Which amendments included the FDA regulating advertising of prescription drugs?

• A. Durham-Humphrey Amendments 1962
• B. Orphan Drug Act 1983
• C. Drug Importation Act 1848
• D. Kefauver-Harris Amendments 1962

Answer: (D)

Regulation of prescription-drug advertising was expanded under the Kefauver-Harris Amendments of 1962. After the thalidomide tragedy, Congress tightened the FD&C Act to ensure drugs were proven safe and effective, and it gave the FDA authority to oversee not just labeling but also promotional claims for prescription medications. Advertisements had to be truthful and non-misleading, with a fair balance of benefits and risks, and they had to disclose potential adverse effects. This created the FDA’s ongoing power to regulate how prescription drugs are advertised to both healthcare professionals and the public. The other acts listed address different issues—Rx/OTC distinctions and labeling for Durham-Humphrey, incentives for rare diseases with the Orphan Drug Act, and drug importation controls with the Drug Importation Act—so they do not establish advertising regulation.