Ensuring Timely Access to Generics Act of 2025
This bill, titled the Ensuring Timely Access to Generics Act of 2025, would reform how citizen petitions under the Federal Food, Drug, and Cosmetic Act (FD&C Act) are reviewed when those petitions concern generic drug approvals. The core idea is to deter petitions that are primarily aimed at delaying generic entry and to streamline the pathway for generics by increasing accountability and timeframes. Key changes include requiring petitioners to file before pursuing certain civil actions, establishing a 180-day deadline to file petitions after the petitioner knows the relevant information, adding a detailed set of factors for the FDA to consider when determining whether a petition’s primary purpose is delay, and providing penalties and dismissal rules for noncompliance with these procedures. The bill also makes technical changes to the language and structure of section 505(q) of the FD&C Act. Overall, the bill shifts the balance toward faster access to generics by tightening petition timing, expanding the criteria to identify potentially delaying petitions, and reinforcing administrative prerequisites before litigation can proceed.
Key Points
- 1Expanded “primary purpose of delaying” standard with detailed factors
- 2- The FDA would consider a comprehensive list of factors to decide whether a petition was submitted primarily to delay a drug application. These factors cover timing relative to knowledge of information, proximity to approval dates, history of multiple petitions, completeness of data, similarity to prior petitions, calls for more onerous standards, and the petitioner’s past petitioning behavior. The secretary can also use or publish guidance describing additional relevant factors.
- 3Petitions must be filed before related civil actions; 180-day knowledge-based filing deadline
- 4- A person must submit a petition (and any supplements) before filing a civil action seeking to delay or block an FDA or Public Health Service Act submission or approval. The petition must describe all information and arguments underlying the relief sought in any related civil action. A petition must be filed within 180 days after the petitioner knew the information that forms the basis of the petition.
- 5Administrative prerequisites and dismissal rules strengthened
- 6- If a person files a civil action without complying with the petition requirements, courts must dismiss for failure to exhaust administrative remedies (without prejudice). If the action is filed without timely petitioning, it must be dismissed with prejudice for failure to timely file. If a civil action challenges issues raised in a timely petition but before the agency has taken final action on the petition, the court must dismiss without prejudice for failure to exhaust administrative remedies.
- 7Revisions to wording and structure of the petition process
- 8- The bill makes several drafting and organizational changes to section 505(q), including renaming certain terms (for example, referring to “submission of this document” rather than “submission of this petition”), and reorganizing subparagraphs for clarity. It also modifies deadlines and the way certain actions are counted within the petition framework (including an added “10.31” reference in one subparagraph, which alters the numerical timing framework in the statute).
- 9Secretary guidance and timing mechanics
- 10- The Secretary may issue or update guidance describing the factors considered under the delay-determination framework, ensuring consistency in how petitions are evaluated.