Bill > S562

This bill, the Ensuring Timely Access to Generics Act of 2021, amends the Federal Food, Drug, and Cosmetic Act to address citizen petitions that may delay the approval of generic drug applications. The key provisions include: (1) establishing factors the FDA can consider in determining whether a citizen petition was submitted primarily to delay generic drug approval; (2) requiring citizens to file petitions before filing civil actions to delay generic drug approval and setting a 60-day timeline for submitting petitions; and (3) allowing the FDA to dismiss certain civil actions filed without complying with the petition requirements. These changes aim to prevent the use of citizen petitions as a tactic to delay generic competition.

Health and Social Services

https://www.congress.gov/bill/117th-congress/senate-bill/562/all-info