[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5158 Introduced in House (IH)]
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119th CONGRESS
1st Session
H. R. 5158
To amend the Federal Food, Drug, and Cosmetic Act regarding the
approval of combination products consisting of a generic drug and a
device, and for other purposes.
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IN THE HOUSE OF REPRESENTATIVES
September 4, 2025
Ms. Scholten introduced the following bill; which was referred to the
Committee on Energy and Commerce
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A BILL
To amend the Federal Food, Drug, and Cosmetic Act regarding the
approval of combination products consisting of a generic drug and a
device, 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 ``Fair Price Device Act''.
SEC. 2. GENERIC DRUGS FOR USE WITH DEVICES.
Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)) is amended--
(1) in paragraph (2)(A)--
(A) in clause (v)--
(i) by striking ``except for changes
required because of differences'' and inserting
``except for changes required or appropriate,
as determined by the Secretary, because of
differences''; and
(ii) by inserting ``, including changes as
a result of differences that are otherwise
permitted under this subsection, such as
changes as a result of appropriate differences
in the device for use with the new drug''
before the semicolon;
(B) in clause (vii), by striking the ``and'' at the
end;
(C) in clause (viii) by striking the period at the
end and inserting ``; and'';
(D) by inserting after clause (viii) the following
new clause:
``(ix) if the listed drug referred to in clause (i) is
intended for use with a device, relevant information as
determined by the Secretary to support that the new drug for
use with the device can be expected to have the same clinical
effect and safety profile as the listed drug for use with the
device when administered to patients under the conditions
specified in the labeling of the drug, which information--
``(I) shall be in addition to information under
clauses (i) through (viii) that is relevant, as
determined by the Secretary, to the evaluation of the
new drug for use with the device and the device
proposed for use with the new drug; and
``(II) may include--
``(aa) information (comparative and non-
comparative) regarding the device and its
performance, including information about the
compatibility of the new drug with the device
and information regarding the delivery of the
new drug when used with the device;
``(bb) comparative analyses of the new drug
for use with the device and the listed drug for
use with its device, including information
identifying any differences between the user
interface of the new drug and listed drug;
information identifying any differences between
the user interface of the device proposed for
use with the new drug and the device used with
the listed drug; and information to show that,
despite any such differences, the new drug when
used with the device can be expected to have
the same clinical effect and safety profile as
the listed drug when used with the device when
administered to patients under the conditions
specified in the labeling of the drug; and
``(cc) comparative and non-comparative
human factors studies.''; and
(E) in the matter following clause (ix), as
inserted by subparagraph (D), by striking ``through
(viii)'' and inserting ``through (ix)''; and
(2) in paragraph (4)--
(A) in subparagraph (G)--
(i) by striking ``except for changes
required because of differences'' and inserting
``except for changes required or appropriate,
as determined by the Secretary, because of
differences''; and
(ii) by inserting ``, including changes as
a result of differences that are otherwise
permitted under this subsection, such as
changes as a result of appropriate differences
in the device for use with the new drug''
before the semicolon;
(B) by redesignating subparagraphs (J) through (K)
as subparagraphs (K) through (L); and
(C) by inserting after subparagraph (I) the
following:
``(J) if the listed drug is intended for use with a device,
information submitted in the application is insufficient to
show that the new drug for use with the device can be expected
to have the same clinical effect and safety profile as the
listed drug for use with the device when administered to
patients under the conditions specified in the labeling of the
drug;''.
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