[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3839 Introduced in House (IH)]

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118th CONGRESS
  1st Session
                                H. R. 3839

     To amend the Federal Food, Drug, and Cosmetic Act to increase 
               transparency in generic drug applications.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              June 6, 2023

    Mr. Dunn of Florida (for himself and Ms. Kuster) 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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