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• • • ® ® .cwd..c.erw.nill,.wro wkillil.. . Rita R Colweu, Pn0 • Jane L Oeigatla PnD ~ Snawm Gataner • Jarnes D Grart • Lawrence C Horow,u MO . louis Lasagna. MD ^ R,Oara A Merrill • aan R Nason MO • Mdan Pus>;ar . Jtlnn Rotner • Frant E Samue~ Jr A Jonn G Srrv,e • Jonn M Tavlor A Joseom 0 w11i1ams A, Eric M Kau Eiecuuve Dnector BQ•G Humpnrey 6ud0lng wase,ngton OC 2020, 2022457305 Advisory Committee on the Food and Drug Administration U.S. Department of Health and Human Sernces Proposed Remarks of Dr. Charles Edwards before the Senate Committee on Labor and Human Resources May 15, 1991 Thank you Mr. Chairman: We very much appreciate the opportunity to take part in this discussion of the report of the Advisory Committee on the Food and Drug Administration. With me here today are Dr. Lawrence C. Horowitz, Mr. Frank E. Samuel, Jr., and Mr. Sherwin Gardner, the Subcommittee Chairs of the 15-Member Advisory Committee. We have brought a copy of our final report and ask that it be included in the record. I won't attempt in these brief remarks to list the Advisory Committee's major findings and recommendations. Let me just say, however, that those of us who served on the Committee are convinced that the issues we addressed and the actions we have proposed do in fact target critical problems confronting not just the FDA, but everyone who has a An measure of responsibility foi the Agency's success - and its failures. We feel very strongly that the report merits prompt and serious consideration by the Department, the White House, and the Congress. The scheduling of this hearing leads me to believe, Mr. Chairman, that you and members of this Committee share that view. I hope I'm right. It might be appropriate at the outset to say a word or two about

• Statement of Charles C. Edwards, M.D. --2-- May 15, 1991 • the scope and focus of the report. Perhaps the most important point -- one that I hope everyone can keep in mind as they view this report -- is that we did not try to address, in any specific detail, the multitude of current, ongoing operational problems facing the FDA. In the first place, Secretary Sullivan specifically, and in my judgment wisely, asked us not to concentrate on FDA's immediate crises or day-to-day activities. That ldnd of inquiry would have involved a level of effort and a degree of involvement with the Agency that would be both impractical and inappropriate for an ad hoc panel of advisors to undertake. But second and perhaps more important, my colleagues and I firmly believe that the broad-ranging recommendations in our report, if adopted and if vigorously supported by the Administration and the Congress, will not only help the Agency deal with its immediate problems, but moreover will transform FDA into an organization that is both less vulnerable to scandal and blunder, and better equipped to protect and promote the health and well being of the American consumer. The central question is: Can s FDA carry out that responsibility today? I think the answer is yes, but it's a close call. The chronic and pervasive shortcomings that FDA has had to cope with for more than a decade have seriously crippled1the Agency. Although our Committee was given no evidence to show that anyone has been directly harmed as a result of FDA's inadequate resources and diminished authority, we feel that FDA is living on borrowed time. An agency charged with such a broad array of vital health protection responsibilities, yet one that lacks ~ the tools to carry out those responsibilities, is in serious danger. And hence, so is the ~ American public. ~D ~ - ~ CO (~o •.1

• Statement of Charles C. Edwards, M.D. --3-- May 15, 1991 • How did FDA get to this state of affairs, and what's to be done about it? Our report seeks to answer those questions. But I would be the first to acknowledge that a complete inventory of the reasons for FDA's decline and a detailed catalog of the measures needed to reverse that trend would extend well beyond the scope of our report. I want to highlight, however, two of the major underlying issues that, in my judgment, account for the severe problems we see at the FDA today. The first is a chronic leadership vacuum. I must say, Mr. Chairman, that the selection and confirmation of David Kessler as Commissioner of Food and Drugs is a most encouraging change. Dr. Kessler brings to this appointment outstanding and relevant qualifications. His professional career has been virtually an intensive preparation to be Commissioner. I,et me emphasize, however, that when I refer to a leadership vacuum, I'm talking not just about the Cammissioner, but also about,the other key Agency managers both in the Office of the Commissioner and in FDA's operating Centers. The Commissioner obviously has the most visible leadership role as the Agency's chief spokesman and policy maker. But effective leadership - or the lack of it - is a critical issue throughout FDA. Furthermore, leadership of a scientific regulatory agency like FDA, implies not just the ability to guide and manage a large, complex organization. It also has to involve scientific leadership - the ability to organize and direct people and programs at the cutting edge of technology. There is,.undoubtedly, any number of reasons why FDA has not attracted ~ ~ outstanding leadership and, more to the point, why present and past administrations . o~ . ~ Oo Oo

Statement of Charles C. Edwards, M.D. May 15, 1991 • --4-- apparently have been content to allow the Agency to endure a long period of decline. Certainly the salaries paid to key officials at FDA, as throughout government, are no match to those available in industry and at major universities. But I think there's another deterrent at work here - one that can and must be removed. The post of Commissioner - and by extension other high-level positions at FDA -- is seen both inside and outside government as relatively unimportant. It is a job that too often is filled by a person with no particular qualifications to oversee a large regulatory agency: someone who will hold the fort for a couple of years and then move on. That concept of leadership for FDA is totally unacceptable. In my view it is at least partly responsible for the decisions of the last decade or so to reduce the Commissioner's authority, scale back the Agency's funding and staffing, and allow its equipment and facilities to deteriorate to the point that they literally threaten FDA's scientific competence. Obviously, without strong and respected leadership, the Agency is not in a position to fight effectively for the resources it needs. In the absence of effective leadership and the internal management systems by which top managers both exert policy control and monitor the Agency's performance, FDA staff understandably have become demor aLz'ed, cynical, and I think it's fair to say, perhaps even susceptible to improper influence when they feel that their Agency is, in effect, a stepchild of the bureaucracy. Strong leadership may not have prevented the generic drug scandal. But it would have lessened the likelihood of such a thing happening. And, if it did happen, a strong, capable Commissioner who had the full confidence and support of the Administration and ~ ~ 00 CC

Statement of Charles C. Edwards, M.D. May 15, 1991 --5-- the Congress, would have discovered and dealt with such a situation much earlier and more effectively. The second issue that I believe underlies many of FDA's problems is the placement and status of FDA in the federal bureaucracy. Here is an agency whose decisions and actions affect the health and well being of people throughout the United States and the world, to say nothing of their economic impact on huge segments of industry. Yet FDA is buried three layers deep in the HHS organization. It's folded into the U. S. Public Health Service, which has no institutional sympathy for regulatory, law-enforcement functions. The Commissioner is accountable to a PHS and Departmental hierarchy that in the past has been • less than fully supportive of the Agency's needs. This pattern is changing, but not far and not fast enough. In the Committee's view, FDA must be separated from the Public Health Service. The Commissioner, as head of a first-level operating agency within the Department, must be armed with the full array of authority for independent action commensurate with his responsibilities. He must report solely and directly to the Secretary and have the authority to run the Agency's operations including regulations, facilities, equipment, and personnel. If these nexssary changes tura out to be unacceptable to the Department or the White House, then Congresa should enact legislation to reconstitute FDA as a free-standing agency. Removal from the Public Health Service - and if necessary from the Department -- might entail some sacrifices. FDA's interactions with other health programs might demand ~ O ~ more elaborate negotiation, for example. But we need to remember that FDA is first and ~ CO C.~ . C~ ~ O

r" • • Statement of Charles C. Edwards, M.D. May 15, 1991 foremost a regulatory agency. As the price of empowering FDA to carry out its responsibilities, such sacrifices would, in my judgment, be acceptable. This past year has been enlightening for me and, I believe, for every member of the Committee. Each of us, from his or her own perspective, had a considerable store of information about the Agency and its problems. But none of us imagined how badly the FDA needs to be revitalized, strengthened, and allowed to reach its full potential as a scientific regulatory agency. I've said little this morning about the exploding scientific universe in which FDA must try to operate. That by itself could be the subject of a full and sobering discussion. But the point I would make here is that Americans have gotten used to miracles in the health-related sciences. They fully expect science to produce drugs and other technologies to diagnose, treat, and even prevent the most serious health problems. They insist on a food supply that is not only safe and wholesome, but one that comes with complete instructions about how the right foods can promote a longer, healthier life. That land of optimistic expectation is not out of place. We are living in an age of scientific marvels. Yet the fact of the matter is that the FDA, incredibly, is not keeping pace • with the spectacular progress in the Ary scientific fields whose technologies and end products the Agency must evaluate and approve or reject. FDA lacks the technological resources, the personnel, the management and information systems, even the regulatory authority and tools it needs to function in a scientific environment that holds enormous promise, but clearly also presents significant risks N: C if it is not closely monitored. ~ CO CT7 , CO h

• Statement of Charles C. Edwards, M.D. --7 -- May 15, 1991 The members of the Advisory Committee on the Food and Drug Administration sought to provide a framework that will enable FDA to meet the heavy, vitally important demands it faces today and will increasingly face in the years ahead. Whether or not we were successful depends on what the Administration and the Congress chose to do with our report. Thank you Mr. Chairman. • ~ O ~ C8 ~ . Cfl a~: