Loading…
H.R. 8908119th CongressIn committeeLatest action May 19, 2026Decoded by AI · checked against the record
The plain-language version leads. The official text is always the reference.
The STOP GAMES Act lets the FDA quickly reject petitions filed mainly to delay generic or biosimilar drug approvals.
40-second read · 4 questions answered below
This bill gives the FDA clearer authority to quickly deny petitions that appear filed mainly to delay approval of competing generic or biosimilar drugs. It lists warning signs of delay tactics, shortens the petition filing deadline to 60 days, requires referrals of suspected bad-faith filers to the FTC, and tightens court rules requiring people to first go through the FDA's petition process before suing.
This mainly affects pharmaceutical and biotechnology companies, particularly brand-name drug makers who file these petitions and generic or biosimilar manufacturers seeking approval. It could indirectly affect consumers and patients who buy prescription drugs.
The changes could reduce brand-name companies' ability to delay competition through petitions, while adding stricter deadlines and procedural requirements for anyone challenging FDA drug decisions.
AI-drafted summary. Verify it against the official text before you act on it. Read the official bill on Congress.gov
Right now: a House committee is reviewing it. If the Senate changes it, it goes back to the House before reaching the President.
Latest action: — Referred to the House Committee on Energy and Commerce.