CONTENTS Letters, statements, etc.-Continued Larrick, George P., Commissioner of Food and Drugs-Continued Regulations for the enforcement of the Federal Food, etc.-Continued Part 180-New drugs Continned New drugs for investigational use— Notice of proposal to amend. Press release, August 9, 1962... Press release re extension of time for filing Regulations as adopted... Press release, January 6, 1963.... Procedural and interpretative regulations Notice of proposal to revise.. Press release, February 13, 1963.. Regulations as adopted.. Press release, June 20, 1963.. Radioactive new drugs for investigational use: Order exempting from general regulations pertaining to new drugs.. Required records and reports Notice of proposed revision. Press release, February 28, 1964. Regulations as adopted.. Press release, May 27, 1964. Part 132-Registration of producers of drugs Notice of proposed rulemaking. Press release, February 13, 1963. Regulations as adopted... Press release, April 4, 1963. Part 133 Drugs; current good manufacturing practice, manufacture, processing, packing, or holding 99, 106 Notice of proposed rulemaking Press release, February 15, 1963. Regulations as adopted.. ----------- Press release, June 20, 1963. Part 146.23-Antibiotic drugs for investigational use; order Statement-Background of the Food and Drug Administration Summary covering the drug Chloramphenicol (Chloromycetin). Smith, Austin, M.D., president, Pharmaceutical Manufacturers As- 59 148 328 189 Excerpt from an article in the New Rochelle (N.Y.) Standard- Pharmaceutical Manufacturers Association statement on public Smith, Dr. Ralph, Director, New Drug Division, Food and Drug Ad- 302 274 311 189 DRUG SAFETY (Part 1) TUESDAY, MARCH 94, 1994 HOUSE OF REPRESENTATIVES, INTERGOVERNMENTAL RELATIONS SUBCOMMITT OF THE COMMITTEE ON GOVERNMENT OPERATIONS, Washington, D.O.. The subcommittee met at 9:45 a.m., in room 1310 of the Longworth Office Building, Hon. L. H. Fountain (chairman of the subcommittee) presiding. Present: Representatives L. H. Fountain, J. Edward Roush, Florence P. Dwyer, and Bill Stinson. Professional staff present: Dr. D. C. Goldberg and W. Donald Gray. Mr. FOUNTAIN. Let the subcommittee come to order. Let the record show a quorum of the subcommittee is present. Under the rules of the House of Representatives, the Committee on Government Operations has the duty of studying the operation of Government activities at all levels with a view to determining its economy and efficiency. The committee has delegated that responsibility, as it relates to the Department of Health, Education, and Welfare and certain other Federal departments and agencies, to the Intergovernmental Relations Subcommittee which is meeting here this morning. For the past year and a half the subcommittee has been studying the efficiency of the Food and Drug Administration, a unit of the Department of Health, Education, and Welfare, in carrying out its responsibilities for the regulation of new prescription drugs. The subcommittee is giving particular attention to the organization, policies, and procedures of the Food and Drug Administration for determining the safety of new drugs approved for commercial sale and for the surveillance of these drugs following their initial clearance for marketing. Few activities of Government bear so directly on the health of the American people as the FDA's heavy responsibility for determining when powerful new drugs are safe as well as efficacious for use in the continuing fight against sickness and disease. While FDA has the legal responsibility for approving or disapproving applications for the marketing of new drugs, others, including the medical profession and drug manufacturers, are also intimately involved in assuring the safety of drugs. Accordingly, we have invited representatives of the American Medical Association, and the Pharmaceutical Manufaoturer's Association, along with officials of the Food and Drug Administration, to participate in these opening hearings. 1. It is our hope that the subcommittee's hearings will provide an opportunity for open and frank discussion of the problems and prospects of assuring the safety of drugs and thereby contributing to a better public understanding of this extremely important subject. Our committee has already contributed substantially, I believe, to public understanding of the nature and the extent of governmental activities for the protection of the consumer through the issuance of three reports. based upon surveys made by the subcommittee. In the first of these reports, issued as House Report No. 1241 in September 1961, we developed a comprehensive inventory of all consumer protection activities carried on by Federal departments and agencies. The first of our reports on the consumer protection activities of State governments, issued as House Report No. 445 in June 1968, deals with the State regulation of drugs and related products. Our second report on State consumer protection activities was issued as House Report No. 921, in November 1963, and deals with the regula tion of foods and related products. Additional reports are planned in this series. Prior to the subcommittee's work in this field, very little was known about the extent to which the Federal Government and the State and local governments were engaged in performing similar activities, the extent of such activities, or about the program relationships between the several levels of government. As we begin these hearings on drug safety today I should like to observe that the Senate Subcommittee on Reorganization and International Organizations under the chairmanship of Senator Hubert Humphrey has been actively interested in certain aspects of drug regulation, notably those involving interagency coordination and scientific communications, and that nongovernmental groups have also concerned themselves with various aspects of drug regulation. We will endeavor during these first few days to obtain a broad view of the way in which drugs are approved for general use and of the problems involved in assuring their initial and continuing safety. I am quite sure that only a very small percentage of the American people understand the full story concerning the approval of drugs: and particularly the many problems that arise in connection therewith. The subcommittee staff has studied intensively a number of prescription drugs which have been withdrawn from the market or otherwise restricted in their use because of injurious effects. These situa tions will be considered during the course of our hearings for the pur pose of examining the adequacy and effectiveness of FDA's handling of these cases, and their implications for the agency's organization, policies, and procedures. While we may examine FDA's administrative performance critically at times, I want to assure you gentlemen representing the agency that our criticism is intended to be constructive and helpful to your agency, as well as to the Congress. Our objective is to clarify the problems associated with drug safety and thereby to help strengthen the work of this very valuable agency of our Government in this crucial area. Before calling our first witness, I believe our distinguished Congresswoman from New Jersey has a statement to make. Mrs. DWYER. Thank you, Mr. Chairman. I sometimes think it took Congress a lot longer than it should have to discover another word for "constituent" is "consumer." It is perfectly evident that the woman who spends 2 minutes in the voting booth spends many hours in the supermarket. I also suspect that she spends more time than she used to in the stationery store because I know that my mail relating to consumer matters certainly has increased. It is the wife and mother, too, who takes a special interest in and has a special responsibility for the health of her family group. Congress for many years has recognized that it has definite responsibilities toward helping to protect the buying public against being misled or exploited in all fields. This is part of our job, and the men and women of the Nation have the right to firm assurances that we are not shirking it. Their letters help us keep on our toes. It would, of course, be a mistake to consider drugs as just "one more consumer item." They are directly related to the health of all of us. For many good reasons drugs have been singled out for far more careful Federal scrutiny and supervision than other consumer products. I think it is fair to say that excellent safeguards have been established-so effective that the possibility a dangerous drug may have reached the market without adequate warnings becomes material for newspaper headlines. But quite appropriately, Congress must review periodically the protective mechanisms it has established. It must find out whether the agencies it has created actually have all of the legal and administrative and scientific tools and resources they require, and whether they make proper use of the regulating tools they already possess. As a consequence, we can look upon a hearing such as the one we are now beginning as very much in the public interest, and as warranting our fullest determination to seek out all the facts. At the same time we must realize that the demonstrated capacity of the United States to create and use improved drugs is one of our great national assets. Therefore, I feel we must be constantly on guard to make sure that no word or action during these hearings may unjustly tend to undermine basic public confidence in those who are involved-the physicians, the regulatory agencies, and the pharmaceutical industry, primarily. I am confident that our chairman, who enjoys a deserved reputation for fairness, shares this conviction. It is easy to win popularity by criticizing those involved. It is far more difficult, but far more responsible, to pinpoint particular shortcomings, draw a ring around these, and seek corrective action, but also to guard against generalizations based upon unfair implications. Our job, as I see it, is to think clearly and to speak carefully. Otherwise, the real service that we can perform could become a disservice. This series of hearings focuses specifically on how the Food and Drug Administration is doing its part of the job. All of us know that it has recently been given broad new responsibility and new challenges at a time when the new drugs themselves are more complex and more difficult to appraise. It is a big and vital task. I want here to express the hope that the work of this committee may point in the direction of measures that will help the agency meet its grave responsibility to protect the health of the American people. Thank you, Mr. Chairman. Mr. FOUNTAIN. Thank you, Mrs Dwyer. As chairman of the subcommittee, I appreciate that statement. It is easy to criticize, and while the committee and the Congress and the DRUG SAFETY American people can demand that the various agencies, including the Food and Drug Administration, do their jobs effectively and efficiently, I think it is also important that efforts be made to provide these agencies with the necessary tools and manpower with which to do their jobs. In order to facilitate the presentation of Commissioner Larrick's prepared statement, I will ask the members of the subcommittee to withhold any questions they may have until its completion. I think there will be adequate time for questioning at that point. However, I do think any questions which are intended for clarification of the testimony as we go along would be in order, provided they do not relate to the points which are covered later in the statement and are kept to a minimum. Our first witness is Mr. George P. Larrick, who is Commissioner of Food and Drugs. I will ask the Commissioner to introduce his associates. STATEMENT OF GEORGE P. LARRICK, COMMISSIONER OF FOOD AND DRUGS; ACCOMPANIED BY DR. RALPH SMITH, WILLIAM W. GOODRICH, W. B. RANKIN, AND M. D. KINSLOW Mr. LARRICK. Mr. Rankin, Assistant Commissioner; Mr. Goodrich, our General Counsel in the Department, in charge of Food and Drug; Dr. Ralph Smith, who is in charge of our New Drug Division and Acting Director of our Bureau of Medicine; and Mr. Maurice Kinslow, who is Mr. Rankin's assistant. Mr. FOUNTAIN. Before proceeding with your statement, Mr. Larrick, I think it would be helpful if you would tell us briefly of your professional background. Mr. LARRICK. If I may, Mr. Chairman, I would like to say first that the Food and Drug Administration and I are very grateful for your introductory statement and Mrs. Dwyer's introductory statement, which make it very clear that the objectives of the committee are to improve the administration of the laws for which we are responsible. What you have done and the publications to which you have referred that have emanated from this committee have already been very helpful. I have no doubt but that there are things that the Food and Drug Administration has done and will do that can be improved. We will welcome constructive criticism and we will very much hope to be guided by it. Regarding my own background, I went to college in Ohio, Wittenburg University, and Ohio State University. I took some courses later here at George Washington University. I entered the Food and Drug Administration as a food and drug inspector, back in 1923. I worked in the field in various inspectional activities for some 5 years. Then I was transferred to the Food and Drug Administration, which at that time was the Bureau of Chemistry in Washington. In Washington, from 1928 on, I worked in quite a variety of assignments, including Administrative Assistant to the then Chief, Chief Inspector, Assistant Commissioner, Associate. Commissioner, and 9 years ago I was made Commissioner of the Food and Drug Administration. Mr. FOUNTAIN. Thank you. You may now proceed with your prepared statement. |