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U.S. Department of Health and Human Services

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This Week In FDA History - June 20, 1963

Photo with caption
  President Kennedy hands a pen used to sign the amendments into law to sponsor Sen. Estes Kefauver. Looking on are (from left) Sen. Thomas J. Dodd, FDA medical officer Frances Kelsey, M.D., FDA Commissioner George P. Larrick, Sen. Philip A. Hart, Sen. Hubert H. Humphrey, Sen. Olin D. Johnston, Undersecretary of Health, Education, and Welfare Ivan Nestingen, Rep. Leo W. O'Brien, and Rep. Kenneth A. Roberts.
June 20, 1963:
FDA announces three sets of regulations governing the manufacture, effectiveness and promotion of drugs. These regulations are designed to carry out the provisions of the Kefauver-Harris Drug Amendments of 1962.

FDA in 2006

The Kefauver-Harris Amendments strengthened the FDA's authority over prescription drugs in several important ways, and the agency continues to enforce these provisions today. Manufacturers must prove that their drugs are effective and safe before marketing them. Clinical trial managers are required to give participants full information about the benefits and risks of drugs being studied. The FDA regulates advertising of prescription drugs, establishes good manufacturing practices as a means to promote quality assurance, and can review certain
company control and production records to verify production procedures. The amendments also required that drugs introduced between 1938 and 1962 be effective. The FDA contracted with the National Academy of Sciences in 1966 to evaluate the effectiveness of drugs approved between 1938 and 1962. The review, called the Drug Efficacy Study Implementation, showed that nearly 40 percent of these products were not effective. A similarly comprehensive study of over-the-counter products began 10 years later.