House Oversight Committee Chair James Comer (R-KY) is pressing the FDA to share more information on its presence in China amid growing concerns on Capitol Hill about Chinese involvement in biotech and other industries.
The FDA’s monitoring activities in China haven’t been compliant since before the Covid-19 pandemic, Comer wrote in a 14-page letter sent to FDA Commissioner Robert Califf. The letter underscores that China is a dominant manufacturer of active pharmaceutical ingredients and that quality control issues at Chinese facilities have led to shortages of drugs and devices.
“Despite acknowledging the FDA’s information gaps in the [People’s Republic of China], the FDA does not maintain adequate staffing to monitor the growing number of facilities in the PRC that are producing APIs and finished drugs that are exported to the U.S.,” Comer wrote.
The letter to Califf was among a total of nine letters that Comer sent to federal agencies on Monday, including the National Institutes of Health and the Department of Commerce, on China’s efforts to “infiltrate and influence” the US.
The letters come as the Oversight Committee is slated to mark up closely watched legislation next week that would effectively force US companies to cut ties with contractors like WuXi Biologics and several other Chinese life sciences companies. A House vote on the bill may come as soon as this week, Axios reported.
Comer gave Califf until May 13 to schedule a briefing on a laundry list of questions, including the agency’s justification for its China office as well as measures it has in place to “protect” staff from being influenced by the Chinese Communist Party. It also asks for the FDA to share information about any programs to incentivize the commercial sector to protect US intellectual property.
Notably, the letter namechecks WuXi, saying that the company has close ties to China and its army. He pointed to reporting from Reuters from earlier this spring that alleged WuXi shared data from a US client with Chinese authorities. It highlighted plans for WuXi STA, a subsidiary of WuXi AppTec described in the letter as a “medical data collection company,” to establish a manufacturing facility in Delaware.
But a WuXi AppTec spokesperson pushed back against the claims laid out in Comer’s letter, telling Endpoints News that they were outdated, inaccurate or misinformed. They said that the letter inaccurately describes WuXi STA and that it is a contract development and manufacturing organization.
“To be clear: WuXi AppTec, including its subsidiaries, is not owned or controlled by the Chinese government, is not affiliated with and has no special ties to the Chinese Communist Party or the People’s Liberation Army, and does not have a human genomics business or collect or deal with human genomic data,” the spokesperson said.
The letter also mentions the genomics firm BGI Group, which is targeted by the Biosecure Act, asserting that BGI is affiliated with the Chinese military and allows the Chinese government to access genetic data.
But BGI refuted the claims in a statement to Endpoints. The company said it does not engage in work for military purposes and said that many military-affiliated hospitals in China also serve civilians.
“Where BGI Group has undertaken joint research with doctors and researchers from these hospitals it has been for civilian and scientific purposes, not linked to defense or the military, and its research results are shared with the world through published papers in renowned scientific journals,” the company wrote.
Comer also asks for several details on the FDA’s inspection operations in China, including on efforts to clear a backlog of inspections. The agency’s inspections have declined in recent years. Between fiscal years 2020 and 2022, the FDA conducted only 40 inspections in China, compared to 131 inspections in 2019 alone, according to House Energy and Commerce Committee Republicans.
An FDA spokesperson told Endpoints that the agency will respond directly to Congress but did not comment on how many China-based employees work for the agency.
This story has been updated to include comment from the FDA.