By Josh Nathan-Kazis

The battle over the weight-loss drug market will enter a new, politicized phase on Super Bowl Sunday, when telehealth company Hims & Hers airs a minute-long advertisement in one of the priciest ad blocks of the year.

Over samples lifted from the rapper Childish Gambino's 2018 anthem "This is America," the Super Bowl ad cites U.S. obesity statistics and says: "The system wasn't built to help us. It was built to keep us sick and stuck."

"Something's broken, and it's not our bodies -- it's the system," the voice-over says.

The Hims ad, posted in late January on YouTube, has drawn a concerned letter from two U.S. senators -- one Republican and one Democrat -- to the Food and Drug Administration. It points to a shift in the fight over knockoff GLP-1 weight-loss drugs, which have been legal while the branded versions remain in shortage.

That period of shortages is likely to end soon, posing a major threat to the telehealth companies that have rushed into the market. Hims sells a compounded version of semaglutide, which is the medicine Novo Nordisk sells under the brand name Wegovy.

The FDA says there's no more U.S. shortage of Lilly's weight-loss drug Zepbound. Novo's CEO says his drug will be off the shortage list "in the near term," as well. Under current regulations, firms generally have to to stop selling compounded drugs once shortages end.

With the market in flux, Hims' ad offers a glimpse at a new political strategy: The company is retuning its message for the era of Robert F. Kennedy Jr, the likely new secretary for Health and Human Services, whose mantra has been to Make America Healthy Again.

The future of Hims' GLP-1 offerings now depends largely on the FDA, and how it enforces the regulations around drug compounding. As Kennedy arrives at the U.S. Department of Health and Human Services, which houses the FDA, Hims has cast its cheaper weight-loss drugs as a MAHA-friendly answer to the healthcare system's high prices.

Other telehealth companies selling compounded GLP-1 drugs have made political appeals before, warning that ending compounding of the medicines will create a crisis for the hundreds of thousands, or even millions, of Americans depending on them. The Hims ad refreshes those lobbying appeals for a new political moment.

The Hims ad is vague about the products the company is selling. The voice-over states that "Hims & Hers offers life-changing weight-loss medications" that are "doctor-trusted," but the voice-over doesn't include the words "semaglutide" or "GLP-1."

The ad doesn't list the risks or side effects of GLP-1 drugs.

FDA rules require that ads that make a claim about a drug's benefits need to include a statement of its risks. Under the regulations, ads that don't mention a specific drug don't need to include that statement of risks.

While the Hims ad doesn't name a drug, the video includes images of Hims-branded vials that look like the compounded semaglutide vials sold on Hims' website.

"Hims' Super Bowl ad does not promote a specific drug or medication and therefore is not required to provide information about side effects or risks," the Alliance for Pharmacy Compounding, an industry group, said in a Friday statement. The FDA didn't respond directly to a question about whether the ad violated its disclosure rules.

"Pharmaceutical advertisements have always pressed the boundaries of trying to imply what they cannot say," says Robin Feldman, a professor at University of California Law San Francisco, who has written on the regulation of pharmaceutical ads. "This particular advertisement follows in that wake."

In a letter Friday to the FDA, Sen. Richard Durbin, a Democrat from Illinois, and Sen. Roger Marshall, a Republican from Kansas, complained about the lack of safety information. Their letter came after drug industry groups, including the pharmaceutical lobbying group PhRMA, raised concerns about the ad.

The FDA hasn't taken public action on the ad. In response to a query from Barron's, the agency said it monitors promotional materials relating to compounded drugs. "If the FDA has concerns that promotional materials are false or misleading, the FDA may take action to seek compliance," the agency said.

"FDA doesn't verify the safety, effectiveness or quality of compounded drugs before they are marketed," it said.

Asked about the lack of disclosure, a spokesperson for Hims didn't respond directly.

"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 to Barron's. "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."

The ad is slated to air days after Kennedy's Senate confirmation cleared a major hurdle. Drug stocks dropped Tuesday as his confirmation passed through a committee vote, though pharma executives like Pfizer's Albert Bourla have said they see areas where they can collaborate with Kennedy.

The stakes for Hims are high. The stock is up 200% since the company said in May it would start selling GLP-1 drugs.

Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com

This content was created by Barron's, which is operated by Dow Jones & Co. Barron's is published independently from Dow Jones Newswires and The Wall Street Journal.

(END) Dow Jones Newswires

February 07, 2025 15:40 ET (20:40 GMT)

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