FDA Explores New Contracting Approach to Advance Public Health Innovation

The U.S. Food and Drug Administration has issued a Request for Information (RFI) seeking input from venture capital firms on developing a new contracting approach to strengthen collaboration between the agency and America’s most innovative companies.  The FDA recognizes that many breakthrough technologies and innovative solutions relevant to its public health mission — including artificial intelligence, biotechnology, medical devices, and regulatory technology — are being developed by firms within venture capital portfolios.  However, longstanding challenges, have limited engagement with innovative companies.  Many existing federal contracting mechanisms favor large systems integrators and intermediaries that focus on labor-based work rather than scalable technologies.  In addition, small business set-aside programs can be difficult for early-stage companies to access and have faced concerns about misuse.

“We should be harnessing the incredible talent of America’s innovators, instead of relying on middlemen and D.C. insiders,” said FDA Commissioner Marty Makary, M.D., M.P.H.  “The FDA is exploring a new approach that enables us to harness innovative capabilities and work directly with American entrepreneurs.”

The FDA is seeking input on a proposed contract model that creates direct relationships with qualified venture capital firms, enabling companies with an approved firm's portfolio to compete for and receive task orders.  These engagements could support a wide range of FDA activities, including research, technology deployment, and regulatory innovation.  Today’s RFI requests feedback on topics including qualification criteria for participating firms, financial and administrative considerations, intellectual property protections, and regulatory compliance frameworks.

“The FDA needs direct access to American innovation.  It’s about time we cut out conflicted middlemen and focus taxpayer dollars on products and tools that will protect the American public,” said Chief AI Officer Jeremy Walsh.