The FDA has launched an immediate review of clinical trials involving the export of US patients’ living cells to China and other “hostile countries”.
According to the regulator, some trial subjects were reportedly not informed about the overseas transfer or manipulation of their biological material before re-infusion. This has raised concerns amid FDA officials regarding data privacy, patient consent and the exposure of US genetic data to potential misuse by foreign governments.
The FDA claims that the Biden administration facilitated the overseas handling of US biological samples by approving an exemption to newly revised data security rules. This reportedly enabled the export of trial participants’ DNA and other biomaterials for use in FDA-regulated studies abroad.
“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 Dr Marty Makary, Commissioner, FDA, in a press release. “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 exemption was part of a broader data protection framework introduced under Executive Order 14117, signed in February 2024. The order aimed to curb the exploitation of Americans’ sensitive personal data by foreign adversaries, with some exemptions put in place for FDA-regulated studies.
Going forward, the FDA stated it is actively reviewing all trials that utilised this exemption. Sponsors will be required to provide evidence of informed consent processes, full transparency regarding international handling and domestic oversight of sensitive biological materials. New clinical studies that do not meet these criteria will be denied approval.
The agency also confirmed it is working closely with the National Institutes of Health to ensure no federally funded studies are affected by these issues.
