A bipartisan group of lawmakers is urging the U.S. Food and Drug Administration (FDA) to take action regarding American clinical trials conducted in collaboration with the Chinese military. The lawmakers are concerned that these trials may be contributing to the “genocide” of ethnic minorities by the Chinese regime and posing a threat to national security.
In a letter addressed to FDA Commissioner Robert Califf, the lawmakers stated that “The Chinese Communist Party (CCP) is engaged in genocide of the Uyghur population.” They emphasized that it is crucial for the FDA to play a greater role in safeguarding U.S. national security interests.
The letter was signed by 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.). They requested answers from Commissioner Califf and called for a potential investigation into this matter.
According to data from clinicaltrials.gov, numerous U.S. biopharmaceutical companies have conducted hundreds of clinical trials over the past decade in partnership with at least one Chinese military entity, with some taking place in China’s Xinjiang region. This region has been notorious for its human rights abuses against Uyghurs, including torture, sexual violence, forced medical treatments, and death as documented by a United Nations report.
The lawmakers expressed concerns about these trials being involuntary for participants due to lack of due diligence on behalf of firms conducting them in Xinjiang. They also raised suspicions that U.S. companies might unintentionally profit from data derived from these trials where victim patients were forced to participate by CCP authorities.
Apart from human rights concerns, there are also national security implications associated with these collaborations. The letter highlighted that such trials generate sensitive proprietary data which could potentially be transferred or co-opted under China’s National Security Law or People’s Liberation Army (PLA).
China’s updated national security law requires any entity operating within its borders to hand over data upon request by Beijing, even if it may be illegal in its country of origin. One example mentioned was PLA’s Academy of Military Medical Sciences being involved as a partner in a U.S.-based clinical trial while being blacklisted by the U.S Commerce Department due to national security risks.
The lawmakers pointed out that previous FDA rejections based solely on data produced in China indicate similar scrutiny should be applied when evaluating clinical trial work done alongside PLA partners.
To address their concerns comprehensively, they have requested information from Commissioner Califf regarding inspections conducted at Chinese military facilities hosting these trial sites, instances where access was denied by authorities at those sites if any occurred, average costs associated with China-based trials, historical timeline for PLA-partnered trial data availability as well as FDA regulations ensuring ethical standards are met while mitigating IP and technology transfer risks.
The deadline set for responses is October 1st.