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To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.

H.R. 1843 Rep. Neal Dunn (R-FL-2) In committee
Bill text PDF
  1. Introduced Mar 5
  2. Committee Mar 5
  3. Passed House Next
  4. Passed Senate Not yet
  5. To President Not yet
  6. Law Not yet
Where it stands
In committee, Mar 5, 2025Next: House vote
602d ago Mar 5, 2025: Referred to the House Committee on Energy and Commerce.
Final votes
No roll callsNo recorded vote on this bill yet
Lobbying
1company, 12 filings
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Companies lobbying on this bill

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Summary

This bill requires the Food and Drug Administration (FDA) to inform generic drug applicants, upon request or during review, whether the drug is qualitatively and quantitatively the same as the listed brand-name drug (and if not, the reasons why). The FDA must also update or publish guidance on how it makes such determinations.

Library of Congress summary, Mar 5, 2025

Summary versions
  • Introduced in HouseMar 5, 2025

Official record from Congress.gov, the House Clerk and the Senate; lobbying from Lobbying Disclosure Act filings. Updated Oct 27, 2026.