STOP GAMES Act of 2026

Key Points

• This bill targets brand-name drug companies that file citizen petitions with the FDA mainly to slow down the approval of cheaper generic drugs. It changes federal law to give the FDA clearer authority to reject these delay tactics.
• Companies would be required to file these petitions within 60 days of learning about the issue. This prevents them from strategically holding back complaints until a generic competitor is about to get approved.
• The FDA gets new power to reject petitions at any time if they were filed mainly to cause delays or if they lack real scientific substance. The bill spells out eight specific factors the FDA can use to identify bad-faith petitions.
• When the FDA catches a company filing a petition mainly to block competition, it must report that company to the Federal Trade Commission for possible enforcement action.
• The bill also requires the FDA to report to Congress detailed information about each petition filed, including who filed it, how much time and money the agency spent on it, and how much delay the petition caused for generic drug approvals.