The Food and Drug Administration has warned Hims & Hers, a major telehealth purveyor of widely popular obesity drugs, to stop “false or misleading” marketing, according to a copy of a letter sent to the company and obtained by The New York Times.
The F.D.A.’s letter was one of about 100 warning letters sent to drug advertisers this week. The agency commissioner, Dr. Marty Makary, said on Tuesday that the letters were being sent to traditional pharmaceutical companies as well as to online pharmacies.
The letter, sent on Tuesday to Hims & Hers, warned the company to halt the use of marketing language that falsely implies that one of its products is approved by the F.D.A. The agency has not yet publicly released the letter.
Hims & Hers has capitalized on a huge demand for weight-loss drugs like Novo Nordisk’s drug Wegovy, offering low-cost, copycat versions made through a process of mixing drug ingredients known as compounding. In the past few years, telemedicine companies like Hims & Hers have emerged as an aggressive new type of drug advertiser.
In the letter, the F.D.A. targeted the company’s compounded version of Wegovy. It said the Hims & Hers website made claims that were “false or misleading,” making the product “misbranded.” It called out examples of marketing language used on the company’s website, including “same active ingredient as Ozempic and Wegovy” and “clinically proven ingredients.”
“Compounded drug products are not F.D.A.-approved,” the letter said. “Your claims imply that your product is the same as an F.D.A.-approved product when it is not.”
Javier Lacayo, a spokesman for Hims & Hers, said the company looked forward to “engaging with the F.D.A. to address any concerns and ensure continued access to safe and affordable health care.” He added that the company’s compounded weight-loss drug offerings “are produced in industry-leading facilities, with ingredients from F.D.A.-regulated manufacturers, and undergo rigorous quality testing.”
On the Hims & Hers website, landing pages for weight-loss treatments state that “compounded products have not been approved by the F.D.A.”
The company spent $449 million on marketing in the first half of this year. During this year’s Super Bowl, Hims aired a spot touting its weight-loss drug offerings but did not detail the drugs’ side effects, as a traditional pharmaceutical ad would. Instead, fine print at the end of the ad directed patients to the company website “for details and important safety information.”
In a letter to the F.D.A. in February, two senators said the ad could mislead patients. Dr. Makary also called out the ad in an opinion piece published in a medical journal on Friday. He accused the company of “highlighting the benefits” of the weight-loss drugs “without any mention of side effects or disclaimers,” calling it a “breach of F.D.A. regulation.”
The letters sent by the F.D.A. this week include a mix of official warnings and so-called untitled letters. Companies can resolve the concerns in the untitled letters by taking down the claims that the F.D.A. deemed problematic. Companies are typically expected do more to respond to warnings, like the letter sent to Hims & Hers, such as correcting the misleading statements in messages targeted to the same audience that saw the original statements, according to Dara Katcher Levy, a lawyer who advises clients on F.D.A. matters.
The agency’s letter to Hims & Hers says that the company should immediately address the violations, such as by taking down misleading language, and must write to the F.D.A. to explain how it will avoid similar missteps in the future.
The pharmaceutical industry spends billions of dollars a year on advertising its products to consumers. The Trump administration said on Tuesday that it planned to initiate a rule-making process that could effectively take drug advertisements off TV. The proposed policy change would reinstate a 1990s-era policy that forced drugmakers to include so much safety information that it was impractical for them to run a 30-second spot.
Telemedicine companies like Hims connect patients online with a prescriber and mail them the medications. Patients typically forgo insurance and use their own money to pay for the drugs, a dynamic that has prompted the companies to aggressively target the public with ads on TV, billboards and in the New York public transportation system.
Hims & Hers reported $420 million in revenue in the first half of this year from a category of weight-loss drugs that includes both brand-name and compounded products.
Hims also offers drugs for conditions that include hair loss, erectile dysfunction and, in a new product line that debuted this week, low testosterone levels in men.
The company said last month it had 2.4 million customers with recurring subscriptions in total, though it did not say how many subscribers have received compounded weight-loss drugs.
Novo Nordisk and Eli Lilly, the makers of brand-name obesity drugs, have been furiously trying to block compounding, which has been cutting into their market share. In June, Novo Nordisk, the maker of Wegovy, scrapped a brief collaboration with Hims, accusing the telemedicine provider of “deceptive promotion.”
The F.D.A. set deadlines this spring for an end to compounding of the weight-loss drugs, now that the medicines are no longer in short supply. But some sales of compounded drugs have continued anyway. Some providers including Hims & Hers have attempted to skirt the rules by offering what they call “personalized” versions of the drugs at different dosage levels or mixed with vitamins, a strategy that experts say falls into a legal gray area.
Until late last year, Dr. Makary was an executive at Sesame, a telehealth company that at the time offered a compounded version of Wegovy but that has since discontinued the offering. Dr. Makary pledged before being confirmed to lead the F.D.A. that he would divest his stock options in Sesame, a privately held company.
The F.D.A. has repeatedly warned that compounded weight-loss drugs do not go through the same approval process as traditional medications and that they may be riskier for patients. The weight-loss drugs, whether brand-name or compounded, often cause side effects like nausea, vomiting and diarrhea that are usually not serious.
One of the F.D.A.’s other letters this week was sent to AstraZeneca, the maker of FluMist, a nasal spray that is an alternative to a flu shot.
The letter, posted online, calls out a TV ad for FluMist featuring teenagers who had ordered milkshakes in a diner, saying it is “false or misleading.” The letter says the ad too quickly runs through the product’s risks. The letter also says the ad misleadingly suggests that the teenagers can order and use the spray themselves, when in fact it must be prescribed for them and administered by a caregiver.
AstraZeneca declined to comment.
Christina Jewett covers the Food and Drug Administration, which means keeping a close eye on drugs, medical devices, food safety and tobacco policy.
Rebecca Robbins is a Times reporter covering the pharmaceutical industry. She has been reporting on health and medicine since 2015.
Dani Blum is a health reporter for The Times.
The post Targeting Hims & Hers, F.D.A. Takes on a New Type of Drug Advertiser appeared first on New York Times.
