PASTEUR Act of 2026
- Bill Number
- S. 4875
- Origin Chamber
- Senate
- Congress
- 119th Congress, Session 2
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2026-06-23: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Last Updated
- 2026-07-09T21:06:00Z
AI-Generated Summary
Summary of S. 4875 (PASTEUR Act of 2026)
Purpose
The legislation aims to ensure the availability of innovative antimicrobial drugs by:
- Stimulating research, development, and market access for lifesaving medicines.
- Promoting appropriate use of such medicines.
- Maintaining high medical care standards.
- Enhancing national health system preparedness.
- Supporting defense of the United States and its military.
Key Provisions
- Contract Program: Authorizes the Secretary of Health and Human Services to enter into contracts with sponsors of eligible antimicrobials to ensure their availability. Eligibility requires the drug to treat an "urgent" or "serious" pathogen (per CDC reports or Secretary determination) and address an unmet medical need.
- Application and Scoring Process: Sponsors submit applications within 2 years of FDA approval or licensure. Applications are scored on three categories: contributions to patient care (e.g., improved outcomes, reduced toxicity), innovative characteristics (e.g., novel mechanisms, first-in-class status), and benefits to health systems/public health (e.g., U.S. manufacturing, reduced resistance burden). A minimum score threshold determines contract eligibility.
- Contract Requirements: Sponsors must ensure commercial availability and supply, report resistance data, develop education and stewardship plans, pursue international registration where needed, maintain supply chains, manufacture sufficient quantities, and follow manufacturing/environmental best practices.
- Annual Payments: Contracts provide annual payments of $75 million to $300 million (adjusted for inflation), reduced by U.S. net revenue from sales. Payments may terminate for market withdrawal, noncompliance, or failure to complete required studies. Pricing and revenue data remain confidential.
- Contract Term: Up to 10 years or until a generic or biosimilar version is marketed.
- Advisory Group: Establishes a 15-member Critical Need Antimicrobial Advisory Group (plus non-voting chair) with infectious disease physicians, experts, and patient advocates to consult on scoring and eligibility. Members must avoid conflicts of interest.
- Stewardship and Surveillance: Creates grant programs for antimicrobial stewardship in hospitals, skilled nursing facilities, and outpatient settings (prioritizing rural, tribal, and safety-net facilities). Expands CDC surveillance for antimicrobial use, resistance trends, and diagnostics data, with public reporting.
- Appropriations: Provides $6 billion for fiscal year 2026 (emergency-designated), with up to 6.5% allocated to stewardship and surveillance activities.
Significant Changes to Existing Law
- Amends Title III of the Public Health Service Act by adding Part X on novel antimicrobial supply contracts.
- Introduces a subscription-style payment model that decouples compensation from sales volume.
- Establishes new grant authorities and enhanced surveillance requirements not previously mandated in this form.
- Creates a dedicated advisory group and specific contract flexibilities outside standard federal procurement rules.
Potential Impacts
- Government Agencies: Increases responsibilities for HHS, CDC, FDA, CMS, and BARDA in contract administration, scoring, payments, grants, and data collection.
- Citizens: Improves access to new antimicrobials for resistant infections, supports stewardship to reduce resistance, and enhances public reporting on trends.
- International Relations: Encourages sponsors to register products in other countries with unmet needs; promotes coordination with other governments for similar incentives.
- Health Systems: Requires facilities to participate in surveillance modules and implement stewardship programs.
Main Stakeholders Affected
- Pharmaceutical and biotechnology sponsors developing antimicrobials.
- Healthcare facilities (hospitals, outpatient clinics, nursing homes) and professionals.
- Patients and patient advocacy groups.
- Federal agencies including CDC, FDA, and CMS.
- The Critical Need Antimicrobial Advisory Group.
Notable Legal, Constitutional, or Political Implications
- Designates funding as an emergency requirement under the Statutory Pay-As-You-Go Act and Senate budget rules.
- Includes protections against disclosure of trade secrets or confidential pricing information.
- Prohibits use of certain comparative clinical effectiveness research that values life extension differently based on age, disability, or terminal illness status.
- Grants the Secretary broad authority to enter contracts without regard to some standard federal contracting laws.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Sen. Bennet, Michael F. [D-CO]
Cosponsors (4)
Sen. Young, Todd [R-IN], Sen. Gillibrand, Kirsten E. [D-NY], Sen. Rounds, Mike [R-SD], Sen. Hickenlooper, John W. [D-CO]
Recent Actions
- 2026-06-23: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- 2026-06-23: Introduced in Senate
Bill Versions
- Pioneering Antimicrobial Subscriptions To End Upsurging Resistance Act of 2026 — issued 2026-06-23 — PDF (28 pages)