Stop STALLING Act

The bill would define "sham" citizen petitions filed with the FDA as an unfair method of competition under the Federal Trade Commission Act, exposing their filers to civil liability. A petition qualifies as a sham if it is either (a) a single petition that is objectively baseless and attempts to exploit the government review process — rather than the outcome of that process — to interfere with a competitor's generic or biosimilar application, or (b) a series of multiple petitions targeting the same application that similarly attempts to exploit the process. The FTC would be authorized to bring civil suits in federal district court and seek civil penalties and other relief.

The bill would also create a rebuttable presumption of sham status when the HHS Secretary has determined a petition was submitted primarily to delay approval and refers that determination to the FTC in writing — provided the petition was part of a series. The defendant could overcome the presumption by a preponderance of the evidence. The bill would apply only to petitions filed on or after the date of enactment and would not limit any existing antitrust remedies.

Branded pharmaceutical companies that file citizen petitions with the FDA to challenge a competitor's drug approval, and generic drug or biosimilar manufacturers whose applications could be delayed by those petitions. The FTC gains new enforcement authority, and the HHS Secretary and FDA gain a referral role. Patients and payers who rely on lower-cost generic drugs are the downstream population the bill aims to protect.

Sham FDA petitions can delay generic drug approvals by months or years, extending branded drug monopolies and keeping drug prices higher. Civil penalties capped at the greater of all drug revenues earned during the review period or $50,000 per day per petition create a financial deterrent scaled to the harm caused — meaning large-revenue drugs would face the largest exposure, and repeat filers who submit series of petitions would face compounding liability.

The FTC would investigate suspected sham petitions and decide whether to bring civil suit in federal district court. The HHS Secretary provides a formal referral mechanism: when the Secretary determines a petition was submitted primarily to delay a generic approval, the Secretary refers that finding in writing to the FTC, creating a rebuttable presumption that the petition is part of a sham series. The defendant may rebut the presumption at trial by a preponderance of evidence and may challenge the Secretary's referral as a third-party claim against HHS in the same civil action. Civil penalties are the greater of the two penalty formulas. Existing antitrust law and other federal remedies are explicitly preserved alongside the new penalties.