Sen. Rick Scott (R-Fla.) sent a letter on Thursday to top officials in the Department of Health and Human Services (DHHS), National Institutes of Health (NIH), and Food and Drug Administration (FDA) calling for a review of the Chinese Communist Party’s (CCP) involvement in U.S. clinical trials and drug approvals.
Sen. Scott urged DHHS Secretary Robert F. Kennedy Jr., NIH Director Jat Bhattacharya, and FDA Commissioner Marty Makary to take “immediate action to ensure that national security considerations are fully integrated into the review of such applications.”
“For years, the CCP has engaged in systematic efforts to acquire American intellectual property, including through economic espionage and the exploitation of research collaborations,” Sen. Scott wrote. “These actions have imposed high economic costs and created substantial national security risks. The biotechnology sector – particularly advanced therapeutics such as cell and gene therapies – represents a strategic domain in which protecting American innovation and sensitive health data is paramount.”
Sen. Scott is the Chairman of the U.S. Senate Special Committee on Aging. The committee most recently introduced the bipartisan, bicameral Consumer Labeling for Enhanced API Reporting and Legitimate Accountability for Base Entity Listings (CLEAR LABELS) Act.
According to the committee’s website, “this bill would require country-of-origin labeling for prescription medicines and their ingredients, ensuring Americans know exactly where the drugs in their medicine cabinets are produced.”
“I have been made aware that Bioheng, also known as Imviva, a China-based company reportedly financed by CCP-linked sources1, has received authorization to proceed under an Investigational New Drug (IND) application and has been granted Regenerative Medicine Advanced Therapy (RMAT) designation and priority review,” the Florida senator expressed in his letter, emphasizing that the decision to prolong accelerated regulatory benefits to a CCP-affiliated entity “warrants careful scrutiny.”
“The United States must remain open to legitimate scientific collaboration, but openness cannot come at the expense of national security or patient protection. A failure to account for these risks undermines both,” he affirmed.
