PASTEUR Act of 2026
- Sponsor
- Sen. Bennet, Michael F. [D-CO]
- Committees
- Health, Education, Labor, and Pensions Committee (primary)
- Last action
- Jun 23, 2026
Bottom line
The PASTEUR Act aims to combat the growing threat of antimicrobial resistance by creating a new market incentive for drug development and promoting responsible use and robust surveillance.
What it actually does
This bill establishes a novel subscription-style payment program for eligible antimicrobial drugs, aiming to incentivize their development and ensure availability by de-linking pharmaceutical company revenue from sales volume. It also creates grant programs for antimicrobial stewardship in healthcare facilities and expands federal surveillance of antimicrobial use and resistance data.
Proponents argue
Proponents argue this bill addresses a critical market failure in antimicrobial drug development, where the low volume and short duration of use for new antibiotics make them unprofitable, leading to a dwindling pipeline. The subscription model ensures a return on investment for developers, securing access to essential drugs for national health security, while also funding crucial stewardship and surveillance efforts.
Opponents contend
Potential opponents might argue that the subscription model could lead to excessive payments for drugs that might not see widespread use, creating a burden on taxpayers. Concerns could also be raised about the potential for moral hazard if drug companies are guaranteed payments regardless of sales volume, or if the scoring methodology is not sufficiently rigorous to ensure true innovation.
The bill is moderately detailed but accessible to an informed reader within a reasonable timeframe, allowing for a thorough evaluation of its mechanisms.
Section 2
Statement of Purpose
This section outlines the overarching goals of the Act, which include stimulating research, development, and market access to lifesaving medicines, ensuring their appropriate use, maintaining high medical care standards for American patients, promoting national health system preparedness, and defending the United States and its military. It sets the policy objectives for the entire bill.
Supporters argue
Supporters argue that clearly stating the purpose helps align all stakeholders towards the critical goal of combating antimicrobial resistance and protecting public health and national security.
Critics contend
No specific opposition is typically raised against a general statement of purpose, though critics might question if the subsequent provisions effectively achieve these stated goals.
Tradeoffs
None directly in the purpose statement itself, but it sets up the tension between market incentives and public health needs.
Section 3, adding new Section 399PP(a)
Authority to Enter into Contracts for Eligible Antimicrobials
This provision grants the Secretary of Health and Human Services the authority to enter into "subscription-style" contracts with sponsors of eligible antimicrobial drugs. The primary purpose is to ensure the availability of these drugs, addressing the market failure where traditional sales models do not adequately incentivize their development.
Section 3, adding new Section 399PP(b)
Eligibility Criteria for Antimicrobial Drugs
To qualify for a contract, an antimicrobial drug must meet specific criteria: it must treat a pathogen identified as an "urgent" or "serious" threat by the CDC's Antibiotic Resistance Threats report (or deemed appropriate by the Secretary in consultation with an Advisory Group), and it must address an unmet medical need. These criteria ensure that resources are focused on the most critical public health threats.
Section 3, adding new Section 399PP(d)
Quantitative Scoring Methodology for Eligible Antimicrobials
The Secretary, in consultation with an Advisory Group and other agencies, must establish a quantitative scoring methodology and a minimum scoring threshold for eligible antimicrobials. The score is calculated based on points awarded across three categories: major contributions to patient care (e.g., improved outcomes, reduced toxicity), innovative characteristics (e.g., new class of drugs, novel mode of action), and benefits to health systems and public health (e.g., U.S. manufacturing, reduced economic burden).
Section 3, adding new Section 399PP(e)
Contract Requirements for Sponsors
Sponsors receiving contracts must meet several conditions. These include ensuring commercial availability and sufficient supply in the U.S., tracking and publicly reporting drug resistance data, developing education strategies for appropriate use, submitting an appropriate use plan, planning for international registration where needed, ensuring a reliable supply chain (including shortage plans), manufacturing sufficient quantities, and abiding by best practices for controlling antimicrobial discharge during manufacturing.
Section 3, adding new Section 399PP(f)
Annual Payments Calculation and Termination
The Secretary will make annual payments to contract sponsors, ranging from $75 million to $300 million (adjusted for inflation), for the contract term. These payments are adjusted downward by the net revenue from U.S. sales of the antimicrobial. Payments can be terminated if the sponsor permanently withdraws the drug, materially fails to meet contract requirements after notice, or does not conduct required post-market studies. Confidentiality of disclosed pricing information is mandated.
Section 3, adding new Section 399PP-1
Establishment of Critical Need Antimicrobial Advisory Group
This section mandates the establishment of a 15-member Critical Need Antimicrobial Advisory Group within 60 days of enactment. Members, appointed by the Secretary, must include infectious disease physicians, experts in antimicrobial resistance/health economics/R&D, and patient advocates, with a non-voting Chair. Strict conflict of interest rules apply, prohibiting compensation from commercial antimicrobial developers during service and participation in matters affecting financial interests. The Advisory Group is subject to FACA but not its termination clause.
Section 3, adding new Section 399PP-2(a)
Health Facility Grant Program for Antimicrobial Stewardship
This provision establishes a grant program, run by the CDC Director, within one year of enactment. These grants support hospitals, skilled nursing facilities, and other healthcare facilities in judiciously using antimicrobial drugs (e.g., through stewardship programs, diagnostic tools, infection reporting) and participating in national surveillance networks. Priority is given to facilities without existing programs, rural hospitals, critical access hospitals, Tribal hospitals, and safety-net hospitals.
Section 3, adding new Section 399PP-2(c)
Surveillance and Reporting of Antimicrobial Use and Resistance Data
The CDC Director must use national surveillance systems to collect and assess trends in antimicrobial resistance and use (antibiotic and antifungal). This includes data on infection types, patient demographics, hospital stays, costs, mortality, and changes in resistance. The Secretary must also obtain reliable human antibiotic/antifungal consumption data by State or metropolitan areas, working with federal agencies and private entities. Efforts to collect resistance data from various healthcare facilities and diagnostics data are mandated. Public availability of this data through regular reports and near real-time updates is required starting two years after enactment.
Section 3, adding new Section 399PP-4
Authorization and Appropriation of Funds
This section authorizes and appropriates $6,000,000,000 for fiscal year 2026, to remain available until expended, to carry out the entire new part. Up to 6.5% of these funds can be used for the antimicrobial stewardship and surveillance programs (Section 399PP-2). The funds are designated as an emergency requirement under the Statutory Pay-As-You-Go Act of 2010 and in the Senate under H. Con. Res. 71 (115th Congress).
Mandates that information disclosed by sponsors for annual payment calculation (e.g., net revenue) be kept confidential by the Secretary and not disclosed to other entities or used for purposes other than payment calculation. It explicitly states this information is not subject to disclosure under FOIA (5 U.S.C. 552(b)(4)) or criminal statute (18 U.S.C. 1905).
Section 3, new Section 399PP(f)(3)
Why it matters:This is standard legislative practice to protect proprietary commercial information, which is often considered a trade secret. It's crucial for companies to participate without fear of competitive disadvantage.
Case for: Supporters argue that protecting proprietary pricing and revenue data is essential to encourage pharmaceutical companies to participate in the program, as they would be reluctant to share commercially sensitive information that could be used by competitors.
Case against: Critics might argue that such confidentiality reduces transparency regarding how taxpayer money is spent and makes it harder for the public to assess the true value and cost-effectiveness of the contracts.
Estimated impact: Ensures pharmaceutical company participation by protecting sensitive financial data, but limits public oversight of specific contract details.
Requires contract sponsors to abide by manufacturing and environmental best practices for controlling the discharge of antimicrobial active pharmaceutical ingredients (APIs) and other agents, specifically referencing the antibiotic manufacturing standard developed by the AMR Industry Alliance or seeking a sustainability certification from BSI Standards Limited.
Section 3, new Section 399PP(e)(8)
Why it matters:This is a technical requirement for manufacturing processes, which is often detailed in specific clauses rather than highlighted in summaries. It addresses a specific environmental concern related to drug production.
Case for: Proponents argue that controlling the environmental discharge of antimicrobials during manufacturing is crucial to prevent the spread of resistance in the environment, which can feedback into human health, making it an essential component of a comprehensive strategy.
Case against: Some manufacturers might argue that adhering to specific external standards adds compliance costs and complexity, potentially impacting the economic viability of producing these drugs.
Estimated impact: Aims to reduce environmental antimicrobial resistance, potentially increasing manufacturing costs for participating companies.
Designates the $6 billion appropriation as an "emergency requirement" under the Statutory Pay-As-You-Go Act of 2010 and, in the Senate, under H. Con. Res. 71 (115th Congress).
Section 3, new Section 399PP-4(c)
Why it matters:This is a procedural mechanism to exempt the spending from certain budget enforcement rules, often used for urgent or unforeseen needs. It's a technical legislative maneuver.
Case for: Proponents argue that the threat of antimicrobial resistance is an urgent public health and national security emergency, justifying the use of emergency designation to ensure immediate and sufficient funding without being constrained by regular budget caps.
Case against: Critics of emergency designations often argue that they can be used to bypass fiscal discipline and add to the national debt without proper offsets, even for important programs, setting a problematic precedent.
Estimated impact: Allows $6 billion in spending for FY2026 without requiring offsets under PAYGO rules, potentially increasing the national deficit.