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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Consequently, Humphrey found it ‘incredible’ that the FDA had not made “systematic use” of outside consultants. Although the agency supplied him with a “nominally” long list of outside consultations, Humphrey found it “com- pletely misleading.” ‘It pretends that an isolated telephone call or letter or short visit for a curbstone—I emphasize—curbstone judgment represented ‘con- sultation.’” “I am surprised,” he continued, “ * * * that FDA states consul- tation has ‘routinely’ occurred. The men * * * inside the agency who have fought and begged for outside consultation * * * have been discouraged at worst, or ignored at best, from above.” PRESSURE AND PERSUASION The atmosphere inside the agency apparently has been one of considerable dis- couragement from above, accompanied by constant harassment from some drug manufacturers. Dr. Moulton has told of cases in which orders came “from above” for medical officers to certify drugs about which they had doubts, the justification being that the manufacturers should “be in a much better position to judge their safety.” She contended that in many of its activities the FDA had become ‘‘merely a service bureau”’ for the drug industry. Dr. Moulton has also complained that manufacturers’ representatives spend “3 or 4 days a week in the New Drug Branch offices, arguing each point step by step, wanting to know and being told exactly where the application is at all times and which chemists and which pharmacologists are assisting in its review.” One physician who worked on the application for Marsilid, the “happiness pill” associated with hepatitis, left the FDA shortly thereafter to work for Marsilid’s manufacturer, Hoffmann-La Roche. The letter he authorized, while in the FDA, to warn prescribing physicians about Marsilid’s side effects did not impress Dr. Moulton, who informed the Kefauver subcommittee that ‘‘the im- portant facts were obscured by so much irrelevant material that [it] failed fo serve as an effective warning.” The FDA’s involvement with the industry was brought home forcibly by the disclosures that the head of its Division of Antibiotics, Henry Welch, was writing articles for professional journals that brought him a profit, as Senator Douglas told Congress last summer, of “approximately $288,000 * * * from the firms he was supposed to be regulating.” Dr. Welch was “allowed to resign” in 1960, when the Kefauver subcommittee fully explored the matter, but even then, as Kefauver found, his superiors “‘were derelict in the performance of their duty * * * they whitewashed it * * *. He was not even asked by [FDA’s top Officials] how much his ‘honorariums,’ as he called them, amounted to. That was an outrageous conflict of interest.” (The matter is now before a grand jury.) When the new drug bill was passed in Congress, both Senator Kefauver and Senator Douglas voiced their concern about the ability of the FDA to administer it, and both called for ‘“‘an infusion of new blood.” Senator Humphrey has made it clear that he has “little reason for confidence in the policy echelons of FDA,” but does not attack Commissioner Larrick personally; indeed he calls him “a faithful and dedicated public servant.” Last October, however, a second Citizens ‘Advisory Committee, reporting on a year-long study of the FDA, recommended that its top posts should “no longer * * * be held primarily by persons whose backgrounds have been as inspectors, but should include scientists with broad experience as well.” The Commissioner’s post was specifically included. Lar- rick, who is not a college graduate, joined the FDA as an inspector in 1923 and rose through the ranks, becoming Commissioner in 1954. His Deputy Commis- sioner started as an inspector in 1925. But the chairman of the citizens committee, George Y. Harvey, who has since become a consultant to HEW on FDA matters, blunted what appeared to be a committee attack on Larrick. He told a press conference that the report was directed ‘“‘to the future,” and that Larrick could carry out its reommendations if he takes them “to heart and attracts the right kind of people.” Attracting and holding the right kind of people may prove exceedingly difficult. Dr. Moulton had quit in disgust so that she could speak out. A former scientific director, Dr. Paul L. Day, found life at the FDA impossible after he had criticized the agency for its “lack of sufficient vision of its proper role in the protection of the health of the American people” and “courage to present, adequately, a bold program.” He resigned. In a recent reorganization, Dr. Kelsey was promoted to head a new Investiga- tional Drug Branch, and she has received from the President the Nation’s highest

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