FDA To Block Clinical Trials That Send US Patients’ Cells to Foreign Labs

The US Food and Drug Administration (FDA) has announced an immediate review of new clinical trials that export US citizens' living cells to China and other “hostile countries” for genetic engineering and subsequent infusion back into US patients.

The FDA claimed these transports and infusions are often carried out without a patient’s knowledge or consent and “may have exposed Americans’ sensitive genetic data to misuse by foreign governments including adversaries.”

A press release issued by the FDA cited mounting evidence that some clinical trials did this without informing participants of the international transfer and manipulation of their biological material. The statement provided no examples of such activity.

A data security rule finalized in December 2024 and implemented in April 2025 by the US Department of Justice imposed export controls to limit sensitive data transfers to countries of concern. However, the FDA said an exemption requested and approved by the Biden Administration allowed US companies to send trial participants’ biological samples for processing overseas as part of FDA-regulated clinical trials.

“The previous administration turned a blind eye and allowed American DNA to be sent abroad – often without the knowledge or understanding of trial participants,” FDA Commissioner Dr. Marty Makary, said in the press release.

The FDA is now 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 don’t meet these standards won’t proceed.

The FDA’s statement lacks information on how many clinical trials may be affected by this block on new studies.

Working with the National Institutes of Health (NIH), the FDA explained that they would ensure that no federally funded research is compromised by these practices, but “additional enforcement and policy measures could be forthcoming.”

“This exemption requested created a dangerous blind spot in our research security that put the privacy and trust of American participants at risk,” NIH Director Dr. Jay Bhattacharya said in a statement. “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.”

This announcement is one of a series of policy changes at the FDA since Makary was appointed as commissioner on April 1, 2025. One such change was the announcement of the FDA’s plans to phase out animal testing requirements in favour of human-relevant lab models. Following this, the FDA announced on June 17 the creation of the Commissioner’s National Priority Voucher (CNPV). The CNPV aims to shorten the review time for drug application submissions for companies “aligned with US national priorities” following a directive from US President Donald Trump.

However, not all FDA announcements and approvals have agreed with directives from elsewhere in the Trump administration. On May 31, the agency approved Moderna’s next-generation COVID-19 vaccine, mNEXSPIKE® (mRNA-1283) for adults 65 and older, as well as individuals aged 12–64 years with at least one underlying health condition that increases their risk for a severe COVID outcome. This was in juxtaposition to the US Health and Human Services Secretary Robert F. Kennedy Jr’s announcement a few days prior, requiring all new vaccines to be tested against placebos and urging the FDA not to authorise COVID-19 vaccines for children and pregnant women.