Bill > S3271

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. Specifically, the bill requires drug sponsors to demonstrate that there was no reasonable expectation at the time of approval that the costs of developing and making the drug available in the United States would be recovered from sales, in order to qualify for exclusivity. The amendments apply to any drug designated as an orphan drug, regardless of the date of designation, approval, or grant of exclusivity. This aims to ensure that orphan drug exclusivity is only granted when necessary to incentivize the development of drugs for rare diseases and conditions.