This legislation, titled the STOP GAMES Act, seeks to amend the Federal Food, Drug, and Cosmetic Act to curb the use of citizen petitions for delaying the approval of generic and biosimilar drug applications . It establishes a new requirement that such petitions must be submitted within 60 days of the information becoming known to the petitioner, aiming to prevent late-stage submissions intended solely to obstruct market entry. A central provision grants the Secretary of the Food and Drug Administration the authority to deny petitions at any point if their primary purpose is determined to be delaying an application's approval or if they lack valid scientific or regulatory issues. The bill outlines several factors the Secretary may consider when making this determination, including the timeliness of submission, the filing of multiple or serial petitions, and the absence of supporting data. Furthermore, if a petition is found to be primarily for delay, the Secretary is mandated to refer the matter to the Federal Trade Commission for potential antitrust review. The bill also revises the process for exhausting administrative remedies before seeking judicial review, removing the 150-day FDA response period and requiring dismissal of civil actions if a petition was not timely filed or if administrative remedies were not fully pursued. Finally, it expands the FDA's reporting requirements to Congress, mandating detailed information on petitions, including resources expended, timing relative to patent expirations , and the quantification of any approval delays caused by such petitions.