FDA Launches Review of Clinical Trials Sending U.S. Genetic Material to China

The U.S. Food and Drug Administration has announced an immediate review of clinical trials that involve the transfer of American citizens’ living cells to China and other hostile countries for genetic engineering.

This urgent action comes amid increasing concerns that trial participants may not have been fully informed about the international transfer and manipulation of their biological material. There are also significant worries about the potential exposure of sensitive genetic data to misuse by foreign adversaries.

This practice was made possible by a data security rule finalized under the Biden Administration in December 2024 and implemented in April 2025 by the U.S. Department of Justice.

The FDA’s review will now scrutinize these practices, especially where participants’ knowledge or consent regarding the international transfer of their genetic material might have been lacking.