Ensuring Timely Access to Generics Act of 2025

This bill changes the federal rules for citizen petitions asking the Food and Drug Administration (FDA) to act on applications for generic drugs, certain other drug applications, and biosimilar drugs. It lists factors the FDA may weigh in deciding whether a petition was filed mainly to delay approval of such an application. A person would have to file a petition with the FDA before suing to block or delay such an application, and would have to file it within 180 days of learning the information it relies on. Courts would dismiss lawsuits that skip these steps or are filed before the FDA makes a final decision on the petition. The bill also removes the 150-day deadline for the FDA to act on these petitions.

Full text and official record on Congress.gov

Sponsors

• Jeanne Shaheen Democrat sponsor
• 2 cosponsors