The U.S. Food and Drug Administration (FDA) has paused clinical trials that export Americans’ cells to foreign companies, a program first approved by the Biden administration.

“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.”

The FDA has called for an immediate review of clinical trials that involved sending American citizens' “living cells” to China and other nations hostile to U.S. interests for genetic engineering and then later put back into U.S. patients, often without their consent or knowledge.

The procedure was approved in the final months of the Biden administration in December 2024 and allowed an exemption permitting U.S. companies to “send trial participant biological samples, including DNA, for use overseas. The exemption included some companies partially owned or controlled by the Chinese Communist Party.

The suspension of the program by the FDA follows another Trump administration executive order in May to end federal funding of gain-of-function research by foreign companies in adversarial counties such as China or other nations where there is not adequate oversight.

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