Which act granted the FDA the authority to regulate prescription drug advertisements?

The Kefauver-Harris Amendment of 1962 is the legislation that specifically granted the FDA the authority to regulate the advertising of prescription drugs. This act was a reaction to numerous issues regarding drug safety and efficacy that arose in the years leading up to its passage, most notably highlighted by the thalidomide tragedy. Prior to this amendment, the FDA had limited power to dictate how prescription drugs could be promoted and advertised, which made it difficult to ensure that consumers received truthful and informative promotions.

The Kefauver-Harris Amendment significantly expanded the FDA's role by establishing requirements for drug manufacturers to provide evidence of a drug's efficacy as well as safety before approval. It also mandated that advertising for prescription medications must be truthful and present a balanced view of the benefits and risks associated with those products. Thus, this amendment is critical in ensuring that the information presented in advertisements is accurate and consistent with the approved labeling of the drug.

The Food, Drug, and Cosmetic Act laid the groundwork for drug regulation in general but did not specifically focus on advertising. The FDA Modernization Act of 1997 made several changes to FDA regulations, but it was the Kefauver-Harris Amendment that initially provided the authority to regulate advertising. The Drug Enforcement Administration Act