II
119THCONGRESS
1
STSESSION S. 1302
To provide for increased transparency in generic drug applications.
IN THE SENATE OF THE UNITED STATES
APRIL3, 2025
Ms. H
ASSAN(for herself, Mr. PAUL, Mr. HICKENLOOPER, and Mr. LEE) in-
troduced the following bill; which was read twice and referred to the Com-
mittee 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 Representa-1
tives of the United States of America in Congress assembled, 2
SECTION 1. SHORT TITLE. 3
This Act may be cited as the ‘‘Increasing Trans-4
parency in Generic Drug Applications Act’’. 5
SEC. 2. INCREASING TRANSPARENCY IN GENERIC DRUG 6
APPLICATIONS. 7
(a) I
NGENERAL.—Section 505(j)(3) of the Federal 8
Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(3)) is 9
amended by adding at the end the following: 10
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‘‘(H)(i) Upon request (in controlled correspondence 1
or an analogous process) by a person that has submitted 2
or intends to submit an abbreviated application under this 3
subsection for a drug that is required by regulation to con-4
tain one or more of the same inactive ingredients in the 5
same concentrations as the listed drug referred to, or for 6
which the Secretary determines there is a scientific jus-7
tification for an approach that is in vitro, in whole or in 8
part, to be used to demonstrate bioequivalence for a drug 9
if such a drug contains one or more of the same inactive 10
ingredients in the same concentrations as the listed drug 11
referred to, the Secretary shall inform the person whether 12
such drug is qualitatively and quantitatively the same as 13
the listed drug. The Secretary may also provide such infor-14
mation to such a person on the Secretary’s own initiative 15
during the review of an abbreviated application under this 16
subsection for such drug. 17
‘‘(ii) Notwithstanding section 301(j), if the Secretary 18
determines that such drug is not qualitatively or quan-19
titatively the same as the listed drug, the Secretary shall 20
identify and disclose to the person— 21
‘‘(I) the ingredient or ingredients that cause 22
such drug not to be qualitatively or quantitatively 23
the same as the listed drug; and 24
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‘‘(II) for any ingredient for which there is an 1
identified quantitative deviation, the amount of such 2
deviation. 3
‘‘(iii) If the Secretary determines that such drug is 4
qualitatively and quantitatively the same as the listed 5
drug, the Secretary shall not change or rescind such deter-6
mination after the submission of an abbreviated applica-7
tion for such drug under this subsection unless— 8
‘‘(I) the formulation of the listed drug has been 9
changed and the Secretary has determined that the 10
prior listed drug formulation was withdrawn for rea-11
sons of safety or effectiveness; or 12
‘‘(II) the Secretary makes a written determina-13
tion that the prior determination must be changed 14
because an error has been identified. 15
‘‘(iv) If the Secretary makes a written determination 16
described in clause (iii)(II), the Secretary shall provide no-17
tice and a copy of the written determination to the person 18
making the request under clause (i). 19
‘‘(v) The disclosures authorized under clauses (i) and 20
(ii) are disclosures authorized by law, including for pur-21
poses of section 1905 of title 18, United States Code. This 22
subparagraph shall not otherwise be construed to author-23
ize the disclosure of nonpublic qualitative or quantitative 24
information about the ingredients in a listed drug, or to 25
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affect the status, if any, of such information as trade se-1
cret or confidential commercial information for purposes 2
of section 301(j) of this Act, section 552 of title 5, United 3
States Code, or section 1905 of title 18, United States 4
Code.’’. 5
(b) G
UIDANCE.— 6
(1) I
N GENERAL.—Not later than one year 7
after the date of enactment of this Act, the Sec-8
retary of Health and Human Services shall issue 9
draft guidance, or update guidance, describing how 10
the Secretary will determine whether a drug is quali-11
tatively and quantitatively the same as the listed 12
drug (as such terms are used in section 13
505(j)(3)(H) of the Federal Food, Drug, and Cos-14
metic Act, as added by subsection (a)), including 15
with respect to assessing pH adjusters. 16
(2) P
ROCESS.—In issuing guidance under this 17
subsection, the Secretary of Health and Human 18
Services shall— 19
(A) publish draft guidance; 20
(B) provide a period of at least 60 days for 21
comment on the draft guidance; and 22
(C) after considering any comments re-23
ceived and not later than one year after the 24
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close of the comment period on the draft guid-1
ance, publish final guidance. 2
(c) A
PPLICABILITY.—Section 505(j)(3)(H) of the 3
Federal Food, Drug, and Cosmetic Act, as added by sub-4
section (a), applies beginning on the date of enactment 5
of this Act, irrespective of the date on which the guidance 6
required by subsection (b) is finalized. 7
Æ
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