WASHINGTON (AP) — Federal health officials issued a warning Tuesday over misleading statements made by biotech billionaire Dr. Patrick Soon-Shiong, who recently told podcast listeners that his company’s bladder cancer drug may be able to treat, cure or even prevent other types of cancers.
The warning letter from the Food and Drug Administration criticizes a TV advertisement and a podcast episode promoting Anktiva, the principal product of ImmunityBio Inc. The drug manufacturer, incorporated by Soon-Shiong, also owns the Los Angeles Times.
Following the FDA's warning, company shares plummeted over 24% during Tuesday's trading.
Anktiva was approved in 2024 for patients suffering from a difficult-to-treat form of bladder cancer, and ImmunityBio is currently seeking further approval to extend the drug’s applications to several other conditions, including various lung and pancreatic cancers.
During a January episode of The Sean Spicer Show podcast titled: “Is the FDA blocking life-saving cancer treatments?”, Soon-Shiong proclaimed that Anktiva was “the most important molecule that could cure cancer.” He later claimed that while its approval is limited to bladder cancer, “it actually can treat all cancers.”
FDA regulators argue that the statements violate federal drug marketing regulations due to the “misleading impression” created regarding the drug. Furthermore, the podcast notably omitted any discussion of the potential risks and side effects associated with the drug, which can include urinary tract infections, pain, chills, and fever. Under FDA law, drug promotions are mandated to present a balanced view of their risks and benefits.
The FDA's letter addressed to ImmunityBio CEO Richard Adcock highlights similar concerns regarding the aforementioned TV advertisement for Anktiva. Both the promotional content refers to the drug as a “cancer vaccine,” which the FDA labels as inaccurate.
ImmunityBio has been given a fifteen-day deadline to rectify the violations and inform the agency of their corrective measures. As of Tuesday afternoon, the podcast link was removed from the company’s website.
Response from ImmunityBio indicated the company would collaborate with the FDA to resolve the issues stated in the warning.
Under the former Trump administration, the FDA increased vigilance over drugmakers and online pharmacies, including heightened scrutiny of company executives’ appearances on television and podcasts.
