1962

Passage of Kefauver-Harris Amendments to the Federal Food, Drug and Cosmetic Act which, in the wake of tragedies, (a) tightened federal control of drug industry’s interstate commerce; (b) required additional evidence [“substantial evidence” deriving from “adequate and well controlled investigations”] of effectiveness of drugs proposed for regulatory approval; (c) increased drug clearance from 60 to 180 days; (d) required “adequate” preclinical toxicity studies prior to human studies; (e) required informed consent for all IND research, “a change without precedent in the U.S. law” (Lasagna, 330-332; Speaker, 367; Hilts, 144-165; Donohue, 670-671). Under FDA Commissioner James Goddard, FDA collaborated with the National Academy of Sciences, National Research Council (= Drug Efficacy Study of the NAS, NRC) reviewed 80% of the 4,000 drugs on the market. Study lasted three years and removed some 300 drugs from the American market, including the entire category of “combination antibiotics” (Hilts, 166-177). The homeopathic position on the amendment “was that their medicines should not be studied, as they could not be evaluated by ‘allopathic review’” (M. Kaufman, 118).