Bill Details
HR.1843 - 119th Congress
Status
Latest action
2025-03-05 - Referred to the House Committee on Energy and Commerce.
Introduced Date
2025-03-05
Policy Area
Health
Committees
View committees (1)
Sponsors
Cosponsors
View cosponsors (1)
7
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AI Summary This summary was generated by AI from the bill text. AI can get information wrong.
This bill would make the process for approving generic drugs more open and clear. It would require the Food and Drug Administration, when asked, to tell a company whether its generic drug matches the brand-name drug in both the type of inactive ingredients and the amount of those ingredients. If the drug does not match, the FDA would have to explain exactly which ingredient or ingredients are different and by how much. The bill also says that once the FDA says a drug does match, that decision generally cannot be taken back after an application is filed, unless the brand-name drug has changed or the agency later finds a written error. In addition, the FDA would have to issue or update guidance within one year explaining how it makes these matching decisions.
- The FDA would have to answer questions from generic drug makers about whether their product is the same as the listed drug in both quality and quantity of inactive ingredients.
- If the FDA finds a mismatch, it must identify the specific ingredient problems and, when amounts are off, say how much they differ.
- If the FDA first says the drug is the same, it cannot later change that decision after the generic application is filed, except in limited cases such as a changed brand-name formula or a corrected agency error.
- The agency would also have to publish draft guidance, allow at least 60 days for public comments, and then issue final guidance on how it will judge whether drugs match, including how it treats pH adjusters.
Official Summaries
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.
Current Full Text
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1843 Introduced in House (IH)]
<DOC>
119th CONGRESS
1st Session
H. R. 1843
To amend the Federal Food, Drug, and Cosmetic Act to increase
transparency in generic drug applications.
_______________________________________________________________________
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.
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