Lawmakers urge FDA to investigate clinical trials run in tandem with China's military

As House lawmakers prepare for a September vote on the controversial BIOSECURE Act, the House Select Committee on the CCP is expanding the scope of its scrutiny on China's biopharma ecosystem.

In a letter addressed (PDF) to FDA Commissioner Robert Califf, M.D., a bipartisan group of lawmakers from the House committee asked that the regulator “play an active role in ensuring the United States remains ahead of the [People’s Republic of China] in biotechnology.”

The lawmakers, led by committee Chairman John Moolenaar, R-Michigan, and ranking member Raja Krishnamoorthi, D-Illinois, called out the practice of U.S. drugmakers conducting clinical trials at medical centers and hospitals belonging to the People's Liberation Army, the military of China. This practice has been going on for more than a decade, the committee members claim.

Rep. Neal Dunn, R-Florida, and Rep. Anna Eshoo, D-California, also signed onto the letter.

Aside from questioning the "trustworthiness" of clinical data generated at these institutions, the lawmakers warned that U.S. biopharmas have run clinical studies with hospitals in Xinjiang, where China has been accused of committing genocide against Uyghur Muslims.

“Given the historical suppression and medical discrimination against ethnic minorities in this region, there are significant ethical concerns around conducting clinical trials in the [Xinjiang Uyghur Autonomous Region],” the lawmakers wrote.

Ethics concerns aside, the group from the House committee further argued that collaborative research with China’s military puts U.S. intellectual property at risk.

In their review of U.S. clinical trials that included sites at China’s military hospitals, the lawmakers specifically homed in on an ongoing trial of Eli Lilly’s Alzheimer’s disease drug donanemab—which was recently approved in the U.S. as Kisunla—and a former study of Pfizer’s Inlyta in liver cancer.

The letter states that Lilly’s trial is being run at the PLA’s General Hospital and Medical School and the military’s Air Force Medical University. The study on Pfizer’s medicine was conducted with a hospital under the PLA’s Academy of Military Medical Sciences (AMMS), according to the lawmakers' letter.

AMMS, according to the lawmakers, is on the U.S. Department of Commerce’s Entity List, which precludes U.S. companies from transferring data to the organization over potential national security threats.

In an emailed statement, a Lilly spokesperson explained that the company "conducts clinical trials around the world to ensure diversity in our research and increase access to our medicines."

"Lilly is committed to IP protections, and we conduct robust assessments of our partners to ensure they meet Lilly standards for research and data privacy," the spokesperson added. "Further, we oversee their activities when conducting clinical trials to ensure quality and data integrity."

Pfizer, for its part, did not immediately respond to Fierce Pharma's request for comment.

In light of the concerns, the lawmakers from the House Select Committee are asking the FDA to answer a slate of questions around U.S. inspections of PLA facilities, the agency’s oversight of IP and technology transfer risks, and other topics.

The select committee issued its letter as the House gets ready to vote on the related BIOSECURE Act next month.

The bill, which was introduced earlier this year by former Republican congressman Mike Gallagher, proposes halting federal contracts with certain Chinese biotech outfits that allegedly pose a national security risk to the U.S. The legislation would effectively prevent other drugmakers from doing business with these targeted firms, threatening a significant chunk of their business.

The bill currently lists respective R&D and manufacturing contractors WuXi AppTec and WuXi Biologics by name, as well as a clutch of genomics sequencing firms, though more companies of concern could be added into the mix in the future.

The House is now expected to vote on the bill next month, Axios has reported.

Within the biopharma industry, BIOSECURE has raised concerns about the potential difficulty of Western drugmakers decoupling from Chinese service providers. The current version of the bill would require U.S. companies to sever ties with Chinese contractors by 2032 to maintain their spots Medicare and Medicaid.

A recent survey by L.E.K. Consulting found that U.S.-based life science companies’ confidence in working with Chinese firms has plummeted since the bill’s introduction in January.

Editor's note: This story has been updated with a statement from Eli Lilly.