What does the Kefauver-Harris Amendment of 1962 require for drugs developed after 1938?

The Kefauver-Harris Amendment of 1962 was a significant piece of legislation in the realm of drug approval and regulation. This amendment specifically requires that drugs developed after 1938 must not only be proven safe but also effective for their intended use before they can be marketed.

The necessity for demonstrated effectiveness was a response to past instances where drugs were marketed without sufficient evidence of their efficacy, the most notable example being the thalidomide tragedy. By instituting this requirement, the amendment aimed to enhance consumer protection and ensure that the drugs available to the public provided real therapeutic benefits, not just safety.

While other options address important aspects of drug regulation and safety (such as competitive pricing and packaging requirements), they do not align with the specific requirement of the Kefauver-Harris Amendment concerning drug efficacy. Moreover, while studying for side effects is a critical part of drug development and regulation, the amendment specifically emphasizes the need for a demonstration of both safety and effectiveness rather than a sole focus on side effects. Thus, the requirement that drugs must be proven safe and effective is the correct interpretation of the Kefauver-Harris Amendment's provisions.