Bill > S1862

This bill amends the Social Security Act to expand provisions related to orphan drugs in the Drug Price Negotiation Program. Specifically, the bill modifies how drugs that were previously classified as "orphan drugs" are treated in terms of calculation time for drug approval. An orphan drug is a medication developed to treat a rare disease or condition that affects a small population. The bill clarifies that when calculating the elapsed time for drug approval, any period during which a drug was designated as an orphan drug will not be counted against its timeline. Additionally, the bill broadens the definition of orphan drugs from covering "only one rare disease or condition" to covering "one or more rare diseases or conditions," using the definition provided in the Federal Food, Drug, and Cosmetic Act. This change could potentially provide more flexibility for pharmaceutical companies in developing and pricing drugs for rare diseases, potentially encouraging more research and development in this often-underserved medical area.

Budget and Finance

https://www.congress.gov/bill/119th-congress/senate-bill/1862/all-info