Bill > S2620

This bill, known as the "Reforming Evergreening and Manipulation that Extends Drug Years Act" (REMEDY Act), amends the Federal Food, Drug, and Cosmetic Act to modify the process for approving abbreviated new drug applications (ANDAs). The key provision requires drug application holders to select a single "covered patent" when filing patent information for newly approved drugs, and this selection cannot be changed or amended. The bill aims to limit patent-related delays in generic drug approvals by modifying the thirty-month period during which brand-name drug manufacturers can prevent generic competitors from entering the market. Specifically, for drugs approved on or after the bill's enactment, the patent selection process becomes more restrictive, ensuring that only one patent can be used to potentially trigger the thirty-month regulatory stay. This change is designed to prevent pharmaceutical companies from strategically extending their drug monopolies through repeated patent filings and legal maneuvers, a practice known as "evergreening," which can delay more affordable generic alternatives from reaching the market and potentially reduce healthcare costs.

Health and Social Services

https://www.congress.gov/bill/119th-congress/senate-bill/2620/all-info