PlainBillCongress, translated.Legislation. Context. Public interest.Referred to the House Committee on Energy and Commerce.
Congressional Research Service
Version 00 · Introduced in House · Mar 5, 2025
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.
People & committees
Rep. Dunn, Neal P. [R-FL-2] · R–FL
Legislative record
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Referred to the House Committee on Energy and Commerce.
Introduced in House
Introduced in House
Primary sources
Text links open the official source. We also preserved the text version used in the PlainBill explanation below.
Source last updated: Feb 5, 2026. Consult Congress.gov for the current record.
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PlainBill explanation
Based on the full Introduced in House · 2025-03-05 text. This explanation has not received human editorial review. This overview describes the proposal’s major provisions; it does not establish what its real-world effects would be.
This bill would let developers of certain generic drugs request information about whether their drug’s ingredient composition matches the reference drug used in their application. The Health and Human Services Secretary would have to identify ingredients that differ and disclose the size of any differences in amounts. A determination that the drugs match would be protected from later changes, subject to safety, effectiveness, and error-related exceptions. These are proposed requirements.
the Secretary shall inform the person whether such drug is qualitatively and 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.
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of the listed drug has been changed and the Secretary has determined that the prior listed drug formulation was withdrawn for reasons of safety or effectiveness; or (II) the Secretary makes a written determination that the prior determination must be changed because an error has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.
The proposed information requirement would cover people who have submitted or intend to submit an abbreviated generic-drug application. Their drug must either be required by regulation to match one or more inactive ingredients and their concentrations in the reference drug, or qualify under the Secretary’s scientific judgment for testing conducted wholly or partly outside a living body to demonstrate bioequivalence—comparable drug performance—when those ingredients and concentrations match.
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.
For an eligible request made through controlled correspondence or a similar process, the Secretary would have to say whether the drug matches the reference drug in ingredient types and amounts. During application review, the Secretary could also provide this information without a request.
Upon request (in controlled correspondence or an analogous process)
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.
If the Secretary found a mismatch, the bill would require disclosure to the requester of the ingredients responsible and the amount of each identified difference in quantity. The bill would require these disclosures notwithstanding section 301(j) and expressly classify them as authorized by law, including for purposes of 18 U.S.C. 1905.
(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.
(v) The disclosures required by this subparagraph are disclosures authorized by law, including for purposes of section 1905 of title 18, United States Code.
Once an abbreviated application was submitted, the Secretary generally could not change or withdraw an earlier determination that the drug matched. A change would be allowed if the reference drug’s formulation changed and its previous formulation was determined to have been withdrawn for safety or effectiveness reasons, or if the Secretary made a written determination that an identified error required correction.
(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.
If an identified error required changing the earlier determination, the Secretary would have to notify the requester and provide a copy of the written determination.
(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).
Within one year after enactment, the Health and Human Services Secretary would have to issue draft guidance or update guidance explaining how ingredient types and amounts would be compared. This explanation would have to address pH adjusters—ingredients used to adjust acidity or alkalinity.
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.
The guidance process would require publication of a draft and at least 60 days for public comments. After considering comments, the Secretary would have to publish final guidance within one year after the comment period closed.
(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.
The new information and determination requirements would apply starting on the date of enactment, even if the guidance had not yet been finalized.
(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.
The supplied official-actions snapshot, updated February 5, 2026, records introduction in the House and referral to the House Committee on Energy and Commerce on March 5, 2025.
Source snapshot updated 2026-02-05T17:34:06Z. 2025-03-05: Referred to the House Committee on Energy and Commerce. 2025-03-05: Introduced in House
A closer look
Reviewed version: Introduced in House · 2025-03-05. These findings describe provisions and who may benefit; they are not judgments of waste, corruption, or motive.
This review covers the supplied bill text. “None identified” does not rule out provisions in later versions or accompanying reports and disclosures.
Provisions outside the bill’s main subject, or policy changes attached to appropriations.
None identified in the reviewed text
No unrelated provision or policy change attached to appropriations was identified in the complete supplied introduced text. This conclusion does not extend to other versions or accompanying materials.
Spending directed to particular recipients or places outside ordinary competitive or formula-based allocation.
None identified in the reviewed text
No congressionally directed spending for particular recipients or places was identified in the complete supplied introduced text. This conclusion does not establish the absence of earmarks in other versions or accompanying materials.
Narrow exceptions, exemptions, or preferential treatment that warrant a closer look.
None identified in the reviewed text
No materially narrow preferential carve-out beyond the policy’s intended coverage was identified in the complete supplied introduced text. This conclusion is limited to that version.
Full text preserved for this analysis. Legislative record snapshot: Feb 5, 2026. How PlainBill uses AI