A group of bipartisan representatives called on the FDA to play an “active role” in ensuring the US “remains ahead” of China in biotech and urged the regulator to investigate clinical trials conducted in partnership with China’s military.
What should follow is an FDA investigation into how China’s military is involved in clinical trials used for the basis of new drug approvals, they wrote in a letter released Tuesday.
The lawmakers said that biopharma companies have conducted clinical trials with China’s military organizations and at military sites, as well as with hospital infrastructure in China’s western region, where they say the country has engaged in genocide against the Uyghur population.
The lawmakers specifically point to a clinical trial for Eli Lilly’s Alzheimer’s disease drug donanemab, which was fully approved last month as Kisunla. They say the trial is actively recruiting patients and is partnered with a Chinese military hospital and medical school, as well as China’s Air Force Medical University. Lilly did not immediately respond to a request for comment.
The representatives also cited a trial testing Pfizer’s Inlyta in advanced hepatocellular carcinoma as it was conducted with China’s Academy of Military Medical Sciences, which is on a Department of Commerce list that precludes US companies from transferring technology because of national security threats. Pfizer also did not immediately respond to a request for comment.
“The United States needs the FDA to take on a greater role in protecting US national security interests,” they wrote. “With this data, it is clear that the FDA should play a greater role in analyzing US biopharma entities’ clinical trial operations” in China.
The letter was co-authored by John Moolenaar (R-MI), chair of the House Select Committee on the Chinese Communist Party, and Ranking Member Raja Krishnamoorthi (D-IL), Rep. Neal Dunn (R-FL) and Rep. Anna Eshoo (D-CA), who say they have uncovered hundreds of pharma trials conducted with the Chinese military or in Xinjiang, where Uyghurs live.
The House is expected to vote next month on a bill that would effectively ban biopharma companies from using certain manufacturers and contract researchers in China. But more legislation may be necessary for Congress to tackle the problems behind biopharma companies using Chinese military hospitals.