HR-2374-116
Placed on the Union Calendar, Calendar No. 577.
Sponsored by Hakeem Jeffries (D-NY)
What it does
The Stop STALLING Act would make it an unfair method of competition to file a petition with the FDA that is objectively baseless and intended to delay a competitor's generic drug application. It would authorize the Federal Trade Commission (FTC) to sue individuals or companies that file such petitions. Those found liable would face civil fines of up to $50,000 for each day the FDA spent reviewing the baseless petition.
Who benefits
Generic drug manufacturers whose FDA applications are delayed by competitor petitions would face fewer obstacles to market entry. Consumers and patients who rely on lower-cost generic drugs would potentially benefit from faster availability and lower prices. Health insurers, employer-sponsored health plans, and government programs such as Medicaid and Medicare that pay for prescription drugs could see reduced drug costs if generics reach the market sooner.
Who is hurt
Brand-name pharmaceutical manufacturers that currently use citizen petitions as a legal strategy to extend market exclusivity would face new legal and financial risk. Companies that file petitions in good faith but are later deemed "objectively baseless" could face costly FTC litigation. Smaller biotech firms with limited legal resources may be disproportionately exposed to liability risk when challenging competitor drug applications, even when their concerns have some merit.
Supporters argue
Supporters argue that brand-name drug companies have systematically abused the FDA's citizen petition process — a process designed for legitimate safety concerns — as a delay tactic to block generic competition and preserve high drug prices. They contend that each day a generic drug is kept off the market costs consumers and public health programs millions of dollars, and that existing law provides no adequate deterrent against this practice. Because the bill targets only "objectively baseless" petitions, supporters say it would not penalize good-faith safety concerns, but would create meaningful consequences for petitions filed purely to obstruct competition. They argue the FTC is the appropriate enforcement body given its existing mandate to police unfair methods of competition under the FTC Act.
Opponents argue
Opponents argue that the bill's "objectively baseless" standard is vague and could deter companies from filing legitimate safety or efficacy petitions out of fear that the FTC will second-guess their legal judgment after the fact. They contend that the citizen petition process exists precisely to allow stakeholders to raise concerns about drug approvals, and that chilling this process could result in unsafe or improperly reviewed drugs reaching the market. Critics also argue that the $50,000-per-day penalty structure is disproportionately severe and could expose companies to enormous liability for petitions that had at least some reasonable basis. They further suggest that the FDA already has tools to expedite review of petitions it deems dilatory, making additional FTC enforcement authority unnecessary and potentially duplicative.