Which amendments required efficacy as well as safety, informed consent for research subjects, FDA advertising regulation of Rx drugs, and GMP?

• A. Kefauver-Harris Amendments 1962
• B. Orphan Drug Act 1983
• C. Dietary Supplement Health and Education Act 1994
• D. Durham-Humphrey Amendments 1962

Answer: (A)

The main idea is that these amendments broadened drug regulation to require real-world effectiveness, protect people in research, control how prescription drugs are advertised, and ensure quality manufacturing.

In the wake of the thalidomide tragedy, this set of amendments made the approval process hinge not only on safety but also on evidence of efficacy, so drugs must demonstrate they work to be marketed. They also established protections for people in clinical studies, requiring informed consent and oversight of research practices. The authority to regulate how prescription drug advertising is presented to physicians and the public was strengthened, so drug information must be accurate about risks and benefits. Finally, they require good manufacturing practices, ensuring consistent quality and safety in how drugs are produced.

The other acts address different aims—such as incentives for rare diseases, regulation of dietary supplements, or the prescription versus over-the-counter labeling—but they do not combine all these protections in the same way.