On additional published views on diverse drug policies: 300. "The Open Literature": Diverse articles in the trade, business, and lay press on issues such as "peace of mind pills," "miracle On the work of the Senate subcommittee and on Senator Humphrey's personal judgment though June 1964: 301. Senate Subcommittee on Reorganization and International Organizations: Comments by Senator Hubert H. Humphrey on contributions by its drug and related studies. 302. Subcommittee Part 4: March 1964 comment by Senator Hubert H. Humphrey on the preceding fourth volume, including a page INTERAGENCY COORDINATION IN DRUG RESEARCH AND REGULATION (Pursuant to S. Res. 27, 88th Cong., as Amended) WEDNESDAY, JUNE 19, 1963 U.S. SENATE, SUBCOMMITTEE ON REORGANIZATION AND Washington, D.C. The subcommittee met, pursuant to notice, at 10:05 a.m., in room 3302, New Senate Office Building, Senator Ernest Gruening, presiding. Present: Senators Humphrey and Gruening. Also present: Dr. Lowell Coggeshall, Chairman of the Commission on Drug Safety and Vice President of the University of Chicago; Duke Trexler, Executive Director of the Commission on Drug Safety; Dr. Austin Smith, President of the Pharmaceutical Manufacturers Association; Dr. Theodore Klumpp, President and Director of Winthrop Laboratories; Dr. Leroy Burney, representative of the Greater Philadelphia Committee for Medical-Pharmaceutical Sciences, and Julius N. Cahn, staff director, Subcommittee on Reorganization and International Organizations, Committee on Government Operations. Senator GRUENING (presiding). The meeting will please come to order. We are resuming today our hearings on "Interagency Coordination in Drug Research and Regulation." STATEMENT PREPARED BY SENATOR HUMPHREY I would like to read an opening statement prepared by Senator Humphrey : "Today, we will hear from three distinguished private witnesses. "I am going to say just a few words with regard to the subcommittee's purpose, the witnesses' statements, the subcommittee's accomplishments to date and our procedure this morning. "First, as to purpose: the goal of this subcommittee is to develop useful recommendations for 'interagency coordination and efficiency,' pursuant to S. Res. 27, 88th Congress. This means, in part, assuring the highest possible standards of administrative and scientific excellence in the Food and Drug Administration and other agencies. "Second, as to our witnesses, these experts will be presenting the first comments to the Congress by nongovernmental medical experts since passage of the October 1962 drug law. This subcommittee, it should be recalled, does not have jurisdiction over that law or FDA's regulations. But we are interested in their effective administration." 2173 STUDY OF ADMINISTRATION OF NEW DRUG LAW "Last October, it will be recalled, I predicted a 'deluge' of administrative and scientific work forms and reports would 'flood' into FDA. The 'flood' has now come. The question is, 'Is the agency doing everything it can do and should do to keep its head above water,' that is, to stay on top of its massive new workload? "No one can expect 'perfection' on the part of FDA under the present trying circumstances. We must be understanding and patient. FDA's problems were not 'made in a day'; they will not be solved in a day. FDA's problems were immensely increased by enactment of Public Law 87-781. We want to help ĚDA. We sympathize with it in the burdens it faces. "And we will try further to understand the problems which are being experienced by drug researchers, by medical schools and the drug industry. They all have problems-problems whose solutions are in the public interest and necessity. "Third, as to accomplishments, I will only say that this subcommittee has achieved many important and concrete results. "I will file in the record as the first of a series of current exhibits, a brief statement on just a few of these many results in the last few weeks. PROCEDURE AT HEARING "Next, with regard to our procedure this morning, as I had indicated in my letters to the witnesses, time will, unfortunately, be very limited today. We have very important events taking place on the floor of the Senate this afternoon, and we are expecting the President's Civil Rights Bill. "Each of the witnesses has an important statement to make. Each of the comments is worthy of a full hearing in the morning and the afternoon. But since we want to hear all of you and have a maximum of time for oral questions and answers, we will need to limit your initial oral presentations. As I have mentioned, therefore, I would like each of you to limit your comments to 10 minutes of oral discussion. Your statement will, of course, be printed in full in the record. "Unfortunately, I face the same problem that almost all the Members of the Senate face: that of conflicting commitments this morning. I should, however, like to state to each of the witnesses that I have already noted your helpful comments. I agree with much of what you say—although, frankly, I have a few reservations on some points. "I do, however, want you to know, Dr. Coggeshall, that I appreciate your altering your busy schedule in order to join with us today. I know that you have a very important 2-day meeting [the conference of Professional and Scientific Societies, June 27-28] set up in Chicago next week. You have invited to that conference a great assembly of leading scientists to consider issues of great consequence to drug progress." Senator GRUENING. Dr. Coggeshall, will you proceed. We have read your very excellent statement. It will be introduced in the record in full. Let me suggest to you that you emphasize the high points extemporaneously in whatever way you think best. 1 See pt. 4, exhibit 245, p. 2145 for a reprint of Senator Humphrey's statement of results of the subcommittee efforts. STATEMENT OF L. T. COGGESHALL, M.D., VICE PRESIDENT OF THE UNIVERSITY, THE UNIVERSITY OF CHICAGO, AND THE FREDERICK H. RAWSON PROFESSOR OF MEDICINE, THE UNIVERSITY OF CHICAGO, CHAIRMAN, COMMISSION ON DRUG SAFETY Dr. COGGESHALL. Thank you, Mr. Chairman. (There follows a biographical summary on Dr. Coggeshall and the text of his prepared statement.) EXHIBIT 247 LOWELL T. COGGESHALL, M.D.: BIOGRAPHICAL SUMMARY A summary of the professional career of Dr. Lowell T. Coggeshall follows: Lowell T. Coggeshall, M.D. (Chairman of the Commission), is Vice President of the University of Chicago. He also is a member of the University's Board of Trustees and holds the Frederick H. Rawson Professorship of Medicine. From 1947 to 1960, he was Dean of the Division of Biological Sciences, one of the four graduate divisions of the University, which includes the School of Medicine and the University Hospitals and Clinics. During World War II, Dr. Coggeshall served the U.S. Government in various technical and advisory capacities. In 1956, he accompanied Vice President Richard M. Nixon to Austria on a survey of the medical relief needs of the Hungarian refugees, and in the same year was on a leave of absence to serve as Special Assistant for Health and Medical Affairs to the Secretary of Health, Education, and Welfare. In 1958, he was elected to membership on the Executive Board of the World Health Organization, and in 1959, served as head of the State Department's International Development Advisory Board on foreign aid. He is a member of the National Academy of Sciences and the American Philosophical Society. He has served as President of the American Cancer Society, the Association of American Medical Colleges, and the Institute of Medicine of Chicago. He was Vice President of the American Society for Tropical Medicine and President of the American Foundation for Tropical Medicine. He also served as President of the National Intern Matching Plan from 1956 to 1959. In 1958, Dr. Coggeshall was a member of two special studies panels on education for the Rockefeller Brothers Fund. He is a member of the Board of Directors of both the Rockefeller Foundation and the Macy Foundation. Dr. Coggeshall received the A.B, A.M., M.D., and LL.D. degrees from Indiana University. He was awarded the L.H.D. (Hon.) in 1956 by Jefferson Medical College and the LL.D by Lake Forest College in 1960. EXHIBIT 248 LOWELL T. COGGESHALL, M.D.: STATEMENT PREPARED FOR SUBCOMMITTEE HEARING There follows the text of Dr. Coggeshall's prepared statement: Mr. Chairman, and distinguished members of the Senate Subcommittee on Reorganization and International Organizations; my name is Dr. Lowell T. Coggeshall. I am vice president of the University of Chicago and Frederick H. Rawson Professor of Medicine at the university. Before and during World War II, I conducted scientific research with animals and with human beings involving several hundred new compounds being tested to combat malaria and other tropical diseases. For 13 years, I served as Dean of the university's Division of Biological Sciences, carrying responsibilities as a medical administrator for research expenditures at an annual level of some $6 million. special adviser in 1956 to Secretary Marion Folsom of the Department of Health, Education, and Welfare, my responsibilities extended to the programs and As budgets of all the medical activities of that department. The principal agencies in that area were the National Institutes of Health and the Food and Drug Administration. I speak today as Chairman of the Commission on Drug Safety, a body which came into being as a result of the thalidomide episode. The commission was formed primarily because there was no organized way for the scientific community to react to the crisis. During the evaluation of the incident and the legislative process it set in motion, it became apparent that there was no one central active group outside of Government to relate the attitudes and interests of the Government, the pharmaceutical industry, scientific societies, the medical profession and its organizations, and the hospitals and universities. The commission was established last August with a grant from the Pharmaceutical Manufacturers Association. The support was offered and accepted under the same conditions of an award to an academic institution which permits complete freedom and independence of the commission in establishing its purposes and in carrying them out. Having been assured of its complete independence, the commission set as its purpose "the broadening of scientific knowledge on predictability of actions of drugs in human beings." Fourteen of the Nation's outstanding authorities from universities, scientific associations and industry, including a Nobel Prize laureate, serve as members of the commission, and nearly 200 scientists are contributing to its work through committee activity. The commission's programs are underway in 17 subcommittees, representing the critical phases of the complex problems of drug safety. There is teratology, the study of prenatal malformations which thalidomide practically dramatized; Dr. Josef Warkany of the University of Cincinnati heads this group. There is the public's role in drug safety; Nobelist Dr. Philip Hench is a participant in this aspect. Dr. Walter Modell of Cornell University heads the committee on the clinical pharmacologist. Other internationally recognized men are directing studies for the commission in animal experimentation, limited and general human trials, investigator competence, the conduct of drug testing, the principles of clinical trials, information and communication, responsibilities of the pharmaceutical industry, the role of the universities, the responsibilities of State and Federal governments. The work is far from finished, and I cannot, therefore, give to the Congress the results and conclusions of its efforts. I must speak personally from my own background and observation in an interim effort to report to you on the commission's work. This is a scientific era. The rapid progress of science is one of the great forces affecting the conduct of Government in all its branches. I speak of science not as a synonym for modern methods and efficiency or mere advanced technology. I speak of it as a force which changes human life and society, which reduces our ignorance and expands our hopes. The power of science bears on our foreign relations, our defense and our general welfare. In all Federal agencies affecting health or our mode of living, it is forcing reorientation and reevaluation of purpose and method. Scientific progress in opening new benefits has stirred strange new problems along the way. It also has encouraged new optimism toward the stubborn, persistent, widespread existing problems in our lives, food, shelter, and health. There is the science that points to the mountain top and commands: scale that height-and the ambitious task is accomplished. There also is the science that, searching through the mists of human ignorance, discovers the mountain and makes a basic addition to our knowledge and changes the human scene. The distinction between the two kinds of sciences is not always so clear, but both kinds of science-basic and applied-must be kept in mind in examining questions of public policy. The significance of discovering new mountains demands priority. The science of the past generation has characterized the period as the atomic age. The great basic achievements have been on the physical side. But the momentum of discovery is building up in the biological sciences. The contributions of the scientists in biology and medicine are creating excitement of anticipation that magnificient new discoveries are drawing nearer. The recent Nobel Prizes strengthen the view that the coming generation may be identified by the advances in our understanding of life itself. In our own country at this time, our medical research and development expenditures are approaching-if they have not already exceeded-a billion dollars annually. Our recent advances in medicine have been so great many author |