HR7352-119

What This Bill Does

The PASTEUR Act creates a new Public Health Service Act part for U.S. novel antimicrobial supply contracts. HHS may contract with sponsors of eligible antimicrobials that treat CDC urgent or serious antimicrobial-resistance threats, or other HHS-designated pathogens, and address an unmet medical need. Sponsors must apply within two years after FDA approval or licensure, HHS must review applications within 90 days, and HHS must issue scoring regulations within 270 days using patient-care value, innovation, domestic manufacturing, product stability, resistance activity, and public-health benefit. Approved products receive subscription-style annual payments for up to 10 years, calculated by regulation, no less than $75 million and no more than $300 million per year before CPI adjustment, reduced by U.S. net revenue. In exchange, sponsors must keep the drug commercially available, maintain supply for susceptibility-test device manufacturers, report resistance data, educate clinicians and patients, submit stewardship and global registration plans when requested, address shortages, manufacture adequate volume, and meet manufacturing and environmental best practices. The bill also creates a 15-member Critical Need Antimicrobial Advisory Group with conflict-of-interest rules, establishes CDC-backed health-facility stewardship grants and outpatient stewardship pilots, and appropriates $6 billion for fiscal year 2026, with up to 6.5 percent available for stewardship grants.

Who Benefits and How

Antimicrobial drug sponsors, biotech companies, pharmaceutical manufacturers, infectious-disease patients, hospitals without stewardship programs, rural hospitals, critical access hospitals, Tribal hospitals, safety-net hospitals, urgent care clinics, hospital outpatient departments, retail clinics, infectious-disease clinicians, CDC surveillance programs, and the U.S. military benefit from a pull incentive for new antimicrobials and funding to improve appropriate use. Patients benefit indirectly because the payment model rewards availability of drugs that may not generate large sales if used carefully.

Who Bears the Burden and How

HHS, CDC, CMS, BARDA, FDA, the Critical Need Antimicrobial Advisory Group, contract antimicrobial sponsors, health care facilities receiving grants, outpatient stewardship grantees, and federal taxpayers bear the implementation and funding burden. Sponsors must accept supply, resistance-reporting, education, stewardship, shortage, manufacturing-volume, environmental, and revenue-disclosure obligations to receive payments.

Key Provisions

• Creates HHS contracts for eligible antimicrobials that address CDC urgent or serious threats or other HHS-designated pathogens and unmet medical needs.
• Requires HHS to score eligible antimicrobials by patient-care benefit, innovation, and public-health or health-system value before awarding contracts.
• Authorizes annual subscription payments of $75 million to $300 million, CPI-adjusted and reduced by U.S. net revenue, for contract terms lasting up to 10 years.
• Requires sponsors to maintain U.S. commercial availability, supply susceptibility-test manufacturers, report resistance trends, educate clinicians and patients, address shortages, and follow manufacturing and environmental best practices.
• Establishes a Critical Need Antimicrobial Advisory Group and CDC-backed stewardship grants for hospitals, rural facilities, Tribal hospitals, safety-net hospitals, and outpatient care settings.
• Appropriates $6 billion for fiscal year 2026 and allows up to 6.5 percent to support antimicrobial stewardship programs.