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Denmark-based Novo Nordisk filed a lawsuit against California-based Hims & Hers, claiming the direct-to-consumer virtual care company sells unapproved, compounded versions of its weight-loss and diabetes drugs Wegovy and Ozempic, a move the pharma giant says puts patient safety at risk and infringes on its intellectual property.
Novo Nordisk’s suit claims Hims & Hers is infringing on its U.S. patent by selling unapproved, compounded versions of its semaglutide-based drugs (the active ingredient in Wegovy and Ozempic) in the United States and alleges that the products are unsafe for consumers.
The pharma company alleges Hims misled consumers and healthcare professionals by marketing its product as a safe alternative to its FDA-approved drugs.
Novo claims Hims & Hers products may contain dangerous impurities or incorrect ingredient levels, which pose potential health risks like immune reactions, overdoses or hospitalizations.
Novo Nordisk is seeking damages and asking the court to permanently ban Hims & Hers from selling compound drugs that infringe on its patents.
In response to a request for comment from MobiHealthNews, Hims & Hers directed the outlet to a post on X.
"Novo Nordisk’s lawsuit is a blatant attack by a Danish company on millions of Americans who rely on compounded medications for access to personalized care. Once again, Big Pharma is weaponizing the U.S. judicial system to limit consumer choice," Hims & Hers wrote.
"This lawsuit attacks more than just one medication or company – it directly assaults a well-established, vital component of U.S. pharmacy practice that has improved patient care for everything from obesity to infertility to cancer. Hims & Hers has a long history of providing safe access to personalized healthcare to millions of Americans, and we will continue to fight to provide choice, affordability, and access."
THE LARGER TREND
Last week, on Feb. 5, Hims & Hers announced it would give providers the option to prescribe a once-a-day compounded semaglutide pill for weight loss "with the same active ingredients as Wegovy."
On Feb. 6, Mike Stuart, general counsel for the Department of Health and Human Services, posted on X that his office referred Hims & Hers to the Department of Justice for investigation of potential violations by the company of the Federal Food, Drug, and Cosmetic Act and applicable Title 18 provisions.
That same day, the FDA released a statement saying it planned to take action against Hims & Hers as "compounded drug products are not FDA-approved" and that the company's marketing implies that its products are the same as FDA-approved drugs when they are not.
"[Hims & Hers] claims concerning compounded semaglutide products are false or misleading under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. §§ 352(a) and 352(bb)], resulting in products being introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FDCA [21 U.S.C. § 331(a)]," the FDA wrote.
The FDA gave Hims & Hers 15 working days to respond to its claims.
One day later, on Feb. 7, two days after announcing it would offer the pill, Hims & Hers posted on X that it would stop offering its compounded semaglutide pill on its platform after having "constructive conversations with stakeholders across the industry," the company said.
Upon news of Novo Nordisk's lawsuit, the pharma giant's stock is up around 3% to around $49.11 per share, and Hims & Hers' stock has plummeted around 21% to around $18.16 per share.
In April of last year, Hims & Hers and Novo Nordisk announced a partnership that would allow Americans to access a bundled offering that included the pharma giant's obesity drug Wegovy and a Hims & Hers membership starting at $599 per month, which included 24/7 care, nutrition guidance and clinical support.
Hims & Hers began offering Wegovy to cash-paying patients with a prescription shortly after the announcement.
In June, the pharma giant announced it was terminating its contract with Hims & Hers, due to concerns about Hims & Hers' "illegal mass compounding and deceptive marketing."
Novo Nordisk alleged that Hims & Hers Health is violating federal law by selling compounded versions of the drug at scale under the pretense of "personalization" and accused the company of using misleading marketing practices that, it said, put patient safety at risk.
Hims & Hers CEO Andrew Dedum responded to Novo Nordisk's allegations at the time in a statement posted on X.
"We are disappointed to see Novo Nordisk management misleading the public. In recent weeks, Novo Nordisk’s commercial team increasingly pressured us to control clinical standards and steer patients to Wegovy regardless of whether it was clinically best for patients. We refuse to be strong-armed by any pharmaceutical company’s anticompetitive demands that infringe on the independent decision-making of providers and limit patient choice," Dedum wrote in the post.
"We take our role of protecting the ability of providers and patients to control individual treatment decisions extremely seriously, and will not compromise the integrity of our platform to appease a third party or preserve a collaboration. The health and wellness of individuals always comes first. We will continue to offer access to a range of treatments, including Wegovy, to ensure providers can serve the individual needs of patients."
Additionally, Hims & Hers posted a comment on LinkedIn, stating: "This is a move by a pharmaceutical giant to protect its own interests by challenging lawful, personalized compounded care. Even more troubling is the effort to conflate lawful compounders with bad actors. That’s misleading and harmful, especially for patients with complex needs."
