A congressional committee focused on US-China relations is examining clinical trials run by multinational drugmakers at sites affiliated with the Chinese military and has begun reaching out to trade groups associated with the industry, people familiar with the matter told Endpoints News.
The House Select Committee on the Chinese Communist Party and congressional offices have contacted the industry’s two largest trade groups, BIO and PhRMA, regarding clinical trials at Chinese hospitals with ties to the People’s Liberation Army, said multiple sources, who spoke on condition of anonymity. These communications come as the committee is planning to send a letter to the FDA on the matter, according to a congressional aide.
China, with its huge population, is an attractive market not just for pharma companies to sell drugs, but also to test them. The country’s share of clinical trials is now third behind North America and Western Europe, and China has seen a 57% increase in its relative share of clinical studies from 2019 to 2023, driven in part by international companies, according to a report from IQVIA earlier this month.
The House committee isn’t examining all clinical trials in China but is focused on sites affiliated with the People’s Liberation Army. The name of the military wing is included in hospital centers that have hosted studies from companies like Pfizer, Eli Lilly and J&J, according to a review of the ClinicalTrials.gov database, a federal registry of trials.
While what action lawmakers might try and take, if any, isn’t clear, the committee’s attention could set up another pressure campaign on the life sciences industry. Committee lawmakers were behind the proposed Biosecure Act, which would essentially force US companies to cut ties with WuXi AppTec and other Chinese medical contractors by 2032.
The outreach to BIO, formally known as the Biotechnology Innovation Organization, and PhRMA, the Pharmaceutical Research and Manufacturers of America, was described as a general inquiry and not a formal request or investigation. The committee’s communications didn’t single out any one company.
A spokesperson for PhRMA said it is “committed to working constructively with Congress to help protect national interests and make sure patients are not unintentionally impacted with disruptions to medicine R&D.”
A BIO spokesperson said the organization “continues to work with members of Congress on both sides of the aisle to educate them on the ecosystem and to ensure that we can continue to get medicines to patients around the world.”
Aspects of the committee’s newfound focus on clinical trials were first reported by BioCentury.
A proposal by Rep. John Moolenaar (R-MI), the chair of the committee, provides one hint of the lawmakers’ interest. Moolenaar’s proposed amendment to an appropriations bill, HR 9027, would prohibit FDA funds from going toward the review of drugs that were tested at People’s Liberation Army sites.
Those sites have been used by many drugmakers.
Eli Lilly is testing whether its drug, selpercatinib, can delay the return of early-stage, non-small lung cancer in patients after surgery or radiation. The study is recruiting patients around the world, including at Tangdu Hospital of the Fourth Military Medical University of Chinese People’s Liberation Army, according to ClinicalTrials.gov.
Eli Lilly declined to comment.
Pfizer last year completed a study of its antibiotic ceftazidime/avibactam in patients with hospital-acquired pneumonia throughout China, notably at Seventh Medical Center, The General Hospital of People’s Liberation Army.
The company didn’t respond to a request for comment.
J&J’s ongoing study is evaluating its drug combo in patients with metastatic castration-resistant prostate cancer, with certain gene alterations. Among the worldwide sites: Western Theater General Hospital of the Chinese People’s Liberation Army.
J&J did not respond to a request for comment.