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Sept 15, 2003

For a more complete listing, visit www.fda.gov/opacom/ backgrounders/miles.html.


1880 PETER COLLIER, chief chemist, U.S. Department of Agriculture, recommends passage of a national food and drug law, following his own food adulteration investigations. The bill was defeated, but during the next 25 years more than 100 food and drug bills were introduced in Congress.

1883 HARVEY W. WILEY becomes chief chemist, expanding the Bureau of Chemistry's food adulteration studies. Campaigning for a federal law, Wiley is called the "Crusading Chemist" and "Father of the Pure Food and Drugs Act." He retired from government service in 1912 and died in 1930.

1906 The original FOOD AND DRUGS ACT is passed by Congress on June 30 and signed by President Theodore Roosevelt. It prohibits interstate commerce in misbranded and adulterated foods, drinks, and drugs. The MEAT INSPECTION ACT is passed the same day.

1914 THE HARRISON NARCOTIC ACT requires prescriptions for products exceeding the allowable limit of narcotics and mandates increased record keeping for physicians and pharmacists who dispense narcotics.

1927 The Bureau of Chemistry is reorganized into two separate entities. Regulatory functions are located in the FOOD, DRUG, AND INSECTICIDE ADMINISTRATION, and nonregulatory research is located in the BUREAU OF CHEMISTRY AND SOILS.

1937 ELIXIR OF SULFANILAMIDE, containing the poisonous solvent diethylene glycol, kills 107 persons, many of whom are children, dramatizing the need to establish drug safety before marketing and to enact the pending food and drug law.

1938 THE FEDERAL FOOD, DRUG, AND COSMETIC (FDC) ACT of 1938 is passed by Congress, containing new provisions: extending control to cosmetics and therapeutic devices; requiring new drugs to be shown safe before marketing — starting a new system of drug regulation; eliminating the Sherley Amendment requirement to prove intent to defraud in drug misbranding cases; providing that safe tolerances be set for unavoidable poisonous substances; authorizing standards of identity, quality, and fill-of-container for foods; and authorizing factory inspections.

1940 The FDA IS TRANSFERRED from the Department of Agriculture to the Federal Security Agency, with Walter G. Campbell appointed as the first Commissioner of Food and Drugs.

1949 The FDA publishes GUIDANCE TO INDUSTRY for the first time. This guidance, "Procedures for the Appraisal of the Toxicity of Chemicals in Food," came to be known as the "black book."

1950 In ALBERTY FOOD PRODUCTS CO. v. U.S., a court of appeals rules that the directions for use on a drug label must include the purpose for which the drug is offered. Therefore, a worthless remedy cannot escape the law by not stating the condition it is supposed to treat.

1962 THALIDOMIDE, a new sleeping pill, is found to have caused birth defects in thousands of babies born in western Europe. News reports on the role of Frances Kelsey, FDA medical officer, in keeping the drug off the U.S. market arouse public support for stronger drug regulation. KEFAUVER-HARRIS DRUG AMENDMENTS passed to ensure drug efficacy and greater drug safety. For the first time, drug manufacturers are required to prove to the FDA the effectiveness of their products before marketing them.

1970 In UPJOHN v. FINCH, the Court of Appeals upholds the enforcement of the 1962 drug effectiveness amendments by ruling that commercial success alone does not constitute substantial evidence of drug safety and efficacy. The ENVIRONMENTAL PROTECTION AGENCY is established and takes over the FDA program for setting pesticide tolerances.

1976 VITAMINS AND MINERALS AMENDMENTS ("Proxmire Amendments") stop the FDA from establishing standards limiting potency of vitamins and minerals in food supplements or regulating them as drugs based solely on potency.

1983 The ORPHAN DRUG ACT is passed, enabling the FDA to promote the research and marketing of drugs needed for treating rare diseases.

1987 INVESTIGATIONAL DRUG REGULATIONS ARE REVISED to expand access to experimental drugs for patients with serious diseases with no alternative therapies.

1988 The FOOD AND DRUG ADMINISTRATION ACT of 1988 officially establishes the FDA as an agency of the Department of Health and Human Services with a Commissioner of Food and Drugs appointed by the President with the advice and consent of the Senate.

1992 The PRESCRIPTION DRUG USER FEE ACT requires drug and biologics manufacturers to pay fees for product applications and supplements and other services. The act also requires the FDA to use these funds to hire more reviewers to assess applications. MAMMOGRAPHY QUALITY STANDARDS ACT requires all mammography facilities in the United States to be accredited and federally certified.

1997 The FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT reauthorizes the Prescription Drug User Fee Act of 1992 and mandates the most wide-ranging reforms in agency practices since 1938.



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