S.3716

The RARE Act modifies orphan drug exclusivity provisions to limit exclusivity to specific approved uses or indications.

The RARE Act, or Retaining Access and Restoring Exclusivity Act, amends the Federal Food, Drug, and Cosmetic Act to change how exclusivity is granted for orphan drugs. Specifically, it restricts the exclusivity period to the approved use or indication of the drug, rather than the broader disease or condition. This change applies to all drugs designated for rare diseases, regardless of when they were designated or approved. The act defines "approved use or indication" as the specific use or indication approved for a drug targeting a rare disease.