This bill would add a new part to the Public Health Service Act to create a program that pays sponsors of newly approved or licensed antimicrobials to ensure those drugs remain available in the United States. The Department of Health and Human Services (the Secretary) may sign contracts with drug sponsors for eligible antimicrobials that treat pathogens listed as "urgent" or "serious" by the Centers for Disease Control and Prevention or that the Secretary, with an advisory group, identifies. Sponsors must apply within 2 years of FDA approval or licensure. The Secretary must establish a points-based scoring system (within 270 days) to decide which drugs qualify.
Contract terms require sponsors to keep the drug commercially available, supply test-device manufacturers, report resistance data, run education and stewardship programs, plan for registering the drug in other countries if asked, address shortages, make sufficient manufacturing volumes, and follow environmental manufacturing best practices. Annual payments to sponsors would begin within 180 days of contract approval. Regulations would set annual payments between $75,000,000 and $300,000,000 (adjusted for inflation) and reduce payments by the drug's net U.S. revenue. Payments can stop if a sponsor withdraws the drug, fails to meet contract requirements, or does not complete required postmarket studies. Contracts last up to 10 years or until an approved generic or biosimilar is marketed using the contract drug as reference.
The bill also creates a 15-member Critical Need Antimicrobial Advisory Group with conflict-of-interest limits, requires CDC to expand surveillance and public reporting of antimicrobial use and resistance (with data publicly available starting 2 years after enactment), and establishes grant programs to support antimicrobial stewardship in hospitals, long-term care, and outpatient settings. The bill authorizes $6,000,000,000 for fiscal year 2026 to carry out the new part and allows up to 6.5 percent of that amount to be used for stewardship and surveillance activities. The text designates the appropriation as an emergency requirement.
The bill was introduced in the House on February 4, 2026, and was referred to the Committee on Energy and Commerce and the Committee on the Budget for further consideration.
The bill states its purposes as: to stimulate research, development, and market access for lifesaving antimicrobials; ensure appropriate use of those medicines; maintain high medical care standards for patients; promote national health system preparedness; and defend the United States and its military.
No publicly available information.