FDA made clear that comments from ImmunityBio founder Dr. Patrick Soon-Shiong about prescription drugs in longform audio can trigger enforcement just like TV or digital ads.
Regulators evaluated the ImmunityBio TV spot and podcast statements as part of the same promotional footprint, signaling less tolerance for inconsistencies across formats.
References to Anktiva’s broader cancer protection or “vaccine-like” effects show how quickly implications of off-label use can escalate into a warning letter.
The Food and Drug Administration put ImmunityBio on notice this week, calling out sweeping claims about its cancer therapy Anktiva across both a podcast appearance and a TV ad.
While the drug is approved for a narrow bladder-cancer indication, the biotech’s founder Dr. Patrick Soon-Shiong said in a podcast earlier this year that it could treat “all cancers.”
Regulators also flagged the company’s TV spot promoting the medication for overstating its efficacy and downplaying risk, signaling the agency is increasingly willing to evaluate brand messaging as one continuous promotional footprint rather than siloed formats.
“These violations are concerning from a public health perspective because the promotional communications create a misleading impression that Anktiva, a treatment for a certain type of bladder cancer, can cure and even prevent all cancer,” the FDA warning letter, posted online Tuesday, stated.
The communication from the FDA’s Office of Prescription...
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