Offshoring of Clinical Trials: A National Security Risk | Select Committee on China Testimony
Concerns are mounting over the increasing trend of U.S. Clinical trials being conducted in China, prompting calls for greater scrutiny of the potential national security and patient safety risks. The issue gained prominence this week following testimony before the House Select Committee on China regarding the offshoring of these critical research endeavors.
Chairman of the Select Committee, John Moolenaar, highlighted the growing reliance on China throughout the pharmaceutical supply chain, stating that roughly 90% of drugs Americans take every day rely on Chinese-controlled inputs. He further warned that China is rapidly closing the gap with the U.S. In pharmaceutical innovation, particularly in clinical trials.
The shift of early-stage clinical trials to China raises concerns about access for American patients who often have limited treatment options. These patients, typically facing severe illnesses, may be denied convenient access to potentially life-saving therapies. Moolenaar emphasized that these individuals “deserve access to breakthrough medicines close to home, not wherever happens to be fastest or cheapest to operate.”
Lawmakers are particularly focused on the involvement of Chinese military-run hospitals in U.S. Clinical trials. Republican John Moolenaar and ranking Democrat Raja Krishnamoorthi have questioned collaborations between U.S. Drug companies and these institutions, raising concerns about data security and potential espionage. An ongoing trial of Eli Lilly’s Alzheimer’s disease drug conducted at a China military hospital is among those under scrutiny.
Senator Rick Scott recently sent a letter to the Department of Health and Human Services, National Institutes of Health, and Food and Drug Administration, requesting a comprehensive review of CCP involvement in U.S. Clinical trials and drug approvals. Scott’s letter cited the CCP’s history of intellectual property theft and economic espionage, warning that the biotechnology sector is a strategic domain requiring robust protection of American innovation and sensitive health data. He specifically pointed to a case where a company proposed collecting donor cells and engineering cancer therapies in China before administering them to American patients, with related data being transmitted abroad.
The concerns extend beyond clinical trials to the broader pharmaceutical supply chain. According to Moolenaar, decades of Chinese state subsidies and lax environmental standards have driven Western competitors out of the market for key pharmaceutical ingredients. The U.S. Now relies heavily on China for active pharmaceutical ingredients and key starting materials, with 83 of the top 100 generic drugs used by Americans lacking a domestic source for these essential components. USAntibiotics in Tennessee remains the sole American manufacturer of amoxicillin, while virtually all global processing of heparin, a critical blood thinner, occurs in China.
Scott’s letter referenced his bipartisan work on the CLEAR LABELS Act, aimed at increasing transparency in the pharmaceutical supply chain and bolstering domestic manufacturing. The FDA has yet to respond to Senator Scott’s request for a review.