119-hr5158

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5158 Introduced in House

    (IH) ]

<DOC>

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.

_______________________________________________________________________

 IN THE HOUSE OF REPRESENTATIVES

 September 4, 2025

 Ms. Scholten 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 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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