BEIJING (dpa-AFX) - The U.S. Food and Drug Administration has announced an immediate review of new clinical trials that involve sending American citizens' living cells to China and other hostile countries for genetic engineering and subsequent infusion back into U.S. patients - sometimes without their knowledge or consent.
FDA said the decision follows mounting evidence that some of these trials failed to inform participants about the international transfer and manipulation of their biological material and may have exposed Americans' sensitive genetic data to misuse by foreign governments, including adversaries.
FDA alleged in a press release that the Biden Administration specifically requested and approved a sweeping exemption that allowed U.S. companies to send trial participants' biological samples - including DNA - for processing overseas as part of FDA-regulated clinical trials. This exemption applied even in cases involving companies partially owned or controlled by the Chinese Communist Party, it added.
The FDA is actively reviewing all relevant clinical trials that relied on this exemption and will require companies to demonstrate full transparency, ethical consent, and domestic handling of sensitive biological materials. New trials that cannot meet these standards will not proceed.
The agency is also working closely with the National Institutes of Health (NIH) to ensure that no federally funded research is compromised by these practices. Additional enforcement and policy measures could be forthcoming.
'The previous administration turned a blind eye and allowed American DNA to be sent abroad - often without the knowledge or understanding of trial participants,' said FDA Commissioner Dr. Marty Makary. '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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