STOP GAMES Act of 2026

drug product); and (bb)the petitioner has not provided comment other than through the petition. (VII)Submission of a petition requesting that other applicants must meet standards for testing, data, or labeling for their products that are more onerous or rigorous than the standards applicable to the applicable listed drug or the petitioner’s version of the same product. (VIII)Other relevant considerations, including the history of the petitioner with the Food and Drug Administration (such as whether the petitioner has a history of submitting petitions which the Food and Drug Administration has determined were submitted with the primary purpose of delay). (iii)Referral to FTCIf the Secretary determines that a petition has been submitted with the primary purpose of delaying the approval of an application, as described in clause (i), the Secretary shall refer the matter to the Federal Trade Commission.; (3)by striking subparagraph (F); (4)by redesignating subparagraphs (G) through (I) as subparagraphs (F) through (H), respectively; (5)in subparagraph (G), as so redesignated, by striking I further certify that the information upon which I have based the action requested herein first became known to the party on whose behalf this petition is submitted on or about the following date: __________. and inserting I further certify that the information upon which I have based the action requested herein first became known to the party on whose behalf this petition is submitted on or about __________, which date was not more than 60 days before the date of submitting this petition.; and (6)in subparagraph (H), as so redesignated, by striking submission of this petition and inserting submission of this document. (b)Exhaustion of administrative remediesSection 505(q)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(q)(2)) is amended— (1)in subparagraph (A)— (A)in the heading, by striking within 150 days; (B)in clause (i), by striking during the 150-day period referred to in paragraph (1)(F),; and (C)by amending clause (ii) to read as follows: (ii) on or after the date that is 151 days after the date of submission of the petition, the Secretary approves or has approved the application that is the subject of the petition without having made such a final decision. ; and (2)by amending subparagraph (B) to read as follows: (B)Dismissal of certain civil actions (i)PetitionIf a person files a civil action against the Secretary in which a person seeks to set aside, delay, rescind, withdraw, or prevent submission, review, or approval of an application submitted under subsection (b)(2) or (j) of this section or section 351(k) of the Public Health Service Act without first submitting a petition to the Secretary under paragraph (1) that describes all information and arguments that form the basis of the relief requested in such civil action, the court shall dismiss without prejudice the action for failure to exhaust administrative remedies. (ii)TimelinessIf a person files a civil action against the Secretary in which a person seeks to set aside, delay, rescind, withdraw, or prevent submission, review, or approval of an application submitted under subsection (b)(2) or (j) of this section or section 351(k) of the Public Health Service Act after the date described in paragraph (1)(A)(i), the court shall dismiss with prejudice the action for failure to timely file a petition. (iii)Final responseIf a civil action is filed against the Secretary with respect to any issue raised in a petition timely filed under paragraph (1) in which the petitioner requests that the Secretary take any form of action that could, if taken, set aside, delay, rescind, withdraw, or prevent submission, review, or approval of an application submitted under subsection (b)(2) or (j) of this section or section 351(k) of the Public Health Service Act before the Secretary has taken final agency action on the petition within the meaning of subparagraph (A), the court shall dismiss without prejudice the action for failure to exhaust administrative remedies.. (c)Reporting to Congress Section 505(q)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(q)(3)) is amended— (1)in the matter before subparagraph (A), by striking specifies; (2)in subparagraphs (A), (B), (C), and (D), by striking the number and inserting specifies the number; (3)in subparagraph (C), by striking and at the end; (4)in subparagraph (D), by striking the period at the end and inserting ; and; and (5)by adding at the end the following: (E) (i)lists each petition submitted during such period and, for each, identifies the petitioner; (ii)quantifies the time and resources expended on each such petition; (iii)states the timing of the petition relative to the expiration date of the patents specified in the pending application in the certification under subsection (b)(2)(A) or (j)(2)(A)(vii), as applicable; (iv)quantifies the delay, if any, caused by any such petition on the approval of any application submitted under subsection (b)(2) or (j), including a description of how any such delay is calculated and an estimate of when any delayed approval would have been granted absent the petition; and (v)in cases in which a pending application and a petition with respect to such pending application are disposed of on the same or nearly the same date, states when the Food and Drug Administration would have disposed of the pending application absent the petition..