Editor's note: This article has been updated with a comment from Hims & Hers CEO and the company.
Pharma giant Novo Nordisk announced that it is terminating its contract with direct-to-consumer virtual care company Hims & Hers, which was launched less than two months ago, due to concerns about Hims & Hers' "illegal mass compounding and deceptive marketing."
In late April, the FDA announced that the national shortage of the GLP-1 weight-loss drug Wegovy had been resolved, stating that Novo Nordisk was able to meet the projected demand.
Following the announcement, the pharma giant began partnering with telehealth companies to offer Wegovy through NovoCare Pharmacy, its platform that allows cash-paying individuals without insurance to obtain the medication Wegovy.
In April, Novo Nordisk announced it was partnering with Hims & Hers to offer Americans access to a bundled offering that included the pharma giant's obesity drug Wegovy and a Hims & Hers membership.
Now, less than two months later, Novo Nordisk is terminating that collaboration, alleging that Hims & Hers Health is violating federal law by selling compounded versions of the drug at scale under the pretense of "personalization."
Novo Nordisk also accuses Hims & Hers of using misleading marketing practices that, it says, put patient safety at risk.
"Based on Novo Nordisk's investigation, the 'semaglutide' active pharmaceutical ingredients that are in the knock-off drugs sold by telehealth entities and compounding pharmacies are manufactured by foreign suppliers in China," Novo Nordisk said in a statement.
"According to a report from the Brookings Institute, FDA has never authorized or approved the manufacturing processes used by any of these foreign suppliers to make semaglutide, nor has FDA ever reviewed or authorized the quality of the 'semaglutide' they produce. The report also found that a "large share of [these Chinese suppliers] were never inspected by FDA, and many of those that were [inspected] had drug quality assurance violations."
The pharma giant said U.S. patients should not be exposed to knock-off drugs composed of illicit and unsafe foreign ingredients and that it will not stop taking action to protect Americans from the dangers of these pharmaceutical ingredients in knock-off drugs.
"Novo Nordisk is firm on our position and protecting patients living with obesity. When patients are prescribed semaglutide treatments by their licensed healthcare professional or a telehealth provider, they are entitled to receive authentic, FDA-approved and regulated Wegovy," Dave Moore, executive vice president of U.S. operations of Novo Nordisk, said in a statement.
"We will work with telehealth companies to provide direct access to Wegovy that share our commitment to patient safety – and when companies engage in illegal sham compounding that jeopardizes the health of Americans, we will continue to take action."
Hims & Hers stock price plunged amid the announcement of the breakup. When MobiHealthNews requested a comment from the company, a spokesperson directed it to a statement posted on X by CEO Andrew Dedum.
"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 on X.
"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 made a comment on its LinkedIn page regarding the allegations, which reads, "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."
THE LARGER TREND
The Hims & Hers and Novo Nordisk partnership announced in April allowed 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.
The partnership allowed Hims & Hers members to have direct access to NovoCare Pharmacy and Hims' offerings, including 24/7 care, nutrition guidance and clinical support.
Hims & Hers began offering Wegovy to cash-paying patients with a prescription shortly after the announcement was made.
The two companies said they would find a way to combine Novo Nordisk's technologies with Hims & Hers' ability to scale access to care.
In May, the FDA raised concerns over unapproved versions of GLP-1 drugs, such as compounded semaglutides, as an option for weight loss.
Until February of this year, compounders were allowed to produce hundreds of thousands of doses of Novo's brand-name medication due to a shortage of the medicine's active ingredient, semaglutide.
However, in February, the FDA announced that Novo Nordisk could fully meet or exceed nationwide demand for all doses of Wegovy and its diabetes medication Ozempic, declaring an end to the supply shortage.
In turn, larger outsourcing facilities that create compounded drugs were given a deadline of May 22 to cease production of the drug, and smaller compounding pharmacies were to stop immediately.
In February, Hims & Hers received backlash in response to an ad played during Super Bowl LIX, in which it presented itself as a solution to America's obesity problem.
Two U.S. senators and the Partnership for Safe Medicines sent letters to the FDA, raising concerns that the ad failed to disclose safety and side effect information on compounded GLP-1 injections required in pharmaceutical advertising.
Last year, Hims & Hers announced plans to launch a generic version of Novo Nordisk's GLP-1 diabetes drug liraglutide on its platform in 2025.
Liraglutide, brand name Victoza, is used to treat type 2 diabetes and is part of the GLP-1 agonists category, which can help with weight loss by curbing one's appetite and controlling blood sugar.
