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• STATEMENT BY LOUIS W. SULLIVAN, M.D. SECRETARY OF HEALTH AND HUMAN SERVICES BEFORE THE COMMITTEE ON LABOR AND HUMAN RESOURCES U.S. SENATE • ON THE FINAL REPORT OF THE ADVISORY COMMITTEE ON THE FDA MAY 15, 1991 ~ FOR RELEASE ONLY UPON DELIVERY p ~ G • . -.~ ~,

Mr. Chairman and Members of the Committee: • I am pleased to be here today to discuss the recommendations of the Food and Drug Administration (FDA) Advisory Committee, issues vital to the FDA and the health and welfare of the American people. In March 1990, I convened this Committee and directed review the mission of FDA, its structure, priorities, and budget. This morning the Committee Chairman, it to staf f ing Dr. Charles C. Edwards, presented to me the Final Report of the Committee. Dr. Edwards and the distinguished members of the Committee have carried out their mission diligently over the past year and deserve our gratitude for a job well done. Mr. Chairman, I know that you, Senator Hatch, and the other distinguished Members of the Committee have a strong interest in ~ FDA and are very knowledgeable about the issues and problems facing this Agency. This Committee has been the driving force behind much of the legislation passed by Congress to strengthen the responsibilities of the FD8 and help it better serve the American public. I look forward to working with the Committee on these matters in the future. I welcome this Report and strongly endorse many of its o FR recommendations. In many respects, the deliberations of the ~ ~ Advisory Committee will help guide our efforts to improve FDA for W m CC ~ . 1-~

2 ~ many years to come. • FDA is a critical agency. Walk into any grocery store in America and you will find that virtually any item on the shelf, down any aisle, with the exception of meat and poultry, is regulated by FDA. Similarly, FDA has the responsibility of assuring the consumer that our over-the counter and prescription medications are safe, effective, and honestly labeled in the marketplace. Almost 25 cents of every dollar spent by consumers in this country goes towards products regulated by FDA. So, our mission is vital and immense. Our challenge is to be exceptionally vigilant, always trying to improve. Many bold and ambitious developments have occurred at FDA over the past year. FDA is on the right course and will continue to move forward in the future, because of the changes we are now making and those that w4l come about as a result of the Committee's Report. However, before turning to the Committee's recommendations, I think it's important to review FDA's current direction. Recent FDA Accomrlishments One very significant development, of course, is the appointment of a most talented and capable physician, Dr. David Kessler, as the new Commissioner. I share the confidence the Members of this Committee have in him and believe that along with the Assistant

3 Secretary for Health, Dr. James Mason, we have the right team to keep FDA up to the challenge it faces. • A major role of FDA is to expedite the review of drug, biologic, and medical device products so that the most advanced therapies possible can be made available to patients while preventing the patient exposure to unreasonable or unnecessary risks. Finding ways to make the product application reviews more efficient without adding risk, is one of the basic challenges faced by FDA. We set the world standard for the safety of our drug supply and we are constantly assessing ways to improve the application review process. It is important also to recognize the role of scientific research- at FDA. FDA conducts in its many laboratories and sponsors extramural research to: assess risks associated with FDA- regulated products; set-ptandards for regulating risk levels; to develop new ways to test products and perform analysis of product samples recovered during inspections, and to conduct basic research on toxicology. These activities help FDA to maintain its position at the state-of-the-art in regulatory science and it provides the data and the theoretical justification for the level of regulation FDA exercises over products. When people take over-the-counter medicines or prescription drugs, or patients get the results of a laboratory test done on a

0- 0 4 medical device, they must have the confidence that the drug or the device is going to perform as represented and in a safe and effective manner. The consumer deserves a level playing field and the information necessary to make an informed choice among products to take personal responsibility for their own health. They need to know the whole truth. Our mission over the last year has been to build confidence in the American consumer that FDA can be relied on to regulate the safety and effectiveness of health and food products in a complex market. The ultimate payoff in enforcement is in providing safer and more effective products for the consumer. FDA has a number of enforcement tools at its disposal such as inspections, warning letters, import detentions, and recalls. In addition, FDA often refers matters to the Department of Justice for institution of civil seizures, injunctions and criminal prosecutions. The Agency initiates in the -peighborhood of 7,000 inspections, 2,000 warning letters, 2,000 recalls, ;26,000 import detentions, and about 200 seizures, civil and criminal proceedings each year. During the last year, FDA has made a strong commitment to demonstrate to the American people that it can effectively enforce FDA laws and regulations. Effective enforcement puts a stop to abuses of FDA regulations and laws by violative firms and provides a deterrent so that others who might consider whether to ~ abuse the system may think twice. ® ~ rn ~ c,D ~ ~

• • 5 We have: o Strengthened the field offices, provided more training for investigators, and are in the process of hiring an additional 100 investigators trained to develop criminal cases; o Developed a streamlined referral process to speed up criminal cases and send a clear signal that we have no tolerance for corruption and deceit; and o Supported expanded statutory authority for products regulated by FDA to debar or otherwise sanction those persons or companies who attempt to manipulate, provide false data, or otherwise undermine the various FDA product approval processes. What is the result of these actions? We hope a better protected - and more confident consumer and products which are safe and effective. In one recent case, FDA investigators discovered that a generic drug firm substituted the brand-name product for its own, made false statements in its FDA application, and then tried to cover up the evidence. After FDA referred this matter to the Department of Justice, a settlement was negotiated by the U.S. Attorney's Oftice whereby the company agreed to pay $10 million - - the largest criminal fine ever levied in FDA's history. This kind of hard hitting enforcement is needed to weed out the irresponsible and disreputable firms from those trying to serve the customer and trying to make an honest buck. ~ ~ ~ Cf~ . ~ ~~~

• • 6 We also need to strengthen the FDA's regulatory presence across- the-board. FDA needs to have -- and be perceived as having -- the stature and status to safeguard 25 percent of consumer goods in this country. The Agency's recent action against food manufacturers who misleadingly use the term "fresh" is an excellent case in point. The nation must understand that FDA has the capability -- and the will -- to be a vigilant and effective guardian of our food and drug supply. In my tenure as Secretary, I have made the timely issuance of regulations a top priority throughout the Department. I did so because consumers and industry both need a clear set of rules upon which to rely. Consumers benefit from understandable guidelines. Also, when industry has clear rules, they are better. able to police themselves. Last year, I said that iCt would get the food labeling regulations out on time -- and we have. FDA has done an excellent job in the food labeling rule-making, turning out multi-part and lengthy rules with many complex issues that have been produced on ~ sch.dulo. As a result, the American public will be better served. While clear regulations are important, we also need to make sure ~ that those industries we regulate have access to correct answers. ~ ~ First, a new office was recently established in FDA to answer ~p ca ~ . °O'~

• • 7 questions. Second, if firms have complaints or problems, they need a means to resolve them. Last fall, FDA and Dr. Mason proposed and I appointed an FDA ombudsman whose role is to help resolve disputes between regulated firms and the FDA, and to take industry complaints directly to the Commissioner. These steps will help to ensure that industry will not be held back due to a misunderstanding of FDA procedures and requirements. This kind of government and industry interaction will help to get new technologically advanced products into the hands of consumers that can make a difference in the lives of the American people. Finally, let me say a word about resources for FDA. Dr. Mason and I have strongly supported increased resources for FDA and we will continue to do so. Under my tenure, the FDA budget has increased by 43% The FY 1992 budget request supports a staffing level for FDA of 8,917 employees (FTEs), the highest in FDA's history. Are these resource levels a good start? Yes, I'm certain of it, and the American public will clearly benefit every day. ~ Increased resources for FDA are a good investment in the safety and effectiveness of our health and food products. For example, we are requesting $15 million to increase the inspection of seafood and bolster the confidence of consumers in the safety of the fish they take to the table.

• • 8 Having reviewed where FDA is headed, we can clearly see that this Agency is fulfilling its mission in an intelligent and aggressive manner. We have reason to be proud of what it has accomplished to date. But, the job is not done. We must now consider how the recommendations of the Advisory Committee can make an important difference in where FDA will go in the future. $ecommendations of the FDA Advisory Committee I strongly support many of the recommendations of the Committee. Dr. Edwards and Members of the Committee are among the brightest and most knowledgeable persons in the country on FDA issues. I especially thank them for their persistence in addressing the difficult and comprehensive FDA issues in approximately 20 meetings plus the countless hours of hard work outside of these meetings required to produce this Report. I understand that the Committee Members themselves laboriously drafted each chapter of the Final Report. I pp,rsonally congratulate them for a fine j ob. Mission and Goals First;- in considering the Ageri~ey's mission, the Committee recommended that: FDA clearly define its overall mission and develop a formal statement of purpose; (1-1) At regular intervals, the FDA must develop and make public a o ~ statement of program priorities that reflects a realistic p~ C.O ~ ~ Oo

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