What significant amendment was made in 1962 regarding drugs?

The significant amendment made in 1962 regarding drugs was the requirement for both safety and efficacy. This change came with the Kefauver-Harris Amendment to the Federal Food, Drug, and Cosmetic Act. Prior to this amendment, medications were primarily required to be safe; however, there was no mandate proving they had to be effective for their intended use. The Kefauver-Harris Amendment was a response to public concern about drug safety and efficacy, heightened by the thalidomide tragedy, where a drug resulted in severe birth defects.

This amendment established a more rigorous drug approval process that requires pharmaceutical companies to provide substantial evidence of a drug's effectiveness, alongside proof of safety, before they can market their products. It significantly influenced the regulatory landscape, ensuring that new drugs would not only be safe for consumption but also deliver the promised therapeutic benefits.

While labeling requirements, child safety regulations, and marketing practices are all important aspects of drug regulation, the 1962 amendment specifically changed the standards for efficacy in addition to safety, making the combination of these two aspects of paramount importance in drug approval.