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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Dr. Kessenich, he said, took the assignment reluctantly and, after a while, told Mr. Larrick he wanted to leave for a job with fewer pressures, even at less pay. Mr. Larrick said he prevailed on Dr. Kessenich to stay until he could find a successor. After considerable investigation and consultation with the Public Health Sery- ice, Mr. Larrick said he picked up Dr. May. He said he wrote a letter offering the appointment to Dr. May and cleared the offer with the Secretary’s office. He added that he explained to Dr. May that [he] still had to go through security clearance but described it as “perfunctory.” Dr. Kessenich left in August and Dr. Ralph Smith has been the acting director ever since. FEAR AS TO “DRYING UP” OF NUMBERS OF NEW DRUGS Senator Humpurey. Dr. May, over a period of years from 1938 to 1962 some 13,000 applications for new drugs remained effective. Views have been expressed in some quarters in the pharmaceutical in- dustry that the application of stricter Federal standards prior to the approval of new drugs will, and here I am quoting their own words, “cripple the drug industry,” and “curtail the prospects of discovery of new remedies.” Would you like to comment on this matter as to the prospective number of new drugs? Dr. May. Yes, sir, and in so domg may I introduce certain items into the record as exhibits. One is entitled “A Report of the Council on Pharmacy and Chemistry of the American Medical Association,” and it appeared in the Journal of the American Medical Association 20 years ago in 1944. Another is entitled “Too Many Drugs.” It is also a report of the Council on Pharmacy and Chemistry of the AMA published in 1949. These reports represent one of those happy moments in history when there was complete harmony between industry, the Food and Drug Administration and the American Medical Association. For this report is under the authorship of members of the FDA, Dr. Aus- tin Smith when he was secretary of the Council on Pharmacy and Chemistry, and under the auspices of the Council on Pharmacy and Chemistry (now known as the Council on Drugs) of the AMA. The item from the Journal of the American Medical Association in 1944 was a detailed exposition of the general principles to be observed in the investigation of new drugs before marketing. This was set forth as sort of a model toward which all would aspire, realizing that it would take time to develop it or that it might be modified in a few circumstances. 3ut it was set forth as a goal by, as I say, these persons who are still vexed with the problem 20 years later. It so happens that if you com- pare this full report with the present law and with the recent regula- tions of the FDA, you will find that by and large the recent legisla- tion and the regulations of the FDA are simply measures to implement what was recommended by these parties 20 years ago. This report is concluded by the statement: A study of this outline for the therapeutic and toxicologie appraisal of new drugs may leave the impression that the task which has been said is far too complex and difficult, requires too much time and expenditure of energy and money and can be circumvented by briefer and less thorough investigations. While this may be true in a few isolated instances, it is not true in a majority of cases of really new drugs. Recent history contains too many instances of disastrous results that have followed incomplete or inadequate investigations on new drugs. This outline is an objective toward which investigations of new

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