Drug industry organizations are speaking out against a Super Bowl ad promoting weight loss medications from the telehealth company Hims & Hers. They argue that the commercial fails to properly disclose the potential safety risks of the drugs.
The ad takes aim at the $160 billion weight loss industry, showing a person using a smartphone to select weight-loss treatments offered by Hims & Hers. Although the ad does not specifically mention the medication, the company offers compounded versions of semaglutide, a weight-loss drug developed by Novo Nordisk and sold under the names Wegovy and Ozempic.
The Partnership for Safe Medicines, a coalition of over 40 pharmacy and community groups, has asked the Food and Drug Administration (FDA) to address the issue and protect consumers from misleading health product advertisements. The group also called on Fox, the network airing Sunday’s Super Bowl, to pull the ad ahead of the game.
Pharmaceutical Research and Manufacturers of America (PhRMA), a trade group representing drug manufacturers, argued that the ad violates federal rules against false or misleading drug advertising. The commercial, which was posted on YouTube ahead of the Super Bowl between the Philadelphia Eagles and Kansas City Chiefs, has drawn criticism for omitting key safety information.
On Friday, Senators Dick Durbin (D-Ill.) and Roger Marshall (R-Kan.) sent a letter to the FDA, urging action on the ad’s potential to mislead patients about the drug’s safety and side effects.
Hims & Hers Responds to Criticism
Hims & Hers, which markets weight loss and other medications, defended the ad. The company stated that it is not a drug manufacturer and, therefore, is not bound by the same advertising standards as pharmaceutical companies. Instead, the company connects customers with licensed health providers who evaluate and prescribe medications when appropriate. Hims & Hers maintained that it follows the advertising guidelines required for telehealth platforms.
In response to the criticism, the company said the drug industry is trying to silence an ad that calls attention to a system that, according to Hims & Hers, fails to prioritize Americans’ health. The company added that the system is “broken” and this is yet another attempt by the pharmaceutical industry to prevent Americans from knowing they have alternatives.
Concerns Over Drug Safety and Marketing
The Partnership for Safe Medicines expressed concerns in a letter to the FDA, stating that the ad is misleading because it fails to mention that compounded drugs are not FDA-approved and could pose greater risks to patients. The group also took issue with the ad’s claim that the drug was “formulated in the USA.” Hims & Hers markets compounded versions of semaglutide, which the letter says was developed through years of research and significant investment by Novo Nordisk.
As of Thursday afternoon, neither the FDA nor Fox had responded to the group’s letters, according to Shabbir Imber Safdar, the group’s executive director.
PhRMA further criticized the ad for not addressing the potential risks and side effects associated with compounded GLP-1 drugs. The commercial refers to the products as “life-changing weight-loss medications” and “doctor-trusted,” but does not mention the risks, according to PhRMA.
The Bigger Debate: Compounding Pharmacies vs. Drug Companies
The dispute over the Hims & Hers ad is part of a larger ongoing debate between drug companies that sell weight-loss medications and compounding pharmacies that offer less expensive alternatives. The FDA permits compounding pharmacies to create copies of drugs when there is a shortage, but stricter regulations apply once the shortage is resolved.
Currently, Hims & Hers markets compounded versions of semaglutide, which remains in short supply, according to the FDA. Novo Nordisk sells the drug under the brand names Wegovy for treating obesity and heart disease and Ozempic for Type 2 diabetes.
In December, the FDA announced that Eli Lilly’s weight loss and diabetes medication, tirzepatide (sold under the brand names Mounjaro and Zepbound), is no longer in short supply. As a result, pharmacies must cease compounding, distributing, or dispensing tirzepatide by February 18, with suppliers having until March 19 to stop distribution.
Compounding pharmacies are regulated by state boards of pharmacy, and the ingredients used are typically sourced from FDA-registered factories. However, the FDA does not verify the safety or effectiveness of compounded medications.
