STOP GAMES Act of 2026
- Bill Number
- H.R. 8908
- Origin Chamber
- House
- Congress
- 119th Congress, Session 2
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2026-05-19: Referred to the House Committee on Energy and Commerce.
- Last Updated
- 2026-06-10T14:57:06Z
AI-Generated Summary
Purpose The legislation amends section 505(q) of the Federal Food, Drug, and Cosmetic Act to clarify and strengthen the process for denying citizen petitions submitted primarily to delay approval of certain drug applications under subsections (b)(2) or (j), or biosimilar applications under section 351(k) of the Public Health Service Act. It also updates related requirements for administrative exhaustion and congressional reporting.
Key Provisions
- Establishes a 60-day deadline for submitting petitions after the relevant information first became known to the petitioner.
- Allows the Secretary of Health and Human Services to deny a petition at any time if it was submitted with the primary purpose of delaying approval or if it does not raise valid scientific or regulatory issues on its face.
- Lists specific factors the Secretary may consider when assessing intent to delay, including late submission, multiple or serial petitions, timing near patent or exclusivity expiration, lack of supporting data, repetition of prior issues, failure to comment during public input periods, and requests for more stringent standards than those applied to the listed drug.
- Requires referral to the Federal Trade Commission when a petition is found to have been submitted primarily for delay.
- Modifies exhaustion of administrative remedies rules, requiring petitioners to file timely petitions describing all arguments before seeking judicial relief, with courts directed to dismiss actions that fail to meet these standards.
- Expands FDA reporting to Congress to include details on each petition, resources expended, timing relative to patents, estimated delays caused, and hypothetical approval timelines absent the petition.
Significant Changes to Existing Law
- Replaces the prior 150-day response timeline with a process allowing earlier denial based on intent.
- Removes the previous subparagraph (F) and redesignates subsequent provisions.
- Updates certification language in petitions to affirm the 60-day timeliness requirement.
- Strengthens judicial dismissal standards for premature or untimely lawsuits against the Secretary.
Potential Impacts
- Government agencies: Increases FDA authority to address petition abuse and mandates new reporting and FTC referrals; may require additional resources for petition review and documentation.
- Citizens: Aims to reduce delays in generic and biosimilar drug approvals, potentially improving access to lower-cost medicines.
- International relations: No direct effects identified in the legislation.
Main Stakeholders Affected
- Brand-name and generic pharmaceutical manufacturers (as petitioners or applicants).
- The Food and Drug Administration.
- The Federal Trade Commission.
- Patients and consumers seeking affordable medications.
- Congress (through enhanced oversight reporting).
Notable Legal, Constitutional, or Political Implications
- Reinforces administrative exhaustion requirements, limiting judicial challenges until the agency completes review.
- Introduces explicit statutory factors and referral mechanisms to deter petition misuse without altering core constitutional authorities.
- Focuses on procedural safeguards in drug approval to balance innovation incentives with timely competition.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Cosponsors (1)
Rep. Bice, Stephanie I. [R-OK-5]
Recent Actions
- 2026-05-19: Referred to the House Committee on Energy and Commerce.
- 2026-05-19: Introduced in House
- 2026-05-19: Introduced in House
Bill Versions
- Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon Act of 2026 — issued 2026-05-19 — PDF (11 pages)