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 rule imposed export controls that limited the transfer of sensitive data to countries of concern. However, 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.
The FDA did not provide details on the sample transfers or the companies involved. A spokesman for the agency did not respond to a request for comment.
The FDA is working closely with the National Institutes of Health to ensure that no federally funded research is compromised by the covert supply of biological samples to China.
The agency said it could take additional enforcement and policy measures in the coming weeks.
The DNA transfers to China are being reviewed under two executive orders: one from the Biden administration and another signed by President Trump last month.
The Trump order restricts “dangerous gain-of-function research on biological agents and pathogens [that] has the potential to significantly endanger the lives of American citizens.”
“If left unrestricted, its effects can include widespread mortality, an impaired public health system, disrupted American livelihoods, and diminished economic and national security,” the order states.
“The Biden administration allowed dangerous gain-of-function research within the United States with insufficient levels of oversight,” the order said. “It also actively approved, through the National Institutes of Health, federal life-science research funding in China and other countries where there is limited United States oversight or reasonable expectation of biosafety enforcement.”
The order bans federal funding of gain-of-function research and increases oversight of biological research.
China has been engaged for more than 10 years in dual-use civilian-military biological research that could be used to produce biological weapons, annual State Department arms reports 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.
The medical establishment in China has few moral or ethical guidelines on research and has used prisoners and dissidents for practices such as organ harvesting, he said.
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.
The State Department’s most recent annual report on arms compliance with treaties said Chinese military medical institutions in 2024 “conducted toxin and biotechnology research and development with potential [biological weapons] applications” that raised concerns about violations of the Biological Weapons Convention banning germ, virus and toxin arms.
Recent Chinese military writings suggest the People’s Liberation Army is engaged in research on biological weapons capable of targeting specific ethnic groups.
The authoritative PLA textbook, “Science of Military Strategy,” includes a section identifying biology as a domain for military struggle.
The book says new types of biological warfare could include “specific ethnic genetic attacks” designed to affect targeted ethnic groups.
Biological warfare analysts say the spectrum of potential biological weapons includes human genome editing for soldiers, genetic manipulation of bacteria and the use of human-computer interfaces that seek to control populations.
China’s Wuhan Institute of Virology, the suspected origin of COVID-19, has been engaged in secret PLA biological weapons research, State Department intelligence says.
China has denied having any biological arms programs and has refused to cooperate with international investigators in seeking the origin of the coronavirus.
• Bill Gertz can be reached at bgertz@washingtontimes.com.
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