Sponsor
Robert Garcia
Representative · D-CA
Representative · D-CA
The bill speeds evaluation and scale-up of medical countermeasures and opens procurement to more commercial innovation, but does so by permitting noncompetitive and constrained contracting practices that can reduce competition, transparency, and flexibility and raise ethical concerns.
Hospitals, health systems, and patients (including those with chronic conditions) can get medical countermeasures faster because HHS can buy tests, prototypes, animal models, and related supplies for evaluation and then award follow-on production to proven prototype participants without a new competition, speeding scale-up.
Small business owners and other private-sector innovators gain more opportunities because HHS may use broad competitive general solicitations to find innovative commercial products and services.
Taxpayers and federal employees get more oversight on very large expenditures because awards over $100 million require a written efficacy determination and notification to Congress.
Small business owners and potential new suppliers may be disadvantaged because allowing follow-on production awards without additional competition tends to favor initial participants and reduces procurement competition.
Taxpayers face higher risk of opaque or wasteful spending because noncompetitive purchases for experimental or test purposes reduce transparency and oversight.
Small business owners working on complex or uncertain R&D could be discouraged because capping awards obtained via general solicitation to fixed-price contracts makes risky, variable-cost projects less viable.
Based on analysis of 2 sections of legislative text.
Expands prototype and acquisition authorities so HHS can test, buy, and move prototypes to production faster, with a new route for buying "innovative" commercial items under limits.
Expands federal authorities to speed development, testing, and limited procurement of medical countermeasures and related supplies during public-health preparedness activities. It clarifies that “design and development” includes tests, prototypes, and animal models; allows prototype transactions to include follow-on production awards to transaction participants (potentially without new competition if original selection was competitive); permits noncompetitive purchases of items for experimental or test purposes; and creates a competitive-solicitation pathway for acquiring “innovative commercial products and commercial services” with limits on fixed-price awards and special review and notice rules for awards over $100 million.
Official title: To amend the Public Health Service Act to authorize the Biomedical Advanced Research and Development Authority to award follow-on production contracts or transactions, procure supplies for experimental or test purposes, and acquire innovative commercial products and commercial services, and for other purposes.
Introduced January 28, 2025 by Robert Garcia · Last progress January 28, 2025