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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

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

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

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.

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

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.

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-

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.

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

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.