Bill > S1214

This bill, the Retaining Access and Restoring Exclusivity Act (RARE Act), sets forth limitations on the exclusive approval or licensure of drugs designated for rare diseases or conditions. Specifically, the bill amends the Federal Food, Drug, and Cosmetic Act to clarify that the 7-year exclusivity period for orphan drugs applies to the "same approved use or indication" rather than the "same disease or condition." This change aims to prevent situations where a drug with exclusivity for one use or indication within a rare disease or condition could block the approval of a different drug for a different use or indication within the same rare disease or condition.