PASTEUR Act of 2026
- Bill Number
- H.R. 7352
- Origin Chamber
- House
- Congress
- 119th Congress, Session 2
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2026-02-04: Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Budget, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- Last Updated
- 2026-07-09T21:05:55Z
AI-Generated Summary
Purpose This legislation amends the Public Health Service Act to create a federal program that supports the development and sustained availability of new antimicrobial drugs. The stated goals are to stimulate research into treatments for resistant pathogens, promote appropriate use of such medicines, maintain high standards of patient care, enhance national health preparedness, and support U.S. defense needs.
Key Provisions
- Contract Program: The Secretary of Health and Human Services may enter into contracts with sponsors of eligible antimicrobials. Eligibility requires the drug to target pathogens listed as “urgent” or “serious” threats by the CDC or deemed appropriate by the Secretary, and to address an unmet medical need.
- Application and Scoring: Sponsors submit applications within two years of FDA approval or licensure. A quantitative scoring system evaluates three categories: contributions to patient care (e.g., improved outcomes, reduced toxicity), innovative characteristics (e.g., novel mechanism or first-in-class status), and benefits to health systems (e.g., U.S. manufacturing capability, reduced resistance burden). Contracts are awarded only if the score meets or exceeds a minimum threshold.
- Contract Requirements: Sponsors must ensure commercial availability and supply in the U.S., report resistance data, implement stewardship education, submit appropriate-use plans, maintain reliable supply chains, follow manufacturing and environmental standards, and meet production volumes.
- Annual Payments: Fixed payments range from $75 million to $300 million per year (adjusted for inflation), reduced by U.S. net revenue from sales. Payments continue for up to 10 years or until a generic or biosimilar version is marketed.
- Advisory Group: A 15-member Critical Need Antimicrobial Advisory Group, including infectious disease physicians, experts, and patient advocates, assists with scoring and eligibility determinations.
- Stewardship and Surveillance: New grant programs support antimicrobial stewardship in hospitals, skilled nursing facilities, and outpatient settings. The CDC must expand surveillance of antimicrobial use and resistance through the National Healthcare Safety Network.
- Funding: $6 billion is appropriated for fiscal year 2026, with up to 6.5 percent available for stewardship activities. The funding is designated an emergency requirement.
Significant Changes to Existing Law The bill adds a new Part X to Title III of the Public Health Service Act, establishing a subscription-style contract mechanism that decouples manufacturer revenue from sales volume. It introduces mandatory scoring criteria, contract conditions, and confidentiality protections for pricing information not previously required under existing antimicrobial approval or surveillance authorities.
Potential Impacts
- Government Agencies: The Department of Health and Human Services, CDC, FDA, CMS, and BARDA gain new responsibilities for contract administration, scoring, payments, grants, and data collection.
- Citizens: Patients may gain access to new antimicrobials for resistant infections, while stewardship requirements aim to slow resistance development and improve appropriate prescribing.
- International Relations: Sponsors may be asked to register products in other countries with unmet needs, though the program focuses primarily on U.S. availability and supply.
Main Stakeholders Affected
- Sponsors and manufacturers of antimicrobial drugs.
- Health care facilities, physicians, and outpatient providers implementing stewardship programs.
- Patients and patient advocates.
- Federal agencies involved in public health and drug regulation.
- The Critical Need Antimicrobial Advisory Group.
Notable Legal, Constitutional, or Political Implications The legislation includes a rule of construction prohibiting the use of certain comparative clinical effectiveness data in payment calculations in ways that could disadvantage elderly, disabled, or terminally ill patients. Advisory Group members face strict conflict-of-interest rules. Pricing and revenue data submitted for payment calculations receive confidentiality protections. The bill designates the appropriation as an emergency requirement under statutory budget rules.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Rep. Carter, Earl L. "Buddy" [R-GA-1]
Cosponsors (23)
Rep. Peters, Scott H. [D-CA-50], Rep. Langworthy, Nicholas A. [R-NY-23], Rep. Levin, Mike [D-CA-49], Rep. Carey, Mike [R-OH-15], Rep. Fitzpatrick, Brian K. [R-PA-1], Rep. Ross, Deborah K. [D-NC-2], Rep. Sewell, Terri A. [D-AL-7], Rep. Smith, Christopher H. [R-NJ-4], Rep. Smith, Adrian [R-NE-3], Rep. Houlahan, Chrissy [D-PA-6], Rep. Auchincloss, Jake [D-MA-4], Rep. Bacon, Don [R-NE-2], Rep. Clarke, Yvette D. [D-NY-9], Rep. Valadao, David G. [R-CA-22], Rep. Meuser, Daniel [R-PA-9], Rep. Gottheimer, Josh [D-NJ-5], Rep. Mrvan, Frank J. [D-IN-1], Rep. McBath, Lucy [D-GA-6], Rep. Raskin, Jamie [D-MD-8], Rep. Quigley, Mike [D-IL-5], Rep. Craig, Angie [D-MN-2], Rep. Fleischmann, Charles J. "Chuck" [R-TN-3], Rep. Salazar, Maria Elvira [R-FL-27]
Recent Actions
- 2026-02-04: Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Budget, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- 2026-02-04: Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Budget, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- 2026-02-04: Introduced in House
- 2026-02-04: Introduced in House
Bill Versions
- Pioneering Antimicrobial Subscriptions To End Upsurging Resistance Act of 2026 — issued 2026-02-04 — PDF (28 pages)