Hims & Hers caused a firestorm last week when it revealed that it planned to launch a knockoff version of Novo Nordisk's new oral weight loss medicine. But the reaction to the move has caused the company to quickly retreat.
Following rebukes from Novo and the FDA commissioner earlier last week, Hims’ plan truly began to unravel on Friday, when Department of Health and Human Services (HHS) General Counsel Mike Stuart announced on X that his agency had referred the online health and wellness company to the Department of Justice (DOJ) for investigation.
The probe concerns potential violations of the Federal Food, Drug, and Cosmetic Act “and applicable Title 18 provisions,” Stuart said. The HHS official posted the notice amid growing backlash to Hims' announcement that it planned to launch a compounded, semaglutide-containing pill for obesity.
Novo swiftly branded the move “illegal mass compounding,” drawing the safety of Hims’ pill into question on the basis of its allegedly “untested delivery mechanism.” The Danish drugmaker pledged to take legal action, and its stance was echoed in a social media post by FDA Commissioner Marty Makary, M.D.
At the heart of the issue is the fact that Novo launched its FDA-approved Wegovy pill just a little over a month ago. Mass compounding of drugs like Wegovy has been a consistent headache for both Novo and its chief metabolic medicine rival Eli Lilly, with the compounding cottage industry initially taking off during shortages of Novo and Lilly’s GLP-1s earlier in the decade.
As pressure mounted, Hims wrote on X over the weekend that it had “decided to stop offering access to this treatment,” referring to its semaglutide-containing pill. The company credited the decision to “constructive conversations with stakeholders across the industry,” reiterating its commitment to providing “safe, affordable, and personalized care.”
In a new X post Monday, Hims alleged that Novo’s lawsuit is a “blatant attack” on the “millions of Americans who rely on compounded medications for access to personalized care.”
“This lawsuit attacks more than just one medication or company – it directly assaults a well-established, vital component of US pharmacy practice that has improved patient care for everything from obesity to infertility to cancer,” the company’s statement continued.
Meanwhile, Novo is proceeding full steam ahead with its legal counterpunch. The company announced Monday morning that it had filed a lawsuit against Hims alleging patent infringement with its compounded pill and other copycat semaglutide products.
“Hims has engaged in promotional campaigns that highlight its compounded semaglutide products, duping consumers and healthcare professionals as to the clinical benefits and safety of these unapproved drugs,” Novo said in its release.
While acknowledging the discontinuation of Hims’ semaglutide-containing pill, Novo stressed that the telehealth firm “continues to unlawfully mass compound injectable versions, made with inauthentic API,” which it argued puts “patient health and wellbeing at risk.”
The initial GLP-1 compounding boom took off during large-scale shortages of Novo and Lilly’s respective incretin drugs for diabetes and obesity. Mass compounding is generally allowed under federal law during supply shortfalls.
More recently, with the shortages resolved and the FDA ostensibly putting an end to mass compounding, Hims and companies like it have leaned on the argument that they are personally tailoring doses for patients, making them legally distinct from their FDA-approved counterparts and legal under U.S. compounding law.
While Novo and Lilly have mounted multiple previous efforts in court to stop the GLP-1 compounding spree, those lawsuits have so far failed to meaningfully curtail the practice, analysts at Leerink Partners wrote in a note to clients Sunday, citing a recent call with legal experts.
Aside from the DOJ investigation and Novo’s lawsuit, the FDA is also stepping up its enforcement tactics, announcing on Friday that it will take “decisive steps” to restrict GLP-1 active pharmaceutical ingredients (API) intended for use in “non-FDA approved compounded drugs that are being mass-marketed by companies.” The regulator called out Hims & Hers by name and put “other compounding pharmacies” on notice, too.
“In promotional materials, companies cannot claim that non-FDA-approved compounded products are generic versions or the same as drugs approved by FDA,” the agency said in its announcement.
The regulator pledged to use “all available compliance and enforcement tools within its authorities” to get a handle on the issue, warning that companies that fail to address violations could face legal action “without further notice, including, without limitation, seizure and injunction.”
Hims’ share price was trading down nearly 25% on Monday morning compared with Friday's closing price, while Novo’s was up roughly 5%.
Editor's note: This story has been updated with a statement from Hims & Hers.