Kefauver–Harris Amendment

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Drug Amendments of 1962
Senate Judiciary Committee
  • Passed the Senate on August 23, 1962 (78–22)
  • Passed the House on August 23, 1962 (passed)
  • Reported by the joint conference committee on October 4, 1962; agreed to by the House on October 4, 1962 (347–88) and by the Senate on October 4, 1962 (passed)
  • Signed into law by President John F. Kennedy
    • on October 10, 1962

    The U.S. Kefauver–Harris Amendment or "Drug Efficacy Amendment" is a 1962 amendment to the Federal Food, Drug, and Cosmetic Act.

    It introduced a requirement for drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval,[1][2] required drug advertising to disclose accurate information about side effects, and stopped cheap generic drugs being marketed as expensive drugs under new trade names as new "breakthrough" medications.

    Background

    The amendment was a response to the

    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. The majority of the tragic birth defects that occurred were in other countries because Thalidomide had not been approved for use in the United States. However, samples were distributed to physicians in the US and 17 birth defects were attributed to its use.[4] Frances Oldham Kelsey
    was the FDA reviewer who refused to approve Thalidomide for use.

    It introduced a "proof-of-efficacy" requirement for the first time.[1] In addition, the Amendment required drug advertising to disclose accurate information about side effects and efficacy of treatments. Finally, cheap generic drugs could no longer be marketed as expensive drugs under new trade names as new "breakthrough" medications.

    The law was signed by President John F. Kennedy on October 10, 1962.

    Effect

    The Kefauver–Harris Amendment strengthened the

    Food, Drug and Cosmetic Act was the main law that regulated drug safety. Informed consent was required of patients participating in clinical trials, and adverse drug reactions
    were required to be reported to the FDA.

    The Drug Efficacy Study Implementation was begun to classify all pre-1962 drugs that were already on the market as either effective, ineffective, or needing further study.

    Estes Kefauver considered the Amendment his "finest achievement" in consumer protection.[citation needed]

    Louis Lasagna, then a prominent clinical pharmacologist at the Johns Hopkins School of Medicine, advised Congress about the proper conduct of clinical research during the 1962 hearings leading up to passage of the Amendment.

    The law also exempted from the "

    Delaney clause
    " (a 1958 amendment to the Food, Drugs, and Cosmetic Act of 1938) certain animal drugs and animal feed additives shown to induce cancer, but which left no detectable levels of residue in the human food supply.

    See also

    References

    1. ^ a b Peltzman, Sam. An Evaluation of Consumer Protection Legislation: The 1962 Drug Amendments. The Journal of Political Economy, Vol. 81, No. 5. (Sep. - Oct., 1973), pp. 1051.
    2. ^ "Promoting Safe and Effective Drugs for 100 Years". The Kefauver-Harris Drug Amendments. U.S. Food and Drug Administration.
    3. ^ O'Reilly, James, Jurisdiction to Decide an Agency's Own Jurisdiction: The Forgotten Tale of the Hynson Quartet, Administrative Law Review, Vol. 58, No. 4 (Fall 2006), pp. 829-843 (15 pages).
    4. ^ "Kefauver-Harris Amendments Revolutionized Drug Development". www.fda.gov. Archived from the original on 2019-05-07.
    5. PMID 14076167
      .

    Sources

    • Abood, R.R., & Brushwood, D.B. (1994). Pharmacy practice and the law. Gaithersburg, MD: Aspen Publishers, Inc.
    • Krantz JC Jr., New Drugs and the Kefauver–Harris Amendment, J New Drugs, 1966, Mar-Apr;6(22):77-9
    • Krantz JC Jr., The Kefauver-Harris amendment after sixteen years, Mil Med. 1978 Dec;143(12):883.

    External links
    Retrieved from "https://en.wikipedia.org/w/index.php?title=Kefauver–Harris_Amendment&oldid=1177033729"