Congressman John Moolenaar Chairman of the Select Committee on the CCP | Official Website
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 have requested information from the FDA regarding U.S. biopharmaceutical companies conducting clinical trials with the People’s Liberation Army (PLA) and in Xinjiang, where allegations of genocide against Uyghur people persist. Representatives Neal Dunn, M.D. (R-FL), and Anna Eshoo (D-CA) joined this inquiry, expressing concerns about potential intellectual property co-option by the PLA through these trials and questioning the ethics of conducting them in Xinjiang.
Publicly available data on ‘clinicaltrials.gov’ indicates that major U.S. biopharmaceutical companies have conducted numerous clinical trials alongside a PLA entity over the past decade. Additionally, some U.S. companies have conducted clinical trials in Xinjiang, where ethnic minorities are reportedly forced to participate in medical procedures that may overlap with FDA-approved research.
The lawmakers stated, “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 further noted, “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.”
In light of these issues, the bipartisan group posed several questions to the FDA:
1. Has the FDA reviewed clinical trials involving PLA facilities or conducted on-site inspections of such facilities?
2. Has access ever been denied to foreign clinical trial sites in China, including those affiliated with or owned by the PLA?
3. How many PLA-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 China?
5. When did FDA first receive clinical trial data involving PLA organizations?
6. Has any U.S. biopharmaceutical organization been notified by FDA about studies conducted with PLA or in Xinjiang? If so, how many notices were issued and during what periods? Were companies responsive?
7. What metrics does FDA use when assessing IP and technology transfer risks? How are these risks calculated when collaborations involve PLA-owned facilities?
The lawmakers' letter can be viewed [HERE].
