H.R. 7352 — PASTEUR Act of 2026

This section declares the purpose of the Act to ensure the availability of antimicrobials to (1) stimulate research, development, and market access to lifesaving medicines; (2) ensure the appropriate use of lifesaving medicines; (3) maintain the highest medical care standards for American patients; (4) promote national health system preparedness; and (5) defend the United States and its military.

This section establishes the U.S. Novel Antimicrobial Supply Contracts program by adding a new section 399PP to Title III of the Public Health Service Act (42 U.S.C. 241 et seq.). The program authorizes the Secretary of Health and Human Services to enter contracts with sponsors of eligible antimicrobials (i.e., drugs treating pathogens designated as "urgent" or "serious" threats in the latest CDC Antibiotic Resistance Threats report or by the Secretary, that address unmet medical needs) to ensure their availability, with annual payments calculated upon approval. To qualify, sponsors must submit applications within two years of FDA approval under section 505(c) of the Federal Food, Drug, and Cosmetic Act or licensure under section 351(a) of the Public Health Service Act; the Secretary reviews applications within 90 days using a quantitative scoring methodology (to be promulgated in regulations within 270 days of enactment, in consultation with specified officials and an advisory group) that awards points across three weighted categories—(1) contributions to patient care (e.g., improved outcomes, dosing, toxicity), (2) innovative characteristics (e.g., first-in-class, novel moiety/target), and (3) health system/public health benefits (e.g., no cross-resistance, U.S. manufacturing)—and approves only those meeting or exceeding a minimum threshold; denied applications may be revised after one year and then every two years. (As background, the program aims to incentivize development of novel antibiotics amid rising antimicrobial resistance, where few new agents have been approved recently despite urgent needs.)