The U.S. Food and Drug Administration (FDA) on June 18 announced a halt to clinical trials that involve sending cells from Americans to “hostile countries” until they can confirm Americans have granted informed consent.
FDA officials said that a security rule finalized in late 2024 under the previous administration, and implemented in April, limits exports of sensitive data to China and other countries of concern, but that the rule contains an exemption for companies sending biological samples such as DNA for processing overseas as part of trials regulated by the agency.
Dr. Marty Makary, the FDA’s commissioner, and Dr. Vinay Prasad, head of the FDA’s Center for Biologics Evaluation and Research, said in a video released by the agency that they only learned about the exception this week….