The U.S. Food and Drug Administration 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.
This action follows mounting evidence that some 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.
Regulatory Background and Policy Changes
The practice 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. While the rule imposed export controls to limit sensitive data transfers to countries of concern, 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.
"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."
FDA Response and Requirements
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.
NIH Portfolio Review
The National Institutes of Health is fully aligned with the FDA in this administration's mission to uphold the highest standards of transparency, ethics, and scientific rigor.
"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," said NIH Director Dr. Jay Bhattacharya.
"Our goal is to protect Americans' sensitive biological data while continuing to support life-saving innovation in a way that is safe, secure, and worthy of the public's trust," Bhattacharya said. "This exemption requested created a dangerous blind spot in our research security that put the privacy and trust of American participants at risk. We are assessing the scope of this issue to ensure that no NIH dollars are supporting clinical trials that compromise data integrity, patient consent, or national security."
National Security Framework
This action is part of a broader national effort to implement Executive Orders 14117 and 14292, which 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.
