FDA Halts New Clinical Trials Exporting Americans’ Cells to Hostile Foreign Labs for Genetic Engineering

The FDA has announced a review of new clinical trials that “involve sending American citizens’ living cells to China and other hostile countries for genetic engineering and subsequent infusion back into U.S. patients – sometimes without their knowledge or consent.” The press release further explains that there is “mounting evidence” that participants did not receive proper informed consent about the international transfer and manipulation of these cells by foreign governments, including adversaries like China.

This exchange of personal genetic information to other countries was made possible by a Biden administration rule finalized in December 2024 and implemented in April 2024 by the Department of Justice (DOJ). The press release explains that the rule was a sweeping exemption allowing US companies to send biological samples, including DNA, to be processed overseas as part of FDA-regulated clinical trials. The exemption also applied to companies “partially owned or controlled by the Chinese Communist Party.”

NIH Director Dr. Jay Bhattacharya said, “In light of the FDA’s actions and new information surrounding the Biden Administration’s egregious policies, NIH is actively reviewing its entire research portfolio to determine whether any federally funded clinical trials utilized the exemption issued under the Biden Administration that allowed American biological materials to be sent abroad for genetic modification – particularly to entities operating in countries of concern.”

The HighWire reported earlier this week about Coinbase CEO Brian Thompson’s quest to create a startup that involves the use of CRISPR gene-editing technology to edit embryos, a process some fear could lead to the creation of “designer babies.” The first instance of gene-edited babies being born occurred by a Chinese researcher who served three years in prison after twins were born in November 2018.

Former FDA Commissioner and current Pfizer board member Scott Gottlieb wrote an op-ed for Stat News last month. He said US drugmakers are sending business to China because it is cheaper to do so. Gottlieb also said US pharma companies didn’t license any new drugs from China five years ago, but “By 2024, one-third of their new compounds were coming from Chinese biotechnology firms.”

The rapid advancement of medical technology includes gene therapy and gene editing technology such as CRISPR. Last month it was announced that mRNA-based in vivo CRISPR therapy was used to successfully treat KJ, a baby with severe carbamoyl phosphate synthetase 1 (CPS1) deficiency (CPS1D).

On June 5, the FDA held a roundtable on cell and gene therapy, during which national security threats related to China were discussed, as well as the US’s falling behind in the development of these new therapies.

Dr. Carl June, known for his pioneering work in CAR T-cell therapy, has expressed concerns that new medical innovations are increasingly being developed abroad. “Despite our early leadership, much of the innovation in this field is now happening offshore, outside of FDA jurisdiction,” Dr. June said. “If we do not modernize our regulatory approach, we risk losing our leadership and undermining the long-term viability of our biopharma industry.  An increasingly common occurrence for me, and I’m sure my colleagues here around the table, is that we develop promising new strategies in our labs for cell and gene therapy, only to see them first tested clinically in China. Why are researchers increasingly taking trials overseas? Simply put, the US process has become too slow, costly, and inflexible, while other countries make it easier to innovate.”

Dr. Tom Cahiil, a biotech investor, also sounded the alarm regarding the national security threat of relying on China for the advancement of these technologies. “We ban Chinese chips from our missiles and block their cars from our roads, yet we still allow China to steal taxpayer-funded medical breakthroughs, conceal clinical data, and sell these inventions back to us, often as medicines we put into our children’s bodies,” Dr. Cahill said. “This isn’t just an economic risk, it’s a national security threat. If we stay passive, China won’t just dominate the future of medicine. They will control the infrastructure, the data, the supply chains, and the standards. That’s a chokehold on American health, sovereignty, and innovation.”

Dr. Sean Morrison, former president of the International Society for Stem Cell Research, said the FDA needs to provide regulatory protection to consumers who can fall victim to false marketing scams. “There are also bad actors in this space who are attempting to sell essentially snake oil to rip-off desperate patients by capitalizing on the promise that you hear from the research in this room, but who are instead selling snake oil,” Dr. Morrison said. “Americans really need the FDA to protect them from those people. Buyer beware is not an effective strategy when it comes to experimental medical therapies.”

The FDA and NIH both issued statements regarding the latest announcement. The FDA is reviewing all clinical trials that were granted this exemption and “will require companies to demonstrate full transparency, ethical consent, and domestic handling of sensitive biological materials.”

The NIH will “ensure that no federally funded research is compromised by these practices.” The statement notes that further enforcement and policy measures “could be forthcoming.”

This news comes during the same week that TTAM Research Institute won the bid to take control of 23andMe, a DNA genetic testing company that filed bankruptcy earlier this year. TTAM is a non-profit owned by Anne Wojcicki, the former CEO of 23andMe and the former spouse of Google founder Sergey Brin.

The concern about the sale of private consumer genetic information, however, persists given the complex regulatory structure. TTAM, as a non-profit, is not subject to the same data protection laws.

The UK and Canada fined 23andMe $2.3 million this week for a 2023 data breach that exposed the personal DNA information of seven million people. TTAM’s purchase of the company’s genetic data must still be approved by the bankruptcy court to proceed.