Stop STALLING Act

New penalties for sham drug petitions

This bill would let the Federal Trade Commission sue people who file sham petitions that aim to delay generic or biosimilar drug approvals. It would define which petitions and applications are covered and who counts as a filer. If a court finds a petition is a sham, the FTC could recover a civil penalty equal to the greater of the filer’s sales of the referenced drug during review or $50,000 per calendar day the petition was under HHS review. If HHS determines a petition was filed mainly to delay approval and refers that finding to the FTC, the FTC could treat the petition as part of a sham series unless the filer rebuts the presumption by a preponderance of the evidence. The rules would apply only to petitions filed on or after enactment and would not replace existing antitrust remedies.