Super Bowl Ad Selling Weight Drug Shows Wild West of Copycats (1)

A Hims & Hers commercial promoting compounded weight loss drugs in this year’s Super Bowl is spurring concerns from industry watchers over how the FDA regulates the gray area of advertising copycat products.

The growing telehealth company is set to air a minute-long commercial Sunday night that promotes the use of its compounded version of Novo Nordisk A/S‘s Wegovy, a blockbuster drug used to treat obesity.

The ad—previewed days before the game between the Philadelphia Eagles and the Kansas City Chiefs that’s expected bring in over 100 million viewers—criticizes the health industry for high costs of weight loss drugs, while positioning Hims & Hers as a company that sells affordable products. It’s a costly endeavor for the company, as Super Bowl ads can range from $7 to $8 million, according to Fox Sports.

Manufacturers and industry watchers are taking issue with statements in the ad, particularly its lack of information on safety, side effects and remarks about the drug’s efficacy.

“The side effects are not present here, knowing that these compounded versions are not FDA-approved,” said Janelle Applequist, an associate professor of advertising at the University of South Florida. “What’s concerning about this ad’s timing and placement is its exploitation of viewer vulnerability. This will be aired during a moment when Americans will be gathered with friends and family to watch the Super Bowl, indulging in chips, beer, soda, and wings.”

The commercial places a spotlight on the oversight of compounded drug promotions, especially as the popularity of copycat weight loss drugs surges. Industry watchers are now pressing the Food and Drug Administration to clarify where it stands on compounded product advertisements.

“Launching an expensive Super Bowl ad shines a giant spotlight on the risks with compounding—FDA hasn’t taken action despite people calling on them to look into the compounding process and how they’re marketing and advertising these products,” said Nick McGee, a spokesperson for the Pharmaceutical Research and Manufacturers of America.

“They’re operating in this Wild West where no one’s holding them accountable to the same standards that companies who actually get FDA approval for their medicines are subject to.”

Novo’s’ semaglutide and Eli Lilly & Co.’s tirzepatide are the leading drugs to treat obesity. The FDA determined the drugs to be in shortage years ago due to increased demand, allowing traditional compounding pharmacies and outsourcing facilities to produce copies of the drug.

A spokesperson for Novo said the company was “deeply concerned about irresponsible advertising by companies like Hims & Hers that use misinformation and mislead the public to drive sales of non-FDA approved, knockoff versions of GLP-1 medicines.”

Hims & Hers did not respond to request for comment.

FDA’s Authority

The FDA’s oversight of compounded drug ads is considered a “regulatory gray area,” Applequist said.

Given that compounded products are copycats, the drug compounder references the FDA-approved label attesting to safety and efficacy, however, they don’t attest to protocols under the Current Good Manufacturing Practice, like brand drugmakers do.

“There’s some confusion here because FDA historically hasn’t done much around compounded drug advertising,” said Joshua Oyster, a partner at Ropes & Gray LLP.

“Compounded drugs arguably are not subject to those regulations, but they’re still subject to statutory requirements that their labeling and advertising promotion not be false or misleading,” Oyster added. “That includes a statutory provision that was included in the Drug Quality and Security Act in 2013, where there was a misbranding provision created for the advertising or promotion of compounded drugs.”

Furthermore, a US Supreme Court decision in 2002 in Thompson v. Western States Medical Center ruled that advertising prohibitions on compound pharmacies and their products are a violation of the First Amendment.

A spokesperson for the FDA said under federal law, prescription drug promotion disseminated by or on behalf of drug manufacturers, including compounders, must be truthful, non-misleading, and accurate. The FDCA states that a compounded drug is misbranded if its advertising or promotion is false or misleading.

One branded industry insider criticized statements in the ad related to the product’s efficacy, particularly the remarks made on the product’s intended use for weight loss and that it’s “life changing.”

“Those are all, into the parlance of FDA, statements of efficacy,” they said. “It is incredibly irresponsible that you make those claims of efficacy and you disclose no risks associated with these products at all.”

Sens. Dick Durbin (D-Ill.) and Roger Marshall (R-Kan.) sent a letter to the FDA on Friday asking the agency to review the Hims ad because it “misleads patients by omitting any safety or side effect information.”

The ad also prompted the Partnership for Safe Medicines, a pharmaceutical industry group, to ask the FDA on Feb. 5 to take action against Hims because the “commercial is misleading in its entirety.”

Debate on Ad

Despite the pushback, Scott Brunner, CEO of the Alliance for Pharmacy Compounding, said he sees “no claims in the ad that violates any law, regulation, or FDA guidance.”

“Some have asserted the ad pushes the envelope about the proper place of compounded medications in our health-care system. Maybe that’s a debate worth having,” Brunner said. “Indeed, the ad comports with APC’s Best Practices for Marketing Claims related to compounded drugs.”

It’s also possible that telehealth companies, not speaking for Hims or specifically on the Super Bowl ad, take the position that their ads are intended to promote “telehealth services” and therefore are not “prescription drug ads” per se, according to Joanne Hawana, an attorney at Mintz.

The distinction between a “drug ad” and a “telehealth ad” would have an impact on whether the FDA or Federal Trade Commission has primary policing authority over the content, she said.

“Under current law, a pure telehealth ad that is trying to induce consumers to buy those services, rather than to buy a certain drug, would absolutely fall within the scope of Section 5 of the FTC Act and FTC’s enforcement authority over deceptive acts and practices in commerce,” Hawana said.