The Trump administration is halting companies from conducting clinical trials in China using Americans’ DNA samples in a program authorized by the Biden administration, according to the Food and Drug Administration.
The FDA said an immediate review has begun on new clinical trials that involve sending living cells of U.S. citizens to China and other hostile states for “genetic engineering and subsequent infusion back into U.S. patients — sometimes without their knowledge or consent.”
The agency moved to halt the program based on what it said is mounting evidence that some of the trials were conducted without informing people involved that their biological material was being transferred and manipulated.
The activity “may have exposed Americans’ sensitive genetic data to misuse by foreign governments including adversaries,” the FDA said in a statement Wednesday.
FDA Commissioner Marty Makary said the unacknowledged transfer of DNA samples has raised questions about the integrity of U.S. biomedical research.
“We are taking action to protect patients, restore public trust and safeguard U.S. biomedical leadership,” Dr. Makary said. “The previous administration turned a blind eye and allowed American DNA to be sent abroad — often without the knowledge or understanding of trial participants,” he said.
The FDA said the suspect transfer of Americans’ biomedical samples was the result of a December 2024 policy by the Biden administration that was put in place by the Justice Department in April.
The Biden rule imposed export controls that limited the transfer of sensitive data to countries of concern. But the Biden administration specifically approved a “sweeping exemption” that allowed U.S. companies to send trial participants’ biological samples, including DNA, for processing overseas in FDA-regulated clinical trials.
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