The U.S. Food and Drug Administration (FDA) announced a review of clinical trials involving “hostile countries,” declaring that projects involving Americans’ living cells are paused.
The FDA has found evidence that some trials fail to inform Americans about transferring their biological material and may expose the information to foreign governments, including that of China. According to the agency, the practice dates back to a Biden-era security rule that “allowed U.S. companies to send trial participants’ biological samples — including DNA — for processing overseas as part of FDA-regulated clinical trials,” the FDA said.
FDA Commissioner Dr. Marty Makary said in a statement that the previous administration “turned a blind eye and allowed American DNA to be sent abroad — often without the knowledge or understanding of trial participants.”
“The integrity of our biomedical research enterprise is paramount. We are taking action to protect patients, restore public trust, and safeguard U.S. biomedical leadership,” he stated.
The National Institutes of Health (NIH) declared that it is “fully aligned” with the FDA’s decision.
“In light of the FDA’s actions and new information surrounding the Biden Administration’s egregious policies, the National Institutes of Health 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,” NIH Director Dr. Jay Bhattacharya said.
He added that NIH’s goal is to “protect Americans’ sensitive biological data while continuing to support life-saving innovation in a way that is safe, secure, and worthy of the public’s trust,” noting that the Biden-era policy “created a dangerous blind spot in our research security that put the privacy and trust of American participants at risk. We are assessing the scope of this issue to ensure that no NIH dollars are supporting clinical trials that compromise data integrity, patient consent, or national security.”
