Senator Calls on Federal Health Authorities to Review China’s Role in US Drug Trials

Senator calls on federal health authorities to review China's role in U.S. drug trials.

Senate Committee on Aging Chairman Senator Rick Scott is raising concerns over Chinese entities

participating in U.S. clinical trials and drug approval processes and calling for immediate

action from federal health agencies. In a March 19 letter to federal health authorities,

shared with the epic times beforehand, Scott pointed to BioHang, a China-based clinical

stage company also known as INVIVA, as being, reportedly financed by CCP-linked sources,

referring to the acronym for the Chinese Communist Party.

Sighting public information, Scott said BioHang has proposed a model of collecting donor

cells in China, engineering the cells to fight certain cancers through what is called

chimeric antigen receptor T cell therapy, and administering the modified cells to American

patients through U.S.-based clinical trials. In the context of cell and gene therapies,

this model raises not only data security concerns, but also patient safety risks related to

chain of identity, chain of custody, manufacturing quality control, and the ability of U.S. regulators

to conduct effective oversight and enforcement when critical processing occurs outside U.S. jurisdiction,

the letter reads, the letter is addressed to the heads of the Department of Health and Human Services,

the Food and Drug Administration, and the National Institutes of Health.

It came one month after the Senator proposed a bipartisan bill, the Clear Labels Act,

to strengthen the U.S. pharmaceutical supply chain.

The legislation, also sponsored by Senate Committee on Aging-ranking Member Senator

Kirsten Gillibrand, would require prescription drug labels to disclose the original manufacturers

of generic drugs and their active pharmaceutical ingredients. Given that China's laws

compel Chinese companies to hand over data, coupled with its state-sponsored economic espionage,

Scott said that Bioheng's model presents significant risks that must be addressed.

In February last year, Bioheng announced on its website that an experimental type of

CARTI therapy had been cleared by the FDA to begin clinical trials for treating T cell cancers,

including certain leukemias and lymphomas, after the agency approved its investigational

new drug application. Eight months later, Bioheng announced that the therapy had been granted

the regenerative medicine-advanced therapy designation by the FDA, a status intended to expedite

the development of treatments showing early clinical promise. According to the NIH Clinical

Trial Database, the study of the experimental therapy is being conducted at multiple universities

and cancer centers across several U.S. states, including Stanford University in California,

Memorial Sloan Kettering Cancer Center in New York, and MD Anderson Cancer Center in Texas.

Scott said this case appears to illustrate broader vulnerabilities in the current oversight

framework, pointing to cases of Chinese trade secret theft and NIH-funded researchers failing

to disclose their China ties. In 2021, Zhou Yu, 51, of Ohio, was sentenced to 33 months in prison

for conspiring to steal trade secrets related to exosome research from an Ohio children's hospital

and sell them to China. Despite U.S. efforts to bring cases to justice and strengthen disclosure

requirements, Scott said that it remains unclear whether national security risks are being

consistently and rigorously evaluated in connection with IND approvals, expedited designations,

and clinical trial authorizations involving entities linked to foreign adversaries.

Scott, who serves on the Committee on Homeland Security and Governmental Affairs,

asked HHS Secretary Robert Kennedy Jr., FDA Commissioner Martin McCarrie,

and NIH Director Jay Bhattacharya to take several actions to mitigate the national security concerns.

The requested actions include reviewing all pending and recently approved clinical trial

applications involving entities with ties to the CCP or the Chinese military.

Re-evaluating Bioheng's RMAT designation, establishing a national security protocol for IND

applications, prohibiting the transmission of U.S. patient data to entities based in or

controlled by countries designated as foreign adversaries, and coordinating with the Department

of Justice and the Federal Bureau of Investigation to identify researchers, institutions,

and companies with undisclosed ties to Chinese state entities.

Scott also recommended the three agencies to conduct a comprehensive audit of all active

clinical trials involving Chinese entities or researchers with potential CCP ties to assess

national security and patient safety risks. The Senator also requested a written response within

60 days, including the steps taken regarding the Bioheng approval, a timeline for the requested

audit, and the implementation of any policies to address similar risks.

The epic times contacted Bioheng for comment but did not receive a response by publication time.