AI & Machine Learning in Biotechnology
STAT+: FDA slams Soon-Shiong and ImmunityBio for making ‘false and misleading’ claims about a drug
Patrick Soon-Shiong, a controversial figure in the biotech industry, was harshly criticized by the U.S. Food and Drug Administration for making several false and misleading claims about a cancer treatment in television ads and in a podcast.
In a March 13 warning letter to ImmunityBio, which is primarily owned and controlled by Soon-Shiong, the agency found fault with numerous comments about the therapy, called Anktiva. The drug is marketed as a treatment for a type of bladder cancer, but the FDA noted both the ad and podcast suggested it was able to treat “all cancers.”
The agency noted that material facts were omitted — notably, that Anktiva must be used in combination with a vaccine; risks were downplayed in the ad and never mentioned in the podcast; and both the ad and podcast indicated that patients treated with Anktiva would be “cancer free,” which was not supported by clinical studies.
Patrick Soon-Shiong, a controversial figure in the biotech industry, was harshly criticized by the U.S. Food and Drug Administration for making several false and misleading claims about a cancer treatment in television ads and in a podcast.
In a March 13 warning letter to ImmunityBio, which is primarily owned and controlled by Soon-Shiong, the agency found fault with numerous comments about the therapy, called Anktiva. The drug is marketed as a treatment for a type of bladder cancer, but the FDA noted both the ad and podcast suggested it was able to treat “all cancers.”
The agency noted that material facts were omitted — notably, that Anktiva must be used in combination with a vaccine; risks were downplayed in the ad and never mentioned in the podcast; and both the ad and podcast indicated that patients treated with Anktiva would be “cancer free,” which was not supported by clinical studies.