Senate Judiciary Committee Advances Bipartisan Bills to Address Drug Pricing and Competition

According to the National Law Review, the package addresses various regulatory and industry strategies that critics say restrict access to affordable medicines. The bills target practices by drug manufacturers, patent holders, and pharmaceutical benefit managers (PBMs).

Read more: Preparing for a Pharmacy Benefit Manager Insurance Business Model

Key measures include:

• Affordable Prescriptions for Patients Act
  • Limits the number of patents (up to 20) a biologics maker can assert in BPCIA litigation.
  • Court approval required to exceed the cap.
  • Treatment method patents are excluded from the limit.
  • Aims to reduce patent “thickets” that delay biosimilar competition.
  • Per the National Law Review, this builds on efforts to make patent litigation more predictable.
• Preserve Access to Affordable Generics and Biosimilars Act
  • Prohibits anticompetitive “pay-for-delay” settlements.
  • FTC authorized to take civil action and impose penalties.
  • Agreements where a generic or biosimilar receives “anything of value” (e.g., exclusive licenses) presumed anticompetitive.
  • Exceptions include reasonable litigation costs and agreed-upon early launches.
• Drug Competition Enhancement Act
  • Targets “product hopping,” where drugmakers switch formulations to sidestep generic competition.
  • Defines “hard switches” (withdrawals of older products) and “soft switches” (market manipulation to shift usage).
  • Certain manufacturer actions would remain protected if justified.
• Stop STALLING Act
  • Seeks to curb abuse of the FDA citizen petition process.
  • FTC could penalize sham petitions designed to delay generics.
  • Fines could reach $50,000 per day or the revenue of the branded product, whichever is higher.
  • According to the National Law Review, petitions would be judged by intent and reasonableness.
• Interagency Patent Coordination and Improvement Act
  • Establishes a task force between the FDA and USPTO.
  • Aims to improve how patent examiners access and use FDA application data.
  • Focus on ensuring examiners can identify prior public disclosures or sales.
• Prescription Pricing for the People Act
  • Requires the FTC to publish a report on PBM pricing and pharmaceutical supply chain practices.
  • Mandates an overview of complaints related to sole-source drug manufacturers.
  • Seeks to improve transparency and inform future enforcement actions.

All six bills received bipartisan backing in committee. While similar proposals have circulated in past sessions, the coordinated movement of this package marks a notable step forward in drug pricing reform.

Source: The National Law Review