The Food and Drug Administration (FDA) on Wednesday halted and ordered a review of all new clinical trials that include sending American cells to hostile nations for genetic engineering purposes.
The order comes after the Biden administration finalized a data security rule last year that included allowing U.S. companies to send cells and other biological samples of Americans to other countries for processing as part of the FDA’s clinical trials.
The actions of sending American cells to countries like China are sometimes done without consent of the patients or even their knowledge, the agency said, and the cells are then infused back into U.S. patients, which could have exposed the patients to misuse by foreign governments.
“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 Dr. Marty Makary said in a statement. “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.”
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Author: Faith Novak
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