Louis Lasagna, then a prominent clinical pharmacologist at the University of Rochester, advised Congress about the proper conduct of clinical research during the 1962 hearings leading up to passage of the Amendment.
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The bill by U.S. Senator Estes Kefauver, of Tennessee, and U.S. Representative Oren Harris, of Arkansas, required drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval.
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He was the lead House sponsor of the Kefauver Harris Amendment, an amendatory act to the federal Pure Food and Drug Act, the law that mandates that pharmaceutical companies disclose the side effects of medications approved by the United States Food and Drug Administration for sale in the United States.