Bill > S3716

This bill, known as the Retaining Access and Restoring Exclusivity Act or RARE Act, aims to clarify and potentially limit the exclusive approval or licensure periods for drugs designated for rare diseases or conditions. The key provisions amend Section 527 of the Federal Food, Drug, and Cosmetic Act, which deals with orphan drugs (drugs for rare diseases or conditions). Specifically, the bill redefines what constitutes an "approved use or indication" to mean the specific use or indication approved by the Food and Drug Administration (FDA) under section 505 of the Act or licensed under section 351 of the Public Health Service Act for a drug designated for a rare disease. This change is intended to ensure that exclusivity periods are tied to specific approved uses rather than the broader rare disease itself, potentially allowing for new approvals for different uses within the same rare disease without infringing on existing exclusivity. The amendments apply to any drug designated as an orphan drug, regardless of when it was designated or approved.

Health and Social Services

https://www.congress.gov/bill/119th-congress/senate-bill/3716/all-info