Drugs

Senator Raises Concerns Over Chinese Biotech Firms in U.S. Clinical Trials

U.S. Senator Rick Scott (R-FL) is urging FDA and other federal health agencies to review and tighten oversight of clinical trials and drug approvals involving Chinese-linked entities, citing potential national security and patient safety risks. In a letter addressed to HHS secretary Robert F. Kennedy, Jr., NIH director Jay Bhattacharya, and FDA commissioner Marty Makary, senator Scott highlighted concerns about Bioheng (also known as Imviva), a China-based biotech company reportedly backed by Chinese Communist Party (CCP)-linked sources. Bioheng has received authorization under an IND and been granted a Regenerative Medicine Advanced Therapy (RMAT) designation, along with priority review status.

Scott says that publicly available reports indicate that Bioheng plans to collect donor cells and engineer CAR-T cancer therapies in China, then administer these therapies to U.S. patients through domestic clinical trials. He warned that such arrangements could expose sensitive patient data and intellectual property to foreign influence while complicating regulatory oversight. He cited risks to patient safety, including chain-of-identity, manufacturing quality, and enforcement limitations when critical processing occurs outside U.S. jurisdiction.

“Communist China’s intellectual property theft and espionage directly threaten this powerful engine of national prosperity,” the senator writes in the letter, noting that the U.S. biotechnology sector employed 2.3 million Americans in 2023 and generated over $3.2 trillion in economic output.

Scott called on the agencies to:

Review all pending and recently approved clinical trial applications involving entities with ties to Chinese state-controlled entities or the CCP.
Reevaluate expedited designations such as RMAT and priority review for such entities.
Implement mandatory national security screening protocols for IND applications and trials involving foreign manufacturing, data transmission outside the U.S., or foreign sponsorship.
Require full disclosure and verification of foreign funding, partnerships, and data-sharing agreements.
Prohibit transmission of identifiable U.S. patient data to foreign adversary-controlled entities without statutory authorization.
Coordinate with the Department of Justice, FBI, and intelligence community to identify undisclosed foreign ties.
Audit all active clinical trials involving Chinese entities for potential risks.

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