Compounded GLP-1 drugs operate under a different regulatory framework than FDA-approved branded medications, and that distinction sits at the center of the Federal Trade Commission's lawsuit against Hims & Hers. Chief executive Andrew Dudum told CNBC the FTC has the framework wrong. His argument: the agency's complaint misunderstands how the company works.
Compounded drugs are formulated by licensed pharmacies outside the FDA's standard approval pathway, placing them under different rules for marketing and dispensing. That is the domain in which Hims & Hers operates, and the domain Dudum says the FTC has misread.
Artificial intelligence came up as well in the CNBC interview, a second area of the company's operations that Dudum addressed alongside the compounding dispute. Hims & Hers has offered no concession on the FTC's account of its model.