The Recent York Stock Exchange with a Hims & Hers Health banner is pictured within the Manhattan borough of Recent York City.
Carlo Allegri | Reuters
Hims & Hers is facing scrutiny from lawmakers over an commercial for its weight reduction offerings that is slated to run throughout the Super Bowl on Sunday.
Sens. Dick Durbin, D-In poor health., and Roger Marshall, R-Kan., wrote a letter to the U.S. Food and Drug Administration on Friday expressing concerns over an “upcoming commercial” that “risks misleading patients by omitting any safety or side effect information when promoting a selected variety of weight reduction medication.”
The Hims & Hers ad, which the corporate released online in late January, is named “Sick of the System” and sharply criticizes the $160 billion weight reduction industry. It shows visuals of existing weight reduction medications generally known as GLP-1s, including injection pens that appear like Novo Nordisk’s blockbuster diabetes drug Ozempic.
The ad claims those drugs are “priced for profits, not patients” and points to Hims & Hers’ weight reduction medications as “inexpensive” and “doctor-trusted” alternatives.
“We’re complying with existing law and are glad to proceed working with Congress and the brand new Administration to repair the broken health system and be sure that patients have decisions for quality, secure, and inexpensive healthcare,” a Hims & Hers spokesperson told CNBC in a press release.
The senators don’t mention Hims & Hers by name of their letter, but they do reference a few of the visuals within the ad, including “imagery of an injection pen with distinctive characteristics reflective of an existing brand-name medication.”
“Nowhere on this promotion is there any side effect disclosure, risk, or safety information as could be typically required in a pharmaceutical commercial,” the senators wrote. “Further, for less than three seconds throughout the minute-long industrial does the screen flash in small, barely legible font, that these products aren’t FDA-approved.”
Hims & Hers began offering compounded semaglutide through its platform in May after launching a latest weight reduction program in late 2023. Semaglutide is the energetic ingredient in Ozempic and Wegovy, which may each cost around $1,000 a month without insurance.
Shares of Hims & Hers jumped greater than 170% last 12 months, due to soaring demand for GLP-1s. They rose one other 8% on Friday, lifting the corporate’s market cap to about $9.5 billion.
Compounded GLP-1s are typically less expensive and might serve instead for patients who’re navigating complex supply hurdles and spotty insurance coverage. Hims & Hers sells compounded semaglutide for under $200 a month.
The FDA doesn’t review the protection and efficacy of compounded products, that are custom-made alternatives to brand-name drugs designed to fulfill a selected patient’s needs. Compounded products may also be produced when brand-name treatments are in shortage.
Semaglutide is currently in shortage, based on the FDA.
Durbin and Marshall said advertisements for brand-name GLP-1 medications include “significant risk disclosures to patients about negative effects and contraindications, including warnings about potential gallbladder, pancreas, vomiting, diarrhea, and other implications.”
A release on Durbin’s website says that the ad in query appears to take advantage of a loophole “regarding promotions of compounded drugs by telehealth corporations.”
The senators said they imagine the FDA can have the authority to take enforcement actions against marketing that might mislead patients, and so they plan to introduce latest laws to handle regulatory loopholes.
WATCH: Recent study reveals why patients stop taking GLP-1 obesity drugs
