FDA says Americans' DNA sent to foreign labs in clinical trials

(The Center Square) – The U.S. Food and Drug Administration announced Thursday it halted all new clinical trials that entail sending Americans’ genetic data to international labs.

Based on “mounting evidence,” the FDA said, some U.S. companies did not inform trial participants that their living cells were sent to foreign labs, including in China, for genetic engineering before reinfusion into patients.

“The previous administration turned a blind eye and allowed American DNA to be sent abroad – often without the knowledge or understanding of trial participants,” FDA Commissioner Marty Makary said. “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.”

Makarty referred to a data security rule finalized under the Biden Administration, which allowed American companies to send their trial participants’ genetic data and other biological samples for processing overseas.  

The FDA will coordinate with the National Institutes of Health to ensure that no federally funded research is jeopardized while the review of the trials takes place. 

The FDA will also impose new transparency requirements on companies handling or transferring sensitive biological data and require them to obtain participants' consent before sending it to foreign labs.

It was not immediately clear which clinical trials will be affected.