21 U.S.C. § 360bbb–5 — Critical Path Public-Private Partnerships

(a) Establishment The Secretary, acting through the FDA Commissioner, can enter into collaborative agreements — called Critical Path Public-Private Partnerships — with one or more eligible entities. The goal is to carry out the FDA's Critical Path Initiative through joint research, education, and outreach projects that spark medical product innovation, speed up product development, manufacturing, and translational therapeutics, and improve medical product safety. (b) Eligible entity An "eligible entity" must meet three things. (1) It must be either (A) a college or university, as section 1001 of title 20 defines it, or a group of such schools, or (B) a nonprofit organization that is tax-exempt under section 501(c)(3) of title 26. (2) It must have experienced staff with clinical and technical expertise in biomedical science, which may include graduate training programs. (3) It must show the Secretary it can (A) develop and evaluate tools, methods, and processes that make medical product development more efficient, predictable, and productive, and that more accurately spot a product's benefits and risks; (B) build partnerships with a wide range of health care players — providers, pharmacists, pharmacy benefit managers and purchasers, health plans, insurers, government agencies, patients and consumers, manufacturers, and academic scientists; and (C) raise money for partnership projects from federal and non-federal government sources, foundations, and individuals. (c) Funding The Secretary cannot sign a partnership agreement unless the entity promises not to take funding, for a partnership project, from any company that makes or distributes FDA-regulated products — unless the entity also promises, in the agreement, that the funding source won't influence the project's results. (d) Annual report Within 18 months of September 27, 2007, and every year after that, the Secretary — together with the partnership's other members — must report to the Senate Committee on Health, Education, Labor, and Pensions and the House Committee on Energy and Commerce. The report must (1) review what the partnerships did in the past year, and (2) cover any other issues the Secretary thinks are relevant. (e) Definition Here, "medical product" includes a drug, a biological product as defined in section 262 of title 42, a device, and any combination of these. (f) Authorization of appropriations Congress authorized $1,380,822 to carry out this section, for the period from October 1, 2022, through December 23, 2022.