1. Short title This Act may be cited as the Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2023 or the STOP GAMES Act of 2023 . 2. Denial of petitions whose primary purpose is to delay approval of certain applications (a) In general Subparagraph (E) of section 505(q)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(q)(1) ) is amended to read as follows: (E) Denial based on intent to delay (i) In general If the Secretary determines that a petition or a supplement to the petition was submitted with the primary purpose of delaying the approval of an application or the petition does not on its face raise valid scientific or regulatory issues, the Secretary may deny the petition at any point based on such determination. (ii) Factors The Secretary may issue guidance to describe the factors that will be used to determine under this subparagraph whether a petition is submitted with the primary purpose of delaying the approval of an application. Such factors shall include the following: (I) Submission of a petition where it appears, based on the date that relevant information relied upon in the petition became known to the petitioner (or reasonably should have been known to the petitioner), that the petitioner has taken an unreasonable length of time to submit the petition. (II) Submission of multiple or serial petitions raising issues that reasonably could have been known to the petitioner at the time of submission of the earlier petition or petitions. (III) Submission of a petition close in time to a known, first date upon which an application under subsection (b)(2) or (j) of this section or under section 351(k) of the Public Health Service Act could be approved (such as submission close in time to the expiration of a blocking patent or exclusivity). (IV) Submission of a petition without any data or information in support of the scientific positions set forth in the petition. (V) Submission of a petition raising the same or substantially similar issues as a prior petition