In a recent development, the FDA issued a stern warning against Dr. Patrick Soon-Shiong, a prominent figure in the biotech industry, for making misleading claims about the capabilities of Anktiva, a bladder cancer treatment developed by his company, ImmunityBio. The warning came after Soon-Shiong asserted during a podcast that Anktiva could treat, cure, or prevent various types of cancers, not just bladder cancer.
The FDA's warning detailed specific concerns regarding a podcast episode and a TV advertisement that promoted Anktiva, both of which were said to create a misleading impression about the drug's capabilities. Following this announcement, shares of ImmunityBio dwindled by over 24% within a single trading session.
In 2024, Anktiva received FDA approval for use in a challenging variant of bladder cancer. However, ImmunityBio is actively pursuing approval for wider applications of the drug. Soon-Shiong, who also serves as CEO of his company and owns the Los Angeles Times, claimed during the podcast titled 'Is the FDA blocking life-saving cancer treatments?' that Anktiva was 'the most important molecule that could cure cancer.'
Amidst these assertions, Soon-Shiong mentioned that the drug could prevent cancer caused by radiation exposure. The FDA responded by noting that such statements violate drug marketing rules because they misrepresent the product and create potential confusion.
Furthermore, the FDA pointed out that critical information regarding Anktiva’s risks and side effects, including urinary tract infections and chills, was omitted from the podcast. Under existing regulations, it is mandated that drug promotions provide a balanced overview that includes both risks and benefits.
The FDA has allowed 15 days for ImmunityBio to amend the issues raised and respond with corrective measures. In the aftermath of the warning, a link to the contentious podcast was removed from the company's website, signaling the serious approach they are taking to resolve these concerns.
As drug promotion scrutiny has increased under the current administration, further actions are anticipated against companies that mislead consumers about their products. ImmunityBio has publicly acknowledged the seriousness of the FDA's warning, expressing intentions to collaborate with the agency in addressing the raised concerns.
The Associated Press Health and Science department, which received support from various educational foundations, remains vigilant in tracking further developments in this critical area of health and regulatory oversight.
