Sen. Rick Scott is turning up the heat on federal health regulators, demanding a broad investigation into how Chinese entities are involved in U.S. clinical trials. The Florida Republican argues that when patient samples or key processing steps are handled overseas, they become both a national‑security vulnerability and a patient‑safety gamble.
In a March 19, 2026 letter, Scott pressed the Department of Health and Human Services, the National Institutes of Health and the Food and Drug Administration to map out the scope of foreign ties in clinical research and report back in writing within 60 days. His push drops fresh scrutiny on how cell and gene therapy materials are shuttled across borders during development.
As reported by the Tampa Free Press, Scott zeroed in on a China‑based company identified as Bioheng, which also operates as Imviva. He pointed to the firm’s model, in which donor cells are collected in China, engineered there, then administered to patients in the United States, and said it raises “substantial national security” concerns.
In the letter, Scott asks federal agencies to review and potentially pause pending clinical trials that involve entities with ties to the Chinese Communist Party or the People’s Liberation Army. He also urges regulators to reevaluate expedited review programs, to require national‑security screenings for any foreign manufacturing or cross‑border data transfers, and to flatly prohibit sending identifiable data on U.S. patients to foreign adversaries.
Company at the center: Imviva/Bioheng
Imviva Biotech, formerly known as Bioheng, has laid out a U.S. development program around its allogeneic CAR‑T candidate CTD402 and says the FDA cleared an Investigational New Drug application for the therapy. In a press release, Imviva Biotech said it not only received IND clearance but also secured Regenerative Medicine Advanced Therapy (RMAT) designation and, in December 2025, dosed the first U.S. patient in its TENACITY‑01 trial.
The company highlights what it calls an “off‑the‑shelf” manufacturing model, which it says is designed to speed access for patients facing relapsed or refractory T‑cell leukemias.
Federal context
Scott’s warnings land in the middle of a broader federal rethink of how sensitive biological materials move around the globe. On June 18, 2025, the FDA announced it was reviewing and halting new clinical trials that export Americans’ living cells to foreign labs for genetic manipulation. The agency cautioned that such transfers could expose participants’ biological data and complicate U.S. oversight.
Under that policy, companies must show full transparency and ensure that sensitive materials are handled domestically before their trials can move forward.
Congressional scrutiny
Congress had already started sounding alarms. In August 2024, the House Select Committee on the Strategic Competition Between the United States and the Chinese Communist Party sent a letter asking the FDA to dig into evidence that U.S. biopharmaceutical firms were partnering with Chinese military‑affiliated medical centers and running trials in Xinjiang.
The bipartisan inquiry warned that such collaborations could help transfer valuable intellectual property to the People’s Liberation Army and might cast doubt on the reliability of foreign clinical data.
“The United States must remain open to legitimate scientific collaboration, but openness cannot come at the expense of national security or patient protection,” Scott wrote, according to the Tampa Free Press. His letter seeks a detailed written response from HHS, NIH and FDA within 60 days, which would give the agencies until May 18, 2026 to answer.
What could change
Scott is framing the debate as a dollars‑and‑jobs issue as much as a spy‑vs.‑science problem. A TEConomy analysis for the Biotechnology Innovation Organization estimates that in 2023 the U.S. bioscience sector employed about 2.3 million people and generated roughly $3.2 trillion in economic output.
If HHS, NIH and FDA put the tighter rules Scott wants into place, from mandatory national‑security vetting to outright bans on certain identifiable data transfers, clinical trials that depend on cross‑border processing could be delayed or forced to reroute. Sponsors and regulators could have to adjust consent forms, oversight structures and manufacturing plans before moving ahead.
Scott’s letter now puts a firm clock on the agencies. Their replies, whether they defend current safeguards, freeze certain trials or opt against any new steps, will help determine whether Congress moves toward new rules or formal investigations. In the meantime, patients in advanced‑therapy studies and the companies running those trials are left watching Washington for signals that could reshape their timelines and trial locations.
