Ensuring Timely Access to Generics Act of 2025
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Progress
Where this bill stands in the legislative process.
- Introduced
- Passed Senate
- Passed House
- To President
- Became Law
Overview
The Ensuring Timely Access to Generics Act of 2025 modifies the Federal Food, Drug, and Cosmetic Act to address concerns about citizen petitions submitted with the primary purpose of delaying generic drug approvals. Specifically, it changes the criteria used by the Food and Drug Administration (FDA) to determine if a petition is intended to delay a drug application, and establishes a process for citizen petitioners to file a petition before initiating a civil lawsuit challenging an FDA decision. This aims to streamline the approval process for generic medications.
Key provisions
- The FDA will consider factors like the timing of the petition relative to known application dates and the petitioner's knowledge of relevant information.
- The FDA can now consider a petitioner's record of submitting petitions to determine if they are primarily intended to delay approvals.
- Petitioners must file a citizen petition with the FDA before filing a lawsuit challenging an FDA decision.
- The petition must describe all information and arguments supporting the requested relief.
- A petition must be submitted within 180 days of when the petitioner knew the information forming the basis of the petition.
- The FDA can dismiss lawsuits filed without first submitting a citizen petition.
- The FDA can issue guidance on the factors it considers when evaluating petitions.
- The FDA can dismiss lawsuits that fail to comply with the requirements for timely petition submission.
Who is affected
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