Ensuring Timely Access to Generics Act of 2025

This bill amends the Federal Food, Drug, and Cosmetic Act to tighten rules on citizen petitions that could delay generic drug approvals. It adds new factors for the FDA to consider when determining if a petition's primary purpose is delay, requires petitions to be filed before related civil lawsuits, sets a 180-day deadline for submitting petitions after the petitioner knows the supporting information, and mandates dismissal of lawsuits that do not follow these rules.

Sec. 2, Ensuring timely access to generics: The bill revises Section 505(q) of the Federal Food, Drug, and Cosmetic Act. It adds October 31 to a list of dates in paragraph (1)(A)(i). It replaces the old test for determining if a petition's primary purpose is delay with a list of factors the FDA may consider, including whether the petition was timely filed, whether multiple or serial petitions were submitted, whether it was filed close to a known first approval date, whether it lacks supporting data, whether it repeats issues already addressed, whether it requests more onerous standards, the petitioner's record of delay petitions, and other relevant factors described in FDA guidance. It removes an old subparagraph (F) and renumbers others. It requires that a person must submit a citizen petition to the FDA before filing a civil lawsuit that seeks to delay or block a generic or biosimilar application. The petition and any supplement must include all information and arguments for the lawsuit. A petition or supplement must be filed within 180 days after the person knew the information forming its basis. It changes rules on when the FDA's failure to act on a petition allows a lawsuit, and requires courts to dismiss without prejudice lawsuits filed without first submitting a required petition, dismiss with prejudice lawsuits filed after missing the 180-day deadline, and dismiss without prejudice lawsuits filed before the FDA has made a final decision on a timely petition. It also simplifies an exception clause by removing a subparagraph and renumbering clauses.