FDA Targets Gene Editing Clinical Trials in China and other “Hostile Countries”

In a somewhat ambiguous press release on Wednesday, June 18, 2025, the Food and Drug Administration (FDA) announced a halt and “immediate review” of new clinical trials where American patients’ cells are sent to China or other “hostile countries” for genetic engineering with the expectation that the cells will be infused back into U.S. patients.^[1] A subsequent podcast published by the agency also said that therapies that involved cells that were sent to China for genetic engineering and intended for subsequent infusion into U.S. patients would not be approved going forward. The announcement said that there is “mounting evidence” that some clinical researchers failed to obtain informed consent from trial participants about the international transfer and manipulation of biological material.

In the announcement, FDA blames the Department of Justice (DOJ) bulk data rule finalized in the last months of the Biden Administration for allowing cells to be sent to China and other countries in FDA-regulated clinical trials. The DOJ rule prohibited and restricted certain transactions involving sensitive personal data, including health data, biometric data, and human genomic data, but allowed transactions that are part of FDA-regulated clinical investigations to move forward. Now calling this a “sweeping exemption” from a rule that was only recently implemented, FDA is using its clinical trial regulatory authority to add restrictions to those clinical trials that are exempt from the DOJ rule.

Specifically, FDA is “actively reviewing all relevant clinical trials that relied on this exemption and will require companies to demonstrate full transparency, ethical consent, and domestic handling of sensitive biological materials. New trials that cannot meet these standards will not proceed.” The announcement said that “additional enforcement and policy measures could be forthcoming.”

On an edition of the FDA Direct podcast published on June 19, 2025, Commissioner Martin Makary provided further detail on the announcement, saying that FDA would like to see clinical trials for gene editing done in the United States or in countries friendly to the United States, and FDA is “not going to approve any more of these gene therapies of American patients, that is, their cells, in China . . . from this point forward.” Commissioner Makary also seemed to open the door to the policy changing in the future, saying that it is “most likely that there is nothing nefarious going on” with gene editing of cells of American patients in China, and moving forward, the Center for Biologics Evaluation and Research would take steps to ensure “informed consent is accurate.”

Currently, the scope of the FDA’s policy on this matter remains unclear. For example, it is unclear how the policy will affect ongoing trials, to the extent they exist. Additionally, questions remain about the informed consent policies that have not yet been announced, including what an informed consent form must say in order to properly inform the patient, whether a patient whose cells have already been sent to China must re-consent to the transfer of their cells outside the US for genetic engineering, or whether the FDA deny approvals of therapies where the study is completed, if the agency determines appropriate informed consent was obtained.  

Stakeholders engaged in genetic engineering research or in transactions related to such research should review informed consent templates and the procedures around sending cells outside the US and monitor further announcements of policy from FDA and other federal regulatory agencies, especially if such research is conducted in whole or in part abroad.