Senate bill targets FDA citizen petition delays
In committeeS. 3014Latest action
Sponsor: Jeanne Shaheen · Senator · NH
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Official title: Ensuring Timely Access to Generics Act of 2025
119th Congress
Topics: Health care
Introduced:
Read the official bill on Congress.govIn plain words
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This bill sets strict deadlines and rules for using a legal petition process that can delay cheaper generic drug approvals.
55-second read · 4 questions answered below
What does this do?
This bill tightens rules around "citizen petitions," which let companies ask the FDA to take action and can be used to slow down approval of generic or biosimilar drugs. Anyone who wants to sue to block a generic drug approval must first file a citizen petition within 180 days of learning the relevant information, or a court must permanently dismiss their case. The FDA also gets a specific list of factors to help identify petitions filed mainly to delay a competitor rather than for genuine safety or scientific reasons.
Who does it affect?
Brand-name drug manufacturers who use citizen petitions as a competitive tool are most directly affected by the new limits. Generic and biosimilar drug makers, patients, and payers are also affected because the rules could change how quickly lower-cost drugs reach the market.
Why does it matter?
If the bill becomes law, courts would be required to throw out delay-related lawsuits that do not follow the new petition rules. The FDA would also have clearer authority to identify petitions filed as competitive tactics rather than for legitimate reasons.
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Where does it stand?
- IntroducedOct 16, 2025
- Senate committeeYou are here · Oct 16, 2025
- Senate vote
- House
- The president's desk
Right now: a Senate committee is reviewing it. If the House changes it, it goes back to the Senate before reaching the president.
Latest action: — Read twice and referred to the Committee on Health, Education, Labor, and Pensions.