Congress Calls Out Clinical Trials in PRC

House lawmakers are raising questions about US biopharmaceutical companies that are conducting clinical trials with China’s People’s Liberation Army and in the Xinjiang region where Beijing is accused of mistreating members of the Uyghur community.

 Chinese biopharmaceutical companies, with their ability  to harness China’s large population of patients to conduct time- and cost-efficient clinical trials play a vital role in the global pharmaceutical industry.  The lawmakers want the Food and Drug Administration to provide information about these practices.

House Select Committee on China Chairman John Moolenaar (R-Mich) and ranking Democrat Raja Krishnamoorthi (Ill) – along with Reps. Neal Dunn (R-Fla) and Anna Eshoo (D-Calif) raise serious concerns that the PLA is co-opting sensitive intellectual property through these clinical trials and question the ethics of conducting these trials in Xinjiang.

Publicly available information on the FDA’s website, ‘clinicaltrials.gov’, reveals that major US biopharmaceutical companies have conducted hundreds of clinical trials alongside a PLA entity over the last 10 years. In addition to work with the PLA, the lawmakers identified US companies conducting clinical trials in Xinjiang. The CCP forces ethnic minorities in Xinjiang to participate in gruesome medical procedures, which likely overlap with FDA-approved research, the lawmakers allege.

“For over a decade, it appears that US biopharmaceutical companies conducted clinical trials with China’s military organizations, and specifically with medical centers and hospitals affiliated with the People’s Liberation Army’s (PLA), to determine the safety and effectiveness of new drug candidates prior to approval... These collaborative research activities raise serious concerns that critical Intellectual Property (IP) is at risk of being transferred to the PLA or being co-opted under the People’s Republic of China’s (PRC) National Security Law,” the lawmakers wrote.

“Conversely, there are also concerns with the trustworthiness of clinical trial data produced overseas from PLA institutions,” the continued. “The FDA has previously declined to approve oncology treatments based on clinical trial data solely produced from clinical trial sites in China, suggesting the FDA should also impose similar scrutiny to clinical trial work done in cooperation with the PLA.”

Questions for FDA

Given the amount of FDA-approved coordination between US companies and PLA entities in China, the bipartisan group of lawmakers want answers to the following questions:

• Has the FDA reviewed clinical trials involving the PLA or PLA facilities or conducted on-site inspections of PLA facilities?
• Has the FDA ever been denied access to foreign clinical trial sites in the PRC, including but not limited to trial sites located on facilities affiliated with or owned by the PLA?

•  How many PLA-owned, operated, or affiliated facilities has the FDA reviewed for clinical trial work?

• What is FDA’s estimated average cost for adjudicating a clinical trial conducted in the PRC?

• What is the earliest date for which the FDA received clinical trial data that included PLA organizations?

• Given FDA’s regulations for ensuring that clinical trials are conducted according to ethical and safety standards, has the FDA ever notified any US biopharmaceutical organization that it has conducted studies with the PLA or in the XUAR? If so, please provide the number of notices and time periods when they were issued, and if companies were responsive.

• What metrics does FDA use when assessing IP and technology transfer risks? Within those metrics, how are the risks calculated when research studies identify collaborations with the PLA or involve PLA-owned facilities as the setting for the research?