The US Food and Drug Administration (FDA) has prohibited new clinical trials that send US patients’ live cells overseas, including to China, for gene editing and return infusion.  

While the scope and impact are unclear, smaller cell and gene therapy companies that rely on foreign manufacturing may be hardest hit, says analytics company GlobalData.  

Regulators haven’t specified how many trials are affected, though therapies like chimeric antigen receptor T-cell (CAR-T), which sometimes use overseas manufacturing steps, could fall under the policy. 

In June the FDA announced a review of new clinical trials that involve sending American citizens’ living cells to China and other “hostile countries” for genetic engineering and subsequent infusion back into US patients. 

The FDA says the action follows “mounting evidence” that some of clinical trials failed to inform participants about the international transfer and manipulation of their biological material. 

“The previous administration turned a blind eye and allowed American DNA to be sent abroad — often without the knowledge or understanding of trial participants,” said FDA Commissioner Dr Marty Makary. “The integrity of our biomedical research enterprise is paramount. We are taking action to protect patients, restore public trust, and safeguard U.S. biomedical leadership.” 

It is part of a broader national effort to implement Executive Orders 14117 and 14292, which direct the federal government to prevent the exploitation of sensitive biological data by foreign adversaries and ensure research funding flows only to secure, transparent, and US-compliant institutions. 

Abigail Beany, Editor, Clinical Trials Arena at GlobalData, commented: “As the FDA’s recent stance continues to evolve, the full impact remains to be seen. However, the decisions cell and gene therapy (CGT) companies make under the Trump administration may indicate a trend toward more cost-effective development strategies.”

Diana Turner, Senior Digital Content Editor, DDW