Placed on Senate Legislative Calendar under General Orders. Calendar No. 46.
The bill bars "reverse payment" settlements that transfer value from brand drug or biologic manufacturers to prospective generic or biosimilar applicants when those applicants agree to delay market entry.
It adds a new FTC enforcement provision treating such agreements as unfair competition, creates a rebuttable presumption of illegality when value is exchanged for delaying activity, authorizes civil penalties (up to three times the value attributable to the violation), requires CEO certifications and expanded reporting to DOJ and the FTC, preserves narrow exceptions, and adds related procedural and notification changes including potential forfeiture of a 180-day exclusivity period.
Targeted, administrable antitrust fix with bipartisan language increases viability, but strong industry opposition and Senate procedural hurdles reduce probability.
Relative to its intended legislative type, this bill is a well-specified substantive statutory change that creates a new prohibition on certain settlement agreements, supplies detailed definitions, establishes enforcement and penalty regimes, and amends multiple related statutes to integrate the new rule into the existing legal framework. It couples substantive prohibition with procedural requirements (certification, notification) and a required FTC report.
Left emphasizes consumer price reductions; right emphasizes regulatory overreach and innovation risk.
Left emphasizes consumer price reductions; right emphasizes regulatory overreach and innovation risk.
Likely strongly supportive: sees the bill as closing a major loophole that lets pharmaceutical firms pay to delay cheaper competition.
Views it as consumer- and Medicare-protective and aligned with antitrust goals.
Generally favorable but cautious: the bill targets clear anticompetitive behavior while including exceptions.
Concerned about fine print, enforcement costs, and impacts on patent settlement efficiency.
Likely opposed or skeptical: views the bill as intrusive regulation that interferes with patent settlements and contract freedom.
Worried about expanded FTC authority and adverse effects on innovation and business certainty.
Reached or meaningfully advanced
Reached or meaningfully advanced
Still ahead
Still ahead
Still ahead
Targeted, administrable antitrust fix with bipartisan language increases viability, but strong industry opposition and Senate procedural hurdles reduce probability.
The bill has not accumulated any surfaced votes yet.
Left emphasizes consumer price reductions; right emphasizes regulatory overreach and innovation risk.
Targeted, administrable antitrust fix with bipartisan language increases viability, but strong industry opposition and Senate procedural hu…
Relative to its intended legislative type, this bill is a well-specified substantive statutory change that creates a new prohibition on certain settlement agreements, supplies detailed definitions, establishes enforceme…
Go beyond the headline summary with full stakeholder mapping, legislative design analysis, passage barriers, and lens-by-lens tradeoff breakdowns.