Volume 3

Interagency coordination in drug research and regulation : hearings before the Subcommittee on Reorganization and International Organizations of the Committee on Government Operations, United States Senate, Eighty-eighth Congress, first session. Agency coordination study, pursuant to S. Res. 27, 88th Cong. Review of cooperation on drug policies among Food and Drug Administration, National Institutes of Health, Veterans' Administration, and other agencies. Mar. 20-June 26, 1963.

United States. Congress. Senate. Committee on Government Operations

Date:: 1963

Credit: Interagency coordination in drug research and regulation : hearings before the Subcommittee on Reorganization and International Organizations of the Committee on Government Operations, United States Senate, Eighty-eighth Congress, first session. Agency coordination study, pursuant to S. Res. 27, 88th Cong. Review of cooperation on drug policies among Food and Drug Administration, National Institutes of Health, Veterans' Administration, and other agencies. Mar. 20-June 26, 1963. Source: Wellcome Collection.

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agents should be directed. It need not apply in all cases, but the reasons for omitting any part should be that the omitted parts are not necessary and not merely that they are troublesome. Finally, it is necessary to exercise sound judgment in deciding whether a product deserves recognition. T will not read the rest of this because this is simply reemphasizing that the people in the FDA must have competency to match the ade- quacy of the data put before them. Now, when this original report from the Council on Pharmacy and Chemistry, prepared by officials of the FDA and Dr. Austin Smith, under the auspices of the AMA, appeared, an eminent pharmacologist, Dr. Chauncey Leake, wrote a letter to the editor in which he expressed concern about some of the minor provisions for testing the toxicology, et cetera, and he also went further to say that perhaps many of the molecular modifications could be subjected to a more cursory examina- tion. The authors of the preceding report made this reply: The pharmacologic properties of drugs cannot be predicted reliably on the basis of the chemical similarity to other well-known drugs [and they list examples]. There are so many exceptions to the so-called relationship between the chem- ical structure and the pharmacologic activity that reliance on that relationship as a shortcut to adequate investigation is extremely risky. Now, to answer more specifically your question about crippling the drug industry or having any deleterious effect on the public health by curtailing the number of drugs, the final paragraph is particularly pertinent: Yinally we seriously doubt that the application of the criteria set forth in our paper will delay the use of worthwhile therapeutic agents. In fact, it is our belief that ill-conceived and poorly executed investigations have contributed materially to delays in the proper and widespread use of therapeutically desir- able agents. Senator Humpurey. Who signed that report ? Dr. May. This was signed by officials of the FDA at that time, Dr. Van Winkle, Dr. Herwick, and Dr. Calvery, and by Dr. Austin Smith, then secretary to the Council on Pharmacy and Chemistry of the AMA. Senator Humpurey. And now is? _Dr. May. President of the Pharmaceutical Manufacturers Asso- ciation. __ My guess is that the body of evidence set forth and the conclusions drawn would be as acceptable to him today as they were then. I do not believe that his present alinements would either allow him or invite him to draw any different picture. Senator Humpnurey. So it is fair to say, then, that the stricter Fed- eral standards prior to the approval of new drugs would not “cripple” the drug industry in terms of its new preparations? Mr. May. Exactly not, and I think in addition the exhibit which I have asked to be entered regarding “Too Many Drugs,” which is a statement from Dr. Austin Smith, points out that quite to the con- trary, the profusion which existed even then, nearly 20 years ago, was already presenting a serious challenge to the effectiveness of medical care, and obviously is not less so today.*° ae For additional comments on the issue of the number and variety of drugs, see exhibit 58, p. 11386.

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