What act was passed in response to the thalidomide birth defects?

The Kefauver-Harris Amendment of 1962 was a significant legislative response aimed at improving drug safety and efficacy, particularly in light of the thalidomide tragedy that led to severe birth defects when the drug was used by pregnant women. Prior to this amendment, the drug approval process lacked rigorous standards for demonstrating the effectiveness of new medications and did not sufficiently ensure their safety.

This amendment established a requirement that manufacturers provide substantial evidence of a drug's effectiveness through clinical trials, in addition to proving safety. It also mandated that drug advertisements contain information about the risks associated with the drugs, enhancing transparency for consumers and healthcare providers.

The other options listed do not directly address the issues that arose from the thalidomide case. The Durham-Humphrey Amendment pertained to the classification of prescription versus over-the-counter drugs; the Food, Drug, and Cosmetic Act was enacted much earlier, in 1938, primarily focused on drug safety but did not address efficacy; and the Poison Prevention Packaging Act was aimed at safeguarding children from accidental poisonings, which is not related to the approval process of pharmaceuticals like thalidomide. This context helps to clarify why the Kefauver-Harris Amendment is the correct answer in relation to the thalidomide