The STOP GAMES Act of 2026 strengthens the FDA's authority to swiftly reject citizen petitions filed primarily to delay the approval of generic or biosimilar drugs.
Eric Sorensen
Representative
IL-17
The STOP GAMES Act of 2026 strengthens the FDA's authority to reject citizen petitions filed primarily to delay the approval of generic or biosimilar drugs. It tightens filing deadlines and establishes clear factors for identifying delay tactics, such as submitting serial or late petitions. The bill also mandates the dismissal of lawsuits filed prematurely or without exhausting administrative review. Finally, it expands required annual reporting to Congress detailing the impact of these petitions on drug approval timelines.
STOP GAMES Act Targets Pharma 'Delay Tactics' to Fast-Track Generic Drugs by 2026
The STOP GAMES Act of 2026 is designed to shut down a loophole that brand-name drug companies often use to keep cheaper generic versions off the market. Currently, companies can file 'citizen petitions' with the FDA to raise concerns about a competitor’s new generic drug. While this sounds like a safety measure, it is frequently used as a legal speed bump to stall approvals. This bill gives the FDA the teeth to immediately deny petitions filed primarily for delay and requires any concerns to be submitted within 60 days of discovering the issue—no more waiting until the last minute to block a competitor’s launch.
Cutting Through the Red Tape
To stop the endless cycle of paperwork, Section 2 of the bill introduces a 'use it or lose it' rule. If a company has a legitimate scientific concern about a new biosimilar or generic drug, they must certify that they are filing their petition within 60 days of finding the evidence. This prevents the common practice of 'serial petitioning,' where a company drops one complaint after another just to keep the FDA’s clock running. For a patient waiting on a more affordable version of their maintenance medication, this could mean the difference between paying a high brand-name copay and a significantly lower generic price months or even years sooner.
Defining the 'Delay Game'
Because 'intent to delay' can be a fuzzy concept, the bill provides the Secretary of Health and Human Services with a specific checklist to spot bad actors. Red flags include submitting petitions right before a drug is set to be approved, filing multiple petitions on issues that could have been handled in one go, or asking for testing standards that are actually stricter than what the original brand-name drug had to meet. If the FDA determines a petition is just a stall tactic, they are now required to refer the case to the Federal Trade Commission (FTC) for a potential antitrust investigation. This creates a real financial and legal risk for companies trying to game the system.
Transparency and the Courtroom
The bill also cleans up how these fights play out in court. It mandates that judges dismiss lawsuits if the company didn't try to resolve the issue through the FDA first, or if they missed that new 60-day filing window. To keep everyone honest, the FDA will have to provide a detailed 'receipt' to Congress every year. This report will name the companies filing petitions, estimate exactly how many months of delay they caused to generic approvals, and calculate the resources the government wasted reviewing meritless claims. For the average person, this means more accountability for the companies that influence the cost of the pharmacy counter.