STOP GAMES Act of 2026

Full Title:
STOP GAMES Act of 2026

Summary#

This bill changes how the Food and Drug Administration (FDA) handles certain citizen petitions that relate to approval of drug applications filed under section 505(b)(2) or 505(j) of the Federal Food, Drug, and Cosmetic Act. It shortens the time for a petitioner to file after learning key information to 60 days. It lets the FDA deny a petition at any time if the petition was submitted with the primary purpose of delaying approval or does not on its face raise valid scientific or regulatory issues. The bill lists factors the FDA may use to find a petition is meant to delay approval (for example, long delays in filing, serial petitions, filing close to patent or exclusivity expirations, lack of supporting data, repeat issues already answered by FDA, or asking for stricter standards than those that apply). The FDA may issue guidance on these factors and must refer petitions it finds were submitted to delay approvals to the Federal Trade Commission.

The bill changes rules about when courts can hear lawsuits that seek to block or delay approval of these drug applications. Courts must dismiss suits that challenge approvals if the filer did not first submit a petition that set out all information and arguments. The bill sets deadlines and makes some late-filed suits subject to dismissal with prejudice.

It also expands what the FDA must report to Congress about petitions. The FDA must list each petition, name the petitioner, quantify time and resources spent on each petition, show the timing of petitions relative to patent expiration, estimate any delay the petition caused to an application and explain how that delay was calculated, and say when the FDA would have acted on the application if the petition had not been filed.

What it means for you#

  • If you are a drug applicant (for example, a generic or follow-on product applicant): petitions that the FDA finds were mainly meant to delay may be denied more quickly, and courts may dismiss legal challenges if petitioning rules were not followed. The bill could speed approval processes in those cases.
  • If you file petitions to raise safety, scientific, or regulatory concerns: you must submit petitions within 60 days of learning the supporting information and provide supporting data and arguments. The FDA may deny petitions that appear primarily intended to delay approval and may refer such cases to the FTC.
  • If you plan to sue to block or delay a drug approval: courts will generally require that you first file a timely petition describing all your claims; otherwise your suit can be dismissed (sometimes with prejudice, depending on timing).
  • For the public: the FDA must provide more detailed reports to Congress about petitions and any estimated delays they cause.

Expenses#

No publicly available information.

Proponents' View#

The bill's short title and provisions indicate its sponsors aim to reduce the use of petitions that primarily delay approval of drug applications and to speed access to follow-on or affordable medicines. The bill gives the FDA tools to deny such petitions, requires clearer filing timelines, tightens rules for related lawsuits, and increases reporting to Congress about petition impacts.

Opponents' View#

No publicly available information.