PASTEUR Act of 2026

The PASTEUR Act of 2026 amends the Public Health Service Act to establish a program for developing innovative antimicrobial drugs targeting the most challenging pathogens and threatening infections, aiming to ensure availability, stimulate research, promote appropriate use, maintain medical care standards, and defend national health security.

Sec. 3, Developing antimicrobial innovations: The Secretary may enter into contracts with sponsors of eligible antimicrobials that treat urgent or serious threats from CDC reports or determined by the Secretary, and address unmet medical needs. Sponsors must apply within 2 years of approval. The Secretary reviews applications within 90 days, denies those below a minimum scoring threshold, and approves others to calculate annual payments. A scoring methodology is established by regulation, with points in three categories: contributions to patient care, innovative characteristics, and benefits to health systems and public health. Contract requirements include ensuring commercial availability, sufficient supply, reporting resistance data, developing education strategies, submitting appropriate use plans, ensuring reliable supply chains, manufacturing adequate volumes, and following environmental best practices. Annual payments range from $75 million to $300 million, adjusted for inflation and net revenue, and may be terminated for withdrawal, material failure, or lack of due diligence on postmarket studies. Contract terms last up to 10 years or until a generic or biosimilar is marketed. The Secretary must also encourage other governmental bodies to offer similar incentives.

Sec. 399PP-1, Critical Need Antimicrobial Advisory Group: The Secretary establishes a 15-member advisory group within 60 days, including physicians board-certified in infectious diseases, experts in antimicrobial resistance or health economics, patient advocates, and a non-voting chair. Members cannot receive compensation from commercial antimicrobial developers, and must avoid conflicts of interest. The Federal Advisory Committee Act applies, but the group is not subject to termination under that Act.

Sec. 399PP-2, Encouraging appropriate use of antimicrobials and combating resistance: The Secretary establishes a grant program within 1 year to support hospitals and health care facilities in judiciously using antimicrobials, including appropriate use programs, diagnostic tools, and participation in CDC surveillance systems. Priority is given to facilities without existing programs, rural hospitals, critical access hospitals, Tribal-serving hospitals, and safety-net hospitals. A pilot program for outpatient facilities is established within 2 years, making grants to physicians, hospital outpatient departments, urgent care settings, and retail clinics, with prioritization for urgent care and retail clinics. A report to Congress is due within 5 years. The Secretary also uses CDC surveillance systems to collect data on antimicrobial resistance and use, including consumption data by state or metropolitan area, and expands efforts to collect resistance data across all health care settings.