A bipartisan group of lawmakers is calling on the U.S. Food and Drug Administration (FDA) to ensure that American clinical trials that are run in conjunction with the Chinese military are not aiding the “genocide” of ethnic minorities by the Chinese regime or putting national security at risk.
Further, “The United States needs the FDA to take on a greater role in protecting U.S. national security interests,” the Aug. 19 letter reads.
In the letter, Reps. John Moolenaar (R-Mich.) and Raja Krishnamoorthi (D-Ill.), chair and ranking member of the House Select Committee on the CCP, respectively; Rep. Anna Eshoo (D-Calif.), ranking member of the Health Subcommittee; and Rep. Neal Dunn (R-Fla.) requested answers and a potential investigation.
According to the database website clinicaltrials.gov, U.S. biopharmaceutical companies over the past decade have done hundreds of clinical trials in which they partnered with at least one Chinese military entity, and these continue.
“As we know, there is simply no ability for firms to conduct due diligence to ensure that clinical trials done in [Xinjiang] are voluntary,” the lawmakers wrote, adding that they believe U.S. companies may be “unintentionally profiting from the data derived from clinical trials during which the CCP forced victim patients to participate.”
The lawmakers noted that the FDA commissioner has the authority to request and analyze data from clinical trials conducted outside the United States.
In addition to the human rights concerns, there is a national security issue.
“Such trials produce sensitive and proprietary data,” the letter reads. “These collaborative research activities raise serious concerns that critical Intellectual Property (IP) is at risk of being transferred to the PLA [People’s Liberation Army] or being co-opted under the People’s Republic of China’s (PRC) National Security Law.
“The transfer of early-stage clinical trial data, including the chemical composition of the therapeutic itself, involves incredibly sensitive data.”
The CCP has updated its national security law to require any Chinese or foreign entity operating in China to hand over data to Beijing upon request, even if it may be illegal in the country of the data’s origins. One of the Chinese military partners in a U.S. clinical trial is the PLA’s Academy of Military Medical Sciences, which is on a U.S. Commerce Department blacklist, prohibiting the transfer of U.S. data to the entity based on national security risk.
“Conversely, there are also concerns with the trustworthiness of clinical trial data produced overseas from PLA institutions,” the letter reads.
The lawmakers noted that the FDA previously rejected a cancer treatment based solely on data produced in China, “suggesting the FDA should also impose similar scrutiny to clinical trial work done in cooperation with the PLA.”
The lawmakers are requesting answers by Oct. 1 as to whether the FDA has inspected these clinical trial sites at Chinese military facilities, whether the agency has ever been denied access to any of these trial sites, the average cost of these China-based trials, how far back the data for PLA-partnered trials go, and the agency’s regulations for ensuring these trials meet ethical and safety standards, as well as prevent IP and technology transfer risks.
