HQ Team
June 19, 2025: The US drug regulator has announced an immediate review of new clinical trials that involve sending American citizens’ living cells to China and other “hostile countries” for the fear of genetic data misuse.
The Food and Drug Administration’s (FDA) review is for trials that engage in genetic engineering of cells and subsequently infuse them back into US patients, sometimes without their knowledge or consent.
The FDA’s move 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,” according to an emailed statement fro the Department of Health and Human Services.
The administration stated that the practice was made possible by a data security rule finalised under the Biden Administration in December 2024 and implemented in April 2025 by the US Department of Justice.
‘Sweeping exemption’
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 US 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,” according to an FDA statement.
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 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.
Additional measures on the cards
“The integrity of our biomedical research enterprise is paramount. We are taking action to protect patients, restore public trust, and safeguard US biomedical leadership.”
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 decision 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 US-compliant institutions.
The FDA, an agency within the US Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.
