Bill > HR4712

This bill, the Fairness in Orphan Drug Exclusivity Act, amends the Federal Food, Drug, and Cosmetic Act to limit the exclusive approval or licensure of orphan drugs, which are drugs designated for rare diseases or conditions. The bill requires the sponsor of an orphan drug application to demonstrate that there is no reasonable expectation that the cost of developing and making the drug available in the U.S. will be recovered from its sales within 12 years of first marketing the drug. The amendments in the bill apply to all drugs designated as orphan drugs, regardless of the date of designation, approval, or exclusive approval or licensure.