Big drama around the Hims & Hers Super Bowl ad is making it's way to the FDA
A pharma industry group is urging the U.S. Food and Drug Administration (FDA) to block what it calls a 'dangerous' Super Bowl ad from the digital healthcare company Hims & Hers (HIMS), promoting an off-brand version of Ozempic.
'As a knock-off copy of a prescription drug, the commercial for this product should comply with FDA prescription drug ad rules,'wrote Shabbir Imber Safdar, executive director of the Partnership for Safe Medicines, in a letter to the agency. 'We request you act to enforce the laws and guidelines that protect Americans from misleading marketing in health products.'
The group also wrote a letter to Fox (FOXA), the broadcast network airing the Super Bowl this Sunday, asking them to pull the 'deeply troubling' commercial.
Members of the Partnership for Safe Medicines include the Pharmaceutical Research and Manufacturers of America (PhRMA), an advocacy group that represents both Novo Nordisk (NVO) and Eli Lilly (LLY), the makers of popular branded weight-loss medications.
Both Eli Lilly and Novo Nordisk have been ramping up production of their GLP-1 medications to remove them from the FDA's drug shortage list, a goal Eli Lilly achieved late last year. The pharmaceutical giants have also filed petitions with the FDA to have their medications added to a list of drugs deemed too complex to compound safely.
'This is a clear attempt by industry groups to cancel an advertisement that directly calls out how they are part of a system that fails to prioritize the health of Americans,' Hims & Hers said in a statement to Quartz. 'The system is broken, and this is just another example of how they don't want Americans to know they have options. We're calling for change, which means putting the health of Americans first through affordable and available care.'
Partnership for Safe Medicines did not immediately respond to requests for comment.
The Super Bowl ad, from the millennial-targeted telehealth company, has a surprisingly political tone — with Donald Glover's 'This is America' as its soundtrack — criticizing the high price tag of branded weight-loss drugs.
'Welcome to weight loss in America — a $160 billion industry that feeds on our failure,' says a narrator in the commercial. 'There are medications that work — but they are priced for profits, not patients.'
The commercialbriefly features the company's GLP-1 injections. The weekly treatment contains off-brand semaglutide — the active ingredient in Novo Nordisk's popular diabetes and weight-loss treatments Ozempic and Wegovy. Unlike Wegovy ads, however, the Hims & Hers spot does not list out risk disclaimers.
Hims & Hers started offering customers in May compounded semaglutide injections for just $199 a month — hundreds of dollars cheaper than Ozempic's nearly $1,000 list price and Wegovy's $1,349 price tag.
GLP-1 drugs are a class of medications that mimic gut hormones that regulate blood sugar and suppress appetite. However, due to their high retail price and skyrocketing demand, many patients have had difficulty getting their hands on these popular medications.
When a medication is in shortage, which Novo Nordisk's Wegovy has been for years, the FDA allows pharmacies to make compounded or altered versions of the drug if they meet specific regulatory requirements. This loophole has led several digital health companies, online pharmacies, and wellness spas to produce and sell cheaper versions of brand-name weight-loss drugs during recent shortages.
Novo Nordisk's executive vice president of U.S. operations, David Moore, told investors on a call Wednesday that the compounded market is having an impact on the company's demand, and that impact is 'growing faster' than anticipated.
With Super Bowl ads reportedly costing up to $8 million for a 30-second spot this year, Hims & Hers likely spent about $16 million for its one-minute commercial.
The story was updated to include a response from Him & Hers.
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