119-s1302

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 1302 Introduced in Senate

    (IS) ]

<DOC>

119th CONGRESS
 1st Session
 S. 1302

 To provide for increased transparency in generic drug applications.

_______________________________________________________________________

 IN THE SENATE OF THE UNITED STATES

 April 3, 2025

 Ms. Hassan (for herself, Mr. Paul, Mr. Hickenlooper, and Mr. Lee) 
introduced the following bill; which was read twice and referred to the 
 Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

 A BILL

 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 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 referred to, 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 authorized under clauses
            (i) and
            (ii) are 
disclosures authorized by law, including for purposes of 

section 1905 
of title 18, United States Code. This subparagraph shall not otherwise 
be construed to authorize the disclosure of nonpublic qualitative or 
quantitative information about the ingredients in a listed drug, or to 
affect the status, if any, of such information as trade secret or 
confidential commercial information for purposes of 

section 301

    (j) of 
this Act, 

section 552 of title 5, United States Code, or 

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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