Hims & Hers Health down as Super Bowl ad draws controversy
An advocacy group that includes the main pharmaceutical lobbying organization, PhRMA, as a member is complaining that a commercial Hims & Hers Health (NYSE:HIMS) is slated to run during the Super Bowl about its weight loss offerings violates U.S. FDA advertising regulations and minimizes risks associated with compounded drugs.
On Feb. 5, the Partnership for Safe Medicines sent a letter to Catherine Gray, director of the agency's Office of Prescription Drug Promotion, to voice its concerns.
"The commercial is blatantly misleading, and poses a substantial risk of harming the approximately 200 million consumers that will see the commercial during Super Bowl LIX," the letter signed by PSM Executive Director Shabbir Imber Safdar reads.
Hims & Hers makes a compounded version of semaglutide, the active ingredient in Novo Nordisk's (NVO) blockbuster obesity medicine Wegovy.
While the 60-second ad, titled "Sick of the System," doesn't directly mention compounded semaglutide, the commercial features medicine vials with the company's logo and includes the phrase "There are medications that work, but they are priced for profits, not patients."
The commercial further states that Hims & Hers' offerings are "doctor trusted" and "formulated in the United States."
"The commercial doesn’t just leave out that Hims & Hers’s products are compounded, unapproved, and riskier for patients, it discloses no risks whatsoever," the PSM letter states.
PSM further points to an FDA drug safety communication that states compounded GLP-1 drugs can be risky as they are not FDA approved, and there are dosing and side effects concerns with them.
Compounded versions of brand-name drugs are permitted by the FDA if the medication is in shortage. However, an FDA drug shortages website shows no dose strengths of Wegovy are currently in shortage.
In late October, Wegovy was taken off a drug shortages list.