# 119-hr-1051: To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes.

119-hr-1051, To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes., is a 119th Congress bill sponsored by Rep. Budzinski, Nikki [D-IL-13] (D-IL); status introduced; PRIA reads it as touching household money (as of 2025-12-21).

- Canonical: https://policyrisk.com/legislation/119-hr-1051
- As of: 2025-12-21
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Bill: 119-hr-1051
- Congress: 119
- Title: To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes.
- Status: introduced
- Introduced: 2025-02-06
- Sponsor: Rep. Budzinski, Nikki [D-IL-13] (D-IL)
- Cosponsors: 0
- Policy area: Health
- Touches household money: yes
- Last recorded action: 2025-12-21

## Summary

**This bill would let certain later generic drug applicants gain FDA approval even if an earlier filer is eligible for 180-day exclusivity.** It sets tight checkpoints: applicants must be ready to market within 75 days of approval, wait at least 33 months after a first filing, and face forfeiture if they miss the marketing window. - Patients and families: Could get generic drugs to market sooner when a later applicant meets the bill's conditions, which may speed access to lower-cost medicines. - Later generic applicants: Would have a narrow path to approval if they certify readiness and no first filer is effectively approved, and they must begin commercial marketing within 75 days or their approval becomes tentative and they may lose eligibility for a later effective approval. - First filers: May see their practical exclusivity reduced if they delay marketing because a subsequent applicant can obtain approval under the bill's conditions. - FDA: Gains authority to approve subsequent abbreviated new drug applications (ANDAs) under specified conditions to balance first-to-file rights with faster generic entry.

## Provisions PRIA read

- New path for second generic filers: mixed, medium. If enacted, FDA could approve a later generic filer even if a first filer has 180-day exclusivity. This would apply only if at least 33 months have passed since a first filer applied, no first filer is already effectively approved, and the first filer is not legally blocked from approval. The later…

## Related bills

- 119-hr-3151: SHIPS for America Act of 2025
- 119-hr-10421: Transforming Education for the Future Act
- 119-hr-4669: FEMA Act of 2025
- 119-hr-7977: Energy Bills Relief Act
- 119-hr-4393: DIGNIDAD (Dignity) Act of 2025
- 119-hr-7481: Department of Homeland Security Appropriations Act, 2026

## Sources
- [119-hr-1051 on Congress.gov](https://www.congress.gov/bill/119th-congress/house-bill/1051)

## Related
- [119-hr-3151: SHIPS for America Act of 2025](https://policyrisk.com/legislation/119-hr-3151)
- [119-hr-10421: Transforming Education for the Future Act](https://policyrisk.com/legislation/119-hr-10421)
- [119-hr-4669: FEMA Act of 2025](https://policyrisk.com/legislation/119-hr-4669)
- [119-hr-7977: Energy Bills Relief Act](https://policyrisk.com/legislation/119-hr-7977)
- [119-hr-4393: DIGNIDAD (Dignity) Act of 2025](https://policyrisk.com/legislation/119-hr-4393)
- [119-hr-7481: Department of Homeland Security Appropriations Act, 2026](https://policyrisk.com/legislation/119-hr-7481)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/119-hr-1051 (as of 2025-12-21).