To revise the orphan drug exclusivity provisions of the Federal Food, Drug, and Cosmetic Act.
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Amends provisions of the Federal Food, Drug, and Cosmetic Act (FDCA) relating to drugs for rare diseases or conditions (commonly referred to as orphan drugs) to require the approval of an application under FDCA new drug provisions, a certification under FDCA antibiotic drug provisions, or a license under provisions of the Public Health Service Act regulating biologic products when the current holder of such an application, certification, or license has had: (1) cumulative dollar sales of the drug exceeding specified amounts; and (2) cumulative research and development costs for the drug not exceeding certain amounts.
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