A Podcast Appearance Leads to a Warning Letter for a Biologics Developer
The FDA issued a warning letter over a TV ad and a podcast appearance by its executive chairman, citing false cure claims, missing risk information, and promotion of unapproved uses.
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Yesterday, the FDA issued a warning letter to a biologics developer, citing alleged violations of federal advertising regulations in a TV advertisement and an appearance by company President Richard Adcock and Executive Chairman Patrick Soon-Shiong in a January 2026 podcast hosted by former White House Press Secretary Sean Spicer.
The letter, issued by the Office of Prescription Drug Promotion (OPDP), takes particular issue with what it calls a "misleading impression that Anktiva," ImmunityBio's drug product, "can cure and even prevent all cancer" and the omission of all risk information associated with the drug.
The letter references prior Untitled Letters sent to the company's wholly owned subsidiary, Altor Bioscience, requesting that ImmunityBio develop a "comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective communication(s) about the concern(s) discussed in this letter."
This is one of the more “aggressive” promotional enforcement letters we’ve seen OPDP issue in recent memory, and it's worth reading carefully for what it signals about how the FDA reviews promotional activity that extends beyond traditional advertising into earned media, executive interviews, and podcast appearances.
The drug and its approved indication
Anktiva (nogapendekin alfa inbakicept-pmln) is an IL-15 receptor agonist approved for intravesical use in combination with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
That indication is narrow by design: the efficacy data come from QUILT-3.032, a single-arm, multicenter trial.
Two details from the approved labeling matter for understanding this letter.
First, Anktiva is approved for use only in combination with BCG, a cohort evaluating Anktiva as a single agent in the same disease setting was stopped early for futility.
Second, the dosage and administration section of the prescribing information states explicitly that Anktiva is for intravesical use only and should not be administered by subcutaneous, intravenous, or intramuscular routes.
What the FDA found
The warning letter here addresses two specific promotional communications: a direct-to-consumer TV advertisement and a podcast episode titled “Is the FDA BLOCKING Life Saving Cancer Treatments?” that aired on The Sean Spicer Show on January 19, 2026, and was also accessible through ImmunityBio’s website.
Sean Spicer’s show is also hosted here on Substack:
The FDA identified violations across several categories. Let’s walk through them.
1. False or misleading efficacy claims
The FDA’s core concern is that both the TV ad and podcast contain representations that misleadingly suggest Anktiva can cure cancer, prevent cancer, and treat all cancers, none of which is supported by the approved labeling or the clinical data.
The letter cites specific statements from the podcast. Dr. Soon-Shiong described Anktiva as “the most important molecule that could cure cancer,” stated that the drug is “approved for bladder cancer, but it actually can treat all cancers,” and called it “the therapy to prevent cancer if you were exposed to radiation.”
In the TV ad, statements about the ability to “treat the tumor, and it doesn’t come back” were presented alongside images of Anktiva vials.
The FDA explains why these claims are unsupported:
QUILT-3.032 was a single-arm study with no comparator arm, which means DFS results are not interpretable due to the single-arm design and lack of a comparator arm.
You cannot determine whether the lack of recurrence is attributable to the drug or to other factors, like the natural history of the disease.
The study does not support claims that Anktiva can cure cancer. The claim that Anktiva can prevent cancer in people exposed to radiation is not supported by any data the FDA is aware of. And the repeated characterization of Anktiva as a “cancer vaccine” is, according to the FDA, false according to the FDA, which notes Anktiva is an IL-15 receptor agonist, not a vaccine.
The FDA also flagged that references to Anktiva as a “single jab” and “a little vial that you inject subcutaneously” misleadingly suggest the drug has a treatment effect as a monotherapy. Again, the single-agent cohort of QUILT-3.032 was stopped for futility. The efficacy data apply only to Anktiva in combination with BCG.
2. Misleading route of administration
Both the TV ad and podcast include representations (visual and verbal) suggesting that Anktiva is administered by injection.
The TV ad shows footage of a vial being removed from its carton, a healthcare practitioner preparing to administer a dose, a patient in a chair after an injection, and another patient being injected in the arm with a syringe.
Dr. Soon-Shiong refers to the drug as a “little vial that you inject subcutaneously” in the podcast.
Anktiva is approved for intravesical use only (instilled directly into the bladder via catheter). The prescribing information explicitly states it should not be administered subcutaneously, intravenously, or intramuscularly. The FDA characterizes these representations as “particularly alarming from a public health perspective,” given that the safety and efficacy of Anktiva via routes other than intravesical are unknown.
3. Omission of risk information
The TV ad presents risk information only after the screen fades to black, which, as the FDA notes, typically signals the close of a presentation, with no signal to alert the viewer that important risk information follows.
The podcast contains no risk information at all. The FDA states that this omission creates a misleading impression about the drug’s safety.
4. Omission of the full approved indication
The FDA, in its letter, says neither the TV ad nor the podcast communicates the full approved indication.
The TV ad references nonmuscle invasive CIS bladder cancer but does not specify that Anktiva is indicated for use in combination with BCG for adult patients with BCG-unresponsive NMIBC.
The podcast suggests use for bladder cancer generally.
The full indication does appear at the end of the TV ad, but again, only after the screen fades to black.
5. Promotion of unapproved uses
Based on the claims in the podcast (that Anktiva “can treat all cancers,” can rescue patients who fail checkpoint inhibitors in lung cancer, and can prevent cancer in people exposed to radiation) the FDA concluded that these provide evidence the drug is intended for new uses for which it lacks approval and for which its labeling does not provide adequate directions for use.
6. Failure to submit the podcast under Form FDA 2253
Federal regulations require that promotional labeling and advertising be submitted to the FDA at the time of initial dissemination. The podcast was not submitted under Form FDA 2253 as required.
Not the first time
The letter explicitly notes that OPDP previously sent two Untitled Letters (September 9, 2025, and January 7, 2026) to Altor BioScience, ImmunityBio’s indirect wholly-owned subsidiary, addressing “presentations of Anktiva that were, in certain respects, similar to presentations in the TV ad and podcast addressed in this letter.”
Those Untitled Letters cited misleading efficacy representations based on the QUILT-3.032 study data.
The escalation from Untitled Letters to a Warning Letter, with the FDA noting that “ImmunityBio continues to promote Anktiva in a similarly misleading manner,” is significant. It signals that OPDP views this as a pattern rather than an isolated compliance lapse.
Practical considerations for industry teams
This letter raises a number of issues that go well beyond ImmunityBio’s specific situation.