US Drug Manufacturer Conducts Clinical Trials in China, Bipartisan Lawmakers Raise Questions

A group of bipartisan lawmakers on Tuesday (August 20) urged the Biden administration to strengthen scrutiny of American clinical trials conducted in China, citing the risk of intellectual property theft and potential coercion of Uyghur participants.

Chairman of the House China Task Force, Republican John Moolenaar, and top-ranking Democrat Raja Krishnamoorthi stated that over the past decade, U.S. pharmaceutical companies have collaborated with hospitals affiliated with the Chinese military to conduct hundreds of clinical trials, including in Xinjiang where the Uyghur minority resides.

According to Reuters, Moolenaar and Krishnamoorthi wrote in a letter to the Food and Drug Administration (FDA) director Robert Califf, “Given the historical suppression and medical discrimination against minorities in the region, there are significant ethical concerns with conducting clinical trials in (Xinjiang).”

The Chinese Communist Party has been accused of carrying out genocide against the Muslim Uyghur population in the region, although Beijing denies such allegations.

The letter was also signed by Democrat Anna Eshoo and Republican Neal Dunn. The lawmakers continued in the letter, expressing deep concerns over these collaborative research activities, warning that critical intellectual property could be transferred to the Chinese military or confiscated under the People’s Republic of China’s National Security Law.

The letter pointed out that hundreds of clinical trials have been conducted in medical centers and hospitals affiliated with the Chinese military, including the General Hospital of the People’s Liberation Army, Air Force Medical University, and military hospitals under the Academy of Military Medical Sciences (AMMS). The U.S. Department of Commerce has already prohibited technology exchanges with AMMS due to concerns over national security.

Lawmakers highlighted in the letter, “Conversely, there are concerns about the reliability of clinical trial data produced through institutions affiliated with the Chinese military.”

“We know that companies have no capacity to conduct due diligence to ensure that clinical trials conducted in the Xinjiang Uyghur Autonomous Region are voluntary,” the letter stated. “Therefore, we believe that U.S. biopharmaceutical entities may inadvertently profit from data obtained from clinical trials where patients have been compelled by the Chinese Communist Party (CCP).”

The letter mentioned that these clinical trials include an ongoing advanced Alzheimer’s disease treatment study.

The letter indicates a growing concern over China’s role in the biotechnology industry. In April this year, Krishnamoorthi and former Chairman of the House China Task Force, Congressman Michael Gallagher, urged the Biden administration to place seven Chinese biotech companies on the Defense Department’s “Chinese Military Companies” list for their collaboration with Beijing’s military.

Lawmakers are also considering legislation to restrict business dealings between the U.S. and certain Chinese biotech companies, including WuXi AppTec and BGI Group.

The letter requested that the FDA respond to a series of questions regarding the trials by October 1, including whether the agency has formally reviewed any clinical drug trials or disclosed the extent of cooperation with the Chinese military.

A spokesperson for the FDA told the New York Post, “The FDA has received this letter and will respond directly to the members of Congress.”