Increasing Transparency in Generic Drug Applications Act
Bill: S.4338 | Sponsor: Sen. Hassan, Margaret Wood (D-NH)
Policy area: Health

Summary:
Increasing Transparency in Generic Drug Applications Act
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 provide for increased 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. SHORT TITLE.

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

SEC. 2. 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 otherwise) 
by a person that has submitted or intends to submit an abbreviated 
application under this subsection for a drug that is generally required 
by regulation or recommended in guidance to contain the same inactive 
ingredients in the same concentration as the listed drug referred to or 
for which there is a scientific justification that an in vitro approach 
can be used to demonstrate bioequivalence based on certain qualitative 
or quantitative criteria with respect to an inactive ingredient, or on 
the Secretary's own initiative during the review of an application 
under this subsection for such a drug, the Secretary shall inform the 
person whether such drug is qualitatively and quantitatively the same 
as the listed drug.
    ``(ii) 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 the 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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