Hims & Hers Is in the FDA’s Crosshairs. It’s a Risk to the Stock.

Hims & Hers relies heavily on advertising to prescribe and sell cheap, generic drugs. (Courtesy Hims & Hers)

Key Points

About This Summary

• FDA Commissioner Makary is targeting Hims & Hers Health over a Super Bowl ad for weight-loss drugs that lacked risk disclosures.
• Hims spent $678.8 million on marketing in 2024 and now faces a crackdown on drug ads, threatening its telehealth business model.
• Hims defended its ad, claiming it raised awareness about obesity and didn’t promote a specific treatment, but Makary remains critical.

Food and Drug Administration Commissioner Dr. Marty Makary is making telehealth company Hims & Hers Health the face of the Trump administration’s crackdown on prescription drug ads.

Twice in the past week, Makary has criticized Hims for the Super Bowl ad the company ran earlier this year that advertised the company’s weight-loss medications without disclosing the risks associated with the drugs.

Makary hasn’t named any other drugmaker or retailer in his public writing on his new campaign against prescription drug ads, which the FDA and the U.S. Department of Health and Human Services announced last Tuesday.

It’s an unpleasant and risky reversal for Hims, which early this year appeared to be framing its compounded weight-loss drugs as a MAHA-friendly response to high drug prices. MAHA, or Make America Healthy Again, is HHS Secretary Robert F. Kennedy, Jr.’s pro-Trump, health-focused political movement.

Now, Hims is in the crosshairs of the Trump administration. The new push to limit drug ads poses a major threat to the company’s business model. Telehealth companies like Hims rely heavily on advertising to prescribe and sell cheap, generic drugs that patients can often get for less through traditional channels.

Hims said in 2024 it spent $678.8 million on marketing, or 61% of its total operating expenses.

Makary’s attack on Hims intensified on Saturday, when in an op-ed published in the New York Times describing his efforts against drug ads, he wrote that online pharmacies “are advertising drugs with only upsides mentioned.”

Makary wrote that this “breach of F.D.A. regulation” was “most overt” in the Hims Super Bowl ad. The charge echoed a similar essay that Makary published Friday in the Journal of the American Medical Association that said Hims had highlighted the benefits of GLP-1 weight loss drugs in the Super Bowl ad “without any mention of side effects or disclaimers.”

The Super Bowl ad cast Hims’ weight-loss offerings as a response to a “system” that was “built to keep us sick,” bringing enormous attention to the firm.

At the time, Hims was selling large volumes of a legal knockoff version of Novo Nordisk’s Wegovy, made by compounding pharmacies. The company was bracing to see its ability to sell the drug largely come to an end as soon as the FDA determined Wegovy was no longer in shortage. The Super Bowl ad seemed like an effort to market its compounded GLP-1 drugs in an anti-system, antidrug industry tone that would make friends in Kennedy’s health department.

The ad “aimed to raise awareness to a critical issue – the obesity public health crisis – by showcasing the impact of obesity and the realities of the lack of access to life-saving holistic weight loss care,” a Hims & Hers spokesperson said in a statement on Monday.

That strategy seems to have backfired. Instead of winning allies in the Trump administration, Hims now seems to have been singled out as a particular target of the FDA and its commissioner.

Investors are so far unbothered. Hims shares are up more than 15% since the FDA and HHS announced their newly reinvigorated efforts against drug ads. The stock climbed Thursday and Friday after the company said it would begin selling testosterone treatments for men. On Monday, after Makary’s latest critique of Hims, shares were down 0.6%.

The Super Bowl ad was controversial before it aired. The company had posted it online weeks ahead of the Super Bowl, and two U.S. senators—a Republican and a Democrat—complained to the FDA on the Friday before the game that the ad didn’t disclose the side effects of GLP-1 drugs.

FDA regulations require ads that make a claim about a drug’s benefits also include a statement of its risks. Ads that don’t mention a specific drug don’t need to include a risk statement. The Hims Super Bowl ad included images of Hims-branded vials that looked like the compounded GLP-1 drugs the company sells, and referred to “life-changing weight-loss medications.”

The Hims & Hers spokesperson defended the ad in the Monday statement, saying it didn’t advertise any one treatment.

Makary doesn’t seem to be buying it. The New York Times reported Friday that Hims was a recipient of one of what Makary has said were “approximately 100” letters the FDA sent to drug companies whose advertisements, Makary says, were “found to violate the law.”

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