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HR 10094

Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2026

119th Congress Introduced by Greg Casar and 12 co-sponsors

The bill requires federal-funded biomedical products to have pricing agreements that limit U.S. prices to international reference prices and uses gov’t oversight to enforce afforda

Introduced in House
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Bill Summary · HR 10094

Overview

  • Bill: HR 10094, the Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2026
  • Introduced in the 119th Congress (August 13, 2026) by Rep. Hoyle (and several co-sponsors)
  • Status: Referred to the House Committee on Energy and Commerce
  • Core aim: Require entities engaging in federally funded R&D of biomedical products or services to enter into reasonable pricing agreements with the Secretary of Health and Human Services (HHS), potentially limiting prices for U.S. residents relative to international reference prices.

Main Purpose and Intent

  • To ensure that biomedical products or services developed with federal research funding are priced reasonably.
  • To tie pricing to government oversight, with the Secretary of HHS empowered to define what is “reasonable” and to enforce pricing provisions in research agreements, licenses, and related rights.
  • To promote affordability for U.S. patients by benchmarking prices against international reference prices and applying additional pricing mechanisms if needed.

Key Provisions and Changes

  • Section 2: Reasonable Price Agreement

    • General requirement: Any federal funding agreement (grants, contracts, cooperative agreements, or other agreements) or licenses conveying patent rights or regulatory test data for a biomedical product or service must include a provision that the product/service price be reasonable, unless waived by the Secretary.
    • High-level pricing safeguard: Prices charged to U.S. residents must not exceed the reference price for large-economy, high-income countries.
    • Reference price definition: Based on the median price charged in Canada and the six other reference countries with large economies and high incomes, or a regulatory-adjusted modification if the Secretary deems it appropriate after notice and public comment.
    • Additional requirements (Secretary’s rulemaking authority): The Secretary may add rules to ensure price reasonableness, balancing incentives for R&D with access concerns, and addressing complexities when third parties control relevant IP or know-how.
    • Possible pricing mechanisms: Mechanisms may include lowering prices or shortening exclusivity periods when targets are met, pricing tied to cost per health benefit achieved, or lowering prices when high costs create access or financial burdens. Combinations of mechanisms are allowed.
    • Waiver authority: The Secretary can grant waivers if in the public interest. Waivers require public notice, opportunity for comment (including at a public hearing), and an economic analysis justifying the waiver.
    • Transparency and reporting: Manufacturers must report to the Secretary:
    • Costs of clinical trials supporting regulatory approval
    • Federal subsidies of those costs
    • Annual revenues by product/service and country of sale
    • Reports must be publicly available
    • No impact on existing requirements: The pricing provisions supplement, but do not replace, other federal or patent-related affordability requirements (e.g., pricing standards in contracts or bayed U.S. Code standards for making government-funded inventions available to the public on reasonable terms).

  • Definitions (Section 2, Subsection g)

    • “Biomedical product or service” includes drugs, vaccines, medical devices, diagnostic tests, assistive technology, cell- or gene-based therapies, and other health-care technologies.
    • “Medical device” aligns with the FDA’s definition in 21 U.S.C. § 321.
    • “Secretary” refers to the Secretary of Health and Human Services.
    • “Six reference countries” are the six non-Canada OECD countries with the largest GDPs and at least 50% of the U.S. per capita income, over the prior three calendar years.

Who Would Be Affected

  • Federal agencies funding biomedical R&D, through grants, contracts, cooperative agreements, or licenses, would incorporate reasonable pricing obligations.
  • Researchers, manufacturers, and other entities developing biomedical products or services with federal support would need to enter pricing agreements and potentially adjust pricing structures to comply.
  • Entities seeking exclusive rights or regulatory data licenses for federally funded innovations would be subject to the price-reasonableness criteria.
  • Government disclosure and transparency requirements would affect firms by mandating reporting of trial costs, federal subsidies, and revenue by country.

Procedural and Timeline Aspects

  • Waivers: If invoked, waivers require:
    • Public notice and written/public comment opportunity
    • Public hearing (if requested)
    • An economic analysis published to justify the waiver
  • Transparency: Implemented reporting and publication requirements would trigger ongoing disclosure and public accessibility of cost, subsidy, and revenue data.
  • Regulatory Process: The Secretary would have authority to issue regulations expanding or detailing the reasonable pricing requirements and the mechanisms to enforce them.
  • Effective date: Not specified in the text provided; typical implementation would follow final rulemaking if enacted, but this detail is not stated.

Additional Observations

  • The bill emphasizes balancing patient access with incentives for biomedical innovation by allowing the Secretary to tailor requirements and consider economic impacts.
  • It introduces a global price comparison framework (reference pricing) to prevent U.S. price inflation relative to other high-income countries.
  • The bill currently focuses on processes and authority; final law would depend on passage and any negotiated amendments during the legislative process.

If you’d like, I can add a concise pros/cons breakdown or compare this bill to existing price-regulation proposals.

Compiled from official sources — confirm details with the bill’s official record.

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