On December 19, 2025, the Food and Drug Administration (FDA), part of the US Department of Health and Human Services, released a request for information (RFI) seeking input from venture capital firms on how the FDA can better access innovative early-stage companies through creative contracting methods in order to spur advancements in public health. The announcement acknowledges that startup companies within venture capital firms’ portfolios often drive breakthroughs in areas relevant to public health related to artificial intelligence, medical devices and other emerging technologies. Historically, however, the FDA and other government agencies have faced challenges accessing companies focused on cutting-edge scalable technologies, as traditional federal contracting methods tend to favor larger entities, systems integrators and labor-based work.

With this backdrop in mind, the FDA is considering a new approach: direct contracts with qualified venture capital firms that would permit the firms’ portfolio companies to compete for individual task orders involving a range of potential activity, including research and development. The RFI, titled “Foundational Innovation and RAPID Engagement” (FIRE), seeks information that would help the FDA gauge respondents’ capabilities for, and craft the requirements associated with, such a contracting mechanism. For example, the RFI requests capabilities statements and background regarding each firm’s investment focus and portfolio makeup, as well as feedback on the criteria the FDA should use to qualify participating venture capital firms, how the FDA might structure intellectual property protections for the firms’ portfolio companies, and potential financial, compliance and administrative considerations. 

Responses to the RFI are due on January 18, 2026, by 2:00 pm ET. Potentially interested venture capital firms are encouraged to contact one of the lawyers listed below with any questions or for help with submissions.

 

Cooley special counsel Erin Estevez also contributed to this alert.

This content is provided for general informational purposes only, and your access or use of the content does not create an attorney-client relationship between you or your organization and Cooley LLP, Cooley (UK) LLP, or any other affiliated practice or entity (collectively referred to as "Cooley"). By accessing this content, you agree that the information provided does not constitute legal or other professional advice. This content is not a substitute for obtaining legal advice from a qualified attorney licensed in your jurisdiction, and you should not act or refrain from acting based on this content. This content may be changed without notice. It is not guaranteed to be complete, correct or up to date, and it may not reflect the most current legal developments. Prior results do not guarantee a similar outcome. Do not send any confidential information to Cooley, as we do not have any duty to keep any information you provide to us confidential. When advising companies, our attorney-client relationship is with the company, not with any individual. This content may have been generated with the assistance of artificial intelligence (Al) in accordance with our Al Principles, may be considered Attorney Advertising and is subject to our legal notices.