Which amendment to the FDCA of 1938 transferred jurisdiction for prescription drug marketing from the FTC to the FDA?

The Kefauver-Harris Amendment of 1962 is the correct choice because it made significant changes to the way prescription drugs are regulated in the United States. Before this amendment, the Federal Trade Commission (FTC) had jurisdiction over the marketing of prescription drugs, which included their advertising. However, the Kefauver-Harris Amendment transferred this jurisdiction to the Food and Drug Administration (FDA), thereby establishing the FDA as the primary regulatory body overseeing the efficacy, safety, and marketing of prescription drugs.

This change was driven by the need for stricter control over drug approval processes and significant public concern following incidents of unsafe medications. The amendment mandated that drug manufacturers prove both the safety and efficacy of their drugs before they could be marketed. It also introduced requirements for informed consent and adverse reaction reporting, enhancing the regulatory landscape for pharmaceuticals.

The other amendments listed, while important in their own rights—such as the Drug Price Competition and Patent Term Restoration Act of 1984 which aimed at encouraging the development of generic drugs, or the Orphan Drug Act of 1983 that provided incentives for developing treatments for rare diseases—did not involve the transfer of jurisdiction for marketing prescription drugs from the FTC to the FDA. They focused on different aspects of drug regulation, like pricing