Federal health officials have issued a cautionary notice regarding misleading claims made by Dr. Patrick Soon-Shiong, a prominent biotech entrepreneur. Recently, he made assertions on a podcast that his company’s bladder cancer drug, Anktiva, has the potential to treat, cure, or even prevent various other forms of cancer. The warning came from the Food and Drug Administration (FDA) and specifically addresses statements made during a podcast episode as well as a television advertisement promoting Anktiva, the flagship product of ImmunityBio Inc.
This scrutiny follows Dr. Soon-Shiong’s remarks during a January episode of The Sean Spicer Show, where he asserted that Anktiva is “the most important molecule that could cure cancer.” He elaborated that while the drug is currently approved for a particularly challenging form of bladder cancer, it could potentially provide treatment for “all cancers.” He further claimed that Anktiva could prevent cancer following radiation exposure.
The FDA responded by stating that these declarations create a “misleading impression” of the drug’s capabilities, as they violate federal drug marketing regulations. The agency pointed out that the podcast failed to mention any risks or side effects associated with Anktiva, which may include urinary tract infections, pain, chills, and fever. Under FDA guidelines, promotional content must deliver a balanced perspective on a drug’s benefits and risks.
The concerns highlighted by the FDA extended to a television advertisement for Anktiva, which mischaracterizes the drug as a “cancer vaccine.” This assertion was deemed inaccurate by the FDA. The warning letter directed to ImmunityBio’s CEO, Richard Adcock, stipulates a 15-day period for the company to address these issues and respond to the FDA in writing.
As a direct consequence of the FDA’s warning, shares of ImmunityBio plummeted by more than 24% during trading on Tuesday. The link to the controversial podcast was subsequently removed from the company’s website.
A spokesperson for ImmunityBio acknowledged the gravity of the FDA’s warnings and confirmed that the company intends to work cooperatively with the agency to rectify the concerns raised. This incident is part of a broader trend, with the FDA, especially under the previous administration, intensifying scrutiny over drug manufacturers and their promotional conduct, including the appearances of company executives on various media platforms.
