To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.
This bill requires the FDA to disclose whether a generic drug's inactive ingredients match those in the brand-name reference drug. It mandates that, upon request from a generic drug applicant, the FDA must confirm if the drugs are "qualitatively and quantitatively the same" in inactive ingredients or specify which ingredients differ and by how much. The policy directly affects generic drug manufacturers seeking FDA approval for their products. This change increases transparency in the drug approval process by providing clear, specific information to applicants about ingredient equivalence.
Bill status
in committee
1 of 4 stages cleared
Introduction
Mar 2025
Committee Review
Floor Vote
President
Introduced Mar 5, 2025
Last action Mar 5, 2025
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Full legislative history
Actions timeline
Total actions
2
Key actions
0
Committee
1
Mar 5, 2025
Committee
Referred to the House Committee on Energy and Commerce.
lower
Mar 5, 2025
Introduced
Introduced in House
lower
1 primary · 1 co-sponsor
Sponsors
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