FDA warns ImmunityBio over false cancer drug claims in podcast

The US Food and Drug Administration (FDA) has issued a warning to ImmunityBio and its founder, Dr. Patrick Soon-Shiong, over misleading claims about the cancer drug Anktiva. The regulator accused the company of making false statements in a podcast, suggesting the treatment could cure or prevent multiple types of cancer.

ImmunityBio has since removed the podcast from its website and pledged to cooperate with authorities to address the concerns raised.

The FDA's warning centres on a podcast in which Soon-Shiong allegedly claimed Anktiva could treat or prevent cancers beyond its approved use. The agency stated that such assertions mislead patients by implying the drug is a universal cure. It also criticised the podcast for failing to mention potential risks and side effects.

The regulator has given ImmunityBio 15 days to respond and correct the misleading information. This action aligns with the FDA's broader efforts to combat false advertising in media, including TV shows and podcasts. Under the Trump administration, the agency intensified its crackdown on drug manufacturers and online pharmacies making unverified claims. The FDA has a history of taking strong measures against misleading health claims. In 2008, Airborne settled for $23.3 million over false cold remedy advertising. During the COVID-19 pandemic, the agency issued warnings to telemedicine firms and individuals promoting unapproved treatments, often resulting in civil penalties or consent decrees. ImmunityBio has stated it will work with regulators to resolve the issue. The company's removal of the podcast suggests an attempt to comply with the FDA's demands before the deadline.

The FDA's warning highlights its ongoing scrutiny of exaggerated medical claims in public communications. ImmunityBio now faces a tight deadline to address the concerns or risk further regulatory action. The outcome will determine whether additional penalties or corrective measures are imposed on the company.