Ensuring Timely Access to Generics Act of 2025

Key Points

• This bipartisan bill from Sens. Shaheen and Collins targets brand-name drug companies that file citizen petitions with the FDA mainly to delay the approval of cheaper generic drugs. It amends the Federal Food, Drug, and Cosmetic Act to give the FDA stronger tools to identify and reject these delay tactics.
• The FDA would get a detailed list of factors to determine whether a petition was filed primarily to delay a generic drug application. These include whether the petition was filed close to when a generic could be approved, whether it lacked supporting scientific data, and whether the company filed multiple similar petitions.
• Companies would be required to file their citizen petitions within 180 days of learning about the information that forms the basis of their complaint. This prevents companies from sitting on information and strategically timing petitions to cause maximum delay.
• Courts would be required to dismiss lawsuits filed by companies that skip the petition process or miss the 180-day deadline. Cases filed without first petitioning the FDA get dismissed without prejudice, while cases based on untimely petitions get dismissed with prejudice, meaning the company cannot refile.