26. "Drug Terminology and the Urgent Need for Reform," New England Page Journal of Medicine, July 7, 1960. 27. "The Council on Pharmacy and Chemistry-Membership, Activities, Method of Operations, Attainments," Dr. Austin Smith, J.A.M.A., February 12, 1955__ 28. "United States Food and Drug Administration and the Pharmaceutical 29. AMÁ resolutions and actions, presented by State medical associations. 32. Advertisements and accompanying material submitted by Dr. Charles 32A. (1) "Social Processes in Physicians' Adoption of a New Drug,' 37. Letter from Noble J. Swearingen, director, Washington Office, Ameri- 566 569 576 579 600 603 617 648 667 688 40. "Do Trade Name Drugs Cost Extra?" Good Housekeeping Magazine, July 1961 829 41. "Generic Prescribing? It Could Be Dangerous," Medical Economics, July 3, 1961. 831 42. "Effects of S. 1552 on the Public's Health," Eli Lilly & Co., June 30, 1961 832 43. "The Drug Explosion," Dr. Walter Modell, Clinical Pharmacology and Therapeutics, January-February 1961 849 44. "Too Many Drugs," Time magazine, May 26, 1961, relating to article by Dr. Walter Modell in Chemical Pharmacology and Therapeutics. 45. Letter by Dr. Austin Smith, Time magazine, June 16, 1961, commenting on previous article.. 856 856 46. Statement by Dr. Allan M. Butler, September 2, 1961, on false statements by drug industry. 857 47. Codes and procedures of Physicians' Council, August 1947 48. Norlutin ad, J.A.M.A., April 30, 1960. 52. Report on Norlutin, Council on Drugs of AMA, volume 169, No. 11. 53. "The Clinical Value of Drugs: Sources of Evidence," Dr. Mindel C. Sheps, American Journal of Public Health, May 1961. 885 886 54. Notice of proposal to amend labeling requirements, enforcement regulations, drugs and devices, new drugs; Food and Drug Administration; Federal Register, July 22, 1960. 894 55. "Chemical structure of tetracycline, chlortetracycline, and oxytetracycline," Patent Ownership and Licensing in Antibiotics Industry, Federal Trade Commission. 444 Exhibit 35 was not provided. OTHER MATERIAL Comparison of S. 1552 and present law which it would amend (committee "Amendment of Antitrust Laws with Respect to Manufacture and Dis- "Kelly, PMA Counsel, Analyses Kefauver-Celler Bills," Drug Trade News, "Costs, Quality, and Promotion of Ethical Drugs," a statement of the "Tests of Penicillin G Tablets," The Medical Letter, April 14, 1961.. Letter from Dr. Maxwell Finland, July 31, 1961, enclosing "The Challenge of New Drugs to the Clinical Investigator," Antibiotics Annual, 1959–60. "The Placebo Effect in Psychiatric Drug Research," Dr. Armand W. Loranger, et al., J.A.M.A., June 17, 1961.. "Statement on Review of Advertising Copy by Outside Groups," resolu- tion of medical section of American Drug Manufacturers Association, Letter from Dr. Charles May, August 28, 1961, on Council of Drugs re- 187 American Hospital Association, statement to subcommittee, August 1181 American Medical Association, comments of August 21, 1961: On subcommittee charts. On Barclay article and DBI ad.... On Equanil and Miltown ads. 135 150 152 On Modell article and Tenuate ad. 160 On AMA advertising policies - 162 On J.A.M.A. advertising standards.. 167 A. Report Special Committee Advisory to The Secretary of Health, Education, and Welfare Mission This Committee was appointed in June 1960 by the President of the National Academy of Sciences at the request of the Secretary of Health, Education, and Welfare. It was asked to review the policies and procedures used by the Food and Drug Administration in reaching decisions concerning the acceptance and certification of new drugs, including antibiotics, and the scientific soundness of the decisions made in recent years. The Committee was also invited to present such recommendations as it might consider desirable for the protection of the public health through the functions of the FDA. B. Procedure The Committee met on 28 June to plan its activities and again on 8 September to discuss its findings and formulate its recommendations. In both meetings it had the assistance of representatives of the Secretary's office and the FDA, who cooperated by providing pertinent information and answering questions arising from the study. The necessary legal steps were taken to permit members unrestricted access to the FDA files. In addition, an extensive file of documents concerning the law and regulations, policies and procedures, staffing and organization, and other pertinent matters was forwarded to each member for background and reference. (A list of these documents is appended.) It It was at once apparent that the Committee could not hope in any reasonable period to examine all, or even a large proportion, of the thousands of voluminous applications for certifiable antibiotic preparations and new drugs. processed under the Federal Food, Drug, and Cosmetic Act in recent years. was therefore decided that the members would select for detailed study a limited number of preparations which they considered to be of especial significance. In all, 29 applications were reviewed, covering 3 preparations of certifiable antibiotics, 14 of antibiotics classed as new drugs, and 12 of other new drugs. C. Conclusions While the proportion of decisions studied was necessarily small, the Committee believes its sampling to be sufficiently representative, particularly of preparations which have been the subject of some controversy, to provide a reasonable basis for conclusions as to the performance of the FDA staff in protecting the public health. Taking into account the limitations of the FDA's authority, funds, and scientific personnel, the Committee found the decisions it reviewed acceptable, despite certain deficiencies in the quality and quantity of the data upon which they were based. It found no evidence of disregard for the public health, and noted that appropriate action had been taken when hazards were established by subsequent clinical experience. folio 932 459 Nevertheless, the Committee concluded that certain weaknesses inherent in the existing law and current staffing and budgetary support hamper the FDA in its task of protecting the public health. Accordingly, it has addressed its recommendations primarily to the correction of these defects. The increasing rate at which medical research is expanding and new and powerful drugs are being developed is multiplying the number of potential hazards to be controlled. Therefore, the Committee believes it essential that these recommendations be acted upon with the least possible delay. 1. The FDA should be given statutory authority to require proof of the efficacy, as well as the safety, of all new drugs. Treatment of a patient with an ineffective drug in place of an effective one may jeopardize his recovery. This is true even though the drug may not be intrinsically harmful, and even though the specific condition for which the drug is given may not be ordinarily regarded as life-threatening. 2. The FDA should be given statutory authority to require manufacturers of new drugs to maintain records and submit reports of clinical experience and other relevant data, not only before but after the drug is released for sale, as requested by the Commissioner in his proposed Factory Inspection and Drug Amendments of 1960. Any evaluation of a new drug is subject to revision in the light of broader experience, and the FDA must be in a position to advise the profession and warn the public promptly whenever new hazards are revealed. 3. The FDA should be given statutory authority to apply certification procedures to all antimicrobial agents used in the prophylaxis and treatment of infectious diseases. The Committee sees no reason for limiting certification to those antibiotic preparations which happen to have come on the market prior to 1950, and further believes that all agents employed for equally serious conditions should be subject to equivalent measures of control. 4. The Committee recognizes the importance to the public health of ensuring that all drugs are prepared under the highest standards of quality control. It therefore endorses the Commissioner's proposals in the Factory Inspection and Drug Amendments of 1960 to clarify and strengthen existing inspection authority, and to require that all drugs be manufactured and packaged under adequate controls. 5. The Committee believes that the information supplied to physicians |