# 119-hr-1843: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.

119-hr-1843, To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications., is a 119th Congress bill sponsored by Rep. Dunn, Neal P. [R-FL-2] (R-FL); status introduced; PRIA reads it as touching household money (as of 2026-04-21).

- Canonical: https://policyrisk.com/legislation/119-hr-1843
- As of: 2026-04-21
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Bill: 119-hr-1843
- Congress: 119
- Title: To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.
- Status: introduced
- Introduced: 2025-03-05
- Sponsor: Rep. Dunn, Neal P. [R-FL-2] (R-FL)
- Cosponsors: 1
- Policy area: Health
- Touches household money: yes
- Last recorded action: 2026-04-21

## Summary

**Greater transparency about whether a generic drug is compositionally the same as the brand drug.** This bill would require the Food and Drug Administration to tell generic applicants, on request or during review, whether a proposed generic is qualitatively and quantitatively the same as the listed brand and to explain any differences. - Generic drug applicants: The FDA would have to disclose if a generic is not qualitatively or quantitatively the same and identify the ingredient(s) causing the deviation. For any quantitative difference the FDA must state the amount of deviation. If the FDA says a product is the same that determination could not be changed after submission of an abbreviated new drug application unless the listed drug formulation changed for safety or effectiveness or an error is found, and the FDA must provide notice and a copy to the requester. - FDA process and guidance: The bill would require the FDA to issue draft guidance, or update existing guidance, within one year after enactment, publish the draft, allow at least a 60‑day comment period, and finalize guidance no later than one year after the comment period closes. The new disclosure rule would apply beginning on the date of enactment even if the guidance is not yet finalized.

## Cosponsors (1)

- Rep. Mullin, Kevin [D-CA-15] (D-CA), 2025-03-05T00:00:00.000Z

## Provisions PRIA read

- Deadlines for FDA generic guidance: benefit, medium. If enacted, HHS would issue draft guidance on how it decides if a generic is the same as the brand drug, including how pH adjusters are judged. The draft would be due within one year after enactment. The public would get at least 60 days to comment. Final guidance would be due no later than one yea…
- More clarity on generic drug formulas: benefit, medium. If enacted, FDA would have to tell generic drug applicants, on request, if their product matches the brand’s ingredients and amounts. This would apply when rules require the same inactive ingredients and levels, or when an in‑vitro test can show bioequivalence. If it is not the same, FDA would name…

## Related bills

- 119-hr-4669: FEMA Act of 2025
- 119-hr-4393: DIGNIDAD (Dignity) Act of 2025
- 119-hr-9599: SECURE 340B Act
- 119-hr-2385: CREATE AI Act of 2025
- 119-hr-5343: Ensuring Patient Access to Critical Breakthrough Products Act
- 119-hr-1566: REPAIR Act

## Sources
- [119-hr-1843 on Congress.gov](https://www.congress.gov/bill/119th-congress/house-bill/1843)

## Related
- [119-hr-4669: FEMA Act of 2025](https://policyrisk.com/legislation/119-hr-4669)
- [119-hr-4393: DIGNIDAD (Dignity) Act of 2025](https://policyrisk.com/legislation/119-hr-4393)
- [119-hr-9599: SECURE 340B Act](https://policyrisk.com/legislation/119-hr-9599)
- [119-hr-2385: CREATE AI Act of 2025](https://policyrisk.com/legislation/119-hr-2385)
- [119-hr-5343: Ensuring Patient Access to Critical Breakthrough Products Act](https://policyrisk.com/legislation/119-hr-5343)
- [119-hr-1566: REPAIR Act](https://policyrisk.com/legislation/119-hr-1566)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/119-hr-1843 (as of 2026-04-21).