Washington, D.C. — The U.S. Food and Drug Administration (FDA) issued a stern warning to billionaire biotech executive Dr. Patrick Soon-Shiong on Tuesday regarding misleading statements he made about the potential of his company’s bladder cancer drug, Anktiva. The warning was prompted by remarks made during a podcast appearance and in a television advertisement, where Soon-Shiong suggested that the drug might not only treat but also cure or prevent various types of cancer.
The FDA's letter specifically addressed claims made during an episode of The Sean Spicer Show podcast, entitled ‘Is the FDA blocking life-saving cancer treatments?’ In that episode, Soon-Shiong claimed that Anktiva was “the most important molecule that could cure cancer” and noted its approved status for bladder cancer but stated, without evidence, that it could be effective against all cancers.
Following the FDA’s warning, shares of ImmunityBio, Soon-Shiong's primary company, experienced a dramatic drop of more than 24% on trading platforms. The FDA has underscored that the statements made by Soon-Shiong create a ‘misleading impression’ of Anktiva’s capabilities, which could contravene federal drug marketing laws.
The FDA's concerns were not limited to the misleading claims; they also highlighted the absence of essential information regarding the drug's associated risks and side effects in the promotional materials. The risks may include urinary tract infections, pain, chills, and fever – none of which were adequately disclosed in the podcast.
The warning letter demands a response from ImmunityBio within 15 days, prompting the company to reevaluate its promotional strategies. A spokesperson for ImmunityBio indicated that the firm takes the FDA’s warning seriously and intends to cooperate fully to rectify the identified issues. This incident aligns with a broader trend of stricter regulation from the FDA regarding drug promotion, particularly enhanced under the Trump administration, targeting misleading drug advertisements and online pharmacy practices.
The FDA's letter specifically addressed claims made during an episode of The Sean Spicer Show podcast, entitled ‘Is the FDA blocking life-saving cancer treatments?’ In that episode, Soon-Shiong claimed that Anktiva was “the most important molecule that could cure cancer” and noted its approved status for bladder cancer but stated, without evidence, that it could be effective against all cancers.
Following the FDA’s warning, shares of ImmunityBio, Soon-Shiong's primary company, experienced a dramatic drop of more than 24% on trading platforms. The FDA has underscored that the statements made by Soon-Shiong create a ‘misleading impression’ of Anktiva’s capabilities, which could contravene federal drug marketing laws.
The FDA's concerns were not limited to the misleading claims; they also highlighted the absence of essential information regarding the drug's associated risks and side effects in the promotional materials. The risks may include urinary tract infections, pain, chills, and fever – none of which were adequately disclosed in the podcast.
The warning letter demands a response from ImmunityBio within 15 days, prompting the company to reevaluate its promotional strategies. A spokesperson for ImmunityBio indicated that the firm takes the FDA’s warning seriously and intends to cooperate fully to rectify the identified issues. This incident aligns with a broader trend of stricter regulation from the FDA regarding drug promotion, particularly enhanced under the Trump administration, targeting misleading drug advertisements and online pharmacy practices.
