Kefauver–Harris Amendment
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The U.S. Kefauver–Harris Amendment or "Drug Efficacy Amendment" is a 1962 amendment to the Federal Food, Drug, and Cosmetic Act.
Quick Facts Long title, Nicknames ...
Long title | An act to protect the public health by amending the Federal Food, Drug, and Cosmetic Act to assure the safety, effectiveness, and reliability of drugs, authorize standardization of drug names, and clarify and strengthen existing inspection authority; and for other purposes. |
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Enacted by | the 87th United States Congress |
Effective | October 10, 1962 |
Citations | |
Public law | 87-781 |
Statutes at Large | 76 Stat. 780 |
Codification | |
Acts amended | Federal Food, Drug, and Cosmetic Act |
Titles amended | 21 U.S.C.: Food and Drugs |
U.S.C. sections amended | 21 U.S.C. ch. 9 § 301 et seq. |
Legislative history | |
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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.