Hims & Hers It faces scrutiny from lawmakers over the ads over the weight loss offerings scheduled to run during Sunday’s Super Bowl.
D-Ill. Senator Dick Durbin, and R-Kan. Roger Marshall on Friday expressed concerns to the US Food and Drug Administration about “future advertising” and “there is a risk of misleading patients by omitting safety or aspects.” I wrote a letter. Information about promoting certain types of weight loss medication. ”
The company released online in late January, HIMS & HERS AD, called “system disease,” and is a sharp critic of the $160 billion weight loss industry. It shows the vision of an existing weight loss drug known as GLP-1. Novo Nordisk’s The huge hit diabetes drug Ozempic.
The ad argues that these drugs are “prices of profit, not patients,” and points out HIMS & HERS weight loss drugs as “affordable” and “doctors trust” alternatives.
“We are complying with existing laws and working with Congress and the new administration to fix broken healthcare systems, ensuring patients can choose quality, safe and affordable healthcare.” A spokesman for HIMS & HERS told CNBC. statement.
The Senator does not mention HIMS & HERS in the letter’s name, but refers to some of the advertising visuals, such as “images of injection pens with distinctive properties that reflect existing branded drugs.”
“Nowhere in this promotion has any side effects disclosure, risk or safety information as is normally required in drug ads,” the senator wrote. “And in just three seconds during a few minutes of commercial, the screen flashes in a small, barely easy-to-read font that these products are not approved by the FDA.”
Scott Brunner, CEO of Alliance for Pharmacy Counting, said Friday that Hims & Hers ads matched the “Help Exploration” pharmaceutical ads.
“Hims Super Bowl ads do not promote certain drugs or drugs, so there is no need to provide any information about side effects or risks,” Brunner said in a statement. “Instead, viewers were encouraged to consult with healthcare providers, consistent with FTC guidelines for non-specific “help seeking” advertising. ”
HIMS & HERS began offering combined semaglutide through the platform in May after launching a new weight loss program in late 2023. Each Semaglutide can cost around $1,000 a month without insurance.
HIMS & HERS stocks rushed more than 170% last year thanks to rising demand for GLP-1. They closed 5% on Friday, raising the company’s market capitalization to around $9.5 billion.
Composite GLP-1 is usually much cheaper and serves as an alternative to patients navigating complex supply hurdles and uneven insurance coverage. Hims & Hers sells compound semaglutide for less than $200 a month.
The FDA does not review the safety and efficacy of composite products, custom-made alternatives to branded drugs designed to meet the needs of specific patients. Composite products can also be produced when there is a lack of treatment for the brand.
According to the FDA, Semaglutide is currently in short supply.
Durbin and Marshall have advertised for the brand name GLP-1 drug that includes “severe risk disclosures to patients regarding side effects and contraindications, including warnings about potential gallbladder, pancreas, vomiting, diarrhea and other meanings.” He said that.
The release on Durbin’s website states that the ads in question appear to take advantage of a loophole “about promoting combined drugs by Telehealth Companies.”
The Senator believes the FDA may have the authority to take enforcement action against marketing that could mislead patients, and plans to introduce new laws to address regulatory loopholes. He said that.
See: A new study reveals why patients stop taking GLP-1 obesity medication
