House Panel to FDA: Probe Pharma-Chinese Military Drug Trials

A group of bipartisan House lawmakers have accused some U.S. drug companies of conducting clinical trials with hospitals affiliated with the Chinese military.

Rep. John Moolenaar, R-Mich., chairman of the House Select Committee on the Chinese Communist Party (CCP), and ranking member Rep. Raja Krishnamoorthi, D-Ill., made the allegations in a letter they sent Monday to Food and Drug Administration (FDA) Commissioner Robert Califf, The Hill reported Wednesday.

"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," read the letter, also signed by Reps. Neal Dunn, R-Fla., and Anna Eshoo, D-Calif.

"As a general matter, such trials produce sensitive and proprietary data. While it is the clinical trial sponsors such as biotechnology companies that design clinical trials and enroll patients around the world in these trials, it is the FDA that has the essential role in determining whether products tested in patients around the world should be approved for American patients."

The lawmakers also accused U.S. drug companies of conducting trials with hospitals in the Xinjiang Uyghur Autonomous Region [XUAR], where the CCP is "engaged in genocide of the Uyghur population."

"Given the historical suppression and medical discrimination against ethnic minorities in this region, there are significant ethical concerns around conducting clinical trials in the XUAR," the letter read. "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.

"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."

The lawmakers asked Califf to provide more information about the trials, including whether the FDA reviewed clinical trials involving the PLA or PLA facilities or conducted on-site inspections of PLA facilities and whether the FDA "ever notified any U.S. biopharmaceutical organization that it has conducted studies with the PLA or in the XUAR." The lawmakers requested a response no later than Oct. 1.

An FDA spokesperson told The Hill the agency received the letter and will respond directly to House members.

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