A bipartisan group of Representatives in the United States House of Representatives sent a letter to Robert Califf, MD, Commissioner of the United States Food and Drug Administration (FDA), outlining concerns about collaborations between United States drug companies and medical centers linked to China’s military.
In the letter – sent before a vote on the BIOSECURE Act – Representatives John Moolenaar, Raja Krishnamoorthi, Anna Eshoo, and Neal Dunn, question whether the FDA has reviewed clinical trials conducted in China or inspected the facilities in question. The Representatives note that the United States “is engaged in a fierce competition with the People’s Republic of China” when it comes to biotechnology and the competition “will not only have implications for our national and economic security, but also for the future of healthcare and the security of American medical data.”
The Representatives go on to say that United States biopharmaceutical companies have conducted clinical trials with China’s military organizations, including medical centers and hospitals affiliated with the People’s Liberation Army, to determine the safety and effectiveness of new drug candidates prior to approval. Even though it is the clinical trial sponsors that design the trials and enroll patients in them, the FDA “has the essential role in determining whether products tested in patients around the world should be approved for American patients.”
The Representatives also raise concerns that United States biopharmaceutical companies conducted clinical trials with hospital infrastructure located within the Xinjiang Uyghur Autonomous Region (XUAR), where the Chinese Communist Party is engaged in genocide of the local Uyghur population. This leads to “significant ethical concerns around conducting clinical trials in the XUAR.”
While the Representatives recognize that the FDA primarily makes determinations on whether responsible parties are in compliance with requirements for submitting information to clinicaltrials.gov and meeting FDA regulatory guidelines, FDA regulations specifically grant the Commissioner the authority to request and analyze data from clinical trials conducted domestically and outside of the United States. Therefore, the Representatives seek additional information on that information, including: whether the FDA has reviewed clinical trials involving the People’s Liberation Army or their facilities (or conducted on-site inspections of the facilities); has the FDA ever been denied access to foreign clinical trial sites in the People’s Republic of China; how many facilities has the FDA reviewed for clinical trial work that are owned, operated, or affiliated with the People’s Liberation Army; and what is the agency’s estimated average cost for adjudicating a clinical trial conducted in China?
The BIOSECURE Act
Under the BIOSECURE Act, United States companies would be prohibited from contracting with certain Chinese biotech firms. The Act notes that China law requires companies to be controlled by a People’s Republic of China entity to comply with national security laws and that those companies can be compelled to turn over their data to the Chinese Communist Party upon request.
In addition to prohibiting United States companies from contracting with certain Chinese biotech firms, United States executive agencies may not obligate or expend any loan or grant funds to procure or obtain biotechnology equipment or services produced or provided by a biotechnology company of concern or enter into a contract to extend or renew a contract with such companies.