Senate Judiciary advances bipartisan drug pricing bills

Legislation advanced

Approved by voice vote, the following six bills now move forward for full Senate consideration:

• Prescription Pricing for the People Act. Directs the Federal Trade Commission (FTC) to conduct a comprehensive 6(b) study on pharmacy benefit managers (PBMs) consolidation and pricing practices, with policy recommendations to Congress. Designed to improve transparency, competition and consumer protections in the drug supply chain.
• Drug Competition Enhancement Act. Targets product hopping by limiting brand manufacturers’ ability to shift patients to slightly altered versions of a drug before generics launch, preserving true market competition.
• Affordable Prescriptions for Patients Act. Cracks down on patent thickets by limiting excessive and overlapping patent filings used to delay generic and biosimilar entry.
• Interagency Patent Coordination and Improvement Act. Strengthens collaboration between the U.S. Patent and Trademark Office, FDA and FTC to identify and address anti-competitive patent practices earlier in the regulatory process.
• The Stop STALLING (Significant and Time-Wasting Abuse Limiting Legitimate Innovation of New Generics) Act. Seeks to prevent tactics that delay FDA approval of generics, such as frivolous citizen petitions and other regulatory stalling mechanisms.
• Preserve Access to Affordable Generics and Biosimilars Act. Prohibits "pay-for-delay" agreements, where brand-name drugmakers compensate generic firms to postpone market entry.

Targeted tactics

The legislative package targets the following patent strategies lawmakers say drugmakers use to extend exclusivity and block generic or biosimilar competition:

• Product hopping. Slightly changing a drug (i.e., form or dosage) to get a new patent and delay generics from entering the market.
• Patent thickets. Filing numerous overlapping patents on a single drug to create legal barriers and delay generic or biosimilar entry.
• Serial patent filings. Repeatedly filing new patents over time to extend exclusivity and delay competition as older patents expire.
• Pay-for-delay agreements. Brand-name drugmakers pay generic manufacturers to postpone launching lower-cost alternatives.
• Regulatory gaming. Exploiting FDA processes, such as filing last-minute citizen petitions, to delay approval of generics or biosimilars.

Industry implications

If passed, this legislation would represent one of the most aggressive efforts in recent years to curb anti-competitive behavior in the pharmaceutical industry. Branded drugmakers may face increased scrutiny over their patenting and litigation strategies, while PBMs may see new regulatory oversight tied to pricing transparency and consolidation.

For regulatory affairs, legal teams and commercial strategists, this package signals a potential shift in the risk environment, especially for high-value biologics and long-established therapies that rely heavily on secondary patents and exclusivity extensions.

Industry response

While major industry groups have yet to issue formal responses, pushback is expected. Stakeholders might argue that some of these patent strategies protect innovation and provide essential incentives for drug development.

At the same time, lawmakers and public health advocates continue to emphasize the cost burden on patients and the systemic barriers generics and biosimilars face in entering the market.

Still, the legislative momentum is real, especially with bipartisan support and broad public concern about drug pricing.

The Judiciary Committee's message is clear: the rules of the game may soon change. How the industry adapts, or fails to, could shape future market dynamics.