Hims & Hers, a prominent telehealth company, is under intense scrutiny as its controversial advertisement, titled "Sick of the System," is set to air during the Super Bowl on Sunday. The ad criticizes the $160 billion weight loss industry, claiming that brand-name GLP-1 medications are "priced for profits, not patients." Hims & Hers offers compounded semaglutide, an active ingredient in popular weight loss drugs Ozempic and Wegovy, for under $200 a month. This contrasts sharply with the approximately $1,000 monthly cost of these medications without insurance.
The advertisement has drawn significant attention from U.S. Senators Dick Durbin (D-Ill.) and Roger Marshall (R-Kan.), who have raised concerns over its potential to mislead consumers. In a letter to the U.S. Food and Drug Administration (FDA), the senators pointed out that compounded semaglutide, which Hims & Hers began offering in May after launching a new weight loss program, is not FDA-approved. They highlighted that the FDA does not review the safety and efficacy of compounded products, which poses a risk to consumers.
"Risks misleading patients by omitting any safety or side effect information when promoting a specific type of weight loss medication" – Sens. Dick Durbin (D-Ill.) and Roger Marshall (R-Kan.)
The senators emphasized that the advertisement lacks essential safety disclosures typically required in pharmaceutical promotions. The commercial includes visuals of existing weight loss medications, such as injection pens resembling Novo Nordisk's Ozempic. However, it only briefly displays a disclaimer in small, barely legible font, stating that these products are not FDA-approved.
"Nowhere in this promotion is there any side effect disclosure, risk, or safety information as would be typically required in a pharmaceutical advertisement" – Sens. Dick Durbin (D-Ill.) and Roger Marshall (R-Kan.)
The timing of this advertisement is crucial as semaglutide is currently experiencing a shortage, according to the FDA. Despite these challenges, Hims & Hers has seen its shares surge over 170% last year, driven by high demand for GLP-1s. The company's market capitalization now stands at approximately $9.5 billion.
In response to the senators' concerns, a spokesperson for Hims & Hers stated that the company is in compliance with existing laws and expressed willingness to work with Congress and the new administration to improve the healthcare system.
"We are complying with existing law and are happy to continue working with Congress and the new Administration to fix the broken health system and ensure that patients have choices for quality, safe, and affordable healthcare" – Hims & Hers spokesperson
The senators have expressed their intention to introduce new legislation to address regulatory loopholes concerning the promotion of compounded drugs by telehealth companies. They argue that without proper regulation, advertisements like the one from Hims & Hers could lead to consumer misinformation and potential health risks.
"Further, for only three seconds during the minute-long commercial does the screen flash in small, barely legible font, that these products are not FDA-approved" – Sens. Dick Durbin (D-Ill.) and Roger Marshall (R-Kan.)