It’s no secret that weight-loss medications, particularly those of the injectable variety, are in high demand. Without insurance, they’re also costly. Wegovy (semaglutide) has a list price of $1,349.02 for a four-week supply. Competitor Zepbound (tirzepatide) is a smidge cheaper at $1,086.37. And as these drugs are FDA-approved for chronic weight management, they’re meant to be taken indefinitely. Even if your insurance covers the bulk of the expenses, you may have to jump through prior authorization hoops.
Telehealth company Hims & Hers has had enough—and is putting its money where its mouth is in the form of its first Super Bowl ad, called “Sick of the System.” The minute-long commercial is abrasive, even chaotic, which is presumably the point. Set to Childish Gambino’s “This Is America,” a takedown of gun violence and systemic racism, the third-quarter big game slot, in no uncertain terms, accuses the pharmaceutical industry of price-gouging weight-loss drugs, thereby fueling the obesity crisis.
“Something’s broken, and it’s not our bodies,” the narrator says, in tandem with a montage of coiffed women being judged in a swimsuit competition, milk being poured over sugary cereal, a magazine flaunting its guide to slimming down for summer. “It’s the system. Welcome to weight loss in America, a $160 billion industry that feeds on our failure. There are medications that work, but they’re priced for profits, not patients.”
Indeed, obesity is a pervasive health issue, and not just in the U.S. As of 2022, one in eight people worldwide was living with obesity, according to the World Health Organization. That’s 890 million adults 18 and older, and 160 million children and adolescents ages 5 to 19. In America, as the commercial highlights, about 74% of adults 20 and older had overweight or obesity as of the 2017–18 National Health and Nutrition Examination Survey.
“As a brand that customers trust, we’re using the voice that we’ve built over the last seven years to raise awareness to this critical health issue,” Hims & Hers said in a Jan. 31 statement to Fortune, three days after the ad launched on YouTube. “For too long the focus of weight loss has been size and pounds lost, when in reality, it should be about access, helping people find the best version of their health, and a system that is built for profit.
“We’re going direct with the ad so that we can change that conversation and help our customers not only understand more fully the challenges facing them, but also to advocate for them and give them the opportunity to access the care that they need.”
Hims & Hers hopes its push for new patients will outlive the 15 minutes of fame characteristic of Super Bowl commercials. It’s all part of the company’s Healthier America campaign, which promises “access to doctor-trusted weight-loss treatment plans tailored to your needs for long-term success.”
To that end, Hims & Hers offers compounded GLP-1s—also called incretin mimetics, the class of medications to which Wegovy, Zepbound, and Saxenda (liraglutide) belong—starting at $165 per month. (Nurses, teachers, veterans, military, and first responders get a $99 per month deal.) Health insurance isn’t required, and neither is a video visit with a doctor.
There’s just one problem: Compounded drugs aren’t FDA-approved.
FDA cautions against ‘risky’ compounded GLP-1 drugs
Taking a compounded GLP-1 medication isn’t the same thing as your pharmacy filling the cheaper, generic version of a drug your doctor prescribed. Though compounded semaglutide, for example, contains the same active ingredient as Wegovy, the Food and Drug Administration doesn’t verify the safety, quality, or effectiveness of such mixed or altered meds.
Given the surging popularity of obesity management drugs in recent years, the FDA put out a warning singling out compounded GLP-1s, calling them “risky for patients.” The agency said it had received hundreds of reports of adverse events linked to compounded semaglutide (392) and tirzepatide (215) as of Nov. 30. Those numbers may be an underestimation, as state-licensed pharmacies that don’t outsource facilities aren’t required to report such incidents.
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Hims & Hers stressed to Fortune the FDA’s caveat that “many of the adverse events reported for compounded products appear to be consistent with adverse events related to the FDA-approved versions of these products.” In addition, the company said it sources ingredients exclusively from FDA-regulated manufacturers. However, in contrast with mainstream drug commercials that ambush consumers with a catalogue of side effects, “Sick of the System,” in a blink, flashes text saying its compounded products aren’t FDA-approved.
Hims & Hers is hardly the only company that swooped in when name-brand GLP-1s were in short supply. Firms from Noom to Weight Watchers offer their own bespoke concoctions. Novo Nordisk’s semaglutide, marketed as Wegovy for people with obesity and Ozempic for those with Type 2 diabetes, has been on the FDA Drug Shortages list since August 2022. Novo Nordisk’s liraglutide, indicated for weight loss as Saxenda and for Type 2 diabetes as Victoza, has been on the list since July 2023.
Eli Lilly’s tirzepatide, marketed as Zepbound for people with obesity and Mounjaro for those with Type 2 diabetes, is another story. Its nearly two-year shortage ended in October, at which time the trade group Outsourcing Facilities Association sued the FDA. The agency in December upheld its initial determination that the tirzepatide shortage had ended, adding that it wouldn’t penalize outsourcing facilities until late March.
Novo Nordisk has nominated semaglutide for inclusion in the FDA’s Demonstrable Difficulties for Compounding Lists. In other words, it wants to stop companies like Hims & Hers from crafting Wegovy-like medications. Meanwhile, Hims & Hers stands firm that patient safety is a pillar of its operations.
“Our responsibility to our customers is to support them every step of the way on their care journey,” Hims & Hers said in its Jan. 31 statement to Fortune. “One of the ways we do that is by being transparent about what is in the medications customers are sent, which is why customers can find a Certificate of Analysis in every order. This transparency isn’t required, but we are always looking to enhance the customer experience, and this was a natural next step.”
Hims & Hers commercial creates compounding controversy
With Super Bowl LIX looming, health advocacy groups are calling on the FDA to prevent “Sick of the System” from airing Feb. 9.
In a Feb. 5 letter to the agency, Shabbir Imber Safdar, executive director of the Partnership for Safe Medicines (PSM), called the ad “blatantly misleading,” noting its written warning doesn’t cut it.
“Hims & Hers clearly understands that they need to explain these critical facts to consumers because they include a disclaimer,” Safdar wrote. “However, the disclaimer appears only briefly in tiny, gray font at the bottom of the screen that is nearly imperceptible to an average viewer, without any accompanying audio disclosure.”
In a similar letter to Fox, the network airing the big game, PSM accused the commercial of failing to comply with FDA and Federal Trade Commission regulations.
Pharmaceutical Research and Manufacturers of America (PhRMA), which lobbies on behalf of industry giants including Lilly and Novo Nordisk, also swiftly slammed the Hims & Hers ad.
“What’s unclear is how regulators are allowing this,” PhRMA said in a Feb. 6 statement to Fortune. “The ad is a clear violation of the Federal Food, Drug, and Cosmetic Act (FDCA), which requires that advertising for prescription drugs—including compounded drugs—not be false or misleading.”
In addition, PhRMA admonished Hims & Hers for appearing to violate guidelines set by the Alliance for Pharmacy Compounding, which say non-FDA-approved drugs can’t be promoted as safe and effective for treating a particular condition.
Health risks aside, the Obesity Society (TOS) wasn’t impressed with the ad’s optics.
“Hims & Hers portrays obesity with images of large, headless abdomens, which does create a visceral negative response by the viewer,” Dr. Marc-Andre Cornier, TOS president, said in a Feb. 7 news release, “and they unfortunately cast a disparaging connotation for people living with obesity.”
TOS urges people to speak with their doctor about obesity medications rather than jump to compounded drugs.
Novo Nordisk, too, joined in the backlash, calling the commercial “irresponsible” and a ploy to drive sales of “knockoff” GLP-1 drugs.
“Obesity is a chronic disease, not a character flaw—we continue to actively confront the stigma and bias associated with it and advocate for access to support and care,” Novo Nordisk said in a Feb. 6 statement to Fortune. “No one should have to compromise their health or be subject to misinformation.”
To Hims & Hers, “Sick of the System” has pushed industry buttons exactly as intended.
“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,” the company said Feb. 7 in a statement to Fortune. “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.”
For more on weight management:
- Exclusive: The COO of Hims & Hers was the third person to try its new weight-loss drugs—and she’s ready to share her story
- Online searches predicted the surge in prescriptions of weight-loss drugs like Wegovy and Zepbound, study says. Here’s what could happen next
- Hate needles? Lilly’s weight-loss pill could get FDA approval next year, CEO says
- Zepbound vs. Wegovy: New clinical trial says this weight-loss medication sheds more pounds
- Most Americans who want to lose weight don’t want to take GLP-1 drugs like Wegovy and Zepbound, new survey says
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