FDA Halts Trials That Send Americans’ Cells to China, Other ‘Hostile Countries’

Regulatory officials said they just learned about an exception to a security rule that was finalized under the previous administration.

Food and Drug Administration Commissioner Dr. Marty Makary in Washington, in a file photograph. Alex Wroblewski/AFP via Getty Images

The U.S. Food and Drug Administration (FDA) on June 18 announced a halt to clinical trials that involve sending cells from Americans to “hostile countries” until they can confirm that the Americans have granted informed consent.

FDA officials said that a security rule finalized in late 2024 under the previous administration, and implemented in April, limits exports of sensitive data to China and other countries of concern, but that the rule contains an exemption for companies sending biological samples such as DNA for processing overseas as part of trials regulated by the agency.

Dr. Marty Makary, the FDA’s commissioner, and Dr. Vinay Prasad, head of the FDA’s Center for Biologics Evaluation and Research, said in a video released by the agency that they learned about the exception only this week.

“Americans have their, can have their cells removed for cancer treatment, sent to China, where they are genetically engineered, that is genetically edited, sent back to the United States, where it’s then infused back into an American,” Makary said. “And so from a pure national security standpoint, it sounds very concerning.”

Prasad said that the cells “can be engineered to be potent killers of targets that can be found anywhere” and that scientists may not be able to fully test them on their way back into the United States.

“In cases of personal health information, Americans’ identity, in cases of national security, I think we have to be extremely strict and really protect American interests here,” he said later.

The FDA said in a statement that there are signs that Americans participating in some of the trials were not informed about their biological material being sent overseas, and that the transfer may have exposed the genetic data to misuse by foreign governments, including the Chinese Communist Party.

The agency said it is now reviewing all of the trials that relied on the exemption to the security rule. Officials say they’re going to require that companies “demonstrate full transparency, ethical consent, and domestic handling of sensitive biological materials” before trials are allowed to resume.

Dr. Jay Bhattacharya, director of the National Institutes of Health (NIH), welcomed the development.

“Our goal is to protect Americans’ sensitive biological data while continuing to support life-saving innovation in a way that is safe, secure, and worthy of the public’s trust,” he said in a statement. “This exemption requested created a dangerous blind spot in our research security that put the privacy and trust of American participants at risk. We are assessing the scope of this issue to ensure that no NIH dollars are supporting clinical trials that compromise data integrity, patient consent, or national security.”

Officials said the moves are aimed at following an executive order signed by then-President Joe Biden in 2024, as well as an additional order signed in May by President Donald Trump.

Biden’s order stated that the access of countries of concern to Americans’ sensitive personal data “constitutes an unusual and extraordinary threat,” and it instructed government officials to restrict such access. Trump’s order directed officials to end federal funding of life-science research occurring in foreign countries without adequate oversight.