If you tuned in to Super Bowl LIX, perhaps you caught the commercial for compounded weight-loss drugs from telehealth company Hims & Hers. The third-quarter ad, called “Sick of the System,” is a dizzying montage of abdominal fat, food, and pharmaceutical greed set to the rhythm of Childish Gambino’s “This Is America.” Controversy has ensued—but not because Hims & Hers positioned itself as the antidote to Big Pharma.
Compounded medications such as those promoted in the Hims & Hers ad aren’t approved by the Food and Drug Administration. Such off-label concoctions aren’t simply generic versions of branded, approved medications; the FDA doesn’t verify their safety, quality, or effectiveness. Novo Nordisk, the Fortune 500 Europe company behind weight-loss injection Wegovy (semaglutide), responded Monday with a print ad of its own.
“Do you really know what you’re injecting into your body?” the ad asks readers of USA Today and the New York Times. Novo Nordisk dubbed the ad “Check Before You Inject.” It features a vial labeled “Compounded Semaglutide” and an uncapped syringe, both casting shadows across what might otherwise be a cheery yellow-gold background. It reminds consumers that if their injections aren’t FDA-approved, they “have no idea what’s inside.”
“Novo Nordisk is warning consumers about the significant dangers of reaching for illegitimate compounded ‘semaglutide’ drugs, which have been shown to contain impurities and ingredients dangerous to patients,” the Denmark-based company said in a Feb. 10 statement to Fortune. “The recent explosion in irresponsible and misleading advertising about compounded GLP-1 (glucagon-like peptide-1) drugs, like the Hims & Hers Super Bowl commercial, puts patients’ safety at risk, and we cannot stay silent.”
Semaglutide belongs to a class of drugs called incretin mimetics, which imitate gut hormones aiding in blood sugar regulation. In addition to Wegovy, incretin mimetics FDA-approved for chronic weight management include Saxenda (liraglutide), also made by Novo Nordisk, and Zepbound (tirzepatide), produced by Fortune 500 firm Eli Lilly & Co. As demand for these medications has soared in recent years, periodic shortages prompted companies like Hims & Hers to step into the market with compounded, sometimes cheaper options.
Controversy surrounding “Sick of the System” began nearly two weeks before the big game; Hims & Hers launched it on YouTube on Jan. 28. Medical and trade organizations, from the Obesity Society to Pharmaceutical Research and Manufacturers of America, condemned the ad for misleading consumers about the safety and effectiveness of the compounded drugs Hims & Hers is selling. The Partnership for Safe Medicines went so far as to implore Fox not to broadcast the commercial.
The fallout has become political, too. Two days before the Super Bowl, Senators Dick Durbin, D-Ill., and Roger Marshall, R-Kan., penned a letter to the FDA in which they teased upcoming bipartisan legislation relevant to the ad.
“We recognize the important roles that pharmaceutical compounding and telehealth play in the health care delivery system, helping to ensure access to FDA-approved products and filling a need for more customized treatments,” Durbin and Marshall wrote. “However, we believe there should be no disparity in pharmaceutical advertising requirements between regulated entities.”
Hims & Hers says patient safety critical in GLP-1 manufacturing
“Sick of the System” has hit a nerve—by design.
“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 Feb. 7 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.”
Still, the conversation has become less about legacy pharmaceutical firms versus industry newcomers and more about patient safety. The FDA has called out compounded versions of popular GLP-1 drugs, saying they’re “risky for patients.” Dosing is of particular concern. Wegovy, for example, comes in prefilled, single-dose pens. Conversely, some companies package compounded drugs such that patients must use a syringe to withdraw the medication from a vial. The FDA has received reports of people mistakenly taking up to 20 times the intended semaglutide dose.
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As of the end of November, the agency had recorded hundreds of complaints of adverse events linked to compounded semaglutide and tirzepatide. However, Hims & Hers pointed out to Fortune that the FDA had noted, “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.”
Hims & Hers did include a disclaimer in its ad saying its compounded medications aren’t FDA-approved, albeit briefly and in minuscule font. The company told Fortune ahead of the big game that it champions patient safety and sources ingredients solely from FDA-regulated manufacturers.
“Our responsibility to our customers is to support them every step of the way on their care journey,” Hims & Hers said in a 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.”
Novo Nordisk isn’t impressed.
“As makers of the only real FDA-approved semaglutide medicines (Wegovy, Ozempic, and Rybelsus), patient safety remains our top priority,” Novo Nordisk told Fortune in a post-game statement. “We are committed to confronting the stigma linked with chronic diseases, like obesity, and expanding access to our authentic, prescription-only medicines.”
For more on weight management:
- Hims & Hers Super Bowl ad slams pricey pharma industry—and fumbles FDA warnings on compounded GLP-1 drugs
- 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
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