Ace the Arizona MPJE 2025 – Your Ultimate Pharmacy Law Adventure!

The correct answer is the Orphan Drug Act, which indeed provides for additional exclusivity for certain brand name drugs, specifically those developed to treat rare diseases or conditions. This law is designed to encourage the development of medications that may not be financially viable in a standard market because of the limited patient population. By granting an extra five years of market exclusivity, the act incentivizes pharmaceutical companies to invest in these potentially underfunded areas of research.

The other options do not directly relate to this type of exclusivity for brand name drugs. The Controlled Substances Act primarily focuses on the regulation of controlled substances to prevent abuse and trafficking. The Waxman-Hatch Act, formally known as the Drug Price Competition and Patent Term Restoration Act, includes provisions for patent term extensions but does not specifically grant an additional five years of exclusivity to brand name drugs. The Food, Drug, and Cosmetic Act provides the foundation for drug approval and regulation but does not pertain to exclusivity periods as described in the question.