What This Bill Does · Plain English
GovGreed Synthesis · AI extraction
This bill amends the Federal Food, Drug, and Cosmetic Act to require the FDA to provide more transparency to generic drug applicants. Specifically, upon request, the FDA must inform an applicant whether their proposed generic drug is 'qualitatively and quantitatively the same' as the branded reference listed drug (RLD). If it is not the same, the FDA must identify the specific ingredient(s) and any quantitative deviations causing the difference. If the FDA determines the drugs are the same, that determination generally cannot be rescinded later unless the branded drug's formulation changes for safety reasons or an FDA error is identified. The bill also requires the FDA to issue guidance on how these 'sameness' determinations will be made.
Top Winners · Companies that benefit if S.1302 passes
70% confidence
As a large generic drug manufacturer, the bill's aim to 'increase transparency in generic drug applications' and reduce regulatory uncertainty directly benefits companies that file Abbreviated New Drug Applications (ANDAs). The bill text amends the FD&C Act to provide binding FDA determinations on formulation sameness, which could streamline the approval process for generics.
70% confidence
Viatris has a substantial generic drug portfolio. The bill's provisions for increased FDA transparency on generic drug formulation sameness, as described in the new section 505(j)(3)(H), are intended to facilitate generic drug development and approval, which aligns with the company's business.
Top winners identified by GovGreed LLM analysis.
Action Timeline
2025-04-03
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
2025-04-03
Introduced in Senate
Frequently Asked Questions
Did S.1302 pass?
S.1302 is still alive. Current stage: COMMITTEE. Pass likelihood: 44%.
What does S.1302 do?
This bill amends the Federal Food, Drug, and Cosmetic Act to require the FDA to provide more transparency to generic drug applicants. Specifically, upon request, the FDA must inform an applicant whether their proposed generic drug is 'qualitatively and quantitatively the same' as the branded reference listed drug (RLD). If it is not the same, the FDA must identify the specific ingredient(s) and any quantitative deviations causing the difference. If the FDA determines the drugs are the same, that determination generally cannot be rescinded later unless the branded drug's formulation changes for…
Who sponsored S.1302?
S.1302 was sponsored by Margaret Wood Hassan (D-New Hampshire).
What companies benefit from S.1302?
Top public companies expected to benefit: TEVA, VTRS. Affected sectors: healthcare, pharma.
Full Bill Text
119 S1302 IS: Increasing Transparency in Generic Drug Applications Act U.S. Senate 2025-04-03 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. II 119th CONGRESS 1st Session S. 1302 IN THE SENATE OF THE UNITED STATES April 3, 2025 Ms. Hassan (for herself, Mr. Paul , Mr. Hickenlooper , and Mr. Lee ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To provide for increased transparency in generic drug applications. 1. Short title This Act may be cited as the Increasing Transparency in Generic Drug Applications Act . 2. Increasing transparency in generic drug applications (a) In general Section 505(j)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(3) ) is amended by adding at the end the following: (H) (i) Upon request (in controlled correspondence or an analogous process) by a person that has submitted or intends to submit an abbreviated application under this subsection for a drug that is required by regulation to contain one or more of the same inactive ingredients in the same concentrations as the listed drug referred to, or for which the Secretary determines there is a scientific justification for an approach that is in vitro, in whole or in part, to be used to demonstrate bioequivalence for a drug if such a drug contains one or more of the same inactive ingredients in the same concentrations as the listed drug referred to, the Secretary shall inform the person whether such drug is qualitatively and quantitatively the same as the listed drug. The Secretary may also provide such information to such a person on the Secretary’s own initiative during the review of an abbreviated application under this subsection for such drug. (ii) Notwithstanding section 301(j), if the Secretary determines that such drug is not qualitatively or quantitatively the same as the listed drug, the Secretary shall identify and disclose to the person— (I) the ingredient or ingredients that cause such drug not to be qualitatively or quantitatively the same as the listed drug; and (II) for any ingredient for which there is an identified quantitative deviation, the amount of such deviation. (iii) If the Secretary determines that such drug is qualitatively and quantitatively the same as the listed drug, the Secretary shall not change or rescind such determination after the submission of an abbreviated application for such drug under this subsection unless— (I) the formulation of the listed drug has been changed and the Secretary has determined that the prior listed drug formulation was withdrawn for reasons of safety or effectiveness; or (II) the Secretary makes a written determination that the prior determination must be changed because an error has been identified. (iv) If the Secretary makes a written determination described in clause (iii)(II), the Secretary shall provide notice and a copy of the written determination to the person making the request under clause (i). (v) The disclosures authorized under clauses (i) and (ii) are disclosures authorized by law, including for purposes of section 1905 of title 18, United States Code. This subparagraph shall not otherwise be construed to authorize the disclosure of nonpublic qualitative or quantitative information about the ingredients in a listed drug, or to affect the status, if any, of such information as trade secret or confidential commercial information for purposes of section 301(j) of this Act, section 552 of title 5, United States Code, or section 1905 of title 18, United States Code. . (b) Guidance (1) In general Not later than one year after the date of enactment of this Act, the Secretary of Health and Human Services shall issue draft guidance, or update guidance, describing how the Secretary will determine whether a drug is qualitatively and quantitatively the same as the listed drug (as such terms are used in section 505(j)(3)(H) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a)), including with respect to assessing pH adjusters. (2) Process In issuing guidance under this subsection, the Secretary of Health and Human Services shall— (A) publish draft guidance; (B) provide a period of at least 60 days for comment on the draft guidance; and (C) after considering any comments received and not later than one year after the close of the comment period on the draft guidance, publish final guidance. (c) Applicability Section 505(j)(3)(H) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), applies beginning on the date of enactment of this Act, irrespective of the date on which the guidance required by subsection (b) is finalized.
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