Kefauver Harris Amendment

Drug Amendments of 1962

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 standardiztion of drug names, and clarify and strengthen existing inspection authority; and for other purposes.
Nicknames	Drug Efficacy Amendment Kefauver Harris Amendment
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
Introduced in the Senate as S. 1552 by Estes Kefauver (D–TN) on July 19, 1962 Committee consideration by 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, 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.

The amendment was a response to the Thalidomide tragedy, in which thousands of children were born with birth defects as a result of their mothers taking thalidomide for morning sickness during pregnancy. 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. It should be noted that Thalidomide had not been approved for use in the United States and that the tragic birth defects that occurred were in other countries. 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. 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.

The Kefauver Harris Amendment strengthened the U.S. Food and Drug Administration's control of experimentation on humans and changed the way new drugs are approved and regulated. Before the Thalidomide scandal in Europe, and Canada, U.S. drug companies only had to show their new products were safe. After the passage of the Amendment, an FDA New Drug Application (NDA) would have to show that a new drug was both safe and effective (previously the 1938 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.

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