FDA halts Biden-era program of sending Americans’ DNA to China for genetic engineering

The Trump administration is halting companies from conducting clinical trials in China using Americans’ DNA samples in a program authorized by the Biden administration, the Food and Drug Administration reported.

The FDA said an immediate review has begun on new clinical trials that involve sending living cells of U.S. citizens to China and other hostile states for “genetic engineering and subsequent infusion back into U.S. patients — sometimes without their knowledge or consent.”

The agency moved to halt the program based on what it said was mounting evidence that some of the trials were conducted without informing people involved that their biological material was being transferred and manipulated.

The activity “may have exposed Americans’ sensitive genetic data to misuse by foreign governments including adversaries,” the FDA said in a statement Wednesday.

FDA Commissioner Marty Makary said the unacknowledged transfer of DNA samples raised questions about the integrity of U.S. biomedical research.

“We are taking action to protect patients, restore public trust and safeguard U.S. biomedical leadership,” Dr. Makary said. “The previous administration turned a blind eye and allowed American DNA to be sent abroad — often without the knowledge or understanding of trial participants,” he said.

The FDA said the suspect transfer of Americans’ biomedical samples resulted from a December policy of the Biden administration that the Justice Department implemented in April... the Biden administration specifically approved a “sweeping exemption” that allowed U.S. companies to send trial participants’ biological samples, including DNA, for processing overseas in FDA-regulated clinical trials...

“This exemption applied even in cases involving companies partially owned or controlled by the Chinese Communist Party,” the FDA said...

Federal authorities arrested two Chinese nationals in Detroit this month on charges of smuggling samples of biological material that law enforcement officials said pose threats to humans and U.S. crops.

Robert G. Darling, a medical doctor and expert on biological weapons, formerly with the Army Medical Research Institute of Infectious Diseases at Fort Detrick, Maryland, said the transfer of Americans’ biological data to China raises major concerns.

China also could use the transfer of sensitive biomedical data on Americans in its reported effort to secretly develop “designer” biological weapons capable of targeting ethnic groups, Dr. Darling said.

It could use genetically engineered DNA samples inserted back into Americans for testing biological weapons. Supplying such DNA to China is “truly one of the nightmarish scenarios,” he said.

“I don’t have a clearance anymore, but there’s no doubt this is a very, very worrisome activity,” Dr. Darling said.

“I think the Chinese are really, really keen on getting the advantage in multiple nefarious ways, and this could be used for such purposes,” he said...

For example, China could use the data to select various traits in the DNA that could be weaponized...