Increased Transparency in Generic Drug Ingredients: Faster Approval for Cheaper Medicines.
This bill increases transparency in the generic drug approval process by requiring the FDA to disclose to generic manufacturers whether their inactive ingredients are qualitatively and quantitatively the same as the brand-name drug. This measure aims to speed up the market entry of cheaper generic alternatives, potentially lowering healthcare costs for citizens. The FDA must also issue guidance on how it determines ingredient equivalence within one year of the law's enactment.
Key points
Generic drug manufacturers can request information from the FDA on whether their inactive ingredients match the brand-name drug's composition.
If the ingredients are not identical, the FDA must disclose which ingredients differ and the extent of any quantitative deviation.
Increased transparency is intended to accelerate the approval of generic drugs, fostering competition and potentially reducing prescription drug prices.
The FDA cannot reverse a positive determination of ingredient equivalence unless the brand-name drug was withdrawn for safety reasons or a written error was identified.
Introduced
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