To amend subsection (q) of section 505 of the Federal Food, Drug, and Cosmetic Act to clarify the process for denying certain petitions whose primary purpose is to delay the approval of an application submitted under subsection (b)(2) or (j) of such section 505, and for other purposes.

[Congressional Bills 119th Congress] [From the U.S. Government Publishing Office] [H.R. 8908 Introduced in House (IH)] <DOC> 119th CONGRESS 2d Session H. R. 8908 To amend subsection (q) of section 505 of the Federal Food, Drug, and Cosmetic Act to clarify the process for denying certain petitions whose primary purpose is to delay the approval of an application submitted under subsection (b)(2) or (j) of such section 505, and for other purposes. _______________________________________________________________________ IN THE HOUSE OF REPRESENTATIVES May 19, 2026 Mr. Sorensen (for himself and Mrs. Bice) introduced the following bill; which was referred to the Committee on Energy and Commerce _______________________________________________________________________ A BILL To amend subsection (q) of section 505 of the Federal Food, Drug, and Cosmetic Act to clarify the process for denying certain petitions whose primary purpose is to delay the approval of an application submitted under subsection (b)(2) or (j) of such section 505, 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 ``Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2026'' or the ``STOP GAMES Act of 2026''. SEC. 2. DENIAL OF PETITIONS WHOSE PRIMARY PURPOSE IS TO DELAY APPROVAL OF CERTAIN APPLICATIONS. (a) In General.--Section 505(q)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(q)(1))-- (1) in subparagraph (A), by amending clause (i) to read as follows: ``(i) the request is in writing, is a petition submitted to the Secretary pursuant to section 10.30, 10.31, or 10.35 of title 21, Code of Federal Regulations (or any successor regulations), and is submitted not later than the date that is 60 days after the information upon which the petition is based first became known to the party on whose behalf the petition is submitted; and'