Bill > S1067

This bill amends the Federal Food, Drug, and Cosmetic Act to address citizen petitions related to generic drug applications. The key provisions include: 1) Requiring petitioners to submit petitions before filing civil actions to delay or prevent generic drug approvals, and to do so within 180 days of knowing the relevant information. 2) Allowing the FDA to consider various factors in determining whether a petition was submitted primarily to delay an application. 3) Requiring courts to dismiss civil actions without prejudice if the petitioner did not first exhaust administrative remedies by filing a timely petition, or to dismiss with prejudice if the petitioner did not file a timely petition. These changes aim to ensure more timely access to generic drugs by preventing delays caused by citizen petitions filed primarily for that purpose.

Health and Social Services

https://www.congress.gov/bill/118th-congress/senate-bill/1067/all-info