To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.
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Progress
Where this bill stands in the legislative process.
- Introduced
- Passed House
- Passed Senate
- To President
- Became Law
Overview
This bill aims to increase transparency in the process of generic drug applications to the Food and Drug Administration (FDA). Specifically, it requires the FDA to inform applicants, upon request or during review, whether a generic drug is the same as the brand-name drug it’s based on, and to disclose any differences if they exist. The bill also mandates the FDA to provide guidance on how it makes these determinations, allowing for public comment and review before finalization.
Key provisions
- Requires the FDA to inform applicants if a generic drug is qualitatively and quantitatively the same as the brand-name drug.
- Mandates disclosure of ingredient differences and quantitative deviations if a generic drug is not the same.
- Establishes a process for the FDA to update or publish guidance on determining drug similarity.
- Requires the FDA to provide a 60-day comment period for draft guidance.
- Sets a deadline of one year for the FDA to finalize guidance.
- Clarifies that the FDA’s determination of similarity is not subject to change unless there’s a change in the brand-name drug formulation or an identified error.
- Authorizes disclosures under section 1905 of title 18, United States Code.
Who is affected
- Generic drug manufacturers
- The Food and Drug Administration (FDA)
- Patients
- Pharmaceutical companies (brand-name and generic)
Bill text
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2 on record
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