I
119THCONGRESS
1
STSESSION H. R. 1843
To amend the Federal Food, Drug, and Cosmetic Act to increase transparency
in generic drug applications.
IN THE HOUSE OF REPRESENTATIVES
MARCH5, 2025
Mr. D
UNNof Florida (for himself and Mr. MULLIN) 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 Representa-1
tives of the United States of America in Congress assembled, 2
SECTION 1. INCREASING TRANSPARENCY IN GENERIC 3
DRUG APPLICATIONS. 4
(a) I
NGENERAL.—Section 505(j)(3) of the Federal 5
Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(3)) is 6
amended by adding at the end the following: 7
‘‘(H)(i) Upon request (in controlled correspondence 8
or an analogous process) by a person that has submitted 9
or intends to submit an abbreviated application under this 10
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subsection for a drug that is required by regulation to con-1
tain one or more of the same inactive ingredients in the 2
same concentrations as the listed drug referred to, or for 3
which the Secretary determines there is a scientific jus-4
tification for an approach that is in vitro in whole or in 5
part to be used to demonstrate bioequivalence for a drug 6
if such a drug contains one or more of the same inactive 7
ingredients in the same concentrations as the listed drug, 8
the Secretary shall inform the person whether such drug 9
is qualitatively and quantitatively the same as the listed 10
drug. The Secretary may also provide such information 11
to such a person on the Secretary’s own initiative during 12
the review of an abbreviated application under this sub-13
section for such drug. 14
‘‘(ii) Notwithstanding section 301(j), if the Secretary 15
determines that such drug is not qualitatively or quan-16
titatively the same as the listed drug, the Secretary shall 17
identify and disclose to the person— 18
‘‘(I) the ingredient or ingredients that cause 19
such drug not to be qualitatively or quantitatively 20
the same as the listed drug; and 21
‘‘(II) for any ingredient for which there is an 22
identified quantitative deviation, the amount of such 23
deviation. 24
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‘‘(iii) If the Secretary determines that such drug is 1
qualitatively and quantitatively the same as the listed 2
drug, the Secretary shall not change or rescind such deter-3
mination after the submission of an abbreviated applica-4
tion for such drug under this subsection unless— 5
‘‘(I) the formulation of the listed drug has been 6
changed and the Secretary has determined that the 7
prior listed drug formulation was withdrawn for rea-8
sons of safety or effectiveness; or 9
‘‘(II) the Secretary makes a written determina-10
tion that the prior determination must be changed 11
because an error has been identified. 12
‘‘(iv) If the Secretary makes a written determination 13
described in clause (iii)(II), the Secretary shall provide no-14
tice and a copy of the written determination to the person 15
making the request under clause (i). 16
‘‘(v) The disclosures required by this subparagraph 17
are disclosures authorized by law, including for purposes 18
of section 1905 of title 18, United States Code.’’. 19
(b) G
UIDANCE.— 20
(1) I
N GENERAL.—Not later than one year 21
after the date of enactment of this Act, the Sec-22
retary of Health and Human Services shall issue 23
draft guidance, or update guidance, describing how 24
the Secretary will determine whether a drug is quali-25
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tatively and quantitatively the same as the listed 1
drug (as such terms are used in section 2
505(j)(3)(H) of the Federal Food, Drug, and Cos-3
metic Act, as added by subsection (a)), including 4
with respect to assessing pH adjusters. 5
(2) P
ROCESS.—In issuing guidance under this 6
subsection, the Secretary of Health and Human 7
Services shall— 8
(A) publish draft guidance; 9
(B) provide a period of at least 60 days for 10
comment on the draft guidance; and 11
(C) after considering any comments re-12
ceived and not later than one year after the 13
close of the comment period on the draft guid-14
ance, publish final guidance. 15
(c) A
PPLICABILITY.—Section 505(j)(3)(H) of the 16
Federal Food, Drug, and Cosmetic Act, as added by sub-17
section (a), applies beginning on the date of enactment 18
of this Act, irrespective of the date on which the guidance 19
required by subsection (b) is finalized. 20
Æ
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