Exemptions to new export control policies have allowed companies to ship patients’ biological materials to foreign laboratories, including those in China and other adversarial nations, according to the FDA.
The FDA suspended clinical trials that send living cells and other biological materials overseas for genetic engineering in what the agency branded as “hostile countries.”
According to the agency’s announcement of the move on Wednesday, it has accrued “mounting evidence” of studies failing to inform their participants of how biological material, such as DNA, collected during a trial, will be treated. In particular, the FDA claims that patients have not been informed regarding the “international transfer and manipulation” of their samples, and may have exposed “Americans’ safety genetic data to misuse” by foreign actors.
The regulator singled out China as one of these adversarial governments, but did not name other countries that it deemed hostile. It is unclear what clinical trials will be affected by the change.
In a prepared statement, FDA Commissioner Marty Makary laid blame on the Biden administration, alleging that the previous government “turned a blind eye and allowed American DNA to be sent abroad—often without the knowledge or understanding of trial participants.”
Makary was referring to a December 2024 ruling—which was implemented in April—that applied certain export restrictions for sensitive data to a select group of “countries of concern.” However, according to the FDA’s release, Biden then hamstrung these export controls by applying a “sweeping exemption” that ultimately allowed companies to ship biological material abroad.
“This exemption applied even in cases involving companies partially owned or controlled by the Chinese Communist Party,” the FDA noted in its press announcement without providing specific details.
The agency is currently looking at “all relevant clinical trials” and will require their sponsors to prove that they have been transparent with their study participants and have obtained “ethical consent” regarding the handling of their biological samples. The FDA is also working with the National Institutes of Health to make sure that “no federally funded research is compromised by these practices.”
The FDA’s announcement comes as biopharma increasingly finds itself a key focus of U.S. national security concerns.
Also on Wednesday, reporting from Fierce Pharma revealed that the Department of Health and Human Services could be withholding federal funding for biotechs that are linked to certain foreign investors. Hanadie Yousef, CEO and cofounder of Juvena Therapeutics, one of the companies whose funding applications were denied, allegedly due to foreign investments, told Fierce that “a lot of the companies that should have gotten phase 2 [funding] were denied because of their Chinese investors.”
Meanwhile, in April, the U.S. Department of Commerce formally opened a national security investigation into pharma imports, focusing on the threats these could pose to the domestic supply chain.
