WASHINGTON—In 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.
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’s disease drug donanemab at the PLA’s General Hospital and Medical School (NCT05508789), and a past study of Pfizer’s Inlyta (axitinib) at the 307 Hospital of the PLA, operated by the PLA’s Academy of Military Medical Sciences (AMMS; NCT01210495). Notably, the AMMS is on the US Department of Commerce’s Entity List, prohibiting direct dealings or data exchanges with US companies.
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.
Amidst the turbulence of the US election process, the US House of Congress is reportedly planning a “China week” in late September, featuring votes on a series of China-related legislative proposals. Among them is the Biosecure Act, which aims to prevent US entities receiving federal funds from engaging in exchanges with various Chinese research and manufacturing service providers, including WuXi AppTec.- Flcube.com
