOFFREY P. REDMOND, M.D. 5 Commerce Square, 23200 Chagrin Boulevard, #325 Beachwood, OH RE: Paul A. Michaels, Clinic No. 2 098 569 0 DEAR GEOFFREY: I had the pleasure of seein$ your patient, Paul Michasls, on Sep.- tember 11, 1991. Paul's past medical history ~s quite detailed, and I will review it bripeaflu~' was well until November 1985 (age 4~/~ years) when he dev, eloped .d,?u,ble sion and lethargy. A neurologic workup was performed and a mimine eplta~uamlc~ 3rd ventricular tumor was icIen~ified. He was shunted in November 19~5~ and Dr. Canady performed a craniotomy as well. Biopsy results showed a grade I astrocytoma. Radiation therapy was recommended,, but Mr..and .Mrs. Michaels, pr,.e- ferred to attempt alternative treatments. At first he wasplacea on a macro-mo~m diet, then followed by Laetrile, obtained in Mexico. The MRI showed an increase in the size of Paul's tumor. In April 1988, the family was see.n, by Dr..B._ ,u~,__n.s.ki, a,,n onc.o.lo~is.t i,n the .Ho.us- ten, Texas area. Dr., Burzynski prsctlc.e.s outs,d.c, ord, mar~.. ,mem,ca~, cLrcmSk~oU~ uoae~ have a ~ancer inst~tuto and treats patients w~tn po~ypep~me suosmnces antineoplastins. Paul has been placed on A-10, 600 cc every 24 hours, ann 300 cc every 24 hours, which he receives by continuous IV infusion. Paul is seen by Burzynski every few months. A review of the MRI eca..ns, indic~te t.ha, t, the tumor actually has shrunk over the last three years of treatment, e, ccoramg ~o me parenzs~ Dr. Burzynski feels that everything is going well, although Paul has had some re-
Page 19: TI14380127
30 cent joint pain due to an increase in sercm uric acid content. He was placed on allopurinol. Paul's vision is followed by Dr. Cohn, who has determined that his vision remains normal in both eyes. On physical examination, Paul weighs 65.7 kg and stands 153 cm tall. Paul's blood pr.essure is 116/70, and his pulse is 80 beats/minute. Paul's neurologic exam- ination is entirely normal. Again, review of his .MRI scan.shows a 2-cm hypo- thalamic mass. This tumor is smaller than on previous studies, and it appears to have been shrinking since the antineoplastin therapy was started in 1988. You apparently are going to be seeing Paul for precocious puberty. I have rec- ommended to the family that Paul receive eye examina~ons every six months and MRI scans every three to six months. I am personally not knowledseable about the antlneoplastin therapy Paul is receiving, but I do know it falls outside of the stand- ard care practices followed pediatric oncologists and neuro-oncologists in the major children's cancer study groups. However, the therapy being given seems to be work- ing, and I would not under any circumstances recommend changing the therapy un- lesj Dr. Burzynski first gave his approval. I did discuss with the family the ap- proach we take to these type of tumors in 1991, s~ecifically improved radiation ther- apy techniques, as well a.s the use of actinomycm-D and vincristine chemotherapy for this particular type of tumor. As I advised, they will continue their oncology cars with Dr. Burzynski. Mr. and Mrs. Michael's should feel free to call me at any time with questions or concerns. Thank you very much for referring this patient to me, and please do not hesitate to call me if I can answer any further questions. Sincerely yours, BRUCIS H. COHEN, M.D. Mr. BARTON. We thank you, Ms. Michaels. Paul, before we begin the questions, is there anything that you would like to say? Mr. MICHAELS. I am a cancer patient of Dr. Burzynski's and I feel very lucky to have found Dr. Burzynski because his medicine is making me better. At the same time, I have no side effects. I can't wait until I am completely better. I want to be healthy. But also because I'm tired of having to worry about the government taking away my medicine. It's like I'm at war against cancer and the government keeps try- ing to take away the only weapon I have. I want to be able to stay on Dr. Burzynski's medicine for as long as I need it. I don't plan on giving up my fight to live and I don't think it's right for anyone else to make megive up. Mr. BARTON. Thank you. The Chair would recognize the chair- man of the full committee, Mr. Bliley, for 5 minutes for questions. Chairman BLILEY. Thank you, Mr. Chairman. Mr. Wright, if I understand your testimony and the documents you have supplied to the subcommittee, your biggest initial problem with the FDA was that your invention was literally too simple for the minds of the bureaucrats in Rockville. Mr. WRIGHT. That's probably right. Chairman BLILEY. After you filed a 510(k) application in 1985 for use of the Sensor Pad as an aid to breast self-examination, the bFDA wanted you to do a study to prove that the pad could diagnose feast cancer and determined that a full pre-market approval ap- plication was needed because the Sensor Pad was not equivalent to any device that was on the market prior to 1976. Is that a fair summary? Mr. WRIGHT. That's a fair summary. They first asked for a study that we did run, but then after we ran it, they didn't want it, after they had approved it. Chairman BLmE¥. Well, since the FDA bureaucrats couldn't reg- ulate soap and water, the FDA couldn't find a substantially equiva- 31 lent device, and in 1986, the Sensor Pad was categorized as a Class III medical device, one that could cause serious injury or death. Mr. WRIGHT. That's right. Chairman BLILE¥. This thing. Mr. W~IGHT. That's right. Chairman BLILE¥. I'll tell you. In retrospect, maybe you should have tried to sell this lethal device to the Pentagon. However, you attempted to work out a reasonable protocol with FDA for several more years without success. Correct? Mr. Wm~HT. That's right. That's correct. Chairman BLILEY. What a sorry state of affairs. Mr. Ja.ffe, has there been any recent incident that you believe may have been an attempt to retaliate against you and Dr. Burzynski because of your appearance at this hearing? Mr. JAFFE. There may have been. I can't say for sure, because all I know, I'm just a fact witness in that regard. I've been basically sitting in front of the Grand Jury or in the Grand Jury anteroom for the last 2 or 3 Grand Juries, anyway, without any incident, And then, for some reason, last Tuesday afternoon, I was sum- marily removed by the U.S. Marshals and told to leave the build- ing. I don't know why that happened, but I was later "told that Tuesday morning, the FDA was told that I would testify. So if there's a connection, there may well be, or perhaps it was just a random act of the universe. I don't know. Chairman BLILEY. You hadn't testified that day, Mr. JAFFE. No. I don't testify. I just sit in the anteroom. Chairman BLILEY. You were just sitting there. Mr. JAFFE. Sitting there as Dr. Burzynski's employees are called to testify, in case anybody has any questions. I'm the person that makes sure the witnesses come on time and the documents get there and all, and I was just removed. I mean, they didn't handcuff me, but they did throw me out. Chairman BLILEY. What did they say? Mr. JAFFE. I have no business being here and was told to leave, Chairman BLILEY. This was a government building. Mr. JAFFa.. The U.S. Attorney's Office. They just said leave. I said I've been here for 4 years. Mr. BARTON. Would the distinguished chairman yield on that point? Chairman BLILEY. Certainly. Mr. BARTON. It's my staffs information that we had a conversa- tion at the staff level with people at the FDA that morning that indicated that you would be called to testify and that afternoon you were asked to remove yourself from the Grand Jury anteroom. So it could be a coincidence, but there was a staff conversation about your testimony with the FDA the morning of the afternoon that you were removed from the Grand Jury room. Mr. JAFFE. Up to that point, I should point out, I had fairly cor- dial relations with the government. After that, I don't think I've been on speaking terms with them. Chairman BLILEY. Has the Chairman concluded? Mr. BARTON. Yes. Chairman BLILEY. Mr. Jaffe, I understand that you represent or have represented a number of health practitioners and small corn-
Page 20: TI14380128
32 pa,n, ies whose treatments and products fall into the area of alter- nahve medicine. Mr. JAFFI~. That's correct, sir. Chairman BLILV.Y. Based on this practice and your related expe- rience, do you believe that the FDA or at least its enforcement ele- me~n,t h.as a bias against unconventional medicine? tv~r, JAFFa. I don't think there's any doubt about that. I think t.hat, by and large, if you're not a multi-zillion dollar drug company that could grease whatever wheels have to be greased at the FDA I don't think you'd get the same kind of treatment, in general. ' ,I w.ill say, how.ever, that that's part of the, in effect, schizo- pr~remc existence here. There are branches of the FDA that Dr. Burzynski has professional working relationships. For example, the manufacturing facilities get inspected by the FDA all the time and there's a professional relationship there, and I think that under- scores the irrationality of it. They come in, they inspect, everything is according to Hoyle in the inspection process. On the other hand, they're trying to put him out of business. His drug is also approved for clinical trials, I should point out, by another division of the FDA, but, yet, the en- forcement division is trying to put him out of business. So the powers beyond me have to figure all this out as to why this is all happening. Chairman BLILEY. Thank you. I see my time has expired, Mr. Ghairman. Thank you very much. Mr, BA~TOI~. We thank the distinguished full committee chair- man. The Chair would now recognize the distinguished ranking member for 5 minutes. Mr, WYDEN, Thank you, Mr. Chairman. Chairman Bliley is a tough act to follow. Let me say right at the outset, Mr. Wright, that nobody who produces a product like yours ought ~o be treated like Murder, Incorporated. I guess the question really becom,e_s why do we think something like this happened. Do we think it s because of antiquated regu- la.tory pro~ce.dures or do .we t_hink it's because the Agency is just full o~ rog~ est My guess is that for the most part. it's due to anti~-~.~,~ proceuures. - " ~ In, the bill that I produ.c..e,d, we've essentially thought of this. Your proauc~ is non-invasiveo It s not a safety problem and people in the country can debate the efficacy. Some say ye~, some say no. Under what I have proposed, someone like yourself could basi- cally get to the market very quickly, begin to sell your product, in return for what amounts to some post-market surveillance. After your product is out in the market, you'd send information dealing with this issue of efficacy. If this had been in place at the time you started all this with the FDA, could we have avoided much of your problem and dealt with this fairly? Mr. WRt~I-IT. Absolutely. We've sat back there and wondered what in the world is going on; did we make somebody mad, what's wrong that we can't seem to go anywhere. And I think Dr. King testified before Congress to the same effect, that this was a no- brainer. It should have been allowed to go to market and, if any- thing, a post-market study. And, also, the FDA's own counsel, the 33 outside counsel, medical counsel, Dr. MacGowen, in the September 1 meeting, testified "I reviewed their first application and I thought maybe we should look at it a little further. However, today, I have reviewed that application. They should be allowed to go to market right now and then a post-market study take place." Their own people were recommending, in some degree, exactly what you're tall~ng about. Yes, that would help. But we don't real- ly know what happened. Mr. WYD~,N. Let me ask you, then, about your situation and the one aspect that troubles me. We have got to have a rule of law, which means that Mr. Barton and all of us up here can debate what kind of FDA reform we're going to have, but when we resolve it, we've got to have a set of rules that everybody lives by, even by those that would like to change it, like new Congress people or what have you. With respect to your case, my understanding is that the FDA seized the product in 1989. The U.S. Court found that you were still shipping an unapproved product in 1990 and an appeals court upheld the U.S. Court ruling in 1991. My question is after that last decision where the court of appeals held that this was a device which required approval under the Food, Drug and Cosmetic Act, did you all still ship that product? Mr. WRIGHT. Absolutely not. On September 11, the judge's deci- sion was published. We notified the courts that we had ceased ship- ments, and we had ceased shipments. There were 5 shipments that slipped through that were in our shipping room that we had noth- ing to do with. We gave orders they weren't to be shipped. They were. We got them back and we refunded all the money that was involved. So there were no shipments made after September 11. On the 305 hearing, no shipments were documented on the 305 hearing. I have gotten word by the grapevine that they're still look- ing at a civil penalty and, yet, in this document, "This is to advise you of the decision not to proceed with criminal prosecution of In- ventive Products based on the charges set forth in the section 305 notice dated June 11," and those 5 shipments were noted in that document. Mr. WYD~.N. I thank you, Mr. Wright. That was an important point. I would just ask, Mr. Chairman, that we hold the record open on this point to ascertain whether the Food and DrugAdmin- istration has any documents which in any way speak to this point on shipping, because I want it understood, Mr. Wright, that I think we need reforms of this Agency. At the same time, we must have a rule of law so that when the debates in the Congress are re- solved, the importance to comply with that rule of law is under- stood. You have been candid and open and we appreciate it. I'll have some questions on another round, Mr. Chairman. Mr. BARTON. Without objection, the record will be kept open for that information. The Chair would now recognize himself for 5 minutes of questions. [The following information was received for the record:]
Page 21: TI14380129
34 35 To: July 28. L99S Compliance BranchlCH:-DOIHFR-MWI40 Inventive Products, :no. Distribution Assistant to ACRA/~F~-I Attn: ~dy Bonano dace ~s Seven~.~ c~rc~ Cou~'~ o~ Appeals issued ~s decision. D~te $~i=D~d SadDle Number ~.~ou~ Shod ~_~ 09111/91 g2-645-632 I000 Units Set.side Hod Pe~arsb~, VA ~9/16/91 92-549-~77 500 units Welr~on Hed 09/23191 92-603-138 300 units Heal~ Baldwinsville, 0912~/91 9~-634-100 500 uni~ Co~unlty Hospital. ~casEer, PA ~0/~1/91 92-607-360 900 unlns H~o~ women's Keal~ ~ie, PA ~ll$~es ware accompilshed a~: Heal~ Se~lCes, Med, 8aldwlnlville, MY (~DC 66420) and Hamo~ Women's Heal~, Erle, PA Additional ac~lons ~a~mn by Inventive after ~be Appeila~e co~'s COhErence in ~lcaqo, IL on October 18, 1991. 2. ~ investigation a~ %he AppaLachian Hand~mrapy Cllnic, Pads ~a~ on ~e following dates: AU~Ic 3, 1993, Au~ 26, 1993, Sep~r 30. 1993 and NoveQolr i0, 1993. o~:icials at ~e Clinic the p~osl O~ usln~ ~hem ~o massage scar ~£ssue o~ ~put~es during 3. Inventive dis~rlbu~sd ~ ~ Pad to ~e S~. Alphonsul Brsas~ Csn~sr, Boise, ID in ~ ~irst ~roe ann.s of were ship~d ~o S~. Alphonsus which th~ fi~ussd as a i~ Invento~ of Sensor Pads. • tire made a shipment of th~ Ls Pa~ on Dace _=~e..~ 11, 1992 (200 4. Inv n ...... ~edical Center, Inc., St. AIDans, VT. and a Le Pads) tO Norunwee~--,, - ship~ent on 3anua~ ZZ, 1993 (100 ~ pads)to Northwes~ Medical Cen~er. Sample 93-598-600 was collec=ed. Plmase con~ac: me should yo~ ~ave any ~es~ions. George F. Bailey Compliance officer co: BFW-11Casper Uldricks Dar.~ : Fro~t To ~ October 4, 1995 Cow, llanos Brmnch/CHl - DO/PJ~- ~W140 Z nv~n~ve pz~4ucts, Allll)l~t tO AC~Jk/~C'I Ann M. A~am~ cot E~
Page 22: TI14380130
86 Mr. BARTON. The stated purpose of the hearing today is to dis- cuss allegations of retaliation and intimidation by the FDA against individuals and companies. Past witnesses that have appeared be- fore this subcommittee have indicated that they were encouraged not to testify. My first question to each of you is has an FDA representative in any way attempted, by word or deed, to either prevent you from coming today or to dictate to you what you said when you appeared before this panel. Mr. WRIGHT. No. Mr. BARTON. Ms. Gorman? Ms, GORMA~. No. Mr, BARTON. Mr. Jaffe? Mr, JAF~E. No. Mr. BARTON. Ms. Michaels? Ms. MICHAELS. No. Mr. BARTON. So they have not attempted that. Well, that's good to know. Mr. Wright, I want to know what the outrageous claim you've made in trying to market the Sensor Pad is. What do you actually tell America when you were trying to sell this pad? Mr. WRIGHT. We tried telling them it helps you do a breast exam, makes it easier and more comfortable. It reminds you to do it. Mr. BARTON. That it helps you do a breast exam. Mr. WRIGHT. That's right. Mr. BARTON. You never claimed that it was a cure for cancer. Mr. WRIGHT. No, sir. We never said you could find lumps, be- cause, after all, we don't want the liability. Mr. BARTON. Okay. If a woman abused the Sensor Pad in the worst way, what's the worst thing a woman could do in attempting to use that pad to herself?. Mr. WRIGHT. Well, I don't think she could hurt hersel£ We have considered maybe that it should have been sold as a pad for other uses. Mr. BARTON. But if she attempted in any way to use it for the stated purpose, she couldn't burn herself. Mr. WRIGHT. This package could be opened and a child could drink the liquid inside and they'd probably get diarrhea, but it wouldn't cause death. I don't know what it could do. Maybe it could reduce them, I don't know. Maybe it could enlarge them. Mr, BARTON. When you were selling the pad, was it sold by phy- sicians, through drug stores? How was it marketed? Mr. WRIGHT. It was marketed through hospitals and cancer care centers by marketable units. It was never sold over-the-counter in a drug store. Mr. BARTON. So it was always sold by a health care professional. Mr. WRIGHT. And it was always taught. The use was taught by a health care professional. There was a movie that we provided, a short, 5-minute rundown on how do you do a breast exam and how you do a breast exam with a Sensor Pad. It was always provided, even to the companies. We sold it to some companies for their em- ployees, the wellness programs. Here, again, this was always one of our stipulations. We do not wish to sell you pads. We want to sell you a program. We want you to make sure that this is an ongoing situation. 37 Mr. BARTON. Now, Ms. Gorman, you found out about the pad how? Ms. GORMAN. I was working for a health care association and a press release about the pad came across my desk. Mr. BARTON. So you were not marketed in the traditional sense that a sales lady or sales person~ Ms. Go~. No. Mr. BARTON. [continuing] attempted to sell you on this device. Ms. GOP.MAN. That's right. Mr. BARTON. You found out about, you asked for one--~ Ms. GOm~AN. That's right. Mr. BARTON. [continuing] used it, and at least it's your belief that it helped detect a tumor that has since been removed from your body. Ms. GOmC_AN. That's right. Mr. BARTON. Now, Mr. Jaffe, I want you to tell me what Dr. Burzynski, who couldn't be here himself, what does he claim to po- tential patients, like Ms. Michaels and her son, when they ap- proach him for treatment? What's the most outrageous claim that he makes? Mr. JA~FE. I would say that he tells people that his treatment, on some instances, has affected in a beneficial way some cancers. He doesn't claim a cure or a panacea to cancer. Mr. BARTON. Does he stipulate in the initial contact that his treatment is not approved by the FDA? Mr. JAFFE. For sure, that it's not approved, that it's not accepted, that it's 8 different ways, that people might get worse on the treat- ment and that he has some limited experience showing that some people have improved on it. Mr. BARTON. Now, you indicated in your testimony that depend- ing on how you count, there is either the fourth or the fifth Grand Jury proceeding against Dr. Burzynski. Is the latest Grand Jury in- vestigating materially new information or is it your opinion that they're basically plowing the same ground? Mr. JAFFE. Same case, FDA violations. It's just interstate ship- ment, whether it's legal for him to do it, why is he doing it, It's the same information. Mr. BARTON. In your practice as an attorney, are you aware of any other type of case in which the same individual, for the same circumstances, has been brought before repeated Grand Juries? Mr. JAFFE. No. I mean, I've never heard of 4 or 5 Grand Juries. I would point out that the FDA subpoenas documents from 10 or 12 years ago recently and they already have most of these docu- ments. We've submitted most of the documents they have in trip- licate in terms of IMD's or to other Grand Juries or under other subpoenas, and the problem is they don't even know what they have. So they keep on requesting the same documents. Mr. BARTON. My time has expired. I'm going to recognize Mr. Burr, but I want to ask one question to Ms. Michaels. You were not contacted by Dr. Burzynski. You contacted him. Is that correct? Ms. MICHAELS. That's correct. Mr. BARTON. And in your contact with Dr. Burzynski, did he or his associates in any way indicate that the FDA had approved this treatment?
Page 23: TI14380131
o0 o 38 Ms. MICHAEbS. No. We knew that it was not approved. Mr. BARTON. So you knew that it was non-approved and it was non.traditional. Ms. MICHAELS. Yes. Mr. BARTON. Now, you testified, that your son's medical records have been confiscated by the FDA. Ms. MICHAELS. Yes, they have. Mr. BARTON. Now, how does one treat your son, who I under- stand is ongoing in his treatment, without medical records? Mr. JAFFE. I can answer that. The FDA has graciously allowed Dr, Burzynski to come to their office to look at Mr. Michaels' medi- cal records. Mr. BARTON. So the records that have been confiscated for this patient and others are still in Houston, Texas. Mr. JAFFE. Yes, and Dr. Burzynski can go to their office, the FDA's office and look at his own medical records. Mr. BARTON. My time has expired. I would recognize the gen- tleman from North Carolina. Mr, BURR. Thank you, Mr. Chairman. Mr. Wright, during the civil litigation over whether the Sensor Pad was a device, did the FDA ever seek an injunction in court to stop the distribution or use of the p.a.ds because there was an imminent threat of safety? Mr. WRIGHT. No, sir, they didn't. No injunction and no other ac- tion to stop the sale of the Sensor Pad. Mr. BURR. Has the FDA ever answered your requests as to why no decision on the salability or approval of your product has never happened? Mr. WRIGHT. No. I would like to have a question sometime--I wish the FDA had been here today. I would like to know someone who has read a PMA or a 510(k) at the FDA. Now, we all submit these things. There are volumes. And we have all of the records in there, but I never can find anybody that's read any of them. Mr. BURR. I can assure you, I can only speak for myself, but I share your frustration in not only how the FDA conducts their business, but what they require to conduct that business and we will address that as these hearings go on. I'm hopeful, with Mr. Wyden's bipartisan help and others, we will look at how we reform the FDA. There was a meeting with a minority stockholder in your com- pany. Mr. WRIGHT. Yes. Mr. BURR. What was the purpose of that meeting, as you under- stand it? Mr. WRIGHT. We finally got the minutes 6 months to 1 year later under the Freedom of Information Act and I couldn't tell that they had discussed much. The thing that really bothered us was the very fact they had a meeting and we couldn't get one. The other thing that bothered us was what if this had been a large corporation and the minority stockholder walks in and says, gee, I want a meeting with you folks and they set it up. Now he gets the information about this feature. Mr. BURR. Was your stockholder aware of the problems that you were having with FDA? 39 Mr. WRIGHT. He was aware we were having problems with the FDA. Probably thought he could walk in there and solve all the problems, which he did. Mr. BURR. Is he currently a source of capital for your business or has that dried up? Mr. WRIGHT. No, he is not. Mr. BURR. In your statement, you reference to a meeting that took place between the Justice Department, FDA attorneys, your- self, and possibly your son and you quoted in your testimony "No matter how or for what you market this product, the FDA will come after you." Sir, is that your recollection of the statement that was made or is that accurate? Mr. WRIGHT. I want to get one thing clear. I was not at the meet- ing. My son, Grant, was at the meeting and I used the word "we," although I was not personally at that meeting. But I've seen the records, I've seen their notes, and I've seen the attorney's com- plaint to the FDA, and everyone told me what was said. We were asking, well, can we sell this for a massage tool to mas- sage your legs, can we use it for this purpose. FDA responded, ab- solutely not, we don't care how you package it or what it's used for~ we're coming after you. Mr. BURR. So based upon the information you have, that quote is very accurate. Mr. WRIGHT. That's true and correct. Mr. BURR. Ms. Gorman, let me ask you- Mr. BARTON. Would the gentleman yield on that point? Mr. BURR. Yes, I will. Mr. BARTON. It's my understanding from staff information that the individual attorney that made that comment has been reas- signed, conveniently, out of the city. She's one of the individuals that we had asked to interview. Mr. BURR. I hope that we'll exercise any option to bring them in, Mr. Chairman, or her in. Excuse me. Ms. Gorman, I know that the chairman asked you do you still have your Sensor Pad. Do you still use your Sensor Pad? Ms. GORMA~. Yes, I do. Mr. BURR. Have you ever heard or seen any statements about the product prior to purchasing it that suggested it would replace any other means recommended for breast examinations? Ms. GORMAN. No. Mr. BURR. So to your knowledge, as a user as an owner of one, that was not driven off of any assurances that the manufacturer, in this case Mr. Wright, made about the product. Ms. GORMAN. Not at all, no. Mr. BURR. Mr. Jaffe, let me ask you just a few questions. I un- derstand that over the course of their efforts to get Dr. Burzynski, the FDA used improper and unethical legal tactics and that a court judge issued a cease and desist order against the FDA in 1985, or- dering the Agency to stop issuing false and misleading information about Dr. Burzynski. Is that fact true? Mr. JAFFE. That's correct, in 1985. Mr. BURR. What type of information?
Page 24: TI14380132
4O Mr. JAFFE. Basically, that it was a subject of an ongoing criminal investigation for FDA violations and trying to dissuade people from undergoing his treatment. Mr, BURR. In the third Grand Jury case, was an Assistant U.S. Attorney presenting the case removed for abusive use of subpoe- nas? Mr, JAFFE. He was removed and he did abuse the subpoena proc- ess. The government said that it was part of a general shakeup, but they couldn't identify any other U.S. Attorney that was re- moved or anything else about the staffing issues. Mr, BARTON. The gentleman's time has expired. We will have an opportunity for a few additional questions, if the gentleman still has additional questions. Mr. BURR. I do, Mr. Chairman. Mr. BARTON. Okay. The Chair would recognize, for a second round of questions, the ranking minority member, Mr. Wyden. Mr, WYDEN. Thank you, Mr. Chairman. I'll be brief. Mr. Jaffe, to what extent, if at all, is your client barred from distributing peer-reviewed articles on their procedure? Mr, JAFFE. I'm not clear on your question. Mr. WYDEN. One of the things that we're concerned about is ac- cess to information, about innovative medical products and devices. I'm c~trious whether your client has been in any way barred from distributing promotional information about their product. Mr, JAFFE. There are two separate questions, promotional infor- mation and peer-reviewed articles. I would say, as a general mat- ter, as someone who represents many of these practitioners around the country, they do not have access to peer-reviewed publications in this country, as a general rule. In particular, Dr. Burzynski sub- mits his publications to some American journals. The technical articles, biochemistry, in some of the major arti- cles, his publications are just turned down. The criticisms leveled against Dr. Burzynsld are published in the peer-reviewed journals. His rebuttals, by and large, are not. But I would say that that is a problem which I have seen in many of these individuals, not just Dr, Burzynski, As to the promotional materials, which is a separate issue, I think there are issues of Federal and State law. Directing your at- tention to Federal law~ Mr. WYDEN. On this point, has he in any way been restricted in making presentations about his product by the FDA? Mr. JAFFE. By the FDA? Mr. WYDEN, Yes. Mr. JAFFE. No, sir. Mr. WYDEN. Well, I thank you. One of the things that we are looking at, again, in an effort to try to bring about reform, is to make it easier to get information out in credible journals. At the same time, we would like to give the Food and Drug Administra- tion the opportunity, if they have questions about the integrity of one of these journals, to, for example, submit an additional state- ment saying that they have reservations about the article. But I gather that was not a problem. 41 Mr. JAFFE. I would say, affirmatively, sir, I don't think that his problems with peer-reviewed journals are directly related or caused by the FDA. Mr. WYDEN. Okay. I thank you. Mr. BARTON. The Chair would recognize the distinguished mem- ber from New York and, before that, indicate that since there is only one Democrat presently attending the hearing, the Chair al- ternates back and forth between sides, that's why Mr. Wyden had a second set of questions. Mr, Frisa. Mr. FRISA. Thank you very much, Mr. Chairman. I'd like to ad- dress this to the entire panel. Is there any established procedure by which someone with a product or a treatment or a procedure that falls outside that which is approved and is established and is tried and true for an innovation for something, again, that falls outside the normal categories to be brought to the attention of the FDA, to say this is different, please listen to our innovation. Mr. JAFFE. Up until a few years ago, there was no vehicle what- soever, and I think that's one of the problems with the leDA regula- tions. They treat everyone the same. And it's well a~.d goo.d if you're a multi-zillion dollar drug company and have the $200, $300 or $400 that it takes to get a drug approved. But if you're a small company, it's very difficult. I know the Congress, through the auspices of Senators Harkin, Daschle and others, have enacted this bill relating to alternative medicine. That has some of its problems now, but you now have an Office of Alternative Medicine which somehow helps. By and large, that's one of the problems. They treat everyone the same. Throughout history, basically, many innovators have been people sitting in basements somewhere that come up with an idea and the problem that I see, just as a theoretical and legislative matter, is that there is no vehicle in the FDA to recognize these kinds of peo- ple, and I think there needs to be. Otherwise, what you're going to have is all research done in institutions. And that's why, after how many hundreds of billions of dollars in 30 years, we don't have a cure for most kinds of solid cancers, because they all get the money. It all gets channeled in there and you have to get through all these processes and there are all these people out there who have interesting ideas that aren't getting tested. So I think you have identified one of the major problems in the drug approval process, and I think it's structural and it needs to be changed. Mr. FR~SA. I think it's obvious that most organizations resist change. I guess it's apparent in this case that there are very seri- ous implications for the way they go about resisting change. It appears to me that the FDA seems to do it with a vengeance. In the case of the Michaels, had you allowed yourselves to be in- timidated by either the fact that this is not a traditional treatment or that there might be consequences for going forward, there might have only been one of you here today. That, I think, is the tragedy, for an Agency that's charged with ensuring the health and safety of Americans. I'd like to see a warning label that the FDA may be harmful to people's health and safety. I just think it's a sorry state of affairs. I'm brand new to the Congress and it just seems agency after agen-
Page 25: TI14380133
42 cy, whether it be the EPA or the FCC or the SEC and the rest of the alphabet soup of agencies and offices that had, at their cre- ation, a very noble and purposeful intent to be a positive force in our government, have just gotten so far away from where they should be. I really thank each of you for making the effort to be here to share with us some of the excesses that need to be corrected so that others don't have to suffer the health or emotional or economic con- ~equences, and so we can get back to basics and finally, at long last, bring some common sense to this town. It's long overdue. Mr. Chairman, I yield back. Mr. BARTON. We thank the gentleman from New York. We'd now recognize the gentleman from California for 5 minutes. Mr. W~IVL~. Thank you very much, Mr. Chairman. I'd like to ask members of this panel about some possible fLxes on the prob- lems that you've outlined at the FDA. Would stronger, more activ- ist management help, particularly if it broke down the turf con- sciousness at FDA? Should we have an independent advisory com- mittee become stronger to deal with the current problems at FDA? Do you think we ought to have an appeal mechanism within or independent of the FDA or do you think FDA, which has put in an ombudsman in response to the generic drug scandal, ought to ex- pand the role of that ombudsman? What recommendations do you have for us as to how we can fLx the problems that you've outlined at FDA? Mr. Wright, do you want to start? Mr. WRIGHT. Yes, Mr. Waxman. I feel that the FDA, as an Agen- cy, is a good Agency. We need the Agency. I'm not here to say abol- ish it. I'm saying we need it for our own protection. But I think there's a lot of people within the FDA--and I'm not talking about Dr. Kessler, I'm not talking about the other people at the top. But there's too many people at the bottom not doing their job. They're not being managed properly. Mr. WAxi~. So management is a problem you would single out. Mr, WRIGHT. Management is the problem. The attitude is the problem. The attitude that we're here to help you, not we're here to put you away. We need a change of attitude. How do you change people's attitudes? I don't know. , Mr. BARTON. Would you yield? And Ill give you additional time. Are you s,a.y.ing, is their attitude today they're here to help you or is their attitude today we're here to put you away? Mr, WRIGHT. Down below, the attitude is still the same as it was in 1985. Mr. BARTON. Which is? Mr. WRIGHT. We're going to get you. Mr. W~. So in 1985, the Republicans were in power and now the Democrats are in power. Mr, WRIGHT. This is all funny, but this all started in 1985 and that was even before the generic scandal. Mr. W~xI~. Well, let me hear some other thoughts from mem- bers of the panel. Strong management is a suggestion and seems to me to make a lot of sense. Mr. JAFFE. If I may. I think that what this device shows is that somewhere along the line, there are people that are making the de- 43 cisions that just don't have any common sense. Sir, I would submit that if you were at the FDA, in charge of this, you would have ap- proved this in 2 minutes and I think that any normal person would. Whether this is a structural problem, it's hard to say. But what I've seen in some of my interaction is that there really is just a fun~ damental lack of common sense in terms of something like this or drugs which-- Mr. W~. So do you think there ought to be a ombudsman or appeals process if somebody is not acting in a way you think is appropriate? Mr. JAFFa.. I think people outside who, let's say, aren't wedded to the institution, who have a different perspective, something maybe that Congressman Frisa was talking about, just common sense. I mean, any one of your legislative assistants or any of the other legislative assistants probably would not have dealt with this particular situation the way it was dealt with. Mr. WAx~. We on this panel, I think, all have common senses but we reach different conclusions. Mr. JAFFE. About this device, sir? - Mr. W~. I'm just talking about the job and doing our job, We hear information and we gel input and we look at it from per- spectives that we have philosophically and representing our con- stituency. Of course, FDA, they're looking at it scientifically, pre- sumably from what is good science. Scientists, Lord knows, dis- agree with each other all the time. Mr. JAFFE. Maybe that's the problem, though. When you take a product like this, who cares? It's not going to hurt anybody. If a drug is completely non-toxic, I think that's one of the points that I've made in writing is that there ought to be included in the effi- cacy requirements some kind of factor of risk of harm. The more harm a drug can cause, the greater the efficacy requirement ought to be. Conversely, the less harm or no harm, maybe you shouldn't have an efficacy requirement at all at this stage or maybe there ought to be post-marketing trials. That's just one idea. Mr. WAXMAN. People can disagree on that, because I know from my own experience that a lot of people said that Laetrile didn't do anybody any harm, per se, but if somebody would use Laetrile, which turned out to be absolutely useless, instead of something that was really important to deal with their cancer, it is doing harm. So from my point of view, we disagree. We have disagreements on this subcommittee as to whether we ought to have an efficacy requirement at all or how strong an efficacy requirement. That doesn't mean, however, that we're acting in bad faith. We have dif- ferent points of view. Thank you, Mr. Chairman. Mr. BARTON. Mr. Burr, we're going to recognize you for two or three questions. Mr. BuPm. I'll be very brief, Mr. Chairman. Let me also say that I'm back and I'd like to enter into the record the Sensor Pad man- ual. On the back of it, it says "This product makes no explicit or implied claims to find breast cancer, breast lumps or any other type of breast disease."
Page 26: TI14380134
o0 o 44 Mr. BARTON. Without objection, so ordered. [The information follows:] Indications for Use: The Sensor Pad@ is indicated as a lubricating aid lot Breast Sell- Examination (BSE) pedormed subsequent to BSE as prescribed by your physician. Warnings: Report any changes detected during either the conventional breast ex- amination or the subsequent breast examination using the Sensor Pad to your physician for proper diagnosis. Breast self-examination is not a replacement for clinical breast exam or mammography. Precautions: Do not use the Sensor Pad@ in the shower. Caring for Your Sensor Pad If ~e P;~d becomes soiled, iust rinse it under warm water and let it dry I.,..~, ....... . .,.THIS PRODUCT MAKES NO: .:.. '!~!'~P~CI.T...,OR IMPUED CI~AIM.',.TO EIND .- | ~: ANY OTHER.~P E OE, BREAST; ....' ...',.-.~:-,.,..:~;~..,..~. :~...~.~.'.:.'<'....~...." ~ .:~:::.~.::~',,'":.~::'< .~:::;...:~ .'..,:......'~'.,.~..:~ U,S, PATENT # 4.6~7,02! ~nd 4.7~},354, INVENTIVE PRODUCTS INC. P.O. Box 51. Decatur. IL 62525 Mr. BURR. Ms. Michaels, let me jump over to you real quickly, if I could, and let me start off with I have a son 10 and a son 9 and I know exactly where your statement comes from. I believe it comes from the heart and I'd make one that was every bit as com- pelling. Has the FDA or the Justice Department ever contacted you or any member of your family or physician not connected specifically with Dr. Burzynski in this case? Ms. MICHAELS. No. Mr. BURR. Has Dr. Burzynski ever made assurances to you or your son about the potential success of his medicine while you've been treated? Ms. MICHAELS. No. 45 Mr. BLrRR. Now, I understand that you live in Michigan. Ms. MmHA~LS. Yes, we do. Mr. BURR. Dr. Burzynski is in Texas. He cannot ship that prod- uct out of the country. How do you access it? Ms. MICHAELS. We go down and get our medicine. Mr. BURR. You go to Texas and get that medicine. Ms. MICHAELS. We bring medicine home. Mr. BURR. Mr. Chairman, I plan to write the Justice Department to ask for a copy of the MRI's of Paul Michaels. I would also ask unanimous consent that if that request is not fulfilled, that we sub- poena those so that every member of this committee can see the films and to see whether, in fact~ Mr. WAXl¢~. Reserving the right to object. Are you asking for a unanimous consent request for a subpoena? Mr. BAR¢oN. Well, the chairman will stipulate that they're not going to be accepted in a unanimous consent request for subpoenas, Mr. WAXMAN. I would hope not. What a way to conduct a com- mittee, to have suddenly, with people out of the room, ask unani- mous consent. Mr. BtmR. I would hate not to try something that I would feel confident you would if I weren't here. Mr. WAXMAN. I wouldn't do it. I wouldn't do it. Mr. BARTON. The chairman is new to the chairmanship, but the chairman has studied the rules and understands them, We will at- tempt to get the information through normal channels, not just for the gentleman from North Carolina, but for all committee members who wish to avail themselves. Mr. BURa. Mr. Chairman, just one final question. Mr. Wright, do you believe that retaliation has taken place in your particular case with the Sensor Pad? Mr. WRIGHT. Absolutely, with no question. Mr. BURR. Do you think that past and current FDA Admtnistra- tors were aware of that retaliation? Mr. WRIGHT. I don't believe it was done necessarily maliciously or anything else, and especially from those people at the top, no, I think it creeps into the factor. Who knows where it's coming from. We started in 1985. They set the tone and that was long before those first hearings on the generic drugs and the scandals and the payoffs. What was going on at that point? I have no idea. Mr. BURR. Mr. Jaffe, do you believe that retaliation took place in Dr. Burzynski's case? Mr. JAFZ~.. Yes. Mr. BURR. Do you believe that past or current Administrators at the FDA were aware of that retaliation? Mr. JAFFE. I think they're aware of it. Mr. BURR. Thank you. I yield back, Mr. Chairman. Mr. BARTON. The Chair has just 1 or 2 questions and then will release the panel. Mr. Jaffe and Mr. Wright, the current ombuds- man's role at the FDA, in your opinion, does that individual have sufficient authority to enforce change if and when that individual thinks that change needs to be made within the Agency? Mr. JAFFE. I would say that that's a structurally inadequate res- olution. I think it has to be imposed from outside. Mr. BARTON. Mr. Wright?
Page 27: TI14380135
o 46 Mr. WRIGHT. She was present at a meeting last week and, no, she either doesn't have enough power or she don't exercise enough power. Mr. BARTON. And the final question. Mr. Wright, in your case, to your knowledge, as of today, what is the status of the Sensor Pad in terms of it being approved, number one, and, number two, of your knowledge, are there any pending legal actions being con- sidered by the FDA against that particular product that your com- pany makes? Mr. WRIGHT. Not that I know of, no. Mr. BARTON. And in terms of the status of the review, do you have an active file at the FDA that the Sensor Pad is still subject to review and hopefully to be approved? Mr. WI~IGHT. We had a meeting, like I said, last week where we came to conclusions, reached some decisions about a study. We fi- nally had come, I believe, to a study. I presented a protocol that I think they're going to accept, I hope they accept. I can get a new PMA on file within 3 weeks with no problem, or a 510(k). I don't care which way they want to go. I'll do everything I can, I'll bend backwards, but we have to have fast action. And I don't mean fast action is 6 months. Mr. BARTON. Finally, if I take this Sensor Pad home to Texas to my wife, am I violating any law and would that get your company in trouble? Mr. WRIGHT. I think I may be violating the law for bringing them here. Mr. BARTON. Beg your pardon? Mr. WRIGHT. I may be violating a law for bringing them here. Mr. BARTON. So if I actually take this to my wife and ask her to read it, I may get you in trouble. Mr. WRIGHT. Yes. Mr. BARTON. Okay. We're going to excuse this panel. The com- mittee is going to recess until 12:15 p.m. and we will hear from our second panel at approximately 12:15 p.m. Mr. Wright~ Mr. WRIGHT. May I make one more comment~I ~m very sorry that the FDA didn't show up here today. I was really looking for- ward to it. I feel that they had as much time to respond to this meeting as I did. Mr. BARTON. More so, actually. Mr. WRIGHT. And they have a lot more personnel than I have. So why they can't be here I don't understand. Mr. BARTON. Thank you, sir. You're excused. [Brief recess.] Mr. BARTON. If the committee could please reconvene. At this time, we would like to hear from our second panel. We have Mr. Roland Jankelson, Dr. Dane Miller, Mr. Reginald Cassagnol, Dr. Robert Watkins, and Dr. Gary Michelson. If each of you would please come forward and be seated. Before we begin to take testimony, each of you should have been made aware by the staff that it's the tradition to take all our testi- mony under oath. Are each of you willing to testify under oath? [Chorus of ayes.] Mr. BARTON. I think you also know that you have the right, under the Constitution of the United States and the rules of the 47 House of Representatives, to be advised by counsel during your tes- timony. Do any of you so wish to be advised? [Chorus of nays.] Mr. BARTON. Then would you please stand and raise your right hand. [Witnesses sworn.] Mr. BARTON. Be seated. Before we take your oral testimony, I'd like to introduce you to the committee. Our first testifier is Mr. Ro- land Jankelson. He's one of the owners of a small medical device manufacturing company located in Washington State. For 25 years~ his company has had a perfect product safety record and compli- ance history, until 1991 when the trouble with the FDA began. Mr, Jankelson will tell the story of his troubles and how he was forced to lay off over half of his employees because of problems with the FDA. Then we will hear from Dr. Dane Miller. Dr. Miller is President, CEO and co-founder of a company called Biomet, Incorporated~ which is located in Indiana. Its products include joint and bone re- placements. The company was founded 17 years ago and until re- cently has had a very good relationship with the FDA. His compa, ny's troubles began after he prepared a white paper relating the experience Biomet had with the FDA regulatory process. He will tell in his testimony what has happened in the last 18 months. Then we're going to hear from Mr. Reginald Cassagnol. He is from Virginia. He owns and operates an aviation business. He has a condition called avascular necrosis of the femoral head in both of his hips. This is a progressive disease leading to the collapse of the hips. Mr. Cassagnol participated in a clinical trial with the non- invasive device called the EBI Avascular Necrosis Treatment Sys- tem, which Biomet markets. He will tell of his personal experience with this device and the concerns that he has about not being able to use it. Then we're going to hear from Dr. Robert Watkins. Dr. Watkins is an orthopedic surgeon from California. He currently practices with the Kerlan-Jobe Orthopedic Clinic. He is an Associate Profes- sor at the University of Southern California. Some of his more fa- mous patients were Charles Haley and Troy Aikman of the Dallas Cowboys, near and dear to my heart. He will testify to his first- hand knowledge of the excessive and, in his opinion, unreasonable clinical trials that one company has had to perform for a device that Dr. Michelson has invented. And then last, but not least, we will hear from Dr. Gary Michelson. He is a practicing orthopedic surgeon in Los Angeles, California. He holds over 100 domestic and international patents, covering both orthopedic implants and the instruments which are used to implant them. Today he is going to give testimony to this subcommittee about how the FDA treated 2 companies differently even though the same device was under review. We'll begin with Mr. Jankelson and then go to your left. Each of your statements is submitted for the record and we would ask for you to summarize it in 5 minutes. Mr. Janknlson.
Page 28: TI14380136
o0 oo o 48 TESTIMONY OF ROLAND C. JANKELSON, DIRECTOR, MYO- TRONICS, INC.; DANE A. MILLER, PRESIDENT, BIOMET, INC.; REGINALD CASSAGNOL; ROBERT G. WATKINS, KERLAN-JOBE ORTHOPEDIC CLINIC; AND GARY K. MICHELSON Mr. JANKELSON. Good morning, Mr. Chairman. I understand that my written statement has been made a part of the record. I appre- ciate the opportunity to testify before the committee today. I be- lieve that my testimony before the Oversight and Investigations Subcommittee will provide another example of the overzealous and outrageous activities of the U.S. Food and Drug Administration. On behalf of all Americans, I wish to thank this committee for the task that it has undertaken in overseeing an Agency which I believe has so little concern for fundamental and civil rights, those rights which we generally take for granted as being the basis of our freedoms in this country and which often, I believe, reflects a lack of concern on the part of this Agency for people who are sick and who are ill. I would like to acknowledge the Medical Device Manufacturers Association, which is, in part, responsible for the invitation and my being here. It is a fact that the FDA Center for Devices and Radiological Health is stifling innovation, sending American companies and jobs overseas and ultimately depriving the American public access to the most state-of-the-art products and, I believe, frequently dooms Americans to sickness and suffering. Myo-Tronics is a small entre- preneurial manufacturing company. We presently employ 13 peo- ple, which is about half the number that we employed just a couple of years ago. The company was founded by my father 25 years ago. For 25 years, it has been a pioneer in developing leading-edge technology for application in clinical dentistry. Prior to what I could only de- scribe as our Orwellian experience for the last 4 years, the com- pany had no problems with the FDA and it has had, for those 25 years, more than 25 years since its inception, a perfect product safety record. Beginning with an exhaustive FDA inspection in 1991 that came out of the clear blue sky, no warning and for reasons totally unre- lated to any issues of health and safety, we have been subjected to a nightmarish sequence of events, including the totally surprised and unexplained lengthy inspection, a warning letter declaring that a.ll of our products were out of compliance, almost total non-respon- siveness in attempted communications with the FDA, a product sei- zure, agonizing negotiations leading to a consent decree, something .that I now consider to be a significant mistake on our part--that is, the agreement to enter into the consent decree--and unprece- dented threat of civil penalties after we had entered into the con- sent decree and after we had brought ourselves into full compli- ance, even in the eyes of the FDA, an FDA ~lental products panel whose work even the FDA has rejected that recommended the harshest classification for the company's products, even though these companies are absolutely non-invasive and, in 25 years, have never prompted a claim with either the FDA or with the company by any doctor or patient using our instruments. 49 The company's history with the FDA over these last 4 years is an example of the FDA's arrogance, adversarial attitude, mis- behavior, overzealous regulation, possible criminal activity, unwill- ingness to investigate itself and punish misbehavior within its own ranks, and what the company feels is a case of a Federal Agency aiding and abetting a small outside gr~oup whose agenda has been to put these types of instruments out of the marketplace. The details of our company's experiences during these past 5 years under FDA Commissioner Kessler's regime are set forth in the written record and in great detail. I think everybody associated with this kind of hearing understands it is very, very difficult to do more than just touch very, very lightly on experiences that are very personal, very stressful, and cover such a wide-ranging series of events, activities, misbehavior. I believe you will be astounded at the outrageous abuse and mis- use of authority which we have endured. Such abuse and misuse transcended incompetence, carelessness and arrogance. It was all of that, but it is our position that the acts documented in the record before you reflect more, reflect a deliberate calculated effort of cooperation between certain FDA officials and employees and outside private interests to improperly and illegally remove the company's instrumentation from the marketplace. We have asked the FDA to investigate these acts to determine whether they violate criminal statutes. As you evaluate our story, please keep in mind these four facts. Until the FDA launched its attack in 1991, for almost 25 years, our company was a model of regulatory compliance, even in the eyes of the FDA. Two, in over 25 years, our company has never had a single claim or complaint, not one involving an issue of product safety, Three, all of our measurement instrumehts are declared safe and effective by the American Dental Association Seal of Acceptance program, And, four, during the entire period from the surprise inspection in 1991, the warning letter that followed, the product seizure, and the consent decree, the FDA never once--never once raised an issue of product safety. The extent to which-- Mr. BARTON. Mr. Jankelson, we've got four other panelists, So could you summarize in the next minute? Mr. JANKELSON. I'm just about at the end. Mr. BARTON. Thank you, sir. Mr. JANKELSON. The extent to which or even if the conduct of the FDA rises to the level of violating criminal statutes, it is a matter that will have to be addressed by appropriate authorities. What is absolutely certain is, one, illegal acts occurred. There were many such acts in many different forms during a long and continuing ex- panse of time andthey were deliberate. Two, the Office of Chief Mediator and Ombudsman has avoided its responsibility to investigate and punish the acts of which I speak specifically in connection with a 1994 advisory panel meeting which was rift with irregularities and, we believe, crimin~ mis- conduct. I have heard the reference or the statement in this hearing that the FDA has informed the committee that it is not aware of any cases, other than the one, which happens not to be ours. I would
Page 29: TI14380137
5O like the committee to know that in November of 1994, the FDA was served with notice of our concern over the irregularities concerning the panel meeting. On January 31, it was provided a 32-page detailed document, laying out improprieties that obviously suggested criminal mis- conduct. As of this date, we have absolutely nothing back from that office other than assurances, which happened to come yesterday-- again, a coincidence--yesterday, that the investigation was con- tinuing. I do not believe that the Office of Chief Mediator and Ombuds- man is a solution. I believe, in our case, it is part of the mis- behavior. Thank you and I will be happy to answer questions. [The prepared statement of Roland C. Jankelson follows. Attach- ments to the prepared statement are retained in the committee files.] PREPARED STATEMENT OF ROLAND C. JANK~LSON, CO-OWNER, DIRECTOR, MYO- TRONICS, INC. My name is Roland Jankelson. I am one of the owners of a small medical device manufacturing c.ompan.y. The Company has been in existence for over twenty-five years. It is the ploneer In the field of electronic measurement technology for applica- tion in clinical dentistry. The company's instrumentation is comprised of four dif- ferent types of technology--computerized jaw tracking, electromyograp.hy, electro- sonography, and transcutaneous electrical stimulation. These instruments are used by dentists who are able, through these advanced technologies, to treat pain pa- tients and for other dental procedures. The instruments are non-invasive. In the more than twenty-five years of the Company's existence, it has never had a single claim or complaint filed with it or the FDA involving product safety. The story I am about to relate covers our experience with the FDA from 1991 to thepresent. It is a story of outrageous, overzealous, and, we believe, illegal behavior by FDA officials and employees. And yes, it is a story of retaliation and retribution. It is about cover-up and the FDA sweeping its misconduct "under the rug~'. It is about an apparent willful and calculated campaign by FDA officials to help persons outside of the FDA inflict harm on our company. It is about a deliberate perversion of the agency's authority. And finally, it is a story about how a company finally de- cided to stand up and make public these, OrwelItan experiences, even though we believe that we will be a target for further retaliation by the FDA for having told our story. It is also a story of real people~our employees, the doctors who use our instru- mentation, and the patients they treat. Prior to 1991, the company employed twen- ty-seven people. It was growing and profitable. This permitted an expanding sco- ne.talc opportunity for our employees, and capital for investment in research and de- velopment. Because of the damage done to our company by the FDA, our employ- ment now stands at about half of its earlier level, and we are hard put to find the resources to properly compensate our talented peo]ole. Our efforts to defend ourselves against the FDA's activities over the past four ~ears have drained huge amounts in legal fees from our small company. Even more evastating, a high percentage of its management manpower has been almost con- tinually engaged in the non-productive effort of defending the company against the FDA onslaught. The negative publicity resulting from these FDA attacks has re- duced sales to a fraction of previous levels. Insurance companies and their consult- ants have seized upon the FDA's actions as reason to deny benefits for needy pa- tients. Patients are being denied the benefits of the Company's instrumentation be- cause of withdrawal of insurance coverage. To understand how it has come to pass that persons inside the FDA have con- spired with outside private interests, it is necessary to understand the long and con- tentious history of efforts by a small group of dental academics to discredit elec- tronic measurement instrumentation, and eliminate it from the marketplace, and how this group, first working through the American Dental Association and then the, FDA, has worked tirelessly to remove electronic measurement instrumentation from use in clinical dentistry. The history of the activities of this group is docu- mented in detail in a compendium prepared by The American Alliance of TMD Prac- titioners, dated June i0, 1995. 51 .... ,~ and how the FDA has par~cipacea in raus p_e.rve.rsma ~, .... ~., ~*:~P~a~Y~,¢¢.,4. h.. ~ ~cade~cs ~ prevent ~e ~A t~m aw~mng ~ ~c~e~- ~%~ ~':~ .:~_~.~:Z =]~ ,f o~r m~s~ement de~ces have been aw~ded ~h aRcs ~e~s ~ o~ pr~u~, ~ ~- : . i~ents ~o~h ~e ~A, ~ese academics ~en ~ed ~ the In Aunt, 1991, two FDA ~pec~rs ~ppeamd at ~e compan~s d~r, flashed their FDA Ins~ec~r badges, and i~tia~a a se~es of e~ents ~at defy belief, Our ~ghtmam had be~n. At ~at t~e, fo~ products were covered by pm-m~ket no~cafio~ (Sl0k) nnd one product was ~aSered, as it had been on the market sin~ before 197~, The Comply ~d a me~c~ous record of re~a~ cow, fiance since i~ inc~ption~ and ~n~i~n las~ we~ over ~en~y man aays~ ~e ~ompany r~vsu ~ ~ . s ~ ~-'-~--z~---~na that NO~ of i~ ~rodu~s were coverea ~y i~ ~u~n~ empl~ m~r~ of over ~en~ yearn duration, ~ one megmty m~eung l~s uc~l T~s ~ed ~ont ~e FDA e~er once que~o~ng ~e safety or s~ca~ ~ese i~t~en~. s~n~e, but ~ avoid a protrac~a ann cos~y ~eg~pu~, ~e a~e~,m r~y~. 510k~s as ~q~reffby the W~ing_~r. '~:ne.~s~ o~ o~r e~:o~ ~___~u~_ _ eve~ conceivable ~q~rement se~ ~o~ i~.~ng.~z~ a~mya,~a ~- M~ch 27, 1995 let~r ~ ~e Senile Dismcz ~mr o~ me ~~A, Tins ~et~r is a ~s~ ...... ~-~-- ~* .... ~on~ ca~" ~olicv w~, we have sin~ been ~m~ me ~o~ssioner had ~pos~d upon ~s ~eney. The Agene~s ~t~ eo~u~e n ~th ~ d~ng ~s pe~od, ~ ~e ~n~ ~t ~ we~ ~bl~ o~ o~n reflec~d ~e, ~encfs lack of unaers~anmng, ot m~ttcan~ ~ssues. ~'or ex~- ple, ~ Au~st 1992, ~ee mon~s ~r f~ng for a new 510k for the Company m~or pr~uct, ~e company re~ived a let~r ~om ~e FDA objee~ng ~ s~ specifi~ c1~s. The Company promp~y responded on Au~st 28, 1992, pointing, out ~e el~s ~ w~ch ~e F~A was ~I~n~we~ ~e~ from ol~ Her model of a different ms--end, ann never ~a appear m me womH ~ " erase for ~e product baln~ ~ewed. • ............ ~- VDA "'~ a In D~ember, 1992, ~e ~o~9~y r~ce~vea ano~r ~e~ ~m ~[_~ uns~eee. ~me ~d phone nm~e[ ~.c~x.we ng? ~y ~p~._~y £~2. fd effo~ ~ contact ~e In~au~ ~eeo m ~e e~A le~wr~ m~ ~ou~Ha~ tvop in ~fing ~ ~ s~e ~at a re~po~se ~as ~de~fpre t~e ~stya[:~ Without any ~r commun~catton from ~ ~A, ann ~mouu any oumr to,,t notice, on Aunt 9, 1993, two U.S. Mamh~Is and an FDA i~pec~r ae~ed an rest w~ant on ~e Companfs major product, ~d seized ~e product invents, mestie sMe, but Mso seized products clearly m~ea xor expo~t ann ae~ons~, use, despi~ o~ pm~s~ that ~ey had no legM ~ght ~ ~ke ~e e~o~ ann aemo u~. We ~me ~ reMize how unconce~ed ~th ]eg~ t~a ~e FDA is when in~ems ~th ~e~ ~n, ra~er ~an fight, we chose ~ c~pera~ ~ the FDA. ~r an ago~zing pe~od of negofia~on ~ a be~igerent and unresponsive FDA, the Comply ~md into a Consent De=ee under which it a~eed ~ forego ce~n cl~s, and ~scon~nue ~pping product while reused 510k applica~ons were being re~ewed by ~e FDA. ~ p~ of ~e renew process, ~e Company sub~t~d doc~entaflon demo~trat~g the e~s~nce of p~or ci~s ~ w~eh ~e Company was leggy enti- tled, but ~e cl~s were refused by the renewer. ~n ye~e~e~ ~t does not feel constrained by ~e law. ~ an aside, ~mugnou~ mt ot mls penoa ot non-commu~cation, negofia~on, and implementation follo~ng ~e Consent Decree~ a 510k for another of o~ produc~ remained in the FDA's renew process for 8~0 days afar i~ttM fding before fm~ly being issued. ~though we e~ec~d that the Consent A~e~ent wqdd e~ our or.d~ .we,~oop l~ed o~e~se. The FDA was far from fi~shed ~ta us. The ne~ fDA at~c~ oceu~ed in Oc~ber, ~994. The Agency convened a Dent~ Ad~so~ Panel to sider classificagon of 'muscle mo~todn~' de~ces, and ~en fllegMly 9~panded the scope of the deliberations ~ include all of ~he products man~act~ea oy our com- pany and o~ o~y comp~fi~r. Inciden~lly, this decision ~ expand ~e scope ~ In- dude Ml of ~e company s inst~en~ oceu~ed during the meeting, a~r mdusfl~
Page 30: TI14380138
52 representatives had testified, but only on the one instrument for which the Panel had been advertised. Anti-instrumentatlon testimony w.as t_hen .allowed on .ai~l f, vu, r product~. To this day, the FDA will not explain why this Panel was assemmea ~o consider just four types of products, when there ~are over, th~.'rty types of..electro,.nlc devices used in the treatment of TMD. These tour pronucr~ comprise me enure product line of our company, and am manufactured by only one other company, in fact, the evidence allows only one conclusion: the October Panel Hearing was a de- liberate attempt to irreparably damage the Company and its products. The multiple events of blatant misconduct are thoroughly documented in a fifty-two page letter of complaint filed on behalf of the two companies with the Office of Chief Mediator and Ombudsman on January 31, 1995, which has been made a part of the record before this Committee. In connection with this Panel, the Panel relied on witnesses with known biases; the anti-instrumentation witnesses were not trained or exp.eri- enced in the clinical use of the instrum.e.ntation; witne.sses presented false, .uns%e.n- tlfic and unsupportable testimony; anti-instrumentation witnesses were g~ven proportionate time and the testhnony of one of the industry .witnesse.s. was,leake, d to at least one anti-instrumentation witness in advance of the meeung; me sole Consultant chosen was a known adversary, who has not practiced for at least ten years and is not ~r~ned or ,e,,x~erienced in the use of the iustnnnentation for which he was the Panel s so-called Consultant (he is one of the anti-instrumentation aca- demics of whom I have spoken). The Panel's Chairman was a losing party in patent litigation with our company, involving one of the very products which the Panel was considering He had also been involved in a contentious business relationship with the only other compa.ny who, so produ~cts ,we,.r.e..aff~ected, b~ the Panel'~s. cens!~d~er~a_~_en~c~ The Panel members themselves promssea nine l~nowle~ge or exper~se .yam to the instrumentation in question. The Panel recommended that the instruments be classified as Class III, a class reserved for the most dangerous products. The FDA, under pressure of complaints from the two affoc.te~., companies, ha.s agreed that it will not use the Panel's work or its recommendations, r~owever, ~t has side-stepped the significant issues of misconduct and, we believe, criminal acts, ln~tead acknowledging only procedural irregularities having to,~o with inadeq,ua.te public notice. We believe that this was a deliberately contrived .lv~ngaroo court m- tended by certain FDA employees to insure that the two compames could not con- tinue in business. It was clearly never intended to be a fact finding process. In this regard, I have included in the record before this Committee a letter obtained through the FOI process. This letter was wr~_ttan b.y .Dr,. Ch.a.r. ].es .Greene: f.o.r ye .a~? one of the leading academic antagonists, and a pnnmp.m heSS testifying before the Panel, to the Executive Secretory zor me ~en~ rroaucm Panel and the Chief Reviewer sitting in judgment of the Company's 510k applica- tions. The letter demonstrates the incestuous prior relationship existingbetween Dr. Greene, Dr. Mohl (subsequently named as the Panel Consultant) andkey FDA em- ployees who would then be involved in canductin~ an official Federal Advisory Panel meeting which would have the fate of the subject instrumentation, and our own company, in its hands. We were soon to learn that the FDA had further punishment in store for our com- pany. In March, 1995, we learned that the FDA was considering the imposition of civilpenalties. In fact we now know that civil penalties were recommended by the Seattle District Office in August 1992, and in June, 1994. In the words of one Dis- trict FDA Official: "the Company needs to be punished'. We understand that the purpose of a warning letter is to notify a company of FDA compliance concerns, pre- sumabl~ so that the company can address them. We are advised by our counsel that the position taken by the FDA in our case regarding product shipment following a Warning Letter is highly unusual--unprecedented, in fact. Clearly, our company continued to be singled out. We believe that only our aggressive efforts in document- ing and exposing the past four years of FDA misconduct prevented the FDA from following through with its threats of civil penalties. We know that there is no way that we can be made whole for the damages that have been inflicted on the Company during these past four years; no way to recover the time devoted to defending ourselves; no way to recover our legal fees; no way for our employees--those who remain--to recover lost wages and benefits; no way doctors can provide retroactive relief to patients who were denied insurance cov- erage because the FDA's actions were used improperly by insurance consultants; and-no way in the foreseeable future to restore the credibility of the Company's in- strumentation lost because of the negative publicity and misinformation resulting from the FDA's activities. What we can do is help you understand how perverted the FDA and its processes have become. I ask that you give no credence to assurances from the commissioner 53 that adequate changes have been, or are being made from within the Agency. Our experience indicates the following: 1. The FDA does not have regard for the legal rights which most of us take for granted, and which are fundamentM to our freedoms in this country. 2. The FDA will not punish wrong doingwithin its ranks. 3. The Office of Chief Mediator and Ombudsman is not an efficient deterrent to FDA misbehavior. In fact, we feel that the unwillinb~_ ess of the Office of Chief Medl- ator and Ombudsmen to act in our case, or, ff it should act in. the future, its delay in taking action, is a significant additional part of the FDA's misbeha~dor in our case. I wish to conclude with a brief footnote which is a positive occurrence. On July 10, 1995, I received a call from a Special Agent, Criminal Investigations, in the FDA's office of Internal Affairs. He has been investigatin~ a limited aspect of the Advisory Panel meeting, but appears inter.este.d in receiwng more information on the total scope of our FDA experience. He has been sent considerable information, I understandthat his office is independent of the Office of Chief Mediator and Om- budsman. I am encouraged, as of now, by his apparent desire to learn more about Thank you for the opportunity to tall our story. Mr. BARTON. We thank you. Again, your statements are all made a part of the record. So try to summarize within 5 minutes. Dr, Miller. TESTIMONY OF DANE A. MILLER Mr. MILLER. Thank you, honorable Members of Congress, ladles and gentlemen. I would like to thank the Center for Patient Advo- cacy for recommending to tl~is subcommittee that we come and speak. I come from the State of Indiana, the home of the Indianap- olis Colts, by the way. I come here to testify with great trepidation. I represent Biomet, a company with 90,000 shareholders, 3,000 team members~ and hundreds of thousands of patients who have benefitted from our total joints, bone healing, trauma, arthriscopic and oral-maxillo- facial implants. I am fearful that what I may say could have an adverse impact on this constituency. I find no fault with the FDA or its employees, but with the proc- ess which you, Congress, or your predecessors caused to develop, The most egregious of the problems with the current process is t]~e withholding of current medical technology from many of our most suffering patients. In an effort to ensure that our FDA prevents corporate and clinical America from compromising the safety of our citizens, Cong~_ess and the FDA are allowing abusive harm through excessive regulatory constraint in the withholding of the most ad- vanced and, in many cases, proven of medical care to America, After following the stories of companies like PhysioControls~ RS Medical and Dew Coming, I am fearful of the potential con- sequences of my appearance at this hearing on Biomet. I look at the Dew Coming story, a company bankrupt by first causing breast cancer, disproven by sound scientific evidence, accused of creating autoimmune and connective tissue diseases, again disproven by ~ood scientific evidence, and now held responsible for some unre- ated cluster ailments of breast implant recipients. This is a sad scenario on corporate America. Let me begin my story by describing what happened in Decem- ber, 1993. I was asked by the Heritage Foundation to publish a white paper on some unusual experiences in our relationships with the FDA. Shortly thereafter, in fact, in late spring of 1994, a sur-
Page 31: TI14380139
54 prising event occurred with our Lorenz Surgical subsidiary in Jack- sonville, Florida. We received a copy of a letter, supposedly signed by an official staff member of the Federal Food and Drug Administration, sug- gesting that our 510(k)'s on 5 different products had been trans- ferred to a newly formed competitor of the company. We could only conclude that the letter was a forgery, but upon checking with the Federal Food and Drug Administration, we were surprised to hear that, in fact, 5 510(k)'s had been transferred to a competitor. After much pain and suffering, we were able, in late 1994, to ob- tain the recovery of our 510(k)'s to allow us to legally continue dis- tributing products that, in many cases, we had distributed for 10 years. Let us now turn to the treatment of avascular necrosis, a disease which Mr. Cassagnol will describe in a few minutes. We have been working on a product which is not yet available for commercial dis- tribution in the United States, which is non-invasive, is an exter- nally-applied pulsed electromagnetic field treatment unit which has benefitted dozens of patients in clinical trials evaluating the prod- uct. We have spent approximately $5.5 million and initially filed our IDE in 1983. Without going into great detail, we have not yet received official word as to the approval or disapproval of our most recently filed pre-market approval application, which we expected, after 18 months of sitting within the walls of the FDA, we expected to hear about. I should point out that there were never any questions of safety with this product. It is a non-invasive, non-implantable product, and is the only non-implantable treatment of av~scular necrosis that we are aware of. The final product I would like to describe is a total shoulder. I'll try to jump to my conclusions as quickly as possible. This is a total shoulder implant, a bipolar implant, which we had hoped to bring to the market 2 years ago or earlier. It is currently in clinical trials in a program that may last, before commercial distribution in the United States, as long as 5 years or more. I don't have time to go into some of the other issues that I have presented in my written testimony, but would hope that members of this subcommittee and members of the public here would take a look at it. ] would like to point out, in closing, that earlier in comments by one of the members of your subcommittee, a suggestion was made that we will be talking about anecdotal events today. I would sim- ply like to point out that when you're talking about hundreds of pa- tients and hundreds of stories of this type, you're not talking about anecdotes anymore. You're talking about data. We would appreciate your support and your help to prevent us from going down the pathway that several quality companies in America have found themselves on through unusual and oppressive behavior of the Federal Food and Drug Administration. Thank you. [The prepared statement of Dane A. Miller follows:] 55 PREPARED STATI~MENT OF DANE A. MIt.LER, PRESIDENT AND CEO, BIO~T, ~s o,po~ty ~ ~s~ before you~ su~£~t~. I ~ ~a ~e ... r, ~r ~. - - ~ - ~ ...... ~- ~f Biomet Inc ~iome~ is a pumic~y nero company ~ ~ • elders. 3 000 Te~ Mem~m and hun~ds 2fthou- pm~a~ly 90,000 sha~h . , . ~ ....... ~ ~ ~ benefited ~om our Term Joint Boas He,rig, 't'ra~a~ ~scopic ~d OrM-M~llofac~M products. I s~nd before you ~th a ~eat of fe~ and trepidation for the future of Biomet, ~r follo~ng ~ s~es of ~o~pa. ~es like PhysmControls and o~em, I ~ fea~ of the cons~uences from this ~mpt at co~c~e c~gcism of our medic~ d~dce re~a~ process. My pu~o~e in appe~ng before you ~day is not as a m~con~nt, but, hope~ly, ~ pro~de input w~ch ~1 ~prove o~ re~lato~,process. I should ~so point out before I go on ~at I ~ proud of m~ Government s e~ly involvement w~ Biomet. In 1978 Biomet w~ founded ~ ~e suppo~ of the Sma~ Business A~stragon through a $500,000 SBA ~ed loan ~ a 1~ ln~ana b~. T~s SBA ~aran~ed never ~ssed a pa~ent ana never recelvea a pa~enz la~ ~ro~g~ouz ~ ~ of ~e lo~. T~ay ~oughout ~e domestic operafio~ of Biomet, we repay that loan in v~o~ fo~ of feder~ ~ revenues ev~r~e da~s..?ha~i~ ~.s~y, combina~on of o~ co~ora~ profit, pa~, ~'l~A anao~ner maerm ~es $500,000 eve~ ~ree days. ~t me ~n my s~ ~s mor~ng sta~ng in D~ember of 199~. ~r se~ng for severM ye~ on ~e He,rage Founda~on's Addso~ Council on ~a~ fo~, I was asked ~ spe~ andprep~e a ~i~ Paper relat~g ~s expe~ence~ made av~able ~ any in~res~d p~e~.~ ~s su~o~e n~ng. ~V jec~ve in pm~ng t~s paper and pumt~y appeanng on pane~s tsomet~es FDA omciMs) m aa~ss re~a~ i~sue~ ~as ~ co~u~cat~ ~ t~e, publi~,~e co~uences of a re~a~ process ~at ~s me o~n ~asea on znee.~erz reacno from Con~e~ ~d a m~w~ch concen~a~s ~o e~xvely on sensatmnMlzed s~es d~ven by the pl~nzi~rs ~. ~t us t~ ~ e~ly s~mer of 1994 reg~ng a s~sing e~ent at our Lorenz S~c~ subsi$~ ~ Jac~on~le, Flo~da. We r~eive~ a copy of a let~r ~t~n by an offi~ at ~s FDA suggesgng ~at five ~ffemnt 510(k) c~aar~ce doo~en~ had been tr~fe~ed ~ a new compe~ng ~st~bution company. These 510(k)s had ~en ob~ned by o~ Loren~ Sur~ subsi~a~ ~om the FDA between 1985 and 1992. ~r evaluating ~e policies re~g o~ers~p of ~se cle~ance~ co~d o~y conclude ~at ~e let~r obtmned I~om one el our c~mmers was romp y a forge~. Upon ~n~cting ~e FDA we were s~p~sed ~ he~ ~at, in fact~ ~ ~r was not a forge~ and ~e FDA co~ed ~e fact that the ownem~pof on 8ep~mber 21, 1994, we Dn~,y were ~o~eo ~y ~ ~H~ )~.~ o~ ~ .~ )~ ~en re~u~e~ ~ us, but o~y if "we have ade~ua~ r~oro~ ~ snow ~na~ this s~e compe~r sub~t~d 510(k)s on iden~c~ro~ucts ~no .~okY~o 510(k) no~ficatmns ~ slightly more ~an four wee~. T~s was a~ a ~e ~nen 510~) cl~ance p~ess ~k many ~on~s under .~o~M ~u~s~n~es, We ~ld ~ more ~ happy ~ pro~de ~y m~r~d pames me ~ se~ o~ aoc~enmuon and coruscations on ~is pec~iar sequence of evep~. . ~t us now tu~ ~ a product for ~ ~rea~ent of a~sc~.ar ~e~osz~ o~ zn~ or~ head. S~ce you ha~e heard, or ~11 he~, ~om a pa~en~ wea~a unaer an mves- figafion~ t~M ~th t~s product, I ~1 ~ot go .~n~. de~s. about ~ ~se~s ~nd ~ ~s~sslng aehfli~ng s~p~s. ~.~ a~s m .aevelop ~ non-~n~ p~sed ~ec~ma~etic field ~ea~en~ u~ ~ ~se~~n ~e e~l~ ~ ~ o~ EBI subsi~. Biomet acquirea ~l ~n e~y 1~. ~ no~ go ~n~. me~e early dens of tMs project, but wo~d o~y point out ~at ~1 e~enses in zne velopment and approvM, p~y ~e re~a~ approval cos~ ~t~ appro~- ma~ly $5.5 ~on. This is a product that, at i~ peak, ~1 pro~ly tre~ ~an 10,000 ~e~ca~ for avasc~ar n~rosis per ye~. ~ a ~m~ o~ 2:DA ~ssion, P~ mj~fion, FBI investigation, quesfio~ of e~cs a~ ~y e~ly events, we finMly, under ~e ~d~ of s~ me~ers ~ m~ ~'p~, ~t~d a reded P~ in ~d-s~er of 1993. We haa ~n pmmou~y.~mo~ ~at ~e c~cM t~als ~th ~s pr~uct were ended and ~at no. ne~ aem~s coma ~ s~pped and ~ed on pagen~ until ~e FDA ~ched i~ concl~smn on.m~ me~i~ ~ab~ oft~s product. ~r a pe~od of con~nuous ~lepnone c~s~ and con~sing co~u~ca~ons about the s~tus of ~s P~, a meeting was ~anged ~th ~e PDA in Janua~ of 1995. The FDA info~ed us ~at we wom~
Page 32: TI14380140
56 be receiving their response letter to this PMA prior to our meeting in Rockville, Maryland about its status. The letter was not provided and we have yet to receive any formal communication from the FDA on this PMA, but have been unofficially informed that the PMA will probably not be approved and that we may have to begin clinical trials all over again. In the meantnne, nearly every clinical investiga- tion site has been inspected as well as our Puerto PAean manufacturing facility and our Parsippany, New Jersey subsidiary headquarters. Adverse findings reports and warning letters have been submitted to EBI and its clinical investigators, respec- tively, following these investigations which solely deal with problems that occurred in tlie early to mid-1980s with this project. It is puzzling to me why acceptable prac- tices that took place ten to fifteen years ago would surface in the last few weeks surrounding this product. The finafproduct currently awaiting FDA approval to be discussed in my testi- mony today is a bipolar shoulder replacement, without getting into a detailed tech- nicaldescription of this product andits benefits, suffice it to say that a bipolar de- sign eliminates fixation problems with the most problematic component of a total shoulder, that component that fits in the scapula, or shoulder blade bone. It also offers eiKnificant advantage in improved stability and reduced cartilage wear when compared to a hemi-arthroplasty or partial shoulder. This particular device was de- veloped with the cooperation of Dr. Richard Worland of Richmond, Virginia. This product was the subject of a USA Today front-page article in May of this year. The bipolar shoulder is made of traditional orthopedic implant materials, and its design has been used for hip replacement surgery for over 20 years. Preamendment hemi- shoulder replacement prostheses to which the bipolar shoulder is similar are Class II devices and have routinely been cleared by the FDA via the 510(k) premarket no- tification process. After two separate 510(k) notifications received non-substantial equivalent determinations, the FDA advised us that the device is Class III, and must have an approved Premarket Approval Application (PMA) before it can be marketed by Biomet. The IDE clinical protocol subsequently approved by the FDA includes 980 patients to be followed for a minimum of two years, including a ran- domized, concurrent control group, which is usually a requirement for drug studies. Meanwhile, we are successfully marketing this shoulder prosthesis throughout much of the world and clinical results indicate superior performance over other al- ternative shoulder products. As a footnote to this story, it is interesting to note that Biomet has transferred the manufacture and distribution of this product to facilities in the United Kingdom. The final activity to be described which appeared to us to be unusually punitive to Biomet as a corporation involved new authority granted the FDA for required post~market surveillance (RPS). It was publicly announced at a meeting attended by the FDA, the American Academy of Orthopedic Surgeons, the American Ortho- pedic Association and others, that the only product in the entire medical device in- dustry thus far identified by the FDA to be singled out under a new discretionary post-market surveillance authority was a "porous plasma spray coated hip pros- thesis." This is technolo~y originated at Biomet over thepast fifteen-year period. A variety of peer-reviewed journal publications, both in the U.S. and in Europe, clearly identi~ this fLxation technology as superior, based on long-term clinical studies, to any other technology in the market place today. In fact, many of our competitors have withdrawnproducts, some of which were approved through the IDE PMA~uroc- ass using other forms of porous in-growth technology based on poor, short andme- dium term clinical results. The porous plasma spray in-growth technology developed by Biomet has, better than any other, survived the test of time. Through the action described above, the FDA has mandated that Biomet conduct post-market surveillance on eight separate hip prosthesis styles, even though the materials and technology are similar for all models. Each model requires a patient population of over 300 separate cases to be followed for a minimum of nine years at a follow-up rate of 80%. History suggests that follow-up rates at this level are impossible over the mandated time permd. Thus far we must follow a total of over 2,400 patients at an estimated cost of $2.4 million. Hip prostheses utilizing alter- native porous coatings (e.g., sintered beads and fiber metal) may be marketed by our major competitors with no post-market surveillance requirement, even though these technologies are supported by clinical data on one stem style only. Even a new company, with no clinicalhistory, can introduce a hip prosthesis with one of the sin- tared coatings into the market place with no post-market surveillance rec,[uirement. Keep in mind as you have heard my stories of recent regulatory actiwty experi- enced by Biomet, we have a slightly less than 10% market share in the orthopedic marketplace today. Furthermore, we have less than a 1% market share in the en- tire medical device field in America. We have been proud of our relationship with the FDA over the past 17~/2 years since Biomet's founding. During the past 18 57 months our ability to communicate and resolve problems through open, unpoliticlzed dialogue with the FDA seems to have changed. In closing~ I wish to emphasize that Biomet wants to compl.y, w~th all F.D.A rules and regulations and work with FDA for the ben.efit of the pa~enzs .we born serve, It is Biomet's hope that, together, we can efficmntly get good medical devices to market by ellminatin~g burdensom~e and~cestly delays .~.at are. not ,b.as.ed ,in safety and efficacy. We at Biomet thanz yo_u mr your attention .ana woum oe nappy to make available to any member of this subcommittee any documents referenced in my comments at your request. Mr. BARTON. Thank you, Dr. Miller. We would now like to hear from Mr. Cassagnol, who I believe is a patient or would like to be a recipient of some of the devices that Mr. Miller just talked about, TESTIMONY OF REGINALD CASSAGNOL Mr. CASSAGNOL. Thank you, Mr. Chairman. I welcome the oppor- tunity to share with you. My name is Reginald Cassagnol, I live in Front Royal, Virginia, where I own and operate my own aviation business. At the age of 33 years, I developed avascular necrosis of the fem- oral head in both of my hips. AVN of the femoral head, as I under- stand it, is a progressive disease leading to the collapse of the hip and, in most cases, it becomes necessary to have a total hip re- placement within 2 to 3 years from being diagnosed. The hip joint is made up of a ball and a socket, The ball part is called the femoral head and is the top part of the thigh bone, There are several conditions known to be associated with the onset of AVN disease, such as chronic steroid use, femora] neck fracture and alcohol abuse. In all other cases, the cause is unknown, What- ever the cause, the blood flow to the femoral head is damaged and, as a result, the bone tissue in the femoral head dies and the tempt to repair and replace this dead bone that the clinical prob- lems arise. The dead bone is reabsorbed faster than it is replaced by new bone. This causes cavities to form in the bone, weakening the struc- ture of the femoral head to the point where it can no longer sup- port the body weight and the femoral head collapses. Severe pain is associated with this progression and the decision to go to total hip replacement is generally made at this time. A series of stages describing the disease progression are com- monly used. In Ficat-I stage, there is hip pain, but no radiographic evidence of the disease. Bone lesions become visible radiographi- cally in Ficat-II stage and stage III. There is clear evidence of head fracture and collapse. Ficat-IV shows narrowing of the joint space and other conditions appear which are associated with the develop- ment of osteoarthritis of the hip. My avascular necrosis was caused by prolonged use of steroid medication to treat Crohn's disease. Crohn's disease is an inflam- matory bowel disease, similar to osteocolitis, but affecting the en- tire bowel and it is characterized by periods of remission and exac- erbation. I was originally evaluated by A. William Dunn, M.D. of the Ashner Clinic in New Orleans, Louisiana. He suggested I consider participating in an experimental program for the treatment of avascular necrosis of the femoral head, utilizing a non-evasive de- vice called the EBI Avascular Necrosis Treatment System.
Page 33: TI14380141
58 In May 1984, I began using the device on my left hip. My left was a stage HI at the time, with some femoral head collapse. Over 50 percent of my left femoral head was diseased. My right hip at that time was considered normal. In September 1984, my right hip was also diagnosed as having AVN disease. My right hip had not collapsed and had less than 50 percent disease involvement and was classified as Ficat-III. I then started treatment on the right side. Initially, my hips were quite painful, but as time went by, the pain decreased. With each follow-up visit to my physician came good news that the disease had not advanced, but remained a Ficat-II on the right and Ficat-III on the left. During the course of the study, I had to stop treatment and restart treatment again due to family problems. I used the device for longer than 1 year. The progression of the disease was halted by the use of the dee vice. Today, llyears after starting treatment, I have no pain in my right hip andonly slight pain on my left hip. I am able to work and operate my own business, participate in sporting activities, such as snow skiing, and have a normal life. I would like to be able to use the device again. My Crohn's dis- ease recently recurred and it became necessary for me to take ster- oid medication for 4 months. Although I am now in remission, I am concerned that my recent steroid treatment will activate the condi- tion of AVN in my hips and that I will be unable to have the ABI AVN treatment system again available for treatment. I feel very fortunate that, at the time, when no treatment other than surgery was available to treat avascular necrosis, the ABI AVN treatment system was available to me. I hope the device will be made available for others needing to be able to benefit from it as I did. Thank you for the opportunity to speak to you on this matter. [The prepared statement of Reginald Cassagnol follows:] PREPARED STATEMENT OF REGINALD CASSAGNOL My name is Reginald Cassagnol. I live in Front Royal, Virginia where I own and operate my own aviation business. At the age of 33 years I developed avascular necrosis of the femoral head in both of my hips, AVN of the femoral head, as I understand it, is a progressive disease leading to collapse of the hip and in most cases it becomes necessary to have a total hip replacement within 2-3 years from being diagnosed. The hip joint is made up of a b~ll and socket. The ball part is called the femoral head and is the top part of the thighbone. There are several conditions known to be associated with onset of AVN disease such as chronic steroid use, femoral neck fracture and alcohol abuse. In other cases the cause is unknown. Whatever the cause, the blood flow to the fem- oral head is damaged and as a result the bone tissue in the femoral head dies. It is in the attempt to repair and replace this dead bone that the clinical problems arise. The dead bone is resorbed faster than it is replaced by new bone. This causes cavities to form in the bone, weakening the structure of the femoral head to the point where it can no longer support the body weight and the femoral head col- lapses, Severe pain is associated with this progression and the decision to go to total hip replacement is generally made at this time. A series of stages describing the disease progression are commonly used. In Ficat I stage, there is hip pain but no radiographic evidence of the disease. Bone lesions become visible radiographically in Ficat II stage and in Ficat III there is clear evidence of head fracture and col- lapse. Flcat IV shows narrowing of the joint space and other conditions appear which are associated with the development of ostecarthritls of the hip. My avascular necrosis was caused by prolonged use of steroid medication to treat Crohn's Disease. Crohn's Disease is an inflammatory bowel disease similar to ulcer- 59 ative colitis but affecting the entire bowel and is characterized by periods of remis- sion and exacerbation. I was originally evaluated by A~ William Dunn, M.D. at the 0chsner Cl|nlc in New Orleans, LA. He suggestedI consider participatingin an experimental program for the treatment of avascular necrosis of the femoralhead utilizing a non-mvasive device called the EBI Avascular Necrosis Treatment System. In May of 1984 1 began using the device on my left hip. My leR hip was a Ficat III at the time with some femoral head collapse. Over 50% of my left femoral head was diseased. My right hip at that time was considered normal. In September, 1984, my right hip was also agnosed as having AV-N disease. My ri~hthip had not collapsed and had less than 50% disease involvement and was classified as Ficat II. I then started treatment on the right side. Initi'ally, my hips were quite painful, but as time went by, the pain decreased, With each follow-up visit to my physician came good news that the disease had not advanced, but remained a Ficat II on the right and Ficat Ill on the left. Du_dng the course of the study, I had to stop treatment and re-start treatment due to family problems. I used the device for longer than one year. The progression of the disease was halted by the use of the device. Today, 11 _years after starting, treatment, I have no pain in my right, hip and oul..y slight pain .~n my .1.ef.t..hip. I am able to wor.k and operate my own business, participate m sport- mg acnwues such as snow skiing and have a normal life. I would like to be able to use t_he device a.gain. My Crohn's Disease recently recurred and it became nec. es.sa.ry for me to take steroid medication for four months. Although I am now in ..nnsslon, I ~ concerned that my recent steroid treatment will reactivate the condl. ~on. of AV~. m m~, ~ps.an.d that I will be unable to have the EBI AVN Treatment ~ys~em agmn avmlaole Ior ~rea~nent. I feel very fortunate that at the time when no treatment other than surgery was available to treat avascular necrosis, the EBI AVN Treatment System was available to me. I hope the device will be made available for others in need to be able to bene- fit from it as I did. Thank you for the opportunity to speak to you on this matter. Mr. BARTON. Thank you. We'd now like to hear from Dr. Wat- kins. TESTIMONY OF ROBERT G. WATKINS Mr. WATKINS. Members of the committee, Mr. Chairman, good morning. I'm Bob Watkins. I'm a physician member of the Kerlan- Jobe Orthopedic Clinic in Los Angeles and an Associate Professor of Orthopedics at the University of Southern California. I'm here today to voice my concern regarding the current state of how the FDA is regulating medical devices and to tell you of my worries about how this is affecting my patients. My perspective is that of a practicing physician and spinal sur- geon. I provide care for a large number of patients with serious spi- nal problems and I want to be able to offer the best available medi- ~eal treatment to my patients. Anything that restricts, delays, inter. res or prevents my offering them the best medical treatment is very difficult to accept. The FDA has negatively impacted my ability to practice medi- cine, and I will present a few simple examples. In recent months, I became an investigator in an FDA-regulated study of an im~lantable spinal medical device. A prospective randomized con- tro~ design was necessary to ensure a timely FDA approval. This is statistical jargon which means that study patients will either be treated with the device or a surgical alternative to which the device will be compared. Patient treatment is dictated by a random process, such as draw- ing a number or like tossing a coin. Such study designs have rou- tinely been used in drug studies without clinical consequence due to the temporary nature of the drug effects. However, in desiring
Page 34: TI14380142
60 these types of studies for surgical implants, the FDA has failed to .recognize the differences between treating patients with an lm~lantable surgical device as compared to simple drug medication. ~pinal surgery is a major medical undertaking and requires months of convalescence and, accordingly, must be performed cor- rectly the first time to avoid unnecessary complications and second- ary procedures. Therefore, this necessitates offering the patient the best available medical treatment, a strategy that does not lend it- self to treatment randomization. Patients ask me what is the best thing to do. They've been in se- vere pain for over 2 to 4 years. They've had failed back operations and failed non-operative programs. They come to me originally be- cause they've been told that I would make a decision based only on what I know to be the best for them. When the time comes for a surgical decision, in order to provide those patients with what I feel is tl~e best treatment, they had to draw a number, running the risk of getting a treatment that I would not recommend as being the best. This has produced a significant injury to our doctor-patient rela- tionships. My last study patient left the office in tears of confusion. It was a brutal experience and a bad intrusion of bureaucratic non- sense in what should be a comforting situation of trust and con- fidence. It's just not the right thing to do and the right way to han- dle these patients. In order to have access to this one particular medical device under study, which, by the way, is already available elsewhere in the world, I had to agree to participate in the study. Subsequent to that, patients have declined to participate in the study. They view the device to be the latest state-of-the-art technique and wanted to receive that treatment and they did not want to be ex- perimented upon. They should not be required to accept an out- moded treatment in order to have a random chance of receiving the new device. Patients who could have benefitted from this device have been denied access through this study mechanism. What is particularly sensitive also is the fact that the FDA seems to have changed the rules mid-game. Another company was al- lowed to conduct a clinical trial of this type of device in which con- current control treatment was required. This means that all study patients got the device rather than some getting an outmoded treatment as a control group. Recently the FDA has allowed this other company to expand the patient population in their non-concurrent control study. Therefore, there is a desirable surgical option available to patients which I am not allowed to provide to my patients. I would argue that the FDA has created a professionally unfair situation. One company has been singled out and held to a higher standard than the competi- tion, It seems that the FDA is punishing one company by giving a competitor an advantage. The device is very simple in itself. It's a substitute for a bone graft, as we know it. Small, hollow tube, three-quarters-of-an-inch in diameter, an inch long. It's filled with the patient's own bone and it's screwed into the disc space to produce a fusion between two vertebrate. Orthopedic devices can't get much simpler than this. 61 It's far less complex than the commercially available rod-based spinal implants and joint replacements that we're all familiar with that are Class II medical devices and not marketed under 510(k) clearances. Another major importance to this device is that it precludes the need for using allograft bone, which is bone from another patient. This can transmit diseases of various kinds and is an unnecessary risk. We need to have timely access to medical devices. We need an FDA that acts with physicians to promote public health, that acts with the medical profession to enhance a trusting environment based on a mutual confidence of the doctor-patient relationship. Thanks very much to the Center for Patient Advocacy for, making me aware of the opportunity to speak. It s a little, obviously, more uncomfortable for me to be here than it is in the office examining patients, but I think it's a very important matter for your concern. Thank you. Mr. BARTON. Thank you, Dr. Watkins. Now, the device that you just commented on, is that the device that Dr. Michelson has in- vented? Is that correct? Mr. WATKINS. Yes, sir. Mr. BARTON. We'll now hear from Dr. Gary Michelson. TESTIMONY OF GARY K. MICHELSON Mr. MICHELSON. Mr. Chairman, esteemed members of the com- mittee, good afternoon. My name is Gary Michelson and I'm an or- thopedic spinal surgeon from Los Angeles. Over the past 15 years~ I have had the opportunity to make significant technological con- tributions to the treatment of those afflicted with various spinal disorders in the form of new implants, instruments and operative procedures. Prior to 1990, such innovations were rapidly converted to im- proved patient care by the 510(k) clearance process. However, since 1990, it is no longer uncommon for such 510(k) clearances to take a year or longer. Worse still, the FDA has chosen to reinterpret the standard of substantial equivalence, such that many products, de- spite being obviously substantially equivalent in form and/or func- tion, are deprived of clearance by the 510(k) route and are subject to the torturous, protracted and expensive IDE/PMA process. This process can delay the approval of the simplest device, a sim- ple bone screw, for example, for 10 years and cost many millions of dollars, as trees are felled and roomfuls of paperwork created. The undue hardship of this process may sound the death knell for many such products. In the end, it is the patients that are hurt. The physicians, who are in the best position to know what would be best for a given patient, are denied access to the process. And American business is hurt as the rest of the world rightfully looks to America as the great medical innovator. To compound the damage, it would appear that not all companies are treated equally by the FDA. I hold the patent for a spinal fu- sion d.evice, which you have illustrated in the handouts, substan- tially equivalent in both form and function to an ordinary cylinder of bone referred to in the art as a bone dow. I licensed this tech- nology to 2 companies. One of these companies was allowed by the FDA to do a study consisting of using the implants in a specified
Page 35: TI14380143
62 number of cases. The second company, after meeting with and cor- responding with, the FDA concluded that it could not perform a study similar to that of company one, but would need to meet a new standard, a higher standard, that of a prospective randomized controlled study, wherein a computer, not a doctor, would decide which patient got what care. Time permitting, I would welcome the opportunity to explain to the members of this committee how this action by the FDA violates rather than upholds its mandate. The ardors of this second type of study virtually assures company one of an unfair economic advan- tage via an earlier commercialization of the product. This is the more disturbing because company two, while being a leader in its field and held in high esteem throughout the industry, has been a vocal proponent of much needed FDA reform. In conclusion, I would offer the following suggestions. The FDA should return to the original intent of substantial equivalence. By example, my fusion device is an improvement on a bone dow. It is stronger, more resistant to dislodgement, and free of the risk of HIV or Hepatitis transmission. This device should be approw.ble by the 510(k) process. The FDA must not, in its desire to never err, unduly delay or, w~rse still, withhold the issuance of a 510(k). The FDA already has wlthin its power the right to demand mechanical, biomechanical, and even clinical data in support of a 510(k) application. That, com- bined with the depth of experience and clinical expertise of the medical community and the post-marketing surveillance mecha- nisms already available to the FDA, should provide for sufficient safeguards while making such innovations more rapidly available to the patients that so badly need them. This would put an end to the ironic situation whereby these in- novations are available throughout the world, but not here. Finally, the FDA must not act or fail to act in a manner that is or gives the appearance of being arbitrary, capricious, obstruc- tionistic~ or retaliatory. To this end, the FDA needs to have open meetings, invite public comment, employ an open policymaking process, consider the impact of their decisions on American busi- ness, and, most of all, as Dr. Watkins said, become a patient advo- cacy agency, Mr. Chairman, members of the committee, I thank you for your time. [The prepared statement of Gary K. Michelson follows:] PREPARED STATEMENT OF DR. GARY K. MICHELSON Good morning Mr. Chairman and members of the Committee. I am Dr. Gary tC Michelson. I am a practicing orthopedic surgeon from Los Angeles, California. My eurgical specialty is directedte treating patients who are afflicted with spinal dis- orders, In addition to attending to the needs of my patients, I spend considerable time developing new medical devices to advance patient care. Currently, I hold over 100 domestic and international patents covering both orthopedic implants and the instruments which are used to implant them, as well as other routinely used sur- gical instrumentation. Fortunately for the patients who receive medical devices which I invented and for me as a troatingphysician, many of my innovations occurred prior to 1990. During that time, the FDA processed marketing applications for new devices in a timely manner and were seldom an impediment to the introduction of equipment to ad- vance surgical treatments. However, since 1990, the FDA regulatory climate has changed. The average 510(k) clearance review time for orthopedic medical devices 63 has, at times, exceeded ten months. This means that, for perhaps even the simplest innovations or for significant changes to existing products, the American public is deprived of new technologies for almos~t.a year after the devices are ready for mar- keting--due solely to PMAregulatory aeiays. . ~ . Additionally, the FDA has seemingly become more conservative in im aecimon- makin~ process in recent ~ears. Substantial equiv~ence .spacers.to. be..m, oro n.ar- rewly mtorpreted at this time. If the FDA does not accept me su~smnual eqmva- lance discussions in the 510(k) notification, the 510(k) is rejected and the company must then perform long term, very expensive clinical studie.s which are .t~,e.n f~ol- lowed by an inefficient, prolonged PMA review process in order to mer~e~ m..e a~e- vice. This IDE/PMA process can ~ake 5-8 years to successfully ,completo..AI!~ the while, surgeons and surgeon inventors like myself are denied reaay access ~o mesa products. To further complicate the state of affairs, not all companies are treated equally by FD~ You may ask how an orthopedic s .u~e.on can .make such. a bold st.atsme.nt. Easily, since I am in a unique position in elealing with compames as an mv, en~r. For example, I hold the patent for a simple anterior spinal fusion device which license to two different medical device companies. One of these companies was al- lowed by the FDA to conduct a straightforward clinical study in which the device was used in a number of spinal surgery cases. The other company felt .that apro- spective, randomized control clinic.el study woul~ b.e .needed to.secure a .tim~ely approval of a study for virtually the same medical ~evice, a mr more ~ura~nsome requirement. From a research perspective, randomized control clinical studies are far more scientifically appealing~ however, studies such as these ere nearly impos- sible to conduct for surgical implants. Therefore one company had the opportu~dty te collect clinical data rapidly and efficiently w~ie the other has undertaken a dlni- col study that will take years to complete. These conditions represent barriers which negatively affect the commercial introduction of a new medical device end place one company at a competitive disadvantage to the other. This would be especially trou- blesome if my company had been ~olitically involved in FDA reform, raising trouble- some questions about the possibility of FDA retribution--retribution which not only hurts the company, but doctors and the patients they treat. It is unfair to complain without offering constructive suggestions to better the sit- uation. Therefore, I offer the following considerations: 1. The FDA needs to focus on promoting quicker access as well as advancing the state of medical care to the American public. Inaction on the part of FDA is not ac- ceptable. Although by not acting on device approvals and thereby delaying the proval procass~ the FDA con never be accused of having made a mistake. This does not serve the public. As an example, my previously mentioned anterior spinal fusion device should have already been clearedunder 510(k). It is a very simple medlc~l device--a threaded, perforated, hollow metal tube which encases pieces of bone from the patient. The dewce is designed to stabilize the spine and promote spinal fusion, It is a surgical alternative to ailogrsft bone dowels which have been used for over 40 years in fusing the spine. My device is superior to bone graft alone in that it provides structural integrity, i.e. resistance to collapse; better osteogenic, i.e. bone forming, properties; and migration resistance, i.e. resistance to movement, than allograft bone graft. In addition, when my device is used with the patients own bone, there is no risk of transmitting deadly diseases such as HIV and hepatitis, which is remotely possible with the use of allogra~ bone. From a regulatory standpoint, there are predicate, legally marketed devices to which this device can be compared for supporting a 510Ck) application. To pour more salt on the wound, my device is commercially available elsewhere in the world, but not in the United States. It is ridiculous that a surgeon in Europe can use my device without restriction to treat their patients; but I can only use them in 20 patients in a clinical study in which 20 other patients will get an undesired treatment, and all treatment will be determined randomly by a computer program. There is no plausible reason why my spinal device shouldbe subjected to this arbitrary level of FDA scrutiny. As the gatekeeper to the introduction of medical devices in America, the FDA should make every effort to allow practicing physicians access to now technologies as soon as possible. Physicians are in a far better position, based on training and experience, to decide the clinical applications of a device once safety has been deter. nnned. To accomplish this goal, the FDA has access to controls such as postmerket surveillance and medical device reporting which can be utilized to assess the device after marketing permission is granted. 2. The FDA should make every effort to treat companies equitably. Inequitable treatment of companies wreaks of favoritism to some and retaliation and retribution to others. Policy decisions should be made in the sunshine and public comments
Page 36: TI14380144
64 mhould be ~olicited. Policy decisions should also take into consideration their impact on competitiveness. In conclusion, t.he FDA should be a patient advocacy group. In being such. they should advocate a physlctan s right of determlnati,on ~and..av ~a~l.ab.fl~t~,. of t~,,e q~esIY medicine mankind can offer. Instead, with the best el ongma~ mrenuons, ~ne ~on- ~oeSS and the FDA have created a system that denies the t~ols surgeons need to their best. The American citizen is slowly receiving less and less of the best. I hope the Congress can act quickly before this situation gets further out of hand. Thank you. Mr. BARTON. The Chair thanks each of you for your testimony and recognizes himself for the first 5 minutes of questions. Since this is a hearing on retaliation, as I asked the first panel, have any of you been contacted by the FDA and discouraged from testifying or in any way coached about what to say in your testi- mony? Mr. JANKELSON. No. Mr. MILLER. No. Mr. CASSAGNOL. No. Mr. WAT~UNS. No. Mr. MICHELSON. No. Mr. BARTON. Good. Mr. Jankelson, my understanding, in your problem with the FDA, they put one of your chief competitors in charge of one of the peer review panels that was to review one of your devices. Is that correct? Mr. JANKELSON. Well, that's not entirely accurate. Our history involves, prior to the 1991 sudden inspection, an ongoing churning of activity by a very small group of academic dentists who, for self- serving purposes, their relationships with insurance companies and other self-interests, have been vocal opponents of the use of elec- tronic measurement instrumentation for use in clinical dentistry. Those were the folks that showed up at the panel as witnesses. One of them was the sole consultant. * To make matters worse, the chairman of the panel was an indi- vidual who only recently had been involved in patent litigation with our company, had lost that litigation, who then went back to the other company, the only other company whose products were affected by that panel meeting, to rearrange a royalty agreemen, t with that company based upon the narrowing of the patent througn the litigation. So this was an individual who had a real axe to grind. Mr. BARTON. Now, under current FDA procedures, is th_ere a pro- cedure for them to recuse somebody with an obvious conflict of in- terest or not to appoint them in the first place? Mr. JANKELSON. I would assume that anybody looking at this sit- uation, at the very least, would say this person needs to recuse himself or simply be disqualified because the conflict of interest was just obvious. Mr. BARTON. And my understanding is because of a complaint about it, the FDA has disavowed at least 1 of the reports from this panel. Is that correct? Mr. JANKELSON. The panel recommended Class III for instru- ments with a lengthy, lengthy history of being absolutely safe and which are non-invasive. They are measurement instruments only. They do not diagnose. What the FDA has done is to state that it will not rely on the recommendations of that committee, but it re- 65 fuses to acknowledge the substantive irregularities that occurred, dismissing the work of the panel only on the basis of what it de- scribes as insubstantial factors, primarily lack of proper advertise- ment. It's a cover-up, as far as I'm concerned. The Office of the Chief Mediator and Ombudsman, which has had this thing now for over 8 months, simply refuses to act. We do periodically get something, like we got yesterday, and I don't think the timing is coincidence, stating that they're on the case and the investigation is continuing. We don't think that the investigation is continuing on a serious basis at all. Mr. BARTON. Now, Dr. Miller, my understanding is that your problem with the FDA began to manifest itself after you gave a speech at the Heritage Foundation in which you said some things that were not complimentary of the FDA. Is that correct or incor- rect? Mr. IVIILLER. That's correct. Not only was a presentation made in 1993, but I have spoken since on several panels and at several con- ferences, in some cases which involved staff members from the FDA, as well. Mr. BARTON. Now, Dr. Michelson, your testimony in some ways is the most disappointing because I'm told that y_ou presented t~he same device on your own behalf and then through som,e sort o.t shell corporation. They approved the shell corporation aevice, took very strong objection to the device that was sent under your own corporate identity. Is that correct or incorrect? Mr. MmHELSON. Mr. Chairman, it's not actually a shell corpora- tion. It's a medical entity of which I am the sole stockholder, So it operates as a corporation. And it's accurate, to a certain extent. It was a number of years ago that we did make application and we did apply for a 510(k), basically stating that this is, in fact, a bone screw. Subsequently, screws very similar to this and of quite a large size have been getting 510(k) approvals for use in the knee as an interference bone screw. But the rest of your statement is correct. When another company subsequently, that had much interaction with the FDA over other matters, applied basically for the same 510(k), they were told no. Mr. BARTON. Now, did the same individual rule or were there dif- ferent reviewers at the FDA on these devices that were identical? Mr. MICHELSON. My best guess is they were different reviewers at different time periods. Mr. BARTON. My time has expired. I would now recognize the gentlelady from California. Ms. ESHOO. Thank you, Mr. Chairman, for today's hearing and thank you to the panelists. There are really so many things that I'd like to ask you. Obviously, each one of us has limited time. I think what I'd like to start out with, because it's the most im- portant, you're all coming at the FDA with a variety of complaints and discontent and they're not all the same, but they are all prob- lems that you're pointing to. So what I'd like to ask each one of you is relative to the problems that you've outlined, what would you recommend be the fix? What I'm very sensitive about is that these hearings and the rec- ommendations that come from them not be a ticket for a free-for-
Page 37: TI14380145
66 all of approvals of mechanisms that can harm the public, and that's not what you're here for either. Obviously, there are problems in this Agency, but I'd like to hear from you, each one of you, as quic_kly as you can. And I know that you can't bring everything to it. What recommendation would you make in terms of a repair or fix to the Agency as it relates to the problem that you've stated here. We'll start with Mr. Jankelson. Mr. JANKELSON. I'll speak for myself. I don't think there's any suggestion that I oppose reasonable regulation. I think that there is a culture within the FDb, That culture, I think, is one of an ex- traordinary mentality, best perhaps illustrated by a meeting that I had with the Seattle Regional FDA Director. I complained to him. I asked him a question, which was when we placed one of your in- spectors, as a courtesy, in our conference room to give him a com- fdrtable place to do his work and then we next found him rifling through files uninvited in the conference room, is that activity that he condones, and his answer was absolutely. Number one, he said, and I'm quoting this, I think, accurately, it's from memory, but accurately, and there were 3 other Myo- Tronics employees, a staff person and an atto.rney in the meeting at the same time. They would corroborate what I'm saying. He said, "Number one, we are a police Agency." He said, "Number two, we"- Ms, ESH00. Who was this person that said this to you? Mr, JANKELS0N. This was Roger Lowell. Ms. ESH00. And is he still there? Mr, JANKELS0N. Yes, he is. He said, "Number two':- Ms, ESHO0. We are a police Agency. Mr. JANKELSON. We are a police Agency. He said, "Number two, we train our inspectors to,, proceed, from the premme" that no one in industry is to be trusted. This occurred in the context of a meeting which I insisted on with him, which I got, because I think I can be pretty persistent. The purpose of the meeting was to discuss why, after we had gone through what we had gone through, had entered into a con- sent decree, had followed that consent decree with activities to bring ourselves in total compliance, when the FDA itself, in that meeting, confirmed for me that we were in total compliance with respect to all 510(k)'s and all manufacturing practices, why we were, at that point, being threatened with civil penalties. Ms, ESHOO. Let me, again, ask you the question. It's a very in- structive story. It's obviously very painful for you because you're the one that has been through it. But we, as the policymakers, need some guidance on what you in the trenches are telling us in terms of this endurance, as you characterize it, and I believe you. I mean, you're here. You swore under oath to tell the truth and I know that you have, even if you didn't take the oath. What would you do? What would you bring to this process that is being spoken to? Mr. JANKELSON. I would say, number one, what's happening here, the oversight from outside of the FDA, I think, is paramount. I don't think that the FDA is capable of reforming itself whatso- ever. 67 Ms. ESHOO. That's a good suggestion. Maybe we can go on to the next person, since the red light is already on. Mr. JANKELSON. Let me say one thing quickly. I think, also, small companies~ Ms. ESHOO. You're the only one that's getting to say anything, though. Mr. JANKELSON. Okay. Ms. ESHOO. I want to hear from the other gentlemen, too. Mr. JANKELSON. Small companies have to in some way have ac- cess to direct remedies for this kind of behavior. Ms. ESHO0. Big agencies and little companies are not an equal set of bookends, I understand that. Mr. Chairman, can they just re- spond quickly? It might be instructive for us. Yes. Mr. MILLER. Only in America are terms like compliance and en- forcement regulatory terms. If you look at the European model-- Ms. ESHOO. Pardon me. I didn't hear you. I'm sorry. Mr. MILLER. Only in America are terms like compliance and en- forcement regulatory terms. Those are police terms. Those are mili- tary terms. If you look at the European model and models in Japan and other parts of the world, the regulatory process, whether it be medical devices or other products, is a process, a joint process car- ried out between and through the cooperation of government and industry. In America, it's an adversarial process and one which doesn't lead to---for the cost at least, doesn't lead to the right kinds of safe- ty and efficacy conclusions that it might. Ms. ESHOO. But what is your recommendation to us? You're say- ing that these are police terms. Mr. MILLER. Recommendation that less money-- Ms. ESHO0. And, most frankly, I don't agree with you. If there is a regulation to protect the public's health, myself being included, I don't think of that as police/bad. I think it's something that is necessary for the common good. I think where we get into trouble is the people that implement things and how they treat those that essentially they have some power over. So we may disagree. Doctor, have you ever called for the abolition of the FDA? Mr. MILLER. Are you asking me? Ms. ESHOO. Yes. Mr. MILLER. Absolutely not. Ms. ESHOO. Thank you. Mr. BARTON. The gentlelady's time had expired, but the other three gentlemen want to answer her basic question about a reform, we'll give you a chance to do that before we recognize the next questioner. We have three others. Mr. CASSAGNOL. From the standpoint of a patient, I was followed through a clinical treatment. It was documented and it only proved positive, no negative. I would like to know why the device is not allowed. Mr. WATIZffNS. I think the suggestion I might make is one of atti- tude and to briefly say that I've been surrounded my entire career in this profession with doctors whose absolute primary concern is what's best for their patients. Every brush I've ever had with an equipment maker or surgical company, their whole attitude was how can we do it better for you and your patients.
Page 38: TI14380146
68 Yet, it seems like you're being faced with the attitude from the FDA that we're a bunch of greedy guys just out to make a buck off some poor person. So it's more an attitude. Sit down and work out what is the standard of care; well, how can we improve this, is this a logical extension of what you're doing now, is it better than what you're doing now, and based on the standards of care that exist. I think just a basic cooperation and change of attitude. Ms. ESHOO. It is a cultural thing. I think in many ways, it's the toughest thing to try and cure, but I think that there is a great deal of accuracy to what you say. Yes. Mr. MICHELSON. I agree with what you said and with what Dr. Watktns said. The number one problem is we do need regulation, but we need a cooperative attitude rather than this adversarial sit- uation and the way it manifests is, the FDA behaves in a pseudo- scientific manner. Let me give you a very brief example. I know time is limited. Spine surgeons for 50 years have been deciding on a patient-by- patient basis who needs a spine fusion. Now the FDA has come in and said, oh, we want to know if you are doing the straight leg- raising test. We want to know if there is three degrees of angula- tton. These people have never seen a patient, they have no idea what goes into making that decision, and now, all of a sudden, we can't get new devices released because they want us to go back and do the work of 50 years ago which none of us are willing to do be- cause we know it doesn't work because that is the only control they will recognize. That will put us all in Volume 2 of the Death of Common Sense. Ms. ESHOO. Thank you very much. Thank you, Mr. Chairman, for giving me some extra time. Mr. BARTON. We thank the gentlelady from California. I would recognize the gentleman from North Carolina, and would give him additional time beyond the 5 minutes because we have ex- tended that courtesy to the other members of the subcommittee. Mr. BURR. Thank you, Mr. Chairman. Inquiry of the Chair, if I may, is Roger Lowell on the list of FDA employees to in fact get statements from? Mr. BARTON. No, not at this time. Mr. BURR. I would suggest, based upon the information that Mr. Jankelson has offered to us and Ms. Eshoo has pursued, that we, in fact, give the FDA, and specifically Mr. Lowell an opportunity to address those statements made about him. Mr. BARTON. We will give him that opportunity. Mr, BURR. Thank you, Mr. Chairman. Dr. Michelson, you talked about Company 1, Company 2, and I think everybody understood that, in fact, it is the same device. I guess my question is, have you approached the FDA on why this happened? Mr, MICHELSON. Perhaps I could submit for the record a letter sent by the FDA to Company Number 2, and what one can see in this letter is, and it is part of this problem that I was just talking about, is, the FDA puts up hoops and says, you have got to jump throu.gh this hoop, and they lift it way up in the air. But even if you jump through the hoop, they never told you, and they will 69 come back and say, we never told you that we would approve the product because there is another hoop over here, and that's what's going on. Mr. BLrRR. Does that letter display that everchanging goal? Mr. MICHELSON. Not as drastically as I just did but, yes, I would like to---- Mr. BuI~. Let me just say to Mr. Cassagnol, though I don't have questions for you, I would like to compliment you for coming in. I think any time we have people who don't have a specific financial interest, especially when there is a health interest, I, as a member of this subcommittee, am really anxious to hear from individuals out there, and certainly in this panel and the panel before we had that, and I thank you for taking the time and probably your own expense to come in. Mr. Jankelson, in your statement, you made several statements about the FDA. Two of them I would like you to expand on just very quickly, coverup and possible criminal activity. Could you ex- pand what your implication is in your statement as it relates to those two things? Mr. JANKELSON. Yes. Had I read my statement, and I was trying to get through it faster than simply reading everything, I would have said that I don't purport to know the legal definition of cover- up, but that I know the act of coverup. If you read the record with respect to the panel, you will see that the irregularities, the misconduct in which the FDA deliberately participated were so flagrant that any agency with any mechanism for redressing misbehavior would have responded in a timely, im- mediate fashion. The Agency, that is the office of chief mediator and ombudsman, first received the complaint regarding that panel process--the panel process occurred in October 1994, in November 1994. When we saw nothing forthcoming, we then, through the auspices of a law firm in this city representing our company and the other company, our competitor, who was affected by this panel, submitted a 32-page document which we refer to as the letter of complaint. That is part of the record. Since that time, we have gotten, from the office of chief mediator and ombudsman the following response, first, that it was agreeing that the FDA should not use the work and recommendations of the panel, and then, I think, on 9. other occasions the response that it was continuing its investigation. It has now been 8 months since that Agency had more than ade- quate information on which to address our concerns. During that time, the FDA has published in its own publication what amounted to an incredible indictment painting the company in the most un- complimentary terms, unfactual, exaggerated~uring that time, insurance company consultants who are, in part, the very academ- ics that participated as the only witnesses in this panel speaking against the instrumentation, have used the panel's recommenda- tions for turning down claim, after claim, after claim for patient re- imbursement, and nothing happens out of the Agency. That is my definition of coverup. Now, your second question?
Page 39: TI14380147
7O Mr. BURR, Well, the second question dealt with possible criminal activity, and I am going to ask you expand on that in a letter back to the committee. I would also ask unanimous consent that if we have additional questions for these witnesses, Mr. Chairman, that we be allowed to submit them to them? Mr. BARTON. Without objection. Mr. BURR. And because the light is there, the chairman, who has given me a grace period that I don't want to abuse, I need to move forward, and I will certainly look at your testimony a little more carefully. Let me just ask you again, Mr. Jankelson, on August 9, 1993, without further evidence, the FDA seized your product. Is that a correct statement? Mr. JANKELSON. Yes. Mr. BuI~. In the interest of resolving matters, your company agreed to a consent decree with the FDA even though you believed you were legally correct and the Agency was wrong; is that, in fact, still correct? Mr. JANKELSON. Correct. Mr. BURR. Were you pressured into agreeing to that consent de- cree? Mr. JANKELSON. I think by financial circumstances, by the task of taking on the FDA, we looked at which was the lesser of 2 evils, conceding to positions that we felt were totally unjustified or fight- ing a legal battle that we didn't feel we were prepared or able to finance. Mr. BuI~. Was there more than one option for you or did, in fact, they box you to where there was only one option? Mr. JANKELSON. Well, I think the option was to do what some firms have done that you have heard of today, which was to go into the court system and fight. In retrospect, that is what I would do again today. Mr. BURR. Do you believe in your particular case that retaliation took place? Mr. JANKELSON. Absolutely. Mr. BURR. Do you think that past or current FDA Administrators were knowledgeable of that retaliation? Mr. JANKELSON. Absolutely. Mr. BURR. Let me move down the line. Dr. Miller, do you believe that, in fact, retaliation took place in your particular instance? Mr. MILLER. Yes, sir. Mr. BURR. And do you believe that there was past or current FDA Administrator knowledge of that? Mr. MILLER. I have no way of knowing, but I would assume so. Mr. BURR. Let me skip down to Dr. Michelson, if I could, and just ask you the same question. Do you believe retaliation took place in the case of your two companies that submitted for the 510(k)'s? Mr. MICHELSON. Well, I don't want to impute a motive. It would appear that way. The reason I make that statement is that Com- pany 1, which was allowed to do the very simple study~ Mr. BARTON. You need to use the microphone, doctor. Mr. MILLER. I apologize. 71 Company 1, which was allowed to do the very simple study, was allowed, after the second company was subjected to this much more rigorous type of a study, which, by the way, will probably never be successfully completed because of the hardship in doing it, to then go back and do more patients according to the simple study, and yet the second company was still held to this different standard. So by looking at those things as they temporarily sequence them- selves, yes. There is certainly something going on that's unfair. The other factor is, the second company has made themselves ex- tremely well-known to the FDA, have been very vocal in seeking reforms, and have had msjor interaction with the FDA over an- other product for quite some period of time. Mr. BURR. Thank you, Dr. Michelson. I would like to thank the whole panel If I could, in ending~ Mr. Chairman, just say to Dr. Miller, I think he made a statement ear- lier that we are now talking about data. Let me suggest, at least from my standpoint, that the young man that we looked at in the first panel, I think we are also talking about human life. I, as a member of this subcommittee, take that very seriously, as you do your own jobs, and I appreciate it. Thank you. I yield back, Mr. Chairman. Mr. BARTON. I thank the gentleman from North Carolina. The Chair is going to let each attending member ask 1 or 2 other questions, and I will start with myself. I want to talk to Dr. Watkins and Dr. Michelson. From your tes- timony, it appears to me that each of .you think that the FDA is beginning to stray into the practice of medicine, which they don't have the statutory authority, as opposed to regulation and approval of devices. Would either of you care to comment on that? Mr. MICHELSON. I would very much. Last year the FDA convened a pa~,el, they selected all the panel members, to hear evidence over so simple a device as a screw which they claim is a completely dif- ferent device once placed into the spine. We as spine surgeons over the past 10 years, have become amply convinced that to do a spine fusion and not use hardware is prob- ably below the standard of care, if not malpractice. However, we are in the paradoxical situation that to use such hardware, we place ourselves in great jeopardy because it has never been approved by the FDA, and we in the hospitals are being sued every day, not for bad results, but because we used hardware that plaintiffs counsel claims is illegal. Now, this committee which-- Mr. BARTON. When you say "illegal" it just means it has not been approved by the FDA? Mr. MICHELSON. That's correct. Mr. BARTON. Or you are using it in what is called an off-label manner? Mr. MIGHELSON. That is correct. And that committee which was appointed by the FDA unanimously recommended that these screws be downgraded from a Class III, which requires an IDE, to a Class II which requires only 510(k). The FDA has ignored that recommendation and there has been no action forthcoming, even though that was last year. This severely affects our ability to prac. tice medicine.
Page 40: TI14380148
72 Mr. BARTON. Dr. Watkins, would you like to comment on that? Mr. WATKINS. I think it does. You know, when you seem to have the FDA and the government opposing what appears to everyone dealing with certain subjects, such as spinal fusion, virtually every- one, opposing what is considered to be the standard of care puts you in a very difficult position. It is not one that you have too much problem, I think, presenting to your patients. You can tell them, not FDA approved is stamped on every informed consent you have, and I have never had a tient--I don't remember a single one every really questioning that because of the rapport that I have with the patient. At the same time, they are trusting me, more than the FDA maybe, that that is the proper thing to do. That is a difficult situation at times. So I think it just puts undue stress on the situation when you are not really having~ Mr. BARTON. I want to make sure that I understand this. This particular device, the spinal implant, you can use that, even though it has not been approved, if you tell the patient that it has not been approved by the FDA, and if you get informed consent to use it. Is that correct or incorrect? Mr. MICHELSON. That is incorrect. We are now confusing two things. We were just talking about sort of ordinary screws that we use all through the body. When we, as spine surgeons, started put- ting those in the spine, the FDA took very strong action to stop the manufacturers from providing them. They have specifically told them they may not teach the use of those screws in the spine to surgeons, even today they are prohibited from teaching surgeons how to do an operation safely that they need to do. That is how much they have interfered into the practice of medicine. But these devices, these cages, may not be used off-label and are not available to be used off-label. So the answer is no. Dr. Watkins nor myself can put these in any body except within the rigors of this study whereby we are required to do an outmoded operation that none of us feel comfortable doing on at least as many people, and a computer will decide which. Mr. BARTON. I believe one of Dr. Watkins' comments was, as they asked for these studies, if we do reform legislation, we need to put in something that differentiates between a short-term impact by a drug as opposed to a device that actually has to be placed in the body on a somewhat permanent basis; is that correct? Mr. WATKINS, Correct. Mr. BARTON. Okay. The Chair would recognize the gentlelady from California. Ms. ESHOO. Thank you, again, Mr. Chairman. Just going through the panel, over how many years have you been dealing with the FDA? Mr. JANKELSON. With respect to problems? Ms. ESHOO. Just dealin~ with them, how many years? Mr. JANKELSON. Since t]~e Device Act of 1976. Ms. ESHOO. Dr. Miller? Mr. MILLER. Since May, 1976. Mr. WATKINS. Since I entered practice, I guess, in 1980. Mr. MICHELSON. As a physician back to 1975, as an inventor, a manufacturer to 1983. 73 Ms. ESHOO. Okay, so these problems span a relatively long pe- riod of time. They are not things that have either been resolved or that have come up in the last few years. I would like to follow up, which is not or should not be a source of pride to anyone~ Mr. JANKELSON. That's not true in our case. I mean, our experi- ence that we have reported here involves the last 4 years. Mr. MmLER. And our experience involves the last 1V~ or 2 years, Ms. ESNOO. And everything was fine before that? Mr. MILLER. That's correct. Mr. MICHELSON. And on my part things changed significantly in 1990. Prior to that time, we received more than 20 510(k)'s and my best recollection is in a 60-day time period. Since then, 510(k)'s are either unobtainable or can take a year or longer. It is a very sig- nificant change. Mr. BARTON. If the gentlelady would yield on that? What changed in 1990, what happened? I mean, why the water- shed? Mr. MICHELSON. I personally don't know. Mr. BARTON. It wasn't a regulation that changed? I mean, it wasn't an act of Congress that changed the way the F.DA had to review your information that you submitted, so something within the Agency changed? Mr. MICI-EELSON. I don't know the answer to that. Mr. BARTON. I yield back. Ms. ESHOO. That's all right. You are the one that is giving me the time. So what you give, you can take away. Thank you for giv- ing it back. I would like to followup on my original question, which Mr. Jankelson took some time, obviously, to point to which reforms he thought needed to be brought to the Agency. So if we could finish with the rest of the panel, and also touch on what resources we may need at centers if, in fact, you think resources needed to be redirected. We have seen how more resources have helped the generic drug program and the approval of new drugs. Could more resources at the centers help reign in the alleged excesses at the field and the reviewer level? The more sunshine, should we have stronger and more independ- ent advisory panels? What about an appeals mechanism, that, to me, on the surface of it sounds like yet another layer, and I am not so interested in adding new layers until we clean out the ones that are there and make it work better. But if you could comment on those reforms or any other ideas, I would genuinely appreciate it. Dr. Miller? Mr. MILLER. Yes. I think the couple of changes in the direction of spending within the FDA I suggest that~ Ms. ESHOO. Would you look at me when you are talking to me, thank you. Mr. MILLER. Yes. Compliance and enforcement should be defunded somewhat and more money spent on the scientific process of product evaluation and approval.
Page 41: TI14380149
74 Ms. EsHoo. Now, do you think that that is better done through stronger and more independent advisory panels, is there a connec- tion between the two? Mr. MILI,ER. Not necessarily. Some have suggested adopting a third party approval process, but I think simply refocusing the process in the area of science, in the evaluation and approval proc- ess would be a major help. Ms. EsHoo. Thank you. Dr. Watkins. Mr. WATKINS. I think making better use in terms of the scientific aspects of the medical problem, making use of existing organiza- tions such as the spine societies that we all contribute all the infor- mation we have to, and there are huge outcome studies set up, there is a bundle of information every year available through the scientific community. Ms. ESHOO. And the scientific community is not being used as you described it at all? Mr, WATKINS. Yes, that's correct. It is not. Ms. ESHOO. Thank you. Mr. MICHELSON. Dr. Watkins is doubly right. He was right, first of all, when he talked about attitude, and the attitude has to be one of cooperation. Yes, the FDA may need to weed out some prob- lems, but you can't attack every problem with a mallet. And he is secondly right about the fact that we have bureaucrats p_l_aying doctor. That is not going to work. I think that when Dr. Watkins was testifying you see the relationship that he has with his patients. He is certainly going to do what he believes is best for his patient, if the FDA will get out of the way, not prevent him from doing what is best, and not force him to do something that is less than his best. I don't want to prolong this, but in my short career, we have seen several instances, and one of them is total joint replacement, where for at least 10 years the doctors who were expert in this art knew we should not use cement, that cement was the weak link that would break down, the patients would be back having surgery. And feet here we are in the unenviable position of putting in these total int components without the cement, and placing ourselves in a position of liability legally for malpractice, and the FDA was say- ing, you can't do this, and putting it on every box. They were wrong, but every doctor doing it already knew that, but it took 10 years. Now we are revisiting that again with pedicle screws and hard- ware. They held an ad hoc committee. They formed this committee, the committee's recommendation was unanimously that this im- proves the success rate by 50 percent. The only action they have taken subsequent to that is to say to the manufacturer-- Ms. ESHOO. You are underscoring the need in terms of the science and the data that comes from the experts actually out in the field, not within the Agency, you are backing up what your col- league said? Mr. MICItELSON. Yes, he was more articulate and briefer. Ms. ESHOO. No, you were very articulate. I am just trying to summarize it because the red light is on. Thank you, Mr. Chairman. 75 And thank you to each one of the panelists. Mr. BARTON. Thank you. I think it is only fair before we release this panel to indicate that the FDA, in asking them to testify, claimed not to be aware that any of you were having any problems, at least at the highest level of the FDA. That is one of the reasons that they were not ready to testify today because they were not aware that you were having problems, or at least not aware that this subcommittee was inter- ested in their opinion on your particular cases. So I want that to be a part of the record. There may be written questions that we will submit to each of you. We do want to thank you all for coming, especially those who came from distances. I have to ask something that is not directly related, but since we have the orthopedic surgeon for the Dallas Cowboys here, I can't let the opportunity pass without asking how Troy Aikman's knees are doing and his back? Is he ready to go? Mr. WATKINS. I only do the spinal surgery, but Troy and Charles and Woods, and the other guys I have taken care of from the team are fine young gentlemen, I can guarantee you that, and they are all healthy. Mr. BARTON. That's good. They are down in Austin, Texas, as we speak, sweating in the 100 degree temperature getting ready to hopefully overtake the 49ers. So this committee is in recess. Ms. ESHOO. Don't go overboard, Mr. Chairman. [Whereupon, at 1:30 p.m., the subcommittee adjourned, to recon- vene at the call of the Chair.] [The following letter was received for the record:] ROLAND JANI~LSON, Tacoma, WA., September 10, 199[~. CHERYL RAYNER THOMAS, COUNSEL Committee on Commerce, House of Representatives Washington, DC RE: Follow-up question from July 25, 1995 Hearing by Subcommittee on Oversight and Investigations DEAR MS. TI~OM~S: On page 131, line 2967 of the transcript of testimony in the July 25, 1995 hearing, Mr. Burr asked me to expand by letter to the Committee on the matter of possible criminal activity by FDA employees. This letter is my re- sponse to that request. The Company believes that it's problems with the FDA, which began in 1991 after many years of a non-eventful, good working relationship with FDA regulators, has involved illegal acts by certain FDA employees conspiring with persons outside the FDA to wage a campaign against the clinical use of electronic measurement instru. mentation in dentistry. The Company believes that this activity involves, among others, the following se, ries of events in which misconduct by FDA employees occurred: 1. The FDA conducted an inspection at the Company's Seattle facility in 1991 that triggered an FDA Warning Letter. The Warning Letter informed the Company that the FDA was requiring new 510K applications on all of its products. The Committee is referred to a letter dated March 27, 1995 from Roland Jankelson to the FDA'S Roger Lowell, which is part of the Committee's record, which describes the issues pertinent to the FDA's warning letter and makes clear why the FDA's position was without merit. Subsequent events and the evidence now in our possession make it evident that deliberate and carefully conceived series of acts that would subse, quently be carried out by certain FDA officials against the Company that would ex- tend into 1995.
Page 42: TI14380150
76 2. Following the Warning Letter, the Company submitte~d .ne, w. 510Ks in an.e,ffort to avoid confrontation with the FDA. The FDA, however, xaima so process aria cmar these, in what now appears to have been a deliberate effort to set the stage for a "Product Seizure". Without notice or warning the FD.A cond_u.cte..d a produ, ct, seizure in August 1993. The FDA used its own publication [see t'lgA wonsumer/danuary- February 1994) to disseminate information that was exaggerated, false, misleading and extraordinarily damaging to the Company's reputation and commercial inter- ests. 3. The FDA reviewer refused to clear predicate claims to which he knew the Com- pany was lawfully entitled, the same claims on which the reviewer based his clear- ance of a competitor's 510K for an equivalent product and the same claims which he was informed by an FDA field inspector were contained in pro 1976 sales lit- erature used by Myo-Tronics. The Company subsequently was confronted with the demand by FDA officials that it agree in a Consent Decree not to use these predi- cate. claims, a condition that has severely handicapped the Company's efforts to market its products. 4. Certain FDA officials collaborated with others outside the FDA to "rig" an FDA Dental Advisory panel to bring about an advisory recommendation that the Compa- ny's products, and those of its only competitor,be labeled.,Clas~s III,, a category ,re- served for the most dangerous types of medical devices. If ~ae rane~'s recommenaa- tions were adopted by the FDA, these products would be placed in the same classi- fication as such devices as breast implants and pacemakers, notwithstanding that they are non-invasive and have never been the subject of a single doctor or patient complaint involving safety. In fact, in over twenty-five years of its existence the Company has not had a complaint or claim involving the safety of any of its prod- UC~, The FDA has announced that the October 14, 1994 Dental Advi~ry Panel was "flawed" and has ruled that the Panel's work and recommendations will not be used. Still, insurance companies and the longtime opponents of these technologies con- tinue to cite the Panel's recommendation to label these devices as experimental and dangerous. Tl~ese instruments are used by hundreds of clinicians in this country and through- out the world. The Am, e_rican Dental Association has granted its Seal of Acceptance to all of the Company s measurement instruments. These Seals are awaxded only aRer rigorous evaluation of the scientific and clinical evidence supporting the effi- cacy and safety of these devices. 5. The FDA threatened to impose civil penalties against the Company, an action that the Company considers is unprecedented following a product seizure and vol- untary Consent Decree. The threats of civil penalties under these circumstances shows how far certain FDA officials were prepared to go in their efforts to punish and damage the Company. The Compan}' believes that since 1991 certain FDA employees have violated laws including criminal statutes in order to carry out a campaign to injure and punish the Company. Our allegations of misconduct, including criminal violations, and the evidence supporting them have been delivered to Mr. Leon Drezek, Office of Internal Affairs, U.S. Food and Drug Administration. Much of this evidence has been gath- ered through FO! inquiries. We have found Mr. Drezek to be an extremely intel- ligent and aggressive investigator who seems highly motivated to seek the truth in these matters. We believe that the Office of Internal Affairs is actively pursuing the investigation of these matters. Of course, we do not know the extent to which others within the FDA will attempt to limit or influence these investigations. The Company understands that the Office of Internal Affairs is pursuing the fol- lowing areas of investigation as they relate to whether FDA employees have violated criminal statutes: I. Whether the Dental Advisory Panel Chairman violated criminal statutes by failing to disclose a prior adversarial relationship between himself and the two com- panies whose products were the subject of the Panel s act~o s. 2, Whether FDA employees engaged in retaliation directed against the Company to punish the Company for complaining about FDA misconduct. 3, Whether FDA employees engaged in conspiracy and collusion to carry out im- proper/illegal conduct to injure the Company. We have just recently delivered to Mr. Drezek additional documentation, some 'ust obtained through FOI discovery, which the Company believes supports addi- ~tional allegations of criminal misconduct, one having to do with a specific Advisory Panel member and the other having to do with a particular FDA employee who played s critical role in the FDA's review of Myo-tronic's 510Ks. 77 I caution the Committee that it would be improper to treat the Company's allega- tions as proof that any particular person or group of persons is guilty of improper or criminal conduct. Although the Company has endeavored to be objective in its evaluation of the information available to it, we are awaiting the findings of the Of- fice of Internal Affairs before making final judgments, and then we will have to wait for the criminal justice process to determine a final disposition as regards indi~id. uals who may be charged under criminal statutes, if, in fact, that occurs. Pending these conclusions, we remaia convinced that there was widespread abuse and mis- conduct by FDA employees in our case, and we anticipate that there are criminal statutes that apply to certain of these activities that will cause them to be violations of criminal law. Finally, I would like to conclude with some remarks about the Office of Chief Me- diator and Ombudsman. I believe that this office has not acted responsibly to ad- dress the very significant issues of abuse and possible criminal misconduct in con- nection with the October, 1994 Dental Advisory panel. It has been nearly one year since the Panel met. Within a month after the Panel meeting, the Company formed the FDA about its concerns, it has been nearly eight months since the two affected companies delivered their thirty-two page complaint to the Office of Chief Mediator and Ombudsman. The Panel's recommendations continue to be widely cited by insurance companies and anti-instrumentation opponents. The companies have advised the Office of Chief Mediator and Ombudsman on several occasions that its announcement that "The Panel was flawed and that its work will not be used" does not adequately address the very real issues the Company believes is the case, The failure of the Office of Chief Mediator and Ombudsman to face the real issues and to provide a determination of these matters on a more timely basis is irrespon- sible, given the impact on the two affected companies. Either the Office of Chief Me- diator and Ombudsman is an ineffective or disinterested mechanism, or it is deltb. erately refusing to publicly identify FDA employee misconduct, and expose and pun- ish the employees involved--in which case it has joined the misbehavior by en~ag, ing in a cover-up. In either case, I would hope that the Committee will give partlcu: lar attention to the Office of Chief Mediator and Ombudsman to find out what, if any, legislative changes should be made to provide a more effective policing mecha- I trust that this letter adequately answers the question and request of Mr, Burr, I am grateful to the Committee and its staff for the work it is doing on the matter of FDA abuse, and its attention to our case. Sincerely, ROLAND JANKELSON, Director, Myo.Troni~s, Inc,
Page 43: TI14380151
ALLEGATIONS OF FDA ABUSES OF AUTHORITY WEDNESDAY, NOVEMBER 15, 1995 HOUSE OF REPRESENTATIVES, COMMITTEE ON COMMERCE, SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS, Washington, DC. The subcommittee met, pursuant to notice, at 9 a.m,, in room 2123, Rayburn House Office Building; Hon. Joe Barton (chairman) presiding. Members present: Representatives Barton, Cox, Greenwood,. Crapo, Burr, Frisa, Dingell (ex officio), Deutsch, Waxman, and Eshoo. Also present: Representative Coburn. Staff present: Alan Slobodin, majority counsel, Cheryl Rayner Thomas, majority counsel, Reid Stuntz, minority general counsel, and Kay Holcombe, minority professional staff. Mr. BARTON. The Subcommittee on Oversight and Investigations will come to order. We would like to thank Dr. Kessler for appear- ing before this subcommittee this morning at this unusually early hour. We will do everything we can to accommodateyour schedule. The Chair has several announcements to make. Because of Dr. Kessler's scheduling conflicts later this afternoon, the subcommit- tee is going to have 2 opening statements on each side, and since we so far have none on the Democratic side, that means we may only have 2 opening statements. All opening statements will be submitted for the record. Given the seriousness of this hearing, we are also going to give Dr. Kessler as much time as he may consume for his opening state- ment. Then we are going to allow members of the subcommittee to ask questions in 10-minute increments instead of 5-minute incre- ments so that we can have some continuity in the questioning. Dr. Kessler, I think you understand that it's the tradition of this subcommittee that all testimony is taken under oath. Do you have an objection to testifying under oath? Do any of the individuals that are with you either at the main desk or on the chairs directly behind you have an objection to testifying under oath in case they may need to answer questions? Anyone? [No response.] Mr. BARTON. You also obviously know that you have the right to be advised by counsel. I would assume you may take advantage of that since I see a number of people with you. Will everybody who assumes that they may be asked to answer a question please stand and raise your right hand. (79)
Page 44: TI14380152
8O [Witnesses sworn.] Mr, BARTON. The Chair will recognize himself for an opening statement. We have been reviewing the testimony.that the FDA has presented to this subcommittee on the hearing issues that are before us today. We have been comparing that with some questions that we had asked at our previous subcommittee meeting. I must admit that comparing your opening statement, Dr. Kessler, to the documents that have been presented, I'm not sure that we are look- ingat the same amount of information. This is a continuation of the proceeding begun on July 25, when you were scheduled to testify on the issue of abuse of power and retaliation by the FDA. At that time you were not able to appear, saying that you needed time to prepare, and you also wished the subcommittee would have time to review the documents that we had already received at that time. You have had the opportunity to prepare your testimony. As I said earlier, after reviewing your responses, I do not think your Agency may be capable of investigating itself in an effective and impartial manner. Iwant to believe that you as a medical doctor and a law school graduate are not personally endorsing or compromising the doctor/ patient relationship, that you do not endorse leaking of documents covered by protective orders and by grand jury secrecy rules. I would hope that after you finish testifying today you will un- derstand why your bureaucrats and lawyers have-fought so hard to keep this subcommittee and the Inspector General of HI-IS out of the investigative loop. I want to believe that you are not person- ally aware nor willing to tolerate the clear discriminatory treat- ment of certain of our witnesses by your employees, whether or not the discrimination was tied to a specific act. In the darkest period of the FDA history to date, the generic drug scandal, the conviction of employees for receiving payoffs were not actually tied to specific acts. Often the charge was receiving il- legal gratuities, an offense punishable exactly as bribery but distin- guishable from bribery in the. fact that no specific quid pro quo needed to be shown. When this subcommittee and most people use the word "retalia- tion" it does not necessarily imply a specifically related predicate act. Just as illegal payoffs can be part of a longstanding illegal fi- nancial arrangement, so can retaliation be discriminatory action because of a longstanding grudge. The question today is, have companies been hurt by the arbitrary abuse of power because they refused to bow to FDA demands or be- cause they otherwise offended the FDA bureaucracy or its counsel? Regulated firms are not privy to internal Agency deliberations. From outside the FDA it is reasonable to interpret an unfair treat- ment at the hands of the FDA bureaucracy as the resulting effect of a specific cause known to have angered FDA officials or their lawyers. If, as is often the case, an FDA bureaucrat waits for some period of time before exercising arbitrary power improperly or ille- gally, the firm can be easily confused about the specific predicate act. Unfortunately, in preparing for this hearing, at least reviewing your testimony, you seem to be more concerned with disproving the 81 cause and effect linkage rather than focusing on the impropriety of the bureaucratic misbehavior itself.. If there was any doubt in my mind the FDA should not be trusted to investigate itself, your writ- ten testimony appears to put that doubt to rest. The problem with FDA self-investigation becomes clear not only from the examination of the 5 case studies before us today, but also from the nature and volume of complaints that this subcommittee has received on its Internet address and from other sources. The problem with FDA self-investigation goes to the heart of its stru~. ture and culture. Congressional Research's American Law Division in its memo. randum to me dated November 14, 1995. outlines the problems in- herent in the FDA's administratively created investigative offices. These offices lack the protections that insulate the Inspector Gen- eral from outside influence and promote overall effectiveness, Such protections include presidential appointment, broad powers, which include all access to records, reports, audits, reviews, documents and other material, protection of appropriated funds from reallocation, and authority to appoint officers and employees, in- cluding legal staff. As the memo notes, the consequence of FDA's current system of self-investigation is "to open the process of investigating employee misconduct to a range of potential risks, including minimal or er- ratic documentation and case files, incomplete or untimely report. ing to the Inspector General and others, and questionable decisions :e~~lte~r~~C~c~iiOenv:nS annO~:df. an agency investigation h As this Congress moves y • forward on FDA reform, unless I am convinced otherwise in today's hearing, I will insist on an independent review process outside of FDA to handle cases like the ones that we have before us today. Seeing no member of the minority wishing to make an opening statement, the Chair would recognize Mr. Crapo. Mr. C~o. Thank you, Mr. Chairman. I don't wish to make an opening statement. Mr. BARTON. Would the gentleman from North Carolina wish to make a brief opening statement? Mr. BURR. Mr. Chairman, I would at this time given that we don't have anyone from the minority here. Mr. Chairman, this is a continuation of what I believe to be one of the most important series of hearings this subcommittee con- venes all year. I appreciate your leadership in encouraging further discussions on serious allegations of the FDA abuses of authority which have been brought to the attention of this subcommittee. While I believe that the FDA should have joined us when we con- vened to discuss these situations earlier this year, I thank Dr, Kessler for joining us today and look forward to learning how he plans to handle these allegations which have been raised against the Agency, and particularly with regard in my case to the Sensor Pad. Mr. Chairman, the problem with the Sensor Pad breast self-diag- nosis aid appears to be twofold. First, the device was too simple for a bureaucracy whose very existence is based on the collection and painstaking review of thousands and thousands of pages of mate-
Page 45: TI14380153
82 rial over years and years for every drug or device application that shows up in the document room. Second, the creator of the device, Earl Wright, was an ordinary citizen and a gifted inventor who was not used to dealing with the high priests at Rockville and foolishly thought that simple logic and the public health were what mattered in the device approval process. Mr. Wright angered the FDA bureaucracy and paid the ultimate price, His application was buried and his products were seized. The FDA declared that his simple plastic and silicone device was some- how intended for diagnosing cancer and could cause death or seri- ous injury. In short, he fought the law and the law won. It is only as a result of investigative reporting and the interven- tion of this and other committees and Members of Congress that Mr. Wright's company is not bankrupt and his exquisitely simple devices are not occupying space in one of our country's landfills. Only in America could you be honored_ as inventor of the year for a device for which your government then threatens to put you in prison. This subcommittee has taken compelling testimony from a women and her doctor who agreed that the Sensor Pad enabled them to detect and treat a case of breast cancer that was not de- tected by any existing means. But this lesson was obviously lost on a bureaucracy whose omnipotence and pride were challenged by a small and harmless medical device company from Illinois. Mr. Chairman, the FDA's disgraceful handling of the Sensor Pad application reflects everything that is wrong with the Agency. No one of either political party wants drugs, devices or other FDA reg- ulated products on the market that are truly harmful and do not work, but the Agency time and time again wastes its resources on products and companies which pose no real harm and whose pri- mary transgression appears to be the failure to kiss the rings or other appropriate parts of the anatomy of the regulatory man- darins in Rockville. We simply cannot continue to operate like this. I look forward to the day when the revealing case studies and other evidence that has been so carefully documented in the record of this subcommittee is translated into corrective legislation so the U.S. drug, device, food, food additives, color, and other assorted FDA regulated industries can develop their products and carry out their business in an atmosphere of rational, reasonable regulation under a system of due process of the law. Mr. Chairman, I yield back. Mr. BARTON. We thank the gentleman. The Chair would now recognize the new ranking minority mem- ber from Florida, Mr. Deutsch, for an opening statement. Mr. DEUTSCH. Thank you, Mr. Chairman. I appreciate Dr. Kessler's appearance here this morning to address the charges of retaliation and other acts of malfeasance raised by witnesses at the July 25 hearing. It is critical for the subcommittee to know the full story, and I realize that those who seek the subcommittee's assistance do not always provide all the facts needed to accurately assess matters under review. But after some initial bugs were worked out on this 83 issue, I understand that the FDA has responded appropriately to many extensive document requests by the majority. I had the opportunity to read Dr. Kessler's testimony yesterday, and there is no q.uestion that he has invested considerable re- sources in fully reviewing the allegations raised in July. It is also clear that Dr. Kessler is not running from responsibility and un,der- stands that his Agency did make mistakes in cases under review, I applaud the FDA and Dr. Kessler for their serious good faith effort at laying out in detail what happened and why. Should any new matters surface today, I would hope that the chairman would ensure that the FDA Js given the appropriate time to review any new allegations to bring out the kind of detailed written response necessary to a fair and balanced record. I look forward to working with the subcommittee to accomplish this. Thank you, Mr. Chairman. Mr. BARTON. I thank the gentleman from Florida. [The prepared statements of Hen. John D. Dingell and Hen. Henry A. Waxman were received for the record:] PREPARED STATEMENT OF HeN. JOtt]~ D. DINGELL, A P~EPRESENTATIVE IN CONGRESS FROM THE STATE OF MICHIGAN Dr. Kessler is here today to respond to allegations that the FDA purposely attack~ its critics because of their criticism of the agency. The inquiry here is not simply whether arbitrary behavior has occurred, or whether poor management worked to the detriment of regulated companies. As Mr. Barton said at the July hearing, these are "allegations of retaliation or appearances of retaliation, discrimination and other acts of malfeasance that have harmed firms regulated by FDA, as well as their pa- tients." Also, Republican counsel wrote to Members prior to the July hearing that the focus is "especially on the issue of whether the Agency engages in unwarranted retaliation, discrimination and other improper acts against persons or companie~ whose actions anger the FDA." These are very serious charges, going to the heart of the FDA's integrity and professionalism. We will learn today that, upon a fuller review of the five cases selected by the Majority, claims of FDA retaliation were decidedly premature. As I said in my state- ment at the July 25th hearing, it was unfortunate that allegations were presented before the most basic investigation had been conducted. Even now, several impor, tent witnesses have not been interviewed by Subcommittee staff. Today, however, Dr. Kessler has the chance to present additional information bearing on these mat- tore which shows that, as a general matter, the allegations of retaliation were over- blown. But even if retaliation has not occurred, we still must seek to rein in arbitrary and capricious behavior if and where it exists, and ensure that FDA interactions with regulated industry are on a professional footing. To those ends, I look forward to a discussion of the reforms I noted in my July statement: stronger management and management systems; an appeals mechanism that works; a credible internal .in. vestigative capability; better and more effective communication and coordination be.. tween FDA headquarters and field offices; more sunshine; improved prefesslonal training; and sufficient resources to put these in place. PREPARED STATEMENT OF HeN. HENRY A. WAXMAN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA Mr. Chairman, I am pleased that today FDA finally has an opportunity to respond to allegations that were made more than 3 months ago. At the July 25 Subcommittee hearing, we heard that FDA deliberately kept medi- cal devices off the market to punish companies or individuals who critlcized the agency. We heard that FDA took enforcement actions against medical device mantl- facturers because FDA employees were angry with those companies, or because the companies complained to higher authorities. These allegations were very disturbing, They went far beyond the usual sorts of complaints---that FDA is too slow, too bu- reaucratic, requires too much information, or stands in the way of technological progress. These were claims of genuinely unprofessional, even illegal behavior.
Page 46: TI14380154
84 It is critically important that FDA itself investigate such charges. It is equally imo portant that the results of FDA's internal investigation be made available to this Subcommittee and that the Subcommittee provide a forum for discussion of FDA's findings. I know that it is your intent, Mr. Chairman, that the Subcommittee's in- vestigations be done in a fair and even-handed way, and Dr. Kessler's appearance here today supports that. I also think that it is important for us to separate two important issues that may become confused in the heat of debate. Companies may be disappointed when FDA doesn't give them the answer they want or baffled when FDA requires what seems to be excessive information, or takes too long to review applications. This is frustra- tion. It is genuine, and often understandable. But it needs to be carefully delineated from claims of malfeasance or misconduct. Today, we will hear from FDA that in its review of the case studies presented at the July 25 hearing, it found some errors of judgment. It found some mistakes. And it found some c~rcumstances where it would like to have done things dif- ferently. FDA's review of all of the existing documents and information did not find deliberate wrongdoing. It did not find improper conduct. It did not, Mr. Chairman, find that FDA acted for venal motives and retaliated against individuals or comp.a- hies. These findings are important in both respects. It is critical that we reco ~g~. ze the agency's integrity and fairness in its dealings with the regulated industry. It is equally important that we, like FDA, recognize areas in which the agency needs to do a better job. , 1 applaud Dr. Kesslers honesty and openness regarding these matters. Clearly, his willingness to sit here today and tell the world that his agency can and should do things differently indicates that we have a Commissioner who is open-minded about cl~ange and reform. FDA is capable of examining its operations in the ,context of itspublic health mission, of recognizing its mistakes, and of taking correcnve ac- tion. This is the good news from today's hearing, Mr. Chairmam I welcome the continuing opportunity to work with this Subcommittee, the Sub- committee on Health and Environment, and the FDA itself to examine the agency's processes and to assist in making them bettor. Mr. BARTON. The Chair would now recognize Dr. Kessler for an opening statement. It will be included in the record in its entirety. You will be recognized for such time as you may consume. We would hope that would be less than 10 minutes. TESTIMONY OF HON. DAVID A. KESSLER, COMMISSIONER, FOOD AND DRUG ADMINISTRATION, ACCOMPANIED BY BRUCE BURLINGTON, DIRECTOR, CENTER FOR DEVICES AND RADIOLOGICAL HEALTH; MARGARET PORTER, CHIEF COUNSEL; RONALD CHESEMORE, ASSOCIATE COMMIS- SIONER FOR REGULATORY AFFAIRS; MITCH ZELLER, DEP- UTY ASSOCIATE COMMISSIONER FOR POLICY; SUSAN ALPERT, DIRECTOR, ODE, CDRH; DIANE THOMPSON, ASSOCI- ATE COMMISSIONER, LEGISLATIVE AFFAIRS; AMANDA PE- DERSEN, CHIEF MEDIATOR AND OMBUDSMAN; ROBERT SPILLER, ASSOCIATE CHIEF COUNSEL FOR ENFORCEMENT, OGC; ROGER LOWELL, DISTRICT DIRECTOR, SEATTLE DIS- TRICT; RICHARD ANDROS, COMPLIANCE OFFICER, SEATTLE DISTRICT; GREG SINGLETON, DENTAL OFFICER, CDRH; KAY COOK, ASSOCIATE CHIEF COUNSEL FOR MEDICAL DEVICES; AND MARINA HOOTEN, CHIEF, ETHICS BRANCH, DMSION OF ETHICS AND PROGRAM INTEGRITY Mr. KESSLER. Thank you very much, Mr. Chairman. I would like to begin by thanking you and the subcommittee for the opportunity to address the allegations that were the subject of your hearing last July. I also, Mr. Chairman, very much appreciate your kindness in trying to help me with my schedule. 85 It was very important that the Agency have adequate time to in- vestigate those issues that were raised on July 25 and to respond here where the~( were raised. As I have stud many times before, improper FDA conduct in any form cannot be tolerated. It must not be permitted. In taking the oath of office as Commissioner of Food and Drugs, I pledged to uphold the laws and faithfully execute the duties of this office. One of my highest priorities has been to ensure that the Agency carries out fairly and objectively its mission to protect and promote the public health. Just as I have sought to ensure that FDA's enforcement program in fact protects the public from unsafe, ineffective, and mislabeled products, I have likewise worked very hard to see that FDA treats companies fairly and evenhandedly, We have sought to achieve these goals through appropriate train- ing, through strong management and supervision, through a work- ing group to make sure the dispute resolution process is adequate and consistent, and through the creation of an independent Office of Internal Affairs staffed by trained investigators who follow up on allegations of misconduct by FDA employees. Mr. Chairman, I do not presume to come before the Congress and suggest that we never make mistakes, because of course we de, What is important is that when mistakes occur, as they inevitably will, we can fix them, learn from them, and then move on, I have studied the testimony of the witnesses who came before this subcommittee last July. After that hearing I asked a group of senior FDA managers to review the facts in those 5 cases, and I have studied the materials they prepared. Are there in these cases things that we wish had been done differently and that we would do differently now? Yes. Did the Agency make some mistakes? Yes, Have we acted to correct those mistakes and to learn from them? Yes. Nevertheless, in 2 of the 3 cases that involved alleged retaliation brought before the subcommittee last summer we have found noth- ing in the record to support a claim that retaliation was involved, FDA's independent Office of Internal Affairs is vigorously inves- tigating allegations concerning a third firm. Mr. Chairman, I noted in your opening statement the issue that you raised of whether in fact in retaliation there should be a cause and effect. My only comment, and I would hope we could talk a lit- tle about that today, is that words have meaning. A charge of retalo iation is very serious. If in fact retaliation has taken place, we need together to make sure that whoever is involved in that is appropriately punished. But as someone who runs this Agency I need to be clear what the charges are. If there are charges of retaliation, then let's deal with them. If there are charges of discriminatory conduct, let's call it what it is. If it's charges of leaking of documents, let's call it what it is. If it's interfering with the physician/patient relationship, let's call it what is, I very much want to work with you, but I need to stress that the words that are used in charges and allegations are very important, because we have to be able to address them. Three of the 5 cases where testimony was presented to this com- mittee last summer involved court actions that resulted in orders
Page 47: TI14380155
86 or agreements to cease the shipment of unapproved products in interstate commerce. They were violations of the law, no question about it. Mr. Chairman, we have provided you voluminous mate- rials on each of these cases and we are prepared to answer any of the questions that you may have. Before doing that, I would like to suggest that a common thread runs through these cases. Reasonable sb]entists will disagree about the quality and quantity Of clinical information the FDA needs to .support decisions about marketing new products. A major point at Issue in many of these cases, however, is whether companies need to do control clinical trials at all to get their products to the mar- ket. Alert observation and careful scrutiny of experience can often suggest effects that lead to more formalstudy, but such observa- tions in and of themselves are not reliable enough to anchor impor- tant scientifically valid conclusions. The larger question we are fac- ing is how to achieve the correct balance between seeing that use- ful products reach the market and l~rotecting American patients from products that do not work or ma~ not be safe. There is much riding on how we strike that balance. If we are to serve the public well, there will be times when firms are going to be disappointed by our decisions. This knowledge in no way re- lieves the FDA ever of our obligation to be fair and open in our dealings with all firms, especially when we do not agree on the point at issue. In the end FDA's decisions favorable to a company cannot cat- egorically be assumed to result from favoritism any more than FDA decisions with which companies disagree must be assumed to stem from bad faith. FDA and industry will work best together when each operates in good faith in a climate that is characterized by reason and scientific exchange. Mr. Chairman, I would be pleased to answer any of the sub- committee's question, [The prepared statement of David A. Kessler follows:] PREPARED STATEMENT OF HeN. DAVID A. KESSLER, M.D., COMMISSIONER, FOOD AND DRUG ~DMINISTRATION, DEPARTMENT OF HEALTH AND H~ SERVICES Mr. Chairman: I would like to begin by thankin~ the Committee for the oppor- tunity to address the allegations that were the subject of this Committee's hearin~ on July 25, 1995. It is very important that the agency, have this opportunity to ad:- ,dre~s ,these issues in the forum in which they were rinsed, and to do so aider having naa aaequate time to review and investigate the allegations. A~. I h.av.e stated previously, improper conduct in any form cannot be tolerated and must not ~e permitted. When I took the oath of office to become Commissioner of Food and Drugs, I swore to uphold the laws and faithfully execute the duties of this office. One of m~ highest priorities has been to insure that the agency for which I am responsible fairly and objectively fulfills its mission to protect andpremote the pub.l!c health, .and implements the statutes within its jurls~iction accordingly. Just .a~ I nave sought to insure through an effective enforcement program that the public is protected from unsafe, ineffective, or mislabeled products, I have sought to ~nsure that companies are treated in a fair and evenhanded manner. We have used a vari- ety of mechanisms to do this: adequate training, strong management and super- vision, improved appeal and dispute resolution processes for industry, and more em- ployee accountability, to name a few. We repeatedly have voiced our commitment to professionalism, evenhandedness, and consistency. We have done so in our mission statement, the Standards of Ethi- cal Conduct For Employees of the Executive Branch, and in the ethics training that each. employee receives when starting at FDA. Over half of all FDA personnel, de- pending on their position, receive further ethics training every year they are with 87 the Agency. Recently, I sent a memor_andu~m~ ,to all ,staff .me.rob.ere reminflin~ th, e.m that one of the fundamental duties of an eu~ empmyee ~s ~o ~e scl~uptuously ~mr, even-handed and ob'ectlve. I also instructed them to be sure that a allegations of retaliation ~d rela~d matters are forwarde.d to the Agency's Chi,ef. Mediator and Ombudsman, who works with other agency offices to address all SUCh issues. Recently, I established a working group within my office to address the consist- ency and adequacy" of dispute resolution processes across the Agency and the effec- tiveness of education regarding the availability of such processes to industry. I also have established a separate Office of InternalAffairs, staffed by trained investiga- tore who work with the Department's Office of the Inspector General to, thor?uglily investigate all allegations of misconduct by Agency personns.1. When mmconauct is found, the employees are swiftly and appropriately sanctioned. We also devote significant resources on training for our employees, so they can perform their jobs co.nsistentl~, and pr,ofessio,n.ally. O,u~. enti~. ~e field.force uses the same training manuals, procea.ur.es, ana compl,lance poncy .g~. aanc, e, ~ur censers,en- gage in extensive in-h.ouse tralmng progr.ams t? m .a~.e cer~mn each reviewer unaer- stands the science and responsibilities of his or her job. Training in dispute resolution is available to ~l, of our man,a.g.e,rs. ,They are ex- pected to resolve problems or issues that arise ~etween an indivmual renewer or inspector and a company. Companies are encouraged to raise issues to the next pervlsory level whenever they believe that an important, de, cisi?,n is unac,ceptab~ ,or an impasse has been reached. If the dispute is not resolveu wimin a cen~er or nma organization through management review, companies are e.n, co.uraged ,to contact our Chief Mediator and Ombudsman. In addition, companies mat may nave concerns about raising a particular issue within a cen~r., or h~ave issues involving more than one center, may directly seek the assistance of that omce. Mr. Chairman, I do not presume to come before the Congress and suggest that we never make mistakes, because, of course, we do. For that reason, we have mech- anisms in place to insure that when we make mistakes, we do what we can to fix them and we apply the lessons we learn from those mistakes to.impro.ve the proce.ss. It will always be true that we can do things bettor; we m.ust always .b.e o~p,en ~ im- provement. We have heard loudly and clearly that we need to do a oetzer joy o~ com- municating with industry. Striking and malntainingthe appropriate relationship be- tween the regulator and the regulated, FDA and the industry~ is essential, It is so important that I discussed it in my first speech after ioining the agency nearly five years ago. I emphasized then what I reiterate now, tn our dealings with industry ~'we must strive to be thoughtful and appropriately responsive--but never arbitrary or disrespectful." I have studied the testimony of the witnesses who came before this Subcommittee on Jul~, 25, 1995. In addition, after that hearing, I asked a group of senior managers to review the allegations and look into the facts surrounding them. I have studied the materials they prepared. We have prepared case reports .that summarize the findings of this review and address the allegations made at that hearing. Four of these reports are included as Attachments to my testimony. The fifth contains con- fidential business information and has been provided on a confidential basis o_n_/_y to members of the Subcommittee. A brief summary is attached to the testimony, We have not included all of the supporting documentation in the case reports, Except for material relating to ongoing investigations, the documentation has been provided to or reviewed by the Subcommittee staff in response to Subcommittee requests for documents on these issues. Let me start with the specific allegations that were raised at the July 25 hearing, Are there in these cases thi,n,~gs whicI~ we wish had been done d/fferent!~y4 and which we would do differently now. Yes. Did the agency make some mistakes. Yes, Have we taken steps to correct those mistakes and learn from those errors? Yes, With re- spect to two of the three companies/individuals that were the subject of tsstimeny related to specific allegations of retaliation, I can say that we have found nothing in the record to support an~ of the specific allegations of retaliation that were raised at the July 25 hearing. With respect to the third company, there is an sngoing In- vestigation being vigorously pursued by the Office of Internal Affairs. At the same time, it should be noted that three of the companies/individuals we will discuss were involved in court actions initiated by the Agency for vlolati.ons of the Federal Food, Drug and Cosmetic Act, on matters related to their testimony, with the result that they either were ordered to or agreed to stop shipping unap- proved products in interstate commerce. Let me briefly review the cases based on what I have learned: Inventive Products and the Sensor Pad: Regarding this device, it is important note, as Mr. Earl Wright kindly acknowledged, that CDRH is actively engaged with the company to resolve outstanding data issues.
Page 48: TI14380156
88 With the benefit of hindsight we can say that if this product came into the agency today, we believe we would deal with the review differently than we did in 1985. CDRH today works very hard to find innovative solutions to device regulation and review problems, and to resolve differences with sponsors as expeditiously as pos- sible. We must understand the Sensor Pad is a novel product, in that th~ere wa~ no device on the market prior to 1976 to which it could be compared. When me ap.plica- tien first came to the agency, there was heightened concern about the possibility of unforeseen effects of this seemingly simple device. This concern resulted, in part, from what the country had just experienced with tampons, another seendngly sim- ple device, and ToxicShock Syndrome. At the same time, when communications be- tween the company and the review staff reached an impasse, CDRH management failed to intervene as quickly as they should have. On the enforcement side, however, it is indisputable that the company was mar- keting an unapproved device in violation of the statute, and continued to do so in spite of a judgement against it that was upheld by the U.S. Court of Appeals. Regarding the specific allegations, Mr. Earl Wright alleged that the agency's issu- ance of a Section 305 notice was related to his company's complaint about the con- duct of an FDA employee at a meeting with the company. When we looked at the facts we found no connection between these two events. Mr. Grant Wright's letter of complaint was dated August 14, 1992 and related to a meeting at FDA head- quarters on August 10, 1992. The 305 notice from the FDA C.,hicago Di.s.trict O, ffice~ was dated August 17, 1992, one business day after Mr. Wrights letter. ]~ was oaseo on work by the District Office that began six months earlier. Mr, Earl Wright also objected to the agency meeting with a minority stockholder. The agency did so because the stockholder requested the meeting on behalf of the company and represented that Mr. Wright would be attending the meeting with him. When he showed up without Mr. Wright, the agency staff, ingood fai~, m,et with him believing he represented the company. Furthermore, the CDRH Integrity Officer found that no information was disclosed at the meeting that was not already publicly available. Finally, Mr. Wright objected to the conduct of an agency lawyer at a meeting be- tween the agency and the company, its counsel, and its consultants in August 1992. Mr. Wright's concerns were referred to the agency's Chief Mediator and Ombuds- man. That office looked into the matter and worked with the company's counsel to reach a resolution that incorporated a proposal by IPI counsel andwas satisfactory to both the Agency and the company. The focus of these efforts shifted from the con- duct at the August 1992 meeting to the process to be followed by the agency in re- viewing the firm's new 510(k). Btomet: The company has suggested that certain agency actions were in retalia- tion for publication of a "White Paper" and a speech given by the President of.the company in which he was critical of the agency. No facts have been presented or found to support that allegation. The agency made a determination, based on infor- mation submitted by one of the parties and a misunderstanding of the underlying facts, in a very complicated dispute involving ownership of a 510(k). This determina- tion was sorted out and corrected in a few weeks when further information was pro- vided to the agency. It is important to note that the agency took no action that com- promised Biomet's right to market products under the disputed 510(k)s--rather FDA initially interpreted that both companies could distribute the devices in ques- tion under existing 510(k)s. The agency reviewed the inspection histories for Biomet and its competitors to see whether there was any differential treatment. It found none. The agency carried out its manufacturingcomplianco inspections because of the high number of Medical Device Reports (MDR) of fractures involving the stem of hip implants. We found that there were, in fact, problems with one device and the company itself had been conducting a retrieval of the products for some time. Biorssearch monitoring inspec- tions of cfinical studies also revealed that at some institutions where the company carried out its experimental trials there was not compliance with human patient protection requirements. With regard to the company's concerns about the products it submitted for mar- keting renew, we found the following: ~the Agency required post-marketing surveillance studies of all manufacturers of a new type of rough coating on plasma-sprayed coated hip implants, to evaluate the potential long term loosening of the implant. This requirement was imposed simultaneously on all manufacturers who used this coating process for com- parable implantable devicesi and, --FDA's Orthopedic and Rehabilitation De,does Advisory Panel concluded in 1985 that it did not find scientific evidence from the data submitted by the company that Biomet's avascular necrosis system would arrest or retard the progress of 89 avascular necrosis disease. Since then, rew.orking of the data .and.tr~i.'ng to find valid historical controls has to data failed to establish that the de~nce is effec. tive. .. Drs. Michelson and Watkin.s: Both doctors, testflle.d ~at, ess..en~.al~ly ~? s~ame product being studied by two different co.mpa .m.es wa.s e.r.e.a ,~a. qui~e mzterenuy, t)ns situation cited in this testimony involvea s~u~es sunmiz.~a ,~ years apart from one another. During those 4 years: the.Agenc.y did deve,l,op ~g.her~stan.d.a.rd,s about.the science supporting clinical studies, in par~ as a re,,stu~ oz zms ~;o ,n~u. z~ee s report.on problems wzth the device review program, as Well as our own internal review, We now emphasize the need for better clini ,cai data. tha.t den. onstratee clinical benefit, In fact, a supplement to the earlier stuay was neld to the same higher standard~ as the latter study. " . Dr. Michelson ]~urther testified that metal spl.nal cages shoul.d,be,.foun,d s.ubst.an~ tinily equivalent to bone dowel, allographs. T.he A.ge.n.cy aoe, s n.ot oeneve mat spmal cages are substantially equivalent..te .b.o_.ne dowel allo~rapns because implanting a titanium metal cage is fundamentally dillerent than using a human bone g~'_aft, Myo-Tronics: The company testified that prior to 1991, it had been a model of reg. ulatory compliance, but that beginning with an exhaustive inspection in 1991 tl~e agency has been engaged in a conspiracy to remove the compnny's instrumentation from the marketplace. Mr. Jankeison was asked b~ the Committee to provide addi- tional detail for the record regarding his claims o.f in.proper agency cond.uct, His let~ ter doing so, dated September 10, 1995, was prowded to the Agency by the Commit. tee on October 18, 1995. . In that letter Mr. Jankelson recharacterized a number of issues thatpreviously had been raised either with the Committee or the Agency, but also raisednew nile, gations. All of the allegations are the subject of an ongoing investigation by the Of, rice of Internal Affairs. Although the Agency does not discuss ongoing investlgatlons, there are facts relevant to the issues raisedwhich are a matter of public record nnd which we can set forth at this time without risk of compromising the ongoing inves- tigation. Prior to 1991, the company had been inspected six times, and five of the inspec. tions identified such things as labeling violations, deviations from Good Manufactur- ing Practices, and a firm-initiated recall. Some of the deviations observed included lack of a quality assurance program, lack of validation procedures, and lack of audit and complaint handling procedures. The 1991 inspection, which Myo-Tronics claims was the start of the Agency's temnts to remove its products from the market, was a routine inspection, It was scheduled in compliance with the Agency's statuto.r~, obligation to inspect registered device facilities every two years. This inspection disclosed objectionable conditions, marketing of devices without 510(k)s, and a follow-up inspection and enforcement action were initiated. As described in the Warning Letter sent to the firm following these inspections, the firm was marketing devices without the necessary 510(k) clearances and doing so with false and misleading claims. Specifically~ along with the established intended uses, the following claims for these devices were made: • "Quick, symptomatic pain relief through the production of endorphi~s and simul- taneous relaxation of muscle spasm." • " it is a conservative ~first step' when confronted with these dysfunctions: Head- "~ches, Cervicalgia, Tinnitus, Temporomandibular Joint Disorders~ Trlgemlnal Neuralgia, Tic Doloureux, Bell's Palsy, Spasmodic Torticollis, Myalgia and sitis." • " stimulates significantly increased blood flow, it promotes healing, reduces swelling and p[raesthema, and restores normal muscle physiolo~y." When the firm continued to market in violation of the statute, the Agency |niti. ated a seizure action in Federal court. The outcome of the action was a consent de- cree in which ~he company agreed to attempt to bring the disputed products into compliance with the Act. In an April 13, 1995 letter to Senator Kay Barley Hutchison, Mr. Jankeison fur- ther alleged that the Agency's pursuit of civil money penalties more than a year after it signed the consent decree, was in retaliation for the company's complaining about the conduct of a Dental Products Advisory Panel in October 1994. The record demonstrates, however, that the Agency considered assessing civil money penalties against the firm as early as August 5, 1992, when it initiated the seizure act!on, The consideration of civil money penalties was separated from the seizure action and not included in the consent decree. The recommendation for such penalties was resubmitted to CDRH by the Seattle District in June 1994, four months before the Panel meeting and five months before the company's complaint. The doeument$ available indicate that the civil money penalties recommendation was based on the
Page 49: TI14380157
9O fact that the company continued extensive marketing and alstribution of its prod- ucts after it had been advised that these products violated the Act. The company was informed by the Seattle District office of the pendency of the ci~fil money penalty issue a_~a meeting in March 1995. The company contended that all issues had been resolved~n the consent decree and argued its case against impo- sition of civil money penalties. Although civil money penalties clearly were not cov- ered by the consent decree, in light of all of the facts and circumstanc.es surrounding the company at that timep the agency decided in April 1995 that this was not an appropriate case in which to pursue civil money penalties. Regarding the conduct of the Dental Products Panel, CDRH :publicly announced its decision to re-hear the issue of classification of muscle monitors approximately within a month of receipt of numerous complaints about the meeting. CDRH's action was based on the conclusion that the notice of the hearing did not accurately reflect the scope of devices actually considered by the Panel. After receiving the company's letter of January 31, 1995, the Agency again an- nounced its intention not to rely on the panel's recommendation, its view that others should not reply on it, and its commitment to re-hear the matter in its entirety. The Agency also agreed to investigate the issues raised, to postpone further Dental Panel action on these products pending resolution of outstanding issues, and to re- consider the scope of products classification that would be the subject of any future Panel, 1 want to reiterate that there is an ongoing investigation being pursued vig- orously by the Agency's Office of Internal Affairs. Dr. Burzynski: This case involves an ongoing criminal investigation by the De- partment of Justice. Consequently, the agency is not at liberty to discuss the details of the case publicly. It is a matter of pubIic record, however, that Dr. Burzynskl was enjoined in 1983 from introducing his products into interstate commerce. Those products are unapproved drugs within the jurisdiction of the Food, Drug and Cos- metic Act. Mr. Chairman, let us look at the products discussed at the July 25 hearing: the AVN device used to treat avascular necrosis of the hip; the bipolar shoulder im- plant; the muscle monitoring device used to diagnose and treat TMJ disorder; the sensor pad device to aid in the detection of lumps ia the breast; the spinal cage de- vice used to treat degenerative disc disease; and, antineoplastons for the treatment of cancer and other terminal disease. A common thread runs through these cases. There are scientific disagreements about the quality and quantity of clinical information needed by the agency to sup- port marketing determinations. What this comes down to, in part, in many of these cases, is whether you need controlled clinical trials to get your product to the mar- ket. Alert observation and careful scrutiny of experience can often suggest effects that lead to more formal study. But such observations are not reliable enou~.h to serve as the basis for important, scientifically valid conclusions. Even a practitioner who has used a treatment frequently has no basis for assuring that a serious adverse effect does not arise when the treatment is applied to the general population. Con- trolled clinical trials, in which results observed in patients getting a treatment are compared to the results in similar patients receiving a different treatment, are best for obtaining safety and efficacy data that will allow assessment of the role of a new medical device in clinical practice. In closing, I want to summarize how I now come to view these issues. As is the case with so much of what we do, the question here is how to achieve the right bal- ance between getting products to mariner and protecting the public from products that do not work or products that may not be safe, We fully understand that noth- ing less than the health and well being of the American people is at stake in how we strike that balance. As you can see from the facts of the cases before you, the issues with which the agency deals involve complex and h|ghly controversial sci- entific and legal determinations. Often, there is no single right or wrong answer. Rather, there are a range of factors, often themselves the matter of much debate and dispute, which must be considered in the aggregate. Our decisions must rep- resent the exercise of independent judgement, informed by training and expertise. If we are doing our job of serving the public, some fu-ms subject to FDA regulation are going to be disappointed at times by the agency's actions; but, knowing that d~s not re, lieve us of.the burden of fair and level dealings with all firms~especiaily when we disagree wit.h the.re. Just as decisions favorable to a company cannot cat- egorically be assumed to be the result of favoritism, neither can decisions with which companies do not agree be assumed to be the result of bad faith. FDA and industry will work best together when each operates in good faith, in a climate that is characterized by reasoned and scientiiic exchange, not acrimonious debate. I'd be happy t~ take questions. 91 Mr. BARTON. We thank the distinguished Commissioner for your opening statement. The Chair is going to recognize Mr. Crapo of Idaho first since he has a pending commitment in another commit- tee. Mr. Crapo will be recognized for 10 minutes. Mr. CRAPO. Thank you, Mr. Chairman. Dr. Kessler, I would like to explore the relationship between the Office of the Inspector General at HHS and the Office of Internal Affairs at the FDA. I would ask unanimous consent that a letter to Chairman Barton from Diane Thompson, Associate Commissioner for Legislative Af- fairs of the FDA, dated August 2, 1995, be placed into the record, Mr. BARTON. Without objection. The letter will also be given to minority counsel. [The letter referred to follows:]
Page 50: TI14380158
92 93 CO 0 D~AIT~.NT OF I~.M.~I & H~JMAN S£31VIC~ I~onor~blm J~ ~ilh~n~on, O.C. 20515-6 t15 re~el~ln~ in,oration on ~e a~AVA~AII of ~l Po~ a~ D~g Accord~ ~o an ar~Acle in ~he Dcce~ ~94 ~ue o£ PDA TODAY, ~he O~Ace o~ Co~A~onez"s OffAce o~ cond~c~ ~A ~ap/oyee l~ICOndU~ invel~Lqa~ionl. In Sell I~l. TO~ Ha~on, s~cial agent ~n char9~ of ~he Cr~a~naA Xnve~c~a~on~ ~Leld office a~er a~uc cvo-an~-a- ~n," It is my unders~andLng tha~ ~ As a £uac~Aon o~ HHS In~c~or Ceneral's office to conduc~ investigations o~ a~lega¢~onl o~ ~A eapioyee ~A~cmnduc~. Please provide a~ a~lo re~eloznq Secretary shalala ~o provide any ~Re O~tlce o~ ~ncernal Affairs. Pleaae prov~d~ eloabLAs~en~ o¢ the O~Ace o£ In~ernaZ A~afrs. Pleaae ~o ~ha onvo~veaen~ o~ any OCX emp¢oyee fn ohe OC¢ice o~ r~lze ~ At is ~e r~ll~ of ~ ~ ot pra~A~ ot ~e OZG, h~, ~o ass~ i~ ~~ ~o pra~A~, ~a OXG hAs~orA~lXy ~ re~ ~ ~1~ aAs~u~ all~a~Ao~ ~ ~o ~ ~or ~s~Aqa~ion. ~e ~ssLble, to dste~Ane ~e~ ~m all~atAo~ ba~ ~1~, ~a P~ior to ~e eetabllshaen~ o~ OZA, PDA's Division o~ ~chics aM Pr~ Inanity (D~X) had ~en vorkt~ coll~ratlvel~ 1~ ~ee re~i~ layers avay ~r~ ~e Co~AssAonsr, a~ As o~Azs~io~lly An ~e sm c~nen~ ~ As res~nlAble for budge~, petiole1, con~ac~, and ~s. ~e re~ aM organizational lo~ion o~ D~X ~de i~ diSPirit ~or D~Z ~o ~i.~ain o~ra~i~nal ia~e~n~ce end to avoid ~e ap~arance o~ con~llct ot interest vhen inveltigating co.henna ~at re~ ~e =a~e eupe~iso~ manag~*n~ as i~ d~s. For ~his reason, lo~ed in ~e O~£1ce o~ ~he co~issioner, reading ~o ~e Deputy C~isslons~/senlor Advisor ~o ~e co~issionar, to co~uc~ lateral Inves~igacio~ inlaying all~ud e~Ioyoe =i~condu~ all~qa~lona ~a~ the OXG ca~o~ investigate. ~a =e~ wi~ vari=u, o~iclals ot ~a OIG and ~S to c~anges in ~e in~ernal investigations ~unc~lona and the ~o establi;h FDA's Office ~ In~a~al A~ai~$ (OIa) ~ an agency o~tlce re~ponaible ~o~ conduc~in~ inves~l~a%io~ ot all~9ed emploMee aiaconduc~. It ~as a~e~ ~a~ OIA ~ould as a centralized inVes~iga%Ive liaison ~=waen ~ and the O~G. Co=pe~a~ive et~o~s wi~ ~e OIG and ~S c=n~inue. ~e es~ablis~en~ o~ OXA was ale= supported In 199] b~ ~e su~o~i~** on Oversigh~ and Inves~iga~ior~s. The Su~o~i~ee, Ne~ed in the Organization, Management, and Ram=urce~ of ~e a~ D~q A~ini$tration~s Cen~er ~or Oevices and ~diol~Ical Healtb~" r~co~ended tha~ PDA dev~lop "an in~e~al capability, reading dirs~ly to ~he Co~i:sioner, to ad~ess a11lga~ion~ vrongdoinq vi~ po~en~ial~y s~A~Acan~ pr~a~ic e~ec~, or ~Id ~ assi~ ~o O~ ~si~tons. ~e aq~ d~id~ ~ r~i~ OCZ ~lcyees in ~ out o~ O~ to co~ O~ york ~e O~ l~£. In addition, ro~tln9 s~ft helpe praven~ "~ ou~," whJ~ il Crazily as~iat~ wi~ 1o~ t~ Animal assi~nts. Z~ is ~nt tO no~e ~at ~ase ~loyees ~o OZA a~ no~ ~Z vhAle ~ey a:e ~o~Anq O~ ~u~tas. con~A~lal a~ ~o: =elaasable ~o ~e p~l~c ~d~ ~'s ~e contidentiali=~ of any of ~ese do~ts vi~ ~o Sincerely~ ~T~~ Diane E, Thompson
Page 51: TI14380159
94 Mr. CRAPO. At the top of page 2 this letter it states, 'We recog- nize that it is the responsibility of the Department of Health and Human Services, HHS Office of the Inspector General to conduct FDA employee misconduct investigations. It is the practice of the OIG, however, to assign its investigators to cases that demand pri- ority attention, including the most serious matters involving fraud, waste and abuse. Therefore, as a practice the OIG historically has referred most employee misconduct allegations back to the FDA for investigation." As we have learned from the good news, bad news memorandum by Ms. Bianchi relative to the Myo-Tronics case, an apparent crimi- nal violation involving the chairman of an advisory panel who is a special FDA employee for that purpose was not referred to the OIG and then sent back to the FDA. This appears to be a clear vio- lation of the responsibilities of the OIG as stated in the Thompson letter. Do I understand that correctly? Mr. KESSLER. I'm sorry. Mr. CRAPO. If I understand the letter that was sent to us by Diane Thompson, the responsibility for these matters is to send them to the OIG for referral and evaluation, and then if the OIG determines that they are not of sufficient seriousness, they will send them back to the FDA for its internal investigation. Yet that was not done in the case of the advisory panel regarding the Myo- Tronics case and the reference of the FDA employee. Was that a violation of the policy not to refer that issue to the OIG? Mr. KESSLER. Congressman, we'd have to ask our Office of Inter- nal Affairs and the Office of Inspector General on the specific case. I am responsible for setting up the Office of Internal Affairs. It was set up in consultation and in conjunction with the Office of Inspec- tor General. We always had as part of our ethics program an investigative arm that worked with the Inspector General. I thought that inves- tigative arm was very weak, and we put trained, highly profes- sional people in conjunction with the Inspector General. My in- structions in working with the inspector general is that our Office of Internal Affairs works very closely on all matters with the Office of Inspector General. I know for a matter of fact that the Office of Special Counsel for Ethics in the Department that always works with the Inspector General is involved in that along with the Office of Internal Affairs. I don't have personal knowledge about how the Office of Inspec- tor General and the Office of Internal Affairs are coordinating this particular case. Mr. BARTON. Will the gentleman yield? Mr. CRAPO. Definitely. Mr. BARTON. Dr. Kessler, the question is, as I understand it, why did your Agency not refer this instance to the Inspector General? Mr. KESSLV.R. I'd have to ask our Office of Internal Affairs, Mr. Chairman, whether or not it was referred. I don't know the answer to that. Mr. BARTON. You have got 10 people with you, approximately. You have got the brainpower trust of the entire FDA with you. Surely one of them can answer that question. 95 Mr. KESSLER. Perhaps one of them knows the answer. I don't think there is anyone from the Office of Internal Affairs. Mr. BARTON. Then let me ask the question. Can anybody who is a representative of the FDA give Representative Crapo a straight answer to his question? [No response.] Mr. BARTON. Silence says that they cannot. Mr. Crapo, would you please continue. Mr. KESSLER. Maybe Ms. Pedersen can answer. Let me have Ms. Pedersen answer the question. She has some knowledge. Ms. PEDERSEN. My name is Amanda Pedersen. I'm FDA's Chief Mediator and ombudsman. It is my understanding that our office was involved in referring this matter to the Office of Internal fairs for investigation. Their process is to develop some of the facts, look a~ some of the documents, and consult before any decisions are made with respect to the matter intimately with the Office of the Inspector General or the Department of Justice. That is their call, but they are performing here as an investigative function that will lead to that consult. I believe that is part of the arrangement that they have with the Office of the Inspector General. Mr. BARTON. Dr. Kessler, you or your associates, we would hope we would get the answer for the record. On what factual basis was the decision made not to refer this to the Inspector General? A re- view of the statute, at least based on my staff's review, is that it should have been. We have documents that we will put into the record that build the case that it was not referred, at least on ap- pearance's sake, as part of some effort to cover up impropriety. Mr. KESSLER. Mr. Chairman, those are strong words. Mr. BARTON. I chose them very carefully, Dr. Kessler. Mr. KESSLER. I understand that. I would ask that you for the record allow the Office of Internal Affairs to get the answer of how they are coordinating this investigation. They should be coordinat- ing this investigation. They should be working very closely with the Inspector General. That's how the office is set up. If you are aware that they are not working together, then I would be happy to look into that and work with you on that. Mr. BARTON. Thank you. Mr. CRAPO. Let me go a little further into this. It's my under- standing from the good news, bad news memo that there was an apparent violation of a statute and that there was discussion to de- termine whether or in some way this could not be referred to the OIG. Let's not get into the details of whether that did or didn't happen. Let me just ask you this. Is it the policy of the FDA that these types of cases, in other words, an allegation of employee mis- conduct that could involve criminal misconduct, should be referred to the OIG, or can the FDA handle them through its internal Office of Investigative Affairs. Mr. KESSLER. It is my understanding, Congressman, if there is credible evidence that meets a certain threshold that certainly the Inspector General should be involved in the case. The Inspector General may choose to rely on certain investigative forces of the in- ternal affairs. That's the way it should work.
Page 52: TI14380160
96 Mr. CP.aPO. Who makes that decision? The question I have is this. Is the decision as to whether it reaches the level of credibility made by the OIG or by the FDA? Mr. KESSLER. That should be done in consultation. The Office of internal Affairs that I set up has 1,811 trained investigators. They are highly professional. Their instructions are to work in very strong collaboration with the Office of the Inspector General. I cer- tainly would hope that that is happening. Mr. CI~I~o. I would like to get a little further clarification of what your answer is. It's my understanding that the statutory re- sponsibility for these investigations rests with OIG. Mr. KESSLER. I would agree with that. Mr. CI~PO. You would agree? Mr. KESSLER. I would certainly agree that in investigation of criminal conduct activities the Inspector General has to be in- volved, and our Office of Internal Affairs should be working very closely with the Office of Inspector General. That's how I set up the office, That was my intent. Mr, CRAPO. Then if there were a failure to refer such a case to the OIG, would that be a violation of the policy? Would that be a violation of the law? Mr. KESSLER. They should be working very closely on all the facts of the case, yes. The Office of Special Counsel for Ethics out- side of the Agency is involved in the Myo-Tronics case. We use the words "coverup." The Office of Special Counsel for Ethics is in- volved, I have knowledge that they are aware of that. So I think there is collaboration going on. Mr. CRAPO. If I could just ask one other quick line of questions, Mr. Chairman. Mr. BARTON. Mr. Crapo, the gentleman's first 10 minutes has ex- pired and the ranking minority member has two other hearings. I will recognize him and then attempt to come back to you before you have to leave. Mr. CP~PO. Thank you. Mr, BARTON. In all fairness, we've had 10 minutes. The Chair would now recognized Mr. Deutsch. Mr. DEUTSCH. Thank you, Mr. Chairman. I'm going to start with an overview of some FDA self-investiga- ,tire capability, just sort of walk those on with the FDA. One of the lndustry's concerns seems to be that the FDA cannot or will not in- vestigate allegations of misconduct or misbehavior involving its em- ployees, but since your arrival at the FDA the Agency has taken several steps to improve its ability to investigate these kinds of al- legations. Can you describe for us what you found when you started at the FDA, what changes you have made, and why you believe they were necessary? Mr, KESSLER. Congressman, I came to the Agency right after the generic drug scandal. There was widespread misconduct both with- in the industry and with several bad actors within the Agency. That had an enormous effect on the public health. We have set up since then an Office of Criminal Investigations; we have set up an Office of Internal Affairs; we have worked very closely with the In- spector General. 97 Six FDA employees--I believe the number is 6--since I've been here have been approached with bribes. They came in and th,e~ worked with the Inspector General and our folks. They were will- ing to risk their own safety. They wore wires, and arrests were made. That's what should have happened in generic drugs. If you take a GS-5 or 6 and they are approached with a potential bribe, similar to what happened in generic drugs, they risked their own safety. I think we have sent the message. This is an Agency of 10,000 peop.le, and I can't be monitoring every one of them, nor can I be monitoring any one of the hundreds of thousands of people involved in the industry and regulatedj~rod- ucts. Yes, there are going to be bad actors, but there is an Office of Criminal Investigations, there is an Office of Internal Affairs, They are very highly trained. There are 1,811 agents. I think that we have shown that we will take any misconduct on the part of anyone very seriously. Mr. DEUTSCH. Could you follow up specifically with changes that you have made? Could you highlight anything that you have done? Mr. K~SSL~.R. There was no Office of Criminal Investigations be- fore I got to the Agency. There was no Office of Internal Affairs. We were just in the process of establishing the Office of Ombuds- man and Chief Mediator. The Office of Criminal Investigations and the Office of Internal Affairs are new. Mr. DEUTSCH. Should the role of the HHS Inspector General in examining FDA matters be greater and should the FDA have its own inspector general? Mr. KESSLER. I believe when we set up the Office of Internal Af- fairs and when we set up the Office of Criminal Investigations those were designed to work very collaboratively with the Office of the Inspector General. Everything that I have heard up to now leads me to believe that in fact that collaboration has been work- ing. ~ Mr. D~.UTSCH. Staff has mentioned the Office of Special Inves- tigations. Could you elaborate on what that does and its history? Mr. KESSLER. The Office of Special Investigations I also set up, They serve more as an early warning system. Employee misconduct activities go to Internal Affairs. The Office of Criminal Investiga- tions deals with criminal conduct on the outside of the Agency. But if we are falling behind, if there is something that we should be doing that we are not doingmI know some on the committee ex- pressed some concerns about inspections and whether we were doing our jobsmthat office, for example, was involved in looking at that question and bringing that to our attention. Mr. DEUTSCH. Let me focus on one of the cases that was raised in July, the Sensor Pad case. I've had the opportunity to look a lit- tle bit at the allegations involved. Specifically, is Sensor Pad on the market in Canada today? Mr. KESSLER. Let me let Susan Alpert answer that question, She's the director of new device evaluation. Ms. ALPERT. No, sir, it's not on the market in Canada at this point in time. Mr. DEUTSCH. It was removed from the market in Canada? Ms. ALPERT. The company was told that they could no longer market in, I believe, July 1994.
Page 53: TI14380161
o0 0 98 Mr. DEUTSCH. Why was it removed? Ms. ALPERT. In conversation with my counterpart in the Cana- dian regulatory authorities, he informed me that it had achieved marketing status through a true notification process where a com- pany goes to market and within 10 days notifies the authorities that they are in fact in the marketplace. The Canadian authorities then go through that list and periodically check the data that sup- port the claims made by such products. In doing that for Sensor Pad there were some questions raised about the support for a claim of increased sensitivity by Sensor Pad. They then asked the company for additional information. They received information. They felt that the claims were not substan- tiated and notified the company they could no longer market it. Mr. BARTON. Would the gentleman from Florida yield? Mr. DEUTSCH. I'd be happy to yield. Mr. BARTON. Did you in your phone conversation recommend to the Canadian authorities that they withdraw their approval? Ms, ALPERT. My phone conversation was a week ago, Mr. Chair- man. Mr. BARTON. There was an individual in your Agency that we have interviewed that had such a phone conversation. Do you recall or have you reviewed that information? Let me ask the question this way. To your knowledge, has any- one with the FDA contacted the authorities in Canada and asked that they withdraw their approval of the Sensor Pad? Ms. ALPERT. To my knowledge, no one has done that. Mr. BARTON. Thank you. Mr. DEUTSCH. Are you saying that Sensor Pad was taken off the market in Canada for the same reason that it has not been allowed on the market in the United States, that is, there is no evidence of safety and efficacy? Ms. ALPERT. As [ said, what the Canadian authorities told me is that they did not feel that the data they received substantiated the claims that were made by IPI in their submission. Mr. DEUTSCH. That's in a verbal conversation you had with them just a week ago? Ms, ALPERT. Yes, sir. Mr. DEUTSCH. If they could provide us something in writing, I think that would help give us a sense in terms of that specific prod- UCt. Is there anything else that you would want to say specifically about that particular case in terms of the allegations, in terms of responding to what has been alleged? Mr. KSSSLER. I think that product came to the Agency in 1985. Today, looking in retrospect, I think there is no question that we would have dealt with that product differently. It was a novel product. I think the record clearly shows--the case went as high as the Seventh Circuit--that in fact there was ship- ment of an unapproved product. The problem was that the first ap- plication came in in 1985, and as I understand it, and correct me, r. Alper~, if I'm wrong. The product was used to help in the detec- tion of breast lumps. There has been some back and forth on what it's actually labeled for. If you look at the first application, I'm told that the first application came in claiming that this device to detect 99 breast masses, the predicate device, was substantially equivalent to the latex glove. I think anyone looking at a latex glove and looking at this, it would be hard to say that those 2 were substantially equivalent. I think that we should not have let this go 10 years. This cer- tainly became a very contentious matter. But these are very real issues. The Agency, as I understand, back in 1985--and I wasn't there~had just come off the tampon issue with toxic shock syn- drome. A very simple device was found to have enormous harm, I understand that there was a concern even with simple devices: Could it mask breast lumps? Would women not go for mammog- raphy? I think there was a desire to get the data, and there certainly was difficulty in how you approve a product. If there is no predi- cate and it was a novel device, how do you approve it under the 510(k) mechanism? Mr. BARTOI~. Would the gentleman yield on that point? Mr. DEUTSCH. I'd be happy to yield. Mr. BARTOrq. Dr. Kessler, is it your judgment today as Commis- sioner of the Food and Drug Administration that that is in fact a medical device? Mr. KESSLER. Let me let counsel answer that question specifi- cally. Mr. BARTON. No. I'm not asking counsel now. You are the Com- missioner of the Food and Drug Administration. It has taken 10 years for 2 pieces of plastic with some silicone to get approval so that women may be able to enhance their ability to self-examine their breasts and perhaps sense a lump in its tiniest stage of devel- opment. You are a doctor. Is it your medical opinion that that is a medical device that should be. regulated? Mr. KESSLER. The answer is yes. Medical devices span fro.m tongue blades to stethoscopes to examination gloves to the most ad- vanced pieces of equipment. That's the way the definition was writ- ten in the Act. What Congress set up in the medical device statute was if you want to go through this 510(k) mechanism to the mar- ket, and you come on the market after 1976, you have to show that you are substantially equivalent to a device that was on the market before 1976. The company said this is a new device and this is what we are substantially equivalent to. If you don't want to go through the substantially equivalent mechanism, then what you need to do is go through the pre-mar- keting PMA and submit data. Mr. BARTON. You've answered that in your medical opinion it is a medical device. Mr. KESSLER. The detection of breast lumps, yes. Anything that aids in the detection of breast masses I would consider a medical device. Mr. BURR. Would the gentleman yield? Mr. BARTON. It's the gentleman from Florida's time. Mr. BURR. Would the gentleman from Florida yield for just one question? Mr. DEUTSCH. I will be happy to yield even though my time is up. Mr. BURR. Dr. Kessler, would that then include soap and water?
Page 54: TI14380162
100 Mr, KESSLER. It depends on how it's labeled. Mr, BURR. Is it not a recommendation by the medical profession today that women to detect cancer or breast lumps should use a practice of soap and water to make such a determination? Mr. KESSLER. Let me let Dr. Alpert-- Mr, BURR. Sir, I want to deal specifically with the statement you just made. Mr, KESSLER. Which is? Mr, BURR. Any application to detect breast lumps should be list- ed as a medical device. Mr. ~SSLER. Certainly any device used to detect breast masses, to aid in the diagnosis of breast cancer. Mr, BURR, Given that the medical profession, sir, has rec- ommended to women across this country that soap and water be used, should then soap be listed on your regulatory authority? Mr. KESSLER. If the~ Mr, BURR. I'm trying to draw a distinction. lV~r. KESSLER. Let me yield to counsel. Mr. BURR. If the soap were labeled to be used-- Mr, KESSLER. If the soap was labeled "use this to detect"--- Mr, BURR. You would ask them-- Mr. KESSLER. Let me yield to counsel. I think the Seventh Cir- cuit certainly has answered the question of whether this is a medi- cal device. Mr, BURR. I'm concerned with determining if soap is. Mr. BARTON. If the gentleman from North Carolina would sus- pend, It's on the gentleman from Florida's time, which has expired. We do need to maintain some sense of regular order. We will allow the Commissioner to answer for the record whether soap and water is a medical device that needs to be regulated by the FDA. If he could put that in writing. [The following information was received for the record:] STATUS OF SOAP AND WATER AS A MEDICAL DEVICE During the Oversight hearing on November 15, 1995 Mr. Burr and Mr. Barton requested that FDA submit for the record a response to the question of whether soap and water constitute a medical device. Under the Federal Food. Drug and Cosmetic Act (FDCA), Section 201(h), a device is defined as: [A]n instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is... (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease .... or (3) intended to affect the structure or any function of the body.., and which does not achieve any of its primary intended purposes through chem- ical action within or on the body.., and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes. Under this definition, the determination of whether a product is a device depends upon the intention of the manufacturer or other person legally responsible for label- ing the device. Whether the person "intends~ for a product consisting of soap and water to be a medical device is determined primarily by the claims made in the product's label, labeling, advertising and promotional material, and other state- manta made by or on behalf of the person responsible for labeling. This intention may, at times, also be discerned from conduct and marketing practices. If none of these factors reveal an intention that the soap and water product is to be used as a medical device, as defined in Section 201(h), then the product is not a medical device, 101 Under this rationale, a soap and water product could constitute a medical device if it is intended for use as specified in Section 201(h). Most soap and water products, however, are intended for personal hygiene. As such, they are exempt under Section 201(i) of the FDCA and do not constitute an FDA-regulated product. On the other hand, some soap and water products are medical devices because their intended use is to serve as cleansing solutions for contaminated medical devices such as surgical instruments. In addition, some soap and water solu.tions are classified as drug, s cause their intended use is to kill or inhibit bacterial growth on the human ~oay~ The fact that the American Medical Association recommends the use .of spa~p aria water for breast examinations does not, by itself, make the product a medical device. Off-label uses recommended by practitioners fall within the "practice of medicine", Mr. BARTON. The Chair would now recognize Mr. Burr for his own 10 minutes of questions. Mr. BURR. Thank you, Mr. Chairman. Dr. Kessler, I'm going to try to stay on the same subject, because it is one that I have a great deal of interest in. I clearly feel that I mirror to some degree what Mr. Wright has gone through. I'm not a bureaucrat. As a matter of fact, Washington is a great place to visit. I don't even want to live here. The thought of possibly spend- ing the first weekend since January in Washingtonmrm hopeful they'll get a budget deal before Saturday. Nonetheless, from everything that I have read, studied and re- viewed on Sensor Pad, I think a grave injustice has been done to this company. For that reason, bear with me as I go through to make sure that you and I agree on a number of the situations in- volved in the Sensor Pad case since for 10 yearsmyou are exactly right---this has been under review and a series of letters and com- munications have taken place between the FDA and IPI. Dr. Kessler, has Dr. Lillian Yin been in charge of the approval process involving Sensor Pad since its beginning? Mr. KESSLER. I'll let Dr. Alpert answer. Mr. BURR. She has been the lead? Ms. ALPERT. Yes. Dr. Yin is the director of the division in which obstetrical and gynecological devices and devices like Sensor Pad are in fact reviewed. Mr. BURR. Thank you. Dr. Kessler, on May 23, 1991, did Lillian Yin meet with a Patrick Nolan, a minority shareholder in Inventive Products? Ms. ALPERT. Yes, Congressman, that meeting did take place. Mr. BURR. Who requested that meeting? Ms. ALPERT. Mr. Nolan did, on behalf of the company, as he stat- ed. Mr. BURR. He stated that Grant Wright or representatives from Innovative Products would be in attendance in that meeting? Ms. ALPERT. Yes, he did, sir. Mr. BURR. Did Grant Wright accompany Mr. Nolan on the day of May 23, 1991 for the meeting? Ms. ALPERT. I was not at the meeting myself, but the minutes of the meeting indicate that he was not there, Mr. Nolan at that meeting announced that none of the principals of IPI were avail- able that day. He apologized for their absence at the meeting. Mr. BURR. Do indeed the minutes of that meeting indicate that though there was no IPI director, officer or representative other than a minority shareholder at that meeting that the meeting did indeed take place?
Page 55: TI14380163
102 Ms, ALPERT. A meeting took place. It was investigated after- wards, sir, and it was noted that no information that was not in the public domain had in fact been discussed at that meeting, Mr. BURR. I appreciate that. I know that Grant Wright indicated concern over it, if I'm correct, that this meeting ever took place. Ms. ALPERT. Yes, he did, and it was investigated. Mr. BURR. Ms. Bianchi stated that the FDA policy regarding such meetings concerning pending product approvals, that she didn't see any inconsistency with FDA policy. Is that a correct as- sumption from her letter? Ms. ALPERT. That is correct at the time that that meeting took place. Mr. BURR. Dr. Kessler, let me ask you, if I may, please sir. Could you state for me what the FDA policy is as it relates to this specific situation, the FDA's continuing a meeting with someone who is not a representative of the company? Mr, KESSLER. I think there is a reg. I'd have to go back and check, but there is a reg that says when people request meetings that we are---counsel can help me on that reg. Ms. PORTER. That's correct, Mr. Chairman. The regulation clear- ly states that when an interested party requests a meeting that the Agency gives them one. r. BURR. Any interested party? If I wanted to come have a meeting on Sensor Pad Ms. PORTER. No, no. Then there are obviously clear rules that apply with respect to agenda, with respect to the scope of the meet- ing, with respect to the purpose of the meeting, with respect to the information that can be discussed, depending on the particulars of the person's interest. The Agency is very careful not to disclose during the course of meetings information that is confidential. Mr. KESSLER. Congrdssman, sometimes the Agency, as I think ~ou will see in a number of these cases, gets caught between--I o.n't know this minority stockholder and Mr. Wright and what was going on there with this minority stockholder. Sometimes we get caught in between parties with different agendas. I would very much like not to get caught between those parties. Certainly if I were asked to have a meeting with a minority stockholder, I would be very reluctdnt to do that. I: don't think that is good practice. Mr. BURR. Dr. Kessler, I appreciate your observation on it, but you also said earlier, unless I misunderstood, you can't be respon- sible for 10,000 people. Mr. KESSLER. Absolutely, Congressman. Mr. BURR. But you have to be, sir. You're the head of this Agen- CY~r. KESSLER. What I have to be, Congressman~ Mr. BURR. For that reason, my question is, is it clearly stated that you have to have a company official? Remember that we are talking about a product here that is pending pre-market approval. Can there be a meeting under your policy? Mr. KESSLER. Dr. Burlington has the policy with regard to the Center for Devices. Mr. BURR. I think it's a yes or no. Does it clearly state it? Mr. BURLINGTON. Mr. Congressman, there is no doubt that it is the policy of the Center that when we are discussing commercial 103 confidential information that we meet. only with duly authorized representatives of the company. Mr. BuPm. Dr. Kessler, is it reasonable for me to believe that Dr. Yin, who has been involved in this process and we are now 6 or 7 years down the road into the 1990's; is it reasonable for me to believe that since she has been involved in this process from the beginning that she would easily identify that Patrick Nolan is not an officer of this company? Mr. KESSLER. I would certainly assume so. Dr. Alpert. Ms. ALPERT. Congressman, Mr. Nolan represented himself to Dr. Yin as speaking on behalf of IPI. Mr. BuP~. Dr. A/pert, I appreciate what he portrayed. My ques- tion is specifically, given that Dr. Yin had worked with this for 6 or 7 years, should she have been in a position to know that this was not an official officer, director or any other representative of the company other than a minority shareholder? Ms. ALPERT. Mr. Congressman, it would not be possible for Dr, Yin to know all of the individuals in the companies with which we deal. I would add that in general today's policy is to receive agen- das, lists of participants, and written requests for meetings on let- terhead from companies, but at the time that this meeting took place that was not the operating policy. .. Mr. BURR. Dr, Kessler, when Grant Wright indicated in a letter which I will read for you. It's a letter dated March 2, 1992. It is to a Delores Willis. Mr. BA_~TON. Does the gentleman from North Carolina wish to enter that into the record? Mr. BURR. I would, Mr. Chairman. Mr. BARTON. Would you ask consent to do so? Mr. BURR. Unanimous consent to enter this letter into the record. Mr. BARTON. Without objection. [The letter referred to follows:]
Page 56: TI14380164
104 (or Leek o£ poAt~) o~14 ~s~ to ~ ~t~oa We ~o ~ ~med, ~ any ~ to beA~ ~e~at~ MT ~he rDA~ ~v~. Z bmLAm o;: came ~s bmU ~ommAy mac- "lLIso~ely, 105 Mr. BURR. I quote the letter. "I was alarmed to learn about the meeting held without our knowledge between the Ob-Gyn Division and minority shareholder on May 23, 1991, concerning our product. The minority shareholder is not an employee, director or represent- ative and in no way had the authority to have such a meeting con- cerning our company. When I questioned Dr. Yin about this meet- ing I received little to no response." I guess my question would be that when Grant Wright indicated that Patrick Nolan is not an official representative of IPI, why did that not initiate an investigation into Patrick Nolan's actions? Clearly he has come before the FDA and misconstrued who he rep- resents and who in fact he is. Mr. KESSLER. I know that the matter was looked into. I have a letter of September 16, 1992, by the integrity officer. I can't an- swer. We'd have to ask that integrity officer what their review found specifically with regard to the representations and whether there were false representations. Mr. BURR. My question here, Dr. Kessler, is, isn't this an exam- ple of where an internal trigger for investigation has apparently failed? Is this not,an obvious departure from what policy is? Mr. KESSLER. I m looking at the minutes of the meeting. It says Mr. Nolan said he is authorized by the firm to be here. Mr. BURR. My question earlier, though, Dr. Kessler, was, is it practical for me to believe that Dr. Yin, who has been in this proc- ess for 7 years with this 1 company, can determine from that 7 years worth of experience with it that Mr. Nolan is not an official representative of the company? I think the conclusion was yes. Mr. KESSLER. Again, I think Dr. Yin would have to answer. Mr. BURR. For the record, let me say that she was invited today and that eventually she will be here and I will ask her this ques- tion. Mr. BARTON. The gentleman's time has expired. We'll have an- other opportunity. We do have several minority members that have been patiently waiting. Mr. BURR. I thank the chairman. Mr. BARTON. The Chair would now recognize the distinguished ranking member of the full committee and the former chairman of this subcommittee who has made this investigative subcommittee the power that it is today, the gentleman from Michigan, Mr. Din- gell, for 10 minutes. Mr. DINGm~.L. Mr. Chairman, thank you very much. A key issue in the July hearing was whether Innovative Products stopped shipping products after the Federal courts ruled against the company. According to Mr. Wright, the company stopped ship- ping after September 11, 1991, except for 5 shipments that were inadvertently made. Yet the case study compiled by FDA says that shipments continued. Can you or Mr. Chesemore walk us through the evidence that supports FDA's contention that Innovative Products made addi- tional shipments? Mr. KESSLER. Mr. Chesemore. Mr. CRESEMORE. Mr. Dingell, the company did make shipments following the appellate court decision of September 11, 1991.
Page 57: TI14380165
106 Mr, DINGELL. They have conceded 5 were made. Were more made than the 5? Mr, CHESEMORE, Five were made between September 11 and Oc- tober 11. Thereafter, Mr. Dingell, the company called the product Le Pad rather than the Sensor Pad, and shipment of that product was documented as late as January 1993. That product was still for breast examination. Mr. DINGELL. I believe that you have an affidavit from a nurse in Idaho on this matter. Mr, CHESEMORE. That is correct. Mr. DINGELL. A compliance memorandum dated July 28, 1995, sets forth other shipments in 1993 and late 1992. Is that correct? Mr. CHESEMOKE. Yes, sir, and that was the shipment I was refer- ring to. Mr. DINGELL. Were any other shipments made~ Mr. CHESEMORE. That s the last shipment that we have docu- mented. Mr, DII~aELL. If these shipments continued, were they legal or il- legal? Dr, Kessler, you or Margaret Porter or Mr. Chesemore. Mr, CHESEMORE. In my opinion, sir, they would be illegal. Mr, DINGELL. Why were they illegal? Mr, CHESEMOP.E. Because of 2 court decisions saying that this was a medical device and it was an unapproved medical device, and therefore it could not be shipped in interstate commerce. Mr, DINGELL. Did FDA ever confront the company with this in- formation or subsequently ask the company whether any ship- ments had continued? If so, what was the company's response? Mr. CHESEMORE. I don't recall that particular question being asked, Mr. DINGELL. Dr. Kessler, can you inform us? Mr, K~.SSLER. I'd have to do it for the record. Mr, DINGELL, Ms. Porter, can you tell us? Ms, PORTER. Mr. Chairman, if I understand your question, it was, did the Agency ever confront them? Mr, DINGELL. Was the company confronted with this informa- tion? Ms, PORTER. The answer is clearly yes, and Mr. Chesemore could speak to that. Mr. DINGELL. Dr. Kessler, Mr. Wright noted in his testimony that you, Dr. Burlington, and Dr. Alpert were not in your current positions when his problems began, but he felt that although the top people at FDA were doing their jobs, the attitude in the lower ranks has remained antagonistic, leading to a conclusion on his part that management is the problem. Could you give us a comment on that point, lease~ p . Mr, KESSLER. Mr. Dingell, I do believe that the issue of Sensor ~eafde, 1.0 years to resolve this dispute, I'm not going to sit here and nd that we needed to be more innovative and work harder with Mr, Wright to resolve this dispute. Yes, there was shipment of an unapproved product. Yes, as Mr. Chesemore testified, there was shipment after the court of appeals, but I think that we could have over this 10 ~'ears have worked harder to get the important data to deal with this product. 107 Mr. Wright also testified, I believe in July, and he was very kind, that Dr. Alpert and Dr. Burlington and the top management throughout was working constructively with him to try to get the data to support the approval of the product. Mr. DINGELL. Dr. Kessler, the case study attached to your testi- mony says that "CDRH has instituted a number of management re- forms intended to facilitate better communications with the compa- nies and more effective dispute resolution." Can you or Dr. Burlington outline the reforms and explain what they are intended to do? Mr. KESSLER. Dr. Burlington. Mr. BURLINGTON. Thank you, Mr. Congressman. We have in fact over the last couple of years put in place policies for communication with companies that have products in front of us or that are antici- pating bringing products in front of us so that we may sit down with the company and have a scientific exchange about the sort of data that will be needed to support the product. This procedure has been widely adopted in the last couple years. We have had more than a couple hundred such meetings this year and in fact have met on several occasions with Mr. Wright and Inventive Products specifically with these aims in mind. Mr. DINGELL. Gentlemen and ladies, I note that we ha~e a prob~ lem here which appears to relate to the creation of a crisis and the relationship of top management to the people with whom Food and Dru~ deals. I have some curiosity. Wouldn't it be wise for the Cen- ter directors to receive a quarterly report on the status of the ,top 5 or 10 controversies or disputes so that appropriate supervision can be brought to bear earlier on the problems? Also, if top man- agement saw a problem or a pattern of problems out of 1 divisions they could then take appropriate action. Isn't this a problem of supervision of information flow inside FDA so that the Agency doesn't appear to know what is going on in the assemblage of its different l~arts? Mr. KESSLER. Mr. Dingell, I t~ink there was an impasse here, You are 100 percent right. When that impasse was hit top manage- ment early on should have worked better to resolve that impasse, Mr. DINGELL. Doctor, we've heard a lot about the Sensor Pad. What is the status of the device today? Mr. KESSLER. Let me let Dr. Alpert answer. Mr. DINGELL. Doctor, would you tell us? Ms. ALPERT. Yes, Mr. Dingell. The Sensor Pad, the same device~ has recently been cleared for a slightly different intended use than the one that Mr. Wright originally asked for and has periodically asked for over the 10 years. Mr. DINGELL. What is that, please? Ms. ALPERT. The clearance is for this pad, now named The Ex- amination Pad, to be used by health care professionals in the ex- amination of soft tissue. Mr. DINGELL. We have here essentially a device; is that correct? Ms. ALPERT. That is correct. Mr. DINGELL. It must be satisfied that the device is safe and ef- fective and that the claims made for the device in fact are true; is that right? Ms. ALPERT, That is correct.
Page 58: TI14380166
OD 0 108 Mr. DINGELL. That's the requirement of law. Was that requirement ever satisfied by the applicant in this case? Ms. ALPIniST. For the intended use that I just mentioned. Mr. DINGELL. For that use, but I'm talking about in the original application. Ms. ALPERT. No. We have recently received information but have not--~ Mr. DINGELL. My time is limited, so let me let you stand on that particular answer. That leaves us then with a question. Did they seek to have this device cleared on the basis of the fact that a similar device was on the market which was used for certain therapeutic purposes? Did they do that? Ms. ALPERT. For the breast examination, sir? Mr. DINGELL. Yes, for breast exam. I've heard that it was equiva- lent to a rubber glove; is that right? Ms. ALPERT. That was their first claim, sir. Mr. DINe-ELL. Are therapeutic claims made on rubber gloves with regard to breast cancer examinations for women? MS. ALPERT. No, sir. Mr. DINGELL. So it was equivalent in all of its particulars to a rubber glove, but a rubber glove is not classed as a device for breast examination; is that correct? Ms. ALPERT. That's correct. Mr. DINGELL. So that did not create the necessary analogy be- tween an existing device in terms of the effectiveness and so forth of the device; is that correct? Ms. ALPERT. That is correct. Mr. DINGELL. A rubber glove is used by a doctQr for a breast ex- amination of patients for the following reasons: because of the sani- tary aspects and because of the sensitivity of the woman involved. Isn't that the reason that these things are used? Ms. ALPERT. Breast exams are generally performed with the bare hand, sir. Mr. DINGELL. Thank you. Thank you, Mr. Chairman. Mr. BARTON. I thank the distinguished ranking member for that line of questioning. The Chair would recognize the vice chairman of the subcommit- tee, Mr. Cox of California, for 10 minutes. Mr. Cox. I thank the chairman. Dr. Kessler, I know even though you were not in attendance at the last hearing you are familiar generally with the testimony we received with respect to Sofamor Danek. Mr. KESSLER. Congressman, I did spend hours studying the testi- mony. Sofamor Danek did not, to my knowledge, testify at the July 25 hearing. Dr. Michelson and Dr. Watkins testified. We've been in discussion with subcommittee counsel on the companies that they were talking about, and I believe Sofamor Danek is one of the com- panies that they were talking about, but Sofamor Danek didn't tes- tify. 109 Mr. Cox. But you are aware that this committee has received testimony about the controversy surrounding Sofamor Danek and their concerns that they are being mistreated by the FDA? Mr. KESSLER. I am aware of the allegations that were raised by Dr. Watkins and Dr. Michelson, yes. Mr. Cox. You are also aware of the FDA study of screws that are used in spinal fusions of the type manufactured by Sofamor Danek, the historical survey that the FDA relied upon, the so-called cohort study? i Mr. KESSLER. Again, we wor.k, ed to n~ake sure I understood what Dr. Watkins and Dr. Michelson s allegations were. As I understand their allegations, they were talking prImarily about a spinal cage system. They were concerned about spinal cages. The chairman asked the question about interference in medical practice with re- gard to pedicle screws. I read about that. But the allegations that they made~ Mr. Cox. I'm asking a pretty straightforward question. Are you aware of the private medical study conducted? Mr. KESSLER. I know there was a retrospective. I've heard of that. I'm not personally aware ofal] the aspects about that study. Dr. Burlington, I'm sure, is. Mr. Cox. But you know the study to which I am referring if I say the cohort study? Mr. KESSLER. I know there was a cohort study, but Dr, Bur- lington is certainly much more knowledgeable than I am. Mr. Cox. The FDA was interested in this study so that it could make a reasoned judgment as to whether devices of this type, pedi- cle screws, should be reclassified for certain indications; is that right? Mr. BURLINGTON. Yes, Mr. Cox. That is correct. The Agency staff worked with a consortium of academic and professional societies to develop a study protocol exactly for the purpose of investigating whether reclassification could be supported or not. Mr. Cox. Dr. Kessler, none of this comes as news to you; you are fully familiar with all of this, right? Mr, KESSLER. On the---- Mr. Cox. The study that Dr. Burlington just described. Mr. KESSLER. I certainly know that that study took place and that the Center relied on that study, yes. Mr. COX. You are aware that the FDA violated a court order with respect to that study? Mr. KESSLER. I personally? I'd have to ask counsel. Mr. COX. No. We cannot ask counsel whether you are aware. I'm asking you, Dr. Kessler. Are you aware that the FDA violated a court order with respect to that study? Mr. KESSLER. A court order with respect to that study? Mr. Cox. Yes. Mr. KESSLER. I have no knowledge of what you are talking about specifically. Mr. COX. Is that right? I don't want to make this a complicated question. Mr. KESSLER. No. I don't know what court order that we are talking about with regard to that study. I would certainly yield to counsel.
Page 59: TI14380167
110 Mr. Cox. I do, and I don't need to be told by counsel. I want to find out, Dr. Kessler, what you know. Mr. KESSLP.R. A court order? Mr, Cox. Yes. Mr. KESSLER. I'm asking counsel. I had a couple of days in prepa- ration for this hearing~ Mr. Cox. Mr. Chairman, I would like to place into the record what I will designate as Sofamor Exhibit 1. ant to make this easy for you by giving you a document. I ~ ....... : .....es wil~ susnend. There is an inquiry Mr. DARTON.. 1I ~ne~ w~ ...... ~.I-~+~man will state his from the gentleman :roe ua~lIornla. ~*~ ~**~-~ inquiry. Mr, Cox. I would like to place into the record what I will des- ignate as Sofamor Exhibit 1, an October 26, 1995, order from the U.S. District Court for the Eastern District of Pennsylvania. Mr. BARTON, Without objection. A copy will also be given to the minority. Mr. Cox. I ask that a copy be provided to Dr. Kessler. Mr. BARTON. Without objection. [Sofamor Exhibit 1 court order follows:] 111 IN THE ~ITED ~TATES DTSTR~CT COURT FOR ~ EASTERN D~STR~CT OY PE~INSYLVAN~A IN RE: 0RT~0PEDIC 3ONE SCREW : PRODUCTS LZA~ILITY L£zIr-ATIOR : : ~S DO~ ~TE5 TO ~L : A~IONS ~D NO~, TO WIT, thi~ CO~ ha~ been a~vlse~ Fixac%on in Thoracic L~ar and Sacral Spinal "Cohor¢ S~udy") . I use by anyone, for ~ny :e~son,
Page 60: TI14380168
112 Mr. BARTON. The Chair would also indicate that Mr. Zeller needs to come forward. He was one of the people that was at the table. The gentle lady can also stay. There is another chair there. You don't have to leave, but Mr. Zeller needs to be at the table. I think there are going to be some questions for him momentarily. The gentleman from California. Mr, Cox. I would ask that Dr. Kessler read the one-page docu- ment. Mr. BARTON. While Dr. Kessler is reading that document, the Chair would ask unanimous consent that Dr. Kessler's notebook of material that was submitted to each member be put in the record with the exception of the confidential material that is proprietary. [The notebook of material referred to is retained in the commit- tee files.] Mr, KESSLER. Congressman, I don't know whether it was yester- day or the day before. Let me tell you what I became aware of, what was raised to me. I don't believe I've seen this before and I don't believe I knew there was a court order specifically. I knew there was an issue about an inappropriate release of certain docu- ments. I knew that was an issue. I think it was yesterday or the day before where it was raised. In my discussions about it they were not in terms of a court order. I guess counsel did say that we had filed in cou~ Ms. PORTER. Mr. Cox, if I may. We are aware of that order. We take it very seriously. Mr. Cox. I know somebody is aware of it, because the FDA had to reply in court to explain why they violated the order. Ms. PORTER. The Agency has taken extraordinary steps to pro- tect both patient and reporter identifiers. Mr. Cox. I'm sorry. You're getting ahead of me now. I want to get back to the basics here. Mr. KESSLER. We just wanted to clarify what I know about. I knew there was an issue. Mr, Cox. I'm speaking to what the FDA Commissioner knows about. Can you take a look at the one page that I have given you? You will see in the second paragraph that the court ordered the FDA to provide a responsive pleading "detailing its reasons for violating Pretrial Order No. 147." Mr. KESSLER. I see that paragraph. Mr, COX. So there isn't much question here that the court has asked the FDA "why did you violate the court order?" Mr. KESSLER. That's clearly what this document says, Congress- man. Mr. Cox. Before I gave you this document, were you unaware that the FDA had violated the court order? Mr. KESSLER. I knew there was an issue about the inappropriate release of documents. Mr. Cox. Were you unaware that the FDA had violated a court order? Mr. KESSLER. I didn't know it in those "~rms." I knew there was inappropriate release. I knew we were filing something in court to make sure that the documents couldn't be used. That was told to me. 113 Mr. Cox. Recently several doctors who are not involved in spinal surgery were subpoenaed by the plaintiffs lawyers in this case be- cause the plaintiff's lawyers had access to all of the confidential names of doctors who participated in the study, and these docto, rs who are now being subpoenaed because they volunteered to assist the FDA in evaluating a medical device believe that the only rea- son they are involved in this case and the reason they are now hav- ing to go through depositions and so on is because of the leak of their names. I'd like to ask Ms. Porter. I've just learned from Dr. Kessler that you didn't tell him that the FDA violated a court order, Why not? Why didn't you tell him? Ms. POaTER. Mr. Cox, I explained to the Commissioner that we became aware of not a leak but an inadvertent disclosure of physi- cian names. Mr. Cox. But why didn't you tell him that the FDA was found in violation of a court order in Federal court? Ms. PORTER. The purpose of the discussion was to explain what had happened and the steps that the Agency was taking and had already taken to secure the protection and the return of the docu- ments. Dr. Kessler was advised about all of the circumstances that led to the unauthorized disclosure and the steps that the Agency was taking and had taken. I would like to say, as I started to say, that this Agency takes very seriously the protection of both patient and physician reporter names and has gone to extraordinary lengths to participate in a va- riety of proceedings in order to protect those names against disclo- sure. It's a very, very important policy for the Agency. Mr. Cox. Ms. Porter, I would agree with you that it is very, very important and that it is a very, very serious matter when physi- cians who voluntarily participate in the Medwatch program, for ex. ample, to report, as do patients, adverse events, patient problems, and so on. When these people believe that their confidence in re- posing their trust in the FDA is going to be violated, obviously they are not going to continue to provide this information, and in the FDA's own words in the court filing that you made medical progress will be retarded. Mr. BARTON. The gentleman's time has expired. We will get back to this, but we do need to recognize the gentlelady from California, Mrs. Eshoo. Ms. ESHO0. Thank you, Mr. Chairman. Thank you for holding this hearing, and to Dr. Kessler, welcome to it, and to everyone else that is at the table as well. Dr. Kessler, what I would like to focus on are 2 areas. You said that you read the transcript of the previous hearing. What stands out in my mind more than anything else are not the detailed par- ticulars of that hearing but the overall sensibility that I walked out of the hearing with. It was that the Agency, in terms of its own internal culture, wasn't well, and because of that there were many manifestations of it: very, very lengthy review processes; sometimes a lack of willingness to take a look at things in a new way so that things could move. I know, Mr. Chairman, I was late for this hearing and there were some questions that were asked at the beginning.
Page 61: TI14380169
O0 0 114 What I would like you to perhaps in the short time that I have asking you questions is to perhaps enlighten us about how the Agency is actually assisting those across the country. We have had this conversation before. You know very well what the 14th Con- gressional District in California represents. If there is a new chap- ter in the life of Silicon Valley, it is through biomed, the biotech companies, and also in terms of medical devices. How is it that the Agency with any kind of specifics both in terms of management a training, changing the culture that has been referred to by many experts who want to blow the Agency up? I'm not one of those either. The American people have a regard for the FDA, and they should. How is it that you have reshaped things so that companies can get through a system that can often be difficult and confusing and especially costly for the small companies? A huge pharmaceutical company has the staying power. The small guys don't. I think that they hold a great deal of promise both in terms of cures for our peo- ple as well as the economic outcome. Are there any specifics that you can point to where the Agency is turning that around both in terms of timeframe, a new process, a new way of looking at things that I can take back to my people and say, this is what Dr. Kessler said on November 157 They're not telling me, most frankly. Since you are here, I would like you to tell me that. Also, what lessons have you learned in the Sensor Pad? Obviously in life there are two sides to every story. There always are. Sometimes it's a 51/49; sometimes it's a 70/30; sometimes it's 90/10; but there are still two sides to every story. What have you learned from that? I think there are some lessons that have been learned, but what have you learned, and what are the manifestations of that in the.Agency? Mr. KESSLER. Congresswoman, the question with regard to Sili- con Valley and the genius in the biotech industry, I think there is no better example than last week when the chairman of the biotech industry organization stood up with us and announced probably, 1 think in everyone's terms, the most significant reforms in the biotech industry in the last decade. Biotech products used to be regulated as biologics. There used to be 2 applications that used to be required, what is called in the trade an ELA and a PLA. The science has matured in such a way that we are now able to characterize and understand those prod- ucts so that last week the Agency announced that it was doing away with the ELA application, and the chairman of the industry trade association stood up and said the only complaint he had with what we were doing was we were underestimating the amount, of money that would be saved by this. It was so dramatic. That shift really was because of the science over the last 2 decades that has evolved that allows us to look completely different on how we should regulate these well characterized products. That's as good an example of how I think we are trying to look at ourselves. With regard to Sensor Pad, I think there are a couple of things we have learned. I don't think we should have let it get this far. 115 It started in 1985. I think we should have sought more creative so- lutions to solving the problem. Ms. ESHOO. What do you have set up now if there is the next Sensor Pad? What do you have in the Agency that sends up the flag? Do you have a flag team? I don't want to oversimplify the complexities of what is involved. In the last analysis there are human beings that are either going to ingest drugs or carry devices in their body or their bodies or going to be touched by any number of products, and each human being is precious. I don't want to diminish any of that, and yet if an Agency is not working smart, having learned from either ex- cesses or shortcomings of the past, then we could be back here, maybe not myself as a Member of Congress, but other members saying, what did you learn from the ABC experience? When you learn things, you can't just say, well, we learned something, and mea culpa. Mr. KESSLER. I'll let Dr. Alpert, because the Center has put into place a number of things that go directly to your point. Congress. woman, some of these are also hard cases. Ms. EsHoo. We have hard jobs. Mr. KESSLER. Here there was clear violation, shipment of unap- proved products in violation of the statute. When you see those vio- lations occurring and you see those violations of law, as Congress, man Dingell pointed out, they only add to the complexity. Ms. ESHOO. Dr. Kessler, I acknowledge there are complexities, there are tough cases. We have hard jobs, but that's not enough. In the end we still have to produce for people. We have to give them sensible answers. This thing got out of whack. You acknowl- edge it; we know it. But what's in the Agency now .that tells us that you are working smart, that you have set something up, that you've learned from it? Mr. KESSLER. The most important thing that I have done, I be- lieve, for the Center for Devices are the 2 people that you see sit- ting next to me. They are real physicians, real clinicians, who I think bring the judgment that is necessary of what is important and what is not important to focus on. Dr. Alpert. Ms. ALPERT. Thank you. Congresswoman, we have done a number of things in the last few years in the Center for Devices and Radiological Health and particularly in the Office of Device Evaluation to provide increased and earlier access to the process for the industry. We are encourag- ing the industry to seek advice and to seek communication with us prior to submitting even their new investigational device exemption or prior to submitting a 510(k). Ms. ESHOO. How do they do that? Can they get on the phone with someone? When you seek communication, what is it? Is it put- ting things in the mail? Who reads them? What's the response time? Ms. ALPERTo It's a series of options. One is that we do take tele- phone calls. There was a period of time in the past where calls were not taken and returned. That has ceased. We have a policy of returning phone calls. We take meetings. We do ask that compa-
Page 62: TI14380170
116 hies request their meetings in writing, but they may fax them into US, Ms. ESHOO. Believe it or not, to my colleagues that are here this morning, I don't know how many of you realize this, but this is a major breakthrough. You couldn't make a telephone call; you couldn't send a fax. I guess you could technically, but it was not the accepted mode of communication. In a country that leads in the communication revolution, I'm glad to hear this. This is a healthy step. Ms. A~P~.RT. Thank you. In addition, we are working actively and interactively during the review process with companies. We also have in the Office of Health and Industry Programs a Division of Small Manufacturers Ass/stance, which has established both a modem access and a flash fax system that provides access for the industry or any interested parties to receive any documents, guid- ance and communications that we have made to the public through a very easy access system. Ms. EsI~oo. Is this front end as people are just applying or are interested in applying7 MS. ALPERT. That's correct. Ms. ESHOO. Mr. Chairman, I see that the red light is on. I don't know if you are going to go around again with a series of question. Mr, BARTON. We are. I can assure you there will be more than one round of questions. Ms. EsHoo. Thank you. I'm sorry I went over my time, and thank you to the panel. We'll get back to you. Mr. BARTON. It's good to establish some breakthroughs. We ap- preciate that. The Chair will now recognize the gentleman from Oklahoma, Dr. Coburn. Mr. COBURN. Dr. Kessler, you just said in response to Congress- woman Eshoo's question that we have real physicians. Who is a real physician and who isn't? That was your comment. Mr. KESSLER. Yes, it was. Mr. COBUI~N. You are making a judgment? Mr. KESSLER. No. Mr. COBURN. Would you explain what a real physician is to this panel? Mr. K~SSLER. I would be happy to. Dr. Coburn, the history of the Center for Devices, the leadership of that Center had previously been led not by physicians, not by people who had clinical judg- ment and people who were using these products. They were very well trained engineers, scientists in the past, but there was not the kind of clinical judgment. Maybe I was a little loose, Dr. Coburn, in my language. Dr. Bur- lington practices still to this day in emergency medicine. What I wanted to do was to bring the kind of judgment to that Center to know what's important, what are the things that really influence, what devices really make a difference. That's what I meant, Con- gressman. Mr. COBURN. Recently in the past week one of the other cabinet level agencies of this administration was revealed to have spent a significant amount of the taxpayers' money to compile a list of those people who changed weekly or monthly on how much nega- 117 tive press they gave that Agency. Is there anywhere within the FDA or of any of your 10,000 employees, which I presume that you are not responsible for by your earlier testimony, a list or a list so- licited of people that are opposing in ranking order the FDA, or re- porters that would be qualified to be on such a list? Mr. KESSLER. I have no knowledge that we spent any money to rate reporters on whether they were favorable or not. Mr. CoBum~. Does a list exist within the FDA of those people who are favorable to the FDA or opposed to it? Mr. KESSLER. Reporters who are favorable? Mr. COBURN. IS there a list within the Food and Drug Adminis- tration? Mr. KESSLER. [ have no knowledge, Congressman, of that, We can certainly ask. I have no knowledge of that. Mr. COBURN. Is Dr. Burzynski a real physician? Mr. KESSLER. Dr. Burzynski is licensed, I believe, by the----- Mr. COBURN. I'm talking in the characterization that you made a minute ago of real physicians. Mr. KESSLER. Congressman, I don't want to characterize Dr, Burzynski. I don't know Dr. Burzynski. I have never met him, I've read certain articles that state his qualifications. Mr. COBURg. Let me go on. What is the basis that the FDA has gone after this gentleman? Let me say, first of all, I would concur withyour responsibility and would worry that if we were pursuing outside of the guidelines for development, et cetera, I would concur with that, but at the same time I want you to try, if you can, to answer for me why have spent a significant amount of the taxpayers' money both with- in the FDA and also the U.S. Justice Department over the last 12 years, 3 grand juries and other investigations, and at the same time a Federal judge has allowed Dr. Burzynski to continue to treat patients within his own State, why the FDA is continuing to pursue cases after him. Would you please explain that to me? Mr. KESSLER. Congressman, I want to be as forthcoming as I can~ but I do not want to do anything to jeopardize an ongoing criminal investigation. There are certain facts that I believe are public. In 1983 that Federal district court that you referred to ordered an in- junction against the interstate shipment of products. As late as 1994--and I would certainly let counsel read it--let me get the spe- cific language from the Trustees [Court of Appeals case]. Mr. COBURN. I've read all the court documents. Mr. KESSLER. I think it's very important. In 1994 the Court of Appeals for the Fifth Circuit found that in fact there was illegal ac- tivity going on 11 years later. That was the Fifth Circuit. Again, 1983 there is an injunction against interstate shipment; 1994, the Fifth Circuit found illegal activity, sir. Mr. COBURN. _.L,.et me ask you this. Are you aware of.any, patient of Dr. Burzynski s during the 25 years of practice that has been rectly harmed by his method of treatment? Mr. KESSLER. I have no such knowledge, Congressman. You used the word "harm." I assume you mean medical harm. I am aware of the trustee's case of the complaint on the $90,000 that the pa- tient was charged. But that's not physical harm. Mr. COBURN. I'm talking medical or physical harm.
Page 63: TI14380171
118 Mr. KESSLER. I understand. Mr. COBUP~. You stated in your testimony to us that the FDA has searched the appropriate records for a cease and desist order and has found no record of any. Mr. KESSLER. Congressman, just for the record---- Mr. COBURN. Let me finish this one. Mr. KESSLER. Thisgoes to your previous question. Mr. COBURN. The FDA has searched the appropriate records for a cease and desist order and found no record of any such order in this case. You go through the trial docket of the Department of Justice attorney. No cease and desist order, no cease and desist order. I would like to submit this for the record, if I might have unani- mous consent to do this. These are the findings from the Southern District of Texas, U.S. District Court. Mr, BARTON. Without objection. [The court order fol[ows:j 119 U~ITED STATES OF A~J~RICA" Plaintiff, Burzvnski Cancer R~e~ch ~fend~s. FILE:D C.A. NO. H-83-2069 Pending be£ore the Court i~ D~fend~ta' Notion ~o P~opoeed ~tte~ to the Co~t f0~ ~d£~ b~ the ~ood ~d A~£n~ttat£o~. ~e Ce~t ~£~ that the ~ot£~s ~houl~ be ~el~inaU InJ~cti~ and for C~t~t. A~ ~ aside, Court suggested ~hac ~he ~A su~£~ ~he proposed le~¢~. would not be appropriate. ~e c~rt c~¢~s. ~e~efore, It is ORDERED, AIL~UDGED AHD DECREED that De[andante' Notion to Enter a Proposed ~rder is hereby DENIED. Ic is f~cher O~V that ~. Burz~ski's Moti~ to Su~t a ~oposed letter to the court for sending by the ~A i~ hereby DENI~. ~e clerk shall file ~hls ~der ~d provide co~sel for all at HousC~, Texas, this ~day of D~e.
Page 64: TI14380172
120 121 IH THE UNITED STATES DISTRICT COURT FOR THE SOUTUE~N DISTRICT OF TE~LA~ BURZYNSKI CANCER RESED-4CR INSTITUTE. ET A6,, DZVISIO~ S C,A.NO.B-E3-2069 Defendants. 0 R D r R kccordlnq ly~ 19e4. FILED JAN21 ~ JL~ E CL~ CLL~ IN THE UNITED STATES D~STRICT COURT FOR THE SO~THERH D$STRICTO~ TEXAS BOUSTON DIVISION UNITED STATES OF ~d~ERICA~ BURZYNSKI CANCER RES£~CH ~NSTITUTE, ET A~., ~fendants. ORDER Pending be~o~e t~e Court CLER~ U3. D~STM~'T COUI~ FILED JAN21 ~6 £S Counter-Pla£nti£E*s Motion for Having carefully considered the Parties' pleadings the Court concludes that the Motion should be DENIED. Counter-Plaintz((S move th~s Court (or an injunction and De. Buczynskk did not submit an IND ptoposeI. For the followin~ reasons thls Court find~ no grounds for Couneer-Pl~In~ffls regard~n~ the search warran~ ~ssued a~alnst Counter-Pla~tl~fs~ Exh~b;t ~ o~ the~ Motion (letter 6ros the ~DA to Bartlett) ks not dated "October 2B, 1985." The bem~uest at the partially faded date is that it represents the date on which the o~v~ously were generated fro= Information provided by (although the information in Exhibit D conoernin~ Counter- P~laint~ff's IND was probably m~sconstrued by Senator Hatch} before October ]B, 1985.
Page 65: TI14380173
123 122 representations. ~ith ~egsrd to Counte~-~lain~iffs' Motion Th~l Coorr 15 very familiar wrth this case end the partial' concludes tha~ Doth Hot,one ahould be Denied. AccordinglY, |¢ ~s ORDERED, AD30OGED, and DECREED ~hat the Counter- Contempt o~ Court shall be DENIED. coun.,l for ,ll part,e,. DOH~ a~ HOUStOn, TexaS, this day O~ igeG. UI~ITED STATZS DISTRICT JUDGE ~L,I 48 ~01 I"IZ lO0"nl1111 Ollr114C'l' O~ ~ FILED J~SS~ I:
Page 66: TI14380174
124 125
Page 67: TI14380175
126 127 ~hl(t tO ~ly t~¢ of t~ eff~t, uo¢ of any ~$~Csl turner. c~ee, anet~r ~88~. [~, 171-172.
Page 68: TI14380176
~0 0 128 129 Mr. COBURN, The FDA under this order filed January 21, 1986, was advised that in any case the cour~ would admonish the FDA-- Mr. K~SSLER. Could you tell me what page you are reading from? Mr. COBURN. I'm reading from page 5. The cour~ would admonish the FDA about giving information re- garding the conclusion that antineoplastons were caused to be shipped interstate and regarding any reference to the search war- rant. I would agree with you that that is not a cease and desist order, but that is an admonishment from the court. I guess my question is the fact that you don't refer at all in here that the court had any interest in changing somewhat the direction of the FDA's com- ments or statements in regard to him. That has been my problem with the FDA, and I've been dealing with the FDA since 1970 both as a medical device manufacturer and then as a physician. I guess what I would say is the fact that even though there is no formal cease and desist order, you have been instructed and ad- monished-my dad taught me what admonish means: here's what you'll do or you'll suffer a consequence--to not do those things. Mr. KESSLER. The court did state that language. Yes, Congress- man. Mr. COSURN. What has been the FDA's response in re.gard to that language? Mr. KESSLER. Let me let Mr. Spiller who has been involved in this case comment, sir. Also, I believe we do have information on the question about harm. I don't have any personal knowledge of this. Mr. COBURN. My question was whether or not you knew of any harm. Mr. KESSLER. Whether we knew of any harm ~ith regard t~--- Mr. COBURN. Whether you knew of any harm. That was my ques- tion, Dr. Kessler. Mr. KESSLER. I think that--- Mr. COBURN, Dr. Kessler, that was my question. I did not ask you--we've already established that you've decided that you can't be responsible for these 10,000 employees. - Mr. KESSLER. Congressman, I think if you are interested in whether the tr+eatment has any medical or physical harm-- Mr. COBURN. No. What I'm very interested in is your leadership within this Agency and whether or not you are made aware and therefore decisions that are manifested based on your leadership are carried out. That's why I asked the question specifically of you, You gave us a tremendous amount of testimony in terms of-- Mr. KESSLER. Congressman, I was-- Mr. COBURN. [continuing] Will you please let me finish? Mr. KESSLER. I was just handed a piece of paper, and I will be happy to submit this. Mr. COBURN. You gave us a tremendous amount--Mr. Chairman+ Mr. KESSLER. Congressman, I was-- Mr. COBURN. I would like the prerogative to finish my statement and ask my question. Mr. BARTON. Let's extend to Dr. Kessler the courtesy to which he is due as the Commissioner of the FDA. We understand this could
Page 69: TI14380177
be a contentious issue. I can assure the gentleman from Oklahoma that I have some questions about Dr. Burzynski also. Mr. COBUm~. You may continue. Mr. KESSLER. Congressman, a note was handed to me, and it simply says two died of infected catheter. No, I don't know any- thing about this. This was a note that was handed to me. Mr. COBURN. Would you give us the names of those people? Mr. KESSLER. That note was handed to me. Mr, BARTON. I think it is a fair question. The gentleman with the striped shirt and the blue tie, could we have your name and your title, please, sir? Mr. SPILLER. My name is Robert Spiller. I'm Associate Chief Counsel for Enforcement. I work for Ms. Porter. Mr, BARToI~. Were you one of the ones that were sworn in? Mr. SPILLER. I was not, Mr, BARTON. Dr. Kessler, do you intend to rely on this gen- tleman? If so, we would have to ask him to raise his hand and be sworn in. Mr. KESSLER. I would appreciate that very much. [Witness sworn.] Mr. SPILLER. In response to the question of whether or not there has been harm in the past 27 years, yes, there has. There were at least 2 patients who died in Canada of infections resulting from the subclavian catheter that was used as the route of administration for Dr, Burzynski's antineoplastons. Mr. COBUrg. May I respond to that, Mr. Chairman? Mr. BARTON. Very briefly, yes. Mr. COBUm~. I think it's also very important to know that subcla- vian catheters are prone for infection, especially when left for a particular time, and if there was in fact a documented case that it came from what was introduced through the catheter or the cath- eter itself, We need to be careful. If the FDA has documented evi- dence that harm has come about through this, then they need to say that, but not say through an infected subclavian catheter. Mr. SPILLER. I'm not a doctor. I don't know whether-- Mr, CoBum~. I am and I do know that. Mr. SPILLER. I don't know whether the infection was attributed to the drug or to the catheter. My suspicion, I assume like yours, is that it came from the procedural route of administration. That route, of course, is chosen ~y _D,r. Burzynski. Mr. BARTON. The gentleman s time has expired. The Chair would now recognize the distinguished gentleman from California, Mr. Waxman. Mr. WAXMAN. Thank you, Mr. Chairman. Dr. Kessler, a pleasure to see you. I regret I haven't been here for some of the earlier questions. On this last case of Dr. Burzynski, it seems to me you are being attacked for spending money, using FDA resources to pursue matters associated with this Burzynski Institute. Is this a good use of FDA's scarce enforcement resources? Mr. I~SSLER. Congressman, if I can answer that question by reading the closing paragraph from the Fifth Circuit in 1994, parts of the last paragraph. It says, "Cancer victims"--then it gives a pa- tient's name--"often are understandably eager to pursue any 131 course of treatment whatever its cost or efficacy that offers the faintest hope of preserving life. Their plight commands sympathy but also attracts opportunists. The State of Texas and the Federal Food and Drug Administration have stepped in to protect cancer patients from those who would prey on their vulnerability. While we do not impute evil motives to Dr. Burzynski, neither can we conclude that he is beyond the laws written to protect his patients. When he oversteps their bounds, the resulting costs are his to bear," I don't know Dr. Burzynski. I can't comment personally on his patients, but these patients are very desperate; they are very vul- nerable. If you look at the history, there have been controversial cancer treatments for the last 100 years that have posed very con- troversial and difficult questions. There is a way to study these treatments. We have encouraged Dr. Burzynski to study these treatments as part of investigational trials. We have wanted to work with him in those investigational trials. That's the way I believe that we should study cancer treat- ments. Mr. WAXMAN. I certainly think there is a potential for a lot of charlatans to prey upon very vulnerable people, and we expect the FDA to be doing the job of scrutinizing those who are out claiming they have some treatment that hasn't been established by valid sci- entffic method and under the protocols established by the FDA, This subcommittee sent out a briefing memo which we didn't see until we got in this morning, and we may never have seen, but they alleged--and I want you to answer this--that "FDA has shown no compunction about violating grand jury secrecy rules in the past when they have attempted to harm his medical practice," They are referring to Dr. Burzynski. Would you respond to that, ei- ther you or Ms. Porter? Mr. KESSL~:R. Certainly. Let Ms. Porter respond. Ms. PORTER. Mr. Waxman, I was just handed a copy of the memo. I have not had an opportunity to review it. Mr. WA~W_AN. They are claiming that you violated grand jury se- crecy rules in the past in order to harm this gentleman's medical practice. Have you violated any secrecy requirements? Ms. PORTER. To my knowledge, absolutely not, Mr. Waxman. Mr. WAXMAN. It seems to me when a claim like that is made by the subcommittee memos that have been distributed to us that this isn't a disinterested subcommittee anymore. It's a subcommittee that is not trying to find out the facts; it's a subcommittee that is out here with a vendetta against FDA, making accusations. Mr. Chairman, at some point maybe we ought to swear in our staff as well as the FDA staff and have them tell us where they get this information which has never been made public before. Mr. BARTON. If the gentleman will restate the inquiry, the state- ment or the request. Mr. WAXMAN. I'm not making an inquiry. I'm making a state- ment, and my statement on my time is we are getting a memo from our subcommittee staff in what ought to be an oversight hearing where we are not taking a partisan position. When a memo of this subcommittee is distributed to the members and this memo says that FDA has violated secrecy rules that the grand jury has set out
Page 70: TI14380178
132 in order to harm Mr. Burzynski's practice, I'd certainly like to know where that statement came from. What evidence do we have of such a situation? Mr. BARTON. Would the gentleman yield? Mr, W~. Sure. Mr, BARTON. This won't take away from your time. I have just asked some of the questions that you have just asked. It is the practice of the subcommittee that briefing memos should be given to minority and majority members of the subcommittee 2 days in advance. This was not. I saw the draft. Mr. WAXMAN. My point is not that it wasn't distributed to me in a timely manner. That is a minor point. It is an important one but it is a minor point compared to the accusation in this memo that FDA has in some way violated the secrecy requirements that are placed upon them. This is an accusation that has been made against FDA. Ms. Porter doesn't know anything about it; Dr. Kessler doesn't know anything about. The one who has made the allegation is your staff. Can we swear them in and get a statement on the record where they have information to this effect? Mr, BARTON. If the gentleman would yield. Mr, WAXM.~. Sure, as long it doesn't come from my time. Mr, BARTON. The staffs of this subcommittee are not the focus of the hearing. If it's the gentleman from California's position that they should be the focus of a future hearing, perhaps we will ar- range such a hearing. Mr. W~XMAN. Reclaiming my time, Mr. Chairman, we have a memo that has been prepared by our staff and they say that Dr. Kessler and Margaret Porter are expected to hide behind the Jus- tice Department at this hearing. "However, we do expect that they will provide answers to questions involving the process if not the substance of the case against Burzynski. It should be noted that FDA has shown no compunction about violating grand jury secrecy rules in the past when they have attempted to harm his medical practice." That is not stated as something we ought to find out about. That is stated as a fact. If that is stated as a fact in a memo prepared by this subcommittee's staff, it raises the question to me, is this a legitimate oversight hearing where we are trying to get to the truth, or is this a vendetta to bring Dr. Kessler in to prosecute him for positions that your staff believes to be true but may not in fact even be true? Mr. BARTON. If the gentleman would yield again. Mr. WAXMAN. Certainly. Mr. BARTON. This is a legitimate oversight hearing. Minority staff has been given the opportunity to participate in all the inter- views and have access to all the documents of the majority staff. With regard to the specific allegation, the assistant U.S. attorney in Houston, Texas, that was on the Burzynski case has been reas- signed, and we can't find out why he has been reassigned. Mr. W~3C_AN. If I could reclaim my time. Mr, BARTON. Just to go to the direct point of your question as to whether there is some vendetta against the FDA, there is no vendetta against the FDA. 133 Mr. W~MAN. Mr. Chairman, if I could reclaim my time. I am talking about a memo that says "To Members, Subcommittee on Oversight and Investigation." Your name !s on it. It was.prepared b your staff, the Republican staff. It wasn t prepared by the major- Y ' d ity and minority. It makes an absolute statement. I haven t rea the other parts of the memo, but the tone of it is pretty accusatory, This is a definite accusation and a serious one. "It should be noted that FDA has shown no compunction about violating grand jury secrecy rules in the past when they have attempted to harm his medical practice," referring to Mr. Burzynski. This Mr. Burzynski is out selling something to the public that is supposed to deal with cancer and not willing to go through the pro- tocols of the FDA which make sure that he is following the sci- entific methods. My question to the witness is, you know nothing about it; is that correct? You know nothing about where you have violated any se- crecy rules? You would deny this claim by the subcommittee staff7 Ms. PORTER. Absolutely, Mr. Waxman. I don't have any knowl- edge of the basis for that. Mr. WAX_MAN. Even in the old days when we had inquisitions people were given the questions or at least the accusations and they were allowed to face their accusers. Here we had a whole panel of witnesses accusing the FDA of things. Now we have the subcommittee majority staff accusing you in a memo to us of facts, and it just seems to me that you are here to just get beat up on. Mr. BARTON. Would the gentleman yield, please. Mr. W~3c_A~. Well, you said please, and I will, but otherwise I wasn't going to. Mr. BARTON. The document that the gentleman is indignant about, from the best I can tell in listening to the gentleman, is a draft document that was prepared for me. It's not an official docu- ment of the committee. Mr. W~. The gentleman is incorrect. This was handed out to all members of the subcommittee. It says "Memorandum to Members Subcommittee on Oversight and Investigations," of which I am one. Mr. BARTON. Would the gentleman allow me to look at the docu- ment? Mr. W~mlAN. "From Honorable Joe Barton, Chairman, subject November 15, 1995, hearing on FDA." It's dated November 14 and it's with regard to these hearings. Dr. Kessler, I want to ask you about this Sensor Pad issue. I un- derstand that within the last several days you have approved a 510(k) application for Sensor Pad. Would you explain how after all of this time in dispute FDA finally was able to make this decision? Mr. KESSLER. It's my understanding, Congressman WaxmanN then I will turn it over to Dr. Alpert who is supervising those deci- sions-that there was data in a 510(k) application that was submit- ted that supported its use among health professionals. Ms. ALPERT. That's correct. Mr. Waxman, we went back several times to look at the mechanisms which 'were available to Mr, Wright and IPI for getting their product to the marketplace. In examining all of the procedures that we have used to clear products under the 510(k) process, there is a mechanism of identi-
Page 71: TI14380179
134 fying products which can be used as accessories to other products and thereby provide them a classification that allows them to go to market via the 510(k) procedures, pre-market notification. It was not a procedure that had been identified previously and was a re- sult of some exhaustive work on the part of staff going back to look for all types of mechanisms. Once we identified that mechanism and there was a reasonable use for the product, for professional use as an accessory to other evaluations of soft tissue, we notified Mr. Wright that this would be a pathway to market for him. Mr. WAXMAN. Dr. Kessler, were you retaliating in any way against the developer of this Sensor Pad? Were you doing some- thing personal against him or his company? Mr, KESSLER. Congressman, no. I don't know Earl Wright. There was one charge. If you look at the hearing of July 25, the lawyer for Mr. Wright said that the subcommittee had notified us that he was going to testify, and on that day he was asked to leave the anteroom for a grand jury. That was the charge. He was asked about that as a retaliation charge. He was sort of implying that there was a cause and effect there. Mr. WAXMAN. Didn't this fellow who developed the Sensor Pad claim that~ Mr. KESSLER. I'm sorry. I'm confusing that. That's an incorrect answer on Sensor Pad. If I can correct it. The allegation on Sensor Pad was that Grant Wright says he complained on August 14, 1992, to the Agency about a meeting at FDA headquarters on August 10. He complained to the Agency and then he received a 305 notice related to his company's complaint. But in fact work on that 305 notice, my understanding is, began 6 months earlier before that complaint. That was the charge of re- taliation. I made a mistake. It was in another case. But that was the charge, that he had complained to the Agency and then he got a 305 notice. I think the record clearly shows that the work on the 305 notice began on February 12, 1992. His com- plaint was on August 14. So I db not believe the facts support any charge of retaliation. Mr. WAXMAN. This now famous memo of our subcommittee ma- jority Republican staff says, "Notwithstanding the simple and ap- parently harmless nature of the Sensor Pad, 10 years after the first approval application was filed with the FDA the device is still off the market, has been classified and reclassified over the years but never approved. But much of this time the FDA at the insistence of the reviewer Dr. Yin has deemed the Sensor Pad to be a class III device, a rating given only to life-threatening devices. Further, in 1993 the Agency notified Mr. Wright and his son that it was considering initiating criminal action against them." My question to you is, could you explain, first, what is the role of the reviewer in determining the classification of a new medical device, and second, when and why is a device placed in class III? Is this classification strictly for life-threatening products? Ms. ALPERT. If I may, Mr. Waxman. In answer to the first ques- tion, Dr. Yin is not the primary reviewer but the division director responsible for products in this area and has been involved over that period of time. 135 We have received multiple applications from this company, and under the procedures of 510(k), if no predicate device exists and a 510(k) cannot be cleared, the product is in by statute class III be- cause it is post-amendments without a predicate. It doesn't have to be a life supporting, life sustaining or even high risk device. If it's post-amendments, unclassified and has no predicate, it is automati- cally a class III product and requires a PMA. As I recently explained, we did find a way in which this product could go through the 510(k) process, and The Examination Pad is now in the marketplace. Mr. WAXMAN. Was Mr. Wright and his son informed that you were considering criminal actions against them? Mr. KESSLER. Mr. Chesemore. Mr. CHESEMORE. Yes, sir, they were. Mr. WAXMAN. For what reason? Mr. CHESEMORE. For shipping these products in violation of a court order. Mr. WAXMAN. You are being accused of doing something wrong because you followed the statute that said if it's a new device which is trying to say it's like another one on the market but there has never been another one on the market you have to classify it as a class III; you are doing what the law requires. Ms. ALPERT. That's correct. Mr. WAXMAN. This memo seems to criticize you for that. Then the law also requires you not to let people go out and send out de- vices or drugs that haven't been approved, and this fellow decided he could go on his own and put it out and sell it; is that right? Mr. CHESEMORE. Yes, sir. That's the reason that the Chicago Dis- trict recommended the action that they did. Mr. WAXMAN. It is hard for me to see what the problem is here for which we have all these FDA employees. Why, at a time when the Government is shut down, do they have to come and answer questions about doing their job, and especially when it doesn't ap- pear that these questions are of a nature where we are trying to get the facts but trying to further accusations that FDA is an Agen- cy that should not have our support? I want to close, Mr. Chairman, my period of time by saying FDA has my support. It's an Agency the consumers of this country de. pend on. I don't want peop-le coming up with some medical device or drug or anything else and telling the public that they have got a cure when they don't, misleading vulnerable people who out of fear of disease and illness will look for any charlatan's elixir of hope. If we are going to have products on the market, I want to be sure that they are not being put together in a way that is adul- terated and ineffective. Dr. Kessler, I thank you for being here, and, Mr. Chairman, I yield back my time and express unhappiness that we are spending a lot of time and wasting a lot of FDA's time when they ought to be doing other things than having to answer, it seems to me, some baseless accusations. Mr. BARTON. I thank the gentleman. Dr. Coburn had put it in the record, but for the personal benefit of Mr. Waxman, the substantiation to the sentence that you ob- jected to about violation of grand jury secrecy rules is found in a
Page 72: TI14380180
136 court document, In The U.S. District Court for the Southern Dis- trict of Texas, Houston Division, dated January 21, 1986, on page 4~ the second paragraph. I will get that to you directly. Mr. WAXMAN. What did that document say? Is that somebody's allegation in a court case that was picked by our staff?. Mr. BARTON. No, sir. Mr. WAXMAN. Is it a judge's decision? Mr. BARTON. It is the finding of the court. Mr. WAXMAN. May I have that document so we can read it right now? Mr. BARTON. [ will read it for the record and then give it to you for your personal review. Mr. WAXMAN. Would you identify, first of all, what the document is for me? Mr. BARTON. I just did. Mr. WAXMAN. It is a court decision? Mr. BARTON. It iS a court document. Mr. WAXMAN. A court document could be anything in the record. It could be somebody's pleadings; it could be a filing. Mr. BARTON. It is the judge's order. Mr. KESSLER. Mr. Chairman, could we get the page? Mr. BARTON. Page 4. It says, "Moreover, the Court finds that it is not necessary for the FDA to provide patients and third parties with information regard- ing the search warrant. However, based on the testimony adduced at the hearing, the Court would not go so far as to find that Mr. Yun is acting in bad faith when he disseminated that information. The Court certainly would find that it exceeds his duties and re- sponsibilities as an officer of the FDA. In the Court's judgment, it is inappropriate for the FDA to release that information to patients and thlrd parties. That information has nothing to do with the i.n- quiries received by the FDA whether the FDA has approved the IND application for the A10 antineoplaston." Mr. KESSLER. Mr. Chairman, may I ask Mr. Spiller and Ms. Por- ter to respond, please? Mr, BARTON. I don't think a response is necessary. Mr. WAXMAN. I think it is an accusation that he should be given a chance to answer. Mr, KESSLER. Again, I haven't seen the memo in question, but as I understand it, the memo says there was violation of 6(e). That's a very serious charge. I would appreciate it if Ms. Porter or Mr. Spiller could respond to what you've just read. Mr. BARTON. Sure. Ms, PORTER. Thank you. There is nothing in the memo and the court's order as I read it that would indicate that there was a viola- tion of 6(e). The Agency would take any such violations, if made, very seriously and would refer them to the inspector general for in- vestigation, I'm familiar with the paragraph to which you are referring. The court did say that without a specific adjudication that some of the statements that were made by employees were inappropriate. That finding, that language was not picked up by the Fifth Circuit on appeal, and in any case should not be, in my view, construed as a violation of 6(e) without more in the record. 137 Mr. BARTON. The other gentleman. Mr. SPILLER. Additionally, Mr. Chairman, you will note that this paragraph, indeed this order does not refer to a grand jury. As I understand the letter, the allegation is that there is a grand jury release. That's the most striking dispa.n.'ty h_ere.. ........ --Mr. BARTON. My understanding is ~t ret-ers to ~ne mves~lgatlon underlying the grand jury inquiry. Mr. SPILLER. Actually, Mr. Chairman, it refers in its second line to a search warrant. As you know, search warrants are not issued by grand juries. Search warrants upon application of government agents are issued by magistrates. It wouldindicate that the search warrant was issued by a court. Grand juries, of course, do issue subpoenas, and when there is a grand jury, then the violation of that is covered under Grand Jury Rule 6(e). Mr. BARTON. So it is your statement that this information and these search warrants had nothing to do and had no relevance and no bearing on any of the grand jury proceedings that Dr. Burzynski was submitted to at that time? Mr. SPILLER. I certainly could not comment. As you have just pointed out, it would be a tremendous violation to do so on the con- tents and matter of a grand jury investigation. Mr. W~. Will the chairman yield to me for a question on this point? Mr. BARTON. Yes. Mr. W~. The statement in the memo prepared by the major- ity staff is FDA has shown no compunction about violating grand jury secrecy rules in the past when they have attempted to harm his medical practice." They made the statement that FDA showed no compunction about violating these rules, which would seem like they are violating ~rand jury rules all the time, and they have at- tempted to harm t~is man's medical practice. It seems to me that there wasn't even a grand jury rule that we are talking about, and this violation may or may not have even occurred. To draw conclu- sions by the staff seems to me to try to harm FDA. Mr. BARTON. The gentleman from California is entirely within his rights to expect that the memos that are prepared for hearings should be as accurate as possible and to the extent it is possible be totally based on fact. Mr. WAXMAN. How about as fair as, possible~too,? • Mr. BARTON. It iS not, to coin a phrase, a ~eaera~ case that one sentence in a 20-page briefing memo could have been more artfully drafted. The gentleman from Pennsylvania is recognized. Mr. GREENWOOD. Thank you, Mr. Chairman. In response to the comments of my friend from California, I want to make clear that this member has no bias or preconceived notions or an agenda with regard to FDA, but we have had some testimony from some folks out there who do not think very well of the Agency, and we have a responsibility to exercise our oversight and investigation xespon- sibilities to look at them. One of those individuals is Mr. Roland Jankelson, who is the di- rector of Myo-Tronics, Inc. In his testimony before this panel he made some pretty broad allegations against the FDA. He described "arrogance, adversarial attitude, misbehavior, overzealous regula-
Page 73: TI14380181
138 rich, possible criminal activity, unwillingness to investigate itself and punish misbehavior within its own ranks, and a deliberate, cal- culated effort of cooperation between certain FDA officials and em- ployees and outside private interests to improperly and ille~,ally re- move the company's instrumentation from the marketplace.' I refer to an advisory panel as "rife with irregularities, criminal misconduct, et cetera." Those are some fairly serious charges and we need to take a look at them and see if there is any truth to that. In March ].992 the FDA sent Myo-Tronics a warning letter rel- ative to 5 of their dental devices. Following this warning letter, the company agreed to submit 510(k) applications for thee,Jr products even though their counsel did not believe the 510(k)s were re- quired, and in fact this issue was never tested in court. Is that correct, Dr. Kessler? Mr. K~SSLER. I would certainly let counsel speak. Ms. PORTER. If you mean by tested in court was there a full adju- dicat!on of the Agency's legal basis, the answer is that matter was not htigated. However, there was a consent decree entered into in, I believe, February 1994 with respect to the seized product under which I believe it was conceded that the products needed further clearance or approval before they could be shipped legally. It wasn't litigated, but certainly there was a determination tween the parties that the products could not be legally shipped without further action. Mr. GI~.NWOOD. Would that further action include a 510(k)? The questio,n_ was that the counsel for the company did not believe that 510(k)s were required and this issue was never tested in court. Is that right, that the court didn't make a determination as to whether the 510(k)'s were required? Ms. PORTER. The court did not make an affirmative determina- tion because the court did not need to. With respect to the seized goods, the parties entered into an agreement under which 510(k)'s were submitted, I believe, or certain changes in labeling were made, Mr. GREENWOOD. Thank you for that response. I would like to place in the record an exhibit, which is a July 28, 1995, memorandum from Roger Lowell, district director of the Se- attle office, to Associate FDA Commissioner Ron Chesemore, and ask that a copy be provided to Dr. Kessler. Mr, BARTON. Without objection. [The memorandum referred to follows:] July 28, 1995 District Director Seattle District, HFR-PA300 Myotrcnics Ron Chesemore, ACRA, HFC-1 fi M~yotr.o, nics req.uested a mee_tin.~ with us on March 22, 1995. They came to our of- ce mr the stated purpose of finding out where they stood with us and why we were continuing to "harass them" by making inspections. Specifically, their complaint was the inspection of March 16, 1995, made by Engineer Prabbu P. Raju, in which we had requested information on individual responsibility. Mr. Jankelson stated during the meeting that he felt the district was fetal/at/rig against his t~rm because the firm had complained about a dental panel. Mr. Jankelson explained that he had been informed that the results of the panel concerning their product were being set 139 aside because of a conflict of interest. Mr. Jankelson indicated the panel director and some of its members had been involved in litigation against his firm, and had a long history of being opposed to Mr. Jankelson's products. Mr. Jankelson also said they had appealed the panel's decision to Amanda Peters,o_n. At the time, l,nor any. one else in Seattle District, had any knowledge of the 'problems" with the dental panel. I gave Mr. Jankelson my assurances that I would investigate and reassess how that affected our actions with Myotronics. I also informed Mr. Jankslson that we had been considering civil penalties against his firm since August 10, 1992, and our case on civil penalties hadnothing to do with the dental panel because we did not know there were alledged problems with the dental panel. The company officials wanted to know why, since they had signed a Consent De- cree w/th us, we were pursuing civil penalties. I explained to them that the agency took seisure to remove products from the market. We took civil penalty actions against a fu'm as a punitive measure. We felt pu..nitive measures were necessary in this case because the firm had continued to distribute its products after we hadin. formed them they should stop distributing the products, both via the Warning Let~ tar and by a Memorandum of Meeting with their head of regulatory affairs, Mr. Adib. The firm officials indicated theirlawyer, Jeff Gibbs, had told them they could continue to distribute their product because it was the practice of Food and Drug not to stop distribution of products while the firm was undergoing 510K review, We informed the firm that advice on the part of their lawyer was incorrect. The firm informed us they would never have entered into Consent Decrees concerning the sol. zure if they understood we were going to undertake civil penalties against the firm, The firm felt the agency is picking upon them, both the seizure, the dental panel and, now, with the civil penalties. I told the firm individuals I would investigate the allegations they had made about the dental panel and get back to them concern. ing our actions on the civil penalties. After this meeting, the district found out from the ombudsman's office that, in fact, the dental panel had been set aside, all of its findings were being set aside, and the information g~ven to us by the firm was essentially correct. The ombuds. man's office aiso inch~cated they were continuing to investigate the dental panel. With this information, I decided the agency was not in a good position to continue further actions against Myotronics and requested that my staff indicate this to the Center for Medical Devices and seek their advice on withdrawal of the civil pen. alties. You must remember that these penalties had been approved by the Center and General Counsel. Subsequent to that, I had conversations with Lillian Gill during which she re- quested that I give to her a memorandum withdrawing the civil penalty request, 1~ did give to her that memorandum. Following my con~versations with Lillian Gill, Jeff Gibbs, the firm's attorney, called me wanting toKnow the status of the civil penalty case. I had understood from IAllian Gill she was going to tell Jeff Gibbs we were withdrawing the penalties and asked Mr. Gibbs if he had conversed with Lil, lian Gill. He said he had, but Lillian had referred him to me for the decision on the part of the agency. I told Mr. Gibbs it was the district's decision to withdraw the civilpenalties case against Myotronlcs. I asked him, at the time, if I should also call the firm. He indicated he would notify his client. Also during the meeting with Myotronics, the firm made allegations concerning of improper conduct on the part of one of our employees. They described cir. cumstances occurring a couple of years ago when they had assigned a room to one of our investigators for use during an inspection. They indicated they came into this room on one occasion and found the investigator leafing through documents whlch had been on a shelf in this room. The firm officials asked me if this was proper be, havior on the part of our investigators. I told the officials of Myotronics that we were a law enforcement agency and we trained our investigators in investigation techniques. I related to them the example of food formulas and our inability to col- lect those formulas, yet we must check formulas against ingredient statements on labels. We trained our people that if they were in a plant and saw formulations or other records in plain view in the plant, they were certainly to look at and record those pieces of information in their diaries. Our records, made at the time of t.hs conversations with the firm, do not record any of these parts of the conversation be. cause we did not consider it critical to the issues we were discussing with the firm, (We have since asked the Investigator who was onsite two plus years ago to respond to this allegation and it is attached.) Since the meetings with Myotronics, we have changed the way we conduct meet- ings with industry. We have received several requests recently, especially from the device industry, to meet with us as soon as a 483 is issued. We now conclude these meetings by asking the firm to summarize the action items or germane points of discussion that occurred during the meeting. We are also asking industry to com.
Page 74: TI14380182
140 pose a memorandum of the meeting and send it to us. We make it a part of our files and, if there are substantial issues we feel were missed during the meeting, we correct the notes and send them back to the firm. We have started doing this for several reasons. Primary among them is that we found out during the Myotronics meeting that the head of regulatory affairs for the firm denies that we ever told him to stop distributing the devices. The Warning Letter issued to the firm implies this. but does not specifically tell the firm to stop distributing and, on advice of our General Counsel, apparently the letter cannot say that. We did tell the firm to stop distributing during a meeting and that is in our records, but we never shared that Memorandum of Meeting with the firm. It was not our practice in the past to share minutes of meetings with industry. We have found this new way of conducting our industry meetings to be highly successful in increasing our commu- nications with industry. ROGER L. LOWELL Mr. BARTON. We also need to get copies to the minority. Mr. GREENWOOD. Has that been accomplished, Mr. Chairman? Does the minority have its copies? Mr. BARTON. I don't think so. Mr. GREENWOOD. Dr. Kessler, while that is being provided, I am going to direct your attention to the paragraph at the bottom of page 3. I will read that. It says, "Since the meetings with Myo- Tronics we have changed the way we conduct meetings with indus- try. We have received several requests recently, especially from the device industry, to meet with us as soon as a 483 is issued. We now conclude these meetings by asking the firm to summarize the ac- tion items or germane points of discussion that occurred at the meeting. We are also asking industry to compose a memorandum of the meeting and send it to us. We make it a part of our files. If there are substantial issues we feel were missed during the meeting, we correct the notes and send them back to the firm." That seems to me to be a pretty sensible policy. I would com- mend the Seattle office for following it. The memo continues, "We have started doing this for several rea- sons. Primary among them is that we found during the Myo- Tronics meetings that the head of regulatory affairs for the firm de- nies that we ever told him to stop distributing the devices. The warning letter issued to the firm implies this but does not specifi- cally tell the firm to stop distributing, and on advice of our general counsel, apparently the letter cannot say that. We did tell the firm to stop distributing during a meeting, and that is in our records, but we never shared that memorandum of meeting with the firm. It was not our practice in the past to share minutes of meetings with industry. We have found this new way of conducting our in- dustry meetings to be highly successful in increasing our commu- nications with industry." Again, I would commend the forward progress, but in this in- stance it looks like your Agency sent Myo-Tronics a warning letter but on the advice of general counsel this letter did not tell the com- pany to stop shipping devices pending the approval of 510(k)'s. Is that accurate? Mr. KESSLER. Mr. Chesemore. Mr. CHESEMORE. I can only speak to what the warning letter says. I do not represent the Office of Chief Counsel. The warning letter says that you have these violations, and one of them was not submitting a 510(k). Then at the end of the warning letter it says 141 unless these violations are corrected that you may be then subject to further FDA action, such as seizure and/or injunction. It is specifically silent on shipping. Following the warning letter, though, the firm did come and have a meeting with the folks from Seattle district, and at that meeting they were specifically told, no, you should not ship this product without the 510(k) being approved. Mr. BARTON. Would the gentleman yield on that point? Mr. GREENWOOD. Yes. Mr. BARTON. What is the legal requirement of the warning? Is there a legal requirement not to ship even though it doesn't say so7 Mr. CHESEMORE. The requirement of the Act is you cannot ship these products unless they are approved. Mr. KESSLER. It's a requirement of the statute. Mr. CHESEMORE. The statute, yes, sir, unless there is a 510(k) in place. It was the Agency's opinion that the firm needed the 510(k)'s, but they did not have them. I would say that if a company does ship after being told that~ as this company was in that meeting with Seattle, they then ship with the understanding that the product may be seized. Mr. BARTON. I'm not trying to be obtuse about this. I'm not an attorney. Mr. CI-IESEMORE. I'm not either, sir. Mr. BARTON. If I were a company and I received that letter and the letter didn't specifically state that I could not ship my product, if I did ship it and if the only time I had been--I guess what I am trying to say is, if it is not in writing, is a verbal admonition to not do something legally binding if the follow-up written document does not contain the verbal warning? Mr. KESSLER. Can I try to answer that? Mr. BARTON. You can try. Mr. KESSLER. Then I will turn it over to counsel to edit. The star. ute is the thing that governs, and the statute says you can't ship unapproved medical devices. That's what governs; that's what is le- gally binding. Ms. PORTER. That's correct, Mr. Chairman. If the implication is that because the Agency didn't specifically say in writing you may not ship that the company was free to ship without a 510(k)~ I think that is an inaccurate inference to be drawn. If the company was told that the products were unapproved and that there might be regulatory action if they shipped, then that is an adequate basis for taking a further action. The company should have been on no- tice that that was the Agency's position. Mr. BARTON. I yield back. Mr. GREENWOOD. I thank the chairman for yielding back. This is an important point. It is hard for this member to under- stand, as I think it is hard for Mr. Jankelson to understand, why the experts on the statute, the FDA, who know that you are not supposed to ship a product without a 510(k) if it meets the quali- fications for a 510(k), wouldn't in a warning letter say not only you need a 510(k), but it's our responsibility as the Agency in charge here to let you know what the law says, and the law says you shouldn't ship without a 510(k), and so don't.
Page 75: TI14380183
142 Ms. PORTER. Mr, Greenwood, the letter, as I understand it, clear- ly says that the products were both adulterated and misbranded, which meant that they were unapproved. The vehicle for bringing them into compliance with the statute, as I understand it, given the particular facts of the situation, the most appropriate route might have been a 510(k), but the letter clearly says that the prod- ucts, in the Agency's judgment, were not in compliance with the statute. Mr. GREENWOOD. Let me make an analogy. This is how Mr. Jankelson feels, if I can put it into different words. A guy is driving down the street and a police officer puts the lights on and pulls him over and says, you don't have a proper sticker on your car, or your tail light is out. You need to get that fixed. And gives him a warning note. The driver says, thank you for pointing that out. I guess I goofed. I didn't know that. Then he starts to drive away. The police officer ~ulls him over again and drags him out of the car and handcuffs im and takes him to jail and says, you're not allowed to drive the car. I just told you it didn't pass inspection. The guy might say, well, why didn't you tell me that? Why did you wait until I got in the car and drove it away? Why didn't you say right then, and by the way, don't move the car anymore? That seems to be what the Agency did here. Ms. PORTER. Mr. Greenwood, are we referring to the March 23, 1992, letter? I just want to be certain we are speaking about the same document. Mr. GREENWOOD. Would you repeat the question for the staff?. Ms. PORTER. I just want to be sure that we are talking about the same document. The document that I have is a March 23, 1992, let- ter. Mr. GREENWOOD. You're right. March 1992 the FDA sent Myo- Tronics a warning letter. That's correct. Ms. PORTER. As I mentioned before, on the first page of the let- ter, in paragraphs 2 and 3, there are express statements that the products are adulterated and misbranded. On the second page there is a detailed analysis of the advice from the Center for De- vices and Radiological Health concluding their determinations with respect to the necessity for 510(k)'s for these products. Mr. GREENWOOD. I understand that. Repeat your second quote from the letter. Ms. PORTER. On page 2, in the middle of the page, there is a full paragraph with several indentations that discusses in some detail the necessity for 510(k)'s. I thought I understood your question to be why the company wasn't informed that it needed a 510(k). Mr. GREENWOOD. No, no. The issue is this. What it appears the Agency did was notify this manufacturer you need a 510(k), but what the Agency did not say and make clear in that letter of March of 1992 was, and we need to inform you that the law says that without a 510(k) you don't ship. So this company was like the driv- er of the car: I'll go get the sticker or I'll get the tail light fixed. But nobody told him to stop shipping, and so he continued to ship, and then you came down on him like a ton of bricks. Mr. KESSLER. Congressman, let me make a couple of points. I've certainly seen many letters from counsel for Mr. Jankelson, from 143 some of the most sophisticated food and drug firms. I don't know who was representing him exactly back in 1992, but he was driving down the street certainly at certain times with very sophisticated food and drug counsel. This letter says the inspection reveals that all of the above-named devices are adulterated. The next paragraph starts, "The inspection also reveals that all of the above-named vices are misbranded." I'd be very happy to go back and talk through your point whether it's possible to be more explicit in these letters and look into that point. It is a fair point. But anyone who is in this business who doesn't understand that a determination when their products are adulterated and misbranded, if there isn't that basic understanding and you are in this regulated industry, I would be very surprised that that doesn't mean to somebody that they are in violation. Mr. BARTON. Will the gentleman yield? Mr. GREE~rWOOD. I appreciate the gentleman's comment. I'll yield in a moment, Mr. Chairman, if I can just make a point. Let's assume that the manufacturer is sophisticated and let's as- sume that he has counsel at the time he received this letter who is sophisticated. The most sophisticated players in this deal are supposed to be you. You're supposed to know the law better than anybody else, and you're supposed to be clear to the regulated pub- lic out there about what their duties are and your duties are, I would turn the question around and say to you, well, shouldn't the enforcers of the law, shouldn't the Agency with the best law- yers and the best minds on FDA regulation make it clear in a let- ter to a manufacturer this is the case, the law says you need such and such, you don't have such and such, and here's what you need to do about that, and item number one is cease and desist ship- ping? Is there a legal reason for the Agency to stop short of making that point? Ms. PORTER. The answer is that what the warning letter does is state the Agency's assessment of the violations and explain the steps that the Agency believes need to be taken in order to avoid regulatory action and to bring the products into compliance with the Act. The letters typically do not, it is my understanding, specify which remedy may be used, The letter says you have to take prompt corrective action or regulatory action may result, including seizure and/or injunction. Mr. GREENWOOD. I recognize the Chair would like me to yield, Mr. BARTON. I gave the gentleman extra time because I used some of his time. Mr. KESSLER. I think that the failure to properly correct these deviations may result in regulatory action being initiated, includ- ing, but not limited to, seizure or injunction. Again, your point is well taken. Maybe we can be more specific. Let me go back and think through that issue. I think the letter made it clear that these products needed to have 510(k)'s. Mr, GREENWOOD. Let me just in two sentences say, if any good can come out of this hearing, one of them is if a letter is supposed to be clear and require behavior on the part of the regulated com- pany, then the letter ought to be as clear as the expectation. Mr. KESSLER. Absolutely, Congressman.
Page 76: TI14380184
144 Mr. BARTON. I will put in the record at this point an E-mail, May 23, 1995, from Roger Lowell to Jim Davis, Dave Batinski, Joe Baca, and Rich Andros. It's on this very point. "Of interest is the contin- ued distribution thing. He says the Act and the regs are in conflict. In retrospect, he would not have approved the action when we first recommended it. He said if the firm considered the 510(k) issue when they make changes and felt it was not substantial and then we come along sometime later, maybe years, and second-guess the firm decision, we cannot expect them to stop distributing until the issues are resolved." I will put that in the record at this point in time. [The E-mail follows:] To: Jim Davis@SEA.INV@FDAORAPAR, David Pettenski@SEA.INV@FDAORRRAPAR, Joe Baca@SEA.COMP@FDAORAPAR, Rich Andross@SEA. COMP@FDAORAPAR From: Roger Lowell@SEA.DD@FDAORAPAR Certify: N Subject: Myotronics/Congressiona~ Date: Tuesday, May 23, 1995 at 4:13:43 pm PDT Attached: None Stove Needleman just called me. He has to brief Burlington re a congressional the center has received on Myotronics. He wanted to know if I still supported the with- drawal memo I'd sent to the center. I said I did. We discussed all the reasons for the withdrawal and he agrees with me this was not a good case and should be dropped. Of interest is the continued distrubiton thing. He says the act and the regs are in conflict. In retrospect he would not have approved the action when we first rec. it. He said if the firm considered the 510K issue when they make changes and felt it was not substantial and then we come along sometime later, maybe years, and second guess the firm decision we cannot expect them to stop distributing until the issues are resolved. The firm should be able to document this decision process. If they make changes and didn't consider the substantial change.issue th.an we a, re on better grounds for doing something. Steve says they hope to discuss at some vice meeting coming up soon with industry. They may also bring up at a red phone. Joe you may want to push them to discuss at a CB red phone. It appears the issue may not be as clear as you lead me to believe. Mr. BARTON. The Chair would now recognize the gentleman from New York, Mr. Frisa. Mr. FRISA. Thank you, Mr. Chairman. Good morning, Mr. Kessler. Do you recall receiving a letter from the chairman of this subcommittee in July inviting you to appear at an earlier hearing? Mr. KESSLER. Yes. I certainly remember that there was a letter. Let me get it in front of me. Mr. FRISA. While you are looking for it, do you recall what your response was? Mr. KESSLER. Let me just get the actual letter so I know which letter. There are many letters that the chairman and I engaged in. Mr. FRISA. It's not necessary for you to find it. Do you recall re- ceiving a letter inviting you to testify? Mr. KESSLER. If I could just have a second to have the letter in front of me. I have a July 17 letter. Mr. FRISA. You have it now in front of you, and therefore I as- sume you recall receiving it. Mr, KESSLER, I certainly~ Mr. FRISA. Do you recall receiving it or not? Mr. KESSLER. The answer is yes. Mr. FRISA. What in essence was your response? 145 Mr. KESSLER. I think there were conversations, Again, I don't know the exact dates, I know there was subcommittee counsel that was talking to~- Mr. FRISA. What was your response, though? Mr. KESSLER. My response to this letter is documented in a re- sponse on July 19. Mr. FRISA. What was it? That you couldn't make it? Mr, KESSLER. No. Mr. FRmA. That what? Mr. KESSLER. If there were allegations, we wanted to listen to those allegations; we wanted to look at the facts and make sure that we had all the facts, and then I said I would be happy in about 2 weeks to come and testify once we've had a chance to look at and hear all the allegations. That was in essence my July 19 let- ter. Mr. FRISA. And the committee acceded to that request? Mr. KESSLER. The chairman and I had a very cordial conversa- tion about that, yes. Mr. FRmA. So then the contention by the gentleman from Califor- nia that you are here today during a shutdown of the government is really not accurate. You had an opportunity to come in July but you preferred to wait to hear the testimony, right? Mr. KESSLER. I said in the July 19 letter that we would be ready--"I believe the review can be accomplished within 2 weeks of the hearing of July 25." So we would be ready in August. Mr. FRISA. It takes some time to get these together. Mr. KESSLER. Sure. Mr. FR~SA. I think the record should reflect that. Dr. Kessler, when Dr. Coburn asked you if you knew of any harm that was caused by Dr. Burzynski, you testified previously that you were not aware; is that correct? Mr. KESSLER. Specific patients that were harmed, that I had no knowledge. Let me just tell you what I've seen. In preparation for this hearing, our new drug review staff that does IND's, that looks at these molecules, prepared a list of possible adverse reactions, Yesterday I asked for the consent form. I saw that. But when they handed me the piece of paper I didn't know specifically about the patients in the trials or patients that were treated outside of the trials. Mr. FRISA. Do you think it was proper and fair to wave around a piece of paper that you didn't have any knowledge of the back- ground? We just had the effect of impugning Dr. Burzynski's rep- utation as a real physician. Was that fair? Did you exercise good judgment in allowing that to occur? Mr. KESSLER. I was asked the question whether there was knowledge about harm that occurred. I'm trying to give- Mr. FRISA. Are you aware of the 2 cases that were referred to on the slip of paper? Mr. KESSLER. I'm not, but there is expertise behind me that does have that. Mr. FRISA. Are you referring to Mr. Spiller? Mr. KESSLER. I believe Mr. Spiller handed me the piece of paper, Mr. FRISA. Didn't he in response to a question state that he was not a physician?
Page 77: TI14380185
146 Mr. KESSLER. But he knows the facts, I believe, of this case very well. Mr. FRISA. Did he not testify that it could not be determined what the actual cause of harm in those cases was? Mr. KESSLER. You can ask Mr. Spiller. Mr. SPILLER. I believe I testified that I could not attribute, as I assume that Dr. Coburn had indicated he could not, whether a death occurring because of septicemia after a drug was adminis- tered by subclavian catheter, as Dr. Burzynski did, was attrib- utable to the drug or to the route of administration. Mr. FRISA. Thank you. So you would now agree then, Dr. Kessler, that we don't have expert testimony that harm was caused as a re- sult? Mr. SPILLER. Absolutely not. Harm was caused by the treatment. I don't know whether it was because of the pipe it was put in through or the drug. Mr. KESSLER. Again, what I know-- Mr. FRISA. Excuse me. Let me just continue. Mr. WAXMAN. Will the gentleman yield? Mr. FRISA. On your time. Are there not other cases causing death through that means using different medication, introduction of different drugs? Mr. KESSLER. The answer to that is yes. These lines are put in. You can get infection through these lines. Whenever you put these lines in you run real risks. Just the placement of these lines can cause harm. I would be very happy, Congressman, to look into this. In fact, I think it should be stated for the record. I read the consent form yesterday for the protocol. It says that the medical complications from Dr. Burzynski's treatments are minimal and lists the poten- tial side effect, and I think it also talks about the catheter. One of the greatest concerns that I saw was the amount of fluids. Not the drug, but you have to give a lot of fluids. I think that was in the material that was submitted to me. I think Mr. Spiller was talking about the overall treatment, the whole period of time. I would be happy to look into it. Mr. FRISA. I think we should look into it, and I would request formally that we submit some documentation. I just think it's out- rageous that we would wave around a slip of paper. You obviously know more about the cases than you led us to believe initially. Mr. KESSLER. Which cases? Mr. FRISA. The 2 cases. Mr. KESSLER. Congressman, what I saw in preparation for this hearing, I asked for a document that our reviewers put together on these drugs, and yesterday I asked for the consent forms, and I looked at those. I know nothing about those 2patients. Mr. FRISA. I think it was ill advised and unfair to introduce the 2 cases when we don't have anything conclusive. Dr. Kessler, let me ask you this. What do we tell the Michaels family? They are patients of Dr. Burzynski. When their son was di- agnosed with terminal cancer--I think that has been established-- with no hope for a cure, Dr. Burzynski apparently introduced treat- ment that resulted in a cure at this point. They were very frus- trated. I am sure you read the testimony. 147 It's a compelling question. What do we do to provide for the pos- sibility that Dr. Burzynski, though maybe he has violated certain other rules or laws, may in fact, though, have something that is valid? I know this case is ongoing, but how can we develop a, mech- anism for treatments which by their nature when they are innova- tive they go generally outside maybe standard practice.;~ Can we de- velop some sort of second channel mechanism for cases like this, or treatments that are developed in the future? Mr. KESSL~.R. Congressman, that's a very important question that you raise. There is nothing more compelling than what you heard on July 25. Patients who have life-threatening illnesses should have access to medicines as early on in the development as can be, especially those when you don't have any other options. Congressman, there needs to be mechanisms. When you do pro- vide medicines at the very early stages, experimental medicines, I do believe that they should be part of clinical trials. I think people should have access to it. I think they should be able to get the drug, but I think that when we are at the very early stages we should be able to do it through clinical trials to make the drug available so we all learn about whether the medicine in fact works, We have worked very hard. We have created the treatment IND; we have created accelerated approval; we have expanded access. There are a lot of patients who receive drugs through expanded ac- cess before drugs are approved, and I think we could even do bet- ter, Congressman. If that drug works, then that family should have access. My only request is it be part of clinical trials. Mr. FRISA. I see that my time has expired. In conclusion, I would just shudder to think whether or not Paul Michaels would have been able to testify had they not persevered and had Dr. Burzynski not provided them the treatment. They might just be another sta- tistic. I think we need to do a much better job, especially when we are talking about terminally ill patients that conventional medicine says have absolutely no hope, and in desperation they said, well, you know what, we have nothing to lose. Let's throw even the law to the wind to try and save our son. Apparently in this case they were successful. Had Dr. Burzynski not provided the treatment, we might have just had his mother and not him here. I yield back, Mr. Chairman. [The following information was received for the record:] Report To: The Ministry of Health, Province of Ontario Re: The treatment of cancer patients with Antineoplastons and the Burzynski c|tn|~ in Houston, Texas By: Drs. M.E. Blackstein and D.E. Bergsagel' ... We are frequently asked what harm Dr. Burzynski can do if his material is safe. The administration of antineoplastons into subclavian cathetdrs for prolonged pe.rio.ds by u~upervised patients is not safe, and we know of two Ontario patients who developed septicemia (infection in the blood stream) after returning from Texasl one of the patients died as a result of the septicemia... Mr. COX [presiding]. The Chair notes that 5 minutes remain on a vote on the floor. The hearing will be in recess until 5 minutes from now. I expect by that time that Chairman Barton will have returned. [Brief recess.] Mr. BARTON. If we could reconvene. Dr. Kessler does have a plane he wants to catch later this afternoon.
Page 78: TI14380186
148 It is the Chair's understanding that Mr. Frisa of New York had completed his first round of questioning. With the exception of the chairman, that would conclude the first round. I would now yield to the gentlelady from California for her second round of questions. Ms. EsI~oo. Thank you, Mr. Chairman. First, I would like to make an observation and a comment. I am new to this committee and you are new to the leadership of it, but in my observation you have conducted the hearings in a solid and decent way, and I think that you are a fair person. I couldn't mean that more. On this issue of the memo that my colleague from California raises, I believe that the staff did overstep, but I don't believe that that is a reflection of you, and I think the best way, if I might make a suggestion, is that the chairman sit down and talk to the staff. People are going to come at the issues in different ways. We will shape legislation; we will make our comments; we will ask our questions; we will take votes on those things. However we differ in our opinions, that's what a democracy is about. But I do think that through the chairman's fair and decent leadership th~at the staff should be made to understand that all of the committee members, whether it's minority or majority, that we need materials that are observant and that they are just as fair as the chairman, and that we not have anything that is overreaching. I understand people make mistakes. That's why the FDA is here today, so that we can ask them about some of the mistakes that they have made and what they are doing about them. Mr. BARTON. I agree with the point. We should scrub the memos sooner and they should be made available more quickly. I agree with the gentlelady's statement. Ms. ESHOO. Thank you, Mr. Chairman. Let me get back to Dr. Kessler. Dr. Kessler, you mentioned ear- lier the example of Bio, the organization, and your recent meeting with them relative to what you described as a victory or a win, and I think that is wonderful and obviously it's a source of pride to you as well. Did the organization share with you at that time the agenda or the recommendations that I'm aware of, that the organization has come up with, recommendations that would assist both the FDA and the representative companies that the organization represents for improvements? Mr. KESSLER. Congresswoman, what happened was the chairman of that organization, Henry Tamir, and I sat down a number of months ago, and I said to them, let's pick your top priority issues in dealing with the Agency. They named 3. Ms. ESHOO. I'm not talking about several months ago. I'm talking about now. Mr. KESSLER. This is a process. This wasn't just 1 meeting. We were working together over many months, and they picked 3 is- sues, 1 that I talked about, the requirement for establishment of licenses, 1 about lot release, the third about clinical holes. We de- cided jointly to work on those issues over the last several months that culminated in the announcement last week. Those were cer- tainly the top of their list. That is not the only issues they have. 149 I am certainly aware of what their priorities are and what they think needs to be done, yes. Ms. EsI-Ioo. I note today that the name of the hearing is "Allega- tions of FDA Abuses of Authority." I really do think that there is a nexus between discontent and some of the subject matter that is being discussed here today. That is why I keep coming back and focusing on the things that I have chosen to focus on. If in fact the Agency were to perform in a more meaningful way with the people that you serve, not only the American people, but the partners that are out there in terms of the various companies in the industry, we all could be better off. That is why I emphasize this. There are bad actors. There is no question about it. There are good actors. But then there are those that get into a foul mood based on how they are treated. I can't emphasize enough to you how much more work I believe needs to be done in this area. I have sensed for the time that I have been around, which is a short time, that the FDA has been extraordinarily skilled, for very good reasons, in its processes, in its efficiencies, and how it deals with the pharmaceutical companies, because they are the cus- tomers that you have dealt with for the longest period of time. So that has refined itself. In the area of medical devices, in my view anyway, and you may view my view as being limited, but it is still m~z take on it, I think that you are using the pharmaceutical yardstick to measure on the medical device side, andI don't see the two being the same. First of all, do you agree with that observation, and second, if you do, what is changing in the FDA to match the view? Mr. KESSLER. Congresswoman, the chairman made a very inter- esting observation that I read at the last hearing. I think the chair- man got it exactly right, and it really goes to the heart of your point. In the transcript that I have, "If we do reform legislation, we need to put in something to differentiate between a short-term im- pact by a drug as opposed to a device that actually has to be placed in the body on a somewhat permanent basis." It is very different. In some ways, Congresswoman, a drug is easy. We are very sophisticated. You take a drug. It has a half life of 6 hours, 12 hours. You take it for 2 weeks. It's in and out of your body. We have developed tremendous sophistication in knowing a lot about those drugs. The challenges of dealing with implants, all kinds of implants that are in the body not for 2 weeks or I or 2 months but for 5 years, 10 years and 20 years--one of the reasons why I have asked Dr. Burlington to come head the Center and Dr. Alpert to run new device review is to try to bring that scientific sophistication to bear, Ms. Esrmo. Let me follow up on that. Do you actually have the breadth and the depth within the Agency to measure what you just described? Mr. KESSLER. It is evolving, Congresswoman. Let me let Dr. Bur- lington answer that question. Ms. ESHOO. I can't spend all of my time on that. Mr. KESSLER. It is evolving. We are not there yet. There are very talented people, but the whole science of how one evolves an im- plant both within the Agency and in the industry and academia,
Page 79: TI14380187
150 that science is evolving and we are all learning. We are not there yet. Ms. ESHO0. Let me turn to something else, Dr. Kessler. A num- ber of serious allegations were made by Roland Jankelson, who is a Director of Myo-Tronics, at the subcommittee's July 25 hearing. I think you made reference to having read the transcripts of the hearing. Documents you provided us relating to your internal investiga- tion appear to indicate that your investigation is focused on those specific allegations, but it seems that this investigation may be a moving target. Just yesterday afternoon we received a memo, the subcommittee majority staff, in which some apparently new charges are made, and I would like to ask you about several of those. The subcommittee memo states that the FDA and Myo-Tronics entered into a court sanctioned consent decree under which FDA agreed to review the company's 510(k) in 60 days, a commitment the Agency did not fulfill. The memo goes on to state that the company "did not seek con- tempt or other sanctions from the court because they did not know that the FDA had no intention of complying with its review com- mitment when it signed the agreement." The briefing memo further characterizes this missed deadline as a "deliberate failure to review the 510(k) under the court sanc- tioned consent decree." According to the information you provided to the subcommittee for this hearing, FDA completed its action on the 510(k) in 63 days rather than 60 days required by the consent decree. Would you explain why you missed the deadline by 3 days? That's a big setup for 3 days, but I think it's still important for us to hear that. Did the FDA deliberately mislead the court in promising to meet that deadline and then intentionally fail to meet that requirement? I don't know why anyone would ever do that or answer yes to it, but you're going to tell me the truth about it. I think we need to be enlightened but we also need to cast some light on this issue. Ms. ALPERT. Congresswoman, we did not intentionally miss that deadline. As I recall the sequence of events, the review division who is responsible was not aware early on of what that deadline was. When they became aware they worked quickly to complete the review of that 510(k) submission, and I believe that my signature is on that letter. Ms. EsHoo. Let me ask you something about deadlines. All the way around, how are they dealt with? You know what this thing reminds me of in a very small way? There are things that draw parallels in my life. One of the things in local government that we had the toughest time with was the planning department. People would come in. They would take their plans in. They would say, this is what I want to do. Three weeks later they would come back and they would say, well, here is what you told me to bring to you, and the inspector at the counter, whomever, said, well, that's not all you needed to do. So there weren't any timeframes. There wasn't a sense of con- 151 sistency that was brought to both the people that came to the counter and those on the other side. I don't want to diminish or minimize the enormous role and re- sponsibility of the FDA and treat it as if it's a planning depart- ment, but I do think that timeliness and what it says to those that you are dealing with--obviously you all know about it, but how are you rebuilding this sense of urgency and efficiency and promise within the Agency itself?. Mr. KESSLER. One of the greatest things that we a.re doing_in that regard, that we worked very hard with this committee and the Congress and the regulated pharmaceutical industry was in estab- lishing the user fee program for drugs. We provided the reviewers with the resources necessary but in return very specific perform- ance standards and holding them accountable to those performance standards. It is very new for the Agency over the last several years, Dr. Burlington can talk about it in devices. You are absolutely right. You have got to give them the resources and then you have got to hold them to performance standards, I believe that, and I think that is what we have done under the user fee program. Mr. BARTON. The gentle lady's time has expired. Ms. ESHOO. Thank you, Mr. Chairman. Mr. BARTON. The Chair would now recognize himself. Before doing so, we would acknowledge that we have the distinguished Senator from Utah. Senator Orrin Hatch is in the back of the room, We are glad to see him slumming on the House side. We appreciate that. Before I turn my clock on for my first 10 minutes, I want to ask some bookkeeping questions for the record. Dr. Kessler, I would like for you or the individuals who have stood and sworn, we need their names in the record and their titles. Could we have that at this point in time? Mr. KESSLER. Absolutely, Mr. ZELLER. My name is Mitch Zeller, and just this week I be- came the Deputy Associate Commissioner for Policy. Ms. ALI'ERT. I'm Susan Alpert and I am the Director of the Office of Device Evaluation within the Center for Devices and Radlologi- cal Health. Mr. BURLINGTON. I am Bruce Burlington and I am the Director of the Center for Devices and Radiological Health. Mr. KESSLER. David Kessler, Commissioner. Mr. BARTON. I know you. Mr. KESSLER. I'm sorry. I apologize. Mr. BARTON. That's okay. Ms. PORTER. Margaret Jane Porter, Chief Counsel. Mr. CH~SEMORE. Ron Chesemore, Associate Commissioner for Regulatory Affairs. Ms. THOMPSON. Diane Thompson, Associate Commissioner for Legislative Affairs. Mr. BARTON. We had some people in the back. If ~hey would come forward and give us their name and title. Ms. PEDERSEN. Amanda Pedersen, Chief Mediator and Ombuds- man, FDA.
Page 80: TI14380188
152 Mr. SPILLER. I'm Robert Spiller, one of the Associate Chief Coun- sel for Enforcement in FDA's Office of General Counsel. Mr. LOWELL. I'm Roger Lowell, the District Director from Seattle District of Food and Drug. Mr. ANDROS. My name is Richard Andros. I'm a Compliance Offi- cer in the Seattle District. Dr. SINGLETON. I'm Greg Singleton, a Dental Officer with the Center for Devices. Ms. COOK. I'm Kay Cook. I'm Associate Chief Counsel for Medical Devices. Mr. BARTON. Arid you are here in Washington~ Ms. COOK. Yes. " Mr. BARTON. Thank you. The Chair would now recognize himself for 10 minutes. Mr. KESSLER. Mr. Chairman, we have one more person. Mr. BARTON. I'm sorry. Ms. HOOTEN. Marina Hooten, Chief, Ethics Branch, Division of Ethics and Program Integrity. Mr. BARTON. The Chair will now recognize himself again for 10 minutes. Dr. Kessler, in your opening statement you indicated that you took the charges at the hearing on July 25 very seriously and that you had asked your senior managers to review those files. Could you name for us who the senior managers were that reviewed the files in preparation for this hearing? Mr. KESSLER. Mr. Chairman, there were a lot of people. There were different people for each file. I can name some and then pro- vide more complete, if you would like me to start~ Mr. BARTON. If you could give us as many now and then the oth- ers. I don't expect you to know them by memory. Mr. KESSLER. Let me give you some now and then we would be happy to provide you. There were a lot more people who reviewed. On Inventive Products, Dr. Burlington, Mr. Chesemore, Mr. Springer, Dr. Alpert. I believe on Biomet, Dr. Burlington, Mr. Chesemore, Dr. Alpert, Lillian Gill, Bob Eccleston. On Myo-Tronics, Dr. Alpert, Ms. Pedersen, Mr. Chesemore, Mr. Springer, Ms. Gill, and on Drs. Michelson and Watkins, Dr. Burlington, Dr. Alpert. There is staff in the Office of Legislative Affairs. I think many peo- ple in the Office of Legislative Affairs, the Office of Chief Counsel, and in the Center for Devices. I know Dr. Burlington's office. We would be happy to provide you with a comprehensive list. Mr. BARTON. IS it safe to say that in general it is the people that are with you? I know there are others. Mr. KESSLER. They are the lead, sir. Mr. BARTON. Did this group have any collective meetings where you brainstormed, so to speak, in preparation for this hearing? Did you have a collective group meeting? Mr. KESSLER. There were a lot of meetings. I held meetings. I think there were some introductory sessions on how we would pro- ceed, how we would get the information. There was a group there. Then I went through and had meetings on each~ Mr. BARTON. It's not wrong. I'm not being pejorative about this. 153 Mr. IZ-ESSLER. I'm just trying to think. I spent a lot of time going through case by case, having at least 1 meeting. I've read all these briefing documents in front of me. Mr. BARTON. Suffice it to say, in your opinion you have made every attempt to thoroughly review the 5 specific cases, you and your senior staff, to be thoroughly knowledgeable on these cases, Is that a fair statement? Mr. KESSLER. I certainly hope so. Mr. BARTON. I want to go through these cases. There are 5 spe- cific cases, and the focus of the hearing is, has there been retalia- tion or intimidation in these 5 cases? Based on your written testi. mony, the indications are that in 3 of the cases you saw no prob- lems; in 1 of the cases there is a pending investigation; and in one specific case, the Burzynski Institute, you just used 1 paragraph on it. Mr. KESSLER. I don't think---- Mr. BARTON. I want to go through now. Mr. KESSLER, But I don't think that's correct, Mr. Chairman, I think my testimony, if it's correct, says that there were 3mas I read this hearing, I was aware of 3 specific charges of retaliation, Two of them we have looked at and do not see any support, The third is an ongoing investigation. There were other charges, Those specific charges of retaliation is what I meant. You said 3 and then 1. Mr. BARTON. I am going to go through them individually and .give you a chance to give your best analysis of what the situation IS. The first case is the Sensor Pad that has taken 10 years and has still not yet been approved. You are saying there has been no tn- t.imidation, no retaliation, that that is just normal practice that a simple device like that would take 10 years. Mr. I~ESSLER. The specific charge of retaliation. Mr, Grant Wright complained in a letter of August 14. He complained about a meeting that was held on August 10. He then stated he received a 305 notice. He implied or stated that that was retaliation, The documents, I believe, reflect that work on that 305 notice began 6 months earlier, on February 12, 1992. Mr. BARTON. In the broader context of this hearing, your testi- mony to this subcommittee is that the Sensor Pad has been ade- quately reviewed and the process by which it has been reviewed is acceptable? Mr. KESSLER. No, sir. Mr. BARTON. That's not your testimony? Mr, KESSLER. No, that is not my testimony. My testimony says-- with regard to the specific charge of retaliation, I just commented, I certainly said with regard to the review of Sensor Pad, today I think in retrospect we wished we had handled it differently than it was handled since 1985. Mr. BARTON. I've got 4 more and m~/time is going to go out here pretty quick. On Myo-Tronics, the allegations were that an individual who had a direct competitive device was named the chairman of the panel that reviewed the Myo-Tronics case. You are saying that that is ac- ceptable?
Page 81: TI14380189
154 Mr. KESSLER. No, I'm not, Mr. Chairman. Mr. BARTON. You are not saying that? Mr. KESSLER. I am not saying that. That is under investigation. What I am saying on Myo-Tronics was that there was a charge of retaliation. There was a complaint by the Myo-Tronics. I believe it was on November 4, 1994. There was a complaint that came in to the Agency about the scope of that panel, how that panel was con- ducted. Then they received notice about the Agency was interested in pursuing civil money penalties. But in fact, I think the documents that were submittedshow that it was over 2 years earlier, on Au- ~orSt 5, 1992, that the Seattle District forwarded a recommendation seizure and began its consideration of civil money penalties. So I am stating that the time line of that alleged retaliation shows that the civil money penalties were not- Mr. BARTON. You are saying there is no specific connection, therefore there is no problem there? Mr. KESSLER. What I am saying is a charge of retaliation. I wanted to be very specific, because these are very serious charges. I wanted to look at that charge of retaliation. The charge was a complaint about the advisory committee and then receiving civil money penalties. In fact, the Agency's work on civil money pen- alties began before that advisory committee or that complaint ever came in. I'm responding to that. Mr. BARTON. On Myo-Tronics, you are saying on a very narrowly defined basis there doesn't appear to be a connection? Mr. KESSLER. Again- Mr. BARTON. I'm not being argumentative. Mr. KESSLER. I appreciate it, Mr. Chairman. You are being very helpful, and I appreciate it. You are correct that I am dealing with the facts that were presented as I understand. Mr. BARTON. Let's go to the third one, the Burzynski Institute. This is the medical doctor who has a non-traditional method for treating certain kinds of cancers. There have been 4 grand jury in- vestigations of Dr. Burzynski. MY understanding is there is a pend- ing grand jury investigation at present. Your best analysis is that that is acceptable, that there should be that many grand jury in- vestigations over that amount of time, that that is within the FDA's authority and the funds and the efforts that have been ex- pended there are totally appropriate? Mr. KESSLER. Mr. Chairman, my position on that, on the advice of the Department of Justice, and we concur in that advice, is that if there is an ongoing proceeding that~ Mr. BARTON. Then comment on the previous 4 grand jury inves- ti agations. Were they all appropriate? M r. KESSLER. Mr. Chairman, respectfully, I can't comment on those grand juries. Mr. BARTON. You can comment on the previous grand juries. Mr. KESSLER. Mr. Chairman, maybe I am incorrect. Mr. BARTON. You don't have to, but you can. Mr. KESSLER. Let's discuss that. Let me ask counsel. As a matter of law, can I comment on those grand ju~. l~roceedin~s? Ms. PORTER. Mr. Chairman, s-omeor;e ~i~h personal knowledge of proceedings before the grand jury, an officer of the government, is 155 precluded by law from commenting on those proceedings. If tho question you are asking is with respect to the ongoing investiga. tion, Dr. Kessler is correct that on advice of the Justice Depart. ment with which-we concur we do not comment on ongoing crimi- nal investigations in order not to jeopardize the proceedings. Mr. BARTON. So it is the official position of the (3ommissioner of the FDA that you have no opinion on the previous use of FDA sources to conduct or instigate or encourage grand jury investiga~ tions about Dr. Burzynski? Mr. KESSLER. I'm sorry, Mr. Chairman. I thought you were ask. ing me to comment on the previous 3 or 4---I don't know your exact words. Mr. BARTON. There have been 4. Mr. KESSLER. And I declined to comment on those 3 or 4 grand juries. What I did say I would be willing to comment on is the facts that I know and I think I can comment on. Mr. BARTON. I am not asking you to comment on the facts. That's why I asked the first question. I wanted to know who your senior managers were that you had review the files, and you gave us a fairly comprehensive list, admittedly knowing there may be other people. I then asked whether most of the folks that had advised you in preparation for this hearing are with you today, and most of them are. I then asked if you had had some group meetings to discuss all of the pending cases, and you said you had, and that is very appro- priate. I then asked on this specific case where there have been, to my knowledge, 4 grand jury investigations and a current 1 pending, if that was an appropriate use of the FDA resources, and you have indicated you don't care to comment on that. This is an opinion on my part. I am going to offer an opinion. If I were in your position, I would have an opinion on that. That goes to the whole heart of what we are here today about, which is whether the FDA intimidates or in any way attempts to retaliate against those individuals and companies which it has regulatory authority over. You should at least have an opinion. Mr. KESSLER. Mr. Chairman, could you help me understand, What is the charge of retaliation with regard to Dr. Burzynski? Mr. BARTON. I am not an attorney, so there could be a legal defi- nition of retaliation or intimidation. It is my opinion as a layman~ if the FDA believes there is an individual or company that is any way trying to advocate the use of drugs that are harmful or medi. cal devices that are harmful, the FDA has every right to try to stop that. You have every right to use the investigative authority and the judicial resources of the Federal Government through the Jus- tice Department to convene a grand jury. That is very appropriate the first time. Perhaps even the second time. It becomes question, able the third time, the fourth time, and the fifth time. It is not, I think, an illogical conclusion to believe that the FDA has a ven- detta against Dr. Burzynski or wants to retaliate for some reason, That's my opinion. It is not necessarily a fact.
Page 82: TI14380190
156 Mr. KESSLER. That is helpful, Mr. Chairman. What I was asking was--again, there are very serious charges of retaliation that have been made at this committee. Mr. BARTON. My time has expired, but a simplified way would be, how many grand jury investigations have to occur that result in no finding of fault before you as Commissioner of the FDA would encourage those within your organization to cease and desist? Mr. KESSLER, Mr. Chairman, how do you know that there were no findings of fault that were returned from that grand jury? Mr. BARTON. There have been no indictments returned. Mr, KESSLER. Mr. Chairman, I would ask counsel to comment, but I don't think as a matter of law those are the same things. Mr. BARTON. If you would like to comment on that. I am baffled by the splitting of hairs here. Ms. PORTER. I think the point, Mr. Chairman, is one that I tried to make earlier, which is that with respect to proceedings before the grand jury any government official who has knowledge of those proceedings is prohibited by rule from disclosing them. Mr. BARTON. I have not asked the distinguished Commissioner to comment on the facts in the investigation. Ms. PORTER. The fact of whether an indictment was requested or whether an indictment was denied is a matter occurring before the grand jury about which someone who is not subject to the rule cer- tainly would not have personal knowledge of. Mr. . BARTON. You are the counsel for the FDA; isn't that correct? Ms. PORTER. That's absolutely correct. I'm the Chief Counsel. Mr, BARTON. So it's your position as the counsel for the FDA that it is appropriate to request and convene a grand jury and then ap- propriate just for fun to stop it without going to the conclusion, that that is an acceptable use of the FDA regulatory authority. Is that your position? Ms. PORTER. That is absolutely not what I said, Mr. Chairman. Mr. BARTON. That's the way I interpreted it. Explain to me how I misinterpreted what you said. I am not an attorney. We have sev- eral other distinguished attorneys on the panel. Mr. KESSLER. ~Vir. Chairman, I didn't hear anyone say that any- one was doing this for fun. Mr. BARTON. I will retract that. You are correct. I shouldn't state that you are doing it for fun. I could state that an informed ob- server could certainly conclude that it has been done to intimidate or retaliate. I think that is a fair statement. Mr, KESSLER. Again, Mr. Chairman, I went to look up the defini- tion of retaliation specifically. It says to return like for like. If you could help educate me. What are we retaliating against in regard to Dr. Burzynski? It would be very helpful if I understood that charge. Mr, BARTON. I am not an English major either; I am an engineer- ing major. So I am not going to quibble over the technical definition of retaliation. But it would appear to me that a concerted attempt over a repeated number of cases to in some way prevent a medical Ipractitioner from utilizing an alternative practice of medicine that ~s not generally acknowledged to be effective, and the FDA not being able to prevent it, but to continue to come back and try to prevent it, shows a pattern of, if not retaliating against the individ- 157 ual, then trying to express to that individual that the individual should not practice that life-giving therapy. To me that would be retaliatory. My time has expired. Mr. KESSLER. Mr. Chairman, ] would just comment to you 2 facts. There was an injunction against the interstate shipment by Dr. Burzynski of products in 1983. Counsel can confirm this, but there was a finding in the Fifth Circuit in 1994 that illegal activity was found to be ongoing. I would commend those 2 facts to you. Mr. BARTON. We can get into the facts of that. Mr. Cox. I'm just trying to understand the exchange between the witness and the chairman. What I understood the chairman to say is that there have been 4 grand juries convened. Mr. BARTON. At least 4. Mr. Cox. And would the purpose of these grand juries be any- thing other than to institute criminal process? Is there any other reason? Mr. BARTON. Well, that's what the counsel and I had a little dis- agreement about. Mr. COX. Would the grand jury be able to start a civil proceed- ing? Ms. PORTER. Grand juries are convened in the course of ongoing criminal proceedings, that's correct. Mr. COX. So the purpose of this was criminal process, is that right? Ms. PORTER. It is a matter of public record that there is an ongo- ing criminal investigation with respect to Dr. Burzynski, that's cor- rect. Mr. Cox. I just am left then with a rather strong inference that if you convened 4 separate grand juries and there's no indictment returned, notwithstanding the prosecutors tell us always that Ws possible to indict a ham sandwich, that probably there's not much there. But I realize that what goes on inside the grand jury is se- cret and we can't talk about it. It's just a question of whether we can infer from the fact that this is done repeatedly to no effect that there is nothing there. Mr. BURR. Mr. Chairman, a point of clarification for my own pur- pose. Mr. DEUTSCH. Mr. Chairman, regular order. Mr. BARTON. I agree. The regular order should be in order and the gentleman from Florida is recognized for 10 minutes. Mr. D~.UTSCH. Thank you. I have the good fortune of actually being an attorney, although my extensive practice did not include very much criminal law. But I can tell you I think the point, just to try to follow up what was said, is that a grand jury not indicting is not, by definition, an acquittal of innocence, because the stand- ard that the grand jury would have to meet would be beyond a rea- sonable doubt. So someone can still be guilty, but the grand jury would not be able to indict even if someone is, in fact, guilty. So I guess the legal- Mr. Cox. Would the gentleman yield? Mr. DEUTSCH. Mr. Cox, if I can continue. And we can get expert testimony from criminal defense and criminal prosecuting attor- neys, but there would actually be a statement that the person is
Page 83: TI14380191
158 no longer a target of investigation, which, in fact, the grand jury or the prosecutor could do, which would be a positive statement. Mr. Cox, I'd be happy to yield. Mr. Cox. Just to correct what I think is a misstatement. The ~tandard beyond a reasonable doubt is the standard for conviction. Mr, DEUTSCH. That's correct. Mr. Cox. Not the standard for indictment in the first place. Mr. D~.UTSCH. Probable cause would be the standard. Mr. Cox. Exactly. Mr. DEUTSCH. Right. Mr, Cox. Which is a much more lenient standard. Mr. DEUTSCH. Right, but it's still a standard which is below pre- ponderance of the evidence. Again, it's not an acquittal by not eing indicted. It is not a positive statement of innocence. Mr. BARTON. Would the gentleman yield? Mr, DEUTSCH. I'd be happy to yield. Mr. BARTON. As a professional attorney, and I don't mean- Mr, DEUTSCH. Who did very little criminal practice. Mr, BARTON. Would you have an opinion Mr. DEUTSCH. This is back to law school. Mr. BARTON. How many times would you recommend a grand jury investigation being brought on the same charges before you concluded that it might not be appropriate to continue the chase, so to speak? Mr. DEUTSCH. As my ripe old age, I've learned not to have the comfort of opinion without the discomfort of thought. Without look- ing really looking at the facts that came across and the timing of those facts, it's really hard to make a judgment call. I don't know what transpired between each of those indictments and what addi- tional information came to those people who would prosecute. But let me follow up the Myo-Tronics claim. Specifically, Roland Jankelson of Myo-Tronics claimed and his testimony last July was in part about, and I'll quote, "an apparent willful and calculated campaign by FDA officials to help persons outside of the FDA in- flict harm on our company." Has the FDA's review to date turned up any evidence to support such a sweeping and serious claim? Mr. [~ESSLERo Congressman, our Office of Internal Affairs is--it's an ongoing investigation. As was pointed out, there are new charges being brought by the company, even very recently. It is on- going and, respectfully, if I can leave it at that, I would appreciate it, Mr. DEUTSCH. The investigation of the claim. Mr. KESSLER. There are many charges that have been brought by the company and there is an ongoing investigation. With regard to the charge of retaliation, I think I was clear. There was a charge of retaliation made that on November 4, 1994, the company com- plained they didn't receive civil money penalties, but you look at the facts and the facts show that the civil money penalties rec- ommendation started 2 years earlier. Mr. DEUTSCH. Just to maybe say that again so it's really clear. That specific allegation clearly was incorrect. Mr. KESSLER. I think the facts show that that's the case. Again, we are looking at all the charges, though, very seriously. 159 Mr. DEUTSCH, Mr. Jankelson's testimony said that, and again I'll quote him, "It is necessary to understand that the long and conten- tious history of efforts by a small group of dental academics to dis- credit electronic measurement instrumentation and eliminate it from the marketplace and how this group, first working through the American Dental Association and then the FDA, has worked tirelessly to remove electronic measurement instrumentation from use in clinical dentistry." Do you or anyone on the panel have any idea what he's talking about? Mr. KESSLER. I've looked at and I've asked to look at the lit- erature on these devices and in reviewing the scientific and medi- cal literature, it is fair to say these are as controversial devices as there probably are. There are people on both sides of this issue. There are very strong feelings. There is not the kind of definitive work, the definitive data, whether these devices really help in the diagnosis and treatment of patients with temporomandibular dis- orders. That kind of data we don't have. There's a tremendous controversy out there in the field, with very strong advocates on both sides. I think it's fair to say that's an understatement of the extent of the controversy. Mr. DEUTSCH. Mr. Jankelson testified also about the company's concern about the FDA's Dental Products Advisory Panel; in par- ticular, the composition of the panel and possible conflicts of inter- est, as well as the actions by the panel. But hadn't he raised his concerns earlier with FDA and hadn't the FDA already set aside the recommendations of the panel? Mr. KESSLER. That's correct, Congressman. We did not do a good enough job in defining the scope of the type of products that the panel was to consider, muscle monitors, When we looked at it, we could have done a better job of defining exactly what was in this class of muscle monitors. I believe that's the reason that you set aside the panel findings. Mr. DEUTSCH. In fact, then you reexamined the claims at that point in time through another panel. Ms. ALPERT. There will be another panel. Mr. DEUTSCH. And you've indicated that the investigation of these and related claims is still ongoing. Why is it taking so long for this investigation? Mr. KESSLER. Because there continue to be new charges that are raised by the company and our Office of Internal Affairs wants to pursue this thoroughly. Investigations take time. We all know that, Ms. ALPERT. If I may, Congressman. During this process, the de- vices remain legally in the marketplace. They're not removed from the market while this process is ongoing. Leading up to a panel meeting or for quite a bit of time after a panel meeting, it's a clas- sification procedure and the devices are not removed from the mar- ketplace. Mr. DEUTSCH. Let me just follow up with Myo-Tronics, It appears that the FDA has had a more complicated relationship with Myo- Tronics than with many companies. Can you elaborate on the sei- zure action in Federal court and a consent decree that resolved the litigation?
Page 84: TI14380192
160 Mr. KESSLER. I'd be very happy to, Congressman. If we could just have the chart, I believe it's chart six. I believe that what the chart basically shows is that there was a 1991 routine inspection and it was found in that inspection the firm was marketing devices with- out the requisite findings of equivalence. In 1992, there was a fol- low-up inspection. A warning letter was sent in 1992. We had a discussion with Congressman Greenwood. The company was told that they didn't have the requisite marketing clearance and not to ship the devices. In 1992, the company continued to ship the devices and then there was a seizure activity. I think that basically summarizes the history that led up to the seizure. Mr. DEUTSCH. Would you categorize the pre-1991 compliance his- tory of the company as poor, average or good? Mr. KESSLER. Let me give you the facts. There were 6 inspections of Myo-Tronics between 1973 and 1988, 5 which revealed--Mr. Chesemore can correct me, but I believe 5 revealed objectionable conditions. I don't believe, Mr. Deutsch, that they were so egregious. They were not the most egregious, by any means. But there were 5 out of 6 found objectionable conditions. If I can let the record stay at that, I think that's the objective findings. We'd be happy to submit the 483's for the record. Mr. DEUTSCH. This is the complete post-1991 history. Mr. KESSLER. No. I only took you through the seizure on August 9, My understanding, and Mr. Lowell can correct me, but I believe the firm is in compliance to date. That was, I belie.ve, one of .t,,he reasons why the civil money penalties recommendation was wi~n- drawn. It was part of the reason. Mr, BARTON. We thank the gentleman from Florida. The Chair is going to recognize, out of order, the vice chairman, Mr. Cox, for some questions, and then Mr. Burr would be next. Mr. Cox. I thank the chairman. I'd like to recap what we've al- ready covered with respect to Sofamor Danek, pedicle screws, the violation by FDA of the court's order, so on. Dr. Kessler, you told me that you were familiar with the study on pedicle screws, screws for spinal fusions, that the FDA used to evaluate the screws as de- vices. That's correct, right? Dr. Kessler. I certainly have some familiarity. Dr. Burlington has much more familiarity. Mr. Cox. And you were familiar with the fact that the study was based on voluntary, confidential information regarding-- Mr. KESSLER. Right. I think I received a letter that pointed out that information. Mr. Cox. And you agree that the breach of the confidentiality of information provided by physicians, patients, other health care pro- fessionals to the FDA, leaking that to the public, let alone provid- ing it to plaintiffs' lawyers, would be a very damaging thing. Mr. KESSLER. Absolutely. We're in full agreement. Mr, Cox. It would be a very serious problem and it would dam- age the credibility of the Agency. Mr, KESSLER. Absolutely. Mr. Cox. And the progress of medicine, in fact. Mr, IrmSSL~.R. Absolutely. 161 Mr. Cox. Then you told me that until this hearing this morning, you were unaware that the FDA, in fact, had given this sort of in- formation to plaintiffs' lawyers- Mr. KESSLER. No. Mr. Cox. [continuing] in violation of the court order. Mr. KESSLER. No. Let me go back and check, Congressman, When you showed me the court order, ] don't recall having seen or known about that specific court order. I think it was either yester- day or the day before, where I asked about the issue and talked about the issue of the inappropriate release, I certainly knew about that. What I just didn't know specifically about was seeing the court order and it's even possible, Congressman, that it's one of the pieces of paper that I just didn't focus on. That was what I didn't, when you showed it to me, recall. Mr. Cox. But if I recall correctly, and we can read back the testi- mony, which was given under oath, you told me you were not aware that the FDA had violated a court order. Mr. KESSLER. I wasn't aware of a specific court order. Mr. Cox. But you are now aware of this. Mr. KESSLER. Let's just make sure that the record is correct. Ms. PORTER. Mr. Cox, if I might. The FDA has been actively par- ticipating in this litigation and had asked the court to be certain that these documents were kept confidential. The FDA had an on- going interest in their confidentiality. So I think to suggest that somehow the Agency was unaware of those proceedings and was somehow surprised by the order, the Agency worked hard to~ Mr. Cox. Ms. Porter, with respect, I haven't suggested anything. I am seeking to establish the testimony of Dr. Kessler, whether, at the time of this hearing, he had been advised by you that the FDA had violated a court order, or by anyone else in the Agency. He tes- tified earlier that he had not been so advised. Ms. PORTER. That's correct, but he had been advised that there was an inadvertent release, that the Agency took prompt steps with the court to safeguard those documents-- Mr. KESSLER. That's correct. Ms. PORTER. [continuing] and asked that they be returned and that his employees provided exhaustive explanation as to how the inadvertent release had occurred. Mr. KESSLER. That's correct. I knew that. Again, I would, be happy~ Mr. COx. Dr. Kessler-- Mr. KESSLER. I would appreciate the opportunity to check the files. It's possible that that court order, and I have no knowledge one way or the other now, could have crossed my desk. But when you showed it to me, it was the first time that I certainly.had fo- cused on that specific piece of paper. Mr. Cox. I'm not trying to in any way trap you in an answer to a question that you're not comfortable giving. I'm simply focused on the fact that, first, you have told us that it would be a very serious thing-- Mr. KESSLER. Absolutely.
Page 85: TI14380193
162 Mr. Cox. [continuing] if this had occurred and, second, that you had not been told that it had occurred in violation of a court order, but you had been told it occurred. Mr. KESSLER. It's a compound sentence, your second point. I had been told that it had occurred. Mr, Cox. But not that it occurred in violation of a court order. Mr. KESSLER. That it had occurred. I was also told that we were working with the court. Ms. Porter told me. Let her tell you the words that she actually told me or Ms. Thompson told me, I don't know who. Mr. Cox. Well, the reason, Ms. Porter, that it makes a difference, as you know, as an attorney, is that if it happens in violation of a court order, then in addition to the concerns that the FDA would have about its own integrity and reputation, there are certain legal responsibilities that devolve upon people who get confidential infor- mation in violation of a court order. Can you tell me what that responsibility is? Ms. PORTER. The point I was trying to make, Mr. Cox, is that the Agency is fully aware of those legal responsibilities and obligations, had previously participated in those court proceedings. Mr, Cox. Yes. Ms. PORTER. And had taken steps to try to assure-- Mr. Cox. I appreciate that you're trying to make that point. Ms. PORTER. [continuing] that the documents remain confiden- tial. Mr, KESSLER. I was aware of that, Congressman. Mr, Cox, Yes. Could you answer the next question, which is are you aware of the responsibilities of someone who gets information m violation of a court order, as happened in this case? Ms. PORTER. If you're referring to the plaintiffs, we-- Mr, Cox. Yes, I am referring the plaintiffs' lawyers, to whom the information was given. Ms, PORTER. We filed substantial pleadings in the court on No- vember 7, with an affidavit explaining what had happened and ar- gument asking not only that the documents be safeguarded, but that they be returned to the FDA because that's where they should properly be and they had been inadvertently disclosed. That is our position. Mr, COX. Did your argument that you filed on November 7 cite an ABA ethics o_pinion? Ms. PORTER. Yes, it did, Mr. Cox. Mr, Cox. Does the ethics opinion tell plaintiffs what they're sup- posed to do when they get documents in violation of a protective order? Ms. PORTER. Yes, it does, Mr. Cox. Those pleadings are a matter of public record. We filed them last week. Mr. Cox. In fact, I've read them. That's why I asked you if you know that certain responsibilities devolve upon people who get doc- uments in violation of a court order, responsibilities that otherwise wouldn't devolve upon them if it were not in violation of a court order, It makes a difference that it's in violation of the court order, does it not? Ms. PORTER. I understood your question to be earlier about the FDA's actions. Certainly there are procedures in each court that 163 govern the confidentiality of documents that are produced confiden- tially and there are sanctions in each court for violations. Mr. Cox. According to the ethics opinion that you cited, what were the plaintiffs' lawyers supposed to do once they got informa- tion that the FDA wasn't supposed to produce to them? Ms. PORTER. We took the position that the plaintiffs should re- turn the documents to the Food and Drug Administration. Mr. Cox. And that they shouldn't read them. Ms. PORTER. That's correct. Mr. Cox. They shouldn't read them or rely upon them in any way. Ms. PORTER. I believe that's correct. I'd want to check the full ar- gument first, but certainly our position is they should not have re- ceived them. Mr. Cox. The opinion of the ABA is 92-386. It's issued by the standing Committee on Ethics and Professional Responsibility. It is attached as an exhibit to your filing. Ms. PORTER. That's correct. Mr. Cox. And that's exactly what it says. So the fact that the doctors, who are now being subpoenaed by the plaintiffs' lawyers, were not themselves involved otherwise in the use of these devices and has caused them to believe that the reason they're being sub- poenaed is that these names were leaked to them by the FDA sug- gests that the plaintiffs' lawyers violated this ethics opinion, does it not? Ms. PORTER. Mr. Cox, I want to take objection, again, to your use of the word "leak," As I think I explained clearly, there was an in- advertent disclosure in the context of massive amounts of material. Mr. Cox. All right. Ms. PORTER. That's not a leak. Mr. COX. Dr. Kessler, do you know how much information was inadvertently provided to plaintiffs' lawyers? Was it a piece of paper? Mr. KESSLER. Somebody told me yesterday the total amount of documents, of how many boxes, the total amount of documents. Mr. Cox. But how much of it shouldn't have been turned over, that was inadvertently leaked? I'm asking Dr. Kessler if he knows, Mr, KESSLER. Again, terms like boxes were used yesterday, but I don't know the numbers, in my head. Mr. Cox. So does it make sense to you that you inadvertently turn over boxes of information or that you inadvertently turn over a piece of paper? Mr. KESSLER. Let me let counsel, I think, who has some of the facts. Mr. COX. I appreciate that you'd prefer me to direct my questions to others, but I'm only trying to find out what you, as the Commis- sioner of the FDA, have been told by your staff about this, I con- sider it to be a serious matter and I wonder whether or not your staff considers it serious enough to tell you. Mr. KESSLER. As I understand what I know is that there was a contractor who was asked to copy I don't know how many boxes. Mr. Cox. Twenty-three. Ms. PORTER. Twenty-three, right.
Page 86: TI14380194
164 Mr. KESSLER. And there was a disclosure, whether it was a box, 2 boxes, I'm told that the contractor got mixed up on boxes. That's what I was told. Ms. PORTER. Boxes number 17 and 20, which are 2 boxes. Mr, Cox. So what we're talking about is that inadvertently, box loads of information were provided to plaintiffs' lawyers that con- tained the names of doctors who participated on a confidential, se- cret basis in FDA studies. And the FDA, in fact, takes so seriously this necessity of confidentiality that you don't even have the names of the doctors in most of these documents, do you? You have a key. It's cryptology, after a fashion. You have PIN numbers. You don't even use their names to protect that confidentiality. Isn't that ri~h~t? ~v~r, KESSLER. That's what I'm told by Dr. Burlington and Mr. Levitt. Mr. Cox. So not only did we turn over documents without the keys redacted, but we also turned over the keys themselves. Is that right? Inadvertently. That's your understanding. Mr. KESSLER. That's what I'm being told, yes. Mr, Cox. Now, I want to ask you whether or not you're aware that any meetings took place at FDA about the release of these documents before the documents were released. Mr, BARTON. The Chair would ask unanimous consent that the gentleman from California have additional time so that we are op- erating under regular order. Mr. Cox. I appreciate that, Mr. Chairman. Mr, BARTON. Without objection, so ordered. Mr. KESSLER. Other people would have to comment on the meet- ings on these documents. Mr. Cox. But you're not aware of any meetings taking place to discuss the release of these documents before the release, in fact, took place. Mr. KESSLER. My only knowledge is over the last couple of days. I think there was a letter that somebody was talking about some- thing and I have a very vague recollection. Mr, Cox. Is it your testimony today that to the best of your knowledge, no person who works for you at the FDA was involved in encouraging or assisting in making public the confidential physi- cian names and so on? Mr. KESSLER. Congressman, I've told you everything I know about this. I've told you. Mr. Cox. And the answer is? Mr. KESSLER. I've told you everything I know. I was told that there was a contractor. I was told that there were documents. There was a lot of boxes. I was told- Mr. Cox. This is an easy question, I hope. As far as you know today, nobody in the FDA under your control was involved in aid- ing or abetting or encouraging the release of this information in violation of a court order. Mr. KESSLER. I don't have any personal knowledge. Mr, COX. That's all I wanted to ask. Mr. KESSLER. I have no personal knowledge of that. Mr. Cox. I just wanted to ask you about this. Is there an inves- tigation underway to find out whether this, in fact, took place? 165 Ms. PORTER. Excuse me, Mr. Cox. You've seen the documents that we've just filed in court, including a full affidavit by the Direc- tor of Freedom of Information for CDRH. We're in the process of working with the court to try to re-secure those documents. Mr. Cox. What the court filing tells me, though, is that the per- son who was in charge of this said that he'll take steps to make sure it never happens again. It indicates to me he's not being dis- ciplined. It also indicates to me that that's the end of the investiga- tion, that no further investigation is going to be made into what happened here. Ms. PORTER. I'm not in a position to comment as to whether there will be further investigation. Mr. Cox. Is there anybody here who is? Ms. PORTER. He has said that he will take steps to see that it doesn't happen cgain. Mr, Cox. I asked the question about whether Dr. Kessler knew of any discussions that took place prior to the time that these docu- ments were released and I asked the question about whether there's an investigation into whether or not anybody on the FDA staff could have been involved in such a thing because this commit- tee has been advised, confidentially, by a person who is not tech- nically a whistleblower, having not claimed that status, but who wishes to remain anonymous, that this person believes that the provision of this information was, in fact, willful. So I ask the question again. Is there an investigation underway to determine whether that's true? Mr. KESSbER. It's the first I've heard, Mr. Cox. Mr. BARTON. Will the gentleman yield? Dr. Kessler, could I ask you, as Chairman of Oversight and Investigations, to conduct an investigation into this? Mr. KESSLER. Absolutely. Mr. BARTON. Thank you. I yield back. Mr. Cox. Dr. Kessler, do you know a fellow named Sidney Wolfe? Mr. KESSLER. I do. Mr. Cox. Have you ever had lunch with Sidney Wolfe? Mr. IZmSSLER. I think I've had dinner with Sidney Wolfe. I can't tell you exactly. I had dinner. I don't know if I've ever had lunch. Mr. Cox. Dr. Burlington, do you know Sidney Wolfe? Mr. BURLINGTON. Yes, sir, I do. Mr. Cox. Have you ever gotten together with him? Mr. BURLINGTON. I've gotten together with him on numerous oc- casions professionally and on a few occasions socially. Mr. Cox. You're familiar with the Health Research Group. Mr. BURLINGTON. Only to a small extent. I'm aware that Sidney is their Medical Director. Mr. COX. Do you have any knowledge, either of the 2 of you, that the Health Research Group is funded by plaintiffs' lawyers? Mr. BURLINGTON. I have no such knowledge. Mr. Cox. Dr. Kessler? Mr. KESSLER. I don't know about their funding. Mr. Cox. If they were, would that be a conflict of interest? Mr. KESSLER. Mr. Chairman, there's a lot of people funded by a lot of different sources in this town and to be honest with you, I can't keep track of all the funding. My job is to deal with conflict
Page 87: TI14380195
166 of interest in this Agency. My job is not to deal with conflict of in- terest outside of other parties. But there's certainly a lot of ~eoDle funded by a lot of different sources that aren't readily a~Dare~ Mr, Cox. Dr, Burlington, do you know when the ]nf~tmatio~, in violation of the court order, was transmitted to plaintiffs' lawyers? Mr. BURLINGTON. No, I do not know when that happened. I would have to refer to the memorandum from Mr. Sadler on the staff. Mr. COX. Ms. Porter, do you know the date? Ms. PORTER. I'm checking the affidavit, Mr. Cox. I believe it was in late October. Mr, Cox. And, Dr. Burlington, did you meet with Sidney Wolfe during October? Mr. BURLINGTON. I've met with him recently. I'd have to check my calendar to see if it was during October. It probably was. Mr. COX, According to the FDA's public calendar, on October 6. Mr. BURLINGTON. Okay. Mr. Cox. And do you remember what you discussed? Mr. BURLINGTON. We discussed a wide number of issues at that meeting. Mr, cox. Did you discuss pedicle screws? Mr. BURLINGTON. That did, indeed, include the proposed down- classification of pedicle screws. Mr. Cox. Dr. Kessler, there appears to have been another leak in this case in violation of the court's protective order. The sub- monthC°mmittee ....... has learned that plaintiffs' lawvers..j , over the ~as~n s, nave a~emp~ed to delay publication of the proposed rule on pedicle screws by leaking documents subject to the protective order to you, to the FDA. These materials were leaked to provide a basis, apparently, for the FDA to launch internal investigations on purported conflict of interest issues, because in correspondence to this committee, we have learned that you have, in fact, begun such investigations on the basis of these documents. I'd like to put into the record at this point, Mr. Chairman, what I'll designate as Sofamor Exhibit 2, which is an index of documents submitted by Mr. Zeller, your Special Assistant. This index con- cerns documents provided to Mr. Zeller by Mr. John Cole. Mr. Cole is an attorney who specializes in mass tort litigation and represent- atives plaintiffs in pedicle screw litigation against Sofamor Danek. The documents, some of which relate to that company, are listed in the index and those documents that the FDA has marked with an asterisk are documents that are covered by the court's protec- tive order. Mr. BARTON. Without objection, so ordered. We'd also need to provide copies of that information to the minority. [Sofamor Exhibit 2 foIlows:] INDEX I OF DOCUMENTS SUBMFFrI~D BY MITCH ZELLER Documents responsive to item I: ~9//79/~93 memo~ fr..SIM~G .Executive Board to H,Yuan re: consulting arrangement* ~ memo tr. Alex ~.ukianov, Danek, to various addressees re: ~t. Joseph's hos- pital sales * Undated stock option agreement signed by Whitecloud * 5/2/95 Plaintiffs' Brief* 167 6/15/95 letter fr. J,Coale to MZ transmitting the following materials: 8/16/94 memo fr. Leonard Farr to Eric Blumbert 3/7/94 memo of meeting be: Acromed and CDRH re: potential prosecution 9/11/91 memo fr, F.Lochner to D,Fernholz, CIN-DO re: interview of P,Ames 5/28/91 FDA 481 for Cardio Medical Products 6/12/95 letter ft. J.Coale to M.Jones and J.Broussard transmitting materials 2/4/?. handwritten note of ¢onvemation with Dr. Balderston 1/30/91 fax ft. J.Watermeier t~ P.Curl re: workshop 1116/86 letter ft. E.Wagner, AcroMed, to M.Zindrick 3/17/93 notes of meeting w/FDA (author unknown) and 3/93 pedicle screw decision paper 5/31195 letter fr. G.Eaton to D.Cooley transmitting 10/5/94 letter to Dr. K criticizing cohort study and attaching Spine article 1/11/93 letter fr. A.Luldanov, Danek, to H.Yuan re: consulting agreement ~]hotocopy of 1/11/93 $35,000 Danek check to NASS 11]? handwritten note fr. A.Lukianov, Danek, to H.Yuan transmitting check 8/8/93 memo ft. J.Pafford, Danek, to M.Crawley re: meeting Yll/~3 letter ft. A.Lukianov to H.Yuan transmitting cheek with photocopy 9/6/9~ letter ft. J.Coale to MZ advising FDA to request access to confiden- tial documents 8/18/95 letter fr. A.Levin to J.Jacobus re: release of documents, w/Sum- mary of Discussion with Jurrian Strobos and transcript of 8/17/95 hearing 8/14/95 transcript, pages 1, 15, 15, 20 * subject to protective order Mr. COX. Dr. Kessler, did either Ms. Porter or Mr. Zeller inform you that some of the documents that FDA received from John Cole were covered by the court's protective order and should not have been provided? Mr. KESSLER. Congressman, I just need to, for the record. The chairman and I talked about this hearing toda~y and said that I would come and respond to the allegations mane on July 25. I'm a little confused, because I've read this hearing on July 26 and I'm not sure that any of these issues or any of these discussions came up. Mr. Cox. Dr. Kessler, that's why I asked you whether you were familiar with the testimony we received about Sofamor Danek. This is litigation about Sofamor Danek. Mr. KESSLER. But Sofamor Danek, if I'm correct, didn't come and testify here. I came prepared to talk about spinal cages. I'm willing to talk about physician-patient relationships. I'm just~ Mr. Cox. Well, Mr. Chairman, if the chairman agrees that this is not relevant-- Mr. t~ESSLER. I thought the agreement I had with the Chair~ Mr. Cox. [continuing] I will not~ Dr. KESSLER. [continuing] was that I would-~ Mr. BARTON. Would the witness and the questioner suspend? We want to be totally fair about this. Some of the issues that Mr. Cox is raising have surfaced since the hearing in July. There is no question about that. So you are correct in that sense. It is also correct, as Mr. Cox is proceeding with his line of ques- tioning, that they bear on the general issues that were raised in the July 25 hearing. So in a sense, you're both right and, in a sense, you're both wrong. Now, you are within your rights, Dr. Kessler, to just say no com- ment. I would hope you would comply in the spirit of the hearing. Mr. KESSLER. Absolutely, Mr. Chairman. We'd be prepared to certainly answer and be as helpful as we can to Mr. Cox. It was
Page 88: TI14380196
168 just a lot of preparation went into this hearing on the specific is- sues of retaliation and that's my only comment. Mr. BARTON. The gentleman's time has expired. He's had 2 con- secutive 10-minute rounds. I'm going to have to insist upon regular order and will recognize the gentleman from North Carolina at this time. Excuse me. We'd recognize the gentleman from Florida. Mr. DEUTSCH. Thank you, Mr. Chairman. Again, I guess just in terms of any other things, just to the last comment, I understand what Mr. Kessler really is trying to do in response to the 5 hear- ings. If there are any incidents that took place since then, it just seems appropriate. It's very hard for him to respond without him knowing. So it just would seem much more appropriate to try to let him know beforehand. You don't have to respond to that. But let me go to one of the other cases which you already, I be- lieve, have responded to, and that's Biomet. According to the msjor- ity staff memorandum for the July 25 hearing and this hearing, the Biomet shows, and I'll quote, "The FDA's virtually unchecked power to continue to investigate any and all aspects of the compa- ny's activities, while its application is held hostage at Rockville." The case study attached to this testimony refers to Dr. Miller's apparent concern that his company had come under special scru- tiny because of its criticism. Would you go over the reasons for the increased regulatory inspections at Biomet in the last few years? Mr. KESSLER. There were several inspections of Biomet and I'd be happy to let Dr. Burlington comment. There was some concern, if I'm correct, about the number of adverse reactions to the stems of certain femoral hip implants and there was compliance inspec- tions involving the stem of those implants, and I'd let Dr. Bur- lington comment. I think there was also some inspections with re- gard to the failure to comply with human patient protections, pa- tient subjects. I'll let Dr. Burlington comment. Mr. DEUTSCH. Would you respond, please? Mr, BURLINGTON. Regarding inspections, about product lines and GMP's, that's a field activity. I'm sure that Mr. Chesemore would also have comments on that. Regarding MDR reports, medical devices that have reports of ad- verse events occurring in patients are one of the reasons that we conduct for cause inspections and, in fact, we have inspected not just Biomet, but also a competitor, and, in those inspections, found evidence of hip implant failure, resulting in fractures, and that Biomet was retrieving products. They didn't choose to call it a re- call, but it's the same sort of activity that we would frequently call a recall, where they pull back the un-implanted implants and ei- ther recondition them or use alternative products. In addition, we have had bioresearch monitoring inspections for cause of Biomet because of a large number of products, a dispropor- tionately large number of products shipped to the number of prod- ucts that were covered by their investigational device exemption, manyfold larger, in fact, that seemed to suggest that something was going on other than that envisioned in the scope of the ap- proved protocol. Mr, DEUTSCH. Is it fair to say that recent manufacturing site in- spections of Biomet facilities are comparable to those of their com- petitors? 169 Mr. CHESEMORE. Yes, sir, I think it's reasonable to say that. Mr. DEUTSCH. Is that stated in the case study? Mr. CHESEMORE. Yes, in the case study that was presented to the committee. Mr. DEUTSCH. And the information supporting that conclusion is available for staff to review. Mr. CH~SEMORE. It is in the case report, yes, sir. Mr. DEUTSCH. And the backup material, as well, is available. Mr. CHESEMORE. We'd be delighted to provide any backup mate- rill that the committee might want, if you don't already have it. Mr. DEUTSCH. You referenced a determination by FDA, later re- verse, concerning the ability of another company to also distribute Biomet products. Can you tell us what that was all about? Mr. KESSLER. Can I have the first chart? Actually, I don't want to take your time, Congressman, but this is one of those---Mr. Niedelman, could you just take us through very quickly? This is one of the most complicated disputes between 2 parties, that I think in the end FDA got caught. Do you want to just take us through, very quickly, these5 charts? Mr. NIEDEL~. We received an inquiry. From 1985 to 1989, both Oswald Leibinger Company, a German corpora_tion., as well as Karl Leibinger, another German corporation, non-related, were pro- viding orthopedic devices to Walter Lorenz Company, a Biomet subsidiary and the U.S. distributor upon its admittance into the United States. Lorenz had submitted 510(k)'s and received market- ing clearance from the FDA for all 11 devices. In 1989, Oswald Leibinger severed his relationship with Walter Lorenz Company and Karl Leibinger began manufacturing the wald Leibinger devices, as well as the original 5. Mr. BARTON. You need to come to the microphone, identify your- self. Were you one of the gentleman who was sworn in earlier? Mr. NIEDELMAN. I'm sorry. I was not. Mr. BARTON. Could you give us your name and your title? Mr. NIEDELMAN. My name is Steve Ni~delman. I'm the Director of the Division of Enforcement II at FDA s Center for Devices and Radiological Health. Mr. BARTON. Remain standing and raise your right hand. [Witness sworn.] Mr. BARTON. Continue. TESTIMONY OF STEVEN NIEDELMAN, DIRECTOR, DMSION OF ENFORCEMENT, FDA CENTER FOR DEVICES AND RADIO- LOGICAL HEALTH Mr. NIEDELMAN. To repeat this chart. In 1989, Oswald Leibinger severed relations with Walter Lorenz, the U.S. distributor. Karl Leibinger, the other German corporation, continued to manufacture the 5 orthopedic devices. They had clearance, that was cleared, plus they back-engineered the Oswald Leibinger devices previously provided to Lorenz. In May 1994, FDA received 2 pieces of correspondence, 1 from the Walter Lorenz Biomet subsidiary and 1 from Karl L.eib~i~ge.r Surgical, a relatively newly-formed firm that was comprlsec~ o[ l~arl Leibinger individuals as well as former employees from Walter Lorenz. Karl Leibinger requested of one part of FDA whether or
Page 89: TI14380197
170 not they could use the 510(k)'s previously submitted by Lorenz and that Lorenz was termed as the exclusive or represented as the ex- clusive distributor for the Leibinger devices. Similarly, Lorenz sent another piece of correspondence to FDA, asking whether or not they were the sole people capable of using the 510(k). FDA responded to Karl Leibinger Surgical, KLS, told them that based upon the presentations done, presented to FDA in a declaration, that since Walter Lorenz was the exclusive distribu- tor, that it was okay to distribute the original 5 devices that Karl Leibinger had manufactured for Walter Lorenz, but they needed 510(k)'s for the devices they began to manufacture as back-engi- neered devices that were originally manufactured by Oswald Leibinger. Karl Leibinger, in turn, took our correspondence, passed it on to its customer, who, in turn, forwarded it back to Lorenz. They chal- lenged FDA's decision that permitted KLS rights to their 510(k). Based upon information that was contained in Walter Lorenz's challenge to FDA and a re-review of the 510(k)'s that had been pre- viously distributed, FDA reversed the decision and notified KLS that they needed 510(k)'s for all 11 devices, and we provided an- other copy to Karl Leibinger's--to Walter Lorenz advising them of our reversed decision. Mr. KESSLER. I'm sure that's all 100 percent clear to everyone. The reason why that's important to go through was there was a charge made that the Chairman or President of Biomet gave a speech in December 1993 and FDA made the decision subsequently in the 510(k) dispute because of that speech. I see no facts that we can find that supports that charge whatsoever. I think you can see that this is really 2 companies who are hav- ing a private dispute. And, furthermore, after that speech, I count about 7 devices that we granted 510(k) approval to that company. Again, it was a charge of retaliation, a serious charge of retaliation, and then we make a decision in a very complicated dispute and that's held as retaliation and I just don't see the facts that support that. Mr. DEUTSCH. Could you elaborate on that, that the companies had other application or matters involving the Agency where the relationship between the FDA and Biomet has gone smoothly? You just mentioned a number of things. Could you just elaborate on that a little bit? Mr. KESSLER. I have approvals that sta~--there is an allega- tion-the speech was in December. We approved a hip in July 1994 and knee in January 1995, a total shoulder in August 1995, a cold pack in 1994, a total hip system in September 1994, 3 dental sys- tems in September 1994, and a total toe in December of 1994. That's what I have in my notes. The Agency was approving the company's devices. Mr. BARTON. The Chair would now recognize the gentleman from North Carolina and indicate that Mr. Burr and Mr. Coburn will be recognized in order unless a Democrat who has not yet asked a sec- ond round of questions does appear. But we are going to let Mr. Burr and Dr. Coburn ask their second rounds. Mr. BURR. I thank the chairman. At this time, I would yield to Mr. Cox. 171 Mr. Cox. I thank the gentleman. Dr. Kessler, we were talking about documents going back and forth in violation of protective or- ders. The first set of documents went from the FDA to plaintiff2 lawyers. The second set of documents, which is described on the ex- hibit that I just provided you with, went from plaintiffs' lawyers to the FDA in violation of a different protective order in the same liti, gation. It was indicated in the correspondence from FDA to this commit- tee that those documents noted with an asterisk are, in fact, cov- ered ~b~ the protective order. Have you ever seen any of these docu- ments. Mr. KESSLER. I don't have any recollection. I was aware that doc- uments had come in. Mr. Zeller told me about those, that he had received certain documents and allegations and he reviewed those documents. I think I said---if my memory serves me correct, I said to send it to--to make sure that there is nothing there of any--sup~ porting any allegations of impropriety. Mr. Zeller can comment. Mr. Cox. Dr. Kessler, did Mr. Zeller tell you that the documents that you were looking at were received by the FDA in violation of a protective order? Mr. KESSLER. Again, I-- Mr. Cox. You don't recall one way or the other, whether he told you that. Mr. KESSLER. I don't recall. I know he told me he had received documents, but I don't recall one way or the other. Mr. Cox. Do you think, Dr. Kessler, if he had told you that, they, were in violation of a protective order, you would have rememoere~l it or is that the kind of thing you might just as soon forget because it happens so often, or is that a sort of unusual thing that would sort of stick in your mind? Mr. KESSLER. Let me let Mr. Zeller comment. Mr. COX. I'm sorry, Dr. Kessler, but I'm entitled to an answer to the question. The reason that I think it's fair to ask you whether you knew that documents that the FDA provided the plaintiffs' were in violation of the protective order and whether it's fair to ask you whether documents you personally reviewed, was made plain to you were received in violation of the protective order, is that ei- ther you weren't told those things or it happens so often that you just can't remember because it's caught up in the ordinary course of business, and I don't know which it is. Mr. KESSLER. First of all, I don't have a recollection whether I reviewed any of these documents or not. You are correct. The Agen- cy receives a lot of documents from a lot of different sources on a lot of different issues. Mr. Cox. To your knowledge, does the Agency violate a lot of court orders? Mr. KESSLER. We are very careful and I have taken the position that we should not--if we receive any documents th~t-are subject to a court order, we need to take great pains, and counsel will tell you. My longstanding position is if we receive any documents sub- ject to a court order, we take great pains to make sure that they are not released. It's something that I just believe. I think we have to-- Mr. Cox. Not released, but not about what about not read?
Page 90: TI14380198
172 Mr. KESSLER. No. Mr, Cox. Would you read them if you knew that they were in violation of a court order? Mr. KESSLER. Again, I don't--violation of a court order, again, a legal term. Mr. Cox. Where there is a protective order on documents. In vio- lation of that protective order~ Mr. KESSLER. Let me give you an example. Mr. COX, [continuing] plaintiffs' lawyers provided the information to the FDA. Mr. KESSL~.R. We've read~ Mr. Cox. Mr. Zeller told this committee in a briefing that that information had been shared with you. We also received cor- respondence which I~ Mr. KESSL~.R. Which information? Mr. Cox. [continuing] provided you, which you have in hand, la- beled Index 1 of documents submitted by Mitch Zeller, and those indicated with an asterisk are covered by the protective order. Mr, KESSLER, You're refreshing my recollection. I do believe that Mr, Zeller gave me certain documents. I don't believe that I did ' other than a very cursory--I basically--my ~ecollection is anything ........ ~1^ ~t ~nake sure there aren t any alle.ga- I told Mr. ],elier to nanu~v --, "--7-- ----*~ hl~. I don't rememuer tions. But he did give me some aocumen~, --- - focusing on those documents in any detail. Mr. BURR. Would the gentleman yield? Mr. Cox. Yes. Mr. BURR. Dr. Kessler, could you define for me the term "go ahead and handle these" as it relates to documents that the court has sealed and, in some way, shape or form, may have ended up in your hands? Mr. KESSLER. My reference was to make sure, if there are allega- tions of impropriety on the Agency's part~ Mr. BURR. My question~ Mr. KESSLER. [continuing] that was why I said to go ahead and handle it. Mr. BUR~. My question, Commissioner, is that there is every rea- son to believe that Mr. Zeller conveyed to you that here are the documents, we have received them and they were sealed by the courts, and that there was a decision made within the FDA other than we can't read these. ' ~ Mr. KESSLER. No. I don't' think--I don't take the position we can't read documents, Mr. ZELLER. Can l answer? Mr. Cox. Actually, I w6uld like to direct the question to Ms. Por- ter, because earlier Ms. Porter told me she was familiar with the ABA ethics opinion and she believed that it imposed on people re- ceiving document~in violation of a protective order the obligation not to read then~ and to return them. Isn't that correct, Ms. Porter? Ms. PORTER. Mr. Cox, I think it's appropriate for Mr. Zeller. The answer is correct, that what one has to do is look at the terms of the ABA opinion and look at how we used it in the case in ques- tion. And in the case in question, which I testified to, our position was clearly that the plaintiffs should return those documents. 173 I think with respect to the matter that you were just addressing~ Mr. Zeller is in the best position to talk about what he did and said with respect to those documents. Mr. COX. Ms. Porter, you're the General Counsel of FDA. Did you advise the court in this matter that the FDA had received docu- ments in violation of the court's protective order? Ms. PORTER. Mr. Cox, I am not aware personally of the cir- cumstances to which you are referring concerning Mr, Zeller, Mr. Cox. Let me ask you whether or not you are familiar with Index I of documents submitted by Mitch Zeller. This was provided to this committee by the FD,a. Have you seen this correspondence? This was attached to your correspondence, the FDA's correspond- ence to us. Ms. PORTER. I don't dispute that it was. I haven't personally re- viewed this list. Mr. Cox. But you don't know about this matter, Mr. ZELLER. Mr. Cox, can I attempt to shed some light on this7 Mr. Cox. Ms. Porter, when documents are withheld from this committee, is that something you'd be made aware of?. Ms. PORTER. I supervise the advice given with respect to docu- ments that are furnished and documents that are subject to some claim of confidentiality. Mr. Cox. Because this list was made available to the committee to explain to us why documents that Congress has requested can- not be provided by the FDA to Congress because they are covered by a protective order. We have been denied access to these very same documents. Mr. ZELLER. Mr. Cox, could I please try to answer the question7 Ms. PORTER. I'm going to change the direction. My understanding is with respect to these documents, and Ms. Thompson can elabo- rate, that the committee was advised that the documents were sub- ject to a court order and that there was a procedure, if the commit- tee so desired, for pursuing access to those documents. I may be not remembering correctly. I don't have the correspondence in front of me. Mr. Cox. So you are, in fact, generally familiar with these docu- ments and that they are subject to a court order. How did the FDA come into possession of these documents? Mr, BARTON. We're going to have to suspend in about 2 minutes in order to vote. There are 2 votes pending. So we won't be back for about 20 minutes. So if we could let the gentlelady conclude her answer and if Mr. Zeller would like to comment, then we'll have to suspend the hearing pending our 2 votes. Ms. PORTER. Mr. Cox, I do not recall personally reviewing this list. I'll be glad to go back and check the records to see if I did. I don't recall personally reviewing it. I don't have the letter in front of me. Mr. Cox. Mr. Zeller. Mr. ZELLER. Just on the last point and then when you come back, we can go through the whole history, if you'd like. We in. formed counsel for the subcommittee of the nature of those docu- ments and said that if the subcommittee was interested in pursu- ing their access to them, that they could be made available for their viewing at our offices and that if, after viewing them, you
Page 91: TI14380199
174 wanted to take possession of them, we would deal with it at that point. So given the nature of the documents, we let you know of their existence and that instead of sending you copies, if you wanted to come out and look at them, you could. That's the way we left it with staff. Mr, Cox. Yes. Frankly, I haven't any beef with any of this. It is perfectly appropriate, if documents are covered by a protective order of the court, to keep them from people, including the Con- gress. My only point is that this is how we were made aware that you got documents in violation of a protective order and in the ear- lier matter where the FDA provided documents in violation of the protective order to plaintiffs' lawyers, the FDA is now in court ar- guing that these plaintiffs have a duty, an ethical duty not even to read the documents and to return them forthwith, whereas the FDA has quite obviously used those documents. Dr. Kessler himself has reviewed them, according to you, Mr. Zel- let, and they are the basis for starting an internal investigation within the FDA that is furthering the agenda of the very plaintiffs' lawyers who leaked them in violation of the protective order in the first place. Mr. ZELLER. Let me say one more thing for the record. Mr. BARTON. This is going to be the last thing before we recess. Mr. ZELLER. It's essential to state for the record that those docu- ments arrived unsolicited and that I did not in any way induce or request documents that, in fact, I did not even know I was going to be receiving. Mr. Cox. But you did know, Dr. Kessler and Mr. Zeller, that they were in violation of a protective order. According to the General Counsel of the FDA, in her earlier sworn testimony today, the obli- gation of people receiving information in violation of a court order is to send that information back unread, and that's not what hap- pened in this case. Mr. ZELLER. I saw several documents marked with an MDL num- ber and stamped confidential. That's all I know. Mr. BAt~TON. We're going to recess. Before we do, though, Dr. Kessler, I need some advice from you. You had indicated you want- ed to leave here at 2 p.m. Mr. KESSLER. I have a 4 p.m. speech in New York. Mr. BARTON. In all due honesty, I must tell you that we have more than enough questions to go well beyond 2 p.m. and I would ask if you would be willing to stay. I'm going to give you, since you've been so gracious to come today, the opportunity to suspend. But if you do, we are going to have to continue this. We could come back tonight. You could fly back. Mr. KESSLER. I'd be happy to fly back and do it tonight. I can ~ive a 4 p.m. speech--if you can let me go give a speech and be ack tonight, I'd be happy to do that. Mr. BARTON. So your preference would be to-- Mr. KESSLER. I would be happy to go give the speech. It would be great if you would let me go give the speech. I'll get on the next shuttle and I'll be back here and I'll come sit here as long as you'd like tonight. 175 Mr. BARTON. So at 2 p.m., you wish to run hop on the shuttle, go to New York, give a talk, come back. Mr. KESSLEa. I'll give the speech. Mr. BARTON. At 7 p.m. Mr. KESSLER. I'll give the speech. The speech is a 30-minute speech. I've got to answer some Q's and A's from the audience. Mr. BARTON. Any chance you could do it by speaker phone? Mr. KESSLER. There are hundreds of docs that are there, I'd be happy to jump back on the next shuttle. I'll rush out, I'll jump on the next shuttle, and I'll come here directly. Mr. BARTON. All right. Then we will try to reconvene within the next 20 minutes for at least 20 more minutes. Then when you feel you have to leave, we'll allow you to leave, but we will reconvene this hearing later this evening. Mr. KESSI,ER. I'm just advised that there's one person-- Ms. THOMPSON. There was one person who was asked to be present to take questions, who, in fact, has patients scheduled this afternoon, who I don't believe could be here at 7 p.m. Mr. BARTON. Well, the most important person is you. Mr. KESSLER. I'll be here on the next shuttle after that speech, Mr. BARTON. The committee is recessed for approximately 15 to 20 minutes. [Brief recess.] Mr. BARTON. Would the subcommittee come to order so our wit- nesses and counsel could be seated as expeditiously as possible. The Chair would recognize the gentleman from North Carolina. Mr. BURR. Thank you, Mr. Chairman. In lieu of some of the formation that I heard in the last segment, Mr. Chairman, I would ask unanimous consent to revise your request of Dr. Kessler on the investigation to stipulate that that investigation should take place by an outside concern other than an internal investigation by the FDA. Mr. BARTON. Is it the gentleman's request that the Inspector General of HHS conduct the investigation? Mr. BUI~. That would be as good a suggestion as I could make, Mr, BARTON. I would like, Dr. Kessler, an opinion on that. Mr. KESSL~.R. I'm sorry, Mr. Chairman. My microphone wasn't on. That's perfectly appropriate. Mr. BARTON. Without objection, then so ordered. Mr. BUR~. Thank you, Mr. Chairman. Mr. KESSLER. Would you like me to start that or would you like to start that? I'd be happy to start that with the Inspector General, Mr. BARTON..l. don't know what the appropriate route is or if we should request the investigation together? Mr. KESSLER. I'd be happy to start it with the Inspector General, Mr. BARTON. And we will concur in your request. Mr. KESSLER. Thanks. Mr. BARTON. The Chair would recognize the gentleman from North Carolina. Mr. BURR. Thank you, Mr. Chairman. As I had the opportunity to listen to the job responsibilities of the individuals of the FDA~ it reminded me of a story of a man who called GM one day and asked to speak to the vice president in charge of headrests and the
Page 92: TI14380200
176 operator on the other end said is that the driver's side or passenger side. We certainly have a great deal of the same people involved in a number of different things and it seems that everybody's got a spe- cific title. I think that one of the reasons that we're here today, Dr. Kessler, is to find out where the accountability is. Quite honestly, I will ask you a question that I hope both of us know the answer. Does the U.S. Congress have the oversight responsibility for the Food and Drug Administration? Mr. KESSLER. Yes. Mr. BURR. So, in fact, Mr. Waxman's accusation that we had no right to be here to discuss these questions with you is, in fact, false. We do. We have a responsibility to the people who elected us to be here and to serve as your oversight body. Mr. KESSLER. Congressman, if you could just help me understand what the actual--I'm not sure what Congressman Waxman said, but if you can just help me understand what it was. I don't want to respond to something I don't know. Mr. BURR. I won't ask you to respond, but certainly that will be in the record and I will cover that with Congressman Waxman. In his absence, I don't want to make an accusation that's not 100 per- cent accurate. Dr. Alpert. Ms. ALPERT. Yes, sir. Mr. BURR. Sensor Pad. Ms. ALPERT. Yes, sir. Mr. BtmR. Quite honestly, if this product is used to perform a self..exam on a breast by any individual imaginable, can that indi- vidual damage themselves with this? Ms. ALPERT. The device itself won't damage the person, that is correct. Mr. BURR. The product itself. Ms, ALPERT, That's correct. Mr. BURR. That's correct. Now, Dr. Kessler, we would all agree that throughout this whole process that there have been some court proceedings, that there was a proceeding to question the FDA's classification of it as a medical device, that there was a pro- ceeding to appeal that to an appellate court and, in fact, the appel- late court ruled in the favor of FDA, and I think we would all agree with that. Let me reconfirm for just a minute that a meeting took place be- tween Dr. Yin and Patrick Nolan on May 23, 1991. Is there any dispute with that? Mr, KESSLER. I don't have the minutes, again, for the actual date, but I think we've already been over that. Mr. BURR. We have been over that, for the record. Dr. Kessler, what is the FDA's policy relative to meetings between parties while litigation or investigations are currently underway? Mr. KESSLER. You need to be a little more specific. Mr. BURR. Well, specifically, on February 25, 1991, oral argu- ments were heard by the U.S. Court of Appeals in Chicago, Illinois. On May 23, 1991, the FDA met with a minority stockholder of IPI. On September 10, 1991, the U.S. Court of Appeals upheld a sum- mary judgment, IPI requests a meeting concluding that with FDA. 177 Was there a proceeding ongoing during the time that that meet- ing took place? Mr. KESSLER. I'm sorry. I'm lost on the facts. Mr. BURR. Were you waiting for a Court of Appeals of opinion while Dr. Yin met with the minority shareholder, Patrick Nolan7 Mr. KESSLER. Were we waiting for the results of the 7th Circuit opinion? Mr. BURR. You have had the oral arguments at the U.S. Court of Appeals in Chicago on February 25. On May 23, the FDA met with the minority shareholder of IPI by the name of Patrick Nolan, Mr. KESSLER. Again, I don't have the dates. I'd have to ask coun- sel. I certainly wasn't aware we were waiting for the results of a Court of Appeals decision. Mr. BURR. Is there an FDA policy against that? Ms. PORTER. I'm~ Mr. BURR. I'm asking the Commissioner, please. Mr. KESSLER. Again, I'm trying to understand what.- Mr. BURR. I'm not looking for a legal definition of what hap. pened. I'm saying regardless of whether it's this instance or an- other one, Dr. Kessler, is there a policy that says that FDA officials cannot or should not meet~ Mr. KESSLER. In fact, I think there's a longstanding reg on the books that says that-- Mr. BuI~. Well, in fact, you responded to Dr. Coburn and said that because there was an ongoing investigation, you did not want to answer his question, that there was a policy or~ Mr. KESSLER. Excuse me. There is a very big difference, Con- gressman, between a 6(e) proceeding, a grand jury, involving crimi- nal, where there is a specific prohibition on talking. Mr. BURR. Is that specified in your FDA Agency policy? Mr. KESSLER. It's very clear that we will not-- Mr. BURR. Is that a written- Dr. KESSLER. [continuing] discuss things~ Mr. BURR. Is that a written policy for one of that nature and one of the nature that I'm talking about? Mr. KESSLER. It iS basic, rudimentary, anyone~ Mr. BURR. I'm talking about written FDA policy, sir. Mr. KESSLER. [continuing] not to discuss 6(e)? It's a~ Mr. BURR. No. Is there a differentiation in policy between a 6(e), and I have no earthly idea what that is, but I'll trust you that it's something a little more severe-- Mr. KESSLER. YOU don't do, right. Mr. BURR. [continuing] than would be the fact that you're wait- ing for an appellate court to make a judgment and you met with.- Mr. KESSLER. Completely different and I don't know what the policies say specifically. Mr. BURR. Should either happen? Should comment on one that's a 6(e) or should FDA have a meeting while a Court of Appeals is in their final decision-making process? Mr. KESSLER. There are certainly meetings that the agency has while proceedings are underway. I'd let counsel comment on the boundaries of those.
Page 93: TI14380201
178 Ms. PORTER. Certainly the chronology that you point out, I be- lieve, is correct, as between the meeting with the minority stock- holder and the Court of Appeals decision. I think that's correct. I'm sorry, but I'm not really understanding the import of your question. Mr. BURR. In every respect, for each of you, let me suggest that because that meeting, at the request of the President of IPI and the question that he raised, there was a letter of response by Patri- cia Bianchi. She is an integrity officer. Mr. KESSLER. Right. Mr. BURR. Define for me an integrity officer. Is that someone who looks into the possible question of ethics or improprieties in the actions of FDA? Mr. KESSLER. Yes. Mr. BURR. So someone at FDA interpreted the meeting for the May 23, 1991 as a possible ethics or questionable violation. Mr. KESSLER. If I'm right, there was a letter that came in~ Mr. BURR. There is a letter and let me read her response, if I could, Dr. Kessler. "FDA acted in good faith and in accordance with ~)hee Agency policy." That is what the integrity officer, Center for vices and Radiology~ Mr. BARTON. Would the gentleman~ Mr. BURR. I would ask unanimous consent that this be entered into the record. Mr. BARTON. I think we need to put it in the record if there's goin~,t.o be a colloquy on it between the Commissioner and commit- tee. without objection, so ordered. [The letter referred to follows:] 179 S~ ~ 5 ~:JZ .~:osidon=, Znvoncivo P.O. ~ox $1~ ~50 ~. ~o~ ~IS ~e~sr ~s ~n r~sponse ~ ¢~a~n ~s~ue~ ~hlch pro~p~4 your ~nvonClv~ Pro~u~' =LnoriCy mco~ol~*=~, Pmcci~ No~, yo~ ~ovtedqm. You note4 ".. ~lm c~* ot situation cou14 up all kinds of s.riou~ ~ms~iona ~u~ I~lcs, ~ln¢e ~ls oE policy (or lacR OZ polio) could le~d ~o Insider info~l~io~ ¢~ancel o£ ~A's ~Inq wi~ ~. Molan. i Said ~A'I pol~ Is ~ ~o dil~SJ lppllCl~ions Vi~ ~nyonl ~m~ you vould accompany hi= to ~a m*atinq. Accordin9 fai~ an~ in ~cco~ancu vl~ aq~ polio. ODE neC vi~ p~son who sa~d ~a~ hi vii a~ng ~n ~ of~:~al :apac~y on ¢O:p~'l b~llf. ~'y~ Gin lie ~EOI ~m i~U~II OE ~I ~I~ ~ hivl ln¢~ol~, no ~£onl=~on val disclosed ~st Vll ~o~ yo~ comply. ~Iss l~au~ and fo~d ~at o~ ~edom of In~o~n O~f~cer had vi~ ODE. Yo~ p~na~ c~plain~ v~s ~8C y~ be%lev~ lnappropr£eca and "threatening." Again at~or soma ln~irles CO meecing~ vi~ companlem ~an havo be*n ~e sub~eCC of past
Page 94: TI14380202
180 to dll:usl t~tu~e ~ketln~ o~ yo~ pr~u~ ~s an ed~t~onal ~ ho~ ~a~ ~ ~ve an~srsd yo~ ~as~lo~ and ~ul~ll~ 181 Mr. BURR. My question is, Dr. Kessler, given that we have estab- lished that there should be or there is a policy, and certainly Patri- cia Bianchi's letter suggests that there is an Agency policy, that her assessment or the internal investigation by FDA concluded that this was an act in good faith and it was in accordance with the Agency's policy, which would lead one to believe that the Agen- cy's policy is that there is absolutely nothing wrong with the FDA meeting with parties that you currently have under investigation or in litigation. In this particular case, it was with the Court of Ap- peals process. Ms. PORTER. That's correct. There is nothing wrong with meeting with such parties. Mr. BURR. So we have gone 180 degrees from where we were. There was a policy, now there's not. Ms. PORTER. The policy that we testified earlier to, Mr. Burr, I believe was the policy consistent with the Justice Department of not commenting on ongoing criminal investigation. Mr. BURR. I'll allow you the wiggle room on that, but I believe that we were more specific in how we covered May 23, Dr. Kessler, in your June 29 memo to all FDA employees, you declared, "Given our special responsibilities, all FDA employees must make every ef- fort to avoid even the appearance of unfairness or retaliatory ac- tion." According to the notes of the July 24, 1995 FDA conference call, Associate Commissioner for Regulatory Affairs Ronald Chesemore indicated that, '~ro the untrained eye, the chronology in the Sensor Pad case looks vindictive." Since Mr. Chesemore has indicated that it looks vindictive, don't you agree that the FDA did not make every effort to avoid the appearance of unfairness or retaliatory ac- tion in the Sensor Pad case? Mr. KESSLER. I'll let Mr. Chesemore comment. You're quoting his words. ~ Mr. BURR. Am I quoting your words incorrectly, Mr. Chesemore? Mr. C~SEMORE. My words had absolutely nothing to do with this meeting that you just previously referenced, Mr. Burr, Mr. BURR. I have switched to another memo of Dr. Kessler's and I am using your first assessment of the chronology, of events of the Sensor Pad, and I believe that--you never made this statement? Mr. KESSLER. Congressman, let's go through the chronology. Again, as I understand it, Grant Wright complained~ Mr. BURR. No. I'm talking about the chronology of contacts~ Mr. KESSLER. But, again~ Mr. BURR. [continuing] over a 10-year period, and I think Mr, Chesemore's reflection was-- Mr. CHESEMORE. Congressman, if I could. My reflection is not on the 10-year period. Those comments~ Mr. BURR. A specific instance. Mr. BARTON. Would the gentleman yield? Has the chronology of contacts been ~put into the record? Mr. BURR. It has not and I would ask unanimous consent that it be entered. Mr. BARTON. Without objection, and a copy given to the FDA and to the minority. [The chronology of contacts follows:]
Page 95: TI14380203
182 183 Chronologics~ Order of FDA Contacts on the Sensor Pad Feb 28, 1985 ....................... Initief Registration of Medical Establishment April |5, 1985 ...................... Submitted 510-l( submission April 29, 1985 ..................... Received DO Number of 510-K Submission May 14, 1985 .................... Submitted letter with Physician Study as requested per phone conversation Jur~e 4, 1955 ......................... received letter asking for written eva~uation from wel~-known physician September 28, 1985 ............. Submitted additional information as requested Hovember 12, 1985 .............. Received letter asking for written evaluation from well-knoWn physician November 13, lgg5 ............ Submitted letter with additional informetion December 13, 1985 .............. Received totter asking for labeling changes to obtain substantial equivalence for Prescrip- tion Device Ja~luat7 13 & 14, J986 ........ Meeting in S~lver Spring, MD to discuss letter of December 23 JenuaP/29, 1986 .................. Submitted protocol and Test Models for additional Study as requested Pebruo~ 13, 1986 ................ Apdl 28, 1986 ...................... June 4, 1986 ......................... June 17. 1986 ....................... June 25, 1986 ...................... Jenue~ 2. 1987 .................... Janua~ 9, 1987 ................... Janue~ 21, I987 .................. Februaq 1988 .................... Janue~ 1, 1989 .................... Februa~ l, 1989 .................. April 17, 1989 ...................... Ap~I 18, 1989 ...................... April 26, ]989 ..................... May 17, 1989 ....................... May 18. J989 .................. September 19, 1989 ............ June 14, 1990 ..................... Ju~y |9, 1990 October 29, 1990 ................ Janua~ 31, 1991 Februaq 25, 199] ................ May 23, 1991 ..................... September 10, 199l ............. Match 2, [992 .................... August 10, 1992 ................... October 6. 1992 .................. Februar/29, 1993 ................ November 23, 1993 Janua~ 18. 1994 ................ Februar/28, 1994 ................ Ma~h 8,1994 .................. July 8. 1994 Ju~ ]8, 1994 ................. September 1, 1994 .......... October 7, 1994 ................ July 19, 1995 .................... July 20, 1995 ........................ luly 25, 1995 ................... August 30, 1995 .................. September 20, 1995 ............. Submitted additional $enor Pads as requested Submitted letter to find out what was happening Received letter to Indicate will be receiving "Not Substantial Equivalence" letter Submitted letter to confirm meeting on June 25 to discuss entire matter Meeting in S((ver Spring, MO with/OA Letter from FDA requesting revision of protocol Conference Telephone call with FDA to discuss Januar/2 letter Letter from F0A requesting revision of protocol {During this time, decision was made to go to market with the Senor Pad since IPI believed it was not a medical device) On site visit to IPI by Mark G. Petereon. FDA Inspector Letter sent from attorney asking legal status of product H. Earl Wright received Inventor of the Year Award for the Sensor Pad from intellectual Properties, Washington. DC FDA litigation begins with seizure of entire Sensor Pad stock IPI tiled claim to Articles under Seizure IPi filed answer to F~A Complaint denying allegations that Sensor Pad is a "device" within FOA jurisdiction FDA filed Comp)aint for aeizure and condemnation of SensOr Pads FDA filed Motion for Summnr/Judgement--US District Court--Danville, IL. Summer/Judgement Granted to FOA by Judge Harold A. 8eker, US District Court, Danville IPI tiled notice to appeal with US Distnct ceud--Tth district--Chicago. IL Reply brief flied by IPI Hntzce of Orat Arguments Oral Arguments--US Court of Appeals. Chicago. IL F0A meets with minority stockholder of IPI. Company bed no knowledge meeting took place and is in lihgation with Agency US Cou~ of Appeals upholds Summa~ Judgement IPI requests meeting with FDA Advisor/panel to discuss this entire matter and find nut what can be done to get the Sensor Pad back on the market Complaint tiled with Oepattment of Ethics & Program Integrity concerning meeting of May 23, 1991 Meeting w=th FDA concerning product Complaint filed concerning meeting of August ]0, 1992 Section 305 r~otice filed Meeting in Silver Spring, MD with Dr. Alpert & Ob/Gyn Division IPi letter to Dr, AIpert IPl letter to Dr. AIpert regarding meeting o| March 8. 1994 Meeting with Ob/Gyn Oiviszon regarding proposed study Letter from Colin Pollard regarding September 1, 1994 OB/GYN Device panel meeting IPI letter to Colin Pollard verifying presence at meeting Meeting with OB/GYH Dewce Panel IPI totter to Dr. Alpert to thank for meeting of September | and her conversation with John- son end Johnson end Merck Since then numerous phone coils and meetings regarding study protocol Meeting with FOA--agreea to review 5]0K within 60 days Were reformed by Subcommittee that in reviewing our FOA records, FOA hod actually decided on action 2 years earlier, but had never notiflied Senor Pad Hearing before O&l Subcommittee. US House Committee on Commerce Phone conversation concerning possible study--no reason given for turning down a protocol that had been submitted July 19 Wright was told he would receive a letter within a week explaining why they would not 5tOK the product Week of September 25. 1995 November 6. 1996 ............... Talked on phone with Dr. Kimber Richter of ODE and was told that they would not allOW post-market study Dr. AIpert and Diane Thompson met with both majority and minority staff to discuss the ap. provel process Mr. BURR. Dr. Kessler, we discussed-- Mr. BARTON. The gentleman's time has expired. I will allow the gentleman 1 or 2 more questions, but Dr. Coburn has been waiting very patiently and since Dr. Kessler has to leave--- Mr. KESSLER, Two o'clock Hight. Mr. BARTON. Your plane leaves at 2 p.m.? Mr. KESS~.ER. The shuttle Js a 2 p.m. shuttle. Mr. BURR. I would yield back, Mr. Chairman. Mr. BARTON. Then I'm going to recognize Dr. Coburn. I thought we had you until 2 p.m. Mr. KESSLER. No, no. There's a 2 p.m. shuttle. It's 4 p.rn.~you're being,very kind, Mr. Chafrman, and I appreciate it enormously, There s a 2:30 p.m. shuttle, also. So just send me off whenever and I'll run as fast as I can. Mr. BARTON. Let's let Dr. Coburn ask a qu~ck 10 minutes of questions. Mr. COBURg. Thank you, Mr. Chairman, and thank you, Dr, Kessler. In preparing for this meeting today, did your Agency spend any money on outs£de sources to prepare you for this tesLi- mony? Mr. KESSLER. Outside sources. Mr. COeORN. Outside of the FDA. Mr. KESSLER. Let me just think through that. I don't think any xeroxJng costs. We had a lot of documents. Mr. COeUR~. W~th the exception of documents or table presen- tations or anything. Mr. KESSLER. No. Mr. COSURN. Did you all have outside consultants help in pre- paring for this testimony? Mr. KESSLER. No. Mr. COSURN. Thank you. Mr. KESSLER. The people around the table are the ones who helped, and others w~th~n the Agency. Mr. COBURN. I want to address something that has concerned me since I've been in Congress and every time I meet with a medical device manufacturer or a drug manufacturer, here is some informa- t£on, Mr. Congressman, but make sure you don't know where IL came from because we don't want that being attributed to us be- cause it may cause us problems. That may be a very unfair characterization of the FDA, but nev- ertheless it is a common statement that I receive. Does that con- cern you? Mr. KESSLER. Absolutely. Mr. CosoP~. How do we solve that problem? Is that an absolute misperception or is it a true perception that's not based on fact? Mr. KESSLER. Well, we need to sort ~t out. There were specific al- legations of retaliation and~ Mr. CosuP~. I'm not talking about~ Dr. KESSLER. [continuing] fear of--and I've heard it, too, Con- gressman, and it's something that we need to work on and we need
Page 96: TI14380204
184 to do better. I think there is always going to be a reluctance on the part--whenever you deal with a regulated body about--talking against---what's a good example--talking against the IRS. There's always going to be, hey, is that--I understand those concerns. We need to work very hard at overcoming that. If there are facts and legitimate facts that we've messed up, I need to know about it and I want companies to bring that in. Mr. COBURN. I understand your concern, but what I really want to deal with--you've made a lot of changes to FDA to make it more responsive, to try to address certain issues. Mr. KESSLER. Right. Mr. COBURN. Have you done anything with inside the Agency to make sure that people far down the line from you are, in fact, not creating that impression? Do you have an internal organization that goes around and prevents that in anticipation for this not to be a problem? Has it become enough of a problem to you that you have done something institutionally to make sure that the people under you don't, in fact, create that impression? Mr. KESSLER. We've done it through a number of different--we work very hard in our training. Mr. COBURN. Would you outline for me, very quickly so you can catch an airplane, what that's been? Mr. KESSLER. Sure. In the end, it's going to come from training. It's going to come from role models and the higher-ups setting the tone. It's going to come from setting up the offices so companies can feel free to come in and talk confidentially and know they'll be pro- tected. And it's also by setting up an Office of Internal Affairs so that if there is wrongdoing, that we will quickly and swiftly deal with it. There are all those issues, but, you're right, it's training and it's leadership at all levels of the Agency. Mr. COSURN. Would it be wise to have people on the outside that are only known by you to work and assess how the FDA actually interacts with these private companies, so that you could have an outside source that you absolutely trusted to give you an assess- ment? My experience with the FDA was not a fun one in terms of my manufacturing experience, because I found them terribly abu- sive and harassing. I mean, these are my personal experiences. If I questioned anything, all it did was cost me more time, more labor, and delayed my approval process. That's my experience and that's 20 years ago and I admit, you had nothing to do with that. But would you not find that if we could create a better atmosphere, with less fear and more coopera- tion, that we, in fact, might make your job easier and the cost of bringing new products to market? Mr. KESSLER. Absolutely, Congressman. We've had a number of grassroots meetings with the device industry. I just sat down with a group from the southwest, talking on how we can deal with a number of those issues. You're exactly right on communication and openness and we certainly can do better and we need to do better in those areas. Mr. COBURN. One last question and I'll finish up. Congressman Dlngell was instrumental in creating an Office of Criminal Inves- 185 tigation for you or there became an availability through statute that you could have that, is my understanding. Mr. KESSLER. Certainly this committee played a role and we cre- ated that office, yes. Mr. CoBURN. IS there any areas of criminal investigation that that office is not, under statute or under your interpretation of what it's supposed to do, off limits? Mr. KESSLER. Say it more specifically so I understand. Mr. COBUP~. Are there any areas of criminal investigation that that office won't investigate; in other words, that are beyond the scope of that office? What are the limits is I guess is what I'm ask- ing you, for my knowledge. Mr. KESSLER. I'd be happy to supply for the record, Congress- man, very detailed-- Mr. COBURN. Would you do that for me, please? Mr. KESSLER. I'd be very happy to supply that. [The information follows:] FDA OFFICE OF CRIMINAL INWESTIGATIONS The Food and Drug Administration's Office of Criminal Investigations {OCI) was formed in March, 1992. OCI conducts criminal investigations relating to violations of the Federal Food, Drug and Cosmetic Act (FDCA) (21 USC 321 et eeq.), Federal Anti-Tampering Act (FATA) (18 USC 1365), other applicable Title 18 offenses and violations of other statutes enforced by the FDA. The special agents, of OCI are charged with investigating all alleged criminal vio- lations within FDA s jurisdiction. These violations range from counterfeit, unap- proved and illegal drugs or medical devices; product substitution; counterfeit steroids and steroid substitutes; health fraud and health care fraud; application fraud; prescription drug diversion; and manufacture or distribution of adulterated or misbrandedproducts, such as the recent OCI investigations related to the mant~- facture and counterfeiting of infant formulas. OCI is charged with enforcing the Federal Anti-Tampering Act and currently, in- vestigates allegations of product tampering such as the 1993 Pepsi tampering hoax involving syringes in Pepsi products. Tampering with products and/or making false tampering claims are felony violations of the Federal Anti-Tampering Act, If in the course of an investigation OCI uncovers evidence of employee rots. conduct, OCI notifies and works with the Office of Internal Affairs (OIA). Mr. COBURN. Thank you. And I said there was one last one, but let me give you my last last one, if I may. Are you aware of the fact that there's an internal Justice Department investigation on possible prosecutorial abuse associated with the Burzynski case? Mr. KESSLER. I'm aware the chairman sent a letter and I became aware that it was referred to the Office of Professional Responsibil- ity. That's what I'm aware of. Mr. COBURN. Thank you. Thank you, again. Mr. KESSLER. Thank you, Congressman. Mr. BARTON. The Chair is going to recognize Mr. Dingell for the final round of questions before 2 p.m. Mr. DINGELL. Doctor, were therapeutic claims made in connec- tion with the Sensor Pad in the initial application? Mr. KESSLER. Dr. Alpert. Ms. ALPERT. The exact claims were very confusing in the early interactions with the company in terms of whether it was intended to establish that the sensor pad did better than the bare hand, and that was the implication in much of the submitted materials, Mr. DINGELL. Would you submit them to the committee, please, so that we could see what they were?
Page 97: TI14380205
186 Ms. ALPBRT. I believe they have been submitted, but we can sub- mit them for the record. Mr. DINGELL. Were those claims changed as~ Ms. ALPERT. Yes, sir. Mr. DINGELL. [continuing] the process went forward? Ms. ALPERT. Yes, sir. Mr. DINGELL. Now, were there any suggestions made that the Sensor Pad would do better than the bare hand? Ms. AbI~EI~T. This is part of what was confusing. There were statements made, there were representations made, and there were attestations made by users to us that, in fact, it was better and they were submitted to us by the company. Mr. DINGELL. They were made to you by the company. Were those allegations ever proven? Ms. ALPERT. Not in a scientifically valid method. Mr. DINGELL. Why do you say that? Ms, ALPI~RT. We have been waiting to receive a study which measures whether or not there is masking of detection by the Sen- sor Pad versus the bare hand or if, in fact, the Sensor Pad makes a more sensitive examination. We have not received such a study. Mr. DINGELL. Was that requested of the applicant? Ms. ALPERT. Yes. That's been the subject of repeated discussion. Mr. DINGELL. And it's not been submitted. Ms. ALPERT. I have not myself walked through or know whether the most recent submission has been in. It has been indicated by Mr. Wright that there will be such a submission. Mr. DINGELL. I was under the impression, when we got into the discussion of the use of rubber gloves, that rubber gloves were used in the examination in the doctor's office or in the hospital or in the clinic or wherever it might happen to be. That is not true? Ms, ALPERT, Not for breast examinations, generally. Mr. DINGELL. Now, why are they not used for breast examina- tions? Ms. ALPERT. Generally, examination gloves are used when you're going to be contacting either contaminated or infectious materials. Mr. DINGBLL. But is there a reason why rubber gloves are not used in a breast examination at a doctor's office? Do they increase or decrease the sensitivity, according to the literature and accord- ing to the views of the doctors? Ms. ALPERT. Doctors and surgeons complain that using gloves de- creases their sensitivity and the manufacturers have tried to ad- dress that. Mr. DINGELL. That's what the doctors think? Ms. ALPERT. Excuse me? Mr. DINGELL. That's what the doctors think? Ms. ALPERT. The doctors sense that they lose sensitivity by wear- ing gloves, that's correct. Mr. DINGELL. You said that no study has been submitted by the applicants with regard to this matter to establish that increased sensitivity results~ Ms, ALPERT. As I said, the most recent 510(k) that's coming in or has recently arrived, that's still to be looked at. The studies that have come in~ 187 Mr. DINGELL. You say they have submitted or have not submit. ted? Ms. ALPERT. Not as of Monday when I last spoke with Mr, Wright. He told me it would be sometime this week. There is a study, a physician use study in the 1993 510(k). Mr. DINGELL. I read this sentence. "In the company's literature, women are told that with the Sensor Pad, they will be able to feel a grain of salt on the table that they wouldn't be able to feel other. wise." Is that true? Ms. ALPERT. That is a claim the company makes. Mr. D]NGELL. It's a claim the company makes. Has it been sup. ported by any documentation in any application made by the peo- ple who are seeking approval of this device? s. ALPERT. I actually don t remember whether it was submitted m any of the applications. Mr. DINGELL. Would you submit that for the record, please? Now, the FDA held its advisory committee meeting, as you will recall, and a representative of the National Women's Health Network tes- tified and expressed some concerns about the Sensor Pad. In light of your recent re-review and your plans to review some of the new clinical information, would you tell us what you will be looking for to respond to these concerns? Most specifically, the Women's Health Network stated, "A device that aids in breast self-exam needs to be safe. A crucial component of safety is proof that the device does not mask lumps that would otherwise be felt." Is there any information to provide that sort of proof?. Ms. ALImEnT. That is what has been lacking in the submissions and has been the focus of our discussions with IPI. Mr. DINGELL. The network also stated that such a device needs to be effective and provides benefit to the woman. Such a benefit, they argued, would have to be defined by the manufacturer and needs to be proven by the manufacturer. Is that in conformity with the law, as you understand it? Ms. ALPERT. Yes, sir. Mr. DINGELL. For example, the manufacturer might claim the de- vice will make it more likely a woman will perform breast examina- tion or that this examination will be better. Is FDA looking for this type of proof and how would these claims be l~roven? Ms. ALPERT. The claims would be proven by studies done in the field with women performing breast examinations and monitoring whether they continue to do those examinations. Mr. DINGELL. Have such studies or has such a study been per- formed? Ms. ALPERT. Not that study. Mr. DINGELL. Not that study. In its testimony, the Women's Health Network stated that the Sensor Pad manufacturer, in some of its marketing materials and in some press statements, talked about saving lives. Also, the company had claimed that with the Sensor Pad, somebody could feel a grain of salt on t~m table, as I've referred to, implying the device allows a woman to feel something with the Sensor Pad that she cannot feel without it. Have these claims been discussed with the manufacturer? Ms. ALPERT. Yes, they have.
Page 98: TI14380206
188 Mr, DINGI~LL. What was the result of that? Ms. ALPERT. Those are, again, claims that we feel need support- ive information, studies and data, and we have not received that data. Mr. DINGELL. You have not received the data. Have you talked about the kind of consumer information that would be provided with the Sensor Pad when it does go on the market? Ms. ALPERT. Yes. Mr. DINGELL. In other words, labeling and package inserts and things of that kind. Ms, ALPERT. Yes, sir. Mr, DINGELL. Would FDA try to prevent misleading claims that cannot be backed up with the facts? Ms, ALPERT. Absolutely. Mr. DINGELL. Isn't that a responsibility under the law of the Food and Drug Administration? Ms. ALPERT. Yes, sir. Mr, DINGELL, To deal with the question of false and misleading advertising and false and misleading claims. Ms, ALPERT. That's correct. Mr, DINGELL. As a matter of fact, under the amendments, as I remember, the device must be not only safe, but it must also be effective. In other words, it must do what it's advertised to do. Is that right? Mr, KESSLER. The medical device amendments. Ms, ALPERT. The medical device amendments of 1976, yes, sir. Mr, DINGELL. Thank you, Mr. Chairman. Thank you. [The following information was received for the record:] 11122/95 DRAERD CIL4.NGES IN LABEL[NO CLAIMS FOR SENSOR PAD I. Premarket Notification #K85-1700 (April 15, 1985 a. Labeling claims For Breast Self-Examination New Senso-TouchTM Sensor Pacl~ {Over the Counter Use} Aid for Early Detection of Breast Lumps Sensor padTM heightens the sensitivity of your touch. b. Promotional material The promotional material states that "the pad is designed so that the bot- tom lies on the surface to be examined, stabilizing the area under it. The top section is then moved over the bottom section with finger tips. The liq- uid in the pad provides the slip, and assures good finger tip contact". It also, gives the incidence of breast cancer in US and discusses the impor- tance of self-examination of breast and early detection of breast cancer (im- plied claim for the detection of breast cancer). 2. The following product labeling and promotional material cited in the memoran- dum of support of plaintif'f s motion for summary judgement in the U.S. District Court (US us 25 cases of devices No. 89-2114, July 1989). a. Labmling claims Sensor Pad is intended to aid in breast examination by enhancing the ex- aminer's sense of touch and ability to detect changes in the breast. b, Promotional Material Promotional material claims that Sensor Pad makes what ever is under- neath "feel larger" and that: 189 when you.., press firmly on the PAD you change the surface you are ex- amining. You no longer examine the surface, but the underlying tissue. The bottom layer of the PAD stabilizes the area being examined. When the top layer is pressed over it, unstable areas such as growths do not move and can be readily examined. 3. Premarket Application # P89.0052 (September 28, 1989) a. Labeling claims Aid for Breast Self-Examination For use as an adjunct to breast self-examination (The submission did not specify OTC or Prescription) b. Promotional Material The promotional material states that sensor pad is designed for use as an adjunct to breast self-examination. It decreases friction thereby increasing hand movement and eliminating the necessity to perform the examination in the shower. It provides a more comfortable and convenient way for con- ducting breast self-examination because it can be performed at any time and the hand does not come in contact with the breasts. 4. Product labeling and Promotional Material cited in the brief court case No, 90. 2599. October 4, 1990. a. Labeling claims A device for aiding in breast self-examlnation, and stresses the importance of regular Breast Self-Examination as a way to protect against breast can- cer. b. Promotional material Promotional material also claims that Sensor Pad makes what ever is un- derneath "feel larger" and that: when you.., press firmly on the PAD you change the surface you are ex- amining. You no longer examine the surface, but the underlying tissue. The bottom layer of the PAD stabilizes the area being examined. When the top layer is pressed over it, unstable areas such as growths do not move and can be readily examined, 5. Premarket Notification #K93.0308 (January 14, 1993) a. Labeling claims Lubricating aid for breast self-examination (Prescription Device) b. Promotional Material The promotional material states that sensor pad is designed to provide sim- ple, convenient, dry method for reducing friction between the finger tips and the breast during breast self-examination. It includes general guidelines for breast self-examination using the sensor pad to detect breast lumps or hardness, however, contains a disclaimer statement which states "This product makes not explicit or ~mplied claim to find breast cancer, breast lumps, or any other type of breast disease". 6. Premarket Notification #K95-5094 (Received November 7, 1995; SE on November 9, 1995). Device name changed to "Examination Pad." Submitted as an accessory to diagnostic ultrasound. a. Labeling claims The pad is indicated for professional use only as a lubricating aid for palpa- tion in the examination of soft tissue. The device is explicitly not intended for personal use. Labeling is silent on the use of the device for examination of the breast. 7. Premarket Notification #K95.5249 (Received November 15, 1995; currently under review), Device name changed back to "Sensor Pad." Submitted as an accessory to mammographic x-ray system. a. Labeling claims The Sensor pad is indicated as an aid for performing breast self-examina- tion using a standard breast self-examination technique (prescription use). b. Promotional material None submitted.
Page 99: TI14380207
190 Mr, BARTON. I thank the distinguished gentleman from Michi- gan. Dr. Kessler, if you need to leave now, I would like--you're al- lowed to leave. I want some of your people to stay because I want to put some things into the record and prepare the groundwork for the next hearing. In consultation with the minority and the members of the major- ity, although you're willing to come back this evening, we've de- cided to continue this hearing on November 29, when the FDA is already scheduled to be here on a censorship hearing. While you have not committed to come to that hearing, we would certainly en- courage you to come. Mr, KESSLER. And I~ Mr. BARTON. Just let me conclude. We understand that you've brought people from outside the Washington, D.C. area that may not be able to come back, specifically your folks from the Seattle office, and we will work with minority and majority staff, if not ev- eryone who is here today can come back, that we can mutually agree on a subset of individuals to be here. There is tremendous information yet to be gone through on to- day's hearing. I want to put some things into the record and t~ut some information into the record about what we hope would be in- vestigated in our next hearing. You're welcome to stay for that or if you need to leave, you're certainly more than welcome to do that, because we said by 2 p.m. we would allow you to go catch your shuttle. Mr, KESSLER. Let me just understand, to follow-up. You're very kind. On November 29-- Mr, BARTON. We have a hearing notice for the FDA on November 29, Mr, KESSLER, I wasn't planning to be here. In fact, I think I have a commitment elsewhere on November 29. What were you saying you wanted to do? Mr. BARTON. Earlier, before we recessed to go vote, you indicated you would go do your speech and come back. Mr. KESSLER. I'd be happy to come back. Mr, BARTON. So I checked with minority counsel and majority counsel and members and our last vote is expected to be around 6 p.m. this evening. Since we have so much to go through, we de- cided since we already have an FDA hearing scheduled, I believe, on November 29, that we will just continue this hearing on Novem- ber 29 and combine it with the hearing we were going to do on FDA censorship. We understand that you brought people not just from the Wash° ington, D.C. area, but from the outlying regions and some of them may not be able, because of expense, to come back. So we would work with you or your designee to determine who should come back for the November 29 hearing. We hope that you can. Mr. KESSLER. I don't know what time. I know some things are on my schedule for November 29. I don't know. Mr. BARTON. Well, I thought it might be advantageous to, since you were willing to, to suspend, come back this evening and go to midnight. Mr. KESSLER. I certainly was willing to do that. 191 Mr. BARTON. In consultation with both sides, we decided that that's not the best course of action. Mr. KESSLER. Sure, and I certainly respect that. I guess the question is leaving folks to continue here and on November 29. That's what I'm trying to----- Mr. BARTON. Just for example, I've only asked one round of ques- tions. Mr. KESSLER. Sure. Mr. BARTON. I've got numerous questions and I'm going t_o_ put some of those questions into the record. So you and your staff can have the opportunity to prepare answers. We've got some docu- ments that we're going to put into the record, again, so that the FDA can review those documents. But we cannot conclude this hearing today and while we perhaps could this evening, we don't think it would be appropriate to do so this evening, stipulating that you were willing to come back, which I admire. So we're going to continue this hearing on November 29 and com- bine it with the censorship FDA issue hearing and hope that you personally will be available on November 29, acknowledging that we had not asked you personally to be available on November 29. Now, unless you have some questions about that, I'm going to put some things into the record at this point in time. Mr. KESSLER. Thank you very much. Mr. BARTON. On the Myo-Tronics case, we're going to put into the record an E-Mail from Pat Bianchi, dated March 20, 1995; a March 6, 1995 draft conflict of interest review of Dr. Bertolami's potential conflict of interest; a December 9, 1992 memo from Greg Singleton; a June 13, 1994 E-Mail from Dr. Singleton to Rich Andros and others; December 7, 1994 letter from Susan Alpert to Dr. Robert Jankelson; a September 25, 1995 memo to the file from Karen Schifter. The copies will be made available to the FDA offi- cials and to minority staff. [The material referred to follows:]
Page 100: TI14380208
192 193 S~b.~e~=~: Dr. ~e~'~col~ and 3e££ GL~be v~ol~:lons of key ~s so~ap~c d~. pro~s~ vo~ ~d ~ so~ -- Neu P~S~ ~ for ~aph 6: *For ~ AU~ ~ m~ ve Op~onal -- you ~ld also add ~ DRAFT CONFLICT OF ~ REV~ OF D~ BERTOLA~ After the ~ ~.leg~on, Ka~y Wad;m- ~Lked w~l~ Dr. ~ ~ ~ w~ ~'~ him how me mp~ ofj~t ~d ~ ~ w~ b~ ~ ~ ~ ~ H~ s~ of yo~ ~t ~ Hot ~ ~ ~ h~ ~, but ~ ~ ~ I ~o~d ndt'~-~'~ ~volv~. F~o~ h: no~ ~ ~ ~ ~ ~ ~ ~ ~ mov~ ~o ~fo~ ~ tg~ hc ~ no lon~ ~ ~ A~ b4t ~ ~ ~ he ~ J~ 26, ~989, he ~ f~m ~e ~ ~. * Dr. Beau ,I~." was appolnted u a ~amul~ ~ Z~//93, ~nd on 2/t 1/94 h~ re~ppoi~ d~c he ~bau~Icd z ~'¢i~d b?~,50~s/ndlawin~hc~u adL~:u~ofAnl~ck. " .
Page 101: TI14380209
194 195 • FL'~y, on a prc-mee~g ques~naai¢ (t0/4/94) he z~:o~zx/~ he wcs a holdrJ for Az~ru,~v 316195 c - • -' " :. • file c:'~wp5 l'~files'~bc.~.oms
Page 102: TI14380210
196 197 le~er hss been sen~ ~o ~he co=~8n~ reques~Ing ~he 8ub=~snion of LndLcs~ions. The PhysLo~ech 4000 Ls under~olnq ~ev~ew by ~he He~ro~o~ branch. ~n update o~ Lie #~stus can be obtained b~ contacting S~eve HLnck~ey a~ (~OZ) 4Z~-%044. lack of da~a suppo[~in~ safety and effectiveness wil~ ~ c~aJl I~ designation which ~u~d proceed through no~tce and co~nt. The devLce~ you,d then be on a hiqh c~llin~ ~or P~s. '
Page 103: TI14380211
198 199 Robert R J~J~k~n, DOS Myo-Tromc.~. Inc. I~42~ . ~3rd ^v~uc Tu~d~, WA 98188 ~t ~t m ~n~ ~ your Nov~ 4, ]~4 1~ ~ Dr. ~ RudhKton ~t ~ ~u=uo~ ~out ~c cl~=~on of m~lc mo~mdn~ d~ a ~c D~ P~ m~¢ held on ~to~ L3-L4. Yo~ l~ qu~on~ ~c ~y of ~c ~b~c nod~ (or ~= o ~¢ F~¢~ R~t~ Hods, ~ ~ [9. [~4. ~no~ ~e ~ [3-t4 D~ P~ ~ m~I ~d ~ ~= ~on o~ mom~onnl d~m ~ ~ ~ i~ ~= nog~ did not s~ w~ ~ ~n bch~ o~ ~ Dr. G~o~_S~n ~ ~¢ ind~ ~ d~ would no[ publhh~ ~ ~d~ ~ of w~ d~ ~ in~ud~ ~ ~¢ h~ of r~mm~do~ ~mm ~a ~m~ ~d m~n~, ~d FDA will pm~dc ~o~ dcvsc~, ~¢ ~on o~ m~c montto~nK d~i~ will ~ p[~ on ~= sch~ul~ ~or Ap~l [g-~0, ~Onllo~n~ d~l~ ~o~, ~¢ FDA will u~ ~c Icrmmology "d~romc dcvscc~ (or ~l~c diaCnofi$ ~or [r~tm~l o{ tcm~mmandibul~ o FDA inv(~ ~n~l~u ~ ad~ ~ m~n~ m give ~ ~ opinio~ or~s~a~. Con~l~m~~s~~ (om~ p~nct m=ndx=~;, a~d (4) R=~00~¢= m ~dv=d~m~u i~ ~f~ ~d ag~i~~ ~ ~ ~A~Dr. Mohl ~ ~ ~ ~I~ ~= h ~= ~ of ~m~ u a di~¢ in a ~1 ~ for ~ ~ m~l; ~o~ ~ did not p~dp~ ~ ~ ~ ~ ~ ~fi~ of For ~¢ Ap~l !~5 m~g, ~A addiQon, ~ o~ ~ ~ m~ p~ ~ ~ m ~y h~ who wish~ ~me ~ ~ ~ or who ~ w~ o~ who ~ qu~on~ ~t o Dr~ ~lmmi'+ +nl~ P~o~ m ~ ~ ~d m~, ~c ~ ~Hty ~ ~mmi~ di~osum tn+o~=~on ~ ~ Dm~ P~u~ P~ md no ~ ~n. Dr. ~l~ did n~ ~d~ ~ ~ ~ h~ p~ar ~un~on ~ ~ dm~ Fu~, tawsui~ invol~n~ ~e ~t ~ ~u~t un~imo~. Dr. ~i ~d not vo~ on th~ d~i~ ~ecter ~o Dr, Burtingmn. t h~ ~ ~ ~d~. con~c~ you to dis~s ~e u~K m~n~. Sin~y you=, C~ ~or Dcvi~
Page 104: TI14380212
20~ H~HO~AHD~TOTH~ONICS FILE Sep~e~ 25, 1995 ~1~ 22, 1994 ~ spoke ~o Ha~-~u oav~$ (CD~). I b~ough~ up the o~ ~hs del~y~ 510(k) on ~hs ~h~sio~ech 4000. She s~d ~i~ she spoke w~h Ml~qs Solo=on ~u~ ~vo weeks ago who said ~a~ application ~aa ~rd ~n ~e ~eu~ tot ~e r~v~ever. Solemn sa~d ~ha~ an application canno~ ~ advaDc~ ~n ~e ~eu~ ou~-ot because o~ ~h~s ~ssue. She sa~d ~hat she und~sto~ ~e qe~ ~lll thln tha~. She lald ~at ~he ~ouqht ~e dil~ict would h~ve been ~oae vindictiveness involv~ in ~e delay. O~o~ise Agency pollcy to ~tart at ~l M~la~. I al~o ~poka ~o Ric~ ~droa (S~-~). Ha dilagraa~ Schloss's opinion t~at ~e eventual approval o¢ ~e ~wo pr~uc~s during the peri~ before approval. H~ever, he a~ees to the curren~ delays in issuing the approval could ~ a prob1~. Regarding a reduction in ~e amount of the Zin~, ~os has no proOlem with any kind of mitigation. He sees it as ~e distrlc~'s role to mec~anically add up the violations and leave 5action 5lO(k) oF the Act requires each person who is daya before introducing the product into commerce. 21 U.S,C $ 360(k). That led at least one commentator to b~llava that, iF FDA took no action within ninety days, the company was free to £ntroducs the device into cousrcs. Lsflar, ~ Acco~n~bflf~v ~nd Hedfcal Devfce Re~la~fon, 2 Hazard J. of L. & Tach. 1, 28-29 (Spring 1989), More recefl~ly, however, a reg~iatlon was codiEiad stating, "Until the applican~ receives an may not proceed to aarket the device." 21 C~ S 807.100(a}(4). According to the preamble, this re~latlon codifies a provision ~ the Sara Medi=al Devices Ac~ of 1990 "that a device for which appoint r~lves an o~ from FDA decl~i~ ~l dev~ ~O ~ s~tantlally ~I~1~." 57 F.R. 51400, 58401 (~ lO, ~992). ~e provision ~n ci~ for au~ori~y p~id~ ~E, for ~sre to ~ s~s~antlal ~ivalance, ~e Secreta~ m~ fi~ o~" ~t ~e device has pa~i~lar ~a~Isti~. 21 O.S.C. S ~s0c(~) (~) (A). o~o~r 6, 1994 I sen~ ~ay I draft oE ~e le~Eer ~o ~-~u Davis. 0~0~ 26, 1994 I s~ke Eo Dav~s ~a~. She een~ ~e lS~E~ ~o B~lin~on's off~ce. She vii1 ~e~ on its s~. I sh~ld ~ ~'~. 201 January 20. 1995 I called Davis today. The letter made its way t~ough t.hl " Canter to Dr. Burling~on's office. He gueetioned why we wlre not going after the president and the guilty aes~rancm parson. Consequently, the file was returned to the dilILrlc~=. April 10, 1995 Gail 5c~merFeld received correspondence From James Woods forwarding a latter From Gibbs that among other things accused her o~ statlng that no civil money penalizes action would be filed. I called Woods and of Ferred my assistance including par~icipa~ion in conference calls evaluating whether ws should bring the case. I allO ipokl tO RicJ~ Andros who still supports the case, but understands that the Center might kill it. April 27, 1995 Per James Woods, CDRH has decided to withdraw this call for a "~rlad of reasons." Woods agreed to include ms on the distrzbutlon list on the w~thdrawal oemo. J~1~s 8, woods called. He IS responding to a Congressional inquiry and needed tO knOW exactly what Gail said regarding civil money penalties. I advised him that he needed to speak tO Gsil directly. J~L~a 15, 1995 I called Cap ~Idriks and gave him my name and nu~r. Hs promlsed to keep me apprised oF the developments. July 27, 1995 I ipoke to JeFf and Gail and offered my serviCeS in working on a r~P°~e to s CO~sIal°nIl
Page 105: TI14380213
202 Mr. BARTON. The questions that we want to continue to ask on November 29, we want to entertain some questions about the Of- fice of Internal Affairs, whether they have significant authority to do internal investigations as opposed to the Inspector General in HHS, We're going to entertain questions about the ombudsman's role, whether that office's role is significantly strong enough to serve as an outlet for internal and external complaints. We're going to consider questions about whether the existing ap- peal profess within the FDA by companies or individuals who feel rulings have not been appropriate, if that's effective, whether there needs to be an outside appeal process. And we are going to con- tinue to look into the 5 specific cases that have been mentioned so far in this hearing. Do any of the FDA officials wish to ask me any questions about what I've just indicate we hope to follow up on? Ms. THOMPSON. Mr. Chairman, can we get copies of the docu- ments you've indicated? Mr. BARTON. Yes, ma'am. That was stipulated in my request and you and the minority staff will get copies. We are going to, I guess, recess--do we recess this hearing until November 29? What's the correct protocol? Mr. DINGELL. If the gentleman would yield. Either is correct. It's the prerogative of the Chair to recess until that time or to an- nounce that there will be another hearing at that time. This is en- tirely the call of the Chair. Mr. BARTON. Then we will recess this hearing until the 29th of November. I want to thank the FDA officials for being in attend- ance today. [Whereupon, at 2:05 p.m., the hearing was adjourned, to recon- vene at the call of the Chair.] ALLEGATIONS OF FDA ABUSES OF AUTHORITY TUESDAY, DECEMBER 5, 1995 HOUSE OF REPRESENTATIVES, COMMITTEE ON COMMERCE, SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS, Washington, DC. The subcommittee met, pursuant to notice, at 10 a.m., in room 2322, Rayburn House Office Building; Hon. Joe Barton (chairman) presiding. Members present: Representatives Barton, Cox, Crapo, Burr, Deutsch, Waxman, and Furse. Also present: Representative Coburn. Staff present: Alan Slobodin, majority counsel, Cheryl Rayner Thomas, majority counsel, Reid Stuntz, minority general counsel, and Kay Holcombe, minority professional staff. Mr. BARTON. The subcommittee will come to order. This is a continuation of an oversight hearing of the Food and Drug Administration. We have with us today the Commissioner of the FDA, Dr. Kessler, and his associates. Dr. Kessler, as you know, it is the tradition of this subcommittee to take testimony under oath. You and your associateshad no ob- jection to that at the prior hearing. Do you or any of your associ- ates with you today have an objection today? Mr. KESSLER. No. Mr. BARTON. Everyone who is with you that you think may be asked to testify, would you all please stand and raise your right hand. [Witnesses swon,.] Mr. BARTON. Dr. Kessler, for the record could you read into the record each of the people that have been sworn or let them come to the microphone and give us their name and their job title within your agency, please. (203)
Page 106: TI14380214
204 TESTIMONY OF HON. DAVID A. KESSL]~R, COMMISSIONER, FOOD AND DRUG ADMINISTRATION, ACCOMPANIED BY BRUCE BURLINGTON, DIRECTOR, CENTER FOR DEVICES AND RADIOLOGICAL HEALTH; RONALD CHESEMORE, ASSO- CIATE COMMISSIONER, REGUI~TORY AFFAIRS; DIANE THOMPSON, ASSOCIATE COMMISSIONER, LEGISLATIVE FAIRS; MARGARET PORTER, CHIEF COUNSEL; MITCH ZEL- LER, DEPUTY ASSOCIATE COMMISSIONER FOR POLICY; GREG SINGLETON, DENTAL OFFICER, CDRH; JOSEPH LEVITT, DEPUTY DIRECTOR FOR POLICY, CDRH; LILLIAN YIN, CDRH; SUSAN ALPERT, DIRECTOR, ODE, CDRH; ROBERT SPILLER, ASSOCIATE CHIEF COUNSEL FOR ENFORCEMENT, OGC; EDWARD J. PARR, JR., TRIAL ATTORNEY, OGC; KAY COOK, ASSOCIATE CHIEF COUNSEL FOR MEDICAL DEVICES; AMANDA PEDERSEN, CHIEF MEDIATOR AND OMBUDSMAN; AND TOMMY HAMPTON, SPECIAL AGENT IN CHARGE, OF- FICE OF INTERNAL AFFAIRS Mr. KESSLER. Be happy to, Mr. Chairman. Why do.n't, we. start with Dr. Burlington and then people can join us from the back row. Mr. BUI~.t,INGTON. Donald Bruce Burlington, Director, Center for Devices and Radiological Health, Food and Drug Administration. Mr. CHESEMORE. I'm Ronald Chesemore, Associate Commissioner for Regulatory Affairs. Ms. THOMPSON. Diane Thompson, Associate Commissioner for Legislative Affairs. Mr. KESSLER. David Kessler, Commissioner, FDA. Ms. PORTER. Margaret Porter, Chief Counsel, Food and Drug. Mr. ZELLE~. Mitch Zeller, deputy Associate Commissioner for Policy. Mr. BARTON. We have got several people in the back. Mr. SINGLETON. Greg Singleton, Dental Officer with the Center for Devices and Radiological Health. Mr. BARTON. Dr. Singleton, are you from the Seattle office or are you here? Mr. SINGLETON. No, I'm right here. Mr. LEVITT, I'm Joseph Levitt. I'm Deputy_Director for Policy in the Center for Devices and Radiological Health. Ms. YIN. Lillian Yin. I'm with the Center for Devices and Radio- logical Health here in Rockville. Ms. ALPERT. Susan Alpert, Director of the Office of Device Eval- uation at the Center for Devices and Radiological Health. Mr. SPILLER. I'm Robert Spiller, one of the Associate Chief Coun- sel for Enforcement in the Office of General Counsel. Mr. PAm~. Edward J. Parr, Jr., Trial Attorney, Office of Chief Counsel at FDA. Ms. COOK. Kay Cook, Associate Chief Counsel for Medical De- vices. Ms. PEDERSEN. Amanda Pedersen, Chief Mediator and Ombuds- man, Office of the Commissioner. Mr. HAMPTON. My name is Tommy Hampton. I'm Special Agent in Charge of the Office of Internal Affairs, Food and Drug Adminis- tration. Mr. BARTON. I believe that's it. 2O5 Dr. Kessler, we received your opening statement at the last hear- ing. There is no need for an additional opening statement, but if you would wish to make some brief opening remarks before we begin questioning, you are certainly welcome to do so. Mr. KESSLER. No, Mr. Chairman. Mr. BARTON. There is no need for an opening statement on be- half of the chairman. Mr. Waxman, would you like to make a brief opening statement before we begin questioning? Mr. WaXMAN. Mr. Chairman, I gather last time we had this hearing with Dr. Kessler and the people from the FDA we had them here for 5 hours and we went through extensive questioning about these 5 cases. We are here again because Dr. Kessler had to leave, and as I understand it, members had more questions, So think we ought to get to the questions and get on with this hearing and let these people all go back to FDA and do their job. This seems to me an extraordinary amount of people that ought to be looking at drugs and devices and doing the people's business stead of responding over and over and over again to the same is- sues if we don't have new things to pursue. Mr. BARTON. We thank you. I think it is the responsibility of the U.S. Congress to conduct oversight and it is the responsibility of this subcommittee to do that task. There have been numerous alle. gations lodged against the Food and Drug Administration that it has been abusive of its power. There are allegations of retaliation, intimidation, harassment of various groups that the FDA regulates, and the only way to get the facts is to do these types of hearings, and I make no apology for that. The Chair would recognize Mr. Burr of North Carolina for 10 minutes. Mr. BURR. Thank you, Mr. Chairman. Dr. Burlington, could I ask you to let Dr. Yin sit at your seat, because I do have a couple of questions for her and I don't have any for you. Dr. Kessler, there was a tremendous amount of information that we covered at the last hearing. I certainly appreciate not only the time that you spent then but also the time now. Could I recap sev- eral things that I think we would agree that we concluded from the last one, and if for any reason we need to stop and expand on it, I would be more than happy to do that. Dr. Kessler, we did establish that Dr. Lillian Yin has been in charge of the review process for the Sensor Pad since its first appli- cation was filed in 1985. Am I correct? Mr. KESSLI~R. Dr. Yin would have to answer that question. Ms. YIN. Yes, Mr. Congressman. Mr. BURR. Dr. Kessler, we established on May 23, 1991, that Dr. Lillian Yin met with Mr. Patrick Nolan, a minority shareholder of IPI, did we not? Ms. YIN. Yes, sir, I did. Mr. BURR. Dr. Kessler, we established both that Mr. No]an re- quested the meeting and that Dr. Yin held this meeti.ng outside of the presence of representatives of IPI? Mr. KESSLER. We discussed the circumstances. Mr. BURR. A meeting took place with the minority shareholder without representatives of Inventive Products, correct?
Page 107: TI14380215
206 Mr. KESSLER. That's correct, but I'm not sure that puts that meeting in context. I think there were representations. Mr. WAXMAN. Will the gentleman yield? Wasn't Mr. Nolan rep- resenting that organization? Mr. BURR. Mr. Waxman, it is the testimony from the last hearing that in fact Mr. Nolan was not an official representative of Inven- tive Products; he was a minority shareholder but not an officer nor an official representative, and that was stated in a letter. Mr. WAXMAN. Did he claim to be a representative of the organi- zation? Mr. BURR. Not in any of the documents that I have had to look at did he claim to be a representative. Dr. Yin, maybe you can expand. It was portrayed by Mr. Nolan that he would bring official representatives from IPI to that meet- ing. A~n I correct? Ms. YIN. He did say that he would come in and he was with the company. That's how we understood it. Mr. BURR. With accompanying individual officials of IPI. Am I correct? Did he bring such individuals? Ms. YIN. He did not. Mr. BURR. Did you hold a meeting regardless? Ms. YIN. We did, for the purpose that he is asking very general questions. At that point there were no documents in house for re- view from the company. Mr. BURR. Dr. Kessler, as Commissioner of the FDA, do you be- lieve that in situations where litigation is pending your employees should draw a clear distinction between official company represent- atives and other interested parties? Mr. KESSLER. I think that when litigation is pending, as always, we should be careful on who we meet and who we talk to. Mr. BURR. I think we are talking here, sir, FDA policy. Should it be FDA policy that anyone attending an official meeting should be a representative of the company or the meeting should not take place? Mr. KESSLER. I can't say that as a blanket statement, Congress- man. Certainly we meet on issues with people who are not mem- bers of companies all the time. Mr. BURR. Is it reasonable to believe that after 7 years of an in- vestigation, Dr. Kessler, that Dr. Yin should have known that Pat- rick Nolan was not an official representative? Mr. KESSLER. I can't answer that question. Mr. BURR. Dr. Yin, is it acceptable to believe that after 7 years that you would have known that Mr. Nolan was not an official rep- resentative of IPI? Ms. YIN. I do not believe we would have that knowledge. Mr. BURR. After 7 years you would not have known who was an official representative of a company that had an application in the approval process? Ms. YIN. That's exactly it. We do not know, because usually com- panies do change their representation a lot, and we do not deal with them all the time. Primarily the people who come to visit us would be Mr. Wright. Mr. BURR. Even though Mr. Nolan stated when he requested the letter that he would bring an officia] representative, that still 2O7 didn't clue you when he walked in the door without anybody that he was not an official representative of IPI? Ms. YIN. Mr. Congressman, as I said before, since there were no documents or submission pending from the company, therefore our discussion with anyone would be very general. Mr. BURR. Dr. Yin, there was litigation between the FDA and !PI pending. Dr. Kessler, is it in fact common practice for the FDA to have a meeting with shareholders and not company representatives while litigation is pending? We are covering ground that you have already agreed to in prior testimony. I don't want to get you too deep and entangled in dif- ferences with what you agreed on. Mr. KESSLER. Mr. Burr, there are no differences. Mr. BURR. I'll certainly pull the transcripts for you. Mr. BARTON. Would the gentleman yield? Mr. BuPm. Yes, I will. Mr. BARTON. I have a housekeeping chore. Is there a mechanism in front of that notebook with a green light on? Mr. KESSLER. I'm sorry. Mr. BARTON. We're trying to determine whether there is a light, Mr. KESSLER. I don't see a light. I apologize for the briefing books, Mr. Chairman. There is a lot of material here. Mr. BARTON. We just simply need to know. Mr. BURR. Mr. Chairman, last hearing that light was broken, Mr. KESSLER. I don't see one, Mr. Chairman. I may have covered it up. Mr. BARTON, We are keeping time. I wanted to see if we had a device that signals when the time expired. Mr. BURR. Dr. Kessler, let me quote you from the last hearing, This was on November 15, in the room on the first floor. You said, "Certainly if I were asked to have a meeting with a minority stock- holder, I would be very reluctant to do that. I don't think that is good practice." Does that jog your memory at all about the position that you took relative to Dr. Yin's meeting with a minority shareholder. Mr. KESSLER. I also think I talked about regs that were on the books that said that meetings would be granted with interested parties on issues, that those meetings should also be public infor- mation in the public record. Mr. BURR. We certainly discussed policy at FDA, and I think now we are talking about good s4nse as it relates to a company that is under current litigation from the FDA and who has gone through a 7 year approval process. Mr. KESSLER. Congressman, I do believe as you look in many of these cases that we have been talking about that we find ourselves, and increasingly we find ourselves, I believe, caught between out- side interests. We were talking about it in other contexts. Mr. BURR. Dr. Kessler, I would suggest to you that in fact when you have got a minority shareholder who is not an officer that a meeting discussing no pending approval would suggest that in fact the minority shareholder might not be as reluctant to continue to participate on a capital position with that company,
Page 108: TI14380216
208 Mr. Chairman, I would ask unanimous consent to submit for the record soma notes, including a statement made by Mr. Ohesemore, the Associate Commissioner for Regulatory Affairs. The notes are of a July 24, 1995, conference call, which indicated that Dr. Chesemore "thinks there is only one firm involved, Inventive, the manufacturer of the Sensor Pad for breast cancer. That particular firm and product has had a tortuous history, including seizures, 305 hearings, civil penalties, et cetera." Mr. Chesemore indicated to the "untrained eye the chronology looks like the agency was vin- dictive." Mr. WAX_MAN. Reserving the right to object, Mr. Chairman. I would like to know more about this. Mr. BARTON. The gentleman will suspend. The gentleman will state his reservation. Mr. WAXMAN. I reserve the right to object because it's not clear to me who was in on this conversation and whose notes these were that the gentleman is seeking to put into the record. Mr. BURR. Mr. Chairman, I would ask for staff to supply Mr. Waxman with the notes of this conference call. Mr. WAX_MAN. If the gentleman would suspend his unanimous consent request. Mr. BARTON. We will suspend the request until minority has had a chance to review the document. We would also ask that the coun- sel for the FDA have a chance to look at the notes. [The conference call notes referred to follow:] MWR Conference Call 7/24/95 I. Mr. Love indicated the commissioner had asked Diane Thompson to notify com- mittee chairs that he would pass on the upcoming hearing because of the timeframe. Mr. Love indicated the hearing was back on andMr. Chesemore and FDA will tes- tify tomorrow (7/25/95). Headquarters is again requesting documents today (7/24/ 95), Mr. Dempster reported receiving a call from Mr. Bonanno concerning the Barton hearing. Mr. Chesemore was digesting the material and raised questions on the ma- terial sent. Four people are clarifying the material. eRA Conference Call 7/24/95 II. Mr. Dykstra reported Mr. Chesemore was planning to attend today's con- ference call. But, was attending a conference call in progress. III. Headquarters is being "flooded" with inquiries about a variety of issues. Mr. Chesemore is being invited to attend various hearings. The "Dingell" Committee now chaired by Mr. Barton from Texas is making numerous document requests. A, Documents concerning retaliation. Mr. Barton decided to hold a hear- ing tomorrow (7/25/95) on this issue. Mr. Chesemore thinks there is only one firm involved--lnventive the manufacturer of the sensor pad for breast cancer. That particular firm and product has had a torturous history in- cluding seizures, 305 hearings, civil penalties, et al. Mr. Chesemore indi- cated to the "untrained" eye the chronology looks like the agency was vin- dictive. Mr. Dykstra emphasized the word "untrained". Mr. Chesemore and Mr. D.y, kstra saw nothing out of the ordinary. A week ago Congressman Barton s committee added four other firms. Mr. Dykstra thanked the dis- trict offices for busily compiling the information. Mr. Chesemore and Mr. Dykstra appreciated the frantic gathering of information for the hearing to- morrow (7/25/95). During the middle of last week Dr. Kessler, Margaret Porter, and Diane Thompson agreed that Dr. Kessler would not testify. A letter was sent last Thursday and Friday indicating he wanted to cooperate with the committee but it would take a couple of weeks topull the informa- tion together. This information was shared late Friday. A discussion was held to testify or not. A pro-meeting was set up. Today, the decision was that the agency was not going to testify instead it would brief important minority staffers with information at this point in time. That briefing is 209 being held in the commissioner's conference room now. Mr, Chesemore is being asked questions one by one. The prospect of whether he will testify remains to be seen. Mr. Chesemore is hopeful. Mr. Bonanno was with Mr. Chesemore and has stated there are one or two more firms to go. IV. Mr. Dykstra indicated on 8/1/95 there will be two hearings one in the morning and one in the afternoon. In the morning Congressman Sheas of Connecticut will hold his hearing. Both hearings concerning breast implants. Medical devices will be the focal point. In the afternoon Congressman Macintosh a member of Congressman Sheas subcommittee will hold a hearing concerning the Indiana petition which re. lates to the medical device issue. Mr. Bonanno indicated the "Indiana Petition" al. loges the agency is making policy and changing the law as it goes along. Regarding 510K's the agency changes the law day to day and is setting new directions and terpretations of the law daily. V. Mr. Chesemore joined the conference call. Good News! Will not have to testify tomorrow morning. VI. An article appeared in today's Washington Times. A "hill" panel will hold a hearing on retaliation, namely, Dr. Bryzinski. "7 federal agents locked up his records". Five or six different firms or clinical investigators complained about retal- iation/abuse of power by the agency. FDA Chief Counsel is the "BATF" of the Gor. porate World. Dr. Bryzinski-antl-neoplasty synthesizing. Can't say a lot about it, He is under grand jury investigation for shipping product PS. He has been under in- junction since 1983. Three or four individuals recognized by NIH for alternative medicine approach to cancer. All others are medical device firms. A. Chicago firm--lnventive---sensor pad manufacturer. B. Detroit firm--Biomeb--orthopedic devices~Devices approved in foreig~n countries, but not approved here. Investigator shows up to start an inspec- tion really does not enter into it. Commissioner had discussion with Barton will testify two weeks following hearing usually--a committee will do inves- tigation then have hearing in this case will have hearing without investiga- tion. Notified last week about the hearing more than anxious to review and work on charges of retaliation and level playing field. Tomorrow (7125/95) will have two panels. Outside witness. A. product approved B. retaliating technique Abuse of authority. Seizure order interesting thing happened tomor- row. Minority--Democrats will talk about how agency not enough time to prepare. Does not know if carry on C-span. This article only one made hear- ing public. More tomorrow quote people hard all defend against. VII. Mr. Chesemore reported the medical device hearing, Mr. Bonanno sent an E- Mail. Someone to talk to tonight. Detroit representatives are William Brubaker and Keith Jasukaitis. Both are standing by. eRA Conference Call 7/10/95 A. Congressional staff sent a letter to the Commissioner indicating wide- spread retaliation by FDA of regulated industry. The Commissioner re- sponded that that type of behavior would not be tolerated. The ~'esult of the letter was an all hands memo last week. This week the press office has been extremely busy. On 7/13/95 HHS will issue our side of the issub. VIII. There are concerns about retaliation. Such is not the case, but Congress asked and FDA is obligated to put something together. eRA Conference Call 7/17/95 IX. Congressman Shays from Connecticut will be holding a hearing on 8/Y95 con- cerning risk assessment involving medical devices. Mr. Chesemore has been asked to testify. Mr. BURR. Dr. Kessler, last month we discussed a September 16 letter from Ms. Bianchi to Grant Wright in response to, among other things, his August 14, 1992, letter outlining concerns about a meeting which took place on August 10, 1992. Both letters I have blown up. Hopefully you can read them. Mr. KESSLER. You have better eyesight than I do. Mr. BURR. I wanted to try to keep, with the number of letters, some semblance of order here.
Page 109: TI14380217
210 in his letter Grant Wright stated, "I believe we are entitled to some explanation as to why we continue to be treated in such a hostile, threatening and unethical manner. Until we receive some fair written explanation of this meeting which responds to each of the concerns I've expressed about the meeting, including the laugh- ter at the end, then I do not consider that the ethical concerns I have raised to Mr. Benson have been addressed (Indeed we have never received any written response to my letter)." He is referring to a letter of March 2, 1992. On March 2 Grant Wright wrote the FDA, specifically the De- partment of Ethics and Integrity, regarding a meeting with minor- ity shareholder Patrick Nolan almost 1 year earlier. [The full text of the letter follows:] INVENTIVE PRODUCTS INC,, August 14. 1992. Ms. Pat Bianshi National Center for Devices & Radiological Health Rockvtlle, MD DEAn MS. BIANCI~I: I wanted to take the opportunity to thank you for your efforts in arranging the meeting of Augus~ 10th concerning our product the Sensor Pad. I appreciate very much your efforts and I only wish that the meeting would have been productive and this letter could have been very short. We seem to have a continuing and very obviously escalating problem with C.D.R.H. I am disappointed and very concerned with the manner in which this meeting, as well as the entire matter, is being handled. I believe we are entitled to an explanation as to why we are being treated in such a hostile, threatening and unethical manner. The meeting began at 10:00 a.m. on Monday August 10, with seven O.D.E. Rep- resentatives, but also with several individuals from the Office of Compliance and two lawyers, including one from the Department of Justice. Does O.D.E. normally staff its' discussions of Pro Market Notifications (the topic for which we asked for the meeting) with Department of Justice lawyers? Do you know how threatening that appears to a small medical device company--if you complain abo~t O.D.E.'s ac- tions to the C.D.R.H. Ethics Office, you get the Department of Justice down en you. Moreover, the meeting was presided over not by an O.D.E. Representative, but by an F.D.A. lawyer, Kay Cook. She immediately informed us that regardless of how or for what use we labeled the product, F.D.A. would "come after us". I take this intimidating threat very seriously and question the legality, much less the fairness and appropriateness, of such a statement. Ms. Cook's opening statement set the tone for the remainder of the meeting and I was, to say the least, stunned by the attitude of those attending this meeting. I don't believe any Company should be treated in such a threatening, rude and unethical manner. I have serious questions after this meeting as to what is going on within the Agency concerning this product. It was obvious C.D.R.H. and other governmental representatives attending this meeting had not the slightest interest in meeting with us. It appears as though this meeting was being held merely to satisfy the fact that the agency had a question- able meeting of which we were not aware of with a minority stockholder of IPI con- cerning our product. ] came to Washington in good faith to try to begin to resolve the issues concerning our product and in no way did I expect to receive such an unprofessional, rude and threatening reception. At the conclusion of this meeting, several of these attending this meeting laughed in the hallway as though this meeting were some type of joke. Our M.D. consultant who is an expert in breast health, Dr. Patricia Redmond com- mented that this was all just a big joke to these people, and I share Dr. Redmond's feelings regarding this meeting. I believe we are entitled t~ some explanation as to why we continue to be treated in such a manner. Until we receive some fair, written explanation of this meeting, which responds to each of the concerns I have expressed about the meeting (includ- ing the laughter at the end) then I do not consider that the ethical concerns I have raised to Mr. Benson have been addressed. (Indeed, we have never received any written response to my letter.~ 211 ] would appreciat~ your earliest attention to this matter and thank you for your interest, efforts and concerned approach. Sincerely, Gait A. V~RIGHT, President, P.S. Mr. Demarco long ago promised us minutes of the improper meeting FDA had, however; we have not seen them to date. Mr. BURI~. As Commissioner, is it the FDA policy to withhold a onse to such serious allegations for 6 months? rearer. BA~TON. The gentleman's time has expired. After Dr. Kessler answers his question, we will recognize Mr, Waxman. You may answer the question. Mr. KESSLER. ][ have a lot of pieces of paper, Congressman. Mr. Bum~. There are a lot of pieces of paper that have accumu- lated over the 10 years of this. Mr. KESSLER. Let me tell you~ Mr, BURR. A March 2 letter. Mr, WAX~. The gentleman should be permitted to answer, Mr. KESSLER. I don't have the March 2 in front of me, Congress- man. I do have the memorandum of a meeting on March 23, 199L This is the people who were at that meeting, 9:30. The. first bulletde said, 'W~e met with Mr. Nolan and the following points were ma The first bullet. Nolan said he is authorized by the firm to be here." I think that goes in part to the points you are raising. With regard to our responsiveness, we would like to be respon- sive as timely as we can. Mr. BuI~. Is 6 months timely? Mr, KESSLER. It depends on the circumstances surrounding it, Congressman. Sometimes things take 6 months to look into. It de- pends on the other things that are ahead of it, Mr. BuI~. Even the question of an improper meeting? Mr. WAXlVlM~, Point of order, Mr. Chairman. Mr. KESSLER, I'm sorry. Mr. Bum~. Even the question of an improper meeting? Mr. BARTON. The gentleman will suspend. The gentleman is rec- ognized for a point of order. Mr. WAXMAN. Mr. Chairman, the gentleman's time has expired, There was an outstanding question. You indicated after Mr, Kessler responded to that question other members would then bs recognized in turn under the rules. I think Dr. Kessler ought to be permitted to give his answer, without further interrogation, to the question that is pending. I assume you will give the gentleman from North Carolina another chance, unless we are here to be wit- nesses to his deposition of Dr. Kessler and not to be participants in this hearing. The rules do provide that members do have a chance in sequence to ask our questions. Mr. BARTON. We are going to adhere to the rules. The gentleman knows that. Dr. Kessler, would you care to elaborate any on your answer to Mr. Burr? Mr. KESSL~a. No. Mr. BARTON, The gentleman will have another chance to ask questions.
Page 110: TI14380218
212 The Chair will now recognize the distinguished gentleman from California, Mr. Waxman, for 10 minutes. Mr. W~. Thank you very much, Mr. Chairman. Dr. Kessler, this subcommittee has taken 5 separate cases and decided to pursue them because the people involved in each of these cases claims that they are being picked on by the FDA, that in some way FDA is retaliating against them, presumably, first of all, because they didn't approve their product, and then second, I don't know why they think they have been singled out. Mr. Burr asked you about one of these cases. I'm going to ask you about another one that has received a lot of attention, the Burzynski case. Dr. Burzynski has been given a lot of attention by this subcommittee. The issue at the last hearing was whether there was retaliation possibly by FDA against Dr. Burzynski to try to hurt his business, his medical business. Statements were made about the possibility that he had continuing encounters with grand juries in the State of Texas related to this kind of retaliation. Since our last hearing, Dr. Burzynski has been indicted on nu- merous counts. I would like to ask whether these indictments are FDA's doing. In other words, is it FDA's fault that Dr. Burzynski was indicted, and to what extent has FDA influenced the grand jury process in the State of Texas? Mr. KESSLER. Congressman, I have reviewed the transcript of the July 25 hearing, and I sat here obviously for our previous hearing. I count 4 times in the record where it was stated by either a mem- ber or a witness that in essence 3 or 4 grand juries refused to in- dict Dr. Burzynski. And there ~ere very strong words used about FDA, about that. I am not 6(e)d on the case. I did not participate in that process, and therefore I don't have knowledge of what went on in that grand jury room. I do understand that in Dr. Burzynski's initial appearance yes- terday before a magistrate judge in the U.S. District Court for the Southern District of Texas in Houston the government attorney, chief of the district's Criminal Division, Mike Clark, informed the magistrate judge in a public hearing that previous information given to this subcommittee by sources other than the government alleging that 3 or 4 prior grand juries had refused to indict Dr. Burzynski was not true, and that in fact this is the first Federal grand jury that had been asked to indict Dr. Burzynski and his in- stitute, and that it did indict him. This does not mean that there might not have been one or more previous grand juries that investigated Dr. Burzynski, but it does mean that any statements made to this subcommittee that pre- vious Federal grand juries in Houston, Texas had refused to indict Dr. Burzynski are not true, and it confirms that the first Federal grand jury to be asked to indict him did so. Mr. W~CM~. The grand jury was asked to indict him for violat- ing the law. What was FDA's role? Were you t,he party that brought the action to the grand jury? What is FDA s role in this? Mr. KESSLER. I'd be happy to have counsel discuss that. Mr. WAXMAN. Yes. Ms. PORTER. FDA conducted the initial investigation. It referred the matter to the Department of Justice and it cooperated and worked together during the course of the investigation. 213 Mr. WAX~AN. You do an investigation. You turn over the results of your investigation to the Justice Department. Then the lawy.ers of the Justice Department have to decide if they believe a cnme has been committed. If they believe a crime has been committed~ they go to a grand jury and ask that the person be indicted, which means that there is sufficient evidence to show that d crime has likely been committed by this person and should stand trial. Is that generally what is going on here? Ms. PORTER. Yes, that's generally correct, Mr. Waxman. Mr. WAXM~. If people think FDA is after Dr. Burzynski, they also have to think the conspiracy involves the lawyers of the Jus- tice Department who look at the law, look at the facts, reach the conclusion that perhaps there is enough here to say that the man has committed a crime. Ms. PORTER. I guess I wouldn't want to comment on conspiracies~ but what I would say is that any decision to bring a criminal inves- tigation and to indict is by the Justice Department. Mr. WAXMA~. Why has he been indicted? Mr. KESSLER. Congressman, I'd be happy to submit the indict- ment, if you would like. Mr. W~x~w~. I would like to have that indictment submitted and ask unanimous consent that it be put in the record. Mr. BARTON. Reserving the right to object. I assumed that that question would be asked at some point. Mr. TAXi, AN. What question is that? Mr. BARTON. The question that was just asked, that the indict- ment be submitted for the record. It's obvious that there have been indictments brought. That is a public fact, and there is absolutely no reason that shouldn't be a part of the record. But at the pre- vious hearing when the majority attempted to ask questions about the allegations that had led to previous grand jury attempts to in- dict, we were told that no comments could be made because there was a pending investigation. I am willing to have put into the record the indictments if FDA and its counsel are willing to answer specific questions about the allegations. If not, then we will not allow the indictment to be put into the record. Mr. WAXMAN. Mr. Chairman, reclaiming my time, the indictment is a specific document. I-would like that document put into the record. Any member can ask any questions they want about that document or any other, and then it is up to the FDA. If you are saying you are going to condition the entry into the record of a spe- cific document that shows Dr. Burzynski has been indicted for vlo. lation of the law, go ahead and object. An indictment is a public document. I am asking that a public document be made part of this record. Mr. BARTON. I understand that. I am not opposed to that, but the indictment is a series of allegations and a grand jury has found in this current grand jury investigation that there may be .reason to believe that some violations have occurred. Mr. WAXWIng. Mr. Chairman, I don't know if this is coming out of my time to ask questions. I would presume not, because that would be grossly unfair. Mr. BARTON. One thing that I am not is grossly unfair.
Page 111: TI14380219
214 Mr. WAXMAN. If the chairman wants to use this time now to de- bate whether a public document can go into the record and if he wants to object, then of course I'll object to any documents anybody else wants to put into the record, but that seems to me a very shortsighted way for us to have a record. Mr. BARTON. Before the Chair rules, the Chair would like to hear from Dr. Kessler. Mr. WAX~. The Chair is not being asked to rule. I've asked for unanimous consent. If there is an objection, object. If there is not, let me go on with my questions. Mr. BARTON. The Chair is conducting a hearing. Mr. WAXMAN. I withdraw my unanimous consent request. Mr. BARTON. The Chair would ask Dr. Kessler if Dr. Kessler and his associates are willing to answer questions about the Burzynski case on the record. Mr. KESSLER. Mr. Chairman, on November 20, 1995, which is since the last hearing on November 15, there was an indictment in the U.S. District Court for the Southern District of Texas in the Houston Division. I think it would be prudent to let the indictment speak for itself. I need to get your words exactly, but I think you just referenced again previous grand juries refusing to indict. I think those were your words. Mr. BARTON. That's correct. I want the gentleman from Califor- nia to know that he had consumed approximately 5 minutes when this started. Mr. KESSLER. Again, Mr. Chairman, let me reiterate what was said. I was not there on the grand jury. Mr. BARTON. ] understand that. Mr. KESSLER. I think this is very important. Yesterday, in Hous- ton the chief of the district Criminal Division informed the mag- istrate judge in a public hearing that the previous information g~ven to this subcommittee by sources other than the government, alleging 3 or 4 prior grand juries had refused to indict Dr. Burzynski, was not true. That doesn't mean that there might not have been one or more previous grand juries that have investigated this case. I think that is very important information, and I would appreciate it if we can make sure-it is very important that we be dealing with the facts and facts that are true here. Mr. BARTON. I understand that. That is what we are attempting to do, Dr. Kessler. Mr. KESSLER. I was not prepared, because I was not 6(e)'d and don't know what happened in the grand jury, to be able to talk at the previous hearing what happened. I still don't know what hap- pened in the grand jury room. I was told what happened yesterday at an open public hearing in Houston. I would certainly prefer to let the indictment speak for itself. I think that would be the most prudent thing. There is an indict- ment now, and having been trained as a lawyer, I think prudence would dictate that we let the indictment speak and let all discus- sions go before the U.S. District Court in Houston. Mr. BARTON. I take it you are not willing to afiswer questions about the allegations that have led to the indictments that the FDA has helped to prepare? 215 Mr. KESSLER. I would be happy to discuss anything in the indict- ment as the indictment states it. That's what I have knowledge of, I'd be happy to read and discuss the points in the indictment, to the best of my knowledge. Mr. BARTON. I want to be clear on this. At the November 15 meeting every attempt to elicit information about the case from you was met with an absolute refusal to comment because it was a pending investigation or a pending proceeding. Mr. KESSLER. Because I was not 6(e)'d, there was, as I believe-- excuse me for one second. Let me check. I think it's fair to infer that with an indictment that was handed down on November 20 of this year by a grand jury that at the time of the previous hearing there was a grand jury underway. First of all, I didn't have knowledge of what was going on in that grand jury room, but even if I did, it would be wrong to discuss that. Mr. WAXiWu~, Will the gentleman yield? Mr. BARTON. I'll be happy to yield. This is an important point and we want to get the facts. Mr, KESSLER. Thank you, Mr. Chairman.. I. ap..prec~iat~e.t.ha.t,.., is Mr. WAXMAN. Mr. Chairman, I apprecla~e me ~act ~na~ ~nls discussion on the unanimous consent request and is not coming out of my time to ask questions. Mr. BARTON. It is not. Mr. WAXMA~. Dr. Kessler, you said 6(e), which is the statute of the law that says you would be committing a crime if you disclosed in a public way information that has been presented to a grand jury. Is that a correct statement? Is that what is going on here? Is that your concern? Ms. PORTER. There are two concerns, Mr. Waxman. Rule 6(e) is Rule 6(e) of the Federal Rules of Criminal Procedure which pro- hibits an official of the government from publicly disclosing infor- mation learned during the course of the grand jury proceedings, That is the core of what Dr. Kessler is referring to. In addition, as we stated on November 15, the Justice Depart- ment has consistently advised us, and we agree with that advice, that to comment on the details of an ongoing criminal investigation risks disrupting those proceedings and prejudicing the individuals involved. That position is all the more true once an ".indictment has been brought and there are criminal proceedings in Federal court. Mr. WAXMAN. So the issue before us right now is you are being told by the Justice Department you can't discuss some of the de- tails. The chairman would like to ask you about those details, I suppose on a case-by-case basis the chairman could ask you and you could make a decision whether you are permitted ~o answer it or not. My unanimous consent request, Mr. Chairman, was t? put into the record a public document. Not something that has been con- fidentially given to a grand jury, but a public document of accusa- tions against Dr. Burzynski that he violated the law. I renew my unanimous consent request to put into this record the public statement of the indictment. You will be permitted to ask questions on the indictment, as will I, but Dr. Kessler has ad- vised us that he is restrained in some of the answers he might give because we are not permitted to ask him to violate the law and he
Page 112: TI14380220
216 is being instructed under the law and by the Justice Department that oversees the law for this administration not to answer some of those detailed questions. Mr. BARTON. Continuing to reserve the right to object, I am going to call a short recess to discuss this with counsel. I want to put this in the record. My personal preference is to put everything into the record and then let the people and the staff that are interested and the members that are interested review the record. I want to go back to the November 15 hearing, doctor. There have been numerous _previous grand, jury proceedings brought against the Burzynski Institute. I don t know whether those prior proceedings in some technical way are still pending or whether they have been legally concluded, but I do know that when you were asked about those previous grand jury proceedings you re- fused to comment because you were advised that this existing grand jury investigation was underway at the time. Mr. WAXMAN. Will the gentleman yield to me? Mr. BARTON. Not yet. My question to you. If we put the indictment that has now come down in the court in Houston into the record under the unanimous consent request from the gentleman from California, are you or your associates who have knowledge of this particular case and are here with you today willing to answer questions about the previous proceedings? Mr. KESSLER. The previous proceedings? Mr. BARTON. The previous proceedings dealing with the previous grand jury proceedings in the Court in Houston. Mr. KESSLER. No, Mr. Chairman, I am not prepared to talk about the grand juries. Mr. BARTON. The Chair will recess for 5 minutes. Mr. WAXMAN. Mr. Chairman, before you recess, if you have to consult with your counsel as to whether to put this document in, I'll withdraw my unanimous consent request and renew it later after you have had a chance to consult with your counsel. Mr. BARTON. The Chair is just going to have a brief recess. Mr. WAX_MAN. The Chair wants a brief recess. Then we will re- turn and I'll still be permitted to ask my questions? Mr. BARTON. Yes, sir. We are going to recess for approximately 5 minutes. [Brief recess.] Mr. BARTON. The subcommittee will reconvene. The Chair is prepared to rule, but before the Chair rules the Chair is going to recognize the gentleman from California, Mr. Cox, who is an attorney, for an interpretation of 6(e) in the Federal code. Mr. Cox. Mr. Chairman, reserving the right to object to the char- acterization of this member as an attorney. I will state more accurately for the record that I am a recovering lawyer and working very hard to make a good record for myself. 217 We did have a caucus with all of our members, including Mr, Waxman and counsel for both the majority and the minority sides. I think we reached a satisfactory resolution of what should be a relatively simple question. The 6(e) secrecy requirement imposed upon the grand jury process applies to what goes on in that grand jury room. The chairman under earlier questioning heard from Dr, Kessler that the Justice Department--I think Ms. Porter also testi- fied to this point--runs these matters, determines whether to in- dict, and so on, and what we ought to do is have a Chinese wali between what goes on in that grand jury room, which must be maintained in secrecy, and what goes on inside the FDA about which we are free to ask fulsome questions to which our witnesses under oath ought to respond. Mr. WAXMAN. Will the gentleman yield? Mr. Cox. Yes. I'd be pleased to yield. Mr. WAXMAN. We had a discussion, the members of the sub. committee, that this is a public document; it's hard to" withhold a public document from the record of this subcommittee. I indicated earlier if the members want to ask questions, members ought to be free to ask any questions they want. You have to decide what you legally are able to answer, and 6(e) is going to prevent some of the things that members would like to have asked and answered, because you are not permitted to talk about what went on before the grand jury, and you probably weren't even there to know what was presented to the grand jury, So questions are asked by members about activities at FDA, You are under oath. You answer to your best ability. You have counsel there. If there is some law that the members here don't know about, I'm sure we'll be informed whether there is any legal reason you can't answer a question. My simple request, Mr. Chairman, was to put into the record the document of the indictment of Dr. Burzynski, which is already in the public domain. I would like to have that in the record. Mem- bers will ask whatever they wish to ask. Mr. BARTON. The Chair is prepared to rule. The Chair is going to accept the unanimous consent request of the gentleman from California, Mr. Waxman, that the indictment be putin the record, The Chair is also going to allow the individuals that are the sub- ject of the indictment to also present material at that same point in the record if they so wish. Mr. WAXMAN. Mr. Chairman~ Mr. BARTON. The Chair is in the process of ruling now. Mr. WAXMAN. There is no pending request for a ruling. There is a unanimous consent request. If there is an objection to it, then it goes down. If the Chair is going to ask unanimous consent to let things be in the record during my questioning, I have serious ques- tions about it. If you want to keep the record open for other people to add other things, that's fine.
Page 113: TI14380221
218 Mr, BARTON. The gentleman from California can have serious questions about it. I am trying to be totally fair. In fact, it's the Chair's opinion that I am being much fairer than our friends at the FDA have been in their ongoing investigation of the Burzynski In- stitute, but that is an opinion. My final point before I recognize the gentleman from California again for the rest of his questioning period is that we will ask you, Dr. Kessler, and your associates, to answer some questions on the record about the Burzynski investigation in the past that are not subject to 6(e), and we would hope that you would be forthcoming and answer those questions. I can't make you. Mr. KESSLER. ][ understand. Mr. BARTON. You can make a comment. Mr. KESSLER. Three points, if I can. First, let me clarify. Right before the recess you asked me wheth- er I was willing to discuss 6(e), and I answered no. If I can expound on that. It's not because I am unwilling. It's because I am unable. Two, I agree with the major points that Congressman Cox made. I think he said it very well. I would like to add, though, that it's not only 6(e), but I think Mr. Cox would probably agree that not only is it 6(e), but when you have an ongoing criminal proceeding, it is only prudent to be care- ful what is said outside of a courtroom. So it is not only 6(e) but the fact that there is an ongoing criminal proceeding. Third point, Mr. Chairman. I am increasingly uncomfortable with an ongoing criminal proceeding. I respect the right of this committee of the Congress to conduct oversight, but I am increas- ingly concerned about how that affects an ongoing criminal pro- ceeding. It is one thing to look into matters once they are closed. I would strongly suggest to the chairman and to the committee that the most prudent thing to do--this is very uncomfortable. You talk about fairness, Mr. Chairman. There have been very strong words used by members of this committee with regard to the Dr. Burzynski case, that people at FDA should be exposed, summarily fired. This is not something that I want to sit here and just be ~uiet about, because there are very serious allegations that have een made. I think I am increasingly concerned about how we are proceeding with the fact that we have a criminal proceeding underway. I would ask the committee to consider letting the criminal proceed- ing go ahead and then when it's a closed matter to be able to do ~our oversight as appropriate. Otherwise there is serious risk. Mr. hairman, I believe that this committee may be crossing the line or very close to the line with regard to a criminal proceeding. I have no problems with oversight, but I would strongly suggest that you wait until it's a closed matter. Mr. BARTON. Before I recognize the gentleman from California again, I understand the Commissioner's uncomfortableness, but your uncomfortableness, Doctor, goes to the very heart of the over- sight responsibility of this subcommittee. Some of these actions that we are now reviewing have been underway for over 10 years. If we wait until it's concluded or it's closed, to use your words, they may never be closed as long as the decision to close it rests within your Agency. 219 That goes to the very heart of what we are attempting to inves- tigate. It is the subcommittee's concern, and possibly a fact, that there is a pattern of practice or a culture within your Agency that creates these long-term, ongoing proceedings. I hope you under- stand that this concern is the very crux of what this subcommittee is attempting through hearings to gather and substantiate the facts on the record. Mr. COX. Mr. Chairman, would you yield? Mr. BARTON. I think we have belabored this long enough, The gentleman from California has asked for unanimous consent to put into the record the indictment that was handed down in the Dis- trict Court in Houston concerning the Burzynski Institute. Is there an objection? [No response.] Mr. BARTON. So ordered. [The indictment referred to follows:]
Page 114: TI14380222
221 220 t~T~ STLTE$ O~ b~TED STATES DTETRICT COURT SOUTHERN DZST~ZCT OF TEXAS THE GrtAND JT~y C~RGES: ~e~L:~ pra~Icl (~e ~z~K~ C~Ini¢) In ~o~on. T~IS, and a!~avhere. AS 0¢ ApK%~ ~7, ~995, B~YNSXI had ~ea¢~ ~oca ~ two t~ou6and ~ive h~t~ (2,~00) p~ti~t~ w~ antlneoplamton. d~scov~ed: ~r~ "AS." ~. ~n ~e I~Ce L970'~ ~d ~p ~ou~h ~iS /nd2¢~en~, B~KZ sold, d:spans~, pr~o~ and l~Zed an~ineop/aa~n to traat ~d preven~ variety of ai~s, AIDS (A~ir~ !~e Deflclen~ S~e) and (8~n ~ode~ci~n~ ~lop~%a Multipl~ ScLerosis, SJo~sn's di~aasa, and Hcw~var, no fo~ of an:Ineop/aston, including ~a ~gs B~ZYNSKI referre~ to as ~, A3, AS, AIO a~d ~2-I, has evar ~a~ appr~ by ~Z~S~ pro~md and !a~l~d 7. ~ IS8~ ~ough ~4, ~Z~KI nod ~e 8~ZYNS~ INSTI~ appro~i~aly Fo~ Million Ooll~ (~40,000,000} In during ~8 s~a p~1od, ~Z~S~ and hla wi~a took in over Fiv~ Mill~on
Page 115: TI14380223
222 223 and ~oL~a~n ~nd ~0. ~S~ and o~ ~= 'all anCineoplas~on /n~av~oul~y. t2, co~n9 co ~m ~z~skL Cl~lc ~ Houston ~o b* ~r~ ~o ~£~ pay a~u~ mpsnc ~, A~ ~ instill p~ ~n Ko~l~on. =0~ o~ ~Z~S~'I patients rmcurned hose in~neoplam~n v~ ~, or ~av~9 ~q~ to b~ve £~ ~ ~o ~h~. t:av*~ ~:om ~e~ h~es Co ~s I~s~ ~. or ~ Car would ship ant~nsoplsston d£~e~ly £~c~ t~s cl~-uic ~o ~a pa%ient's home. :~ed and ~n~lv~ ~l ~uc~ion o{ ~o ~t~eop~i~on ~n~o I~, s~s~ ~ ~u~ $34~.50 ~ily for a ~*~I~ ~ss of in~rav~oully l~ni~E~ ~ineop~on, ~ $6~S d~ly Ear a d~ily ~or capsul~s O~ ~s oral ~tineoplas~on. @~Z~SKI bLLI~ for ~nch Food and ~g Act), n~ c~ified nc 21 O.S.C. 55 301-392, 19. ~e ~ S~ FO~ and ~ug ~il~ra~ion (FDA) ag~ r~lponsible tot ~otl~ ~ h~l~ and cOerCe ~0 ~e p~ll Of th~l ¢ou~. ~neEally, ~A p~C co ~e r~8 o~ ~e Fo~ and D~ 20. Ti~o 21, O.S.C. 5 321[Q) (1) (B) ~ (C) de~os ~o 2~. T~;I~ 21, U.S.C. S 321(p)(1) deEln~s ~a ~ "new raoo~de~ or SUqglSEed in its la~lling.
Page 116: TI14380224
224 225 ~11 0~0~ ,~,"~T'Zmm (~) ~2!{~)(~) ~ 321(p), S~Ce i: ~as in~e~ tar use In Ln~r~u~on In~o in~ta~ c~r~, or ~o ~ve ~ul~ ~m introduction cr d=~vo~ for In~r~ton into in~m~e co~oe of ~e new ~ug ~95, B~Z~S~ h~d ~rMtsd only six (5) o~ his pa~ien=s ~de: FDA- O~ ~30~ ~ Lssued an order ~t pe~etually res~ain~ and en~oLnsd ~Z~SK: l~ tha ~em f~ directly or ind~ly ci~ing ~y of ~8 folloV~g a~i ~0 be (a)1. In~ or dml~veEi~ Eor In~E~UC~iO~ In~o (i) ~ approv~ a~It~ion ~L~ed ~8~t to Title 31; U.S.C., ~l~od p~uan~ ~o T£tla 21. U.5.C., ~355(I) ~ re~la~on ~1 3~ la~ling, uo~ o~I, ~I i:l~l~t =Clarion: HoW ~ ;
Page 117: TI14380225
226 22~ TEXAS D~q b. B~S~ ~ or ~o~d ~ kn~ ~ his ~nd v. S~anislav ~. B~z~k~. Z7 P.3d 153 (5~ C~. 199~), ;nj~c~lon au~r~zed hi~ ~o dls~rlhu~e an~eoplas~on in T~a~, f~i~ ~d oregon weE~ i11eqal, and Dr, ~Z~SKI kn~w or sh~l~ have ~o~ :~o~hw~s~ ~) ~s [lle~li~y of ~a ~tin~laston transits," th,~ his "~ial disclo~el ~o (No~ves~ ~) ~poled a du~y on c~aract~ of his p~ixl dlsclos~e~." 37. ~ Uni~ S~a~a~ Supr~ Co~ refused ~o r~iaw ~e Fif~ (COnCept: V~o~a~ion of C0~ Order -- t8 U.S.C. ~ ~01 & ST~S~W R. B~Z~S~I :~ow~ngly, ~n~en~ional~y ~d vil~fulIy d~so~y and resist ~he lawful dal~v~r~g for i~odu~ion ~o in,eremite ¢~lrcs, and ¢aus~q wn~n s~h intr~u¢~1o~ and ~llverlez of an~aoplas~on were made and a. no a~li~tion p~nt ~o TLUle 21, U.S.C., S 555(b) or (~) had
Page 118: TI14380226
Page 119: TI14380227
230 231 30 4 ~1/9/9 4 ~OlaSl 9~ ~4 OH A~-L and AMTINEOPLAST ON ~ODGKIN~ S CALIFOP~TZA CALIFOrnIA ANTZMEOP,~.,AST ON AS2-1. and ANTZN~OpLAST ON AS2-1 an,t AIO and HODGKI~ ' S LYMI~OMA NOP- HODGK~N ' S LYMP~OMA 32~7 ~287 3287 3287 3315 Jl ~a 39 5 40 91619~ WEST 3592 ~.~ZN CAHCER ~592 3721 ~g~ yO~-~o ~OUGH S~-F~/E ~OUg~ ~Ir~-Eigh~ o~ ~e ~n~oduction ~o ~L~ Indi¢~ as i~ f~lly ~et tO~ h~ein. ~ ~Rocmmmu~ .~z~x~o~o~ (c~T) coozs CurT.~n~ Proc~dur~l Terminology COd~ (C~T cad~.) are publilhed by
Page 120: TI14380228
232 233 ~ SCR~ ~0 DEFRAUD 47. Bag~,.i"~lnq on oc ~t~* ~y z, ~99X, ~ concern9 ~o.~h ~* ~aa o£ devise a s~e~ ~ ~A~L~ to d~r~, ~ ~or ob~g ~ney ~4 prop~y by ~ o¢ false ~ Cra~ prltl~ ~1 d~le bill£~, ~ ~id~ ~alse, ~Zmte ~d Ln~u~ion in~ Ln~te c~Cl ~i~ B~ clued ¢1. ~e s~ ~o d~ra~ cons~¢~ of a pL~ ~ a~SKI, t~ so ~c a~ c~Zd ~aLIy ~A~ ~eXf ~ ~. Z~ va~ a ~ o¢ ~e l~ ~ da~d ~ ~ vo~ld snd dad claim fo~m he c~uel~ to be 51. As ;a~¢ of th~ ~_h~ma, B~Z~ wo~d t~ ~id ~e CPT codes 96414, w~en =~I ~ not ~nls~er, ~ could" no~ have 52. As pa~ 0£ ~o l~m, ~Z~BKX would ~ d~a ca~e ~ C~ 9935~ to k~ance cla~ ~ W~ O~i~ ~ ~I for pa~ nO~ ~0 C. ~ ~¢~pl~n CE~ v~e n~ a~rovM ~ ~e Fo~ and 54. ~ p~ of ~e s~, B~S~ ~d o~s he con~oll~ ~i~ ~ do ~s ~cl~ a=vis~ ~ ~ m~ ~ ~ ~t ~ ~ vtolat~
Page 121: TI14380229
234 235 2602 4/15/92 flCF~ ZSO0 (4/2/92 - ~17/9~ ~TI"J: Hcdic~Z C~La oep~,, P.O. 80X gSO, Oanvar, CO 80201 47 48 4~ 5'. 52 q 53 54 55 56 57 2863 2959 2959 3040 3049 3049 3226 1500 (1119193 I,~a1 0¢ Oa~h~ ~a, HE 68175 613193 RCFA 1500 {5128/g3 - 5/31/g3 foc $1,260) to Mucu~ of ~u~u,~ of Oll~a Plaga, ~, HE ~6175 6/3/93 H~A 1500 (6/1/g3 - 6/2/g3 ~o~ $630) to Hutu~ o£ ~ 9L~¢~, 0~, ~ 68275 6125193 ~ 4/12/93 7/13/94 LS00 (6/18/t3 - 6123193 $20S$) ~o LibeL'l:y Medical Clat~ BOX 2817, Cain~r~ille, GA 30503 HCZ~ 1500 (~/18/94 - 6/23/g4 ATTH: He~cal Cla~ D~p~., Galnesv~Z~, GA 30503 ¢o¢ $20S5) Shield; ~00 5Eoadvn~t D~verr ~ 80273 for Sl~oo) B~efi~ plan/ HCFA 1500 (1z/5/93 - 12110193 Bene~i~ Fl~n; A~n: Med/cal Cla~ma.Dep~., P.O. BOX 6222, HCYA 150o (2/14/9~ - 211919~ • or 52,055; 2120194 - 2/25/94 for $2,055; ~/~6/94 - 2/21/9t ~h~eld; ~n~, HA 02171-91~0
Page 122: TI14380230
236 237 59 60 65 67 3306 4/13/94 1/5195 7113194 7127194 7/27194 9/271~ ~o~ $2,05B: 2/15/95 - 2118195 ~or $2,055; 2/~9/95 - 2/23/95 ~.O. BOX 9150, Q~).:I~Cy, MA 02171-9150 HC~A 1500 (3/26194 - 3/31194 for SIOE0) to GE~A; At~n: ~iG&l cla;m~ De~; P.O. ~OX 10504, K~nSas C~, M0 64171-0504 HC~A 1500 61~/25/54 - 12/30/94 ~2~0} ~ G~; A~: P.O. ~X 10304, ~nsa~ City, MO 64171-0304 ~CFA 1500 (7/7/94 - 7/12/94 A~tn: M~d/cal Clai~ Dmp~ 712 IL~ S~E, ~A LS00 (7/7/94 - 7/12/g4 for $4110) ~o ~c~ ~aniona1: P.O. ~520, ~v~s~on~ ~ 77553 H~A 1500 67/I~/94 - 7/18/9~ EC~ 1~0o (71~3194 - 71~194 fo~ $t110 ~nd 7119194 - 7/24194 ~ $6110) to xLcan Na~lonal; AtOm: CLalm~ Pep~., P.O. 1520, ECFA ~$00 (~/16194 - e/21194 £or $2055 and 9/22194 - 9/27/94 for $2055) ~o G~Ld~n Rul~ Insurance; AtEn: Medical ClaL~z 712 11~h L~runc~villt, ~L 92439 69 7O 7L 72 75 3592 3721 9/Z7/9~ I ~16195 7IlO/gS 5112/95 ~C¥~ ~$00 (9116194 - 9121/94 ~Or $2056 and g122/~4 - 91~7/94 rot $2055] to Am~Lc~I HCFA 1500 (5/3195 - Cot $2055 ~ 3/9/95 - ~/14/95 ~or $~05S) to ~ A~soc Le~¢er C~i~re. ~at HC~A l~O0 (4/6/95 - 4/11/95 20547 Wav~Iy H~A iS00 {3/23/~5 - 3/2~/95 for S20SS: 3/29/95 - 3/31/95 for 510~7.50) uo PE~ZC; HCP~ L500 (4125195 - 4/30/9~ fo~ $2055) ~o R~A ~500 (612S/9~ - 6/a0/~5 for $23~0) ~o P~C; H~A 1500 (4/29/95 - ¢or $615,00} ~0 ~lua ~L33 $ W Top~ 81vd, To~e~, ~ 66~29-0001 TopeJc~, KA 66629-0001 All :n V~O~a~lO~ O~ T~le 18, Unload S~atss Cod~, 5e,=U~ar~ 1341 and 2, FORZP~SOH 0~' TI~ GRAND GATWELL~ GRIFFTH JONES ~ H. LEC~CQ ~V: CLARK CT J~L~al D[v~,slon
Page 123: TI14380231
238 Mr. BARTON. The Chair would recognize Mr. Waxman of Califor- nia for approximately 5 minutes. He hdd used approximately 5 minutes when this discussion erupted. Mr. WAXMAN. Dr. Kessler, I took note, as I am sure you did, of the chairman's words that he is being fairer than the FDA. You have sat through this hearing and the previous one where accusa- tions have been made against the FDA that you have been hound- ing Dr. Burzynski. Prior to that there was another hearing. Clearly this subcommittee is pursuing this issue to try to prove their case, not to find the facts, but to prove their case. It seems to me the core of their accusation is that it wasn't a good use of FDA's enforcement resources for the Agency to continue to pursue Dr. Burzynski's violation of the law. What do you think Dr. Burzynski's indictment says about that point? Mr. KESSLER. Congressman, I think the indictment should speak for itself. Two points. I think the Chair has been exceptionally fair. Certainly personally. I appreciate that. But I do believe that all 5 of these cases present a fundamental public policy issue. It's as his- toric to me as it can be. What these cases represent is whether you are going to have a marketplace that is based on buyer beware, ca- veat emptor, or whether the American people have a right to make sure that the drugs they put in their bodies and the foods that they eat and the products they use are safe and effective. That's what the fundamental issues to me in these 5 cases are. Mr. WAX~AN. I think the most dramatic illustration of that point, and I think you are going to the fundamental point that is really in dispute, is that Dr. Burzynski is accused of selling, and making perhaps millions of dollars in the process, a drug to pa- tients who are paying for this product for which he is not bother- ing, as best I can tell, to collect any data as to whether it's effec- tive, has not sought to go through the process at FDA to establish its safety and efficacy, or at least certainly its efficacy, and that if we don't have an FDA stopping people from selling drugs that have never been approved, then what we have is a wide open market. You say buyer beware. Clearly it's buyer beware. Anecdotal infor- mation to promote the sale of a product for commercial enrichment of the seller and the manufacturer will prevail over sound science to determine whether this product .is really going to do anybody any good. Cancer issues are the most dramatic. If someone goes and takes some fly-by-night snake oil that someone is selling them and foregoing real treatment that we know can work, we are not doing something casual; we are in effect misleading people into therapies that are not going to save that person's life and keeping them from therapies that might. We had a whole debate in the 1970's over laetrile. There were ~eeople who wanted to sell laetrile as a cancer cure. Finally, we said t's get a clear determination of whether laetrile is effective. After the study was undertaken, it was determined that laetrile was not effective. I just think that we ought not to repeat over and over again the fundamental flaw, that we shouldn't let the public be subjected to drugs that have never been approved as effective, par- ticularly when people are out selling these drugs in order to make money by convincing people that they are effective, however sincere 239 they may be. Sincerity is not the issue; science, as far as I am con- cerned, is the essential point before us. I have asked that this indictment be entered into the record, Are you familiar with the indictment? Mr. KESSLER. I have read the indictment, Congressman. Mr. WAxa'g_AN. The first count is for criminal contempt, which I gather is for the intentional violation of the 1983 and 1984 Federal court orders you mentioned 3 weeks ago. Is that correct? Mr. KESSLER. I'll let Mr. Spiller answer that question. Mr. SPILLER. Mr. Waxman, I am being stingy with my answers lest ! exceed the bounds of the indictment. You have asked what is the----- Mr. WAXMAN. I started with the first count. Mr. BARTON. The gentleman's time has expired. We will let the gentleman answer the question and then we will have to recognize Mr. Crapo. Mr. SPILLER. The first count involves an allegation of contempt of 2 orders of a Federal District Court judge that were entered in May 1983 and May 1984 in a civil case brought by the United States to enjoin Dr. Burzynski's introduction and distribution of his antineoplaston. Mr. W~. The other 40 charges are that he introduced an unapproved drug into interstate commerce apparently as recently as September of this year. Is that right? Mr. SPILLER. The indictment sets out the dates, and there are 40 counts that allege introduction of the drugs into interstate com- merce. That includes one of September 6, 1995. Mr. WAx~. Am I correct that the indictment says Dr, Burzynski received $40 million from~ Mr. BARTON. The Chair is going to insist on regular order. The gentleman's time expired about 4 minutes ago. The Chair is going to recognize Mr. Crapo of Idaho. Mr. CRAPO. Thank you, Mr. Chairman. Dr. Kessler, I am going to focus our attention during my ques- tioning on the Myo-Tronics case. Mr. KESSLER. If I can change my books, Congressma-n. I have a lot of books here. Mr. Cm~eo. While you are doing that, I am going to ask that a document be put into the record. As you know, Mr.. Chairman, Myo-Tronics has charged that the October 1994 Dental Products Advisory Panel was stacked against them and that the FDA's own investigation has established that the chairman of the panel had a clear conflict of interest, which was not disclosed, involving Myo- Tronics. I would like to place in the record a December 7, 1994, let- ter to Dr. Jankelson of Myo-Tronics from Dr. Alpert, director of the Office of Device Evaluation, and ask that a copy be provided to you and Dr. Alpert. Mr. KESSLER. If Dr. Alpert can join us at the table, I would ap- preciate it, Congressman. Mr. BARTON. We need to also provide that to the minority. Mr. KESSLER. Also, if I can get a copy, please. Mr. BARTON. Without objection. [The letter referred to follows:]
Page 124: TI14380232
24O 241 DI'PAI~T/~4[.NT OI IIf..Af~TII & IIU,'d^N Rolx~ R. ,lankcJson. ODS Myo-Tromc.x. Inc, I~423 - S3rd ^venuc South Tulc~a. WA g~188 Oe:u Dr. JxnV.=t'son: Thts ,sm mspons~ co your November qu~uo~ ~au~ the ~fi~Uon of m~ mom~ m~ hel~ on ~cob= of~cs~, ~a FDA h~ ~ully r~l~ ~ ~ you ~. [ w~ld li~ ~ ~ ~¢ =l~ofour f~cw w~th you. Pubhc No~c~ The ~ Nour~, ~ S=i~eznber tg, 1994. z,'mm, mc~ 13,14 Dental P~u~ P~ m~ ~d lis~ ~e cl~ of mu~e mommnng d~ ~ ~ ~ i~. ~e nou~ did noc ~ w~ d~ ~ o( ~c ~ve-m~uon~ d~ Unfonu~y. ~ no~ puohs~ • defimdve fis~ o[ wh~ d~ w~ mdud~ und~ ~ h~g o[ muscle mom~nn~ d~ AS a ~ll~ we We ~ ~n~ by num~ ~o 0c ct~sLfi~ at ~e ~b~ m~g. ~fom. we r~om men~Uons {ram ~ ~m~ ~d m~ng, ~ FDA will p~d= ~o~ oO~numW ~or ~ p~d co ~n~ ~ cl~fi~on of m~e mommnn~ ~cv~ccs. ~c d~fi~uon of mu~¢ momtannE ~=v~ ag~a foc ~ u~mmE m~ng of ~= D~ P~u~ Dcv~ ~ ~vdy scneaul~ for April 18-~. I~. In oraer (o ehm~ ~nfus~on a~( wha~ aev~ arc mclud~ ,n0m~onn~ ~cv~ ~o~. th= FDA wdi u~ thc (crm~noto~y "~l~n~c aerates ~or U~e ~a~nos~s ~or ~r~(mcn~ of com~roman~bular ~ufic jo~ ~ ~ ~ ~dfi~ for ~ d~, ~ ~ ~ ~ ~ for ~ ~ m~ as a discussant in z nonvoting capacity for ~e October m~ting; thczcfoze~ hc did not participate in the vo~," on th,- cl,~fific~on of the muscle monitoring dcvic=s, For the April [995 meeting, FDA pL~'~ to ~xp~nd th,- number of consultants provsdlng expe.r~ views to the p~ncJ to ensure tha~ z b~'~:e of opinions is rcpre.~nted. FDA m~l:c,s ¢vP.,ry effort to allow all opinions on i~uc.s to be he.zrd. Spcdo~z idenufied in z numbs" of w-ays. We conta.c~ practice and organzz~dons and ~k them (o identify individuals w~th exl:~dse to zpe~k. In addiuon, all of our pand meetings provide an opportunity to ~ny indiviOml who w~shes tim," on the agcmcla or who wish= to'sp~mJc at th,- open public ~=~ion, At the Dental Pn)duct~ Panel mez~Jng theft: w~z~ a number of slx:aJte~ who slated lha.t thcse devices have a proven record of mfery and cffecdv~less, ~nd were ochers who raised quesLions about the diagnostic value of their u.~. Wlth ch," c×cepcmn of lhc FDA speaJcr.r, all the specters that requr.sled time wen: lislr.d m a.Jphabet~c~l order on the agenda. Every l:~t~:)n lhat r~z:lul~l~d time Io sp~ w~ g=vcn Ibc oppo~unicy to address the panel. All spealc¢.n mad,- the.jr preen=icons during Ibis Ol:~n pa.ncJ meeting and prior to th¢ dine at which panel actually ~ its ddibc~tcons and voted on l.hc muscle monitoring dcvlm. o Dr. l~rtolami's Prior m each adviso~ panel m~ng, the Cenu~"s Integrity and Commit.tee iVLl~gemeat Staff soliciL~ from each panel member any information thaz may p~l a potential c~nflic~ of inmzz:sL Dr. B~n~lami's finan~al intm~l disdosun~ information ~ analyzed prior to ~ Oc.tz~ 13-14 meedn¢ of th," D=~ Preduc:zs Pznel and no basis ~ found to disallow his participation ~s Omirper~n. Dr. Be.,~lami did not anticipam a concern with his prior Involvemmt with Arthmmlc, Inc., Ixzau.m he had resigned from the Board of Dimc:~r~ in Janua~ 1989. We have invt~tig-il~l Dr. Involv~lle.~. l with Ardu'otek. Dr..B~laml ~ I~ ns a co-lnventor on patent tilled "M~thed and Appazatus for the Acoustic De~cdon and Analysis of loinl Disord~x" which is owaed by Arthrole~. However, ~s nol~cl abow, Dr. Bmolami n~igned from the Azthro~c's Board of Direc~r~ in January of t989, and thus, l~s not ~ ~ with the company and has not tecc~ved any remuneration ficc~ that tim-" Further, Dr. 13~z~lami wa~ no! ~waz~ of any lawsuits involving the papal f'ded subseClUmt to lanuary 19~i9, II is important ~ note thal the ~n of an advimry panel only votes to bnm~ a de. Becau.~ the panel vote on the ~cafion of the mu.wJ," monitoring d~.ices was unanimous, Dr. Bermlami did not vole on ~ i.~'ue. In addition, our Commitu:e Iv[anage~at Office" mvisit~:i th¢ imu¢ and found no oonfli= Of inumm~ involving Over the past few years, FDA h~ ~oc:u.~ considerable attentJon on the integl'i~ and c~dlblllty of the =ch'~sory commitl= proce~. We ~ppreciate the comm~Is you have provided in your letter ~o Dr. Burlington. [ hopo ~is ~T~on~ addresses, your concerns adequately. As the Agency pr,'par~ for the April meeting, the Executive Sdcr~, Dr. C.~ lyn Tylenda~ will contact you to discuss the upcoming mecmng. Sincer~.ly yqur~. Office of D~wic:~ Ev~u~ton Center for D~vices and R~diolog~c~! H~alth
Page 125: TI14380233
242 Mr. CnAPO. Dr. Alpert may want to assist you in answering these questions. In the paragraph entitled "Public Notice" Dr. Alpert writes that the Federal Register Notice which announced the agen- da of the panel meeting listed the muscle monitoring devices but did not specify what devices would be included. I am trying to summarize the letter here. When the panel discussed the three types of devices, jaw track- ing, stimulation and sonographic, many complaints were received from parties that felt that the FDA hadn't given proper notice and that for that reason the FDA had decided not to act on the panel recommendations. Is that a fair summary of that part of the letter? Ms. ALPERT. Yes, Mr. Congressman, it is. Mr. KESSLER. I certainly believe so. Mr. Cm~PO. I believe that letter also states that a new meeting will be held April 18 to 20, 1995. Did that ever happen? MS. ALPERT. No, sir. We canceled that meeting. Mr. CRAPO. On page 3 of the letter you wrote that the FDA had investigated Dr. Bertolami's involvement with Arthrotek, including the patent that he co-owned with the company, and found that he had resigned from the company in January 1989, had not received any remuneration since that time. Since that time we have learned from a document that is already in our record, the draft CDRH conflict of interest investigation of Dr. Bertolami, that this is incorrect and that Dr. Bertolami re- mained on Arthrotek's board, received patent royalties from the company, loaned the company money, and was otherwise associ- ated with Arthrotek after January 1989. Is that correct? Ms. ALPERT. At the time that we wrote the letter we believed that he had resigned, and that information in the letter was based on our best knowledge at the time of this letter. Mr. CRAPO. You have anticipated my next question. The letter states that there was an investigation. Had you been misinformed by your staff?. How was it that the FDA could investigate this mat- ter and still put a person on as the chairman of the panel who had this type of conflict? Ms. ALPERT. There are 2 issues, Mr. Congressman. The first is that to the best of our knowledge Dr. Bertolami did not have any longer a conflict for his chairing that panel at the time that the de- termination was made. Mr. CRAPO. Have you concluded at this point that there was that type of conflict? Mr. KESSLER. Let me answer that. On I think approximately February 28, 1995--I have to go back and check that date--the matter was referred to the Office of Internal Affairs, and that is still ongoing. There has been no determination to date, Congress- man, as told to me by the Office of Internal Affairs. Mr. BARTON. Would the gentleman yield? Mr. CP~PO. Yes. Mr. BARTON. Dr. Alpert, the letter that you signed indicates that there had been an investigation and that there was no conflict of interest. Either that investigation was not done very thoroughly or there really wasn't an investigation, because people within the 243 FDA have conducted a more thorough investigation and find that there is a conflict of interest. Mr. KESSLER. Mr. Chairman, the conclusion that you just reached that there was a violation, as told to me by the Office of Internal Affairs, there has been to date no such determination by the Office of Internal Affairs that in fact there is a violation of a statute. Mr. CRAPO. Dr. Kessler, can you tell us when we can expect such a determination from the FDA? Mr. KESSLER. I'd have to ask. Mr. BARTON. My information, Dr. Kessler, is that the gentleman in question owned stock in a competing company. Is that incorrect? That would appear to me to be a conflict of interest, I may be mis- informed. Mr. KESSLER. My understanding is that the Office of Internal Af- fairs has not reached a determination. Mr. BARTON. So when I state as a fact that the chairman of the panel owns stock in a competing company, that is, according to your investigation, not a fact? Mr. KESSLER. At what point did he own stock, Mr. Chairman? I don't have it in my head. Mr. Credo. Dr. Kessler, let me ask it this way. If it is deter. mined that the chairman of the panel was on the board of a com- peting company, that he received patent royalties from a competing company, loaned money to the competing company, and was other- wise associated perhaps through stock ownership with the compet- ing company, would that be a conflict, in your mind? Mr. KESSLER. First of all, there are specific elements of section 208 and whether something is a conflict. There certainly are waiv- ers from section 208 where there can be stock ownership. That can be waived. We'd have to get into the elements of section 208, Mr. CP~a'o. The question was, in your opinion, if we have an in- dividual who is a member of the board, receives patent royalties, loans money to and is otherwise associated perhaps through stock ownership with a competing company, is that a conflict? Are you telling me that there is a way that that could not be a conflict? Mr. KESSLER. Understand, you are dealing with the reputation of an individual with an ongoing investigation. I don't give the opinions. I say this fully respectfully. In something as serious as this, when we have a conflicts of interest charge, where you have a section 208, you have a statute, I shouldn't be giving you my per- sonal opinions. Mr. Cm~PO. Let me ask you a hypothetical question. I am not naming any individuals, any companies or any products. If you had a product that you had submitted to the FDA and it was going to be subject to a panel, would you want someone who was a member of the board, received patent royalties from and loaned money to a competing company to be the chairman of the panel for your product? Mr. KESSLER. No. Mr. CRAPO. Neither would I. About how much money was spent in the salaries and expenses on the advisory committee meeting that was held in September? Do you know?
Page 126: TI14380234
244 Mr. KESSLER. I don't have that. Mr. CRAPO. You can submit that for the record. Mr. KESSLER. I'm sorry. If you can repeat the question. Mr. CRAPO. I'm just talking about the cost of the advisory panel meeting that ended up not being able to function because of the im- proper notice. Mr. KESSLER. I'd be happy to do an analysis. I don't know that. We have a lot of advisory committees, almost every week. [The following information was received for the record:] Dental Products Panel Meeting Expenditures 0cto~' 12.t4, 199¢--Gailher~burl HIRO~ Co~t Elements Amount Conference Management Contractor= $14,829 Salaries (Members and Consultants) 4,650 Transcription 3,312 Travel (Panel Members) .................................................................................................... ........................................ 9,163 Travel (Consultants) 4,576 Total Cost $36,530 =Intrudes conlractor labo~ hours to¢ grern~inl on $~ta and postmeeting ~Jpput; dirK't m~et[n~ ¢~ts (i.e., meetinl: io~m rental, han@uts, rnillin|$, audlovi.~ll ~quipment and eummaq minutes) and ind~'ed retl~ (i,e.. fdnae t~efits, profit, i~ral and Idrninistcatlw r~tls and ova'head) Mr. CRAPO. The December 7 letter that I just put into the record also states that when the panel asked the FDA to clarify what de- vices were considered in the muscle monitoring category, Dr. Greg- ory Single,ton, of t_he FDA sai.d that the 3 c~egories in question were inciuaea, and those are the 3 categories I referred to earlier. Is that correct? Mr. KESSLER. That's certainly what the letter says, Congress- man. Mr. BARTON. The gentleman's time has expired. We will have a second round of questions. The Chair recognizes the distinguished ranking minority mem- ber, Mr. Deutsch of Florida, for 10 minutes. Mr. DEUTSCH. Thank Mr. Chairman. I would like to followYu°;'On some questions that I asked in the ~revious hearing, the first series of questions regarding the Sensor ad. One allegation swirling around the Sensor Pad, although I am not sure any of my Republican colleagues have stated it publicly, is that the FDA somehow conspired with the Canadian government to request that Canada reconsider approval of the device. Is that true? Mr. KESSLER. There certainly have been those allegations that I've heard, that have been made. Mr. DEUTSCH. Let's not answer the allegation question. Let's an- swer the factual question. Mr. KESSLER. I asked Dr. Alpert to call the Canadian govern- ment in preparation for this hearing. MS, ALPERT. According to Dr. Freeland, who has a position simi- l,ar t? m.~y own in the Canadian government, he informed me that cmarJy they were aware that Sensor Pad was an.issue in the Unit- ed States, but they had not been contacted by the FDA to change their minds, that they went through their own process, which is to 245 look at products that have gone to market with a notification t.o ~pe. riodically check those products, check their files to see if the mint- marion supports the claims of those products. They looked at the file for Sensor Pad. They questioned whether the information was sufficient. They asked the company to provide additional information. They reviewed that information and con- cluded that the scientific information did not support the claims and informed the company that they could no longer market legally in Canada. That was in July 1994, I believe. Mr. DEUTSCH. I want to be absolutely clear since this is an issue that has come up. As far as you are aware, prior to coming to tes. tify but after subsequent investigation there was no contact from FDA at all to the Canadian government. Mr. KESSLER. The allegation, I believe~ Mr. DEUTSGH. Let me just be clear. Obviously there is constant communication between FDA and the Canadian government. Specifically in terms of informing them in any way to reject or discontinue their approval of the Sensor Pad produdt. Ms. ALPERT. I'm unaware that anything of that sort took place, Mr. D~.UTSaH. At this point, we would think if it did exist you would have some type of paper trail that would exist that it did take place. Ms. ALPERT. I would expect that. Also we did receive information from the Canadian government which clarified the process that they took with IPI. I think that speaks for itself. Mr. DEUTSCH. I've asked the Canadian government to provide something in writing. Has the FDA received such a communica- tion? Ms. ALPERT. Yes, we have, sir. Mr. DEUTSCH. Could you provide it to us? Mr. KESSLER. We'd be happy to submit it, Congressman Deutsch, [The following information was received for the record:]
Page 127: TI14380235
246 Noveml~! 30. 1~95 ill: llrllii S¢~lar Pad l.)~vlccl luch ~ Ihe Br~sl Scnlor Piid li~ lloi subjca so pmmlli~i ri~ic*. The mu.,~i holily the Dh'¢¢ior whhin I0 lliy~ of fir~i lile in =ci:onlinc~ willl Sccll.n 24 oi" the M~hcil l:~vic~ Regulliionl.. Thi~ llolifi~tion impli=i lhc mlmfficlurc c~n comply with rcqulr¢n~nll of" lhc Food and Dnil~ Aci ~ M~icll [,~vic~ R, ellUlliiur~. 'l'h~ lln,~sl ~en~r Pu~ w~ nolifiul in Ci on April III, 1916. The Mcdlcal L~vic~ Bureau main~ • close ,.,s~:i~fion with m~ir,~l prol~,~io~,,li~ i, C~n~J, and/'oregOn ~egul,~toO' agcn~es, in ~6d~iun to revi,'wing sci~mific ~ m~dicll lilenl~use as it p~r, ams to medical device issues. |fptobMms ~c: ~den~B~l ~e M~lic~ L.~vic=~ R=~ulali,n~ allow For com:c(ivc u~lions to I~ ~n. lkll -',¢Ule monllorlnl of mcdic*l d~icc/' info~ii~ idcnti5~ ~n~ rig~ ~ ~cn~or Pad. Follo~n~ review of I~ ~lb~un submill~ ~lb ~c nuti~ion Ap~l I ~. 19~. ili~ul~lu~r wa~ ill[O~cd l~ 11, 1994 lhil ~ could ~o Io~tcr ~11 Ik~ ~1 in Ci mlo~lion to ~h~ Hcilih Pml~on ~h ~ r~eivc i ~ii~ ~m ~e Di~mr ~ ~ further ~vidcncc i~ sut~ci~nl Medical ~VlCel Bu~au Canad 247 Mr. DEUTSOH. Dr. Alpert, I understand that you were told by the Canadian authorities that there was no relationship between FDA's action and the Canadian request to Mr. Wright for more data on the effectiveness of Sensor Pad or Canada's subsequent decision not to allow Sensor Pad on the market. So nothing at all occurred in this area in terms of our office, your office and their contact with the Canadian government? Ms. ALPERT. That's correct, sir. Mr. DEUTSCH. It would seem from this information and further examination of the facts that this allegation of retaliatory action is meritless. I hope the FDA is not intimidated by allegations like this and will continue to communicate with the Canadian regulatory of. ficials in order to protect the public health. Dr. Kessler, can you assure the subcommittee that the FDA will continue to communicate with the Canadian officials and those of other countries in furtherance of your duties? Mr. I~SSLER. Yes, I can, Congressman. Mr. DEUTSCH. You might want to elaborate a little bit just so you can explain the difference between just the normal communication that occurs. What would normal communications be as opposed to specific criticism of this particular product in an ongoing basis with the Canadian government? Mr. KESSLER. We meet at several different levels. There is a tri- partite meeting annually between us, Canada and the U.K. At one of those tripartites we talked about communication. The Canadian government asked that we fully share our press releases, our talk papers, a good free flow of information back and forth. Dr, Alpert, I'm sure, can tell you that there is almost constant communication, We even review drug applications, AIDS drugs applications. We have reviewed jointly with the Canadian government so that we are able to approve important new AIDS drugs the same day as the Canadians. It's a very close relationship. Mr. DW.UTSCH. Let me give a perspective that I have. I think we on this committee and in Congress need to be careful that our ac- tivities do not appear to even cross the line between legitimate oversight and telling the Agency which products to approve. I was distressed by a "Dear Colleague" letter we received after the November 15 hearing citing an editorial from the Washington Times supporting the need for FDA reform. This editorial described the Sensor Pad as a simple, safe, and, by all accounts, effective product. I think it's important for us to recognize that The Washington Times does not have the expertise or responsibility to determine whether a product is safe and effective, and neither do we. This is something FDA is charged to do by law and it is in the interest of consumers that they do it effectively and appropriately. Dr. Alpert, at the last hearing you were asked a series of ques- tions about the Sensor Pad that had been raised at an Agency advi- sory committee by the Woman's Health Network. Those questions related to how FDA would ensure that any device like the Sensor Pad was effective for its labeled use. What this woman's organiza- tion said was that the Sensor Pad would need to provide a benefit to women which needs to be proven by" the manufacturer.
Page 128: TI14380236
248 I understand that you are currently reviewing another 510(k) for the Sensor Pad for use as an aid to breast self-examination. Would you walk us through the process that is underway in this review and tell us exactly what the reviewer is looking at, what FDA is looking for in the application, what the steps are, how long this process will take, and can you predict when FDA will have finished with its analysis and be able to say definitively that this product is or is not safe and effective for its intended use as the law re- quires? Mr. KESSLER. Mr. Deutsch, let me answer it generally and then anticipate what Dr. Alpert is going to say. When you are dealing with a device for the detection of breast lumps and breast cancer, obviously everybody, I am sure, agrees that if a device has a risk of masking a breast lump, that is a very serious question and needs to be done thoughtfully and thorot~ghly. We have looked back at the 10 year history and have said in the previous part of this hearing that, if confronted with the facts, we wished that we had done things differently. I apologize for this, but let me anticipate Dr. Alpert's answer. The problem is any back and forth, any discussions with a com- pany, any review of an application while it's ongoing, we are not permitted to discuss that publicly. We'd be happy to work with the committee to make sure you can have that information. We can't talk about ongoing applications where there isn't a decision. There has been a 510(k) that has been recently approved for health professionals. That, I think, is public. Mr. DEUTSCH. Could you walk through the timeframe and the process just so we see what is going on without mentioning specif- ics and the 510(k)? Ms. ALPERT. Yes, that I can do, because the committee has been made aware by the company and the public, therefore, of the exist- ence of a new 510(k). It did reach the Agency on November 15 of this year. It was assigned to a reviewer in the appropriate branch in the Division. It is being reviewed by a clinician. When his review is completed, he will write an essessment of the scientific informa- tion he reviewed and make a recommendation about a clearance or non-clearance of the product, about the labeling for such a product, and about any studies that might be needed in the post-market pe- riod for such a product. All of that would be part of his rec- ommendations at the completion of his review. We expect that such a review takes on the order of weeks. He is well into the process of the review of the science that was sub- mitted in that 510(k). Mr. DEUTSCH. I know it's not directly right on point on these 4 things, but this is a public setting. There was an article in the Wall Street Journal. I don't know if you have had an opportunity to re- view it. Mr. KESSLER. This morning I was told about it. I have not seen it. Mr. DEUTSCH. I'm sure you can respond in writing. Mr. BARTON. The gentleman's time just expired. Before I recog- nize Mr. Cox, just a policy question. Apparently under current law, the Sensor Pad, since there was no preexisting device, had to be classified for review as a class III medical device. 249 Mr. KESSLER. I'll let Dr. Alpert answer that question. Mr. BARTON. Would FDA be supportive of a reform that gave some discretion about which classification to put new devices into for review? Mr. KESSLER. It is a very important question, Mr. Chairman, It took me when I was teaching food and drug an awfully long time to figure that out. Let me let Dr. Alpert comment specifically. It's a very important issue, Mr. Chairman. Ms. ALPERT. I agree that it is an incredibly important issue. The case of Sensor Pad does bring forward the issue that a device which on its surface looks simple, because it is a post-amendments device is in fact classified automatically under the statute into class III, requiring the PMA. The requirements for PMA are dif- ferent than those for a 510(k) or a pre-market notification product. The process of classifying, of taking a post-amendments device and going through an original classification procedure in order to put it into class I or class II is in fact quite a time consuming and re, source consuming process. Mr. KESSLER. Mr. Chairman, the 1990 amendments did help in this regard. But increasingly there are issues that are raised with the 510(k) process. The 510(k) process as opposed to the class III that requires a PMA, 510(k) says in essence you have to be sub- stantially equivalent to a device that was introduced on the market before 1976. In 1980 and in 1982 there obviously was a nexus. But now you end up with devices that sometimes are substan- tially equivalent to a device that was introduced in 1990, that was substantially equivalent to a device in 1986, and then you have got to find a predicate. As we move beyond 1976, I'm not sure that the public is well served by simply being able to draw an analogy to a pre-1976 device. Again, the amendments did give us some ability to do this, The real issue is, does the device work and is the device safe? That's more important to me, Mr. Chairman, than whether it is just simi- lar to or substantially equivalent to a pre-1976. Again, I think those are very valid questions that you raise. Mr. BARTON. [ agree with the Commissioner. The Chair recognizes the gentleman from California, Mr. Cox, for 10 minutes. Mr. Cox. I thank the Chairman. I hope, Dr. Kessler, you know that Congress has been conducting oversight of Federal agencies for an awfully long time, that the Democratic Congress for 40 years conducted oversight of Federal agencies, and this Congress in the last year has conducted some oversight of Federal agencies, and that we are very interested in seeing to it that the Food and Drug Administration is living up to its charter. You understand that, of course. Mr. KESSLER. Congressman, I used tosit behind the members in a previous time. I am sitting on this side of the table. I certainly respect that. Mr. Cox. We discussed the last time you were here something that you said you weren't entirely prepared for, and I hope that as we take it up again you will have had a chance to think about it in the meantime.
Page 129: TI14380237
25O The FDA is regulating bone screws. You are in the business of regulating bone screws which have been used in one form or an- other for about 50 years in people's spines and have been approved for use in the anterior and sacral spine. I have got 2 back screws stuck in my back. I know at least that much about them. These back screws which are approved for use, for example, in the lumbar spine where mine are, are not approved for use in another backbone called the pedicle, which might be about a centimeter--I know you are looking around for things. Mr. KESSLER. I'm sorry, Congressman. I apologize. I just want to have the relevant materials. We are switching cases. I apologize for that, Congressman. Mr. Cox. Let me just ask you a quick question to focus your at- tention, if I might. Your Agency, the FDA, considers that using these screws in the pedicle bone rather than in the lumbar spine, even though the area of use might be as near as one centimeter away from bones where it is approved, is an unapproved use; is that right? Mr. KESSLER. Let me let Dr. Burlington answer that question specifically. Mr. BURLINGTON. Mr. Cox, the pedicle is actually part of tie ver- tebrae in the lumbar spine and the other bones of the spine. It's a specific part that is vulnerable both to being injured during ~ lacement of the screws and because of the contiguous structures, ecause of sitting immediately in front of where the screw would go are the great blood vessels of the body. Mr. COX. Actually, Dr. Kessler, I don't want to veer off into un- necessary detail. This is just by way of background to bring us up to speed about why I am interested. If you could give me the same answer you gave to 20/20 when you talked about this on the air. Can you tell me whether the screw is approved for use in the pedi- cle? Mr. KESSLER. There has been a 510(k) application, I believe, that was approved in January 1995 and some subsequent ones that ap- proved the device for severe spondylolisthesis in L5 and S1. L5 is a part of the sacrum, Bruce? Mr. BURLINGTON. In the lowest vertebra of the spine above the sacrum, an attachment to the sacrum itselfi Mr. Cox. Let me put the question in terms that other members of this panel can understand. The part of the spine right near to a part where the screw is approved and it's not approved? Mr. KESSLER. It's approved for certain indications in certain por- tions of the spine and not in other indications. Mr. Cox. Is there a company that is trying to get the screw ap- proved for use in that adjacent part of the spine? Mr, KESSLER. I don't know whether it's public. Mr. Cox. Are these hard questions? They are not meant to be. Mr. KESSLER. What is hard is if there is an application pending, Congressman, we don't talk unless the company has talked about it publicly. , Mr. Cox. We ve talked about it publicly in this hearing, in the last hearing. Sofamor Danek, for example. Mr, KESSLER. You are, Congressman. The problem is we just have to be careful on our side. 251 Mr. Cox. I guess that's what I really want to ask you about, how careful you have been. As you know, Sofamor Danek, which has this application before the FDA, is also being sued by some entre- preneurial lawyers who are seeking to make money from the fact that the screw, even though it has been in use for roughly 50 years for different parts of the spine, is not approved in this one part of the spine. There is private litigation going on about pedicle screws, is there not? Mr. KESSLER. Yes, Congressman. " Mr. Cox. You're aware of this? Mr. KESSLER. Yes, I am. Mr. Cox. There is a protective order issued by the court in that case making sure that information that comes from the FDA and that is used in that case remains confidential, right? Mr. KESSLER. Congressman, you raised that at the last hearing. Mr. Cox. So you know the answer to that question is right. Mr. KESSLER. That's correct, but I also learned since the last hearing that that order was at the Agency's request. In fact, as I understand it, as I have been briefed since that last hearing, and counsel can correct me, that originally the judge in that case asked that all information be released--let me let Ted Parr answer. Mr. Cox. I'm sorry, Dr. Kessler. I understand--I read the docu- ments, as apparently you did not before the last hearing--that the FDA participated in requesting this confidentiality order at the front end. I alsd understand that the court subsequently issued an order on October 26, 1995 stating that the U.S. Food and Drug Ad- ministration-this is an order of the court; we discussed this the last hearing--in violation of that very pretrial order released to the plaintiffs committee certain unredacted information ~revealing the identities of physicians and/or patients. I'm just trying to get us to the point where we were at in the last hearing. You told me at the last hearing, Dr. Kessler, that you believe that it is very important for the FDA to maintain the con- fidentiality of patient names and physician names in connecti,on with studies for FDA approvals, andtherefore you felt that the vio- lation of this protective order by the FDA was a very serious mat- ter. Did you not say those things under oath? Mr. KESSLER. I certainly did say that it was a very serious mat- ter. Congressman, after this hearing I read stories about this issue as discussed at the last hearing, and what I found interesting was the stories started with the fact that we were illegally helping law. yers on the plaintiffs' side. When I went back and ] found out that we were the ones who had petitioned the court.- Mr. Cox. The truth of this, Dr. Kessler, is very-mundane, The FDA participated in requesting the protective order in the first place because it is fundamentally necessary for the FDA to conduct its business that patient and physician names be kept confidential, It's also true that the FDA violated the protective order, and all we are talking about now is whether this was intentional or not. Isn't that correct? Mr. KESSLER. We discussed that at the last hearing, Congress- man, yes. Mr. Cox. All right.
Page 130: TI14380238
252 Mr. KESSLER. I just didn't know-- Mr, Cox. You heard some evidence of----- Mr, WAXMAN, Will the gentleman yield? Mr. Cox. I think I'm just about out of time and I haven't even gotten to the point of asking questions on new information. I am simply trying to bring us up to speed from where we were last time, Mr, KESSLER. My only point here is I think the inference was that we were helping the plaintiffs' lawyers in these cases. Mr. Cox. Dr. Kessler, you're aware that this committee received information that that was the case. I think it's perfectly reasonable that in an Agency of several thousand people that the Agency is capable at once of going to the court and requesting a protective order and somebody else within the Agency is capable of violating that protective order, and that is one of the things that we are try- ing to investigate here. Mr, WAXMAN. Would the gentleman yield? Mr, KESSLER. I'm sorry. The information you received that we were helping? I need to understand that, Congressman. Mr. COX, As we discussed at the last hearing, this committee re- ceived information that the violation of the protective order was not inadvertent. We asked you at that time whether you would assign the IG or request that the IG conduct an investigation into this. Mr, KESSLER. Alld I did so. Mr, Cox. I note that in your letter you did not make any ref- erence to the fact that confidentiality has in fact been violated. When I discussed this with Ms. Porter last time, for example, we covered the fact that the failure of a party to return these docu- ments forthwith, the failure of the party to desist from reading these documents is a violation of ethics, and the FDA itself put this into its legal filing before the court. Mr, WAXMAN. Will the gentleman yield? Mr, BARTON. The gentleman's time has expired. If you will con- clude this one thought, then we will give Dr. Kessler a chance to answer it and then we'll recognize Dr. Coburn. Mr, Cox. When you wrote to the IG, you asked that this be looked into without indicating why. You did not indicate that it was within the knowledge of the FDA that in fact apparently the plaintiffs' lawyers had used and relied upon this information which was subject to a protective order, that subpoenas were issued targeting the people who were supposed to be maintained in con- fidence by the FDA, or that any information had come your way that might lead one at least to stzspect that this might not have been an inadvertent violation by the FDA. Why didn't you ask the IG to look into Chose things? Mr. KESSLER. Let me read the first line. I'm sure you have this. We can submit this for the record. I don't want to read the whole thing, Thls is from me to the inspector general: I request that your office undertake an investigation into the dis- closure by the Food and Drug Administration of certain informa- tion protected from disclosure under FDA policies and a related court order. 253 It sounds like a pretty fair statement, Congressman. It sounds like a fair statement and a fair characterization of what I heard and what the chairman had asked me to do. Mr. Cox. I will yield to the chairman because my time has ex- pired, and we will pick this up in short order. Mr. BARTON. We will. Mr. WAX.MAN. Mr. Chairman, I ask unanimous consent to take 1 minute to address this question the gentleman has raised, that the subcommittee has information about violations. I would like to know what information the gentleman has. Mr. BARTON. You are asking for him to have 1 minute or you to have 1 minute? Mr. WAXMAN, I'm asking that we get a clarification. A charge has been made. I want to know what information the gentleman from California has that he says the subcommittee has received that in- dicates there has been a violation. Mr. BARTON. The gentleman from California on the minority side asks unanimous consent for 1 minute, Is there objection? [No response.] Mr. BARTON. The gentleman is recognized. Mr. WAXMAN. I would like to yield to my colleague from Califor- nia who made that statement. I would like to know what informa- tion you have. It ought to be on the record. You say the subcommit- tee has received it. We've never received it. I want to know what it is, this information that has led you to make this charge. Mr. BARTON. The gentleman is recognized for 1 minute. Mr. WAXMAN, The question, of course, is intentional disclosure. Mr. Cox. I think the appropriate way to look into this is to have the inspector general look into it, I would say to my colleague from California. Mr. WAXMAN. I want to know what you have. What do you have? What information do you have? Mr. BARTON. You have yielded the gentleman 1 minute. Let the gentleman have his 1 minute. Mr. Cox. I will get into this in a fulsome way when it is again my time to ask questions and adduce evidence. What I do not want to do is conduct the IG's investigation in 60 seconds or what re- mains of an exchange with my colleague from California. Mr. WAX]vtAN. If I could reclaim my time. Mr. BARTON. The gentleman's time has just expired. Mr. WAXMAN. If the gentleman would permit. We have been let- ting the chairman ask a lot of procedural questions and go into substance. I know Mr. Coburn is waiting to ask his questions, but this is an essential point. This is what Senator McCarthy said', I have before me evidence thatpeople are communists. If the gen- tleman from California has evidence, it ought to be shared .with the minority and our staff, if it is evidence that has been given to this subcommittee. Mr. BARTON. We understand. This is not going to be a brief hear- ing. Mr, Cox. Would the gentleman from California yield me an addi- tional 10 minutes right now to go into this? Mr. WMtMAN. I would ask unanimous consent you be given that additional time.
Page 131: TI14380239
254 Mr. BARTON. The Chair is going to recognize Dr. Coburn, who has waited patiently for almost 2 hours. The Chair is going to rec- ognize Dr. Coburn for 10 minutes. Mr. WAXMAN. Point of order, Mr. Chairman. He has waited through a lot of time that the Chair has used up in asking ques- tions in between. None of us have objected to that. It seems to me if we are going to have a collegial opportunity to investigate these issues, we ought not to close off the gentleman from California, Mr. Cox, from responding to something I think is very serious. Mr. BARTON. We are not closing anyone off. There are members who have waited patiently. They deserve their first 10 minutes. Mr, COBUm~. Mr. Chairman, I'd be happy to yield and I will so yield now my 10 minutes to Mr. Cox from California. Mr, BARTON. If the gentleman from Oklahoma has no objection and the gentleman from California has no objection, then we will recognize the gentleman from California, Mr. Cox, for an additional 10 minutes. Mr. Cox. I thank the gentleman from Oklahoma and I thank the chairman. I would read at this point from the transcript of our last hearing. Mr, KESSLER. If I can get a copy of what you are reading from. Mr, Cox. I'm not going to even ask you about this, Dr. Kessler, because I think the appropriate way to proceed with this is with an IG investigation. What was discussed at the last hearing is as follows. I am read- ln~, now from my own remarks at the hearing. "I asked the question about whether there's an investigation into whether or not anybody on the FDA staff could have been involved in such a thing because this committee has been advised, confiden- tially, by a person who is not technically a whistle-blower, having not claimed that status, but who wishes to remain anonymous, that this person believes that the provision of this information was, in fact, willful." ,, And I asked the question at that time, Is there an investigation underway to determine whether that's true?" In addition to a referral to the IG, is there such an investigation underway at FDA at this moment? Mr. KESSLER. [ had originally, I believe, asked the Office of In- ternal Affairs to do this, but then the Chair asked me to do this at the Office of Inspector General. I need to confer with the Office of Internal Affairs. It's at the IG, Mr. Cox. Mr, Cox. To further enlighten my colleague from California who is very interested in this subject, I would recount that we discussed at the last hearing that the physicians who are now targeted by subpoenas by these plaintiffs and who participated in the presum- ably confidential FDA study believe that the only way that they could now be getting these subpoenas is that their names were given to the plaintiffs from the unredacted master data file that was provided by the FDA to the plaintiffs. As a matter of fact, we have learned that since the FDA turned this confidential information over to the plaintiffs that there has been a fourfold, nearly quintupled increase in the rate of issuance of subpoenas to these people. As a matter of fact, the North Amer- 255 ican Spine Society tells us that while 75 percent of its members did not participate in this study at all that two-thirds of the people who are getting these subpoenas did in fact participate in the study. So it's a very nicely targeted effort bz the plaintiffs, rather obviously, it seems to me, using this information, Would you infer from the fact that all of these subpoenas are being issued to people who participated, to doctors who participated in these studies that that information has in fact been used by the plaintiffs? Mr. KESSLER. I'll let counsel answer. Ms. PORTER. Mr. Cox, no we would not draw such an inference, The order from which you were reading earlier, the October 26 order directing the FDA to provide an explanation for the disclo- sure, the concluding paragraph of that order states that the plain- tiffs committee has advised the court that as of this date it is has not used, duplicated or released any of the unredacted materials, and the court is relying on the plaintiffs' assurances as being an accurate representation. Mr. Cox. Ms. Porter, I think that is a disingenuous response. What you are telling me is that people who are violating an ethics opinions, a formal opinion of the American Bar Association, that was the position that the FDA took in its filing with the court, cause they did not send this material back to you, as they should have, did they, Ms. Porter? Ms. Porter, did they send it back to you or not? Do you have to confer on that subject? Mr. KESSLER. She's conferring with the lawyer on the case. I think that's only fair, Congressman. Ms. PORTER. Mr. Cox, it's my understanding there are further proceedings ongoing and the plaintiffs have not yet returned the materials. Mr. Cox. Isn't it the case that the ABA ethics opinion which the FDA itself attached to its filing, Opinion 92-368, says that it is the obligation of a lawyer who gets confidential information, in this case information in violation of a protective order, to send it back right away, and didn't the FDA go to court and demand that that take place? Ms. PORTER. Mr. Cox, that's correct, but there is a hearing on the FDA's motion next Monday. I gather the court will review the pro- ceedings, the filings that the Agency has made, and take next steps. Mr. Cox. But it's your view, Ms. Porter, as a lawyer that it is the ethical obligation of someone receiving information in violation of a protective order, as occurred in this case, to send it back with- out reading it and without using it, and you hope that they have not; isn't that right? Ms. PORTER. Mr. Cox, as I explained in my earlier testimony, the agency took the position in the circumstances of this case, that is, where plaintiffs have received information as part of a litigation discovery proceeding that has been inadvertently disclosed, that it is their obligation to return the materials. That is the position that we took in the filing; that is what the court will hear next Monday, Mr. Cox. Are you parsing it that freely becau_se in another case where there is another protective order violated you were on the
Page 132: TI14380240
256 receiving end and you didn't send it back? Let me ask you about this same litigation. Isn't it true that a fellow named John Coale provided some information to Mr. Zeller here that was in fact in violation of another protective order? Mr. ~[ESSLER. I will certainly leave it to counsel to characterize whether it is finely parsed. Mr. Cox. Didn't Mr. Zeller receive information from a lawyer named John Coale that was covered by a protective order? Mr. KESSLER. We can let Mr. Zeller~ Mr. Cox. I'm asking Ms. Porter. Ms, PORTER. Mr. Cox, with all due respect, I think Mr. Zeller should speak to what he did and didn't do. Mr. COX. With all respect, Ms. Porter, we covered this at the last hearing, and the FDA. Mr, KESSLER, But, Mr. Cox~ Mr. Cox. Fm sorry, Dr. Kessler, but you will not answer my legal ~tqhtuestions without referring them to lawyers, so I'm goin~ to ask e lawyer. This is a purely legal ques,tio~, I think. It ~nvo[ves this igation, There is a protective order. Ive got it here in front of me. Documents were provided by a lawyer named John Coale to Mr. Zeller, who is seated at your left, in violation of that protective order, That is, documents that were covered by that protective order were provided to Mr. Zeller, who is not a party to that pro- ceeding. Isn't that correct, Ms. Porter? Ms, PORTER. Mr. Cox, I have no personal knowledge of what Mr. Coale did and didn't do. Mr. Cox. Let me then read from correspondence from the FDA dated October 27, 1995, signed by Sharon Holston, the Deputy Commissioner, addressed to this committee. The index at Tab A-l--this is an index to documents that were provided to this committee at our request--identifies the docu- e ~ mnts prov, ded by attorney John Coale and others to Mitch Zel- ler," The index indicates the documents that are subject to the con- fidentiality order and therefore not enclosed. The FDA took the position wecouldn't have the documents be- cause they were covered by the confidentiality order. They are asterisked on the attached index. So we know exactly which docu- ments were subject to protective order. This is the FDA writing to us. Mr. Zeller, would you care to comment on that? Mr. ZELLER. Yes, I would. I did receive documents from Mr. Coale roughly in mid-June, but you are the one who drew the dis- tinction between the capacity in which I received these documents, which is not as an attorney involved in litigation but as somebody who had the power to investigate privately and confidentially with- in the Agency fairly serious allegations. It was in that context that I received a number of documents, some of which we then learned were covered by a protective order. Mr, COX, When did you learn they were covered by a protective order? What month? Mr, ZELLER. I don't recall specifically. I would say that it was sometime during the month of August. Mr. Cox. Have you returned those documents to John Coale? Mr. ZELLER. I have not. 257 Mr. Cox. Did you read the documents? Mr. ZELLER. I did. Mr. Cox. What do you know about John Coale, Mr. Zeller? What kind of a lawyer is he? Mr. ZELLER./El I know is that he is a plaintiffs attorney. Mr. Cox. You don't know anything else about him? You don't know that he was the subject of a 60 Minutes profile? Mr. ZELLER. No, sir. Mr. COX. Have you had any previous dealings with him? Mr. ZELLER. No, sir. Mr. Cox. How many times have you met with him? Mr. ZELLER. Once. Mr. Cox. In your life? Mr. ZELLER. Yes, sir. Mr. Cox. And he gave you these documents? Mr. ZELLER. When I received those documents we did not meet, Mr. Cox. So you met at another time? Mr. ZELLER. Correct. Mr. Cox. When was that? Mr. ZELLE]~. Early September. Mr. Cox. What was that about? Mr, ZELLER. To receive additional documents. Mr. Cox. In the same case? Mr. ZELLER. Correct. Those documents were not covered by the protective order, but to receive some additional documents. Mr. Cox. I'd like to draw your attention to a book that is pub- lished by Doubleday. It was excerpted in the New York Times mag- azine. It's called The Litigators. It has got a chapter on John Coale. Mr. BARTON. The gentleman's second 10 minutes has just ex- pired. Mr. KESSLER. Mr. Chairman, if I can respond to the end of that, I would appreciate it. Mr. BARTON. The gentleman's time has expired. Mr. Cox. I will reserve further inquiry into this matter with John Coale for a subsequent round of questioning. Mr. BARTON. Without objection. The Chair recognizes Dr. Coburn for 10 minutes. Mr. WAXMAN. Mr. Chairman, he has al~'eady yielded his time. Mr. BARTON. No. We gave unanimous consent for him to have an additional 10 minutes. Mr. WAX_MAN. The chairman is incorrect. Mr. BARTON. The Chair is going to recognize Dr. Coburnfor 10 minutes. Mr. WAXMAN. Mr. Chairman, the gentleman from Oklahoma was recognized for 10 minutes and he yielded his 10 minutes to Mr. Cox. It seems to me that there ought to be an opportunity for us, Mr. BARTON. But that was after we had already agreed to a unanimous consent request by the gentleman from California, Mr, Waxman, that Mr. Cox have 10 additional minutes to continue his line of questioning. Mr. W~. I don't believe that's correct, Mr. Chairman, I think there might have been a misunderstanding on your part or mine, but it seems to me the gentleman from Oklahoma was recog- nized for his questions and he yielded his 10 minutes.
Page 133: TI14380241
258 Mr. BARTON. That is not the Chair's understanding of the re- quest, Dr. Coburn has been here for almost 2 hours. Mr, Cox. Mr. Chairman, it strikes me that in any case since there are no other members on the minority side that even if Mr. Coburn yielded that it would be his turn, would it not? Mr. BARTON. I have not had 10 uninterrupted minutes to ask questions. Mr. WAXMAN. I haven't either, Mr. Chairman. Mr. BARTON. You've had two uninterrupted periods in which you have asked questions. Mr. WAXMA~. Of 5 minutes. Mr. BARTON. We are not going to get into a debate. Dr. Coburn, you are recognized for 10 minutes. Mr, COBURN. Thank you, Mr. Chairman. Mr, WAXMA.~. Mr. Chairman, may I inquire after this 10 minutes what your intent is? Mr, BARTON. You may inquire. I will recognize myself for 10 min- utes and then we will ask Dr, Kessler if they wish a lunch recess. They have been very patient. Mr. WAXMAN. Mr. Chairman, I just want to appeal to my col- leagues on the Republican side of the aisle. There are all of you and one of us. Mr, BARTON. I would.- Mr, WAXMAN. Hear me out, Mr. Chairman. Just don't cut me off. If we start off with Mr. Burr and he had his 10 minutes and then Mr, Cox had his 10 minutes and Mr. Coburn had his 10 minutes and he yielded it, and so Mr. Cox had 20 minutes, it seems to me that to add another 10 minutes to the Republican side of the aisle before you come back over here is just not the way to do business. It's contrary to the rules. Mr, Cox. Mr. Chairman, if you would yield, it strikes me that if minority wishes to participate in this hearing it is their obligation as Members of Congress to show up. Mr, WAXMAN. Yes, and they are entitled 10 minutes in sequence. Only 10 minutes. Mr. Cox. If they don't come to the hearing, then the member from California can't assume to have all their time. Mr. W~, I did not agree to a 10 minute unanimous consent request to give the gentleman from California 20 minutes. Mr. BARTON. The Chair is going to regain Mr, WAXMAN. I would like to ask the transcript be read back for the question of whether there was unanimous consent. Mr. BARTON. The Chair is going to regain order. I think the gen- tleman from California, Mr. Waxman, has a point to a certain de- gree, but as the gentleman from California, Mr. Cox, just indicated, every member of this subcommittee has been notified of the time and place of this hearing. It is not the majority's obligation to co- erce members of either side to attend the hearing. Mr. WAXMAN. How did Mr. Cox get 20 minutes when the rules provide for 5 minutes? Mr. BARTON. The gentleman from California, Mr. Waxman, asked that he have an additional 10 minutes to continue the ques- tioning. 259 Mr. WAXMAN. The chairman is incorrect and the record will so disclose. That was not the request, and Dr. Coburn was recognized and he yielded his time. Mr. BARTON. After the chairman had ruled on the gentleman from California's, Mr. Waxman's request, the gentleman from Okla- homa, Mr. Coburn, did, if I may use a phrase, magnanimously agree to yield 10 minutes, but it was not necessary because we had already accepted your request. Mr. Cox. Mr. Chairman, if you will yield, there are only 5 Mem- bers of Congress at this hearing. There is ample time for all of us to ask our questions. The chairman is being exceptionally generous in permitting us to ask questions for 10 minutes rather than 5 minutes, which is the normal rule, and I would think that if my colleague from California would desist we could get on with asking the questions and be much more charitable toward our witnesses. Mr. WAXMAN. Mr. Coburn, I would like to ask you. Did you yield your 10 minutes of questions to Mr. Cox or not? Mr. COBURN. Mr. Waxman, I think this hearing right now is ex- actly what the American people are sick of, and let's get after it, Mr. WAXMAN. Did you yield your 10 minutes or not? Mr. BARTON. The Chair is going to recognize Dr. Coburn for 10 minutes. Mr. WAXMAN. Then will we have an opportunity on this side be- fore you break? Mr. BARTON. After Mr. Coburn is recognized, I'm going to recog- nize myself. After that, if you wish a second round before we ask Dr. Kessler if they want to take a lunch break, you will be given that opportunity. Mr. WAXMAN. Thank you, Mr. Chairman. Mr. BARTON. Dr. Coburn. Mr. COBURN. Dr. Kessler, practicing medicine is a whole lot more fun than this. I think you would agree. Mr. KESSLER. Dr. Coburn, I am getting to that point. Mr. COBURN. I want to visit with you for a minute and try to make sure I convey to you I understand you have a very difficult job and it's not easy. I understand that people expect different things from you. I also understand that discretion has to be a part of your job, and I am willing to allow you any forgiveness anywhere where we think that any of us could not have done a better job. So I am not critical there. Mr. Waxman, I'm sorry. I can't even hear myself ask a question right now. If you would please give me the courtesy. Mr. BARTON. It's not Mr. Waxman's fault. It's the chairman's fault. The Chair is engaging in a dialogue. Mr. WAXMAN. I accept my responsibility and I apologize. Mr. COBURN. What I want to get to is, regardless of the focus of these hearings, there are lots of people with cancer and we give them no help. Conventional treatments fail and there is nothing there for them. Pull me a contrast with people that are struggling for anything. Science has failed; we can't give them anything, Pull me a contrast on how your Agency in its benevolence and caring wants those people to be able to receive potential, maybe very mini- mally potential treatments that are provocative, that are unproven.
Page 134: TI14380242
260 How do we handle that compassionately and accomplish giving them every opportunity, even with the fact that "buyer beware" has to be a.part of that agreement? Mr, I~ESSLER. Dr. Coburn, that is an enormously important and thoughtful question. I in ways you can only imagine wish more than anyone that I had available, for example in certain forms of ~elioblastoma, tools to take care of patients for which there is no ef- ctive treatment. I will tell you, Dr. Coburn, as I am sure you have been in that situation, that it is very important, very important to provide hope when patients want hope. Sometimes it's time to quit and you've got to know that too. You and I have been there. I have used drugs when there are no standard treatments, which I am sure you have. I have used experimental drugs as part of pro- tocols on patients where my database is 4, 5, 6 patients. Not a lot of evidence, as you know. And I do believe, as we talked last time, that we should make available drugs, certainly if there is a reason to believe they may work, to those who want them as early as pos- sible, That's why we have done a number of things. We have expanded access. There are literally tens of thousands of patients, AIDS pa- tients, for example, who have received drugs before they have been approved. That makes getting the answers a little harder, because if you make it available, it is going to take a little longer to get the answers. But there is a balance. You've got to balance access and balance it with getting the answers. I think we can do that, but I strongly believe that when you provide access, we have an obligation to do that under a clinical trial setting. Open access, but to be able to collect the kind of data that we can use to determine ultimately whether something works. Mr. COBURN. Contrast that for me. Again, this is all so I will have an understanding of the thought pattern. Contrast that with what we are doing in terms of personal exemptions. Let me kind of build a little background. There are things about the Burzynski case that I don't want to get into. There are things that I see that are wrong, things I see on both sides that are wrong. It just seems to me what I see is a different standard coming from the FDA, that if in fact we have personal exemptions and if we turn our heads to buying groups for AIDS, and if we make a very wide discretion in terms of one disease that has very, very lit- tle hope--and that we don't turn around and offer the same wide discretion that has very little hope provided we do no harm---I'm with you on that; our first job is to not harm someone--but if we can say that we have failed in medical science, that we have not been able to accomplish what everybody would want us to accom- plish, and that we can also show that there is negligible harm, then why don't we have a similar process for untreatable cancers like we have with AIDS? Is it because we have raised the aware- ness, properly so, of AIDS and we have concentrated on that? I truly see a great difference in the FDA's approach to AIDS ver- sus cancer. I think the Burzynski case, even with all the problems associated with it, there is a difference. 261 Mr. KESSLER. Let me talk personally now. Not about any of the facts in front of any grand jury or anything to do with an indict- ment. What I don't understand, Congressman, is why a physicia~ who is treating cancer patients and manufacturing a drug doesnt do that under clinical trials. I don't understand that. Mr. COBURN. And I'm not here to defend Dr. Burzynski. What I want to do is look at the process. The fact is you all have three ap- proved clinical trials for him at this time, right? Mr. KESSLER. There is one. The NCI IND, I believe, Congress- man, has been withdrawn because of either lack of cooperation or lack of patients. He has 2, I believe. Don't hold me to the numbers, Mr. COBURN. The point is there is no question that it has been ~redetermined through case court history that er.ror.s w. ere .made on is part. And I agree with you. What I want to do is draw the con- trast. If this gentleman sets up in Mexico tomorrow and does ex- actly the same thing, the personal exemption status that you all grant, they're going to have the same medicine. Or if they produce it overseas, they are going to have the same medicine. Mr. KESSLER. Let me help with my thought process on that, There is a very big difference, in my opinion, between dealing with someone who manufacturers a drug, what we call at the FDA the sponsor, someone who is going to make it, in the indictment--it's not secret. The indictment alleges $40 million in revenue. It's very different for the policies that apply to the manufacturer, the spon- sor, the physician in this case who dispenses the drug and bills for it and an individual patient. I have not been presented with a com- passionate use request, and I get them sometimes directly, that I elieve I've turned down. I believe patients should have access, I also do believe that if you are going to charge, if you are going to sell a product, I think you have certain obligations under the statute. I think there is a very big difference. The personal exemp- tion is for the patient to be able to bring in a drug. The food and drug laws apply to the sponsor, the manufacturer. There is a very big difference, Dr. Coburn, in my opinion. But I understand, Mr. COBURN, I want to concentrate, Dr. Kessler, on the patients. Mr. BARTON. The gentleman's time has expired. If you would like one additional thought. Mr. COBURN. What is likely to get lost in all this is all those peo- ple out there where we have failed to treat their brain cancers. You now as well as I do there are some positives in some of this re- search. Not good. We don't know the science. The IND has not been approved. There are only 12 patients in it right now, and it is less than what either of us would ever want to have as a minimum standard. But for those people who have no other choice, who have no other opportunity, who have no other hope, shouldn't they be al- lowed that opportunity? The 300 who arelalr.eady" get.t.ing thi.s medi- cine, if in fact there is no harm, shouldn t they be allowed to nave that medicine? Mr. KESSLER. I believe the compassionate use has a very real place. Dr. Coburn, I wish more than anyone that we had things that work in brain tumors. Mr. BARTON. The Chair is going to recognize Mr. Waxman for 10 minutes before he recognizes himself. Dr. Kessler, after Mr. Wax- man's questions, do you wish to take a rest break?
Page 135: TI14380243
262 Mr. KESSLER. I would appreciate a break, but not exceeding the time it takes. Mr. BARTON. ~ much time as you may consume is the standard term, The Chair would recognize Mr. Waxman. Mr, WAX~. Mr. Chairman, thank you very much for your gen- erosity in yielding this time to me so I can pursue my second round even though you haven't pursued your first. I think it is very mag- nanimous of you. Let me follow up on these last points that Dr. Coburn raised. When we talk about a personal use exemption, if someone were to go down to Mexico and buy a drug that had not been approved, that means we don't prosecute that individual, because that is the patient and the patient is looking for something to be available. Mr, KESSLER. That's correct. Mr. WAXM~3~. On the other hand, if there is somebody out there claiming they have a drug and they don't bother to get an IND, they don't bother to collect the data to see whether ~he drug is working, but they go out and tell people "come to me, I m a doctor, I've got a drug that will cure you, andI want you to pay thousands of dollars for the opportunity to take this drug that no one knows whether it works or not," that seems to me a pretty culpable action. Isn't that the distinction we are looking at? Mr. K~SSLER. For the manufacturer, absolutely, Congressman Waxman. Mr. W~xI~. The patient is trying to save his life. The manufac- turer is trying to suck money out of people who are desperate. That is what really bothers me in terms of looking at these two different perspectives. Mr. KESSLER. If you look at the Fifth Circuit opinions, at two of them, and the language in them, that is exactly the point that I believe the Fifth Circuit makes in looking at this. Mr. WAXl~A~. We have a law that says you can't go out and sell drugs that you manufacture without trying to get the data to see whether it works, follow a scientific method to see whether it is a valid drug, and you certainly can't go out and charge people money for it. That is the law. Dr. Burzynski has been indicted. Thirty-four counts of that in- dictment allege using the mail in furtherance of fraud, including false billing of insurers. As I understand these charges, they in- clude garden variety fraud and lying in an effort to rip off insur- ance companies. Is that an accurate statement? Mr, KESSLER. Congressman Waxman, I would appreciate it if the indictment could speak for itself. Mr. WAx~. I would refer people to pages 16 to 25 of the indict- ment. As I understand it, the indictment says that Dr. Burzynski and his institute received about $40 million from the antineoplaston business from 1988 through 1994, and that Dr. Burzynski and his wife got more than $5 million in this same period. That's what the indictment says. I refer to page 3 of the indictment. I am also correct, as I understand it, that the indictment says that his patients had to pay about $13,000 before they even start- ed, paid between $340 to $685 daily for intravenous doses, and 263 paid up to $200 daily for oral doses. That's on page 4 to 5 of the indictment. It seems to me these charges in the indictment, whether they are correct or not, they point out that the Congress set up the inves- tigational new drug procedure specifically to get new drugs into the hands of patients in the context of scientific studies and that this accusation accuses Dr. Burzynski of having treated only a handful of his patients under the FDA authorized clinical trials. Is that your understanding? Mr. ~ESSLER. Congressman, I want to be respectful. I really do believe the defendant is entitled to his day in court. Mr. W~. That's the accusation in the indictment, Dr. Kessler. Isn't the purpose of IND's to help more patients in the long run by requiring clinical trials so that the knowledge gained from the treatment of these pioneer patients can be utilized? Isn't that what an IND is all about? Mr. K~SSLEg. Absolutely. Mr. WAX_~L~. So if we don't have an IND going on, we just have somebody selling a drug; we're never going to know if that drug worked. Mr. KESSLER. You are correct. Mr. WAX.V~. That means that other people who want to benefit from a drug that may be helpful to them will not have the scientific information but only somebody trying to tell them something on an anecdotal basis. Mr. KESSLER. We'd be kidding ourselves, Congressman, if that weren't the case. Mr. W~XM~. I don't think we want quacks and frauds pushing drugs on people who are so vulnerable because they are suffering from a terminal disease like cancer. What we want is the FDA to get these drugs out to people as quickly as possible. Are you able to get a drug that has some promise available to people right away, before the final approval? Mr. KESSLER. I have spent the last 5 years trying to do exactly that, to try to get literally tens of thousands of patients access to drugs through expanded access before they are approved. I believe in that. Mr. WAXl~. If any other company or individual, such as any of the pharmaceutical companies that deal with the FDA on a regular basis, had wanted to test a new drug in humans, would they have been required to submit an IND application? Mr. K~SSLER. Yes, Congressman. Mr. WAXMAN. Under the terms of this IND, what would FDA ex- pect from the person using this experimental drug on human pa- tients? I am especially interested in whether FDA would place re- strictions on whether the manufacturer of the product or the doctor administering it would be able to charge patients for this experi- mental drug. Mr. KESSLER. Yes, there are restrictions. Mr. W~MAN. Under the law? Mr. KESSLER. Yes. Under our regulations. Mr. W~¢~. Is an IND required for any testing on humans of any unapproved experimental drug?
Page 136: TI14380244
264 Mr. KESSLER. Yes, Congressman. Mr, WAXMAN. Do you know, Dr. Kessler, under current policies for reimbursement most health insurance companies don't reim- burse for experimental drugs? So for the vast majority of patients with life-threatening cancers who cannot come up with thousands of dollars out of their own pockets, would the therapy be available to them if a doctor said he didn't want to make it available without them paying? Mr, KESSLER. They are generally made available by the drug company. I have personally advocated the drugs at a certain point in the IND process, for example, at the treatment IND; I have ad- vocated personally that the insurance companies reimburse if in fact they are the standard of care. But that is not necessarily the policy of major insurers. Mr. • WA.X.VIAN. The manufacturers of drugs during these clinical trials generally do make these drugs available? Mr. KESSLER. In the vast majority of cases, they are made avail- able, yes. Mr. WAX.~AN. ] would just point out that in Dr. Burzynski's case he made the drugs available, charged the money for it, and one would question--I'm not asking your view of it, but I'll lay it right on the table. Maybe one of the reasons he refused to engage in the normal IND process that is required for every other drug manufac- turer is that he wanted to be able to charge and not make these drugs available the way an ordinary pharmaceutical company would even though the law would require it under, an IND. Mr. KESSI,ER. Congressman, Dr. ~,oburn is not here. Burzynsk] has been going on for a decade• The quickest way to get the an- swers, the simplest way to get the answers is to do the clinical trial. In my opinion, my personal opinion, a clinical trial could have been done many times. We are still sitting here and we don't have the data on whether these work. I don't know whether they work or they don't work. But the quickest way sometimes is to do the clinical trial, and that is why the public policy as reflected in the statute requires an IND. Mr. W~XMAN. Mr. Chairman, at the last hearing Mr. Cox had asked some questions and made some statements about a Dr. Sid- ney Wolf from Public Citizen. Dr. Wolf has sent us a letter that he would like to have in the record since information was stated about him and his organization, and I would like to ask unanimous con- sent that his letter be in the record. Mr. BARTON. Without objection, with the stipulation that the routing slip on it will not be put in the record at the request of the person on the routing slip. [The letter referred to follows:] 265
Page 137: TI14380245
266 Mr. Cox. Does the gentleman have a copy of that for other mem- bers? Mr, W~. Certainly. Mr, Chairman, I thank you again for your generosity to me. I re- gret the fact that there seemed to have been some misunderstand- ing earlier, but I think you have been very fair and to me very gra- cious, I yield back the balance of my time. Mr. BARTON. I appreciate that. We are all human, to quote the Speaker, and sometimes things are not as correctly done as per- haps they should be. We are going to recess until 12:45 p.m. That's approximately 30 minutes. When we reconvene the Chair will recognize himself and then Mrs, Furse, who is now in attendance, and then we will start our second round of questions. We are in recess until 12:45 p.m. [Whereupon at 12:15 p.m. the subcommittee was recessed, to re- convene at 12:45 p.m. this same day.] AFTERNOON SESSION Mr. BARTON. The Chair will reconvene the subcommittee. Before we recessed, we had heard the second round of questions from Mr. Waxman of California and indicated that when we recon- vened the Chair would recognize himself for 10 minutes. The Chair will now do so. • Dr. Kessler, just to put into perspective this hearing, the hearing that we s.tarted on November 15 and that we are continuing today is a result of a hearing in July in which specific incidents of har- assment, intimidation, and retaliation by your Agency were alleged by witnesses before our subcommittee. Rightfully you asked that you be given an opportunity to respond and you began that re- sponse November 15 and are continuing that response today. There are 5 specific incidents, the Sensor Pad, a company called Biomet,a company called Sofamor Danek, the Dr. Burzynski Insti- tute, which we have had several discussions on today, and a com- pany called Myo-Tronics. I want to focus my first round of questions on Myo-Tronics. This is a company that came into existence in the early 1960's. They make dental products, all of which have 510(k)'s that have been ap- proved. On or about August 1991, there was an inspection of their company, and as a result of that inspection, MyooTronics received a letter in which they were requested to make a number of changes. Since that time it is the company's allegation that there has been a pattern of intimidation or harassment exhibited against them. So I want to focus my questions on the Myo-Tronics case. During the November 15 hearing, in the context of that particu- lar company, you were questioned about your Agency's policy of re- ferring alleged misconduct to the Inspector General. On page 23 of the transcrtpt of the November 15 hearing the following exchange took place. "Mr. CI~PO. It's my understanding that the statutory respon- sibility for these investigations rests with OIG. "Dr, KESSLER. I wouldagree with that. "Mr. CRAPO. You would agree? "Dr. KESSLER. I would certainly agree that in investigation of criminal conduct activities the Inspector General has to be in- 267 volved, and our Office of Internal Affairs should be working very closely with the Office of Inspector General. That's how I set up the office. That was my intent." Dr. Kessler, do you recall this exchange, and is it an accurate de- scription of your policy? Mr. KESSLER. I recall the exchange. It's certainly the words that I said. I have gone back and I have talked to our Office of Internal Affairs since then. I think I have more specific answers to those questions. Mr. BARTON. Would you also agree today that the Office of the Inspector General, the entity with the statutory responsibility, should be notified of the possible violation at an early stage of the investigation? Mr. KESSLER. That is what I have discussed since the last hear- ing, exactly what the standard is. I have done that with the Office of Internal ~ffairs. I think that there have been about 160 cases that the Office of Internal Affairs has conducted, or 156. It's something like that. It's 156 total investigations; 35 investigations where allegations have been substantiated; 60 cases where they have been refuted; and 61 pending investigations. Certainly Mr. Hampton as an 1811 investigator can comment, The standard that that office has used is if there is reason to be- lieve the elements of a statutory violation have been committed, basically probable cause, then the case certainly goes to the Inspec- tor General. Mr. B~TON. Dr. Kessler, I want to refer you to a March 20, 1995, memorandum from a Pat A. Bianchi. This was put into the record on November 15. I ask that you get a copy of that before you, and I would assume that you have got that. Mr. KESSLER. I have that, Mr. Chairman. Respectfully, you have been enormously fair both personally and to the Agency. If I am over the line, correct me, Mr. Chairman. I just need to state that I am enormously concerned that the name of an individual is cited in that memo. Personally, Mr. Chairman, I would ask at least that name be redacted so that that individual's privacy could be pro- tected. Mr. BARTON. I understand that. I am in receipt of your letter of yesterday or the day before in which you have in writing asked what you just asked me orally. I reviewed the letter, and I must respectfully say that I cannot agree to redact the name, because this particular gentleman is the chairman of the advisory panel, The appointment of this gentleman as chairman over the advisory board is one of the allegations that has been made against the FDA. It is absolutely relevant to the case. There is no way that we can redact that and pursue the investigation. I understand your concern. Mr. KESSLER. I'm before you, Mr. Chairman. The Agency is be- fore you. To me, fairness for an individual for which there is an in- vestigation ongoing, for which in this memo, I am told, that this first sentence of the second paragraph does no_t.~adequately re- flect~ Mr. BARTON. We'll get to that.
Page 138: TI14380246
268 Mr. KESSLER. But it goes to the issue of fairness and privacy to- ward the individual who is not before the committee. We spent a lot of time with Mr. Cox talking about fairness. Here you are talk- in~. I think, a more fundamental issue. You are talking not about wl~ conducted a study that we have spent hours talking about or minutes talking about; we're talking about whether someone rio- , , " 8 Res ectfullv, I just have to tell you that I feel lated section 20 . p _ ' ' 1 I'm verv stron~l_v that I would ask y.ou t.o. rec, on.slder. Tl~,a~t s_,,al~l._^._ do~g. I ha-v~ no personal interest in this whatsoever. I Don ~ ~mw this gentleman. Mr. BARTON. You've made the request. Respectfully., under the powers of the Constitution of the United States, I've g~ven it care- ful consideration and I cannot accede to your request, because, to use your term, it's fundamental to the purpose of the hearing. The subject of this memo is Dr. Bertolami and Jeff Gibbs. Dr. Bertolami was the chairman of the Dental Products Advisory Com- mittee which considered the classification of Myo-Tronics products in October 1994. Isn't that correct? Mr. KESSLER. Yes. Mr. BARTON. And Rich Thomas is a counsel in the FDA's Office • ' t of the Special Counsel for Ethics. Isn t tha correct? Mr. I~ssbEa. Rick Thomas. Not in FD/~ sir. Mr. BARTON. HHS? Mr. KESSLEr~. Yes, Mr. Chairman. , Mr. BARTON. I want to quote from this memo under the heading First, the bad news." Mrs. Bianchi, who is an employee of the FDA, states that "Rick believes that Dr. Bertolami did violate 208 during the meeting when he discussed products in which he had a financial interest, his Arthrotek patent." Dr. Kessler, 208 refers to section 208 of Title 18 of the U.S. Code. Isn't that correct? Mr. KESSLEI~. That's correct, Mr. Chairman. Mr. BARTON. This memo states that Mr. Gibbs of the Office of the Special Counsel for Ethics of HHS believes that Dr. Bertolami~ Mr. KESSLER. Mr. Gibbs is not with the Office of Special Counsel. Mr. Thomas is. Mr. BARTON. [continuing] violated the statute. Isn't that correct? Mr. KESSLER. This memo states that. Mr. BARTON. U.S. Code 208 is a criminal statute. Is that not cor- rect? Mr. KESSLER. That's correct. Mr. BARTON. These types of cases should be referred to the In- spector General under your stated policy, which I think you just elaborated again. Isn't that correct? Mr. KESSLER. You're making an assumption, Mr. Chairman, that this memo is correct, that that is what Mr. Thomas said, one. Mr. BARTON. In the plain English of it, that's the way I interpret it• Do you not read the same sentences that I am reading? Mr. KESSLEr~. In preparing for this hearing I spoke to Pat Bianchi. I also spoke to Rick Thomas. Both tell me that that first sentence is an incorrect statement. Furthermore, Rick Thomas about a week ago or in preparation for this hearing gave me his notes. Mr. Thomas told me that he did not conclude that there was 269 a violation. Ms. Bianchi told me that in fact she unartfully wrote down~ Mr. BARTON. We understand that people can go back and, for whatever reason, try to rephrase or reinterpret. Mr. KESSLER. Mr. Chairman, I would strongly urge you to look-- this is a memo that somebody else--I call you up. You write down what I said. But I have notes of what I said that are done at that time, and these notes, I think, show that what Mr. Thomas--again, I wasn't on that phone call, Mr. Chairman. Mr. BARTON. No one has indicated that you were. Mr. KESSLER. I wasn't on that phone call, but these notes indi- cate, as well as what Mr. Thomas and Ms. Bianchi said, that there was a possibility of a violation. Mr. BARTON. It doesn't say that. I understand that we can now go to the principals and they can refresh their memories and decide that what they wrote is not in fact what they intended, but the plain fact of it is that it states in this memo that this individual did violate 208. If in fact that was true or not true, the fact that there is a memo that states that would indicate to me that that should be turned over to the Inspector General for an investigation. I would think you would agree with that. Mr. K~SSL~R. Mr. Chairman, this memo is dated March 20, 1995. I believe I stated earlier today there was a referral to the Office of Internal Affairs on, I believe, February 28, 1995. That investiga- tion commenced before this memo was ever written. That investiga- tion started. This memo ha§ no affect on that investigation. If in fact, I've been told by the Office of Internal Affairs as I said earlier, there is a reasonable belief that the elements of a crime are com- mitted, then there is consultation. There has been a consultation of late, but there has not been a conclusion by the Office of Internal Affairs which began this investigation before this memo that in fact-- Mr. BARTON. Dr. Kessler, I'm not stating that this particular interoffice memo is factual. I'm not stating that it relates the truth as all parties know it today based on additional information, The point that I am trying to get at is, if we are investigating allega- tions of misconduct within your Agency and based on your stated policy, at least as I understand it, when there is reason to believe there has been a violation, the investigation of that violation is going to be turned over to the Inspector General. Here we have in black and white a memo that states a violation did occur. I don't understand why we wouldn't immediately turn that over to the In. spector General to be pursued. Again, that goes to the heart of can your Agency police itself internally. Mr. KESSLER. This committee recommended in 1993 that I set up an organization within the Agency reporting to me to do internal affairs. I've done that. These are very well trained investigators. I think on the average they have 13 years of criminal law enforce- ment experience. If these investigators conclude that there is rea- sonable belief that a crime is committed, then they turn it over under their past policy. They have not concluded. These are parties in this memo that are not part of the Office of Internal Affairs, They are not conducting the investigation.
Page 139: TI14380247
270 Mr. BARTON. I want a plain answer. If you as Commissioner of the FDA have knowledge that an employee of the Agency which ~iou are the head of has committed a criminal offense, do you be- eve that investigation should be immediately turned over to the Inspector General of HHS? Yes or no. Yes or no. Mr. K~SSLEI~. If I have information about criminal wrongdoing of an employee of the FDA, then I bring in those law enforcement offi- cials who are well trained in this, who know the elements of a crime, who look at the facts and in their professional judgment, not my opinion as a presidential appointee--they are the ones who are charged with determining whether there is a reasonable cause of whether a crime has been committed. Your question assumes, Mr. Chairman, that that first statement is correct. It is not. Mr. BARTON. The statute, as I understand it, gives the respon- sibility of the investigation to the Inspector General of HHS, and I simply asked if you want to adhere to the statute, and I take your long-winded answer to be a no. Or it depends. Or it might be. Mr. KESSLER. That is no way correct. Mr. BARTON. So then it's a yes. Is it a yes? That's not a fake question. Mr. KESSLER. The way~ Mr. BARTON. Then we will put it down as a maybe. Mr. KESSLER. Mr. Chairman, this is very serious stuff. Mr. BARTON. I know it's serious. Mr. KESSLER. This is very serious stuff. This committee made a recommendation to set up an Office of Internal Affairs. I have taken the few resources and I have moved them into this office and created this office of well trained investigators. They do initial fact- finding as set out in both the delegation of the Secretary of HHS and in our regs. If they have reason to believe that a crime is com- mitted, then they refer it to the Inspector General. Mr. BARTON. I'll stipulate that you don't stipulate that this memo constitutes official policy, but this memo in the second section where it says "Now the good news" after stipulating in the first sec- tion the bad news, in the second section begins to say "However, we maybe able to prevent this being referred." Mr. KESSLER. This was referred, Mr. Chairman. This went to the Office of Internal Affairs. Mr. BARTON. I understand that. Mr, KESSLER. These folks writing this memo had no affect at this time. This was already underway. Speaking to the head, the Spe- cial Agent in Charge, once this is referred and that investigation begun, these peep[e, me, no one could stop that investigation. Mr. BARTON. With all due respect, Dr. Kessler, you and I are en- ~oaged in what I call a nonintersecting conversation. I do not doubt r a minute that this Office of Internal Affairs is a good faith ef- fort on your part and your Agency's part to set up an investigative authority within the FDA. Mr. KESSLER. Thank you. Mr. BARTON. I don't have any question about that at all. Mr. KESSLER. Thank you. Mr. BARTON. Again, when you look at the five specific cases be- fore us, reasonable people can look at the facts in these cases and 271 come to the conclusion that the FDA is not capable of conducting these investigations internally. If in fact that conclusion is true-- I'm not saying that it is--you have to have the ability to refer these and you have to have the authority which resides in your office that they should be referred to an outside power, i.e,, the inspector general, by statute. Mr. K~SSLER. The only disagreement, and again it's a fine point~ is it shouldn't be me. Mr. BARTON. It's critical. Mr. KESSLER. It's critical. It's not me. Once this is in the Office of Internal Affairs, I do not and should not get involved in whether • "s referred The authority rests--and that why there are something. 1 . .. • " t's 1811 criminal investigators. In fact, you bring u.p My.o-T~ron,,ms. I my understanding that Myo-Tronics wrote and prmse~l--we ap- plaud and appreciate the thoroughness and aggressiveness with which the Office of Internal Affairs is conducting its investigation." Mr. BARTOI,~. With all due respect, doctor, that is beside the point. We are trying to establish if the current organizational enti- ties in place within your Agency have the power and use the power to self-police. Mr. KESSLER. And the answer is yes. Mr. BARTON. That is not an answer that I believe the record sub- stantiates. I understand you stipulate that that's the answer, Mr. KESSLER. If you would come and talk to the criminal age,nts, the 1811 investigators, and understand how they operate, I beheve you will find that we do have that c~pability. Mr. BARTON. My time, if it hasn t expired, should have expired, I do have one other question on this point. We have received a document that I am going to be asked to be placed into the record. It is a fax transmittal from the National Performance Review to you. The fax is from a Mr. Bob Stone, and the cover letter is addressed to you. It says, "Dear David, a neighbor of mine who seems to be a rea- sonable guy gave me the enclosed package of material. The situa- tion he describes sounds pretty alarming. Please look it over and advise me what I should tell him. It has already been sometime since he first wrote. I'd like to get back,, to him by the end of the month. Thanks for your help, Bob Stone. Attached to the cover letter is a legal brief from Myo-Tronics' at- torney, Mr. Gibbs to Mr. Stone, and this is dealing with the Myo- Tronics case. When your office received this, there is a handwritten note on the fax transmittal sheet that says "Kessler has it and is personally taking care of it, per Kay Hamrick." Do you have a copy of that? Mr. KESSLER. I remember it. Mr. BARTON. I'm going to ask that it be placed in th~ record. [The documents referred to follow:]
Page 140: TI14380248
Ro~.rHNG SLIP GENERATED BY: HF-40 DATE: AUG ~4, DUE D~XE FAX TRANSMITTAL COVER SHEET 750 Seventeenth Street N.W, .~.~ Wa~lnp.on, D.C. 2~6 voice 202.632.01 SO f~ 202.632.0~90 Dare: ~. To." ~:~ ~', Telephone Number: Fax Number: Special ~age or Commen~= Number of Pages Plus Cover Sheet ~
Page 141: TI14380249
~uewuJe~oO le~Je.l~d eq,l Du!~u~Auleld
Page 142: TI14380250
276 277 Mr. Robert stone Page 2 Hr~N, PHB2S @ I~iCNA.~b~ P.C I~ 1992, FDA 8ent'My~-tronics a '~warning leCte=.° The warning letter allayed that the c~any needed to a~C a pr~ckeC notification because the co~y was ~k~g new c~ had been ~ak~ng ~in~e before 1976, ~woze ~herefo~e grandfath~red. However, there Wa~ no cle~ av~u~ hywhi~ tro~cs could expl~ ~ts position to ~. ~e ~gency ~p it~ ~ ~hat a new 510(k) was nee~d, ~M~-~=o~=s never 27, 1995.} Instead of betCllng FDA, Myo-t~nlcs cooperuted and . new 510(k). F~ responded by seizing i~e prod~ct|. FDA has said that the co:pony's products were seized because they had shipped products after being told - in The war, leg letter - that the p=oducCe were unlawful. I am~ez1~l~xed by ~hll s:~. In n~rou~ co~t cases, ~ has sta~ed ~ha~ w~ let~or~ woze noC f~nal a~ ac~io~, b~t o~y ropre~ted ~ opinion of ~e author, Ye~, here ~baaed ~o seizure on ~e dimc~sued, ~ c~et~ed a ~e CatS-22: go b~pt or ~ve yo~ After the prcduc~e wars seized, Myo-tronics decided to work with F~A and sign a consent decree. The consent decree obligated FDA to review the 510(k) in sixty dayJ. F~ missed the deadline. The reasons: Lt lost the $10(k) s~asion, and the reviewers had never been tol~ shout the court deadline. i/ Hyo-troni=s has Just received a copy of m 1992 ~ memorandt~no This memo=-~dum purports ~o document what was said at • meeting betwel~ a Myo-tronics representative and two FDA District offlcinls. The m~rand~ ~rlz@~ ~h~ conversatiun. It is eX~r~ly tro~1~q ~'s snfotc~ant decisions for th~ p~ ~ee ye~s were b~sod ~n a m~d~ ~bat -- ~o~ to Myo-~onlcs - ~naccuro~ely charac~etlzed ~he c~y'e position. Inclden~ally, ~hls i~ not ~ isolated ins~ce~ I have ~'8 meeting notes oft~ con£ain in~cc~racies. May 12,.1995 HY~U~N, I~s @ MONAUrAl, P,C Instead, the company gave FDA extra ti.mo in which ~o complete its review. O~co again, there was no reciprocl~yo year, Myo-tronlc| was in~pected ~y FDA's Seattle District. ~he 1992. It was clear that he was trying ~o ga~her inform~tion • upport ~ enforc~ action agai~t ~he co~y ~volvln; ov~s ~hat had tak~ place ye~ a~o. M~-tronlos ovsn~11y leaned ~a~ ~WaSr In fa~, co~iderln~ civil ponal~les. The putative bas£~ wa~ ~at ~o co~y had s~ed dsvice~ Needless to say, this caused con~idezable After a series of telephone calls ~d le~ts~e said ~hat it would ~t seek civil p~l~i~s. Yet, headin~ o~ ~e civil penal~es proceedln~ cos~ the c~y ~ez~, ~d~nay. I~ Is ~e~ll~le ~a~ ~ co~d even resider civil p~altles again~t M~-tronics when f11~ng a 510(k)~ ~m. ag~¢y ~d already p~is~d ~s co~y by seizing its de~cel, ~ there was ~ h~w~soeve~ to p~lic. (Thin in precisely the ~d of case where Prlstd~ Cl/~Con said penalties nho~d noC be Sought.} ~he~e, An specifically said ~ had considered - ~ :e:sc~ed -- seeing civil In the meantime, in the fall of 1994, F~kheld a pmnel meeting to claseif~ dental dlagnos~ic devices. This ect10n, ~oo, was both improper and highly da=aglng to Myo-~ronics. Although dentists use many different products to diagnose dental condit~cne, the meeting's a~aDda was crafted in such s way as to apply to on~y the products of Myo-tronics and one othe~ small company. I have written a lengthy letter to F~A se~ting over the last few years, F~A has issued well over one thousand warning letter Co device c~mp~es. A su~st.ntlul peruentaqe of these alleged that the cO~y needed 4 new 510[k), Many co~las respo~ed by s~tlnq a new devicel while ~e 510(k) was bolng r,v~ewed. I~ les~In~ a It ~uld cri~le U.S. heal~h c~e. ~d, it wo~d be grossly ~f~r, ~l~ce there is no appeal or corrective mechanism.
Page 143: TI14380251
T~e low points include: aub~ec~ of ZAti~a~ion with Myo-~omios an~ ~he othe~ company. Nevertheless, he di~ n~r recuee hlm#elf. Zn £ect, At a~peaza t~at he concealed h/s fLnancAal staMsa FD~ c~ose only one coneultan~ ~or ~hs p~el. He hat been s long-~ine foe o£ MMo-~ronica an~ Ate px~ucte, p~el thai: ~d the c~ns~c~c were ~acisive. ~ As obligated bY low ~o ~oose e~er~s to sere on advisory panels, Y~e~d, i~ chose people wi~ vlz~lly no The panel voted to claezi~y devices ~hat were not on the s~en~. T~e F~A officials did noih~; to block ~hle vote. Zndesd, one FDAof~icial said Chat as long p~al c~d vo~e~ even tho~ allowe~ ~o A COPy of Myo-troni~' testimony ~ae leaM~d te ~he critics of ~hei~ devices ahead of time. s~n~la ~oup, we:e each 9ivan full speaking ~lota. Two week~ lats:~ at another davlce ~anel meeting, F~A F~ has nays: ~xpLai=ed why these handf~l of devices and not v.he dozens of =~her devices used for slmila~ puttees -- were the sut~ect of the p~ek baals oz rationale. eased on this tainted proceeding, the panel ~ecomme~ded that the devices be placed in Class IZI and pre=arket approvals ~e~ulred, This recommendation has been used hy c~itlca of the 2~9 "~lawed." ~evez, de~ite-o~.ce~aCed re~eacs, seven.~nCh~ latec i~ ~s a~111 no~ p~llcly =e~s~ed the mee~g. Nor ~ eve: ac~owledged ChaC ~h# ~#~ was ~reov,~, ~ha8 saA~ ~at At plane ~o convene a new in CMe fall of 199S to d.is~s these s~e devicai. ~ough we will head ~other p~el meeting wi~ou~ a~essing Chess mul~ip~e r~rt made av~il~le to M~-~nics, ~heze ~ be no asa~a ~Cob~t me~t~g. ;-. on ~e c~y. ~lo~,t ~¢ been~ived. The c~y has 1oa~ ~ney, M~ag~en% h~ be~ ~Ae to foc~ on developm~ an~ m~ion, because it has been ~orced ~o so mu~ affor~ ~o ces~nd£n~ to ~'s repeated ~ ~wa:c~ed a~ks on the c~y, Vice Pre~id~ ~ze's i~tiatAve to reengAneor ~ Ls c~en~la. I~ will he1~ ~ s~e a~eas. H~weve~, i~ wi~l preyer ~ ~:~behavin~ ~e e~ way in the ~e Cowa=d ~onics or ~y othe= c~y. Nor would i~ a~ess Che ~Y ~e ~le8 or ~will~n~ess ~o negotiate wi~ in.stay, ~ Please c~l if you have any ~stions ~ou~ H~-~ronics o~ P~ ~sg~a~ion generally. Je~fzey N. CO: Mr. William £, ?rim/niham
Page 144: TI14380252
280 Mr. KESSLER, I don't have the fax transmittal, but I certainly re- member the document that came in. Mr. BARTON. In my second round oi~ questioning we are going, to discuss this document. Since Mrs. Furse is not here, we are going to recognize Mr. Burr for 10 minutes. Mr. BURR. Thank you, Mr. Chairman. I'm a little concerned, since the majority of my information comes also from a letter from Ms. Bianchi, possibly what the validity of it is after the last ex- change. I would just note for the record that Ms. Bianchi is listed as an Integrity Officer. Dr. Kessler, I would suggest that if in fact there is information going out under her signature that you believe is not indicative of facts, maybe you ought to look at some internal investigation on this individual. Let me read you a statement out of your testimony when we last got together: "I have studied the testimony of the witnesses who came before the subcommittee ou July 25, 1995. In addition, after that hearing I asked a group of senior managers to review the allegations and look into the facts surrounding them, and I have studied the mate- e~ ,, rials they prepar a. I read that for one reason, because I want to ask this next set of questions to you as the Commissioner. Earlier we discussed a September 16 letter from Ms. Bianchi to Grant Wright in response, to among other things, his August 14, 1992 letter outlining concerns about a meeting that took place on August 10, 1992. Mr. KESSLER. If that letter is going to be important, I need to get it in front of me again, Congressman. Mr. Bum's. I will try to stick with those 2 letters. Mr. KESSLER. August 14? Mr. BURR. The August 14 letter from Grant Wright. Mr. KESSLER. I have that one, sir. Mr. BURR. Mr. Wright raised several questions in that letter. Relative to the August 10 meeting that Grant Wright requested for an update on the approval process, was FDA counsel present at that meeting? Mr. KESSLER. Let me get the minutes. Mr. BURR. I think if you look at Ms. Bianchi's letter, she in fact confirms that. Mr, KESSLER. There are minutes. Let me switch my books, Con- gressman. I apologize. I have the minutes of an August 10 meeting and I have the names representing the Office of General Counsel in that. Mr. BURR. Am I correct that the counsel that was represented there was Kay Cook? Mr. KESSLER. Yes, that's what the minutes reflect. Mr. BURR. Dr. Kessler, is it common practice for FDA counsel to be present in meetings regarding pending product approvals? Mr. KESSLER. I'll let counsel answer that. Mr. BURR. I'd prefer that you answer that as the Commissioner. Mr. KESSLER. I can give you my opinion. Mr. BURR. Is it common practice? Mr. KESSLEl~. I can give you my opinion. Mr. BURR. As the Commissioner of the FDA, I wish you would. 281 Mr. KESSLER. My understanding as I reviewed this case, was that Mr. Wright brought counsel to this meeting. I think at the quest---Dr. Yin is here--I think there was a feeling on the part of staff~ Mr. BURR. Is it a common.practice, though? " Mr. KESSLER. If there are lawyers in the room from the side, absolutely. Mr. BURR. Let me clarify one other thing. There was not current litigation between the FDA and Inventive Products at that time? Mr. KESSLER. I'd have to check the chronology. Mr. BURR. The section 305 had yet to be filed and the appeals process had ended. Mr. KESSLER. Mr. Chesemore tells me that's correct, sir. Mr. BuP~. Dr. Kessler, in Bianchi's letter she stated, "It's not un- common for the Agency's lawyers to come to meetings with compa- nies which have been the subject of past actions." Is that consistent with what you understand FDA policy to be? Mr. KESSLER. That it's not inconsistent for lawyers to come to the~- Mr. BURR. Based upon a company having gone through past liti- gation. Mr. KESSLER, It certainly makes sense to me. Mr. Bu~. Is it common practice for counsel of FDA to chair such a meeting? Mr. KESSLER. It depends on the setting. Mr. BURR. Remember, this is a requested meeting for an update on the approval process. There is no current litigation. There is supposedly no future litigation considered. Yet Kay Cook chaired that approval meeting. Mr. KESSLER. In looking at the minutes and page 2 of this memo, I think this was not solely a meeting--it certainly seems that some of the most striking comments were made by the lawyer from the other side. Mr. Bulm. Dr. Burlington, did Kay Cook chair that meeting? Mr. BURLINGTON. Mr. Cox, I was not at that meeting. The, min- utes that I've read indicate that Kay Cook was at the meeting. I don't know who chaired it. Mr. KESSLER. I believe she did, from what I have been told. Mr. BURR. I'm not sure how Mr. Cox is thought of at the FDAD but I'll just clarify I'm Mr. Burr. Mr. BURLINGTON. My apologies, sir. Mr. KESSLER. Was there an application pending? Mr. BUP~R. There has been an application pending for 10 years, It is difficult to figure out on that day whether there was one. The stated purpose of that meeting was an update on the approval process. Dr. Burlington, you participate in these meetings. Is it common practice for FDA counsel to chair a meeting? Not this one. Has it ever happened? Have you ever been in one that an FDA counsel chaired on an approval Mr. BURLINGTON. Mr. Burr, we separate functions. If we are dealing with a pre-approval or an approval issue, we generally~ Mr. BURR. With all due respect, if you would just answer the question yes or no. Is it common practice?
Page 145: TI14380253
282 Mr. BURLINGTON. We ordinarily would not have FDA counsel chairing a meeting dealing with an approval issue. Mr. BURR. Thank you, Dr. Burlington. Is it the policy of the FDA, Dr. Kessler, to request Department of Justice officials in discussions about future marketing of prod- ucts pending approval? Mr. KESSLER. I'll let counsel answer that. Mr. BURR. As I stated at the beginning, I'd like for you to answer it, because I'm concerned about FDA policy. We have no pending litigation; we have an approval update. Mr, KESSLER. I'm not sure there was a pending approval. I'm not sure there was an application. Mr. BURR. The Department of Justice is located in Washington. You are located in Maryland. Somebody has gone out from the De- partment of Justice to participate in that meeting. Mr. KESSLER, Congressman, the people at that meeting are here. If you want to get to the facts, they requested it. Mr. . BURR. I am concerned about what the policy is. It seems very unusual--I go back to Mr. Chesemore's comment--to the untrained eye, and I will admit I am very much an untrained eye. Is it com- mon practice at the FDA to not only have a counsel from the FDA in an approval meeting, and is it common practice to have a De- partment of Justice counsel at the same meeting? Is that common practice, Dr. Kessler? Mr, KESSLER. I don't know how many times it occurs. I assume it doesn't occur a lot of times. I don't believe that this was nec- essarily an approval meeting, though. Mr. BURR. Given the Sensor Pad 7 year history, Dr. Kessler, do you believe that the actions of the FDA by having Department of Justice off~cials there, by having the meeting chaired by your coun- sel intimidated the Wrights? Mr. KESSLER. Congressman, as I read the minutes of this meet- ing, in retrospect my own belief is that I would want the Depart- ment of Justice there. Mr. BURR. For what purposes? Mr. KESSLER. Again, I wasn't there, but it says, "Mr. Appler said that if they get a non-substantial equivalence decision, they intend to market a product without FDA approval, because they will mar- ket the product for educational purposes." Mr. BURR. IS it in fact not the practice to pull DOJ counsel in when one would be thinking about some type of criminal prosecu- tion? I realize that's an open-ended question and I won't make you answer it. Let me ask you a hypothetical. If you were Grant Wright and you walked into this meeting--In Grant Wright's letter, and you can refer to it, and I hope I've got this correctly, he stated--understand for the record, this is a statement made by Mr. Wright. It is not substantiated in the minutes of the record. But he made this state- ment about Kay Cook, that she started the meeting by saying "she immediately informed us regardless of how or for what use we la- beled the product, FDA would come after us." Mr. KESSLER. Ms. Cook is here. Mr. BURR. She is here, and I am not asking about the specifics. 283 Mr. KESSLER. Congressman, if you are not looking to get at the facts, then I don't know why I am here, with all due respect. If we don't want to get to the facts, you are asking me questions about my opinion- Mr. BURR. Dr. Kessler, I am trying to get to the facts and under- stand the situation that we are in. We have an individual who has claimed that that was said. We have the FDA who says that was not said. I'm not here to debate whether it was or it wasn't. Mr. KESSLER. But you said it was said in the meeting. Mr. BURR. I said that Mr. Grant has accused Ms. Cook of making that statement. Mr. KESSLER. Don't you think fairness dictates if you read that to have the response? Mr. BURR. Ms. Cook, did you make that statement? Ms. COOK. No, sir, I did not. Mr. BURR. Thank you very much. Would you come up to a mike and say that? Ms. COOK. No, sir, I did not say those words. Mr. BURR. Dr. Kessler, if you were in a meeting where you were in Mr. Wright's position and the counsel who chaired that meeting said that or something similar, would that be intimidating to you7 Mr. KESSLER. Congressman, if my lawyer said- Mr. BURR. That's not-- Mr. KESSLER. I will answer your question specifically. If I'm Mr. Wright and my lawyer said that if they get a non-substantial equivalence decision that we will market this product anyway with- out FDA approval and says we'll market it for some educational reason, and counsel for FDA says that that is not acceptable, that that would be violative, I don't believe that FDA's statement, if that's what was said, that wouldn't intimidate me. That would tell me very clearly that FDA is not going to allow me to market the ~roduct without approval. And in fact, I would appreciate that, ongressman, because it would put me on notice. Mr. BURR. I'll allow you the same latitude that I allowed myself in asking the hypothetical question. Mr. BARTON. The gentleman's time has expired. Mr. BURR. I'm wrapping up, Mr. Chairman. " Dr. Kessler, Grant Wright did make a serious accusation about what went on in that meeting. To whom did you assign the inves- tigation of the possibility that your coun~sel said what was stated by Mr. Wright? Mr. KESSLER. I didn't assign the responsibility. Mr. BURR. So Ms. Bianchi researched it on her own from the minutes, from the individuals, found it not to be with merit? Mr. KESSLER. I believe the letter Mr. Wright sent in was ad- dressed to Ms. Bianchi. Mr. BURR. Ms. Bianchi's response letter of September 16, 1992, I guess, would be the only investigation that was concluded. Mr. KESSLER. I believe the Ombudsman office also was involved, Mr. BURR. You made a statement on June 29. It was a memo to employees. Mr. BARTON. Would the gentleman please---- Mr. BURR. I'm wrapping up, Mr. Chairman.
Page 146: TI14380254
284 "Given our special responsibilities, all FDA employees must make every effol:t to avoid even the appearance of unfairness or re- taliatory action." To this point in the approval process, do you believe that all FDA employees have avoided even the appearance of unfairness or retal- iatory actions as it relates to Sensor Pad and the individuals? Mr. KESSLER. Congressman, as I have stated in my testimony last time and again this morning, I think looking back at this we should have sought some more creative ways to deal with this product. I believe that. This has been a long regulatory process. Just reading these minutes, for the lawyer for the other side to say we're going to market without FDA approval, I think that on all sides this could have been done better. I believe that. But I don't see where there is retaliation. I think there are mistakes, and I don't believe that counsel should chair a meeting; I don't think lawyers for companies should say we are going to go market the product without FDA approval and use some educational possibility. I think there were a lot of mistakes in this. I think there is a lot we can learn. Mr. BuRe. Mr. Chairman, you have been very patient. Let me ~st add this to the end. I truly think that these hearings have en to determine whether the internal triggers exist so that when certain things like these happen that there are investigations, that there are people, employees of the FDA that if they are at fault are held accountable. Our responsibility as this committee is to hold ac- countable the FDA. I know that we have been testy over the last 2 sessions that we have had. Truly, our effort is to get down to what is fact, what is fiction, were there improprieties or weren't there. If there were, what has FDA done to make sure that they don't happen again. It was Roger Milliken that once said, '~1'o continue to do the same thing and expect a different result defines a fool." I want to make sure that in fact we don't have a flawed system, that in fact if it remains the same, we are going to be here several years from now looking at 5 new cases vath potentially the same situation, the Commissioner looking back at it, whether it's you or someone else, saying, had we to do it over again, we would do it differently. Mr. BARTON. We thank the gentleman for those words. We recognize the gentleman from California, Mr. Cox, for 10 minutes. Mr. Cox. I thank the chairman. Dr. Kessler, I mentioned earlier this morning that I have 2 screws in my back. Mr. KESSLER. I have one here. Mr, Cox. As a result, when there was an advertisement in USA Today headlined "Do You Have Screws or Plates or Rods in Your Back?" I noticed it. It says, "For information regarding a class ac- tion lawsuit, call the phone number listed below." Tbe man who took out the ad is John P. Coale, Esquire, who promises free con- sultation and more information. Obviously he is interested in these screws. The FDA, of course, has been proposing to down classify pedicle screws, meaning that they might be more widely used. You have a published proposed rule on that subject right now, do you not? 285 Mr. KESSLER. That's correct. Mr. Cox. Have you ever heard of John Coale, Dr. Kessler? Mr. KESSLER. Certainly after these hearings. I certainly did hear the name before. I never met him, to the best of my knowledge. Mr. Cox. I was about to draw your attention to a book, a very fine book, published by Doubleday called "The Litigators." It was excerpted in New York Times magazine, and it has a chapter on John Coale. The chapter begins as follows: "Lawyer John Coale, a courthouse hustler who represented drunk drivers, was in the back seat of a taxicab near his Washing- ton, D.C. home when he heard the first radio reports of the worst disaster the world had ever known. This is the story of how he came to insert himself into the litiga- tion arising out of the Bhopal disaster in India." Mr. KESSLER. [[ remember reading that. Mr. COX. "This is going to be the biggest case in a long, long time, Coale thought to himself as his cab headed down Mass Ave- nue of the Capitol Hill section of Washington. That was Coale, al- ways playing the angle. He brought in plenty of business with his cornball television ads, but he aspired to something more than de- fending drunk driving cases. Coale, who was nothing if not an op- portunist, immediately saw in this awful disaster a chance to change his luck, a chance to attain the fame and wealth that surely would be his." There are some quotes from John Coale in this chapter about his practice. Because a lot of journalists got after him, he became quite notorious in this connection. I apologize to the sensitive ears present, but I am going to read his quotes: "I'm not going to bullshit you, he said. I want the money. I'm the bad boy. I'm a known sleazebag." All of those things are in quotes. There is a warrant out for his arrest. Are you aware that there is a warrant out for this man's arrest? Mr. KESSLER. No. Mr. Cox. It has been issued by the State of North Carolina: There is probable cause to believe that on or about the date of the offense shown he committed a violation of law. You are directed to arrest the defendant and bring him without unnecessary delay before judicial officers to answer the charges above. He cannot enter the State of North Carolina without being ar- rested, and so he hasn't and this arrest warrant remains outstand- ing. He is not subject to arrest for doing something having nothing to do with this. He is subject to arrest for unlawful solicitation, at- tempting to procure clients, and so on, in violation of the law in a wrongful death case. In other words, for breaking the rules that apply to all lawyers. The State Bar are the ones who complained about him and they are the ones who want him arrested. The American Trial Lawyers Association does not approve of this man either. This is the man that you, Mr. Zeller, took documents from in vio- lation of a court order. Mr. KESSLER. Excuse me. Mr. Cox. Dr. Kessler, I just want to ask you some questions.
Page 147: TI14380255
286 Mr, KESSLER, I just need to understand what you just said, Con- gressman. In violation of a court order? That Mr. Zeller took docu- ments in violation of a court order? Mr, Cox. Yes. Do you not believe that John Coale violated a pro- tective order? Mr, KESSLER. I can't respond as to Mr. Coale. Mr, COX. The FDA has told us in writing that the FDA possesses documents. Mr, KESSLER. That's fine. That's very helpful, as long as you are referring to Mr. Coale and not Mr. Zeller. I appreciate that. I have no disagreement there. I just needed that clar/fication. Mr. Cox. Mr. Coale provided documents that were subject to a court order, a protective order, to Mr. Zeller. Because this is the second time that the FDA has recently in connection with this very t 1[ lgatlon become involved in violating court orders, as we just read earlier, the court found that the FDA violated the court order. You don't dispute that, do you? Mr. IZ~SS[,~R. Congressman, would I-- Mr. Cox. I have the court order right here. It's dated October 26. Mr, KESSLER. Congressman, I dispute the implication that we left here last time with. We left here last time that there was a court order that FDA violated. That led certain reporters to write a story that we were illegally helping lawyers for 200 patients. The reason i am bristling at that is that we asked for the court order. That was never said. In fairness, the implication that is left--it wasn't me, but it was counsel--why would they ask for a court order if we wanted to side with one side or the other? Mr, Cox. Dr. Kessler, I think the subject of this hearing does not deal exclusively with what you did, but rather with what FDA is doing, We had some conversation at an earlier hearing about whether or not you can be responsible for all the people who work at FDA, and you will recall that your testimony was that you can- not. Mr. Kt~SSLER. We can have a long discussion on that. Mr, Cox. We n edn t at this point. The question before us right now is whether or not the FDA has been involved in the passage of information back and forth in violation of protective orders. The answer, of course, to that question is we know at least with respect to the finding of the court on October 26, 1995 is that there was a violation of protective order by the FDA I'll just read it to you. It's not that s~mebody else violated the protective order. It says "The U S Food and Dr~, (FDA) ~n v~olat~on of Pretrial Order number 147 released to the plaintiffs certain unredacted information revealing the identities of physicians ancYorpatients." As we discussedearlier, what was released to these people was not just the names of physicians and patients but rather FDA had gone to the trouble of making sure that even in the documents themselves the names weren't used but rather codes for the names, and there was a key that you had to have along with those codes in order to find out who these people were, and somehow both the code and the key for the code were transmitted to the plaintiffs so that they could figure out the names of all these people, and now these people are being subpoenaed. 287 I understand, Dr. Kessler, and it is very important for us to pre- serve the bona tides of those who are entitled to that presumption here, that we are going to investigate whether or not this was in any way illicit. But it was a violation of a court order, certainly. The penalty for that, as you know, is contempt of court. We will find out whether or not in due course there was an issue there if the IG will help us get to the bottom of this. But there is another court order in the same case that prevents further documents from being made public. Those documents were provided by John Coale, a disreputable person, to Mr. Zeller. I want to know whether or not Mr. Zeller ever talked to you about those documents. Mr. KESSLER. He did. Mr. Cox. Did he tell you that the documents came from John Coale? Mr. KESSLER. If I remember the documents that I saw briefly, there was a cover letter from Mr. Coale to Senator Breaux's staff. That is what I remember briefly skimming, and there were some attached documents. Mr. Cox. Did Mr. Zeller tell you that these documents were pro- vided to the FDA by John Coale in violation of a protective order of the court? Mr. K~SSL~I~. I have no recollection of him saying that. Mr. Cox. Mr. Zeller, did you tell Dr. Kessler that these docu- ments were provided to FDA in violation of a protective order? Mr. ZELLI~R. I didn't learn about that specific protective order until sometime later. Mr. Cox. When sometime later you learned about it did you tell Dr. Kessler? Mr. ZELLER. That was in the context of preparing to submit docu- ments to the subcommittee. I don't recall. Mr. Cox. At that time did you tell Dr. Kessler? Mr. ZELLER. I don't believe so. Mr. Cox. You never told Dr. Kessler that the FDA received these documents in violation of a court order? Why not? Mr. ~.ESSLER. That FDA received them in violation? Mr. ZELLER. There was nothing wrong with my receipt of those documents and my use in investigation of the allegations contained in those documents. My responsibility was not to further disclose or release those documents. Mr. Cox. And you did not tell Dr. Kessler that there was any issue whatever associated with the provision of these documents to the FDA by John Coale in violation of a court order? Mr. ZELLER. what difference would that have made to my inter- nal investigation? Mr. Cox. Because, frankly, Mr. Zeller, aren't you a member of the bar? Mr. ZELLE~. I am. Mr. COX. The FDA attached a legal opinion, a formal opinion of the American Bar Association, to its filings with the court very re- cently, and in connection with the violation of the protective order by the FDA demanded that the people who got the documents in violation of the protective order give them back right away because that would be their obligation.
Page 148: TI14380256
288 Mr, ZELLER. In the context of litigation. Mr. Cox. Do you take it, Mr. Zeller, to be the case that that pro- tective order had no application to the FDA whatever? Mr, ZELLER. When I received those documents in mid-June FDA was not in any way connected to the litigation, and I did not re- ceive that in the context of any. Mr. Cox. The fact that the protective order means that nobody else in the rest of the world is supposed to get these documents has no application to the FDA? Mr. ZELLER. If I receive documents that raise serious allegations about wrongdoing and some of the documents are covered by a court order~ Mr. Cox. So you read the documents? Mr, ZELLER. I read the documents and I used them. Mr, Cox. Do you know under the ABA opinion your obligation is to not read the documents and to return them? Mr. KESSLER. Congressman, I would appreciate the opportunity, because----- Mr, Cox. Dr. Kessler, I would appreciate the opportunity to con- duct the questioning of Mr. Zeller without interruption. Mr. Zeller, you were the one who received these documents. Dr. Kessler was not, and that is why I am addressing these questions to you. Mr. ZELr~.R. Mr. Cox, if your point is~-- Mr, Cox. You also just told me that you did not tell Dr. Kessler that these documents were provided to you in violation of a protec- tive order. You also just told me that you read the documents. Did you notice that on the documents they stated that they were sup- posed to be under seal? Mr. ZELLER, That they were what? Mr. Cox. Supposed to be under seal. Mr. ZELLER. No, I didn't. Mr, Cox. Did they say "confidential" on them? Mr, ZELbER. They said "confidential." Mr. Cox. We have already been over this, but you found out sub- sequent that these are in fact subject to a protective order. Mr. ZELLER. Some of them, yes. Mr. Cox. And you did not at any time tell Dr. Kessler of this fact, and you take the view, I understand, and please correct me if I'm wrong, that the protective order which says that these docu- ments must be maintained in confidence which was violated by John Coale in g/ving them to you because he was covered very di- rectly by that protective order has no application to the FDA? Mr. KESSLER. That's correct. Mr. Cox. Dr. Kessler, if you choose to answer the questions that I am putting to Mr. Zeller, I will address the rest of them to you. If that is correct, why would you not provide those same docu- ments to this committee? Mr. KESSLER. I wasn't involved in the decision of what gets pro- vided. Mr. Cox. Let me ask you right now. Because that protective order has no application to you, Dr. Kessler, and to FDA, when this committee asks for these documents, why can we not have them? Mr. KESSLER. I was not involved in that decision. 289 Mr. Cox. All right. Then please let me conduct the questioning of Mr. Zeller. Mr. KESSLER. There is an inference here. If I can have just 1 minute. Mr. Cox. I will have to ask the chairman w.hether he would be lenient with my time. ~ Mr. KESSLER. I would appreciate it if I coulc~, have 1 minute to respond. Mr. Cox. If I may have additional time to permit more fulsome responses by Dr. Kessler. Mr. BUR~t [presiding]. With unanimous consent, the gentleman is extended 5 additional minutes. Without objection. Mr. COX. Please proceed, Dr. Kessler. Mr. KESSLER. If the implication, Congressman Cox, of your ques- tion is that Mitch Zeller or the Agency violated the protective order or any legal obligation, the answer in my opinion--and I'm not a member of a bar, but I am well trained, I believe, as a lawyer-- is categorically no. Mr. Cox. With all respect, Dr. Kessler, that's not the question that I put. Mr. KESSLER. But that's the inference, Congressman, that,I be- lieve is on the table. Mr. Cox. Dr. Kessler, you are free to draw whatever inferences you wish from questions or answers at this hearing. The question that I am putting and attempting to put very specifically isufirst of all, I'll ask you the question I askedMr. Zeller. Does the protec- tive order apply to the FDA or not? Mr. KESSLER. I've not read the protective order, but I don't be- lieve that the protective order bound Mr. Zeller. It is a completely different situation when you are a party and you are counsel and you are involved in the litigation. They are very different. Mr. Zel- ler was acting in his investigative capacity as a public health offi- cial. You understand why I just can't allow the inference. Mr. Cox. Dr. Kessler, this committee asked for those documents and we were told that we could not have the documents because producing them to us would violate the protective order. If that is not correct, I would appreciate it if forthwith those documents would be provided to this member and to the balance of the mem- bers, Democrat and Republican, on this committee. Ms. THOlVrPSON. Mr. Cox, I'm the Associate Commissioner for Legislative Affairs. Although I don't believe I signed that letter, I was certainly involved in the preparation of that letter. At the time the request for the documents came in we were aware that ap~ro- tective order existed, which is obviously different from what Mr. Zeller was aware when he received them. Second, the determination was made as a prudential matter, be- cause of the seriousness with which the Agency views its obligation to protect confidential information of all sorts, to advise the com- mittee that those documents were subject to a protective order. We also advised the committee that should it choose to obtain access to those documents, we would seek leave of the court and advise the committee the same. Mr. Cox. So your position at the FDA is that you can receive these documents from self-described--I don't mean to impugn
Page 149: TI14380257
290 someone's reputation, but it was in quotes. He described himself as a sleazebag. You can receive these documents in violation of the court order from Mr. John Coale, self-described sleazebag, without leave of court, but that for the Congress to get those same docu- ments from the FDA would require leave of court. Is that your position, Dr. Kessler? Mr. KJ~SSLER. My position is that when we are acting in our pub- lic health and investigative capacity, not as a party to litigationm when we are a party to litigation, then I believe we are bound, but when we are in a public health investigatory situation, then I do believe that we can receive, and it is appropriate, and a's I read dicta in the Fourth Circuit, it is appropriate for Federal officials to receive. I have tried over the years to be prudent, Congressman, in mak- ing sure that if I have seen something that is subject to a protec- tive order that we do not publicly release it. As I read at least the dicta in the Fourth Circuit--we read it, but there is a big difference between reading it and using it for investigative and public health purposes and releasing it. Mr. Cox. Dr. Kessler, as you know, the committees of the Con- gress include an Intelligence Committee, which shares secrets far more delicate than those that you are describing here. There was no indication made to this committee by the FDA that you were willing to share that information with us under any circumstances other than leave of court. Ms. THOMPSON. Mr. Cox, I believe we did indicate that those doc- uments were subject to a protective order. Mr, Cox. That's exactly right. MS. THOMPSON. If the committee felt it was necessary to obtain those documents, we were certainly willing to work width the com- mittee. We also indicated that we thought there was a possibility that those documents would be part of what is the subject of an ongoing investigation, and we also attempt to maintain the confidentiality of those investigations so as not to prejudice the fact of those inves- tigations. So there were two elements involved with these particular docu- ments, We cited both of those elements. I don't know that we ever heard any further request from the committee regarding those doc- uments. Mr. Cox. I am flabbergasted at the approach that you take to the respective roles of the FDA and the Congress. It is obviously the view of the FDA that you can read these documents, and without substantial additional work on the part of this committee involving the court, which you did not--did you notify the court, by the way, that you got these documents in violation of the protective order, Ms. Porter? Ms. THOMPSON. I don't believe that we ever received a request from a committee to do so. Mr. Cox, I'm not asking whether you were requested by this committee to do that. I just want to know whether you have ever let the court know that you received these documents in violation of a protective order. Ms. Porter. 291 Ms. PORTER. Again, Mr. Cox, the characterization of received in violation of a protective order, as Dr. Kessler indicated, is not a characterization that we would- Mr. COX. Did you let the court know that Mr. John Coale pro- vided these documents to you in violation of a protective order? Ms. PORTER. I don't believe we have told the court that Mr. Coale provided the documents to Mr. Zeller. Mr. COX. Why is that, Ms. Porter? Do you believe you have no ethical obligation to inform the court that Mr. Coale violated this protective order and that you were the recipient of documents in violation of that protective order? Ms. PORTER. Mr. Cox, again, I would disagree with the character- ization that we are in receipt of documents in violation of a court order. Mr. Cox. What kind of documents are you in receipt of?. Ms. PORTER. Mr. Zeller received documents that in some in- stances indicated they might be subject to a protective order, but our view, our strong position- Mr. COX. Ms. Porter, with all respect, the correspondence ad- dressed to this committee--you are under oath right now--did not say they might be subject. They said those documents were subject. Ms. PORTER. Some of them were. That's correct, Mr. Cox. Mr. Cox. Given that the documents are subject to a protective order, they were provided to you in violation of that protective order by Mr. Coale; you did not notify the court that Mr. Coale vio- lated the protective order and that you had received the documents through that means; is that correct? Ms. PORTER. Mr. Cox, I have not personally reviewed the protec- tive order. I would not want to take a position with respect to the court as to Mr. Coale's conduct. What we did do with respect to this committee is offer to seek leave from the court to make these docu- ments available, and as far as I am aware, the committee has not asked us to pursue that. We would be delighted to do so. Mr. COx. Ms. Porter, I would refer you not only to the ethics opinion that the FDA attached to its filing with the court that states that the recipient of information in violation of a protective order has an ethical obligation not to read it and to return it, but also to the model rules and the prudential and common sense and good conscience bases for that opinion. Ms. PORTER. Mr. Cox, it is very, very important to stress with respect to the filing that we made as well as with respect to the position that Dr. Kessler has stated that our position is that those rules apply in the context of adversarial discovery litigation. Mr. Cox. Ms. Porter, you cannot have it both ways. Either they don't apply to you, in which case you could provide those docu- ments to the Congress, or they do apply to you. Ms. PORTER. Mr. Cox, when we did receive those documents in the context of litigation proceedings in this case, in the context of representing defendants in depositions, we took precautions to en- sure that those documents would be protected, because we received them in that context. Mr. Cox. In fact you did more with the documents. Mr. BARTON. The gentleman needs to wrap this up. He has had an additional 5 minutes, and that expired 2 minutes ago.
Page 150: TI14380258
292 Mr. Cox. The purpose of that extension, I should add, was to pro- vide an opportunity for Dr. Kessler to answer a question. Mr. KESSLER. I had requested a minute. Mr. BARTON. I don't want to shut this off, but we do need to con- clude. Mr. ZELLER. Mr. Cox, could I please add-- Mr. Cox. All I want to get to in my remaining scarce time is whether or not, Dr. Kessler, the FDA used that information in any way, Mr. ZELI~.I~. Mr. Cox, could I please add one thing for the record? Mr. Cox. I'd again have to ask the chairman, because my time is short. Mr, BARTON. It has been stipulated numerous times we want the truth. So the gentleman and I assume under oath he is going to tell the truth. So if you will put it on the record very quickly, then Dr. Kessler can answer, and then we will recognize Dr. Coburn. Mr. ZELLER. Just one very brief point, because I sense that it is hanging over this exchange, and it has to do with your description of Mr. Coale and Mr. Coale's description of himself and the rela- tionship between that and my receipt and use. and the Agency's use of the documents. As fax as I am concerned as a public health offi- cial, this issue is about the documents, the contents of the docu- ments, and not about Mr. Coale's character. Let's talk hypothetically. The most despicable human being on earth could be in possession of documents that would be very rel- evant and important to a public health agency like FDA, and if the most despicable human being on earth comes forward with that in- formation and the information is credible, put aside who the person is, we have an obligation to at least look into it. That's all I wanted to say. Mr. Cox. And you did in fact, did you not? Mr. ZELLER. I sure did. Mr, Cox. What exactly did you do? Mr. ZELLER. I received the documents. There was at least docu- mentary substantiation for allegations that were made about fail- ure to disclose financial interest. After bringing myself up to speed on the long history of pedicle screws at the Agency, I sat down with the Associate Commissioner for Management at the agency. The case was referred to our ethics branch for a first cut at the allega- tions, and the ethics branch and the Associate Commissioner for Management came back to me and said that there were three cases involved; for 2 of the 3 cases the allegations were serious enough to be referred to the Office of Internal Affairs. Mr. Cox. Did the down classification of the pedicle screw get de- layed for this reason? Mr. ZELLER. At that point the proposed down classification had been forwarded to the Commissioner's office, and we did take sev- eral weeks to look into the charges. Mr. Cox. Did you eventually find that the charges were war- ranted? Mr. ZELLER. The Office of Internal Affairs concluded that there was a failure to disclose but that it did not constitute a violation of the law. 293 Mr. Cox. Therefore it did not in the end affect your judgment to publish a proposed rule; it only de.layed it; is that right? Mr. KESSLER. There was one issue, and Mr. Zeller can answer that question. There is a question that I became aware of, and I recommended that the rule go forward but an audit be conducted afterwards. Mr. ZELLER. Separate and apart from the issues of failure to dis- close a different allegation was made about the quality of the audit that was done of a very important study. Mr. KESSLER. And whether that audit was independent. Mr. ZELLER. Right. The adequacy of the audit and the independ- ence of the audit. Those charges were substantiated. In light of the information that was brought forward by Mr. Coale and another in- dividual, we agreed that there were problems with this audit. We didn't want it to hold up publication of the proposed rule and de- cided that we would do our own internal audit while the rule-mak- ing was ongoing. Mr. Cox. Dr. Kessler, returning to where I was before Mr. Zeller wanted to add to this, do you have any other knowledge of reliance that the FDA placed on the documents that were given to you by John Coale? Mr. KESSLER. Say it again. I want to answer it accurately. Mr. Cox. Just state in your own words, if you would, what reli- ance FDA placed or what use FDA made of the information pro- vided to you by John Coale. Mr. KESSLER. I think Mr. Zeller fairly described how the Agency looked into those documents, what issues they raised. Mr. Cox. And you considered that relevant, at least at first, to the proposed down classification of the pedicle screw? Mr. KESSLER. It's my understanding that there was advice of cer- tain people who said these things. I originally said they should be looked into; other people thought it was relevant they should be looked into; I think we could be severely criticized when we don't look into things. Mr. ZELLER. Mr. Cox, the answer to that question is yes. At the time that we got the allegations with documental, support, they could have had bearing on the rule-making. That s the key. Th y could have, and we had to look into it. Mr. KESSLER. And in fact the audit was a close call, I will admit. As I understood, I recommended to the center that I thought they could go ahead publishing it, but it was up to them. I think the agreement on that cohort study was that there would be an inde- pendent audit of the data. It looked like from the little information that I had available that it wasn't as independent as previously thought. I made the recommendation to go ahead. But I think that's probably relevant to the down classification. Obviously it goes to the question of the reliability of the data. Mr. Cox. I am very concerned, Mr. Chairman, that effectively what John Coale was able to do here, based on the testimony we have just received, is to delay further the publication of a proposed rule on back screws. The purpose that he set out to achieve was clearly achieved. He violated a court order in order to do it. What we have also learned from this testimony is that notwith- standing the fact that FDA knew that these documents were pro-
Page 151: TI14380259
294 vided in violation of a court order they did not notify the court and still have not as of this date. I'd ask you, Dr. Kessler, whether or not you have, or if you have not, whether you would be willing to ask the IG to look into this matter. Ms. PORTER. Mr. Cox, I just want to go back to our earlier discus- sion to be sure we are correct. We have not and do not take the position that we know what Mr. Coale did with respect to the order. As Mr. Zeller indicated, our focus was on the documents, documents that he received in the course of his investigation. When we know of something that occurs in the course of proceedings in which we are involved in litigation, as was the case with respect to the inadvertent disclosure, we took the position that we took in the litigation. I want to be very clear that we have not looked into the other matter. Mr. BARTON. If I could conclude this. Mr, COX. I yield back to the chairman. Mr. BARTON. It has been established that someone has violated a court order and that FDA knows about it; FDA has done nothing to notify the court; you've invited this committee several times in the last 5 minutes for us to request that you notify the court. Is there somebody within the FDA or a department within the FDA that has the authority to investigate this and then notify the court? Mr. KESSLER. The conduct of a party such as Mr. Coale is under the jurisdiction of the court. I'm sure from these discussions which are public the court will take notice. Mr. BARTON. It's your position that the FDA has got no obliga- tion to do anything on this issue, not do an investigation, not notify the court; is that correct? Mr, KESSLER. I don't know what violation we would be inves- tigating. I would be happy to work with you, Mr. Chairman, on your access to the documents. Mr. BARTON. To use the terminology that has been introduced, the inadvertent transmission of documents against the court order. It has been established, I believe, that the FDA-- Mr. KESSLER. On the inadvertent release of documents by the Agency~ Mr. BARTON. That's your term. Mr. KESSLER. By the inadvertent release of documents by-- Mr. Cox. Dr. Kessler, if you might yield, I would ask you please to permit th.e Inspector General to have a free hand in this inves- tigation rather than determining the conclusion in advance. The purpose of the investigation, as I understand it, is to discover the answer to the question. Mr. KESSLER. Absolutely. On the inadvertent disclosure of the documents that we talked about last time~ Mr. Cox. If it is indeed inadvertent, then there is nothing to in- vestigate, is there? Mr, KESSLER, Mr. Cox, you are 100 percent coi'rect. I am wrong in use of that term. That was how I was briefed. I am 100 percent wrong, Mr. Cox, in using that term. Mr. Cox. I should say that this committee does not believe, Dr. Kessler, that you personally did this. We are only concerned that 295 this might have occurred without authorization by you as a result of the action by some malefactor of the FDA. Mr. KESSLER. On disclosure of the unredacted documents, you are 100 percent correct. We have asked the IG, and you are correct. Mr. BARTON. With that final conclusion, let's recognize Dr. Coburn for 10 minutes. Mr. CoBum~. Thank you, Mr. Chairman. There is something here that is worrying me, and it should worry the American public a great deal. We have just heard testimony that nobody in the FDA believes that the release of these docu- ments to you, because they weren't going to be used in some form of litigation, violated this court order at all, that there is no obliga- tion on your part to come back and now notify the court because the FDA is above and beyond the meaning of that court order. The thing that is troubling me is not the fact of it; it's the fact that everybody sits there and says that we're above the law, that because we are not going to use this information in some type of litigation and we have a reason to need to know because we are a public health office, that we are above the court. That's exactly what has been said here. The FDA has just testified before this body that because they were not and they do not perceive them to be a party in litigation, that therefore the transfer of these documents to you as an organi- zation does not require you to notify the court that somebody has given you the documents that were sealed. What bothers me is that you have now placed yourself above everybody else in this country. Everyone. Mr. KESSLER. You have an obligation if you have documents~ Mr. COBURN. I'm going to notify the court myself that you all have these documents(because nobody else here wants to. Mr. KESSLER. Dr. Coburn, are you saying that the U.S. Congress when it gets documents subjected to a protective order when it's not a party.- Mr. COBURN. We have an obligation to tell the court. Mr. COX. Will the gentleman from Oklahoma yield? Mr. COBURN. Yes, I'd be happy to yield. , Mr. Cox. I would just read from the court s order itself: Confiden- tial discovery material may not be used by any person receiving such discovery material for any business. It shall be used solely for purposes of this litigation and the agreed State court litigation and for no other purpose without prior written approval from the court. Mr. KESSLER. Who does that bind, Mr. Cox? Mr. Cox. The ethics opinion that the FDA sent to the court makes it very clear, it seems to me, that there are ethical obliga- tions on members of the bar, including Mr. Zeller, that would re- quire them to act in accordance with the court's order. All of us have an obligation when somebody violates a court order, it seems to me, to assist the court in enforcing its process. Mr. CO,URN. Let me reclaim my time, if I may, because it's short. My point being no criticism of you. The fact is we now have put before the Congress and this committee that there is a dif- ferent standard with respect to the FDA in terms of--- Mr. KESSLER. No, Dr. Coburn, I don't believe that's correct.
Page 152: TI14380260
296 Mr. COBURN. L~t me finish my point. I'm not an attorney. I admit that. But what I heard is what the American people are going to hear out of this hearing, and what they heard was it's be- cause we're not going to use it in litigation and we have a need to know; therefore we have no responsibility to pay any attention to the sealed nature of this information; and therefore we have no ob- ligation to give it back to the court and notify the cour~ that we have in fact obtained information that we are not supposed to have. That's my point. The point is not the mechanics of it; the point is the arrogance of this Agency. That's exactly what the American people are feeling right now, that our whole government is above us, that they are not responsive, that they have a different stand- ard than what we have as individuals. Mr. KESSI~ER. Dr. Coburn, respectfully, I disagree. Again, I'm not a member of a bar, but I have been legally trained. The issue is who that court order binds. I don't believe that your statements can reflect that we were bound by that. In fact, I believe there is dicta in the Fourth Circuit. There is not a lot of law on this issue, but there is dicta in the Fourth Circuit. Mr, COBURN. The point is, are you ethically bound to notify this court that you have information that they have asked not to be re- . leased? Is there any ethics that you should notify the court, Ms. Porter? Ms. PORTER. Dr. Coburn, as Dr. Kessler was trying to explain, other investigative agencies, and it has been reflected in judicial precedent, during the course of investigative proceedings receive and use documents that are subject to a court order. It is not a question of being above the law. It is a question of what the gov- erning law is. Mr, COBURN. I understand that. Ms. PORTER. The governing law is very dear. Mr, COBURN. My question is, should you not ethically now notify this court that you have that information? There is no ethical re- quirement that you should do that? That's what I'm asking. I don't tare what the law is; I want to know what the ethics of it is. Should you let this court and this judge know that this protective order on this information has been violated? Mr. I~SSLER. I do not believe that a public health or law enforce- ment agency, as long as it doesn't induce the documents to tome into the agency, as long as it's not a party, I believe it is appro- priate and I believe there is appropriate public policy that would support a public health or a law enforcement agency being-- Mr. COBURN. Wonderful. Therefore you would obviously agree to give us all that information. Mr. BARTON. I want to hear the last part of your answer. You said "I don't believe there is..." What did you just say? Mr. I~SSLER. I believe that there is appropriate public polity for law enforcement as well as public health agencies, as long as they don't induce the release of information, as long as they are not a party to a court order, to have knowledge of things and be able to investigate things that may be relevant. Mr. COBURN. Then why would you have to seek the leave of the court to give us the documents? 297 Mr. KESSLER. There is a difference. Where I draw the line, Con- gressman~ Mr. Cox. If I might, Congress cannot have them? Mr. KESSLER. Congressman, I'd be happy to work with you. I really would be happy to work with you on these documents. Ms. PORTER. Dr. Coburn, if I might. If the question is disclosure to Congress, you should know that we have done a little research on this subject, and not surprisingly, this has come up before. There have been instances in which other Federal agencies have been requested by oversight committees to provide information that is subject to a protective order which they have entered into and which they have been a party, Mr. COX. Ms. Porter, if you will yield, that is not this case. Ms. PORTER. I understand, Mr. Cox. My only point was that is- sues have arisen in other context with respect to disclosure to Con- gress. I think the point that both Dr. Kessler and Ms. Thompson were trying to make is that not as a legal matter, but as a pruden- tial matter~ Mr. COBURN. I understand all that. My question is simply this. If the FDA is not accountable to the court for this information and the FDA~ Mr. KESSLER. Of course~ Mr. COBURN. Let me finish, please. If the FDA is not accountable to notify the court that this information violates a court order and if they are not accountable to give it to the Congress, because the Congress certainly is as trustworthy as the FDA, then who in the world is the FDA accountable to for this information? Who are you accountable to? Nobody? Who are you accountable to? If you are not accountable to us and you are not accountable to the court, who are you accountable to? Mr. KESSLER. Congressman, you handed me an index of the doc- uments and the committee handed me last time an index of the documents. I said that I would be very happy to work with the committee. Mr. CosUl~. Dr. Kessler, that's the mechanics of it. Mr. KESSLER. We're accountable to the people, Congressman. Mr. COBURN. Through who? That's part of the purpose of an oversight committee. Mr. KESSLER. And it's part of the responsibilities of three branches of government. Mr. COSURN. So if in fact the court has no bearing on your han- dling of this information as you interpret the law~ Mr. KESSLER. Whether we have an independent responsibility to notify. Mr. COBURN. I understand that. That's your opinion-and I've taken that. At the same time that logic that says that you are not keeps you from giving it to this committee. Mr. KESSLER. I think we need to be thoughtful on how we give it to this committee. Mr. COBURN. Dr. Kessler, pardon me. You all have sent a letter to this committee that the way we get this information is to take leave of the court. Is that not true?
Page 153: TI14380261
298 Mr. KESSLER. It certainly would be a prudent way to do it, Con- gressman, but I would be happy to work with the Chair and dis- cuss what the prudent ways are to do this. Mr. COBUI~. My point is that we have a different standard. Mr. KESSLER. Congressman, with all due respect, the letter that I saw on this was addressed to the staff of Senator Breaux. It's like the FDA has documents that no one else has, as I understand it. That's the way I saw that letter. I don't know whether Senator Breaux or his staff have these documents, and I have not asked. But that was the letter that I saw. Mr. COBURN. Dr. Kessler, I am not accusing you of not wanting us to have this information. Please understand. What I am worry- ing about more than anything is I want the American public to ab- solutely trust the FDA. I want them to think that there is no ques- tion that they are going to do the right thing every time; that they are going to have their best interest on balance with common sense so that they can get the benefits of what the Food and Drug Act was all about. That's what I want them to have. What I have just heard this afternoon gives me great cause for alarm that many people sitting out in Oklahoma are going to say, FDA can't work for us, because they are not us. Mr. BARTON. The gentleman's time has expired. Mr, KESSLER. Can I respond? Mr. BARTON. Yes, sir. Mr. KESSLER. I think, Dr. Coburn, that, if anything, the way we have handled these documents should give confidence. One, we've looked at allegations. I have sat here and gotten criticized that I have not investigated other allegations quick enough. You could criticize us for not. So we have looked at that. We have been pru- dent on how we handle things now that we know they are under a court order. That should give you confidence. I'm willing to work with this committee. I think if I looked at this from the American people's side, I would say, hey, they are doing their job. They are investigating things. They are looking at things. They are seeing whether there are problems. They are try- ingto strike the right balance on how to handle documents. Mr. • COBURN. Could I ask one simple question? How long has the doctor been in Washington? How long have you been in and around Washington? Mr. KESSLER. This go-around, sir? Mr. COBURN. Total. Mr. KESSLER. It's 5 years ago this month that I was nominated by the President, and I was here previously. Mr. CoBum~. I would surmise that the reason that you would think that is because you've been here and not out of here. That's why you would think that. Mr. BARTON. The Chair is trying to be as magnanimous as pos- sible in the time, but I don't think we have adhered to the 10 minute rule once today. Dr. Kessler, I'm going to recognize myself for 10 additional min- utes of questions. I want to go back to Myo-Tronics. When I was last asking questions I had referred to a memoran- dum. 299 Mr. KESSLER. Again, I apologize. If you could extend yourself 30 seconds while I get the document. Mr. BARTON. I want you to get 2 documents before you. I want you to get the interoffice memorandum dated March 20, 1995, from Pat Bianchi, and I want you to get the fax transmittal dated gust 24, 1995, from the National Performance Review. Mr. KESSLER. I have both of those, Mr. Chairman. Thank you, Mr. BARTON. I did not give you an opportunity in my previous round on the interoffice memorandum. You alluded to the fact that there were additional facts that had come to your attention since that memo. I will give you the opportunity now to state any addi- tional information that regards the March 20 memo that you might want to put into the record. You stated that what was in that memo, to your knowledge today, was not factually correct. Mr. KESSLER. The first sentence of the second paragraph, Mr. Chairman, that says "Rick believes that.., did violate 208." In con- versations with both Rick Thomas and Pat Bianchi, and most im- portantly, in talking to the Office of Internal Affairs, that certainly does not reflect the current state of affairs, and according to those people didn't reflect it at the time of the conversation, and I made reference to Mr. Thomas' notes. Mr. BARTON. If yOU can, will you provide to this committee any information that makes that first sentence in that second para- graph incorrect? Can you provide that to the committee? Mr. KESSLER. We'd be happy to give you Rick Thomas' notes, which I think are relevant to that first sentence. [The notes referred to are retained in the committee files.] Mr. BARTOS. Is there anything else? I don't want to belabor that point. I just want to give an opportunity for you to put everything on the record. Mr. KESSLER. That was the msjor point in our conversations. I appreciate it. Mr. BARTON. I want to refer to the fax transmittal dated August 24, 1995. This is a fax transmittal from Mr. Bob Stone to you, As I indicated, it indicates that an individual on your staff, Kay Hamrick, who I am told is your personal assistan~is that correct? Mr. KESSLER. That's correct. Mr. BARTON. Indicates in her writing that you are going to per- sonally take care of it. Mr. KESSLER. That's not quite correct. Let me tell you what my recollection is. Mr. BARTON. What I have before me says, log in AF. Kessler has it and is personally taking care of it, D/per Kay Hamrick, and it's dated 8/23/94, which is actually 1995. Mr. KESSLER. I think that's probably an accurate statement on Ms. Hamrick's part. It's probably Dennis Myers per.Kay Hamrick, I think that's probably an adequate reflection from where they sat, Mr. BARTON. Give me your analysis of what you did. First, let me just ask the question. Did you ever see this information in that time frame? Mr. KESSLER. Yes, I saw this. Mr. BARTON. You saw it in this August timeframe when it came in?
Page 154: TI14380262
300 Mr. KESSLER. I saw it. I can't tell you exactly the date, but I cer- tainly did see it. Mr. BARTON. Once you saw it, did you indicate to either Dennis or Kay that you would take care of it? Mr. KESSLER. What I remember--and I have to sort it out--was either asking Mary Pendergast or Diane Thompson or both. I have some recollection of asking them to look into this. Mr. B~,RTON. So you do have a recollection that you actually saw the material? Mr. KESSLER. Yes. Mr. BARTON. I'm assuming if you saw it you read it. Mr. KESSLER. How many pages were the attachment? Mr, BARTON. Approximately 6 or 7 pages. At least what I have before me. There may have been more. Mr. KESSLER. My recollection was a pile, and I think it's fair to say that I saw it. I don't think necessarily that I read it. Mr. BARTON. Did you read, to your recollection, the cover letter dated May 12, 1995, by hand delivery, signed by Jeff Gibbs, which is approximately 5 pages long? Do you have recollection that you readthat? Mr. KESSLER. I certainly remember visually seeing the Bob Stone memo. I can't tell you, Mr. Chairman. I haven't read this again. Mr. BARTON. Do you at least have knowledge that you remember that it referred to the Myo-Tronics case? Mr. KESSLER. The whole package did, yes, sir. Mr. BARTON. Your recollection is that you glanced at this pile of material that had this hand notation that you were going to per- sonally take care of it, and you asked 1 or 2 people to look into it without reading the base material that was presented to you. Mr. KESSLER. I think that's a fair statement. ~ . Mr. BARTON. In your capacity of having to do many things and look at much material, like many of us in authority positions, you asked a staff person to look into this. Did they ever come back to you with any kind of a report on what you asked them to look into that the notes say you would personally take care of?. Mr. KESSLER. I would have to refresh my memory, Mr. Chair- man. Ms. Thompson is here. Ms. Pendergast is not. Mr. BARTON. Let's ask Ms. Thompson. Do you have recollection that you looked into this for Dr. Kessler? Ms. THOMPSON. My recollection, Mr. Chairman, is that Dr. Kessler asked me to look at the package and to suggest after doing that and whatever else I wanted to look at what an appropriate re- sponse in this matter would be. Mr. BARTON. What did you do once he had made that request, to your recollection? Ms. THOMPSON. My recollection at this point is that I looked through the package. I probably read the letter but skimmed the other materials. I did some checking. I determined that this case was something that was in the Agency. I believe I did some very preliminary ~assessment. If my .~ecoltection serves me right, when ' ' ri So obviousl the whole we got th~s 1~ was after the July hea ng~ Y , issue of Myo-Tronics had been put on the public record, aria my recollection is that I suggested to Dr. Kessler that the only appro- 301 priate response would be that this entire matter is under investiga- tion. Mr. BARTON. Did you make that suggestion, to your recollection, in writing or in a telephone conversation or as you passed in the hail on the way to the elevator? Ms. THOMPSON. My recollection is that it was not in writing, and it was most likely as we passed in the hall on the way to the eleva- tor. Mr. BARTON. In addition to him asking you to look into this, to your recollection, did he ask anybody else in the Agency to look into this,,or were you the sole person, to your knowledge, that was supposed .~o look into this? Ms. THOMPSOr~. I have no knowledge of whether he asked anyone else. Mr. BARTON. The point that I am trying to get at is, here we have an indication where obviouslY someone who knows Dr. Kessler well enough to say "Dear David" and this is somebody who is affiliated with the current administration has asked that an issue be looked into, and we at least have a notation by Dr, Kessler's personal assistant that he will personally look into it, and he, to his recollection, asked you to look into it, and perhaps one other person who is not here. Mr. KESSLER. There may have even been a third. Mr. BARTON. There may be 3, but the one person who is here today who acknowledges that they were asked to look into says that she did look into it and decided that there was no justification to go anywhere and didn't even think it was serious enough to put a memo in the file on it. Ms. THOMPSON. Mr. Barton, I'm sorry. I may have misspoken. I believe what I said was that Dr. Kessler asked me for my advice as to what an appropriate response would be to this particular package given the note and where it was from. I did not take that to be instructions to look into the substantive, if you will, allega- tions or the specific handling. My charge was what is an appro- priate response in this context. I was not doing, if you will, any sort of an investigation of the allegations that were set forth. Mr. BARTON. Based on what you just said, your response to the task that you were given was to informally inform Dr. Kessler that nothing needed to be done. Mr. KESSLER. No, no, no. Mr. BARTON. That's not correct? Mr. KESSLER. No, it's not. The dates are relevant. When I got this my sense was that Myo-Tronics was being looked at thor- oughly already and all the issues were being looked at by a number of senior managers within the Agency. My sense in asking the question was not to start over and look into the allegation, but how do you deal when you have a request from someone in the adminis- tration on something that we are looking at and have under inves- tigation. That's what I meant. Mr. BARTON. As of today, Dr. Kessler, what has your response been back to Mr. Stone, who sent you the material originally? Has there been a response back?
Page 155: TI14380263
302 Mr. KESSbER. I'd have to go back and I'd have to supply that for the record. I really would have to look into that to make sure that I am accurate. Mr. BARTON. I understand that you are going to refresh your memory, which you have the right to do, but to your knowledge today, has there been any response back to Mr. Stone? Mr. KESSLER. There may or may not have been, and I just have to go back and do the homework. Mr. BARTON. But to your knowledge, you have not personally called him? Mr. KESSLER. I have to go back and understand. I don't have it straight in my mind exactly what the response was, and I would be happy to do that homework and get back to you, Mr. Chairman. Mr. BARTON. I am concerned. I don't think the request from Mr. Stone is inappropriate. I think if he has got personal knowledge of you outside the Agency, he has got every right to send you a memo asking you to look into this. I would assume your assistant asked you a~out it. You said you would look into it. That's an assumption on my part, but I think if that is correct, you had every right to say you would look into it. I think you also have the right to dele- gate it to other people to look into it for you and report back to you. ince this is in August and we are now in December, ] would think by this point in time somebody would have gotten back to you and at least given you some sort of a report. Apparently you can't recol- lect that, but you are busy. Mr. KESSLER. I recollect having some conversations. The actual substance I'd have to do some homework on. Mr. BARTON. I'm concerned that something that came to your personal attention--again, you have every right to make a decision to handle this personally or not handle it personally, but you're having trouble recollecting. I would like foryou to refer this Myo- Tronics case and the way it has been handledto the Inspector Gen- eral and refer all substantive materials that deal with the case to the Inspector General so the body who has statutory authority to investigate these types of situations can perform a real and thor- ough investigation and a prompt response. Will you do that? Mr. KESSLER. There is an ongoing investigation. There is an enormous amount of time that has been spent by the Office of In- ternal Affairs. I would be very happy for them to consult, Mr. Chairman, if you would like. Mr. BARTON. I want to be totally clear on this. If you do not be- lieve that it should be referred immediately to the Inspector Gen- eral and all relevant materials transferred so they can conduct this investigation, I am going to in my capacity as chairman of this sub- committee write a letter, copy you obviously, and the Secretary of Health and Human Services, that that be done immediately. Is this something that has been done, at least to your personal knowledge? Do you have to refresh your memory on what if anything you de- cided to do about this. Mr. KESSr.ER. It goes back to before August. I certainly was aware in July. Wasn't there July testimony in front of you? Mr. BARTON. My point, doctor, is that we have evidence that you've stipulated to as factual, that you were at least aware that somebody was asking you to look into this, and somebody close to 303 you said that you would look into it, and here it is December and you can't remember what you've done about it. So I want the In- spector General to get the materials and to really investigate. Mr. KESSLER. There was an ongoing investigation and there has been an ongoing investigation from February 28 of this year. As understand it, there are new allegations, new issues, new facts that have been submitted to the Office of Internal Affairs as time has progressed that they have been asked to look into. To me that is what matters. I didn't do an independent, other than getting prepared for this hearing and providing the committee with the best kind of case re- ports that we could provide. That's what we worked on. We worked on the case reports. There was an investigation underway. That's what is in place. I have every confidence that the Office of Internal Affairs is doing a thorough job, and I believe Mr. Hampton just told me that they have been in consultation with the IG. There has been a lot of work on this. If you want this to be at the IG, Myo-Tronics to be at the IG~ Mr. BARTON. I do. I'm asking if you will agree with me in that and instruct the people within your Agency to turn that material over. If they want to continue in their investigation, I'm not op- posed to that. I want the statutory authority, in this case the In- spector General of health and human services, to conduct the in- vestigation on Myo-Tronics, to get the material, and to do it thor- oughly and to report to you and to this subcommittee as soon as possible. Mr. KESSLER. VChat allegation are we talking about? Just help me so I know what I am referring. Mr. BARTON. I'm talking about all the allegations that have been alleged by the company since the inspection that was made on that company in the summer of 1991, the panel that was put together that was chaired by an individual who allegedly had an adverse business interest, and the individuals within the FDA who again have, according to the company, allegedly had a preconceived con- clusion as to the outcome of the dental advisory ~panel's rec- ommendations on the products that Myo-Tronics had been manu- facturing and selling since their existence as a company in 1968, I believe. Mr. KESSLER. Mr. Chairman, I'm very respectful of your request. I'd be happy to ask our internal affairs office to give those docu- ments to the Inspector General, to work with the Inspector Gen- eral. I'd be happy to write a letter to the Inspector General telling him of your request and asking them in cooperation with us to get back, just as you said, to you and to us, for them to do it jointly. I have no problems with that. I think we need to just recognize the amount of work. Mr. BARTON. I'm not asking that the Inspector General recreate the wheel. I'm just saying that they be brought into this case. Mr. KESSLER. I'd be happy to have them work together and relay your request, Mr. Chairman. I'd be happy to do that. Mr. BARTON. The Chair's time expired about 10 minutes ago. The Chair is now going to recognize Mr. Burr. The Chair hopes that this round of questions will be the last round of questions, because
Page 156: TI14380264
304 there are members of the FDA who have patients to see at 3:30 p.m., and Dr. Kessler and his staff have been very patient with us in a second hearing on this subject. I hope that we can wrap this up in this final round. Ms, THOMPSON. Mr. Barton, Dr. Singleton needs to leave by three so he can see his patients by 3:30 p.m. I misspoke earlier when I mentioned the time to you. Mr. BARTON. Thank you. Mr. BURR. I would be shocked in fact, Mr. Chairman, if Dr. Coburn didn't want to deliver some babies this afternoon himself with the active schedule that he keeps. Dr. Yin, could you come back up to the table? There might be several questions that I would like to refer to you. They are some of your documents, and I'd like you to be there to comment on them. Dr. Kessler, as I understand it, in June 1993--I have June ll-- the FDA filed the official 305 notice against IPI. Can anyone with FDA confirm that that was the correct date? Mr. CHESEMO~. Yes, sir, June 11, 1993 was the date of the hearing. Mr. BURR. Isn't in fact a 305 notice criminal in nature? Mr. CHESEMORE. A 305 notice is a notice by the Agency that we are considering prosecution. Mr. BURR, Criminal prosecution, correct? Mr. CHESEMORE, Yes, sir. Mr, BURR. There was a decision made in early April 1994 to drop the pursuit of the section 305. Am I correct, Mr. Chesemore? Mr. CHESEMOB.E. That is correct. Mr. BURR. On April 12 the Wall Street Journal did a hatchet job on the Agency. It suggested that the FDA keeps many medical de- vice producers in limbo with long delays in approving new prod- ucts. Dr. Kessler, did that trouble you as the Commissioner of the FDA, their accusations? Mr. I~SSLER. I believe I took notice. I think it's a fair statement. Was that the right-hand column? Mr, BURR. That was the April 12 front page article "Safety First." Mr. K~SSLER. I believe I took notice. Mr. BuI~. Mr. Chairman, I would ask unanimous consent that that be entered into the record. Mr, BARTON. So long as minority and the representative of the FDA have access to it. Without objection. Mr. BuP~. I think they have been distributed, Mr. Chairman. [The Wall Street Journal article follows:] 305 THE WALL STREET JOUI~NAL [April 12, 1994] SAFETY FIRST--HOW A DEVICE TO AID IN BREAST SELF-EXAMS IS KEPT OFF THE MARKET OTHER NATIONS APPROVED IT, BUT U.S, DEMANDS PROOF SIMPLE PAD ISN'T RISKY N[NE-YEAR BA2TLE WITH FDA By Brent Bowers It is about as simple as a medical device can get: two sealed plastic sheets with lubricant in between. It is laid over a woman's breast like a cloth during an exam. ination, to reduce friction. Glenda Richardson thinks it probably spared her death from breast cancer. John Withers, a surgeon at the Maul Clinic in Hawaii, says it is one of the most effective weapons against breast cancer in years. And Patricia Redmond, a New York trained radiologist, says it "can absolutely save lives." But don't try buying it in the U.S. Though many doctors and cancer specialists hail the Sensor Pad as a useful tool in detecting the disease that many women fear most, and though it years ago sailed through approval processes in countries in Eu- rope and Asia, the Food and Drug Administration won't let Inventive Products Inc, sell it in this country. Grant Wright, the president of Inventive Products, and his father, Earl; the j~_ad's co-inventor, have been fighting for nine years to get clearance for the product, What began as an FDA request for more information has degenerated into a long, debili: rating struggle and allegations that the Wrights violated federal law. So frustrated did the Wrights become about the bureaucratic maze that six years ago they started selling the pad to U.S. hospi_tals without FDA clearance. That triggered a court bat- tle that they lost in 1992. Now they are back to trying to win FDA blessing for the pad. Stifling Innovation? But if the dispute isn't resolved seen., Grant Wright says, he will close his Deca- tur Ill, company, which costs about $4,000 a month to operate and has already bused through $356,000 in legal fees. "I'm 33, with a wife and three kids," he says, "I've got to do something with my life." Mr Wrhzht's struggle, in the eyes of some, is more than just the tale of a small- town entrepreneur s tangle w~th far-away bureaucrats; ~t m more, too, than a study of how the medical-devicee industry in the U.S. copes with the world's most strim gent regulatory system. To some advocates of his simple device, it is a manifestation of the way the nation's litigation-driven aversion to risk can stifle innovation in the medical marketplace. '~/v'e as a society refuse to take risks and want 100% guaran- tees that our lives are going to be perfect," says Mary Palmore, a Chicago gyne- cologist. Dr. Palmore acknowledges that the FDA has a legal duty to ensure that the pad isn't falsely promoted as a diagnostic tool but suggests that the agency itself may be caught up in what she sees as a national obsession with safety. "The FDA is con. cerned that in our litigious society, a woman will say: 'I used it, and I got cancer anyway,'" Dr. Palmore says. The agency says that safety, not litigation, is its main concern. And it strongly defends its refusal to authorize the Sensor Pad. "Their intention is very worthy," Susan Alpert, director of the FDA's Office of Device Evaluation, says of the Wrights, But the issue for the a~ency is of ensuring that we don't allow to market any device that poses significant ask without an attendant benefit." Indeed, many consumer advocates and health-care specialists applaud the FDA's rigor in screening devices, and some complain that it doesn't act forcefiflly enough, The FDA, meanwhile, faces a huge backlog of applications for new medical devices, which has stretched the average review time to 196 days. The agency says it is working hard to whittle the backlog of more than 5,000 applications. How Pad is Used Breast cancer took an estimated 46,000 lives in the U.S. last year and was the secend-biggest cancer killer of women. Early detection is essential in defeating it~ and frequent self-examination is essential to that effort. But many women don't find this easy, and that is where the pad comes in. Its lower sheet clin~s to the skin while the top sheet "floats" on a thin layer of liquid silicon, eliminahng friction so a finger can explore the contours of an object as small as a grain of salt. "The thing tI~at amazes me" says the younger Mr. Wright, "is that the research spending [on breast cancer] keeps going up and I can t get this simple $7 product into the hands of women who want it."
Page 157: TI14380265
306 His father, Earl, once thought the Sensor Pad wouJd be a big success. Mr. Wright, 63, is an established inventor whose products range from a blood-serum filter used in laboratories to nonaerosol foaming pumps usedby hospital surgeons. Mr. Wright in 1986 set up Inventive Products as a subsidiary of his Earl Wright Co. solely to make and market the Sensor Pad. He put his son in charge. Gaining approval to sell it in other countries wasn't a problem. Inventive Products applied for marketing authorization in Canada in 1985 and got it within 30 days, Grant Wright says. He also says the pad has been approved in Japan, Singapore, Korea Thailand and most West European countries, although Inventive Products hasn't actively promoted it abroad. ' We've had no problems anywhere in the world," he says. Except at home, when the Wrights sought FDA clearance for the device in 1985, the agency's initial response was positive. Still, the government wanted more infor- mation. "Every time we submitted information, they asked for more," the son re- ca~ls. Aider several months, the agency denied approval for the pad--but indicated its concerns might be met by extensive labeling changes. The FDA wanted the labeling to state that the Sensor Pad could be sold by pre- scription only. And it wanted all references to breast cancer deleted. The label was to include the chemical composition of the device. It also was to describe the 10- inch diameter pad's "susceptibility to heat, sunlight, soap, Formalin, alcohol and ether mechanlcal agents." Mr. Wright says he immediately set about complying with the requests. But ~bout three months later, he says, the FDA inexplicably notified him that it wouldn t re- consider approving the product. Instead, he was told, Inventive Products would have togo through a laborious "premarket approval" process for new medical devices. This process is meant to keep new, mostly high-technology instruments off the market until they can be adequately tested for safety. Few people would disagree that the FDA should get convincing evidence that invasive devices are safe. More then 200 people died in the 1980's when their Bjork-Shiley heart valves fractured, for instance. But Mr. Wright argues that the Sensor Fad poses no direct risk to users. The FDA responds that the indirect risk--that a cancerous lump would go unde- tected-is potentially lethal. The agency's Dr. Alport says the fact that a device is simple doesn't necessarily mean iris benign; everything depends on its "intended use." She dismisses endorse- ments from doctors and patients~which, she says, many device makers trot out~-- a~ anecdotal evidence that is insufficient to make a scientific case. "Reporting doesn't do it--data does,~ she says. In 1992, only 12 medical devices were given FDA premarket approval, including heart pacemakers, lenses that are implanted into the eye after cataract surgery and devices for smashing kidney stones. Of the simple, noninvasive pad, "I've never seen a product like this held off the market," says John Isaacs, a gynecologist ~n Evans- ton, Ill., who is the author era textbook on breast disease. But the FDA says the Sensor Pad needs to be scrutinized because it isn't "sub- stantially equivalent" to a product already on the market, a legal requirement for quick approval of simple devices. The Wrights argue that the pad is substantially equivalent to soap and water, a mixture the medical community has long rec- ommended to reduce friction in breast self-examination. Clinical Tests Required To obtain premarket approval, the FDA said, Inventive Products would have to conduct exhaustive clinical tests on women, comparing the number of breast-cancer cases detected through self-examination with and without the Sensor Pad. Such tests, Mr. Wright says, would require a huge sample--a minimum of 82,000 women--to product statistically meaningful results. An FDA spokeswoman disputes that figure. "We want to be as reasonable as we can," she says. "The number will be much less than that." Mr. Wright says he has already done two trials with simulated breast models, which he claims yield more accurate results. In the first, women examined the arti- ficial breast~ for lumps using both the pad and their bare hands. In the second, they used both those methods and also a third method--~oap and water on their hands. The tests showed that the pad enhanced sensitivity and resulted in increased lump detection, Mr. Wright says. The FDA rejected his trials as insufficient, The prospect of starting over with the lengthy, expensive tests the FDA demanded pushed the Wrights to change their course, Because they never considered the pad to be a medical device as defined by federal law, they decided in 1988 to market the product directly to hospitals. The 307 Wri hts say they--and their attorney--figured the FDA either would recognizo its • . g ......... ,-- T---^-*~v~ Products to court and force the issue, lack otjur~s~c~on or ~aav ~w,~ ~ • er 15 mon~s, the W~gh~ sold 250,000 pads te some 200 hosp~t~s. But A~ 1989, federal agen~ r~ded ~e company's Decatur plant and a n~ber of hos- pit~s and co,scald the pads. • a a~r Eark W~ght was named a fin~ist in the - T~ta~~e~ Y damon's inverter-of-the-year con~st for his hancing de~ce." ~ss in Coua ............ ~a~ ~ ~u~s~c~on over ~e pad But in Grant W~ght cn~mngea me z~ ~ ~ ~ 1990, a U.S. ~st~ct co~ in Dan~le, Ill., ~ed for the FDA. Mr. W~ght appe~ed, and two yea~ lair an appe]la~ cou~ in Chicago upheld ~e ~ing. At that point, Inventive ~duc~ ~ld the FDA it had ceded m~keting ~e pad. But Mr. W~ght ~'t ~ve up. In Ma~h 1992, he filed an ethics compl~nt ~th the FDA's ~ty office ag&~t some agency offi~s a~r lea~ug they had met ~th a ~nofity sha~holder of ~e company ~out ~s knowledge, ~r ~e corn l~nt, he says, ~e FDA t~edhos~le. At a m~ting in Was~n~n s~ 19~ ~ ~sc~s ~q~ements for ~m~ket app~val, he says, an FDA law. ~ ~--~--~ b-- 10 o~er a~ency offici~s and a Justice Depa~ment la~er~'told ye~ n~e~ ~t o~ ~duc~ ~ m~ket." ,, ~ne out of o~ way ~ show the W~gh~ how ~ get their product marke~d, Such ~ comment doesn't make sense," she says. ~. W~ght promptly fired off let~m ef compl~nt about ~e meegng to the FDA and ~ ~presenta~ve John Dingell of Mi~igan, who is kno~ for flailing ~e FDA for i~ ~ss~ps. More letO,s flew back and fo~h. ~ FD~ ~ty o~cer wr~te ~at ~e FDA was ac~g in g~d f~th. Mr. W~ght mspon~ea ~y ceman~ing an m- vestiga~on of ~e FDA Ia~er who arcaded the Au~st meeting. A couple of days lair, ~s W~hin~n la~er sent a seven-page let~r ~ a Dingell staffer, a~using ~e FDA of ~oun~n~' Inven~ve Produc~. Fo~ monks lair, ~e W~gh~ received notice from an FDA compliance o~cer ~at ~e agency was invesfiga~ng them for possible ~olations of feder~ law fo~ ~ell. m ~e pad in 1990-91 Mr Grant says he has re~ived no word about the inves~tga- " g '. • " ' " • Chica elastJune But hesa ~,he ~on sin~ an FDA a~ms~ahve hearing m .... g , ~ ,, ~ ~. gown ~e message: "If you squawk, ~ey ~11 slap you arounu, ~ne ~ ~g ~y re~ia~ a~ions. Suppo~ From Meanw~le, membem of the me~c~ community continue to suppo~ the Sensor pad, Dr. Withem, ~e s~geon at Ma~ Cli~c~ says the pad has t~ce enabled h~ women a false sense of sec~ty, one of ~e ~:~a ~ ~ncerns.,,~.~ ~on that ~e Sensor Pad incr~ses my ~ac~le ability, ne says, ~ maavv e~ier." G~e ~t~rhagen, me~cM ~rec~r of the cancer cen~r at St, Joseph Me~c~ Cen~r in B~ba~, C~if., says ~s~ she conduced for Invengve Products sever~ earn a o in~m~d that women who used the pad we~ 22% more Hkely ~ peffo~ ~.n~l~ bre~t ex~s "This de~ce is ha~less," Dr. ~t~agen s~s,~ • ,~,,.~ ............ r ...... , ad She na~ dent doubts that she wo~d have ~und two small l~ps w~thout the p . a do~le masS.my, "It probably saved my life," she says, adding ~at she gave one ~ her 19-year-old daugh~r. M~ ~an.. a 55-year-old ~r. in Washin~a, is ce~n the pad. saved her, Her s~geon, ~en~e ~le says me aerate may *~a~ ~y.~V -:* • " " uio~$" to Con~de~ng ~e le~ty of ~reast rancor, Dr. ~ley says, ~t ~s just ndic keep ~e pad off ~e market. Po~n~al domed appears ~ be huge. ~en a Pit.burgh hospi~l offered on local For ~1 that, ~e FDAs Dr ~pe~ believed mat revenues rroauc~s "'1 for "~e delays it has encoun~red. '~hem are lo~ of diffe~nt ~nds and yearn." . , , . The elder Mr. W~ght has managed ~ commerc~ze ~e Sensor pad s ~chnolo~ for a much smiler m~ket, He has built the Slipp, a nylon ~nd plastic sheet ~ed in hospi~s to tra~fer pagen~ from a ~ey ~ a b~. About 500 have ~en sold.
Page 158: TI14380266
308 But his son spends much of his time in his nearly empty headquarters explaining to doctors why he can't send them samples of the Sensor Pad. Last year, he laid off his own brother, reducing his work force to himself and hi~ secretary from a peak of 28 six years ago. "We're at the point of surrender," he says. Mr. BuPJt. Isn't it a fact that on April 13, 1 day after this article ran, the FDA press office created talking points to refute specifi- cally many of the points made in this article? I see some heads in the back going yes. Mr. KESSLER. I was handed a talk paper. Mr. BURR. Mr. Chairman, I would also ask unanimous consent that that talk paper be entered into the record. Mr. BARTON. Without objection. [The FDA Talk Paper follows:] FDA TALK PAPER April 13, 11~4 SENSOR PAD FDA is receiving inquiries about Sensor Pad, a thin plastic pad filled with liquid silicone designed to aid in breast self examination. This product is net currently approved as safe and effective by FDA. The agency has informed the manufacturer, Inventive Products Inc. of Decatur, Ill., that it must conduct clinical studies on the p~duct's safety and effectiveness and obtain pro- market approval from FDA in order to legally market it. FDA is requiring the firm to conduct clinical trials because the agency has not seen valid scientific evidence that tlke product will actually help women detect lumps and aid in the detection of breas£ cancer. FDA is concerned that rather than aid in detection, the product might actually miss lumps or mask their presence. Detection of lumps has important health impli- cations for American women. If a product making this claim does not perform as intended, women who depend on it are put at grave risk. Inventive Products submitted a pre-market notification (510K) for Sensor Pad in 1985, saying the device was substantially equivalent to a legally marketed product. Upon review, FDA concluded that the device and its use were different from other devices. The firm was told that it would need to submit a full premarket approval application (PMA). Despite the denial of its application, in 1987 the firm began illegally marketing Sensor Pad to hospitals. Thin led to a series of seizures of the product by FDA. When the firm contested the original seizure, a federal court ruled in favor of FDA, concluding that the pad was an adulterated medical device. The firm appealed the ruling, contending that the product was not a medical device. In 1991, a federal appeals court affirmed the original ruling that the pad was a medical device and that an approval PMA would be required before the device could be marketed. Following the initial seizure and throughout the legal process, the firm continued to distribute the device, and FDA continued to seize it. In 1989, following the initial seizure, the firm submitted a PMA to the agency. This application contained little information and it was inadequate as a basis for determining safety and effectiveness. FDA has been working with Inventive Products for the past nine years to assist in its attempt to bring its product to market. The agency is continuing to work with the firm to help it identify what is necessary to show the product is safe and effec- tive. FDA has met numerous times with the manufacturer to discuss the type and quality of data that are needed and the ways clinical trials can be conducted so as to be the least burdensome on the firm yet still provide the necessary information on safety and effectiveness. Mr. KESSLER, I don't know the history of when this was written or over what period of time. Mr. BURR. The date on it, and I would hope that that would be an indication, was April 13, one day following the Wall Street Jour- nal front page article. Mr. KESSLER. That would be when it was issued, Congressman. 309 Mr. BURR. I think if you read it, Dr. Kessler, you'll see that it does address specific points that were raised in the Wall Street Journal article. Is it common practice for the Agency to ~o in and try to prepare some type of points? I know it wouldbe xor a con- gressional office if we had a bad article. Mr. KESSLER. Facts matter, Congressman, and to the extent that we have an obligation to make sure that the facts are accurate, in general I would strongly encourage us to do that. Mr. BURR. Dr. Alpert, I want to make sure that I understood you correctly earlier when you said that you have no knowledge of any- one at FDA contacting the Canadian health organization as it re- lated to Sensor Pad. Ms. ALPERT. I believe the question I answered was whether we had contacted them encouraging them to change their opinion of the Sensor Pad. Mr. BURR. And your answer? Ms. ALPERT. My answer was not to my knowledge did anyone di- rectly contact them and ask them to change their regulatory opin- ion on the Sensor Pad. It was then clarified that we do in fact share talk papers and so forth with other regulatory agencies around the world. Mr. BURR. Dr. Alpert, do I understand you correctly that you share information about the approval processes of pharmaceuticals and devices or public relation talk papers? Is there a distinction there? Ms. ALPERT. We share many issues. When we make statements to the public that are going to be in the press, we let those folks know as well. That's very common. We also share information about the approval process. Mr. BURR. Didn't in fact Earl Wright receive a letter on May 5 from the Canadian health protection branch stating almost ver- batim several points from the FDA talk papers? I'll come back to that to enter it into the record. But in fact he did receive one that was almost verbatim to the talking points. Dr. Kessler, did you or anyone that you are aware of at FDA sub- mit, after the Wall Street Journal article, a request to Canada in the form of additional information that you had to try to influence their status on the pre-market approval of Sensor Pad? Mr. KESSLER. I asked Dr. Alpert to call Canada in the last month or so. Mr. BURR. I'm specifically dealing with the timeframe in between April 13, when the talk paper was prepared, and May 5, which was the date of the letter that Earl Wright received from the health branch. Mr. KESSLER. Leading up to the Canadian decision, I asked Dr. Alpert to call Canada to see whether in fact there were any calls from the FDA. Mr. BURR. What date was that? Mr. KESSLER. What date did I ask her to call? Mr. BURR. Approximately, Mr. KESSLER. This issue was being raised by the committee. I'm told since November 15. Mr. BURR. This period that I'm talking about is very much prior to that.
Page 159: TI14380267
310 Mr. KESSLER. I asked Dr. Alper~ to call Canada recently, over the last month or so, to go back and ask them whether anyone called, because that allegation was being made. It was right before the 15th is what Ms. Thompson tells me. Ms. ALPERT. Dr. Kessler asked me to check with the Canadian government before the hearing on the 15th. I spoke to that issue at the hearing on November 15, and then subsequently I called Canada and asked them to submit in writing what process they went through. Mr. BURR. Which I think the FDA was kind enough to distribute to us earlier in this hearing. Ms. ALPERT. That's correct. Mr. BURR. Mr. Chairman, I would ask unanimous consent to enter the letter to Earl Wright from the Canadian health protection branch which shows that similar terminology was used as the FDA talking points did. Mr. BARTON. Without objection. [The letter referred to follows:] 311 Ot~Wa, XIA OL2 ~, E. wr£gh~ ~rl wright Co. P.O. ~ox 51 De~t~, IL, 62525 U.$,A. ~e Uni~ S~ltee FO~ end D~g A~inie~ranion is r~uirlng yo~ £I~ ~ co~U~ clini~l ~iale on ~eneo-Touch Slnlo~ Pad ~cauea ~ey have not seen valid 24 of ~e Me~i~l Devicl Regulation, yo~ company ,u~i~t~ info~atlon to i~ica~a ~e~ ~la pr~uc~ was being of Ee~ for sale in Please advise US If ~e a~e~ no~iflca~ion ~nfo~l~£0n il c~rent and Lf ~e pequot ~la~io~, ~I Wrlght Co. el ri~le~ ~0 SU.~llr, by May 20, Z~94, IVld~Co to eatabl~eh ~e of ~e device for ~e purples reoo~a~. The na~e {el. baled on clinical ~lals] ra~er ~ ~¢cdotal0 A cOpy Of ~e Regulations la enclosed for your raflr~c~. Note tha~ l~,ao~Ion 28(2) of the uubl~o~ by ~y 20. 1994. AIIiS~t Deputy EncY.. Canad
Page 160: TI14380268
312 Mr. BURR. Dr. Kessler, is it common for the FDA through their public relations or press office to request that things be distributed to other countries? Mr. KESSLER. If I'm correct, and I'd have to double check, when I was at the tripartite meeting in Canada several years ago this issue came up. There is always one country wanting to know what is happening in the other country. Mr. BURR. Draw a distinction for me, if you will, from press office and public relations. Mr. KESSLER. It's several years ago. But I even remember a con- versation where there was an agreement--I'd have to go back and look at the recordmwhereby Canada and England wanted this kind of information on a routine basis so they knew what is going on. I have some recollection that at the tripartite that was discussed. Mr. BURR. How many employees does the FDA have in public re- lations and/or press office? Mr. KESSLER. I'd have to supply that for the record. Our freedom of information office is also in our press office. Mr. BURR. Would you break that out and supply that for the record for me? Mr. KESSLER. I'd be happy to, Congressman. [The following information was received for the record:] The Office of Public Affairs has 67.8 FTEs. Communications Section--24.4: These emplo]yees edit, write and publish a widely distributed consumer magazine, produce an internal newsletter for FDA employees, and generate visual information for FDA conferences and seminars. FOIA staff--22.2: These employees respond annually to more than 50,000 inquiries by in- dustry, the media, andothers that are submitted to the agency under the Freedom of Inforrnation Act. Pres~ Section--19.2: There are 13 professionals and 6.2 support staff whose primary job is to answer thousands of media inquiries annually about regulated products~ FDA policies and other public health matters within FDA. They write and disseminate press releases, Talk Papers, and backgrounders on newly ap- pro,red health care products, tampering and other public health hazards, ann important agency initiatives. Speech writers--2: In addition to writing speeches for all senior managers of the agency, the speech writers write and edit reports, testimonies, and scientific articles for all senior managers. Mr. BURR. Dr. Kessler, what is the job responsibility of Cathy Norcio of the FDA? Mr. KESSL~.R. I'll let Dr. Burlington answer the question. Mr, BURLINGTON. Cathy Norcio heads the Executive Secretariat in the Center for Devices and Radiological Health. Mr. BURR. What is the job responsibility of Pam Chisler? Mr. BURLINGTON, Pam Chisler works for Cathy Norcio in that of- rice. Mr. BURR. Thank you, sir. Mr. BARTON. The gentleman's time has expired. Mr. BURR. I just have a couple of additional questions, Mr,. Chairman. Mr. BARTON. I'm not surprised. 313 Mr. BURR. I would ask unanimous consent, Mr. Chairman, to enter into the record the phone records of Dr. Yin from 2/1/95 and ask those be supplied to the table if in fact they don't have them, Mr. BARTON. Dr. Yin is here. Do you have any objection to that? I think they are your records. Ms. YIN. No. Mr. BARTON. Without objection. [The phone records referred to follow:] /,
Page 161: TI14380269
314 Mr. BURR. Thank you, Mr. Chairman. Dr. Yin, as I interpret your phone records from that day, you first called Sharon Snyder. Sharon Snyder happens to be listed as the contact person on the talk papers. From Sharon Snyder you re- ceived several numbers that I have found to be the numbers of Ca- nadian health protection branch, a name of an individual in Can- ada who was very intricately involved in the Sensor Pad, Mary Jean Bell. The second entry would be contact with Dr. Bell, and your notes: "took it off the market based on FDA USA." I would ask you, did you have a conversation with Dr. Bell in Canada and make any formal request prior to this about the FDA's wish that Canada not have this pre-market approval up there? Ms. YIN. No. Mr. BURR. Have I accurately described your phone records of that day? Ms. YIN. My phone record here is extremely cryptic, if you look at it. If you ask me did I need a phone number, I got a phone num- ber and I got a name when I called Dr. Bell: Why did they take it off the market, and did they base it on USA information? Be- cause in my view, at the FDA we really don't have information one way or the other. There were no studies. So we don't know whether it's good, whether it's bad. That's why I listed those things that I needed to ask her. Mr. BURR. Dr. Yin, the importance of this phone record to me is the fact that I would find it odd given that the branch of the FDA that would go through the approval process would in fact have to turn to the press office to acquire the numbers of the Canadian representatives that were going through the approval process. There is certainly every indication that in fact~ Ms. YIN. Mr. Congressman-- Mr. BURR. If I'm misinterpreting your phone records, please clar- ify. Ms, YIN. I think so. May I clarify it for you? Mr. BURR. Yes, ma'am. Ms. YIN. Ms. Snyder would call me to ask me to do certain things: what would the Canadians say about this? Then I would get a phone number from her. Mr, BURR, Then you got the phone number from Ms. Snyder? Ms, YIN. Most likely she would have provided the phone num- bers, because it is more convenient for them to have it than for me to look it up, Mr. BURR. So Ms. Snyder in the press office was the one that had the Canadian phone numbers? Ms. YIN. I think so. Mr. BARTON. This is going to have to be the last question. Mr. BURR. I realize that, Mr. Chairman. Dr. Kessler, why did it take over a year for the FDA to notify IPI that the FDA had dropped the section 305 proceedings? Mr. KESSLER. There is no good answer to that. It should not have taken that long. Mr. BURR. Let me editorialize for one second. One could conclude from the scenario we just went through that in fact the decision was made to drop--all of a sudden there was a downpour of bad press of which the Sensor Pad was the key person, and then all of 315 a sudden it took a year for notification. I will give you every oppor- tunity, Mr. Chesemore, to tell me I'm wrong. Mr. CHESEMORE. Mr. Burr, I can assure you that the Chicago district probably didn't even know these conversations were going on. There was absolutely nothing like that happening. Mr. BURR. Mr. Chairman, I would only go back and say that in concluding I would hope to remind Dr. Kessler and certainly give him one more opportunity to tell me that he believes that even the appearance of unfairness or retaliatory action does not exist in thi.s particular case. Mr. KESSLER. Congressman, I think we have been through .it, and I stand by my previous. Mr. BARTON. Dr. Kessler has admitted that there is no good ex- cuse. I think he has been straight on that. Mr. BURR. I thank the chairman for his patience. Mr. BARTON. Mr. Chesemore, do you have a final comment? Mr. CH~SEMORE. I just want to assure Mr. Burr that we have in- stituted a new process at the FDA so that hopefully this does not happen again, that that much time goes by before a company knows they will not be subject to a 305. Mr. BURR. Mr. Chesemore, if we get just one change of something that is broken out of these 2 day-long hearings, I think we have been successful. I hope we will get many more. Thank you. Mr. BARTON. Before the Chair recognizes Mr. Cox, Dr. Singleton, who is going to have to leave at 3 p.m., has sat through 2 hearings. His name is in the record numerous occasions, but he has not yet been given a chance to state anything. Would Dr. Singleton in his own words like to put anything on the record before he leaves? That's not a trick question. You have sat here, and I want to give you a chance to tell your side of whatever you think needs to be told before you leave. Dr. SINGLETON. I would put it back to you and just say if you have any questions of me, that's fine. I have nothing more to add, Mr. BARTON. I don't have any direct questions. The Chair would now recognize Mr. Cox for 10 minutes. Mr. Cox. I thank the chairman. In this final round of questioning I will finish up to the extent that it is possible my questions and I hope the committee's business on the back screw matters~ the various court orders that have been violated, and so on. I don't know that you have read this book that I referred to ear- lier which contains a chapter about John Coale. So I don't know that you had any reason to know that he had said that he's the bad boy, "I'm a known sleazebag," according to this man; that he is the subject of a great deal of scrutiny by media organizations; that he advertised in USA Today to drum up clients on this back screw matter; that there is a warrant outstanding .for his arrest that he is evading. Now that you know all those things and yod know that this is the man that violated a court order in order to provide Mr. Zeller, who works for you, documents, do you think that the FDA ought to contact the court and let the court know that its order has been violated by Mr. Coale in this matter? Mr. KESSLER. I'd be happy to think about that question a little more, Congressman Cox.
Page 162: TI14380270
316 Mr. COX. Let me ask you the question this way. You explained earlier that your handling of these documents that you received from Mr. Coale when he violated the court's order in providing them to you was a matter of prudence and good judgment. Mr. KESSLER. We try. Mr. Cox. Let me understand this. In the exercise of prudence and good judgment, why would the FDA as a matter of policy choose to keep the court in the dark? What is the public policy being served by your not informing the court that this occurred? Mr. KESSLER. No one is talking about keeping~ Mr. Cox. I am. That's what I'm talking about. Mr. KESSLER. I certainly don't view it as keeping the court in the dark. Mr. Cox. Is there any public policy that is served by your not telling the court? Can you think of any public policy that is ad- vanced by you, the Commissioner of the FDA, not advising the court that to the best of your knowledge Mr. John Coale, self-de- scribed sleazebag, warrant out for his arrest, has violated a protec- tive order in providing documents to the FDA? Mr. KESSLER. I think the question of how one handles documents that come in to either a law enforcement agency or public health agency that are under protective order when both the law enforce- ment agency or the public health agency is not a party and has not induced the release, I think that has broad implications for how law enforcement and public health agencies get information. That's why I think it needs to be thought about. I just don't think in one case that could potentially have implications for~ Mr. Cox. Have you not thought about this, Dr. Kessler, before today? Mr, KESSLER. I've thought about the general issue, yes. Mr, Cox. Have you not thought about this specific issue before today? Mr, KESSLER. I've thought about it in the context of the general issue, Mr. Cox. What about this hearing, since we had a hearing on that very subject? Mr, KESSLER. I take the position, Congressman, that no one should induce anyone to give documents, that if we are a party, then we are bound~ Mr. Cox. Let me explore that. If Mr. Zeller had not accepted the documents, then Mr. Coale would not have been able to violate the protective order, would he? Mr, KESSLER. If you want to get into a proximate cause discus- sion, I'd be happy to. Mr. Cox. I'm just trying to ask a simple question, Dr. Kessler, of why it is that we are advancing the public interest by refusing to share with the court the fact that we know, we, Dr. Kessler, the Commissioner of FDA, knows that someone with a very disrepu- table---- Mr. KESSLER. I'm not refusing a court's request, Congressman. Mr. COX. [continuing] past has violated a protective order of that court in litigation you are involved with~ Mr. KESSLER. I don't believe the court has--- 317 Mr. Cox. [continuing] where you yourself have been asked by the court in the same litigation to explain why the FDA has violated another protective order. Mr. KESSLER. Again, we are not the only one, I believe, in receipt of these documents. Mr. Cox. The Congress certainly is not in receipt of those docu- ments, and you have not provided them to us and have expressly explained in some great intellectual effort why you can't provide them to us. Mr. KESSLER. Congressman, I'm not sure that's a correct state- ment. I would ask you to look into it. The document that I saw, the cover letter, was addressed to Senator Breaux's staff. So per- haps the Congress is, or at least a member is. Mr. Cox. I never got that document, Dr. Kessler. I have a docu- ment that is addressed to this committee from your Agency. Mr. KESSLER. You did give me an index last time. Mr. Cox. That index was attached to a letter that the FDA sent to this committee. Mr. KESSLER. If I can have the index. Perhaps Mr. Zeller can help, because I asked this question. Mr. ZELLER. Mr. Cox, one of the documents that I received from Mr. Coale that was given to the subcommittee in the stack of docu- ments that I got was a copy of a letter that Mr. Coale or his office had sent to 2 staff people of Senator Breaux, and I believe you have that letter. Mr. KESSLER. That was in fact the first letter that was on top of the pile. That's why I recollected that letter when my memory has been refreshed. Mr. BARTON. Just for clarification, we don't have any information that we have received that. Mr. KESSLER. It was given to me last time. I could be wrong. Wasn't I given an index and asked whether I had seen certain doc- uments? Mr. Cox. Yes. That's the index that is attached to a letter that you sent to this committee. Mr. KESSLER. Right. Mr. BARTON. We didn't get the documents, Dr. Kessler. Mr. KESSLER. I understand. Mr. Cox. The documents indicated with an asterisk. What is the last thing that it says on the bottom of that index by the asterisk7 Mr. BARTON. We didn't receive any of those documents. We were told they were part of the internal affairs investigation. Mr. KESSLER. There's a 6/12/95 letter, it says on this, from J. CoMe to M. Jones and J. Broussard, transmitting materials. Mr. Cox. Dr. Kessler, do you have the index now before you? Mr. KESSLER. I do. Mr. Cox. What is the last line on the second page of that index? Mr. KESSLER. An asterisk: "Subject to protective order." Mr. Cox. If you look on the preceding page, you will see that there are in fact documents marked with an asterisk. That indi- cates to you, I take it, that those documents are subject to a protec- tive order. Mr. KESSLER. That's exactly what it says, Congressman.
Page 163: TI14380271
318 Mr. Cox. Those documents, according to the cover letter sent by the FDA to this committee, were not provided to us because they are subject to a protective order, and these documents are ex- pressly those in the category that we asked for, documents pro- vided by attorney John Coale. Mr, ZELLER. Mr. Cox, below the fourth asterisked item, it says 6/15/95 letter from John Coale to MZ, transmitting the following materials. The fifth item below that, which is not asterisked, is 6/ 12/95 letter from J. Coale to M. Jones and J. Broussard. Those are the staff for Senator Breaux. I believe we provided you a copy with that letter. Mr. K~SSLER. We'd have to check. Mr. BARTON. We don't have a record of that transmittal. Mr. Cox. But those documents are not subject to the protective order, correct? Mr. ZELLER. The letter to Senator Breaux was not covered by the protective order. Mr. KESSLER. The letter to Senator Breaux's staff, I believe. Mr. Cox. But any other documents on here, I take it, are not subject to the protective order unless they are marked by that same asterisk. Mr. ZELLER. That's my understanding. Mr. Cox. Then we are just going in circles here, folks. The truth is that the FDA gave us a letter and said we are not going to send you documents that are covered by the protective order. You didn't provide those documents to us. You are still hanging on to them; you still haven't provided them to us. You're view is that you get to keep them when John Coale violated a protective order and pro- vided them to you but that you cannot share them with us unless we get leave of court. You don't need leave of court to get them; the Congress does. That's where we are. Mr. KESSLER. No. Congressman, I think I said today that I would be very happy to work with the Chair. Mr. COX. What does work with the Chair mean? Are you going to provide these documents, or what? We are just going around in circles. I want to be as charitable as possible, but I have to say that Dr. Kessler is testing the patience of at least this member, because I've been working on this matter for a month. Mr. BARTON. Dr. Kessler, are you or your designee willing to pro- vide these documents under whatever security arrangements are necessary to Mr. Cox and others of this subcommittee for their re- view? Mr. KESSLER. It's my understanding that the only ones that were not provided are the ones with the asterisks. Let me go back and check that. Mr. BARTON. Even the ones that were provided, Congressman Cox's allegation is they were provided apparently illegally to the FDA. Why can they not be provided to the Congress? Mr. KESSLER. Mr. Barton, I think Mr. Cox's point and your point is a good point. I think that a possible answer could be that we will turn them over to you; we'll notify the court that we are going to do that. That may be a very appropriate response. I just am a little reluctant under the glare of lights and having sat here now for 5 319 hours to make a decision off the top of my head that is not thought- ful. That's my only request, Mr. Cox. Mr. Cox. If I might resume, Mr. Chairman. Mr. BARTON. Sure. Mr. Cox. Dr. Kessler, in fairness to the members of this commit- tee, to our entire staff who has been working with the FDA prior to these hearings, this is hardly off the top of your head. This is our second hearing. It's the second time you and I have gone into it, and there has been an intervening period. Mr. KESSLER. I think it's fair to say you're right. There have been hours of discussion. But you are asking me now to make those documents available to you, and I have suggested one possibility. I remain committed to working with the Chair and to do it in a thoughtful way. Mr. Cox. I hope, Dr. Kessler, that you will notify the court, be- cause it is the right thing to do, that the FDA received documents in violation of a protective order. I hope you will do so as a matter of prudence and good judgment. I hope you will do so as a matter of sound public policy. When people violate court orders, when they violate orders of se- crecy, the court has to have a means of enforcing those orders. If people are free in our society simply to accept those documents, use them for whatever purpose they wish and not report back to the court, the court's process and our judicial system is quite obviously undermined. I take this matter very seriously, because we have been looking at this for sometime, and the FDA apparently is playing fast and loose here. You found perhaps a technicality that permits you to say we can use these documents even though John Coale is violat- ing the court's order. Mr. KESSLER. Congressman Cox, I'm sure you are too well trained a lawyer and know that-- Mr. COX. So are you, Dr. Kessler. Mr. KESSLER. V~no a court order binds is not a technicality. It's a very important legal point. Mr. Cox. What we are asking you to do is to report to the court that the person who is bound by that court order has in fact vio- lated it. Do you have no obligation to do that? Mr. KESSLER. I'd be happy to discuss- Mr. BARTON. We have plowed this ground several times. Mr. COX. I appreciate the chairman getting us back on track. Mr. BARTON. I just want to concur with the gentleman from Cali- fornia. I don't even have the advantage of being trained as a law- yer. I'm a poor engineer. But it appears to me that there is an ethi- cal question. Dr. Coburn raised it; Mr. Cox has raised it. We are going to pursue this on a bipartisan basis with counsel on both sides of this subcommittee staff, with you or your designee. I don't think violating court orders is trivial, and I think there is an ethical obligation above and beyond the technical aspects of the law to do something about that. I don't know whether ethically I have an obligation as the chairman of this subcommittee to do something. I'm going to find out. I don't know whether you or your designees have an obligation. But somebody has an obligation. I think we can agree to work to get to the bottom of this.
Page 164: TI14380272
320 Mr. KESSLEr. I'd be happy to do that, Mr. Chairman. Mr. BARTON. Mr. Cox, do you have any final comments? Mr. Cox. Yes. I appreciate the chairman wrapping that up, be- cause I want to inquire about a different aspect of this. Who currently has custody of the Coale documents? Do you know, Dr. Kessler? Mr. ZELLER, Are you talking about all the documents or just the ones subject to the protective order? Mr. Cox. The ones subject to the protective order. Mr, ZELLER. I have a copy of the documents subject to the protec- tive order. Mr. Cox. How about the documents that are not subject to the protective order that were provided also by John Coale? Mr. KESSLER. Ms. Thompson. Ms. THOMPSON. I think the Office of Legislative Affairs has those. Mr. BARTON. Could we at least have those, because we don't show that we received those? Ms. THOMPSON. Chairman Barton, the letter of October 27 that is being quoted from, if you look on page 2, we specifically say that the documents other than those subject to protective order have been provided and were provided previously. Mr. BARTON. We understand that, but I have checked with my staff twice, and they show no record of receiving them. Ms, THOMPSON. We would be happy to provide them again. Mr. BARTON. We could have gotten them and thrown them away, but we don't show a record that we have them. I'm not saying you were at fault, but send us what you said you sent us again. Ms. THOMPSON. I appreciate that, and we will do so expedi- tiously. Mr. BARTON. Thank you. Mr, Cox. Mr. Cox, Am I correct that you provided some of the Coale docu- mentation to Deputy Commissioner Mary Pendergast? Mr. ZIZLLER. I don't recall that. I recall giving Mary Pendergast a copy of the proposed rule that had been transmitted to me from the Center. I don't remember sharing the Coale documents with her, Mr. Cox, According to the October 12 letter from Congressman Barton to Dr. Kessler, Mr. Zeller provided some of that documenta- tion to Ms. Pendergast. That, I am advised by staff, is according to interviews that you gave to them. Is that not your testimony? Mr, ZELLER. It may not have come from me. It may have come from the ethics branch after I met with the ethics branch. I don't recall giving her the documents myself, but she ultimately received some information, because technically the request for internal af- fairs to begin their own investigation came from her. You asked me did I give her the documents. I don't recall personally giving her the documents. Mr. Cox. Is it your view, however, that she has some such docu- mentation? Mr. ZELLER. In all likelihood, in order to write the cover letter. My guess would be she got it from the ethics folks rather than from me, 321 Mr. Cox. Dr. Kessler, do you recall that Ms. Pendergast had to be forced to recuse herself from the FDA's breast implant crack- down? Mr. KESSLER. I think "forced"~ Mr. Cox. I'm sorry. I'm quoting now from a Forbes magazine ar- ticle about it. Mr. KESSLER. I don't think that is an accurate description. Mr. Cox. But she did in fact recuse herself?. Mr. KESSLER. No. I think what happened~ Mr. Cox. She did not recuse herselff Mr. KESSLER. Congressman, if. I could~ Mr. Cox. We have the recusal letter here. She did in fact recuse herself. Mr. KESSLER. If I can see the recusal letter, I would appreciate it'Mr. Cox. Mr. Chairman, I'm going to have to take a little bit longer for questions if we are going to do this. Mr. KESSLER. I just need to see the recusal letter. Mr. BARTON. Could we let Mr. Coburn have his last round of questions and then come back to you for one additional round? Mr. COX. Yes, by all means. Mr. KESSLER. ] can tell you the circumstances of that. I just need to see it. Mr. BARTON. While we are doing that we will get this letter to Dr. Kessler for his review. Mr. Coburn, you are recognized for 10 minutes. Mr. COBU~N. Dr. Kessler, could we have Mr. Spiller come up to the table? Mr. KESSLER. Sure. ~ Mr. COSURN. I have some questions and I want to get at the heart of some matters. During our last meeting, when I asked on Dr. Burzynski if there had been anybody that had been caused harm by him, Mr. Spiller said yes, there had, there had been 2 patients in Canada. We went through a little bit of a course on talking about that. The reason I want to come back to that today is I think that you all are the experts, and your expertise is based on science._Al- though we as politicians are guilty far too often of innuendo and inaccuracy, the one thing that we want from the FDA is for you to not be human like we are. When I asked that question we were very quick to be told that in fact 2 people in Canada had died. Mr. KESSLER. I think I was asked the question specifically--I'd have to get the transcript~whether there was any harm. Mr. COSURN. Right. Then you referred to Mr. Spiller and we talked about that. Mr. KESSLER. You asked whether I had knowledge of whether there was any harm. Mr. COSURN. And Mr. Spiller in fact said yes, there had. Mr. KESSLER. He had handed me a note. Mr. COBURN. In fact, in reading the things that the FDA gave in terms of the Canadians, there was no factual evidence whatso- e,~er in this doctor's mind after reading any of that that Dr, Burzynski had anything to do with the association of the death of
Page 165: TI14380273
322 those two patients. There is no proof of that whatsoever in any- thing that has been submitted to this committee or in the testi- mony that Mr. Spiller gave. Mr. SPILLER. Could I respond to that? The memo from the 2 Ca- nadian doctors dated after their visit to Dr. Burzynski on Novem- ber 15, 1982, by coincidence 13 years to the day before the hearing, indicated that they did visit and looked at Dr. Burzynski's best cases,and that they looked at people who had received the drug from him, and they did conclude~ Mr. COBURI~. Just a moment. We're talking about the specific people that you referenced that died in Canada, that you said died at the hands of Dr. Burzynski, that were related t~ Mr. SPILLER. No, sir, I did not say that. I did not say that they died at the hands of Dr. Burzynski. Mr, COBURN. That's true. You did not say that. Mr. SPILLER. Your question was, had that arisen from his treat- ment, and I believe that memo says that 2 patients did suffer septi- cemia and 1 of them died. Not from the cancer, but from the septi- cemia. Mr, COBURg. In response to the question that I asked in terms of harm coming from Dr. Burzynski, you in fact brought forward 2 patients from Canada that in fact had septicemia. The point I am trying to get to is not whether you did or you didn't. The implica- tion is that here is the FDA saying something happened that as a matter of medical fact did not happen and is not proven to have happened. It's conjecture. Let me finish, Dr. Kessler. I'll be more than happy to give you a chance to respond to it. Mr. KESSLER. Thank you, sir. Mr. CoBuP~. My point is that I want to make sure that the infor- mation that we get from you all in terms of how you answer wheth- er somebody has been harmed is based on the very science that you use to judge whether a drug is effective or whether the process was right or anything else. In this case I find that that is not the case. I think that is beneath the FDA. The second point that I want to make, and then, Dr. Kessler, I'll give you a chance to respond, is that in fact we have testimony that it was overheard that Mr. Spiller has in fact said--I'll be happy to give you the reference to the individuals--as far back as, I think, 1983, when this first started with Dr. Burzynski, that he let it be known that the FDA had other ways of controlling people that were not controllable through the regular process. I'll give you some quotes here in just a minute from people that I can reference that have given this. The point being the whole purpose of this hearing is to make sure that we get a commitment from you to do what I know that you want to do, and that is to make sure that we don't have a vengeful, spiteful Federal agency that if they knock heads with somebody then they are going to spend the rest of their time trying to prove a point rather than work for the health and well being of the people in this country. .I am not saying that has happened. What I am saying is I am very much concerned that the impression that that has happened by what people have said and what people have testified to, that 323 is not what you want; that's not what I want. What I want from Dr. Kessler is a statement saying that that is what we are going to try to clean up, the impression within the FDA that that is hap- pening, because that is an impression, some of it very falsely and inaccurately being created, some of it maybe not so falsely and in- accurately being created, but the fact is that your Agency is the one that we have to rely on. I would like foryou to respond to the 2 questions that I've asked because I promisedyou that I'd let you respond in full. Mr. KESSLER. Thank you, Dr. Coburn. Do you have in front of you the report to the Ministry of Health of Canada? Mr. COBURN. Yes. I've got it right in front of me. Mr. KESSLER. I agree with you that perceptions are very impor- tant and we have an obligation to make sure that the correct per- ceptions are there. Let me read beginning on page 13, number 9: We are frequently asI~ed what harm Dr. Burzynski can do if his material is safe. The administration of antineoplastons into subcla- vian veins for prolonged periods by unsupervised patients is not safe, and we know of two Ontario patients who developed septice- mia infection of the blood after returning from Texas. It says one of the patients died as a result of the septicemia. In addition, Dr. Burzynski does harm by misleading patients and giving them false hope. Furthermore, some patients may be di- verted from standard curative therapy by the lure of a false siren. Mr. COBUP~. We don't disagree with the last half of that. I take exception with this statement, because the~, have made an assump- tion that this is secondary to Dr. Burzynszi. You and I both know that the insertion of subclavian catheters, the administration of medicines in lymphopenic and neutropenic patients of medicines of- tentimes is associated with a very high risk of infection and septi- cemia. Mr. KESSLER. That's correct. Mr. COBm~. That has nothing to do with either the medicine or who is administering the medicine. Mr. KESSLER. And Mr. Spiller very clearly, if you look at the record, made that point, Dr. Coburn. Mr. COBtmN. He did not until I asked the question about subcla- vian catheters. The point being, Dr. Kessler, is that's beneath the FDA. The point is, if somebody died from it, you all ought to know it before you say it. You ought to know it without a doubt. There should have been an autopsy; you should have proven it. The fact is that didn't happen, so it shouldn't have been said. That's my point. I ex- pect greater than that from the FDA. There is no question that Dr. Burzynski may have harmed some other people because he is doing things outside of what we know is goodand standard care, in my opinion, in certain instances, and what I know about what he has done. So there is no question about that. To say that somebody has had physical harm without being able to prove that I think is wrong. Mr. KESSLER. I don't think it's unreasonable, Dr. Coburn. Maybe this is where we disagree, and again, it's one of the reasons why you're right. We tend to audit data and go back and look at data.
Page 166: TI14380274
324 But I think that the report to the Ministry of Health for the Prov- ince of Ontario, I think that deserves some weight. Mr, COBURN. Sure. Mr, KESSLER. That's all I'm saying. In fact, if you go on and look in this report, when you look at this report- Mr. CoBur~N. I read the entire thing last night. Mr, KESSLER. It raises a lot of concerns. Mr, COBURN. There are lots of questions of concern about Dr. Burzynski. I agree with you 100 percent. There are lots of concerns about him. But I want something better than that from the FDA. I want people to look at the FDA and say every time we're going to be able to trust them, they're always going to be measured in their response, they're always going to be fair in how they deal with this, we can trust that their opinion is not based on spite or slight or get even. The thing that worries me about the Dr. Burzynski case is that we are now 12 years into it, and in 1983 we have a quote saying we've got other ways of getting you after the first case. I'm going to give that to you right now. Mr. KESSLER. I think we should let Mr. Spiller have an oppor- tunity. Mr. COBURN. The representative was John Johnson, an attorney representing Dr. Burzynski at that time, was told by Mr. Spiller the following: "If Judge McDonald didn't close Burzynski's case that the FDA had other ways of closing the clinic and the FDA may have to commence a criminal grand jury if Judge McDonald didn't agree to close the clinic," That's a quote from Mr. John Johnson about what Mr. Spiller told him in 1983. Then we hear, as far as this committee, there have been inquiries into now 4 grand juries. Mr. KESSLER. You are reading that. Dr. Coburn, look at this re- port. In this article he is talking about Dr. Burzynski. He claims that 4 patients achieved a complete remission. Then they go follow up on those, and they find---- Mr. COBURN. I read all that. Mr. KESSLER. And you say I shouldn't rely on this but you are relying and impugning the Agency-- Mr. COBURN. No, sir. What I am saying is you all should rely on all of the information, not part of the information. The NCI in fact, the National Cancer Institute, has said in fact there is some bene- fit, retrospectively, that they saw 4 or 5 patients that from a retro- spective---- Mr. KESSLER. Worthy of a clinical trial. Mr. Co]~um~. Right. So therefore you all have done the proper thing. You've said, okay, you want to do this? Let's set up a clinical trial. I think you're right. I'm not against that. What I'm trying to create with you, and the point I'm trying to get across-- Mr. BARTON. The gentleman's time has expired. Mr, KESSLER. You asked me whether harm was caused. That started this. Not you. I apologize, Dr. Coburn. I think Mr. Frisa asked me that question, whether harm was caused. Relying on a report to the Health Ministry of Canada I don't think was done flippantly. You know this as well as I do. Unless you do the clinical trial, we are not going to have good data on those 25 patients. 325 Mr. COBURN. Right. You and I both agree that that needs to hap- pen. Mr. KESSLER. We agree. Mr. COBURN. I want to just summarize with one request, and that is, when this is all over and we are through, that we can sit and say and know without a doubt that you as the leader of the FDA through the reflection of your leadership will let it be known that no one dare do anything in the FDA in terms of getting back, in terms of vendetta. I can't tell you how many dru~ companies are afraid for me to use their name about things with the FDA because of their fear that somebody working for you will slow down a process, cost them tremendous amounts of money, raise issues that don't need to be raised, that have anything to do with safety or efficacy on drugs, because of the power of the FDA. With that power comes awesome responsibility to be more than fair. All I want is when we are through that you are dedicated to that. Mr. KESSLER. You're correct, Dr. Coburn. Mr. BARTON. The Chair is going to recognize Mr. Cox for 10 final minutes and then the Chair will ask some wrap-up questions and housekeeping questions to conclude the hearing today. Mr. KESSLER. Can we have an opportunity to see Dr. Coburn's document? Mr. BARTON. Without objection. Mr. COBURN. We'll get that to you. Mr. KESSLER. Thank you very much. Mr. BARTON. Mr. Cox. Mr. Cox. I take it Mr. Zeller is still with us. Dr. Kessler, you now have your recollection refreshed and you re- member that Mary Pendergast did in fact recuse herself? Mr. KESSLER. I'd be happy to tell you the circumstances of that. Mr. COX. Did you just not recall that she recused herself?. Mr. KESSLER. No. I just wanted to see the actual letter and the actual recusal. That's what I wanted to see before I spoke. Mr. Cox. Why did you answer no before? Mr. KESSLER. Because I didn't think she formally recused herselfi That was the question. I had asked her to step out of the breast implant. I asked her to do that. I know she did it. What I didn't have in my head was whether she formally recused herself, because in fact there were other documents, I believe, from Jack Kress afterwards saying that the recusal was not necessary or appro- priate. Mr. Cox. The recusal letter, as you know, says, "At the time I recused myself I informed Dr. David Kessler." Reading just briefly, because it's in plain English from the Forbes article on the subject, it says, "Kessler's regular meetings with Public Citizens"-- Mr. KESSLER. I wouldn't read from that. That Forbes article con- tains a number of inaccuracies. I'd be happy to tell you the cir- cumstances surrounding Mary Pendergast's recusal. Mr. Cox. You can respond at the appropriate point. I am now quoting from the Forbes magazine article: "Kessler's regular meetings with Public Citizen's Sidney Wolf reportedly be- came an embarrassment to the Bush administration, and Mary Pendergast" the women who now has the John Coale documents,
Page 167: TI14380275
326 at least one of the people who has them---"had to be forced by in- dustry and White House pressure to recuse herself from the FDA's breast implant crackdown'- Mr. KESSLER. That's an incorrect statement. Mr. Cox. I'd appreciate it. Mr. KESSLER. I apologize. I shouldn't have interrupted you. Mr. Cox. Up here on the dais we don't do any better job, it seems to me, of letting everybody go on at full length, so I understand. It's like playing tennis with a bad partner. Mr, BARTON. The Chair is trying to show great discretion so that we have an unscripted interchange. Mr. Cox. I appreciate that. I'll be brief and use the time that I've got economically. "Mary Pendergast had to be forced by industry and White House pressure to recuse herself from the FDA's breast implant crack- down because of a potential conflict of interest. Public Citizen sells breast implant litigation kits to plaintiffs' lawyers." I take it the part of that Forbes report that you disagree with is that your regular meetings with Public Citizen's Sidney Wolf be- came an embarrassment to the Bush administration. Mr. KESSLER. No, that she had to recuse herself because of in- dustry or White House pressure. I think that is what I took excep- tion to, Mr, Cox, For this purpose it matters not what were the motives. She did in fact recuse herself. Mr. KESSLER. At my request. Someone called me and said that the industry was going to go after her. In this town, because the issue was so highly visible, I asked her to stay out of it. Subse- quently, I asked Jack Kress for an opinion on whether I was right. Mr, Cox. This is another press report. If we don't like Forbes, this is the Legal Times. Mr, KESSLER. Family Ties. Mr, BARTON, Does the gentleman wish that in the record? Mr, Cox. Yes. I ask unanimous consent. Mr, KESSLER. In fact, what we learned from that was I had asked her because I was told that certain people were going to go "go after her." Mr, Cox. Dr. Kessler, I appreciate your interest in making these points at random, but I've really got to be able to conduct the ques- tioning, because I'm going to be cut off. Mr. BARTON. We are going to put that article into the record if Dr. Kessler has no objection. [The Legal Times article follows:] FAMILY TIES FORCE STAFFER INTO RECUSAL TOP AIDE TO FDA CHIEF, MARRIED TO NADERITE, EXITS IMPLANT DEBATE [By Sheila Kaplan] Advocates for breast implants may lose the war over the controversial devices, but they did manage to win one skirmish last month when they got a key Food and Drug Administration official barred from considering the issue because of an alleged conflict of interest, And this controversy featured an unusual role reversal: Advocates for the roughly $500 million implant industry claimed that a Ralph Nader-founded public-interest group was too cozy with government regulators. 327 On January 6, FDA Commissiener David Kessler issued an interim ruling calling for a moratorium on the use of silicone-gel breast implants until new information about their safety can be assessed by an agency panel. But, prompted by industry complaints, Kessler made that determination without guidance from one of his top aides, senior adviser Mary Pendergast. t's concern about Pendergast stems from her marrlage to David The indus ~ ....... ou Vladeck, a semor attorney at the Pubhc C~t~zen Litigation Group. Vladeck s gr p litigates for, among other Nader-founded organizations, the Health Research Group, which has played a major role in publicizing the risks of the breast implants and in seeking a ban. When ~tuart Pape, a partner in D.C.'s Patton,_Boggs & Blow who represents the American Society of Plastic and Reconstructive ~urgeons Inc., learned of the rela- tio,,,nship, he called Kessler, an old friend. ~ ........ I viewed" m self.., as a messenger or. conveyer oI. mlormauon,. . . ,says rape wnOi,m worked at the ~DA from 1974 to 1979 m several positions. I said, Dr. Kessler, hearing a lot of moaning and groamng aDOU~ ~ . PencIergast, who has worked as a lawyer for the agency since 1979, became Kessler's senior adviser shortly after he became commissioner in late _1_99.0. ~She works on a wide range of issues and, until her recusal, was one of about 20 stoners advising Kessler on the breast implant case. Pendergast and V]adeck were married in 1982, PROTECTING THE PROCESS Because the FDA had to issue at least an interim decision on the implants by Jan. 6, Kessler says, he did not have a lot of time to consider fully the complaint about Pendergast. Seekingto ensure "the integrity of the decision," w.hatever it turned out to ~e, l(essler says,he recused his aide the day after Pape called. .. '] did not want to compromise the breast implant decision in any possit)le way, ex~,.lains Kessler. 'q made a quick judgment." I do recognize that we need,, to think thoughtfully about the way to deal with two- profession families," he adds, ~here are other dualprofessional couples, and I think we need to figure out how to manage conflicts." For his part, Vladeck says he has never handled the Health Research Group's work on breast implants, and adds, "Since Mary has assumed her .position a.s.o.ne of Dr. Kessler's advisers, I have done nothing at all in terms of working on any~mng that's FDA-related." Pendergast declines comment on the matter. But Alan Morrison, director of the ' itizen Liti ation Group, says he supports the FDA chiefs move, Public C g - • ' ime "I thought it was not required, but surely it was not a good us.e. of. FD,A, s~.t , to get int~ a skirmish with breast implant manufacturers over a smesnow, ~om- SO~ SaVS. If t~e government did the sensible thing, rather than only what the law requires, everyone wouid be a lot better off in most cases," Morrison adds. Morrison also says that if Pendergast had not been recused from the issue, manu- facturers and surgeons' groups would have been likely to sue. Such a move would have delayed what has already become a lengthy and contentious process. HEALTH HAZARD OR HEALTH AID? Public concern over silicone-gell breast implants surfaced in 1988, when the Health Research Group petitioned the FDA to ban them. Since then, the group has continued to amass research on the health ha.za.rd~s ,associated.with t,he_i ,m, pl~?tnS" and has made this information available to pla~ntu~s mwyers suing on ~enan o - jured women. The public interest group has also sued the FDA under the Freedom of Informa- tion Act to release reports submitted by Dew CornJng Wn.'ght, which manufactures most of the implants used in the United States. Other ma~or manufacturers include Bioplasty Inc., the McGhan Medical Corp., and the Mentor Corp. Manufacturers, surgeons, and some women with the implants have flooded the FDA and Capital Hill with about I0,000 letters praising the procedure and asking to keep the devices on the market. The lobbyin~ campaign has been highly emo- tional--stressing the theme that if silicone-gel ~mplants are banned, women will "risk their health by seeking surgery from unregulated sources," as one of the physi- cians' sample letters to Congress puts it. In addition to Pape, other lobbyists working the issue for the industry have in- cluded Roger Stone, a partner in Black, Manafort, Stone & Kelly Public Affairs; Nancy Taylor, a partner in The Law Office of Deborah Steelman, in the District;
Page 168: TI14380276
328 Wayne Pines, executive vice president and director of medical issues for Burson- ~VIarseller, and John Kent, chairman of D.C.'s Kent &O'Conner. Although the FDA's outside advisory committee in November recommended keep- ing the products on the market pending further review, negative information about the implants, which Dew Coming Wright had withheld from the FDA, surfaced in litigation and in Congress, prompting the agency's interim opinion. Kessler's ruling--which amounts to a call for a voluntary ban since the agency doe~ not regulate physicians--is in effect until the advisory panel looks at the issue next month. Kessler says his decisions concerning Pendergast is not intended as a precedent. He adds that t.he FDA will soon take up the issue of otential conflicts ' of staffers' family relationships in a more formal way. p growing out Under federal ethics rules, the financial interest of his or her spouse is considered to apply to a government employer. Gloria Frank, an attorney-adviser in the De- partment of Health and Human Services, which overseas the FDA, says that cial interest" may be interpreted to include a spouse's salary, as well as stock or other financial holdings. Among the other FDA staffers with spouses who could spawn oonflicts is Deputy Commissioner for External Affairs Carole Scheman, whose husband, Paul Fiduccia, is a~p..a.rtne.r ~in,tl?e D.C. office of Chicago's Winston & Strawn. Fiduccia doesn't work on ~'~.~-rela~ea msues, says managing partner J. Michael McGarry III, but the law firm does represent clients in the food and drug industries. Mr. COX. I just have a few questions that I need to ask you about this. Mr. KESSLER. But it was subsequently determined there was no need to recuse. That's the only thing I'd like on the record. Mr. Cox. In fact, having read all of the documents, I think that is a mischaracterization. Whatyour own documents that I have viewed say is that while you do not think there is a violation of section 208, the statute, that to avoid the appearance of a conflict of interest she was going to recuse herself, which is a perfectly ap- propriate thing to do. The appearance of the conflict might have been created in the facts and circumstances because her spouse was in fact employed by Public Citizen; Public Citizen was selling breast implant litigation kits. Litigation kits are basically how-to s on how to start a civil lawsuit. Those are the circumstances in which with your consent or at your direction, if I take your testimony properly, this women recused herself, She's a senior person at the FDA. She is now in- volved in this bone screw matter, having received~ Mr. KESSLEI~. She's Deputy Commissioner as well as Senior Ad- viser. Mr. Cox. [continuing] documents that were provided by one John Coale, whose bona tides and lack thereof we have gone into in this hearing. Mr. ZELLER. Mr. Cox, can we just make very clear what her role was, because I think it's central to your line of questions? Mr. Cox. Yes. You will be given that opportunity momentarily. Are you aware, Dr. Kessler, that Public Citizen is selling bone screw litigation kits? Mr. KESSLER. I wasn't aware of that. I know they have sold kits on other litigation. Mr, Cox. They sold kits on breast implant litigation kits, right? Mr. KESSLER. I was aware of that. Mr. Cox. Litigation kits on how to start a lawsuit, which is de- signed obviously for the purpose of proliferating litigation. 329 Is the group selling something that makes money from litigation, in your view, someone who has a financial interest in the matter that is the subject of the litigation kits? Mr. KESSLER. Mr. Cox, I went down this road in breast implants only to find out that I made a mistake in asking Ms. Pendergast to recuse herself. We've learned long ago not to hold a spouse re- sponsible for the other spouse. Mr. Cox. Let's go directly then to the FDA. Public Citizen has challenged your advisory panel's decision on bone screws, has it not, with a citizens petition? Mr. KESSLER. There was a citizens petition that came in, Mr. Cox. Challenging the FDA advisory panel's recommendation on bone screws? Other people want to say yes to that question for the record? There are some heads nodding over here. Mr. KESSLER. Yes. Mr. Cox~ So you are aware then that Public Citizen has an inter- est in this matter, in the outcome of the matter? Not a financial interest for purposes of this question. An interest in the bone screw rulemaking. Mr. KESSLER. I'm aware of the petition. Mr. Cox. On the same date that Public Citizen filed its petition it held a press conference, and on that same day the FDA issued an anonymous update about the use of bone screws in the pedicles of the spine. Are you aware of that? Mr. KESSLER. An anonymous update? Mr. Cox. Not attributed to any person in the FDA. Mr. KESSLER. I'm not sure what you are referring to. I apologize, If you can tell me what you are referring to, it would be helpful. Mr. Cox. The date was December 20, 1994. Is there anybody here on the panel that is aware of the chronology of the rulemaking on bone screws? Mr. KESSLER. I'm sure I have it in one of these books, Congress. man. Let me just see what I have. Mr. COX. The FDA stated at that time that these devices are in~ vestigational, not approved by the FDA, that doctors should not use them without warning patients that they are unapproved, all state- ments more closely consistent with the position that Public Citizen was urging than with the Agency's own decision made previously internally in concert with its advisory panel to down classify them, Why is that? Mr. KESSLER. I'm not sure what documents. If I can see what documents you are referring to, it would be helpful. Mr. Cox. I'll describe it for you since I don't believe we have time to make copies of this and share it. I will ask unanimous consent that it be included in the record. Mr. BA~TON. We will provide it to the FDA and the-minority. Mr. Cox. The title of the document is "Update on Pedicle Screws." It is issued by the FDA, dated December 20, 1994, and it is as I just described. It was basically a step backwards from where the Agency was headed prior to that time. The Agency was headed, based on the advice of the advisory panel's recommendations, to down classify pedicle screws. [The document referred to follows:]
Page 169: TI14380277
330 DEPARTMENT OF HEALTH AND HUMAN SERVICES, FOOD AND DRUG ADMINISTRATION, December 20, 1994. UPDATE ON PEDICLE SCREWS FDA has recently received a number of inquiries about certain screws used in sur- gery to stabilize the spine. We hope the following information helps to answer these questions, How are the screws used? Screws are used to stabilize the spine after spinal injury, or to c.orre.ct, se.vere, s~li,- nai curvatures and other abnormalities. A pair of the screws is place~l iaor~zon~al~y into the rear of the bony bridges, called pedioles, that are connected to each verte- bra, one on each side. (Thus they are called "pedicle screws" when used for this pur- pose,) Vertical rods (or plates) are attached to the screws, The rods are connected to the pedicles of a second vertebra by means of another set of pedicle screws, straightening or strengthening the spine. How widespread is this use? Pedicle screws have largely replaced other methods of spine stabilization such as wires, reds and hooks in the 30-70,000 spine stabilization procedures performed an- nually in the U.S. About 300,000 people have been implanted with the screws. Why is FDA concerned about the screws? Because, despite their widespread use, not enough is known about the possible short.term adverse affects of the screws when they are used in the pedicles of the spine, nor about their long-term effectiveness. Under the law, before o~rthopedic screws can be marketed as pedicle screws, their manufacturers must sul~mi~ sci- entific data to FDA establishing that these devices are safe and effective for this purpose, Limited studies of pedicle screws have been ongoing for a number of years, and FDA has approved, using the screws in these studies. But the studies are still not complete, and the manufacturers have not yet accumulated enough data to show, one way or the other, whether the screws are safe and effective. Are there any spinal screws approved by FDA? Yes, Those that are inserted into the front of the spine rather than the rear have been approved. Screws used in certain portions of the lower spine (the sacrum) are also approved. But no screws have been approved for use in the pedicles of the spine. tf pediele screws aren't approved, how can they be used so widely? In practice, surgeons often use orthopedic screws that FDA has.el,eared for o~thce~ purposes, such as repairing long bones m the arms and legs, as pedicie screws. ~uc hse of approved medical devices for non-approved purposes is called "off-label use," and has traditionally been regulated by the hospitals in which physicians practice and by their state medical boards, not by FDA. However, FDA has taken two actions to be sure that all parties are a,,dequately informed that using screws in the pedicles of the spine is considered an 'off-label" use. Firstl to be sure physicians understand the re.~ulatory status of the screws, FDA requires that manufacturers include in the labehng for the screws a statement that they are not approved for use in the spine. And second, FDA has advised physi- cians that they have an obligation to discuss any "off-label" use of these screws with the patient, explaining the ~enefits, drawbacks and limitations of knowledge about the procedure, and making it clear to the patient that this particular use of the screws has not been approved by FDA. Widespread use of screws in the pedicles of the spine was encouraged in the past by some of the screw manufacturers, who promoted this practice to surgeons through training courses given during professional meetings. As a result of FDA warnings, this type of illegal promotion has largely ceased. Does the lack of FDA approval mean the screws are unsafe? Not necessarily. There simply isn't enough scientific information at this point to say for sure whether the screws are safe for use in the pedicles of the spine or not. There is some evidence that the screws might be beneficial in treating certain spe- cific conditions, such as spinal fractures, degenerative spondylolisthesis (slippage of the spine), tumors and scoliosis (spinal curvature). In light of this evidence, an FDA advisorypanel of outside experts recommended in July 1994 that FDA re-classify those pedicle screw device systems intended for two specific uses--treating spinal 331 fractures and spinal slippage---inte a less stringent regulatory category. FDA is now considering whether to take this action. But the effectiveness of the screws--or any other surgical procedure---in treating low back pain or simple disc problems is far more uncertain. Despite this, many of the 30-70,000 spine stabilization procedures performed annually m the U.S. are to treat these conditions. What about the problem of screws breaking inside the body? Although some news stories have implied that the screws break very commonly~ the actual breakage rate is not known. Limited information suggests that.the~ screws now being used break less frequently then those, used i~n the.,mid:1980's,, b, ec,ause. of improvements in product design and testing. More imormacton Is neeaea about breakage rates before FDA can decide whether the screws are safe and effective for use in the spine. ls progress being made in getting scientific information on the effectiveness of the screws? Yes. FDA is working with surgeons and manufacturers to design sound clinical studies and get them underway. These studies will provide the needed information about which spinal conditions, if an$, can be successfully treated with the screws, the kinds of adverse effects that can be expected, and how often they occur, In the meantime, what about peopl~ contemplating back surgery? Patients considering back surgery in which pedicle screws might be used to bilize the spine should keep in mind that these devices have not been approved for this purpose, and that FDA cannot assure that they are safe and effective. They should also remember that there is little evidence that the screws are effectivo in treating low back pain or simple disc problems, Patients should ask their doctors to explain beforehand both the potential benefits and risks of the screws, as wall as alternative treatments, including non-surgical ones. Patients should also keep in mind that, as with any surgery, it is important to choose a surgeon who is skilled and experienced in performing the procedure. What are the surgical alternatives to the screws? The goal in these procedures is to stabilize the spine temporarily until two or more adjacent vertebrae permanently fuse together. This can be done with the usa of hooks or wires, which are approved by FDA, rather than the screws, Surgery c.an also be done using implants attached from the front of the spine rather than the rear. And fusion can be accomplished surgically without the use of implants by in- serting bone graRs between the vertebrae, followed by the prolong~ed use of braces or casts. How about people who already have the screws? Some news stories have implied that a large proportion of pediclo screws fail in use. Although the actual failure rate is still unknown, the medical literature indi- cates that the screws probably fail only a small percentage of the time. This means that most patients with the screws are not likely to have serious problems with them. However, patients who are experiencing problems or concerns that relate to their surgery should consult with their doctors. Mr. COX. I wonder if you have any recollection of those events and why that happened in that way. Mr. KESSLER. I'd have to ask other people. Mr. BARTON. The gentleman's time has expired. I will certainly let him finish this particular line of questioning if he could do so expeditiously. Mr. Cox. Three months after receiving the Public Citizen petition and after this document was issued, the FDA rejected all the claims that Public Citizen made, Do you know exactly when that was, Dr. Kessler? Mr. KESSLER. When we issued the proposed rule? Mr. COX, Yes. Mr. KESSLER. Dr. Burlington. Mr. BURLINGTON. I don't have that date fresh in my mind, sir, Mr. ZELLER. The down classification?
Page 170: TI14380278
332 Mr. Cox. The rule. Mr. ZELLER. September 27, or late September. Mr. Cox. The net result of this is that there have been signifi- cant delays in the publication of a rule on back screws because of the involvement of people who obviously are interested in litigation surrounding this matter. This member takes it very seriously that people who have a financial interest, people who have a litigation interest in a particular matter have such ready access and have such obvious impact on the timetable by which the FDA accom- plishes its mission. I told you at the outset that I had seen the USA Today advertise- ment directed at people such as myself who have screws in their back, asking me to join a class action against the manufacturer of the screw. I think that in the interest of the public health and the interest of the advancement of medicine it's vitally important that device manufacturers be free from such harassment, and I consider it to be harassment when one casts such a broad net in USA Today and says, do you have a screw in your back? If so, join my lawsuit for fun and profit. The history of this fellow recounted in books such as the Double- day volume that I've described published in the New York Times magazine, the fact that this fello_w,_, self-described sleazebag, has a warrant out for his arrest, that he s the subject of ethics complaints the trial bar, all of this would suggest to me that a commis- sbiYoner who is trying to have public integrity maintained at the highest levels would be very, very wary about accepting documents from such a person designed to influence their moneymaking schemes, using those documents with full knowledge that the man who gave them to you violated a court order, not advising the court even after this Congress has put you on notice that that, in our view, is the appropriate response, all of these things cause this member to believe that things are not as they should be. I will just ask you one thing in conclusion, Dr. Kessler. The sec- ond matter, the second protective order of the court that was vio- lated in this case---- Mr. K~SSLER. The second protective order? Mr. Cox. There are 2 protective orders, the one that the court found that the FDA violated, and the one that John Coale violated. Ms. PORTER. Mr. Cox, with all due respect, we've said repeatedly and I think it's important to say here again, we are focusing on the character of the documents. We have not looked into whether Mr. Coale violated a protective order. Mr. Cox. Ms. Porter, we have gone through this at this hearing, and I've got to say that we have got in .writing from the F, DA your statement that these documents violated the protective omer. Mr. BARTON. We don't need to plow that. Ms. PORTER. You've got in writing a statement from us that the documents are subject to a protective order. That is absolutely cor- rect. Mr. Cox. Have you, Ms. Porter, read the protective order? I just read it publicly in the hearing record. It's quite dear, it seems to Mr. BARTON. Let's conclude. 333 Mr. Cox. I'm trying to keep this at the public policy level, be- cause the purpose of this oversight hearing is to inquire into whether the FDA is able to police itself, whether allegations of con- flict of interest, whether allegations of retaliation are being han- dled properly within the Agency. What I am being told is that in this case it is the FDA's view that there is no obligation to inform a court of law that its own process has been violated even though the FDA knows that that is what happened. I am told that there is no responsibility to concern ourselves with the appearance of conflict of interest that is gen- erated when people with an obvious financial interest in litigation surrounding something that is the subject of the FDA's rulemaking are back channeling, in this case in violation of a court order, infor- mation to the FDA and when there is obvious evidence that the FDA's own rulemaking process has been slowed down by these in- volvements with such people. So I want to put this discrete ques- tion to you in conclusion. On this second violation of a court order, this one by Mr. John Coale, on the use of the information provided by Mr. John Coale to the FDA, will you refer this for an impartial examination by the IG? If there is nothing there and if the IG so reports, that will be the end of it. Mr. KESSLER. Congressman, I just want to clarify something, I'm thinking about the answer to your question as I do that. Are you in any way implicating or making any allegations against Mary Pendergast? Is that what is going on here? Am I missing this? That sounds like what is going on here. Mr. Cox. Dr. Kessler, Ms. Pendergast is not a witness before this committee at this time. Mr. KESSLER. But you've raised her name; you've raised her rela- tionship. Mr. Cox. You, however, are. Mr. KESSLER. I am. Mr. COX. All of my questions are addressed specifically to you and to the people with whom you have surrounded yourself today, Mr. KESSLER. Is there an inference here that you are leaving? Mr. Cox. It is your responsibility, not anyone else's, to concern yourself with both appearance and actual violations of law and eth- ics by your people. Mr. KESSLER. Let me state unequivocally for the record--I'd be happy to go into it now in detail if you'd like, but I know the hour is late--if you look at the history of pedicle screws over the last decade and you look how some have come onto the market, and you look at the issues, and I'd be happy, Congressman, to go in~ Mr. Cox. I just wish you would answer my question. I asked you a simple question about an IG investigation. You are doing every- thing possible to not answer it. Mr. KESSLER. An IG investigation of who? Mr. Coale? Mr. Cox. Of the FDA and your handling of this matter. Mr. KESSLER. Of what matter? Mr. BARTON. The violation of the court order.
Page 171: TI14380279
334 Mr. Cox. The matter that I have gone into in 3 rounds of ques- tioning here, the disclosure by Mr. John Coale in violation of the court order of documents to the FDA. Mr. KESSLER. Excuse me. Are you saying that the Agency vio- lated a court order here? Mr, COX. I am asking you for a simple answer to this question, and that is whether the matters that we have discussed in a ful- some way this morning may be referred- Mr. KESSLER. I just want to know the allegation. I thought we were discussing whether there was reason to-~- Mr. BARTON. I'm not an administrative law judge and I've tried to give great discretion to both the questioner and the answerer, but we can't just get into a debating match here. The questi~on before you, Dr. Kessler, is, are you willing to refer to the Inspector General an investigation of a court order that was violated by representatives of the FDA? Your counsel has indicated several times that there may not be such a violation. Mr, KESSLER. I have no information that FDA has violated a court order. I thought this discussion over the last several hours was whether Mr. Coale had violated a court order. Mr. Cox. I don't think there is any question about that. Mr. KESSLER. Is that what you want referred to the IG? Mr. Cox. There is no point investigating that fact. We know he violated the court order. The FDA has already told us this in writ- in~Ir. KESSLER, I don't make those determinations and I don't have that information. Mr. Cox. Mr. Chairman, it's quite obvious that Dr. Kessler under oath or otherwise is unwilling to answer the question that I put to him, which is whether he would refer this to the IG for an impar- tial investigation. Mr. KESSLER. Because I need to know the allegation, Mr. Cox. Mr. BARTON. With all due respect, Dr. Kessler, we've tried to give it to you in plain English at least a half a dozen times. I want to conclude this hearing. I know you want to conclude this hearing. I would be willing to let Congressman Cox ask the question in as clarifying a way as he can one more time and then gi.'ve you a chance to give a straight answer to it before we recogmze myself to conclude. Mr. COX. I will yield myself 45 seconds to recap the entirety of what we have covered on this specific matter today. • ' 0 Mr, BARTON. Justput your question. Let s try t define what you want the Inspector General to investigate. I think that's his ques- tion. Mr. KESSLER. Right. Mr. Cox. The FDA has received documents through Mr. Zeller that have been shared with you, that have been shared with Mary Pendergast, that have been shared with others at the FDA on which the FDA has taken action and as a consequence of which ac- tion rulemakings have been retarded. The information was provided in violation of a protective order of the court in pending litigation covering the same matter. The person who violated the court order and who provided this informa- tion to the FDA and Mr. Zeller is, according to his own words, a 335 known sleazebag, someone who is the subject of an outstanding ar- rest warrant for violating ethical and legal rules in connection with the fomenting of litigation. The FDA has not upon receiving this information in violation of protective order notified the court that it is in possession of such information; it read all of the information; it used it and relied upon it. I have serious questions about this means of handling that infor- mation. Because you, Dr. Kessler, have been personally involved in what I consider to be that serious lack of judgment, I am asldng you to refer for an impartial investigation this subject matter to the IG. Mr. KESSLER. I don't have independent knowledge that the infor- mation was provided in violation of a court order, Congressman, Mr. Cox. Dr. Kessler, I don't want to ask the question again, Mr. BARTON. The answer is no. For whatever reason, he is not willing to do that. Mr. Cox. Mr. Chairman, based on what we have learned today, I think there is much for the American people to infer about how the FDA handles document disclosures. This issue goes directly to the integrity of the Agency, and I would ask that a separate sub- committee investigation and hearings be pursued in this area. Mr. BARTON. The Chair will take that under consideration. Mr. ZELLER. Mr. Chairman, one very small point, Mr, Cox did say bewould get back to the facts of Ms. Pendergast's role and we never got to that. Mr. BARTON. I beg your pardon. Mr. ZELLER. I said earlier to Mr. Cox that I would like to make a statement about Ms. Pendergast's role. He said we would get to that. We didn't. I would like to make that statement now. Mr. BARTON. Briefly. Mr. ZELLER. Very briefly. The decision had already been made by the ethics branch that internal affairs needed to investigate 2 of the 3 cases. All Ms, Pendergast did was transmit the ethics findings in a cover letter to OIA. To suggest a larger role on her part would be wrong. Mr. BARTON. I don't think Congressman Cox suggested a larger role. Mr. KESSLER. I am just not sure of the last statement, I have concerns about leaving inferences with as little information on this, Mr. BARTON. The Chair respects your concerns. We are going to give you every opportunity to continue to work with the committee on the issues Mr. Cox has raised. Mr. KESSLER. We'd be happy to. Mr. BARTON. I want to stipulate that I share Mr. Cox's concerns, I'm not convinced that there is not grounds to do an independent investigation, but I am certainly willing to cbntinue to work on. this• Mr. KESSLER. We'd be happy to work with you. Mr. BARTOl~. The Chair is going to recognize himself to conclude today's hearing. First, there are a number of questions on Biomet that Congress- man Frisa was going to ask. He has been detained unavoidaably,
Page 172: TI14380280
336 Those questions will be submitted to you and your designee for written responses. Mr. KESSLER. We'd be happy to respond. Mr. BARTON. Again, to try to condense this, there have been 5 specific cases that this subcommittee has heard testimony on: the Sensor Pad case that Mr. Burr has gone into in some detail; the Myo-Tronics case that Mr. Crapo and myself have gone into; the Biomet case; the Sofamor Danek case that Mr. Cox has gone into; and the Burzynski case that Dr. Coburn has gone into. There have been 5 specific cases. On the Sensor Pad case, my understanding is there is a pending 510(k) proceeding that is attempting to be expedited. My question is on the Sensor Pad case, and I asked a question earlier. It ap- pears to me that we need to change existing law so that devices are not automatically classified as class III devices if there is no predicate prior to 1976. Dr. Kessler, while this pending 510(k) is underway, are you or your designee willing to work with this committee to help draft a legislative remedy so that devices in the future similar to the Sen- sor Pad are not subjected automatically to the class III regulatory morass? Mr. KESSLER. We don't draft legislation. Mr. BARTON. I've got a bill. Mr. KESSLER. The Departmen.t higher-ups do legislation. I'd be happy to work through the policy implications of that. Mr. BARTON. If I submit to you or your designee a draft bill by me, who has the authority to introduce legislation as I'm a Member of Congress, I can do that. Before I do that, I am more than willing to let you or whoever you refer it to look at it for your comments. Mr. KESSLER. We'd be very happy to provide assistance to the committee, Mr. Chairman. Mr. BARTON. I appreciate that. On the Myo-Tronics case, I have asked that this case be referred to the Inspector General at HHS, and you indicated that you would do so; is that correct? Mr. KESSLER. Exactly the way I stated it in my testimony, yes. Mr. BARTON. On the Sofamor Danek case that Mr. Cox has been very concerned about, he requested that certain aspects of that be referred to the Inspector General, and that is something that you are taking under advisement. Mr. KESSLER. That's a fair statement. Mr. BARTON. On the Burzynski case, there is a grand jury in Houston, Texas that within the last 2 weeks did bring forward nu- merous indictments. As a consequence of those indictments, yester- day-if I'm misstating this, I want to be corrected--representatives of the Federal Government went before a Federal magistrate in Houston and asked that the Burzynski Clinic be shut down. I am told that Dr. Burzynski has 300 patients currently receiving his treatment or his therapy. Does the FDA wish that if in fact the clinic is shut down that those patients stop receiving the medica- tion? Mr. KESSLER. My sense is that those patients should have access to medicine under clinical trials. 337 Mr. BARTON. So if in fact the clinic is shut down, it is not at least your opinion that the patients currently receiving the treatment be refused that treatment; is that correct? Mr. KESSLER. I think they should receive treatment under clini. cal trials. Mr. BARTON. To your knowledge, are there such clinical trials derway at this time? Mr. KESSLER. Yes, there are. Mr. BARTOI~. I want to conclude. We are going to continue to monitor the situation on these cases and others. The purpose of these last 2 hearings has been to give you and the representatives of the FDA the opportunity to answer the allegations that were brought at the previous hearing. I am going to carefully review the record. I am not persuaded as of today that there have not been efforts to harass, intimidate, or retaliate against companies and individ- uals that are regulated by the FDA. I think the record is still ope,n on that. I personally believe that the record upon review may ind~- care that we do need reform legislation that creates an independent review board outside of the FDA and an appeals process that really ean be used. I am going to take that under advisement. Before I conclude, is there anything that you would wish to put on the record that you have not been given an opportunity to? Mr. KESSLER. Only a thank you to the Chair for your personal fairness and in the way you have allowed us to present as thor- oughly as you have over these last 2 hearings. Mr. BARTON. To use your words, this is an uncomfortable posi- tion to be in. You've got an obligation as a representative of the ex~ ecutive branch. We have an obligation as a representative of the legislative branch. Sometimes those obligations are in conflict. But we both represent the citizens of the United States of America. There is nobody on this subcommittee that is attempting to allow, using Mr. Waxman's phrase, quacks and charlatans to run amok among the American people. By the same token, we do not want to let the representatives of the Federal Government that regulate the health and safety of food and drugs in this country be above the law and be a power unto themselves. Somebody said power corrupts and absolute power corrupts absolutely. Somewhere we have got to find a middle ground on this. I believe you have the best interests of the citizens at heart, and I believe that this subcommittee does. So if we work together, we can make the reforms necessary internally and externally so that the FDA does what its mission is. With that, we are going to conclude the hearing. [Whereupon at 3:50 p.m. the hearing was adjourned.] [Responses to subcommittee questions by the Food and Drug Ad- ministration follow:]
Page 173: TI14380281
DEPARTMENT OF HEALTH & HUMAN SERVICES, PUBLIC HEALTH SERVICE~ FOOD AND DRUG ADMINISTRATION, February 7, 1996. The Honorable Join. BARTON, Chairman, Subcommittee on Oversight and Investigations, Commerce Committee, Washington, DC 20515.4306 DEAR MR, CHAIRMAN: This is in response to letters from you and Congressman Coburn, dated December 18 and December 6, 1995, respectively, regarding matters that wore discussed during the Subcommittee's hearings on November 15 and De- cember 5, 1995. The following information is being submitted for inclusion in the hearing record. RESPONSE TO MR. COBURN'S FURTHER BURZYNSKI INQUIRY During the December 5, 1995 hearing, Mr. Coburn stated that the Subcommittee had a quote from a Mr. John Johnson, a laywer involved in the Burzynski matter, about a statement allegedly made by Mr. Robert Spiller, a Food and Drug Adminls- tration (FDA) attorney to Mr. Johnson. (Tr. p. 196, at lines 4772-87.) In his letter of December 6, Mr. Coburn clarifies that the referenced ' quote' was in fact a state- ment ~by a third person, Mr. Richard Jaffe, an attorney representing Dr. Burzynski, regarding a conversation Mr. Jaffe claims took place between Mr. Spiller and Mr. Johnson in 1983. The December 6, 1995 letter also notes that Mr. Coburn does not have any confirmation that the alleged comment was ever made. We appredate the acknowledgement that there is no confn'mation that the alleged comment was ever made. Without a specific allegation as to what was said, how- ever, it is impossible to provide a specific refutation. At the same time, Mr. Spiller does not believe that he said the words that have been characterized as a quote, nor that he said any words to that effect. In order to provide as much clarification as possible, we have attempted to discern how such an allegation might have devel- oped, and offer the following explanation. Mr. Spiller was one of the government attorneys from the Department of Justice and FDA who represented the United States in the 1983 injunction case against Dr. Burzynski, and in the Plaintiffs Motion for Summary Judgment that preceded Judge McDonald's injunction of Dr. Burzynski's interstate commerce in anttneoplastons. In the motion, the United States described the enforcement options available to FDA in such matters, noting as higher courts had that terminally ill patients, as all others, are entitled to the protection of the Federal Food, Drug, and Cosmetic Act from unapproved drugs. In 1996 Mr. Jaffe cited this paragraph in an affidavit filed in the district court in the pending criminal matter. It may be that the entirely appropriate 1983 description in a court pleading of FDA's enforcement options has become, through a multiple hearsay chain of repetitions over the years, the basis for the alleged statement about "other ways of getting you." RESPONSES TO FOLLOW-UP QUESTIONS FROM MR, FRISA ON BIOMET Question: 1. Doctor, in preparation for these hearings on the Biomet case study, wore you advised by your staff that FDA was reading and using a document that appears to violate a protective order? Response: The Commissioner was not advised that, with respect to the Biomet case the "FDA was reading and using a document that appears to violate a protec- tive order. Question: 2. Based on the information presented, shouldn't FDA personnel have inquired as to whether it was covered under a protective order? Response: Based on the manner in which the documents were presented, there was no reason for such an inquiry. At the time Mr. Johnson supplied certain docu- ments to the FDA Detroit District Office, he did indicate they were subject to a pro- tective order, but that his release of the documents was in accord with the condi- tions set forth by Ralph Cohen, a Biomet attorney. In a March 25, 1995 letter from Mr. Cohen to Mr. Johnson, Mr. Cohen stated, "...in order to avoid any appearance, even though erroneous, that Biomet is attempting to withhold documents which should have been turned over to the FDAt Biomet has authorized us to advise you that it has no objection to your giwng the FDA documents which were submitted to the trial court as part of the plaintiffs evidence in support of its class certification mo- tion." 339 This letter was included in the documents Mr. Johnson supplied to the Detroit office. Regarding your sp.e.cific reference to. the thr~ee-page report, u.po,n re.c,eil~t, of t~h,e doc- ument by our Detroit office, a .cemphance .omcer..was ~n.,con, mc~ w~r,n ~wr. d_o,nnson on November 8, 1994 and inqmred about the ong~n oz me aocument. Mr. Jonnson replied that the document had been obtained from Biomet during the judicial dlscov- ery process, and he could only speculate as to its origin, denying any knowledge of the authors. It was assumed by the Detroit office that this document was vnthin the sco~e of Mr. Cohan's agreement with Mr. Johnson, as Mr. Johnson did not indl- care otherwise. Question: 3. When FDA personnel receive docmnentation subject to a protective order, do theyhave an obligation to not~ the court? Why or why not? Response: Based upon our review of relevant statutes and case law, as well as American Bar Association's Model Rules of Professional Conduct, neither FDA per- sonnci nor private citizens have an obligation to inform the court when documents subject to a court protective order are improperly,dis.clos,ed. Question: 4. Doctor, should FDA have inqyea into me background of Mr, John- son to determine if he was a reputable source. Question: 7. Does this editorial suggest to you that Mr. Johnson is an unbiased, responsible source of information on whom FDA should rely.? . . Response: Given the ever present mismatch between mvestigational resources available to FDA and the broad spectrum of products for which the Agency has reg- ulatory responsibility, the Agency always is open to receiving information that can help us fulfill our mission of protecting and promo~ng the public health. We regu- larly receive information about products we regulate from health p.rof.e.ssionals, con, sumers, academic and clinical researchers, private attorneys, orgamzatmns that rep- resent these various constituencies, as well as from the clinical and scientific lit- erature. We take very seriously our obligation to ensure the veracity of information given to us. The information supplied to FDA by Mr. Johnson was not the sole basis for the decision by the Center for Devices and Radiological Health (CDRH) to inspect Biomet facilities to determine the cause of premature fractures associated with the firm's hip implants. After receiving all of the materials from Mr. Johnson, Detroit District officials enlisted assistance from technical experts in CDRH to determine if the materials demonstrated a serious health problem and could provide at least a partial basis for ./~gency action. In early April 1995, Detroit investigators met with Center experts to discuss the problems of particulate disease ("metallosis'), which was the main focus of the documents provided by Mr. Johnson. At that meeting, De. troit staff also learned about a more immediate and serious-problem involving metal fatigue associated with Biomet's nitriding process, which was attributed in a groW. ing body of adverse ~ncident reports to premature failure of the femoral stem portion of the hip implant. It was this "fracture problem" that led FDA to conduct "for cause" inspections at Biomet and a competitor firm, in addition to classifying Biomet's product retrieval as a recall. FDA is continuing to monitor the progress of Biomet's corrective actions. Question: 5. Dr. Kessler, do you agree with Mr. Johnson's statement comparing hip and knee implant surgery to Auschwitz? Question: 6. Dr. Kessler, are these surgeons as criminal if not more so than Dr. Mengele? Response: The issues of informed consent and human subject protection are of great concern to the Agency. We respectfully decline to comment on the character. izations used by Mr. Johnson, but would be pleased to address such issues fully on the merits should the Subcommittee so desire. Question: 8. Dr. Kessler, ~ou]d you be interested in what Mr. Johnson did not disclose to FDA about Biomet s process for producing titanium hip implants7 Response: The Agency always is interested in obtaining info.rmation th.at could be useful in assuring the safety and effectiveness of the products that it regulates. Question: 9. As the letter from Biomet's lawyer, Ralph Cohen indicates, the mate. rial that Mr. Johnson apparently sent to FDA in violation of the protective order was prepared not by Biomet but by Biomet's competitor. In addition, BiQmet. sent to the Committee copies of two peer-reviewed articles on the propriety of using, a plasma spray process for porous coating of components of total hip replacement de. vices. Is that the kind of material that FDA should have? Response: The two journal articles, both of which were published in Clinical Orthopaedics and Related Research, were in the public domain, thus freely available to the Agency. As indicated in our answer to questions four and seven, we regularly receive all types of information. Our obligation is to ascertain the veracity of the information we receive.
Page 174: TI14380282
340 Question: i0. At the November 15 hearing, Dr. Kessler. you indicated your full agreement with Mr. Cox that patient-doctor confidentiality beprotected with respect to information submitted to FDA such as the Master Data File, Medwatoh, and ad- verse reaction reports. As a matter of fairness, consistency, and reciprocity, shouldn't the same policy concerns be present with respect to disclosures not just from the FDA to the outside, but from the outside to the FDA? Response: As you note in your question, FDA regularly receives and reviews clini- cal data regarding patients, such as adverse reaction reports. Information of this kind is essential to the Agency in evaluating the safety and efficacy of medical prod- u.cts and is zealously guardedto prevent unauthorized public disclosure. While the e.~en.c~, c.annot say that it has never received patient information that was not prop- erJy amclosed, FDA has not and does not encourage anyone to violate patient-doctor confidentiality. Question: 11. Dr. Kessler, are you aware that many states recognize a physician- patient privilege and that there are even state laws on the books that protect again$t the release of confidential physician-patient information? ~ P g phys'cian-patient information. ~#uestion: 12. Suppose a private outside party with a financial and/or political agenda was able to access private patient information without the consent of these patients, in viol.at.i.on, of state law, and leaked this information to the FDA. What m',e. ~e res, ponsib.ihtles of an FDA employee if they are leaked such information in vmmtion ot state law and physician/patient vrivile~ee~ Response