Washington, D.C. In a sweeping new directive aimed at tightening biosecurity, the U.S. Food and Drug Administration (USFDA) has blocked the export of American genetic material to countries deemed “hostile,” citing concerns over national security and ethical violations in global clinical trials.
The order halts approval of new clinical studies that involve sending biological samples — such as blood, tissues, stem cells, or DNA — to countries including China, Russia, Iran, North Korea, Cuba, and Venezuela.
According to officials, the agency uncovered that several trial sponsors had been transferring living cells and genetic material from U.S. citizens to foreign labs without explicitly informing participants. In some cases, there was no disclosure that these samples would be genetically manipulated overseas.
“Americans deserve to know where their biological data is going and how it will be used,” said USFDA Commissioner Dr. Marty Makary. “We can’t allow foreign entities, especially from adversarial nations, to have access to our citizens’ DNA without strict oversight and consent.”
This move follows a broader federal push to control the flow of sensitive personal data to geopolitical rivals. While an executive order issued in late 2024 already restricted certain data transfers, clinical trials were initially exempt — until now.
The National Institutes of Health (NIH) is also conducting a parallel audit of federally funded trials to assess whether genetic material was exported without adequate safeguards. All new applications involving overseas labs must now prove full participant transparency and compliance with U.S. export laws.
Industry insiders say the new policy could disrupt some ongoing research partnerships, particularly in the field of gene therapy and personalized medicine. However, many experts believe the action is long overdue.
“It’s not just about science anymore — it’s about sovereignty over human identity,” said Dr. Leila Brooks, a bioethics researcher at Johns Hopkins University.
The FDA has clarified that the ban applies only to new trials and does not retroactively cancel existing research. However, all current studies involving overseas data sharing are now under review.
With biotechnology becoming a key focus in global competition, the FDA’s bold stance signals that genetic privacy and national interest will take center stage in American medical research moving forward.
