APPENDIX Dr. Apter's critique of studies identified by Dr. Crout as meeting standards of 21 CFR 130.12___ 529-536 "In Praise of the Lowly Package Insert" by J. Richard Crout, M.D______ 540-544 Letter to editor, Lancet, January 20, 1973, re withdrawal of propranolol and myocardial infarction__ 540 536-540 527-529 Medical officer's summaries-Inderal-for angina pectoris. Memorandum by Dr. Crout, re approval of propranolol for angina pectoris listing studies meeting standards of 21 CFR 130.12. October 7, 1971, meeting of advisory group on drug-related carcinogenesis_523-527 sis__ 523-527 OMB advisory committee management administrative guidelines and management controls___. 544-556 USE OF ADVISORY COMMITTEES BY THE FOOD AND DRUG ADMINISTRATION WEDNESDAY, MARCH 6, 1974 HOUSE OF REPRESENTATIVES, INTERGOVERNMENTAL RELATIONS SUBCOMMITTEE OF THE COMMITTEE ON GOVERNMENT OPERATIONS, Washington, D.C. The subcommittee met, pursuant to notice, at 9:30 a.m., in room 2154, Rayburn House Office Building, Hon. L. H. Fountain (chairman of the subcommittee) presiding. Present: Representatives L. H. Fountain, Don Fuqua, Clarence J. Brown of Ohio, and John H. Buchanan, Jr. Also present: Dr. Delphis C. Goldberg, professional staff member; Gilbert S. Goldhammer, consultant; and Richard L. Thompson, minority professional staff, Committee on Government Operations. Mr. FOUNTAIN. Let the subcommittee come to order; a quorum is present. On October 6, 1972, the President signed the Federal Advisory Committee Act into law. This act seeks to promote more efficient and economical use of outside advisory committees. It is aimed at reducing and limiting the number of advisory committees to those that are absolutely essential. I think Congress clearly intended that advisory committees shall not be employed if an agency can itself do the job without such committees. The use of outside experts to advise the Federal Government is well established historically, and such groups have often provided invaluable help to all branches of government, and they are still doing so. However, the evidence shows that unless advisory committees are closely controlled, they have a tendency to multiply and they may be utilized for unsound or improper purposes. This subcommittee has had a long-standing interest in FDA's use of advisory committees. In the past, FDA has established advisory committees sparingly generally on an ad hoc basis in special and complicated situations. Even in those limited instances where ad hoc committees were employed, questions were sometimes raised about their appropriate role. For instance, in 1965 this subcommittee examined some aspects of an FDA advisory committee's consideration of the antimotion sickness drugs, meclizine and cyclizine. Our inquiry prompted William S. Warren, dean of the Columbia University Law School, to sound a warning about the dangers which might result from FDA reliance on advisory committees. He cautioned at a December 1965 conference that recommendations of a panel of experts were likely to be adopted by the FDA Commissioner with out-and I now quote from his statement-"without the soul-searching critical analysis to which he would subject the same recommendations from his own official staff, even if that staff consisted of the very same experts." In 1970, this subcommittee held hearings on FDA's regulation of the cyclamate sweeteners, and examined in that connection HEW's use in 1969 and 1970 of a medical advisory group on cyclamates. Based on these hearings, the House Committee on Government Operations, in an October 8, 1970, report, found that HEW had improperly used an outside advisory body "to make recommendations on matters that had already been decided, involving a basic issue which the advisory body was not qualified to decide." The committee recommended that HEW and FDA, and I quote, "confine their use of scientific advisory bodies to the consideration of clearly defined issues which are within the competence of such bodies. Such bodies should not be asked to give advice on matters which the regulatory agency itself has the capability to resolve." The number of FDA advisory committees has increased greatly since 1972, particularly in the area of new drug review. Moreover, according to FDA documents, FDA is expanding the role of advisory committees to share with them its responsibility for agency decisionmaking. This comes at a time when the trend in the Federal Government seems to be toward fewer advisory committees. The Deputy Director of OMB, Mr. Frederic V. Malek, testified last month before the Senate Subcommittee on Budget, Management and Expenditures that 16 percent of the Government's advisory committees were abolished in a recent 6-month period. The Federal Advisory Committee Act of 1972, by specific statutory language, requires that Congress maintain close oversight through its committees to keep the use of advisory committees in the executive branch within proper responsible bounds. It is in keeping with this statutory obligation that these hearings have been called. Excessive and/or improper use of advisory committees is wasteful, illegal, and may well destroy the incentive and morale of an agency's career personnel. It is important, also, that a regulatory agency such as the FDA not use advisory committees for the purpose of diffusing executive responsibility for difficult regulatory decisions, or as a means of delaying decisions, or as a means of having someone ratify a decision they have already made. The subcommittee has an obligation to examine the circumstances which have caused a very large increase in the numbers of FDA advisory committees, and in the frequency of their use. We want to learn through these hearings whether this increase is proper and legal in the light of the requirements and intent of the Federal Advisory Committee Act. We want to know, too, whether or not they are essential for the discharge of FDA's enforcement responsibilities. We will also inquire into such related matters as the openness of meetings, whether the committees are well balanced, whether the minutes of meetings are sufficiently detailed, and whether the quality of the advice given by committees is adequate. The hearings which begin today were scheduled in order to explore these matters as fully as possible in the time available to us. I might add that the subcommittee staff met with the FDA Commissioner on January 16, 1974, and discussed with him some of the subcommittee's concerns. At that time the Commissioner was given written and oral critiques detailing the facts and impressions obtained by the staff from a careful reading of selected transcripts of advisory committee meetings and other FDA documents. In the next few days we will examine in some detail FDA's practices and procedures with respect to the establishment and use of advisory committees, the character and the quality of advisory committee proceedings, and the use made of committee recommendations. As I indicated earlier, we will also examine the extent to which FDA's use of advisory committees conforms with the requirements of the Federal Advisory Committee Act. I might conclude the statement by saying that this examination should not be construed and is not intended to imply that the committee has already formed opinions on this subject. Only by a thorough and planned inquiry can we determine just what the situation is. Mr. Brown? Mr. BROWN of Ohio. Thank you very much. Mr. Chairman, I appreciate the opportunity to offer a few opening observations. The major questions before the subcommittee in this series of hearings is how effective are the FDA advisory committees; do they perform the functions for which they were intended; is the information which they are provided adequate for them to make recommendations; and are the recommendations which the advisory committees make truly independent evaluations of the efficacy and safety of the products under consideration. In brief, do the advisory committees function in such a way that the regulatory authority and responsibility of the FDA is enhanced, improved, and strengthened? On the basis of information made available to this subcommittee, we know that the frequency with which the advisory committees have met has tripled from 1972 to 1973. In 1972, 24 public advisory committees held 55 meetings involving 327 members. În 1973, 45 public advisory committees held 167 meetings involving 399 members. Obviously, their role is increasing rather than decreasing. The quality of the advice of the committees is, of course, based on the quality of the people who sit on the committees. The background, expertise, and interests of the members of the advisory committees color the quality of their product just as surely as the competence of a practicing surgeon bears heavily on the success rate of his operations. Equally important is the quality of information with which these committee members must work. Studies and evaluation conducted by the FDA independent of the manufacturer are also a major part of the information on which decisions and advice is given. Advisory committees are something of a misunderstood child of government. They are strongly criticized by their detractors as vehicles for passing the buck and consuming the taxpayer's dollars. The question is whether without them the taxpayer's dollars might be consumed more quickly. Their advocates praise them as a vital source of expert opinion without which a regulatory agency could not function. There have been many attempts to regulate advisory committees including the Federal Advisory Committee Act, Public Law 92-463 which attempted to establish "* ** a system governing the creation and operation of advisory committees in the executive branch of the Federal Government ***" The restrictions and regulations of this act will play a substantial role in the course of these hearings. Mr. Chairman, you and I both serve on the Intergovernmental Relations Advisory Committee which functions not as a legislative body or an executive department, but rather as its name implies, in an advisory role. Clearly, one of the major considerations of this series of hearings will be to determine if the advisory committees which serve the Food and Drug Administration function in the same fashion. It is a part of our purpose here today and for the remainder of these hearings to insure that the advisory committees operate on a basis of competency, not conflict; that their relationship with the FDA be advisory and not adversary. An eminent 17th century French philosopher described the workings of his profession by saying: "We may give advice, but we do not inspire conduct." At the conclusion of these hearings, it is my hope that we will have shed some new light on the operation of the advisory committees, offered some advice of our own on how they might be improved, and, not insignificantly, set an example of how they should conduct themselves. Thank you, Mr. Chairman. Mr. Chairman, let me say that I am involved in some legislation from the subcommittee on which I am the ranking member of the Interstate and Foreign Commerce Committee, when it meets this morning at 10 o'clock. So it will be impossible for me to remain throughout the hearings this morning; however, I would hope consideration of that legislation would be concluded before this committee sitting here concludes its hearings today, and that I will be able to return and ask some questions at that time. If not, I will certainly be here tomorrow. Mr. FOUNTAIN. Thank you very much. We appreciate your presence, and all of us understand the difficulties when we have committees meeting at the same time. I would also thank you for your opening statement, which I think is a well-thought-out and meaningful addition. Our first witness this morning is Dr. Alexander M. Schmidt, who is the Commissioner of the Food and Drug Administration. Dr. Schmidt, if you and your associates would come up and take seats at the table, we can begin. I want to extend a welcome to you. I believe this is the first time you have had a chance to appear before this subcommittee. It is a pleasure for us to have you here. Mr. BROWN of Ohio. Let me also welcome Dr. Schmidt here. This is the first time we have him testify before our committee since he took over the responsibilities of the Food and Drug Administration and this is the first opportunity that we have had an opportunity to meet. So I look forward for the chance, if not to hear all your testimony, at least to read it and then have the opportunity to exchange views with you. Mr. FOUNTAIN. Before we begin our hearings on the use of the advisory committees of the FDA, I would like to conclude very briefly some unfinished business. I have reference to the hearings before this |