Citizen Portal
Sign In

Senate Judiciary Committee advances package of bills to curb drug-pricing tactics

2915012 · April 3, 2025

Loading...

AI-Generated Content: All content on this page was generated by AI to highlight key points from the meeting. For complete details and context, we recommend watching the full video. so we can fix them.

Summary

The Senate Judiciary Committee on the markup day reported a package of bills aimed at lowering prescription drug prices by targeting product-hopping, pay-for-delay deals, sham petitions and improving interagency patent coordination; most measures passed by voice vote while two amendments to the "Stop Stalling" bill failed on roll call.

The Senate Judiciary Committee reported out a package of measures intended to reduce prescription drug prices and speed generic and biosimilar entry, voting the bills out of committee for floor consideration.

Committee members said the package addresses several practices they say slow or block competition — including pay-for-delay agreements, product hopping, dense patenting strategies and frivolous or last‑minute petitions to federal agencies. The legislation also directs the Federal Trade Commission (FTC) to study pharmacy benefit managers (PBMs) and creates a task force to improve information sharing between the U.S. Patent and Trademark Office and the Food and Drug Administration.

Why it matters: Committee proponents said the bills are meant to make it easier for lower‑cost generics and biosimilars to reach patients, reduce abusive patent tactics that extend exclusivity, and increase transparency around PBMs and other intermediaries that affect drug prices.

What the committee did and key provisions

- S.527, the "Prescription Pricing for People Act of 2025": Requires the FTC to examine the roles of PBMs and other intermediaries in the prescription drug supply chain and recommend steps to improve competition and transparency. The committee approved S.527 by voice vote. Supporters noted the FTC is already investigating PBM conduct and said a directed study will bolster transparency.

- S.1040, the Drug Competition Enforcement Act: Prohibits "product hopping," where brand manufacturers shift patients to slightly altered products to impede generic entry. The committee approved the bill by voice vote; Senator Marsha Blackburn asked to be recorded as voting nay on S.1040, according to the clerk.

- S.1041, amendments to Title 35: Aims to limit strategic patent filings and streamline voluntary resolution paths for biologics and biosimilar litigation to speed competitors to market. Approved by voice vote.

- S.1097, the Interagency Patent Coordination Improvement Act of 2025: Establishes a task force and processes to improve information sharing between the Patent Office and FDA on patent matters affecting pharmaceuticals; approved by voice vote.

- S.1095, the "Stop Stalling Act": Targets sham citizen petitions filed to delay generic or biosimilar approvals. The committee approved the bill after two proposed amendments were rejected in roll call votes. One amendment (SIL5444), which would have removed a statutory presumption that an HHS referral indicates a sham petition, failed on a roll call with the chair announcing "ayes 3, nays 19." A second amendment (SIL54445) to change the penalty cap language from "revenue" to "net profits" also failed on a roll call. After those votes the committee reported S.1095 to the Senate floor.

- S.1096, the Preserve Access to Affordable Generics and Biosimilars Act (a pay‑for‑delay prohibition): Makes pay‑for‑delay agreements presumptively unlawful unless defendants convince a court the agreement is pro‑competitive. The committee approved S.1096 by voice vote.

Procedure and next steps

Committee leaders said these bills previously passed committee by voice in earlier Congresses but were not taken up on the Senate floor; they said they are sending the measures to the floor again and expect further procedural steps and potential amendments during floor consideration. Several senators urged careful drafting to avoid unintended impacts on innovation and to preserve legitimate patent protections.

Votes at a glance

- S.527 — Prescription Pricing for People Act of 2025 — Outcome: reported out by voice vote; Vote: voice; Notes: directs FTC study of PBMs. - S.1040 — Drug Competition Enforcement Act (product‑hopping) — Outcome: reported out by voice vote; Vote: voice; Recorded nay: Senator Marsha Blackburn. - S.1041 — Amendments to Title 35 (infringement by claimed purposes / patent thickets) — Outcome: reported out by voice vote; Vote: voice. - S.1097 — Interagency Patent Coordination Improvement Act of 2025 — Outcome: reported out by voice vote; Vote: voice. - S.1095 — Stop Stalling Act (sham petition deterrence) — Outcome: reported out; Vote: amendments voted down by roll call (SIL5444 failed 3‑19), final bill reported. - S.1096 — Preserve Access to Affordable Generics and Biosimilars Act (pay‑for‑delay) — Outcome: reported out by voice vote; Vote: voice.

Speakers who spoke on the bills emphasized bipartisan intent to address high drug prices while some members pressed for limits to avoid chilling legitimate patent activity or public‑interest petitions. Committee staff will transmit the reported bills to the Senate calendar for floor consideration.

Ending: The committee completed the markup and adjourned after reporting the package to the floor; sponsors said they will continue to refine bill text as the measures move through subsequent Senate procedures.