Ensuring Timely Access to Generics Act of 2025
Sponsored By: Senator Shaheen, Jeanne [D-NH]
Introduced
Summary
This bill would tighten rules on citizen petitions to reduce tactics that delay generic and biosimilar drug approvals and promote timely access to generics.
Show full summary
- Generic and biosimilar developers: Would face fewer late-stage obstacles because the FDA would get clear factors to identify petitions submitted with a primary purpose of delay.
- Petitioners (companies or others filing challenges): Would have to file a petition before suing and submit any petition or supplement within 180 days after they knew the underlying information.
- Courts and litigants: Courts would be required to dismiss suits that skip the new petition or timeliness steps, with dismissal with prejudice for late petitions.
- Food and Drug Administration: Would be able to consider a listed set of factors when judging delay and issue guidance explaining those factors.
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Bill Overview
Analyzed Economic Effects
3 provisions identified: 0 benefits, 0 costs, 3 mixed.
New petition rules for drug approvals
If enacted, you would need to file a citizen petition with FDA before suing to block certain generic or biosimilar approvals. The petition must include all facts and arguments you will use. Petitions and supplements must be filed within 180 days after you knew the basis. Courts would dismiss suits that do not follow these rules. The FDA could also treat petitions as delay tactics using listed factors and issue guidance.
Small timing change for FDA reviews
If enacted, the bill would shift a cutoff by one day. Approvals would count as final agency action 151 days after petition submission instead of 150. That one-day shift can change when courts may review petition-related approvals.
Technical deletions to petition rules
If enacted, this would remove two specific subparagraphs from the FDA citizen-petition rule, section 505(q). The deletions would take effect upon enactment. How this matters in practice depends on what those deleted clauses required before.
Sponsors & CoSponsors
Sponsor
Shaheen, Jeanne [D-NH]
NH • D
Cosponsors
Sen. Collins, Susan M. [R-ME]
ME • R
Sponsored 10/16/2025
Sen. Baldwin, Tammy [D-WI]
WI • D
Sponsored 10/21/2025
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov