Fair Price Device Act

[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 ex