PASTEUR Act of 2026
- Sponsor
- Rep. Carter, Earl L. "Buddy" [R-GA-1]
- Committees
- Energy and Commerce Committee (primary)
- Last action
- Feb 4, 2026
Bottom line
The PASTEUR Act aims to stimulate the development and ensure the availability of new antimicrobial drugs by offering predictable, subscription-based payments, while also promoting responsible use and surveillance.
What it actually does
This bill, the PASTEUR Act of 2026, establishes a program within the Public Health Service Act to incentivize the development of novel antimicrobial drugs. It authorizes the Secretary of Health and Human Services to enter into subscription-style contracts with drug sponsors, providing annual payments for eligible antimicrobials that address urgent or serious public health threats. The bill also includes provisions for antimicrobial stewardship programs, enhanced surveillance of resistance, and specific manufacturing requirements for contract recipients.
Proponents argue
Supporters argue that the current market for antimicrobials fails to adequately incentivize the development of new drugs due to low sales volume and short treatment durations, leading to a critical shortage in the fight against antimicrobial resistance. They contend that a 'pull' incentive like this subscription model provides the necessary financial predictability to de-risk R&D, ensuring a pipeline of lifesaving medicines and strengthening national health preparedness against superbugs.
Opponents contend
Critics may contend that the proposed subscription model represents a significant cost to taxpayers, potentially leading to overpayment for drugs that might otherwise be developed through traditional market mechanisms or existing incentive programs. Concerns could also be raised about the potential for market distortion, the effectiveness of the scoring methodology in identifying truly innovative drugs, and whether the emergency designation for funding bypasses appropriate budgetary scrutiny.
The bill is moderately complex due to its technical language regarding contract mechanisms and regulatory requirements, but it is concise enough that an informed reader can grasp its core provisions within the time typically allotted for legislative review.
Sec. 3, new Sec. 399PP(a)-(b)
Establishment of U.S. Novel Antimicrobial Supply Contracts
This provision authorizes the Secretary of Health and Human Services to enter into contracts with sponsors of eligible antimicrobial drugs. To be eligible, a drug must treat a pathogen identified as an 'urgent' or 'serious' threat by the CDC or deemed appropriate by the Secretary, and address an unmet medical need.
Supporters argue
Supporters argue that this contract mechanism directly addresses the market failure in antimicrobial development by providing a predictable revenue stream, thereby incentivizing companies to invest in this critical, but often unprofitable, area.
Critics contend
Critics might argue that this represents significant government intervention in the pharmaceutical market, potentially distorting competition or leading to overpayment for drugs that might have been developed anyway.
Tradeoffs
The provision seeks to balance the need for innovation in a public health crisis with concerns about government spending and market efficiency.
Sec. 3, new Sec. 399PP(c)-(d)
Application and Scoring Methodology for Eligible Antimicrobials
This section details the process for drug sponsors to apply for a contract, requiring submission within two years of FDA approval or licensure. It mandates the Secretary, in consultation with an Advisory Group, to establish a quantitative scoring methodology based on criteria such as contributions to patient care, innovative characteristics, and benefits to health systems and public health. A minimum scoring threshold must be met for contract eligibility.
Sec. 3, new Sec. 399PP(e)
Contract Requirements for Drug Sponsors
As a condition for receiving a contract, drug sponsors must ensure commercial availability and sufficient supply of the antimicrobial in the U.S., track and report drug resistance data, develop education strategies for appropriate use, submit plans for international registration, ensure a reliable supply chain, and adhere to best practices for manufacturing and environmental control of antimicrobial discharge.
Sec. 3, new Sec. 399PP(f)-(g)
Annual Payments and Contract Term
The Secretary will make annual payments to contract recipients, ranging from $75 million to $300 million (adjusted for inflation), reduced by net U.S. sales revenue. Payments can be terminated for market withdrawal, material non-compliance, or failure to conduct postmarket studies. Contracts last for 10 years or until a generic/biosimilar equivalent is approved and marketed.
Sec. 3, new Sec. 399PP-1
Critical Need Antimicrobial Advisory Group Establishment
This section mandates the Secretary to establish a 15-member Critical Need Antimicrobial Advisory Group within 60 days. The group will consist of infectious disease physicians, experts in antimicrobial resistance/health economics/R&D, and patient advocates, with a non-voting Chair. Members are prohibited from receiving compensation from commercial antimicrobial developers during their term and must avoid conflicts of interest.
Sec. 3, new Sec. 399PP-2(a)-(b)
Antimicrobial Stewardship Grant Programs
This section establishes two grant programs: one for hospitals, skilled nursing facilities, and other healthcare facilities to support antimicrobial stewardship efforts (prioritizing rural, critical access, Tribal, and safety-net hospitals); and a pilot program for outpatient facilities (physicians, urgent care, retail clinics) to implement or expand stewardship programs, with a report to Congress on its impacts.
Sec. 3, new Sec. 399PP-2(c)
Enhanced Surveillance and Public Reporting of Antimicrobial Use and Resistance Data
This section directs the CDC to expand its use of the National Healthcare Safety Network and other surveillance systems to collect comprehensive data on antimicrobial resistance trends, antibiotic and antifungal use (including consumption and prescription data by State/metro areas), and diagnostic test usage. The collected data must be made publicly available through regular reports and web updates, with efforts to provide near real-time access.
Sec. 3, new Sec. 399PP-4
Authorization and Appropriation of Funds
This section authorizes and appropriates $6,000,000,000 from the Treasury for fiscal year 2026, to remain available until expended, to carry out the provisions of this part. Up to 6.5 percent of these funds may be used for the antimicrobial stewardship and resistance combating programs established in section 399PP-2. The amounts are designated as an emergency requirement.
The bill defines 'contract' as 'a transaction other than a procurement contract, grant, or a cooperative agreement.'
Sec. 3, new Sec. 399PP-3(2)
Why it matters:This phrasing is standard legislative practice to grant the Secretary maximum flexibility in structuring the financial agreements, potentially allowing for more innovative or less bureaucratic arrangements than traditional federal contracting vehicles.
Case for: Supporters would argue this flexibility is crucial for designing a novel 'pull' incentive that can adapt to the unique challenges of the antimicrobial market, avoiding the rigidities of traditional procurement.
Case against: Critics might argue that this broad definition could reduce transparency and oversight compared to standard procurement contracts, potentially leading to less accountability for how federal funds are spent.
Estimated impact: This definition impacts the administrative and legal framework under which billions of dollars in contracts will be awarded, affecting the level of oversight and the speed of implementation.
The Secretary is granted authority to enter into contracts 'without regard to such provisions of law or regulations relating to the making, performance, amendment, or modification of contracts of the United States, as the Secretary may determine to be inconsistent with the furtherance of the purposes of this part.'
Sec. 3, new Sec. 399PP(i)
Why it matters:This is a significant grant of executive discretion, likely intended to expedite the program and overcome potential bureaucratic hurdles. While common in emergency or high-priority legislation, it can also be seen as an attempt to bypass standard checks and balances.
Case for: Proponents would argue this authority is essential to rapidly implement a novel program addressing an urgent public health crisis, allowing the Secretary to cut through red tape and adapt quickly to unforeseen challenges.
Case against: Critics would contend that such broad waiver authority undermines accountability and transparency in federal contracting, potentially opening the door to mismanagement or favoritism without adequate oversight.
Estimated impact: This provision significantly impacts the administrative and legal oversight of all contracts under this program, potentially streamlining processes but also reducing traditional safeguards.
A rule of construction states that nothing in the subsection authorizes the Secretary to use comparative clinical effectiveness research in a manner that treats extending the life of an elderly, disabled, or terminally ill individual as of lower value than extending the life of an individual who is younger, nondisabled, or not terminally ill for the purposes of calculating annual payments.
Sec. 3, new Sec. 399PP(f)(5)
Why it matters:This is a politically sensitive carve-out, likely included to address concerns from patient advocacy groups and prevent potential discrimination in how drug value is assessed, particularly in the context of health economics and comparative effectiveness research.
Case for: Proponents would argue this ensures that the program's payment calculations are ethically sound and do not inadvertently devalue the lives of vulnerable populations, upholding principles of equitable healthcare access.
Case against: No specific opposition is typically raised against such ethical safeguards, though some might argue that it could complicate economic modeling if certain health economic methodologies are constrained.
Estimated impact: This provision ensures that the valuation of antimicrobial drugs for payment purposes does not incorporate age, disability, or terminal illness as factors for reduced value, impacting the ethical framework of the program.
Contract recipients must 'abide by manufacturing and environmental best practices for the control of discharge of antimicrobial active pharmaceutical ingredients and other antimicrobial agents or products, including the antibiotic manufacturing standard developed by the AMR Industry Alliance... or seeking a sustainability certification from BSI Standards Limited.'
Sec. 3, new Sec. 399PP(e)(8)
Why it matters:This provision addresses a growing concern about the environmental contribution to antimicrobial resistance, particularly from manufacturing waste. Its inclusion reflects a comprehensive approach to AMR, but its technical nature and placement might lead a casual reader to miss its importance.
Case for: Supporters argue this is a crucial step to combat antimicrobial resistance globally, as environmental contamination from manufacturing can drive resistance. It promotes responsible corporate practices.
Case against: Some manufacturers might argue that adhering to these specific standards could impose significant additional costs, particularly for facilities in developing countries, potentially impacting the overall cost of drug production.
Estimated impact: This provision could lead to improved environmental practices in antimicrobial manufacturing worldwide, reducing the spread of resistance genes from industrial discharge.