BRUSSELS/FRANKFURT/PARIS (dpa-AFX) - The U.S. Food and Drug Administration announced it has halted new clinical trials that involve sending living cells from American citizens to China and other hostile nations for genetic engineering, after which the cells are infused back into U.S. patients.
The FDA now said it 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 noted that the process of sending cells to foreign labs is being done sometimes without the knowledge or consent of the patients.
The FDA's decision follows clear evidence that some of these trials failed to inform participants about the international transfer and manipulation of their biological material. The process may have exposed Americans' sensitive genetic data to misuse by foreign governments, including adversaries.
According to the agency, the transfer of Americans' cells to foreign countries was made possible by a data security rule finalized under the Biden Administration in December 2024, and implemented in April 2025 by the U.S. Department of Justice.
The rule imposed export controls to limit sensitive data transfers to countries of concern. Meanwhile, 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. The FDA noted that the exemption applied even in cases involving companies partially owned or controlled by the Chinese Communist Party.
The regulator is now actively reviewing all relevant clinical trials that relied on this exemption.
The agency is also working closely with the National Institutes of Health or NIH to ensure that no federally funded research is compromised by these practices. Additional enforcement and policy measures could be forthcoming.
FDA Commissioner Marty Makary said, 'The previous administration turned a blind eye and allowed American DNA to be sent abroad - often without the knowledge or understanding of trial participants. 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.'
FDA's latest action is part of a broader national effort to implement Executive Orders 14117 and 14292. These orders direct the federal government to prevent the exploitation of sensitive biological data by foreign adversaries and ensure research funding flows only to secure, transparent, and U.S.-compliant institutions.
For More Such Health News, visit rttnews.com https://www.rttnews.com/content/health.aspx
Copyright(c) 2025 RTTNews.com. All Rights Reserved
Copyright RTT News/dpa-AFX
© 2025 AFX News
