Kefauver–Harris Amendment

Kefauver–Harris Amendment

The Kefauver–Harris Amendment or Drug Efficacy Amendment is a 1962 amendment to the Federal Food, Drug, and Cosmetic Act. It was signed into law by President John F. Kennedy on October 10, 1962. The amendment was a response to the Thalidomide tragedy, in which thousands of babies worldwide were born with birth defects as a result of the drug being marketed without proper testing for safety and efficacy.

Background

The Kefauver–Harris Amendment was introduced by Senator Estes Kefauver and Representative Oren Harris, following the thalidomide tragedy that occurred in Europe in the late 1950s and early 1960s. Thalidomide was a drug marketed as a safe, over-the-counter sedative, but it was later found to cause severe birth defects when taken during pregnancy.

Provisions

The amendment introduced a series of significant changes to the Federal Food, Drug, and Cosmetic Act. It required drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval, established good manufacturing practices, and mandated the reporting of adverse side effects.

Safety and Efficacy

The amendment requires that all new drugs must be proven safe and effective for their intended use before they can be marketed. This was a significant change from the previous law, which only required proof of safety.

Good Manufacturing Practices

The amendment also established standards for good manufacturing practices to ensure that drugs are produced consistently and meet quality standards.

Adverse Event Reporting

The amendment requires that manufacturers monitor and report any adverse events associated with the use of their drugs.

Impact

The Kefauver–Harris Amendment has had a significant impact on the drug approval process in the United States. It has led to increased safety and efficacy standards, and has helped to prevent the marketing of unsafe or ineffective drugs.

See also

• Federal Food, Drug, and Cosmetic Act
• Thalidomide
• Estes Kefauver
• Oren Harris

External links

• FDA's page on the Kefauver-Harris Amendment