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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.
Summary
This bill amends the FDA's generic drug approval process to provide clearer guidance for approving generic drugs that are used with medical devices. The bill allows for appropriate differences in the devices used with generic drugs and requires applicants to submit additional information demonstrating that the generic drug will have the same clinical effect and safety profile as the original drug when used with the device. This information can include device performance data, compatibility studies, and human factors testing to show that any differences in device design or user interface do not affect the drug's effectiveness.
AI-generated plain-language summary of the bill text — neutral, and may be imperfect. See the full text below for the exact wording.
Sponsor (1)
1 cosponsor
- Rep. Maloy, Celeste [R-UT-2] (R-UT)
Actions (2)
- Sep 4, 2025 Referred to the House Committee on Energy and Commerce. · house
- Sep 4, 2025 Introduced in House
Similar bills (6)
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Text versions (1)
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Full text
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;”. <all>
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