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To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.
To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.
Summary
This bill amends the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. It requires the FDA, upon request or during review of a generic drug application, to inform applicants whether their proposed drug is qualitatively and quantitatively the same as the brand-name listed drug. If the drugs are not the same, the FDA must identify which ingredients differ and specify the amount of any quantitative deviations. The FDA must provide written determination if it changes a prior finding that drugs were the same, and such changes can only occur under limited circumstances. The FDA must issue guidance within one year on how it determines qualitative and quantitative sameness, including assessment of pH adjusters.
AI-generated plain-language summary of the bill text — neutral, and may be imperfect. See the full text below for the exact wording.
Sponsor (1)
- Rep. Dunn, Neal P. [R-FL-2] (R-FL)
1 cosponsor
- Rep. Mullin, Kevin [D-CA-15] (D-CA)
Money behind the sponsor
Top reported contributors to Neal P. Dunn’s campaign committee (2024 cycle) — who funds the bill’s sponsor, not a claim about this bill. Data from FEC.
- KEDRICK CERRY $13,200
- ADVANCED UROLOGY INSTITUTE $12,400
- APPLIED RESEARCH ASSOCIATES $11,600
- NULL $11,110
- AUDIENTIS LLC $10,000
Organizations whose employees gave the most — itemized individual contributions grouped by the donor’s reported employer (FEC Schedule A). Full finance for Neal P. Dunn → · Outside spending →
Actions (2)
- Mar 5, 2025 Referred to the House Committee on Energy and Commerce. · house
- Mar 5, 2025 Introduced in House
Similar bills (6)
Bills with similar text or summary — includes reintroductions across Congresses. Ranked by semantic similarity of the bill text (computed locally); a neutral discovery aid, not a claim the bills are duplicates.
Text versions (1)
Bills are re-published as they move (Introduced → Reported → Engrossed → Enrolled …). Each stage below is a separate text; pick two to see what changed. Data from Congress.gov.
Full text
IN THE HOUSE OF REPRESENTATIVES
March 5, 2025
Mr. Dunn of Florida (for himself and Mr. Mullin) introduced the following bill; which was referred to the Committee on Energy and Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. 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, 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 required by this subparagraph are disclosures authorized by law, including for purposes of 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. <all>
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