House lawmaker brings FDA into biosecurity crackdown on China

Amid a U.S. biosecurity crackdown on certain Chinese life sciences service providers, the House Committee on Oversight and Accountability is dialing up the pressure by unleashing a salvo of letters to different government agencies—including the U.S. Food and Drug Administration.

In a letter sent (PDF) to FDA Commissioner Robert Califf, M.D., this week, the committee's chairman, James Comer, R-Kentucky, warned that China’s influence over global pharmaceutical supply chains constitutes an act of economic warfare. Comer stressed that the People’s Republic of China (PRC) is attempting to “further dominate the pharmaceutical market and monopolize data collection to the detriment of Americans.”

The FDA has a unique responsibility when it comes to protecting U.S. citizens against China’s alleged efforts to “weaponize genomic and medical data” and “selectively export drugs and medical supplies," Comer argued.

The chairman is requesting a briefing with FDA staff to respond to a litany of questions surrounding the drug regulator’s communication about quality risks, intellectual property issues, the status of the agency’s overseas inspection backlog in China and more.

The round of letters sent out Monday marks the second phase of the House Committee’s government-wide investigation into the Chinese Communist Party. Along with the letter to the FDA, Comer’s Committee sent briefing requests to groups like the Department of Energy, the Department of State, the Federal Bureau of Investigation, the National Institutes of Health and more.

In mid-March, Comer’s group sent a separate tranche of letters to agencies such as the Department of Justice, the Environmental Protection Agency and the Drug Enforcement Agency.

The FDA did not immediately respond to Fierce Pharma’s request for comment on Monday’s letter to Commissioner Califf.

According the website for the FDA’s China office, the country ranks third among nations that export drugs and biologics to the United States. In the wake of the COVID-19 pandemic—which wreaked havoc on global pharmaceutical supply chains—many industry experts and lawmakers have called for the U.S. to wean itself off its dependence on drug ingredients, finished products and manufacturing and research services from overseas.

While the FDA is naturally on deck to oversee any pharmaceutical or medical products coming into the U.S., the House Committee argues in its letter that the agency’s China branch has “not been compliant with regulatory requirements for some time.” The letter specifically cites a 2022 report from the Regulatory Affairs Professionals Society calling out the FDA for resuming unannounced facility inspections in India, but not in China.

Comer further warned that China is increasingly working to merge its military and pharmaceutical technology sectors, drawing connections between China’s People’s Liberation Army (PLA) and medical firms like the Beijing Genomics Institute (BGI). According to Comer, BGI allows the Chinese government “full access” to the medical data it collects.

In addition, Comer contends China is attempting to seize U.S. intellectual property through collaboration with American scientists, corporate espionage and cyberattacks, as well as “forced disclosures” from manufacturing facilities operating in China.

Meanwhile, Comer argued the FDA’s oversight efforts in China are slipping. The chairman specifically suggested that the FDA does not maintain adequate staffing to monitor the growing number of facilities in China that are producing active pharmaceutical ingredients and finished drugs bound for the U.S. market.

The Committee’s letter comes at a tense time for U.S. relations with certain Chinese companies operating in the pharmaceutical industry.

Earlier this year, a group of bipartisan lawmakers rolled out draft legislation for the BIOSECURE Act, a proposed law that would seek to keep foreign funding out of the hands of “foreign adversary biotechs” and potentially limit the ability of other drugmakers participating in Medicare and Medicaid to work with those companies of concern.

The bill specifically names Chinese CRO giant WuXi AppTec, plus a handful of genomics companies that allegedly pose a U.S. national security risk by “engaging in joint research with, being supported by, or being affiliated with a foreign adversary’s military, internal security forces, or intelligence agencies.” More Chinese firms could be added to the target list at a later date.