The FDA has stopped new clinical trials that export American citizens’ living cells from the U.S. to “China and other hostile countries for genetic engineering and subsequent infusion” back into American patients.
Officials said they took the action in response to “mounting evidence that some of these trials failed to inform participants about the international transfer and manipulation of their biological material and may have exposed Americans’ sensitive genetic data to misuse by foreign governments.” The statement about the ban on new trials contains no examples of such activities.
The FDA said misuse of genetic data by foreign governments was made possible by a final rule that the Department of Justice (DOJ) published in December. The rule implemented a Biden era executive order about preventing access to Americans’ bulk sensitive personal data.
According to the FDA, “the Biden Administration specifically requested and approved a sweeping exemption that allowed U.S. companies to send trial participants’ biological samples—including DNA—for processing overseas as part of FDA-regulated clinical trials.” The exemption extended to “companies partially owned or controlled by the Chinese Communist Party,” the FDA said.
The FDA said it “is actively reviewing all relevant clinical trials that relied on this exemption and will require companies to demonstrate full transparency, ethical consent and domestic handling of sensitive biological materials.” The agency will block new trials that fall short of the standards.
Before finalizing the rule, the DOJ sought feedback on whether to exclude human biospecimens intended for direct medical use from restrictions. Feedback led the DOJ to exclude “human biospecimens intended by the recipient ... solely for use in diagnosing, treating or preventing any disease or medical condition” from restrictions.
In response to another commenter, the DOJ said the rule exempts certain data transactions that involve clinical investigations regulated by the FDA or are part of the collection and processing of clinical care data to support authorization by the FDA.
The FDA’s statement lacks information on how many clinical trials may be affected by its halt on new studies. When finalizing its rule, the DOJ cited a study by the Science and Technology Policy Institute that found one trial that was active in the U.S., involved more than 100 participants, gathered genomic data and had a site in China.