Moolenaar, Lawmakers Uncover Evidence of U.S. Pharmaceutical Companies Working with Chinese Military and in Xinjiang, Asks FDA to Investigate

Chairman John Moolenaar (R-MI) and Ranking Member Raja Krishnamoorthi (D-IL) of the House Select Committee on the Strategic Competition Between the United States and the Chinese Communist Party requested information from the FDA about the alarming practice of U.S. biopharmaceutical companies conducting clinical trials alongside the People’s Liberation Army (PLA) and in Xinjiang, where the CCP is engaged in genocide of the Uyghur people. Reps. Neal Dunn, M.D. (R-FL) and Anna Eshoo (D-CA) joined the inquiry, in which the lawmakers raised serious concerns that the PLA is co-opting sensitive intellectual property through these clinical trials and questioned the ethics of conducting these trials in Xinjiang.

Publicly available information on the FDA’s website, ‘clinicaltrials.gov’, reveals that major U.S. 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 U.S. 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 write, “For over a decade, it appears that U.S. 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.”

They continue, “Conversely, there are also concerns with the trustworthiness of clinical trial data produced overseas from PLA institutions. 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.”

Given the overwhelming amount of FDA-approved coordination between U.S. companies and PLA entities in China, the bipartisan group of lawmakers request answers to the following questions:

1. Has the FDA reviewed clinical trials involving the PLA or PLA facilities or conducted on-site inspections of PLA facilities?
2. 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?
3. How many PLA-owned, operated, or affiliated facilities has the FDA reviewed for clinical trial work?
4. What is FDA’s estimated average cost for adjudicating a clinical trial conducted in the PRC?
5. What is the earliest date for which the FDA received clinical trial data that included PLA organizations? 
6. Given FDA’s regulations for ensuring that clinical trials are conducted according to ethical and safety standards, has the FDA ever notified any U.S. 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.
7. 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?  

View the lawmakers’ letter HERE