Bill > HR7383

This bill, the Retaining Access and Restoring Exclusivity Act (RARE Act), amends the Federal Food, Drug, and Cosmetic Act to set limitations on the exclusive approval or licensure of drugs designated for rare diseases or conditions. Specifically, the bill clarifies that the exclusivity period for an orphan drug applies to the approved use or indication, rather than the entire rare disease or condition. It also requires consideration of the needs related to the approved use or indication when determining whether to grant an exclusivity extension. These changes aim to promote competition and improve access to rare disease treatments.