Which amendments addressed advertising claims for drug products?

• A. Shirley Amendments
• B. Harris-Kefauver Amendments
• C. Orphan Drug Act
• D. Stark Law

Answer: (A)

Advertising claims for drug products were addressed by the Shirley Amendments. These revisions to the Pure Food and Drug Act prohibited false or misleading labeling and advertising of drugs, making it unlawful to claim therapeutic effects that couldn’t be proven. The goal was to curb deceptive statements about cures or guaranteed results and ensure that drug advertising reflects what evidence supports. The other options focus on different regulatory issues: the Harris–Kefauver amendments require safety and efficacy evidence before a drug can be marketed and tighten overall drug regulation; the Orphan Drug Act provides incentives to develop treatments for rare diseases; and the Stark Law deals with prohibitions on physician referrals under Medicare, not drug advertising.