H.R. 5158

119th CONGRESS 1st Session

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 · Sponsor: Ms. Scholten · Committee: Committee on Energy and Commerce

Table of contents

• H.R. 5158
  • SEC. 1. Short title
  • SEC. 2. Generic drugs for use with devices

SEC. 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 () is amended— 21 U.S.C. 355(j)
  • in paragraph (2)(A)—
    • in clause (v)—
      • (i) by striking except for changes required because of differencesand inserting except for changes required or appropriate, as determined by the Secretary, because of differences; and
      • (ii) by inserting before the semicolon;
    • in clause (vii), by striking the at the end;
    • in clause (viii) by striking the period at the end and inserting ;
      • (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—
      • 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
      • may include—
      • 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;
      • 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
      • comparative and non-comparative human factors studies.
    • by inserting after clause (viii) the following new clause:
    • in the matter following clause (ix), as inserted by subparagraph (D), by striking through (viii)and inserting through (ix); and
  • in paragraph (4)—
    • in subparagraph (G)—
      • (i) by striking except for changes required because of differencesand inserting except for changes required or appropriate, as determined by the Secretary, because of differences; and
      • (ii) by inserting before the semicolon;
    • by redesignating subparagraphs (J) through (K) as subparagraphs (K) through (L); and
      • 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;
    • by inserting after subparagraph (I) the following: