Hims and Hers Super Bowl Ad Controversy: Pharmaceutical Industry Groups Criticize Weight Loss Drug Promotion
The Hims & Hers Super Bowl ad controversy has sparked criticism from pharmaceutical industry groups, who argue that the weight loss treatment advertisement aired during the Super Bowl fails to clearly disclose the potential safety risks of the medications being promoted.
The ad, which also targets the $160 billion weight loss industry, has a person choosing options from the company’s product line via smartphone. It does not name the drug in question, but Hims & Hers sells compounded versions of semaglutide, a drug developed by Novo Nordisk under the brand names Wegovy and Ozempic.
The Partnership for Safe Medicines, a coalition of more than 40 community and pharmacy organizations, called on the FDA to step in and stop what they said was deceptive advertising. The group also asked Fox, the network that will broadcast the Super Bowl, to yank the ad before the game.
PhRMA, the trade group that represents drug manufacturers, claims that the ad is a violation of federal regulations since it does not contain necessary safety information. The ad has already been posted on YouTube and will air during Sunday’s championship game between the Philadelphia Eagles and the Kansas City Chiefs.
On Friday, U.S. Senators Dick Durbin (D-Ill.) and Roger Marshall (R-Kan.) wrote to the FDA, cautioning that the ad could mislead consumers by omitting crucial details about the safety and side effects of the drugs.
A San Francisco-based company called Hims & Hers argues that it isn’t a pharmaceutical company and therefore not subject to the same advertising restrictions. The company provides patients with access to registered providers, where the latter evaluates them online and gives them prescriptions if necessary. Hims & Hers said that it adheres to the requirements for advertising telemedicine.
The company responded by saying the pharmaceutical industry was trying to silence an ad that exposes flaws in the health system. “The system is broken, and this is just another example of how they don’t want Americans to know they have options,” Hims & Hers said in a statement.
The Partnership for Safe Medicines wrote in a letter sent Wednesday to the FDA that the one-minute ad is “misleading in its entirety” because it does not make clear that compounded drugs are not FDA-approved and may pose additional risks. The ad further said that the drug was “formulated in the USA, adding that Hims & Hers is selling a version of semaglutide, a prescription medicine approved by the FDA and made by Novo Nordisk following a multiyear development and cost of billions of dollars.
Until Thursday afternoon, neither the FDA nor Fox responded to complaints made by Shabbir Imber Safdar, executive director of the Partnership for Safe Medicines.
In its complaint against the ad, PhRMA criticized the lack of information it had regarding side effects and the potential risks in compounded GLP-1. The ad promotes the drugs as “life-changing weight-loss medications” and as being “trusted by doctors”, it said.
The Super Bowl ad controversy spotlights an ongoing debate between pharmaceutical companies selling brand-name weight-loss drugs and compounding pharmacies that manufacture cheaper alternatives. The FDA allows compounding pharmacies to create copies of drugs during shortages, but once supply issues are resolved, these pharmacies are subject to tighter regulations.
Hims & Hers has available compounded versions of Novo Nordisk’s semaglutide under a new classification by the FDA, which deems it still a short supply. Sema-glutide is an obesity and heart disease treatment that comes as Wegovy, while Type 2 diabetes patients receive Ozempic under Novo Nordisk.
In December, the FDA declared that Eli Lilly’s tirzepatide, marketed as Mounjaro and Zepbound for weight loss and diabetes, was no longer in short supply. This means that compounding pharmacies have to stop distributing tirzepatide by February 18, while suppliers selling bulk quantities have to stop distribution by March 19.
Compounding pharmacies are governed by state pharmacy board regulations, and the source of their ingredients comes from FDA-registered factories. However, the FDA does not verify whether these compounded drugs are safe or effective for the consumers.
