To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.
Sponsored By: Representative Rep. Dunn, Neal P. [R-FL-2]
Introduced
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.
Show full summary
- 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- FDA process and guidance: The bill would require the FDA to issue draft guidance, or update existing guidance, within one year after enactment, publish the draft, allow at least a 60‑day comment period, and finalize guidance no later than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.
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Bill Overview
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
Deadlines for FDA generic guidance
If enacted, HHS would issue draft guidance on how it decides if a generic is the same as the brand drug, including how pH adjusters are judged.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 year after the comment period closes.
More clarity on generic drug formulas
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 the ingredient(s) that differ and the size of any quantitative difference; FDA could also share this during review on its own. After an application is filed, FDA could change a “same” finding only if the brand’s formula changed and the earlier formula was withdrawn for safety or effectiveness, or if FDA finds an error and issues a written change, and it must notify the requester and share that document. These disclosures would be legally authorized and would start on the date of enactment, even before guidance is finalized.
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Sponsors & CoSponsors
Sponsor
Rep. Dunn, Neal P. [R-FL-2]
FL • R
Cosponsors
Rep. Mullin, Kevin [D-CA-15]
CA • D
Sponsored 3/5/2025
Roll Call Votes
No roll call votes available for this bill.
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