Bill > S3131

This bill, the Optimizing Research Progress Hope And New Cures Act (ORPHAN Cures Act), aims to expand and clarify the exclusion for orphan drugs under the Drug Price Negotiation Program. It proposes two key changes: 1) the Secretary of Health and Human Services shall not consider any period during which a drug or biological product was previously approved for a rare disease or condition when calculating the time elapsed since its approval, and 2) the definition of an orphan drug is expanded to include those approved for one or more rare diseases or conditions, as defined under the Federal Food, Drug, and Cosmetic Act. These provisions are intended to support the development and availability of treatments for rare diseases.