- Targeted stakeholdersReduces abusive filings that delay generic and biosimilar approvals.
- Targeted stakeholdersLikely accelerates competitor entry, potentially lowering drug prices for some medicines.
- Targeted stakeholdersDeters firms from using administrative process to block competition, improving market fairness.
Stop STALLING Act
Placed on Senate Legislative Calendar under General Orders. Calendar No. 45.
The Stop STALLING Act authorizes the Federal Trade Commission to treat objectively baseless citizen petitions filed to delay approval of generic drugs or biosimilars as unfair methods of competition.
It allows the FTC to sue for civil penalties and other relief, creates a presumption that a petition is part of a sham series when HHS refers a petition as delay-focused, and sets penalty calculations (revenue-based or per-day fines).
The bill preserves existing antitrust law remedies, limits judicial review of HHS referrals (with a narrow exception), and applies to petitions filed after enactment.
A narrowly focused, technocratic antitrust measure with bipartisan potential but significant stakeholder opposition and plausible legal challenges.
Relative to its intended legislative type, this bill establishes a substantive enforcement regime by making certain sham petitions an unfair method of competition enforceable by the FTC, defines key terms, sets out a presumption mechanism tied to HHS referral, and prescribes civil penalties. It integrates with existing statutes by reference and preserves other antitrust remedies.
Progressives stress chilling of legitimate safety petitions
Who stands to gain, and who may push back.
- Targeted stakeholdersMay chill submission of legitimate safety and public-health petitions due to fear of penalties.
- Targeted stakeholdersRaises legal and compliance costs for entities contemplating petitions.
- Targeted stakeholdersRevenue-based penalties could be very large and disproportionate in some cases.
Why the argument around this bill splits.
Progressives stress chilling of legitimate safety petitions
Likely cautiously supportive of measures that speed generic competition and lower drug prices, but worried about chilling legitimate public-health petitions.
Concern centers on HHS referral presumption and limited judicial review possibly deterring safety or access complaints.
Would seek stronger safeguards for bona fide petitions raising patient safety or equity concerns.
Generally favorable because it targets abuse of regulatory processes and promotes competition, but cautious about procedural fairness.
Will emphasize need for clear standards, due process, and predictable penalty calculations to avoid unintended consequences.
Likely to support with modest clarifications or implementing guidance.
Supportive of measures that prevent competitors from gaming regulatory processes and promote market competition.
Skeptical about expanding FTC enforcement powers and potentially large penalties, and concerned about federal agencies gaining deference that limits judicial oversight.
Would favor preserving strong anti-delay tools but seek limits on agency discretion.
The path through Congress.
Reached or meaningfully advanced
Reached or meaningfully advanced
Still ahead
Still ahead
Still ahead
A narrowly focused, technocratic antitrust measure with bipartisan potential but significant stakeholder opposition and plausible legal challenges.
- Pharmaceutical industry lobbying intensity
- HHS willingness to make referrals regularly
Recent votes on the bill.
No vote history yet
The bill has not accumulated any surfaced votes yet.
Go deeper than the headline read.
Progressives stress chilling of legitimate safety petitions
A narrowly focused, technocratic antitrust measure with bipartisan potential but significant stakeholder opposition and plausible legal cha…
Relative to its intended legislative type, this bill establishes a substantive enforcement regime by making certain sham petitions an unfair method of competition enforceable by the FTC, defines key terms, sets out a pr…
Go beyond the headline summary with full stakeholder mapping, legislative design analysis, passage barriers, and lens-by-lens tradeoff breakdowns.