# 119-s-3014: Ensuring Timely Access to Generics Act of 2025

119-s-3014, Ensuring Timely Access to Generics Act of 2025, is a 119th Congress bill sponsored by Sen. Shaheen, Jeanne [D-NH] (D-NH); status introduced; PRIA reads it as touching household money (as of 2026-05-02).

- Canonical: https://policyrisk.com/legislation/119-s-3014
- As of: 2026-05-02
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Bill: 119-s-3014
- Congress: 119
- Title: Ensuring Timely Access to Generics Act of 2025
- Status: introduced
- Introduced: 2025-10-16
- Sponsor: Sen. Shaheen, Jeanne [D-NH] (D-NH)
- Cosponsors: 2
- Policy area: Health
- Touches household money: yes
- Last recorded action: 2026-05-02

## 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**.** - 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.

## Cosponsors (2)

- Sen. Collins, Susan M. [R-ME] (R-ME), 2025-10-16T00:00:00.000Z
- Sen. Baldwin, Tammy [D-WI] (D-WI), 2025-10-21T00:00:00.000Z

## Provisions PRIA read

- New petition rules for drug approvals: mixed, low. 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…
- Small timing change for FDA reviews: mixed, low. 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: mixed, low. 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.

## Related bills

- 119-s-524: Coast Guard Authorization Act of 2025
- 119-s-1874: Title VIII Nursing Workforce Reauthorization Act of 2026
- 119-s-3990: PrEP Access and Coverage Act of 2026
- 119-s-4189: INSULIN Act of 2026
- 119-s-2178: Equal Dignity for Married Taxpayers Act of 2025
- 119-s-1241: Sanctioning Russia Act of 2025

## Sources
- [119-s-3014 on Congress.gov](https://www.congress.gov/bill/119th-congress/senate-bill/3014)

## Related
- [119-s-524: Coast Guard Authorization Act of 2025](https://policyrisk.com/legislation/119-s-524)
- [119-s-1874: Title VIII Nursing Workforce Reauthorization Act of 2026](https://policyrisk.com/legislation/119-s-1874)
- [119-s-3990: PrEP Access and Coverage Act of 2026](https://policyrisk.com/legislation/119-s-3990)
- [119-s-4189: INSULIN Act of 2026](https://policyrisk.com/legislation/119-s-4189)
- [119-s-2178: Equal Dignity for Married Taxpayers Act of 2025](https://policyrisk.com/legislation/119-s-2178)
- [119-s-1241: Sanctioning Russia Act of 2025](https://policyrisk.com/legislation/119-s-1241)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/119-s-3014 (as of 2026-05-02).