Increasing Transparency in Generic Drug Applications Act of 2022
Bill: H.R.7032 | Sponsor: Rep. Kuster, Ann M. (D-NH)
Policy area: Health

Summary:
Increasing Transparency in Generic Drug Applications Act of 2022
This bill requires the Food and Drug Administration 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).

To amend section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 
 U.S.C. 355(j)) with respect to a process to inform persons submitting 
   an abbreviated application for a new drug whether the new drug is 
  qualitatively or quantitatively the same as a listed drug, and for 
                            other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Increasing Transparency in Generic 
Drug Applications Act of 2022''.

SEC. 2. DETERMINING WHETHER PROPOSED NEW GENERIC DRUGS ARE 
              QUALITATIVELY OR QUANTITATIVELY THE SAME AS THE LISTED 
              DRUG.

    (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 otherwise) 
by a person that has submitted or intends to submit an abbreviated 
application for a new drug under this subsection or on the Secretary's 
own initiative during the review of such abbreviated application, the 
Secretary shall inform the person whether such new drug is 
qualitatively and quantitatively the same as the listed drug.
    ``(ii) If the Secretary determines that such new 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 the new drug 
        not to be qualitatively or quantitatively the same as the 
        listed drug; and
            ``(II) the quantity or proportion of any ingredient in the 
        listed drug for which there is an identified quantitative 
        deviation.
    ``(iii) If the Secretary determines that such new 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 new 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 under 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 guidance describing how the Secretary will 
        determine whether a new 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 as required by paragraph 
        (1), 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, 
                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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