The Significance of the Kefauver-Harris Amendment in Improving Drug Safety and Regulation in the United States

Kefauver-Harris Amendment (FDCA)

Piece of legislature that required new drug products to be proven BOTH safe and effective.

The Kefauver-Harris Amendment, also known as the FDCA (Federal Food, Drug, and Cosmetic Act), was passed by the US Congress in 1962, and it was an amendment to the previous FDCA that was passed in 1938. The Kefauver-Harris Amendment was introduced in response to the thalidomide disaster that occurred in Europe, where thousands of children were born with severe birth defects due to their mothers’ use of the drug during pregnancy.

The Kefauver-Harris Amendment required that all new drugs must be proven to be both safe and effective before they could be approved by the US FDA (Food and Drug Administration) for marketing and sale in the United States. Prior to this, drug companies only had to prove that their drugs were safe, but not necessarily effective.

The Kefauver-Harris Amendment also required that pharmaceutical companies provide detailed information about their new drugs, including results from clinical trials, potential side effects, and contraindications. It also required that the FDA approve the labeling and advertising for each drug to ensure that it accurately reflected the drug’s safety and effectiveness.

The Kefauver-Harris Amendment significantly improved drug safety and regulation in the United States. It required drug companies to conduct extensive pre-market testing and provided the FDA with the authority to withdraw drugs from the market if they were found to be unsafe or ineffective. It also created an incentive for drug companies to invest in research and development to create better drugs, as they would be able to reap the financial rewards of selling their drugs if they were proven to be safe and effective.

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