FDA to halt trials that send Americans’ cells to labs in “hostile” countries

The U.S. FDA announced an immediate 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 U.S. patients.

According to the FDA, there is mounting evidence that some trials failed to inform participants about the international transfer and manipulation of their biological material. The concern is that the trials “may have exposed Americans’ sensitive genetic data to misuse by foreign governments including adversaries.”

Beyond the specific mention of China, a list of hostile countries was not provided.

The FDA press release points to a data security rule finalized under the Biden Administration in December 2024 and implemented in April 2025. The rule granted an exemption that allowed U.S. companies to send trial participants’ biological samples, including DNA, for processing overseas as part of FDA-regulated clinical trials.

“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 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.”

The FDA says it 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 agency says it is working closely with the National Institutes of Health to ensure that no federally funded research is “compromised” by these practices. Additional enforcement and policy measures could be forthcoming.

This is not the first mention of concern regarding clinical trials abroad. In August 2024, a group of bipartisan House lawmakers sent a letter to then-FDA Commissioner Robert Califf, pressuring him to respond to concerns surrounding U.S. biopharma companies conducting clinical trials in China.

Citing clinicaltrials.gov, the letter noted that over the last ten years, major U.S. biopharma companies have conducted hundreds of clinical trials in China that included at least one entity with the People’s Liberation Army (PLA), China's military arm, in the name as a research trial partner. The letter also noted that trials were conducted with hospitals in China’s Xinjiang Uyghur Autonomous Region (XUAR), where the Chinese Communist Party is engaged in genocide of the Uyghur population.