Pharma group slams Hims & Hers over Super Bowl GLP-1 ad

An ad for compounded versions of weight-loss drug semaglutide by telehealth company Hims & Hers has attracted the ire of a pharmaceutical trade organisation that calls the campaign "nothing short of reckless."

The Partnership for Safe Medicines (PSM) – which tackles issues such as counterfeiting of medicines, supply chain security, and regulation of online medicine sellers – has written to the Fox Corporation and the FDA to explain how the promotion violates US rules on prescription drug advertising. It has already appeared online and is due to run in a prime slot during the Super Bowl LIX coverage on Sunday.

According to the PSM, the ad fails to convey that the semaglutide on offer is a compounded product and not FDA-approved and omits side effect information that is required in any promotion of a prescription medicine.

GLP-1 agonist semaglutide is the active ingredient in Novo Nordisk's blockbuster weight-loss drug Wegovy, which achieved sales of around $8 billion last year.

Supply constraints have meant that the drug appears on the FDA's shortage list, which opens the door for compounding pharmacies to offer versions of the drug to patients. Last year, Novo Nordisk petitioned the FDA to try to block compounded versions of its drug, arguing that it is too complex to be made safely by these manufacturers, but so far has been unsuccessful.

The PSM claims in its letter to the FDA that the commercial is "dangerous, blatantly misleading, and poses a substantial risk of harming the approximately 200 million consumers that will see the commercial during Super Bowl LIX."

It is calling on the regulator to take swift action to prevent the dissemination of the ad, which does include a disclaimer that compounded products are not FDA-approved, but this appears "only briefly in tiny grey font at the bottom of the screen that is nearly imperceptible to an average viewer, without any accompanying audio disclosure." It also discloses no risks, omitting the "fair balance" requirements of medicine promotion in the US.

"Heavy on hyperbole and light on ethical transparency, this marketing blitz promotes altered, poorly regulated versions of legitimate pharmaceutical medications […] intended for people living with serious medical conditions, including diabetes and obesity," said PSM executive director Shabbir Safdar.

"Compounded drugs have a role to play in medicine, but they can present significant health risks – particularly with complex injectable products like Hims & Hers is advertising," he added. "The FDA says compounded drugs are a last resort for patients during a shortage and should never be the first choice in therapy. But the many millions of people who tune into the Super Bowl won't learn that from this ad."

For its part, Hims & Hers maintains that the 'Sick of the System' ad – its first for a Super Bowl – "highlights the growing public health issue of obesity in America" and ties in with the company's mission "to improve the health of Americans by providing access to essential, transformative care."

It accuses the pharma industry of selling weight-loss drugs at unreasonably high prices and claims that its semaglutide products are "accessible, affordable, doctor-trusted, and formulated in the USA." The company says its semaglutide injections are fulfilled and shipped from Hims & Hers' affiliated pharmacies.