S.3014

Ensuring Timely Access to Generics Act of 2025 amends the Federal Food, Drug, and Cosmetic Act to modify citizen petition rules.

The Ensuring Timely Access to Generics Act of 2025 amends the Federal Food, Drug, and Cosmetic Act to change the rules for citizen petitions. It requires petitions to be submitted within 180 days after the petitioner knew the information forming the basis of the request. It also mandates that a petition must be filed before a civil action seeking to delay or prevent an application's submission, review, or approval. The bill allows courts to dismiss actions without prejudice for failure to exhaust administrative remedies or with prejudice for failure to timely file a petition.