FDA Issues Warning to Biotech Billionaire Over Misleading Drug Claims

Tue Mar 24 2026 20:40:42 GMT+0000 (Coordinated Universal Time)

Federal health officials have cautioned Dr. Patrick Soon-Shiong, a biotech pioneer, regarding misleading statements about his company's bladder cancer drug, Anktiva, potentially impacting its market position.

Dr. Patrick Soon-Shiong's controversial claims about Anktiva's ability to treat other cancers led to a 24% drop in ImmunityBio's stock after the FDA issued a warning. The FDA's letter criticized misleading marketing statements made during a podcast and a TV advertisement, requiring the company to address significant concerns within 15 days. Soon-Shiong's statements raised alarms about the accuracy and legality of drug promotions that failed to mention potential risks.

In a significant regulatory move, federal health officials have issued a warning to Dr. Patrick Soon-Shiong, a prominent biotech billionaire, regarding recent claims made about his company's bladder cancer drug, Anktiva. During a podcast, Soon-Shiong suggested that Anktiva may not only treat but also cure and prevent other types of cancers, a statement that has drawn scrutiny from the Food and Drug Administration (FDA).

The FDA's warning letter challenges both a podcast and a television advertisement that promote Anktiva, which was approved in early 2024 specifically for patients with a difficult-to-treat form of bladder cancer. After the FDA's warning was made public, shares of ImmunityBio Inc., the company that Soon-Shiong leads, plummeted more than 24%.

Although Anktiva is FDA approved for bladder cancer, Soon-Shiong controversially remarked on the podcast that the drug could treat all forms of cancer. He claimed that it contains “the most important molecule that could cure cancer” and stated, “We have the therapy to prevent cancer if you were exposed to radiation.” These representations have alarmed regulators, who assert that such statements violate federal drug marketing rules.

The FDA highlighted that the promotional materials failed to include critical information about the risks and side effects associated with Anktiva, which can include urinary tract infections, chills, and fever. Under current FDA regulations, drug promotions must provide a balanced view of a drug's risks alongside its benefits.

The warning, directed at ImmunityBio's CEO Richard Adcock, specifically addresses concerns about a television ad referring to Anktiva as a “cancer vaccine,” a characterization the FDA has deemed false. The company is expected to respond within 15 days to rectify the issues raised in the warning letter. Following the announcement, a link to the controversial podcast episode was promptly removed from ImmunityBio's website.

A spokesperson for ImmunityBio stated that the company takes the issue seriously and intends to collaborate with the FDA to address the concerns outlined in the warning. Under the previous Trump administration, the FDA ramped up enforcement actions against drug manufacturers, particularly those leveraging digital platforms for marketing.

The situation underscores the critical importance of truthful and accurate drug marketing practices, especially in a landscape where misleading claims can lead to significant public health implications and economic consequences for companies.