WASHINGTON, D.C. (WDNews) – The U.S. Food and Drug Administration has put a sudden stop to new clinical trials that send Americans’ living cells to hostile nations for genetic manipulation over national security concerns.
Announced June 18, the FDA’s move follows evidence that some patients were unaware their DNA was being exported abroad and genetically engineered before being returned for use in U.S. treatments.
FDA Commissioner Dr. Marty Makary said the prior administration enabled this risk through a loophole: a December 2024 rule that allowed companies to send biological samples overseas, even to companies partially controlled by the Chinese Communist Party.
“The previous administration turned a blind eye and allowed American DNA to be sent abroad — often without the knowledge or understanding of trial participants,” Makary said. “We are taking action to protect patients, restore public trust, and safeguard U.S. biomedical leadership.”
Moving forward, the FDA will require new clinical trials to prove full transparency and ethical consent. Trials that can’t meet these standards will not be allowed to continue.
The FDA is also coordinating with the National Institutes of Health to ensure that no federally funded studies are affected. The crackdown aligns with Executive Orders 14117 and 14292, which aim to block foreign adversaries from accessing sensitive U.S. biological data.
More policy changes and enforcement actions are expected in the coming weeks.
