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.
Constitutional context
The bill rests primarily on Congress's Commerce Clause authority (Art. I, §8) to regulate interstate commerce in pharmaceuticals and to define unfair competitive practices. The FTC's authority to police unfair methods of competition derives from the FTC Act, itself grounded in Commerce Clause power. The bill does not implicate the Taxing/Spending Clause or the ACA's framework directly. Under the post-Loper Bright environment, courts would independently review whether the FTC's interpretation of "objectively baseless" falls within the authority Congress clearly granted, rather than deferring to the agency. The major questions doctrine (West Virginia v. EPA) could be raised if the FTC sought to expand enforcement broadly, though the bill's scope is relatively targeted.
Checks and balances
The bill would expand executive branch enforcement authority by granting the FTC — an independent federal agency — new power to bring civil suits and impose financial penalties related to FDA petition activity. This shifts some oversight of the FDA petition process from the FDA itself (executive/regulatory) to the FTC (independent agency/quasi-judicial). Congress retains authority to define the scope of "objectively baseless" and set penalty limits, preserving legislative primacy over the substantive standard. Courts would serve as the check on FTC enforcement actions through judicial review of individual cases.
Historical precedent
The Hatch-Waxman Act (1984) established the generic drug approval pathway and created the citizen petition process; subsequent FTC studies (2001, 2012) documented petition abuse patterns. The Medicare Prescription Drug, Improvement, and Modernization Act (2003) added some limits on late-filed petitions. This bill would be the first to attach direct civil penalties to baseless petitions via FTC enforcement.