The U.S. Food and Drug Administration (FDA) on Wednesday initiated an immediate review of clinical trials that involved sending Americans’ living cells to China and other foreign adversaries for genetic engineering and subsequent infusion back into U.S. patients, sometimes without their knowledge or consent.
The move comes amid growing concern over the security and ethics of cross-border biomedical research and the handling of sensitive genetic data.
Mounting evidence has shown that some clinical trials failed to inform participants that their biological samples would be transferred abroad, raising red flags about consent and potential misuse of genetic information by foreign governments.
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The practice became possible after the Biden Administration approved a sweeping exemption in late 2024, enabling U.S. companies to export biological samples for processing abroad, even in trials regulated by the FDA.
While the original intent of a 2024 data security rule was to limit data transfers to countries of concern, the exemption, implemented in April 2025, allowed exceptions even for companies partially owned or influenced by the Chinese Communist Party.
FDA Commissioner Dr. Marty Makary criticized the policy, “The previous administration turned a blind eye and allowed American DNA to be sent abroad, often without the knowledge or understanding of trial participants.” He emphasized the need to protect patient privacy and restore confidence in U.S. biomedical research.
As part of its response, the FDA will now require companies involved in such trials to prove full transparency, obtain ethical consent, and ensure domestic processing of biological material. New trials failing to meet these standards will not be allowed to proceed.
The agency is coordinating closely with the National Institutes of Health (NIH) to examine federally funded research for any links to the exemption.
NIH Director Dr. Jay Bhattacharya confirmed the agency is conducting a portfolio-wide review to assess whether any NIH-supported trials were affected.
“In light of the FDA’s actions and new information surrounding the Biden Administration’s egregious policies, the National Institutes of Health is actively reviewing its entire research portfolio to determine whether any federally funded clinical trials utilized the exemption issued under the Biden Administration that allowed American biological materials to be sent abroad for genetic modification, particularly to entities operating in countries of concern,” Bhattacharya said in a statement on Wednesday.
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