HR3546-119

What This Bill Does

The Prescription Drug Price Relief Act of 2025 requires HHS to establish within 30 days a process to review all brand-name drugs at least annually for excessive prices. A drug is excessive if its domestic average manufacturer price exceeds the median price in the five reference countries: Canada, the United Kingdom, Germany, France, and Japan, where pricing information exists for at least three countries. HHS may also find a price excessive based on patient population, patient value and access, therapeutic benefit, federal subsidies and investments, R&D recovery, and other factors. For an excessively priced drug, HHS must waive or void government-granted exclusivities and grant open, nonexclusive licenses allowing any person to make, use, sell, import, and rely on regulatory test data for the drug. FDA must prioritize review and act within eight months on generic or biosimilar applications referencing licensed drugs. HHS may sue manufacturers that raise prices after an excessive-price determination before license-based competition begins. Licensees pay reasonable royalties capped by IRS pharmaceutical royalty averages or set by HHS based on patient value, population, public investment, health improvement, R&D recovery, and affordability for federal, state, local, and nongovernmental purchasers. HHS must maintain a public database of brand-name drugs, determinations, petitions, licenses, and generic or biosimilar applications and report annually to Congress. Manufacturers must report U.S. and reference-country prices, revenues, R&D spending, federal subsidies, patents, exclusivities, and related information. Manufacturers may not engage in FTC Act section 5 anticompetitive conduct that interferes with licenses or affordable prescription drug availability.

Who Benefits and How

U.S. prescription-drug patients benefit if excessive-price findings trigger generic or biosimilar competition and lower prices. Generic drug manufacturers benefit from open nonexclusive licenses and prioritized FDA review. Biosimilar manufacturers benefit from the same license path for excessively priced biologics. Federal health programs benefit if royalty-capped competition lowers drug purchasing costs. State Medicaid programs benefit from public excessive-price data and potential lower net drug costs.

Who Bears the Burden and How

Brand-name pharmaceutical manufacturers can lose exclusivities, face open licenses, report detailed financial data, and face lawsuits for post-determination price hikes. Patent holders and drug approval holders receive only reasonable royalties rather than monopoly returns for excessive-price drugs. HHS staff must run annual reviews, excessive-price determinations, licenses, royalties, public database updates, and congressional reports. FDA staff must prioritize and act within eight months on generic and biosimilar applications tied to licensed drugs. FTC enforcement staff must monitor anticompetitive behavior that interferes with the license system.

Key Provisions

• Requires annual excessive-price reviews of brand-name drugs using five reference countries.
• Voids government-granted exclusivities and grants open nonexclusive licenses for excessive-price drugs.
• Requires prioritized FDA review within eight months for related generic and biosimilar applications.
• Creates reasonable royalty rules for patent and approval holders.
• Requires a public excessive drug price database and annual congressional reports.
• Requires manufacturer reporting on prices, revenues, R&D spending, subsidies, patents, and exclusivities.
• Prohibits anticompetitive behavior that interferes with open licenses or affordable drug availability.