Calling VC Firms: FDA Wants to Work With You

FDA wants to capitalize on the talent of venture capital (VC) firms that are developing innovative solutions that can be applied to FDA’s public health mission. On December 17, 2025, FDA issued a Request for Information (RFI) for its FIRE program, which stands for “Foundational Innovation and RAPID Engagement.”  The proposal is intended to solicit input from VC companies that have capabilities in “artificial intelligence, biotechnology, medical devices, and regulatory technology,” in an attempt to allow those companies to better compete for FDA contracts that “could significantly benefit FDA operations and the broader public health ecosystem.”  FDA Commissioner Marty Makary stated that FDA is exploring this new approach to harness the talent of America’s innovators, rather than relying on “middlemen and D.C. insiders” who are the typical recipients of federal contracts.

Specifically, FDA seeks to gather information to facilitate a potential contract vehicle that would:

• Establish direct contractual relationships with qualified VC firms.
• Enable any company within an approved firm’s portfolio to compete for and receive task orders under the vehicle. To adhere to federal contracting requirements, portfolio companies will be treated as subcontractors.
• Streamline the procurement process for innovative technologies and services.
• Provide a scalable mechanism for engaging with the startup ecosystem.
• Maintain appropriate oversight and compliance with federal acquisition regulations.

The RFI includes 19 questions to which interested parties must respond, and the entirety of the response can be no more than 20 pages, exclusive of appendices. FDA will understand a failure to respond to a single question to mean that the company “does not understand the question and does not demonstrate the capability to provide services required.” Responses also must “demonstrate capability, not merely affirm the respondent’s capability.” At the same time, the RFI states that responses can be broad and “specificity is not necessary at this time.” The questions fall under the following categories: interest and feasibility; structural requirements; venture capital firm qualifications; financial and administrative considerations; regulatory and compliance framework; and implementation timeline and process.

From our perspective, perhaps most interesting is the question about identifying and managing conflicts of interest. If FDA implements this contract vehicle, it is possible that companies with submissions before the agency could also be contracted with the agency to provide certain services; this may be particularly true in the area of AI. Secretary Kennedy has been very vocal about his perspective on the “corporate capture” of FDA by regulated industry. It is not clear how FDA could therefore contract with a VC firm, or a portfolio company of the firm, to provide services while reviewing submissions from the same entity without creating a conflict.

We would be happy to help any interested parties submit comments to this RFI.  Responses are due by 2 pm ET on January 18, 2026.