US lawmakers are intensifying their scrutiny of the involvement of Chinese military hospitals in hosting clinical trials, urging the US FDA to delve deeper into the matter. In a correspondence addressed to FDA Commissioner Robert Califf and endorsed by key members of the bipartisan US House Select Committee on the CCP, the congressmen are unequivocally demanding that the FDA “take an active role in ensuring the United States remains at the forefront of biotechnology over the PRC, and that the American biopharmaceutical sector serves the interests of American innovators and patients.”
The House Select Committee congressmen are particularly concerned about the FDA’s oversight of US biopharmaceutical firms potentially generating clinical data through trials at hospitals affiliated with the People’s Liberation Army (PLA) and those in the Xinjiang region. They highlight significant risks, including the leakage of intellectual property (IP) and ethical issues. The letter cites ongoing trials, such as Eli Lilly’s evaluation of the Alzheimer’s drug donanemab at the PLA’s General Hospital and Medical School (NCT05508789), and a previous study by Pfizer involving the 307 Hospital of the PLA, overseen by the PLA’s Academy of Military Medical Sciences (AMMS; NCT01210495). The AMMS is listed on the US Department of Commerce’s Entity List, prohibiting US companies from engaging in transactions or data exchanges with the entity.
The Select Committee has imposed an October 1, 2024, deadline for the FDA to furnish information on several fronts, including details of prior inspections of PLA-affiliated trial sites and the FDA’s role in assessing IP risks. Data suggests that 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 distinct drugs.
Amidst the turbulence of the US election process, the US House of Congress is planning a “China week” in late September, with an agenda to vote on multiple China-related legislative proposals, including the Biosecure Act. This act is designed to prevent US entities receiving federal funds from engaging in exchanges with a range of Chinese research and manufacturing service providers, such as WuXi AppTec.- Flcube.com
