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Telehealth company Hims & Hers was in the middle of a controversy over its Super Bowl LIX ad for compounded semaglutide weight loss that reignited a heated debate with drug industry groups and lawmakers Its “Sick of the System” ad bashed the high cost of weight-loss medications by portraying Hims & Hers as the cheap alternative, hence the accusations of misleading advertising and safety concerns.
The controversial Super Bowl ad
The 60-second spot, to be aired during Super Bowl LIX, took on obesity as “America’s deadliest epidemic” and lashed out at the $160 billion weight-loss industry. Set to the tune of Childish Gambino’s “This is America,” images rolled out before the viewer of injecting pens—looking very much like brand-name medications for weight loss, Ozempic and Wegovy—now with a large price tag. The ad claimed the health care system is “broken” and that “profit in the pharmaceutical industry is more important than patient health”. Hims & Hers touted its compounded semaglutide as an “affordable, doctor-trusted” alternative with its copycat version costing less than $200 a month versus Wegovy’s $1,000 price tag.
But the message of the ad itself immediately received pushback. Some critics charged that Hims & Hers was hypocritical to slam the weight loss industry while advertising a weight loss drug. Others felt that the ad was misleading by omitting critical safety information and disclosure that the advertised medication was a non-FDA-approved compounded drug.
The big problem is that Hims & Hers sells compounded semaglutide, which is essentially a knockoff of the prescription drug Wegovy. A compounded drug is one that is made on a custom basis by a licensed pharmacist or physician for a particular patient. This would normally happen when an FDA-approved drug is unavailable or in short supply. While compounding is legal under certain conditions, compounded drugs are not directly regulated by the FDA and do not undergo the rigorous safety, effectiveness, and quality evaluations that FDA-approved drugs do.
The FDA has warned that compounded drugs can pose risks to patients because they are not subject to the same rigorous evaluation. The agency also has received adverse event reports from patients who have used compounded semaglutide and issued specific warnings against several compounders for using salt forms of semaglutide different from the semaglutide used in approved products.
Industry pushback and regulatory scrutiny
The Partnership for Safe Medicines, an industry group that deals with issues such as counterfeit medicines, said it was “deeply disturbed” by the Hims & Hers ad. The PMA argued that the ad “promotes altered, poorly regulated versions of legitimate pharmaceutical medications” intended for people with serious medical conditions.
Two U.S. senators, Dick Durbin and Roger Marshall, wrote to the FDA expressing concern that “This ad risks misleading patients by omitting any safety or side effect information when promoting a type of weight loss medication”. The senators called the situation a “regulatory loophole” in need of repair, highlighting the difference in standards between compounded medications and FDA-approved medicines.
Hims & Hers’ defense
Hims & Hers defended its Super Bowl ad and the compounded semaglutide it offers. The company called the criticism “a blatant attempt by industry groups to cancel an advertisement that explicitly points out how they contribute to a system that neglects the health of Americans”. They believe that they are in compliance with all applicable advertising laws and regulations and that compounded medications are subject to a different standard than FDA-approved medications.
Hims & Hers has been vocal about how their compounded semaglutide is an affordable alternative to expensive brand-name medications like Ozempic and Wegovy, whose prices are driven by profit rather than patients. The company representative stated, “We challenged the industry to make changes — and their response has been to try to silence this ad. To us, it’s clear the problem isn’t the ad itself, but the message it carries”.
The bigger picture
The uproar over Hims & Hers’ Super Bowl ad is part of a broader, ongoing battle for power within the pharmaceutical industry, mainly between manufacturers of brand-name drugs and the sellers of compounded versions. Novo Nordisk, maker of Wegovy and Ozempic, has in the past called on the FDA to stop compounders from producing copycat versions of its medicines, warning of deep safety risks. Eli Lilly, the manufacturer of Zepbound and Mounjaro, has filed lawsuits against online sellers for wrongfully copying its medicines.
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