The Drug Price Competition and Patent Term Restoration Act of 1984 is commonly known as

• A. Hatch-Waxman Act
• B. Orphan Drug Act
• C. FDA Modernization Act
• D. Comprehensive Drug Abuse Prevention Act

Answer: (A)

This law is known as the Hatch-Waxman Act, named for sponsors Henry Waxman and Orrin Hatch. It created the modern framework for generic drug approvals by allowing abbreviated new drug applications (ANDAs) so generics can prove bioequivalence to a brand-name drug rather than duplicating full trials, which speeds entry and reduces costs. It also restores a portion of patent life to compensate for time spent waiting through FDA review, helping balance incentives for brand-name patents with the goal of earlier generic competition. Additionally, it introduced protections like first-to-file and 180-day exclusivity for the first generic applicant. The other acts listed address different topics (rare diseases, FDA modernization, controlled substances).