WASHINGTON\u2014In an unprecedented move, US congressmen have intensified their demands for the US Food and Drug Administration (FDA) to delve deeper into the role of China’s military hospitals in hosting clinical trials. A letter addressed to FDA Commissioner Robert Califf, signed by prominent members of the bipartisan US House Select Committee on the Communist China Party (CCP), urges the FDA to actively ensure the US maintains a biotechnology edge over the People’s Republic of China (PRC) and to safeguard the interests of American innovators and patients.<\/p>\n\n\n\n
The committee members have expressed concerns over US biopharmaceutical companies potentially accruing clinical data through trials at hospitals affiliated with the People’s Liberation Army (PLA) and those in the Xinjiang region. They highlight the risks of intellectual property leakage and ethical issues. The letter cites ongoing trials, such as Eli Lilly’s Alzheimer\u2019s disease drug donanemab at the PLA\u2019s General Hospital and Medical School (NCT05508789), and a past study of Pfizer\u2019s Inlyta (axitinib) at the 307 Hospital of the PLA, operated by the PLA\u2019s Academy of Military Medical Sciences (AMMS; NCT01210495). Notably, the AMMS is on the US Department of Commerce\u2019s Entity List, prohibiting direct dealings or data exchanges with US companies.<\/p>\n\n\n\n
The Select Committee has set an ambitious deadline of October 1, 2024, for the FDA to report on several fronts, including details of prior inspections of PLA-linked trial sites and the FDA’s role in assessing intellectual property risks. According to the data, approximately 490 multi-regional clinical trials by multinational corporations have involved Chinese hospitals with ‘military’ in their title, with nearly 250 active trials for 170 individual drugs.<\/p>\n\n\n\n