The Stop STALLING Act would give the Federal Trade Commission (FTC) new tools to deter and punish sham citizen petitions filed with the Food and Drug Administration (FDA) that are aimed at delaying or blocking approval of generic drugs or biosimilars. A “sham” petition is defined as an objectively baseless petition (or a series of petitions) that seeks to interfere with a competitor through the government process rather than through the petition’s outcomes. When the FTC believes a petition or series qualifies as a sham, it can bring civil action for unfair competition and seek civil penalties. The bill creates a presumption that a petition is part of a sham if the Health and Human Services (HHS) Secretary determines the primary purpose was to delay FDA approval and refers that determination to the FTC. This presumption can be rebutted by proving, by a preponderance of the evidence, that the series is not a sham. Penalties can be substantial, tied to either revenue from the drug during FDA review or a per-day amount for each sham petition under review. The act applies to petitions filed after enactment and does not alter the core antitrust framework, but it adds a targeted mechanism to address abusive petitions in the drug approval process.
Key Points
- 1Defines scope and terms, including “covered petition,” “covered application,” and “sham,” to target FDA citizen petitions related to generic drug/biosimilar approvals.
- 2Creates FTC enforcement: a sham petition or series is an unfair method of competition under the FTC Act, enabling civil actions for penalties and other relief.
- 3Establishes a presumption of sham status if the HHS Secretary determines the petition’s primary purpose was to delay approval and refers that determination to the FTC; allows a contrary showing to defeat the presumption.
- 4Imposes civil penalties for sham petitions, up to the greater of drug-related revenue earned during review or $50,000 per calendar day for each sham petition under review; penalties stack per violation.
- 5Limits review of HHS referrals (judicial review is restricted, with narrow third-party review rights); preserves existing antitrust law and FTC authority; applies only to petitions filed after enactment.