WDNews, Washington, D.C. Due to national security concerns, the U.S. Food and Drug Administration abruptly halted new clinical experiments that send American live cells to hostile countries for genetic alteration.
Following evidence that some patients were not aware that their DNA was being transported overseas and genetically modified before being returned for use in U.S. treatments, the FDA made its decision public on June 18.
According to FDA Commissioner Dr. Marty Makary, the previous administration created this risk by allowing businesses to transmit biological samples abroad, including to businesses that were partially owned by the Chinese Communist Party, through a rule issued in December 2024.
According to Makary, the previous government ignored the issue and permitted the export of American DNA, frequently without the trial participants’ knowledge or consent. We are acting to protect U.S. biomedical leadership, restore public confidence, and protect patients.
In the future, fresh clinical studies will be needed to demonstrate complete transparency and ethical consent, per FDA regulations. Trials that fail to achieve these requirements will be terminated.
To make sure that no federally funded research are impacted, the FDA is also working with the National Institutes of Health. Executive Orders 14117 and 14292, which seek to prevent foreign adversaries from gaining access to critical U.S. biological data, are in line with the crackdown.
In the upcoming weeks, more enforcement actions and regulatory adjustments are anticipated.
