The Partnership for Safe Medicines (PSM) has launched a strong criticism against telehealth company Hims & Hers over their planned Super Bowl LIX advertisement for compounded semaglutide, marking a significant escalation in the debate over marketing of compounded weight-loss medications.
PSM, an organization focused on medicine safety and supply chain security, has formally approached both Fox Corporation and the FDA regarding the advertisement, which they claim violates fundamental US prescription drug advertising regulations. The commercial, already available online and scheduled for a premium slot during the Super Bowl, has drawn particular scrutiny for its promotional approach.
Regulatory Concerns and Safety Issues
The primary concerns raised by PSM center on two critical regulatory violations. First, the advertisement allegedly fails to properly communicate that their semaglutide product is compounded rather than FDA-approved. Second, it omits mandatory side effect information required for prescription medicine promotions in the United States.
"This marketing blitz promotes altered, poorly regulated versions of legitimate pharmaceutical medications," states PSM executive director Shabbir Safdar. He emphasizes that while compounded drugs serve a purpose in medicine, they can pose significant health risks, particularly with complex injectable products.
Market Context and Supply Dynamics
The controversy unfolds against the backdrop of Novo Nordisk's Wegovy shortage, which generated approximately $8 billion in sales last year. The drug's presence on the FDA's shortage list has created an opening for compounding pharmacies to produce versions of semaglutide, despite Novo Nordisk's previous attempts to block such production on safety grounds.
Advertisement Specifics and Disclosure Issues
The PSM's letter to the FDA characterizes the commercial as "dangerous, blatantly misleading, and poses a substantial risk of harming the approximately 200 million consumers" expected to view it during the Super Bowl. While the advertisement includes a disclaimer about compounded products not being FDA-approved, PSM argues this appears only briefly in small, grey font without audio disclosure.
Company Response and Position
Hims & Hers defends their "Sick of the System" advertisement - their first Super Bowl commercial - as addressing America's obesity public health crisis. The company positions their product as an accessible and affordable alternative to higher-priced pharmaceutical options, stating their semaglutide injections are "doctor-trusted and formulated in the USA" through their affiliated pharmacies.
Regulatory Implications
The FDA has historically maintained that compounded drugs should be considered a last resort during shortages, not a first-line therapy option. However, this crucial safety message is notably absent from the advertisement, raising concerns about public health implications and regulatory oversight in pharmaceutical marketing.
