Increasing Transparency in Generic Drug Applications Act
- Introduced Mar 14
- Committee Mar 14
- Passed Senate Next
- Passed House Not yet
- To President Not yet
- Law Not yet
Where it stands
In committee, Mar 14, 2023Next: Senate vote
1324d ago Mar 14, 2023: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Final votes
No roll callsNo recorded vote on this bill yet
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1 companyCompanies by sector
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Votes
No recorded roll-call vote on this bill yet
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Summary
Increasing Transparency in Generic Drug Applications Act
Full summary1 paragraphs
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 14, 2023
Summary versions
- Introduced in SenateMar 14, 2023
Actions
- SenateIntroduced in SenateMar 14, 2023
- SenateRead twice and referred to the Committee on Health, Education, Labor, and Pensions.Mar 14, 2023
Bill record
Text versions1
- Introduced in SenateMar 14, 2023PDF: Introduced in Senate
Committees1
- Senate Health, Education, Labor, and Pensions CommitteeReferred To Mar 14, 2023
Sponsor and cosponsors3 cosponsors
- Sen. Maggie Hassan (D-NH)Sponsor, Mar 14, 2023
- Rand Paul (R-KY)OriginalJoined Mar 14, 2023
- Mike Braun (R-IN)Joined Mar 28, 2023
- John Hickenlooper (D-CO)Joined Apr 25, 2023
Amendments0
No amendments offered
Cost estimates and reports0
No cost estimate or committee report yet
Titles2
Short titles
- Increasing Transparency in Generic Drug Applications ActShort Title(s) as Introduced
Official titles
- A bill to provide for increased transparency in generic drug applications.Official Title as Introduced
Subjects5
Policy area
Legislative subjects
Administrative law and regulatory proceduresDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationPrescription drugs
Related bills5
- H.R. 3561 118th, Related bill PATIENT Act of 2023
- S. 1114 118th, Related bill Expanding Access to Low-Cost Generics Act of 2023
- H.R. 3839 118th, Related bill To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.
- H.R. 5378 118th, Related bill Lower Costs, More Transparency Act
- S. 4338 117th, Reintroduction of Increasing Transparency in Generic Drug Applications Act
Official record from Congress.gov, the House Clerk and the Senate; lobbying from Lobbying Disclosure Act filings. Updated Oct 28, 2026.