FDA says billionaire's claims about cancer drug Anktiva are misleading

The FDA has issued a warning that biotech billionaire Dr. Patrick Soon-Shiong made misleading claims about Anktiva, his company's bladder cancer drug. Federal health officials posted the warning after determining that Soon-Shiong's statements about the medication did not align with agency standards or approved labeling. The move underscores the FDA's enforcement authority over drug marketing claims, even when made by company founders or high-profile executives. Anktiva received FDA approval, but manufacturers must restrict their promotional statements to what has been clinically demonstrated and approved. The warning signals potential regulatory consequences if Soon-Shiong's company continues making unsupported claims about the drug's efficacy or safety.