FDA Scrutinizes Clinical Trials Exporting U.S. Genetic Material

On June 18, 2025, the U.S. Food and Drug Administration (“FDA”) announced an immediate review of new clinical trials that export American citizens’ biological materials to countries of concern, such as China, for genetic engineering and subsequent infusion into U.S patients. According to the announcement, this action is in response to fears that some clinical trials transferred biological material abroad, sometimes without the knowledge or consent of participants, risking misuse of Americans’ sensitive genetic data by foreign governments.

While the Department of Justice Final Rule implementing Executive Order 14117, Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern (28 C.F.R. Part 202), published on January 8, 2025, and effective April 8, 2025 imposes certain export controls on sensitive data transfers to countries of concern, there is a broad exemption allowing companies to send trial participants’ biological samples for processing overseas as part of FDA-regulated clinical trials. 

The FDA is now reviewing all relevant trials that relied on this exemption and is requiring companies to “demonstrate full transparency, ethical consent, and domestic handling of sensitive biological materials.” New trials unable to meet these standards will not be permitted to proceed. 

The FDA is coordinating with the National Institutes of Health (“NIH”) to ensure that federally funded research is not compromised by these export practices.  This initiative is part of a broader federal effort to prevent the potential exploitation of Americans’ sensitive biological data by foreign adversaries and ensure that research funding supports only “secure, transparent, and U.S.-compliant institutions.” The announcement indicates that additional enforcement and policy measures could be forthcoming. 

The FDA’s immediate pause on clinical trials involving the export of Americans’ cells addresses pressing ethical and security concerns but also introduces potential challenges for the biotech industry. U.S. Companies involved in exporting biological materials for clinical trials should consider assessing current practices and overall long-term global strategies to safeguard sensitive patient data for research and product development.