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Online sellers of knockoff GLP-1 drugs have seized on shortages as an opportunity to advertise a more steady, lower-cost supply of the products compared to branded versions. 

One such company, Hims & Hers, will make that pitch to the Super Bowl’s massive audience with a commercial it released last week. However, the spot has come under heavy fire from lawmakers and patient groups.

On Friday morning, Sens. Richard Durbin (D-IL) and Roger Marshall (R-KS) sent a letter to acting Food and Drug Administration Commissioner Sarah Brenner requesting the agency review the Hims & Hers spot. The ad is “slated to air during the Super Bowl on Sunday to more than 120 million Americans,” wrote the lawmakers, yet runs the risk of “misleading patients by omitting safety or side effect information.”

Under section 502 of the federal Food, Drug and Cosmetic Act (FDCA), they pointed out, FDA is required to ensure that prescription drug ads be truthful, not misleading, and balanced. 

Patient groups have also decried what they perceive as an advertising double-standard. Publicly posted online, the ad is one of a number of spots by health brands set to air during the game along with those from Pfizer and Novartis. 

But while Hims’ ad touts its ability to prescribe and dispense GLP-1 drugs to patients, with text and claims about weight-loss drugs and imagery of a pale-blue injection pen (resembling an existing brand-name treatment), it does so without the burdensome information around side effects and other risk disclosures to which pharma companies must refer in their own promotional efforts. 

Consider that, as per guidelines for direct-to-consumer marketing, ads for Novo Nordisk’s branded version of the same class of medicines, Wegovy (semaglutide), contains significant information on side effects and contraindications, including warnings about potential gallbladder, pancreas, vomiting or diarrhea and other implications. 

But telehealth providers are not covered by the FDA’s general oversight of the prescription drug promotions of drug manufacturers, packers or distributors. Nor do prevailing DTC restrictions apply to compounded medicines.

That loophole means these drugs aren’t approved by the FDA, nor evaluated by the regulator for safety, quality or effectiveness before they’re marketed. That’s a fact one could miss in Hims’ ad, since for only three seconds during the minute-long commercial does the screen flash this disclaimer in small, barely legible font. 

The absence of risk disclosures is only one aspect of what makes Hims’ ad problematic, patient advocates argue. To the tune of a catchy soundtrack — Childish Gambino’s “This is America” — the multimillion-dollar ad’s message is that the weight-loss industry, pharma included, are exploiting Americans with overweight or obesity without really coming to their aid. 

Those elements, joined by visuals of fast food and unhealthy habits, seem designed to evoke strong negative emotions. Whereas Hims’ products, the narrator claims, are “affordable,” “doctor-trusted” and “formulated in the U.S.A.” 

As such, the Hims’ spot “co-opts the narrative about affordability without adhering to the integrity standards expected of prescription drug advertising,” reads a statement issued by advocacy group Generation Patient, which called on the FDA to investigate Hims & Hers before the ad runs. 

Portraying the decision to seek obesity treatments as being all about price “makes it seem like the reason why someone would take this medication is because it’s affordable, not necessarily because it might be the right medication for them to take,” Sneha Dave, executive director of the group, explained in an interview with MM+M. 

Indeed, the compounding industry’s trade association, of which Hims & Hers is a member, recently released guidelines for how the industry should and shouldn’t market knockoff medicines. The guidelines suggest compounders “avoid promoting a compounded drug based on its price compared to a commercially available drug.”

These medications are dispensed in situations such as where an FDA-approved product is inaccessible due to shortage. Once the shortage is over, as is the case with the branded versions of these drugs, marketing strategies that emphasize price over the necessity of a compounded medication for a particular patient are discouraged for fear of prompting regulatory action, warned the Alliance for Pharmacy Compounding.

Nor is there proof to back up Hims’ claim that its compounded semaglutide is “made in the U.S.A.” On the contrary, components used to compound semaglutide are often sourced from ex-U.S. entities. 

The above situation is not uncommon among those who market compounded weight-loss drugs. Research, published in JAMA Health Forum, shows that many websites for mass-produced, compounded GLP-1 drugs don’t include information about the drugs’ adverse effects, warning and contraindications, including hospitalizations, and use misleading language suggesting the compounded product is FDA-approved or equivalent to an FDA-approved GLP-1 drug. 

Sens. Durbin and Marshall plan on introducing bipartisan legislation that would clarify that compounders must follow the same rules for FDA-approved prescription medicines. 

Beyond what’s missing, the ad also raises questions about the appropriateness of using music or trends to capture people’s attention versus simply sharing information in a very objective, factual way that doesn’t sway people one way or another. Such questions are especially relevant during the Super Bowl, which many people watch for the creative ways in which products are framed during the numerous commercial breaks. 

“The Hims & Hers advertisement has a very trendy feel to it,” added Dave. “That’s what makes it even more potentially harmful, especially for younger patients who are more in tune with songs like these and oftentimes more able to relate to ads like these.”

Other consumer and patient groups seized the moment to underscore the need to exercise caution in this area. The National Consumers League, which has a long history of helping the public avoid fakes and unregulated products, was one.

NCL this week urged consumers and health professionals to heed the warning from the FDA “that compounded versions of GLP-1 (glucagon-like peptide-1 (GLP-1) receptor agonists) drugs now widely promoted on television and online are not FDA approved and may cause serious health problems.”

Unsurprisingly, pharma lobbying and other industry groups called out the Hims ad, as well. 

The spot “is a clear violation” of the FDCA, “which requires that advertising for prescription drugs — including compounded drugs — not be false or misleading,” contended Pharmaceutical Research and Manufacturers of America (PhRMA), whose public affairs team invited reporters to “reach out if you have any questions.”

“It’s clearly an ad to sell a prescription drug,” added Shabbir Safdar, executive director of watchdog group Partnership for Safe Medicines, of Hims’ spot. “But even if you close your eyes and pretend it’s not, it still violates the rules.”