Congress moves to strip patents from high-priced drugs, unleashing generics

What it does

This bill directs the Secretary of Health and Human Services to identify brand-name drugs with 'excessive' prices by comparing U.S. prices to those in Canada, the UK, Germany, France, and Japan, and to consider factors like patient population size, therapeutic value, and R&D costs. When a drug is deemed excessively priced, the government must waive patent protections and grant open licenses allowing generic and biosimilar manufacturers to produce the drug, paying only a reasonable royalty to the original patent holder. The bill also requires drug manufacturers to report detailed pricing and R&D data annually, establishes a public database of excessive-price determinations, and imposes civil penalties on manufacturers who fail to report or provide false information.

Why we flagged it

The bill's core function is to empower the Secretary to identify excessively priced drugs and strip patent protections to enable generic/biosimilar competition. This is fundamentally a price-control and intellectual-property-waiver mechanism, not merely a transparency or reporting measure.

What the text implies

• The bill grants the Secretary broad discretion to define 'excessive price' using multiple subjective factors (therapeutic value, patient population size, cumulative global revenues, etc.), creating potential for inconsistent or politically influenced determinations without explicit appeal or judicial review standards.
• Waiving patent exclusivity and granting open licenses may reduce incentives for pharmaceutical R&D investment in future drugs, particularly for rare diseases or high-risk therapeutic areas where patient populations are small and development costs are high.
• The royalty-rate mechanism allows the Secretary to set rates 'taking into account' government subsidies and R&D recovery, potentially creating a precedent for government price-setting in other industries and raising constitutional takings concerns.
• Manufacturers face civil penalties of 0.5–1% of annual drug revenues multiplied by days of reporting delay, which could accumulate to tens of millions of dollars for large-revenue drugs, creating strong pressure to comply but also potential for disproportionate punishment.
• The public database and annual congressional reports will expose detailed R&D costs, marketing spend, and global revenue data, which competitors and foreign governments may use to inform pricing strategies or trade negotiations, potentially undermining U.S. negotiating leverage.

Who it affects

Ordinary citizens stand to benefit from lower drug prices through generic and biosimilar competition triggered by excessive-price determinations, reduced out-of-pocket costs, and increased access to affordable medications. The mechanism directly targets high-priced brand-name drugs and creates a pathway for cheaper alternatives, which is a clear public health and consumer benefit.

Who stands to gain

• generic drug manufacturers
• biosimilar manufacturers
• pharmacy benefit managers (PBMs)
• health insurance companies
• Medicare and Medicaid programs
• patients and consumers

Named in the bill

HHS Secretary, FDA, NIH, Pfizer (PFE), Bristol Myers Squibb (BMY), Guardant Health (GH), West Pharmaceutical Services (WST), DaVita (DVA), Canada, United Kingdom, Germany, France — and 3 more

Where it stands

4 cosponsors: 4 Democrats.

• May 21, 2025 — Introduced · Congress.gov: “Introduced in House”
• May 21, 2025 — Referred to House Committee on the Judiciary and House Committee on Energy and Commerce · Congress.gov: “Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a…”

Dates and quoted wording are Congress.gov's action record; the timeline shows status changes, not every procedural step.

Money around this bill

2 lobbying clients named this bill on 3 disclosure filings across 2 quarters, Dec 2025 to Jun 2026. Those filings disclosed $3,850,000 in lobbying spend. A filing names 10 bills on average, so that figure is what each filing reported, not a share belonging to this bill.

More lobbying clients named this bill than 41% of bills with at least one filing.

Ro Khanna, the sponsor, reported $0 in PAC receipts in the 2026 cycle.

• America's Health Insurance Plans Inc (ahip) — $3,010,000 on 1 filing
• Grifols Shared Services North America Inc — $840,000 on 2 filings

Lobbying Disclosure Act filings through Jul 20, 2026. A filing shows who paid to lobby on a bill it names, not what changed.