US SB3716

Amends Section 527 of the Federal Food, Drug, and Cosmetic Act to narrow orphan drug exclusivity from the entire rare disease to only the specific approved use or indication within that disease

Limits the 7-year market exclusivity period for orphan drugs so competitors can seek approval for different uses or indications of the same rare disease condition

Allows FDA to approve subsequent drugs for the same rare disease if they target a different use or indication than the already-approved orphan drug

Applies retroactively to all drugs with orphan drug designation, regardless of when they were designated or approved

Introduced by Senator Baldwin on January 28, 2026, and referred to the Committee on Health, Education, Labor, and Pensions