U.S. Rep. John Moolenaar (R-MI) led a bipartisan group of his colleagues in questioning the U.S. Food and Drug Administration (FDA) about allowing major U.S. biopharmaceutical companies to conduct clinical trials alongside the People’s Liberation Army (PLA) in Xinjiang, where the Chinese Communist Party (CCP) is engaged in genocide of the Uyghur people.
“These collaborative research activities raise serious concerns that critical intellectual property is at risk of being transferred to the PLA or being co-opted under the People’s Republic of China’s National Security Law,” the lawmakers wrote in an Aug. 19 letter sent to FDA Commissioner Robert Califf.
“Conversely,” they wrote, “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.”
Rep. Moolenaar, chairman of the House Select Committee on the Strategic Competition Between the United States and the CCP, joined committee Ranking Member Raja Krishnamoorthi (D-IL) and two other lawmakers in signing the letter, which pointed out that publicly available information on the FDA’s website, clinicaltrials.gov, reveals that major U.S. biopharma companies have conducted hundreds of clinical trials alongside a PLA entity over the last 10 years.
In addition to working with the PLA, the lawmakers also identified U.S. companies conducting clinical trials in Xinjiang, where the CCP forces ethnic minorities to participate in gruesome medical procedures, which likely overlap with FDA-approved research.
Given the overwhelming amount of FDA-approved coordination between U.S. companies and PLA entities in China, the lawmakers requested that Califf answer several questions, including if the FDA reviewed clinical trials involving the PLA or PLA facilities or conducted on-site inspections of PLA facilities.
“Although the FDA primarily makes determinations on whether responsible parties are complying with requirements for submitting information to clinicaltrials.gov and meeting FDA regulatory guidelines, FDA regulations specifically grant the commissioner the authority to request and analyze data from clinical trials conducted domestically and outside of the United States,” wrote Rep. Moolenaar and his colleagues.
“As such, data from U.S. biopharmaceutical companies who conducted clinical trials at institutions affiliated with the PLA or other organizations in the [Xinjiang] are likely already in FDA’s possession,” they wrote, adding that responses should be submitted to them no later than Oct. 1.