Over 100 million Americans watched Hims & Hers (HIMS+4.77%)’ controversial Super Bowl ad taking on the weight-loss drug industry this Sunday during the Super Bowl.
The ad took 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,” said a narrator in the commercial. “There are medications that work — but they are priced for profits, not patients.”
The ad briefly featured the company’s GLP-1 injections. The weekly treatment contains compounded or off-brand semaglutide, the active ingredient in Novo Nordisk’s (NVO-2.80%) popular diabetes and weight-loss treatments Ozempic and Wegovy. Where the controversy comes is that, unlike Wegovy ads, the Hims & Hers spot did not include a list of risk disclaimers.
Several industry groups and lawmakers called the commercial misleading and urged the U.S. Food and Drug Administration (FDA) to take action against the ad. Meanwhile, Hims & Hers said the backlash was “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.”
Here is everything you need about Hims & Hers’ compounded weight-loss drugs.
Compounding is the process of customizing an approved drug by a state-licensed pharmacist or physician to meet the specific needs of an individual patient. The alterations of these medications can include making a higher dosage, reformulating a drug to not include ingredients a patient may be allergic to, and changing a pill into liquid form.
Outsourcing facilities can also compound drugs under the supervision of a licensed pharmacist.
There are about 7,500 pharmacies in the United States that focus on compounded drugs, according to the American Pharmacists Association.
Typically, the Food, Drug, and Cosmetic Act prohibits compounding drugs that are just copies of commercially available medications. However, drugs that are in shortage are not considered by the U.S. Food and Drug Administration (FDA) to be commercially available.
Wegovy is currently in shortage due to increased demand, according to an FDA database. Because of this, compounders are allowed to buy semaglutide from drug ingredient makers to compound it into injectable formulations. These formulations could be mixed with B vitamins or L-carnitine.
Hims & Hers in May began offering customers 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.
The compounded formulations are not FDA-approved, so the agency does not review the safety and efficacy of these products
The FDA said last year that it had received adverse event reports from patients taking a compounded semaglutide and recommended that patients not use a compounded drug if an approved drug is available. The agency specifically warned about reports of some compounders using salt forms of semaglutide — which is different from the semaglutide used in approved products like Wegovy — in their formulations.
For its part, Hims & Hers said they conducted exhaustive research and vetting for over a year before partnering with a leading U.S. manufacturer of generic and compounded drugs.
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