Novo Nordisk, makers of GLP-1 medicines for weight loss and diabetes, is suing telehealth company Hims & Hers over its sale of compounded versions of those drugs.
Novo Nordisk makes three medicines using the active pharmaceutical ingredient (API) semaglutide, but are prescribed separately: Wegovy comes as a pill or an injection for weight loss, while the Rybelsus pill and Ozempic injection are prescribed for type 2 diabetes.
Novo Nordisk says that the versions sold by Hims & Hers are risky and that the sales are illegal.
“Hims & Hers is mass marketing unapproved knock-off versions of Wegovy and Ozempic that evade the FDA’s gold standard review process – that’s dangerous and deceptive to patients, and undermines the scientific innovation and regulatory rigor in place to ensure these treatments are safe and effective,” said John Kuckelman, a senior vice president and general counsel for Novo Nordisk, in a release announcing the suit Monday.
Novo Nordisk wants a judge to permanently ban Hims & Hers from selling the compounded alternatives to its medicines.
In a post on social media, Hims & Hers said that “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. This lawsuit attacks more than just one medication or company – it directly assaults a well-established, vital component of U.S. pharmacy practice.”
The sales that Novo Nordisk objects to include an aborted release by Hims & Hers of a compounded GLP-1 pill, a month after the Wegovy pill produced by Novo Nordisk became available. Hims & Hers axed the launch of its pill after “constructive conversations with stakeholders across the industry,” as well as pressure from the Food and Drug Administration.
On Friday, the FDA said it will restrict GLP-1 ingredients like semaglutide from being used in compounded drugs that are not FDA-approved, including the compounded products marketed by Hims & Hers.
The FDA also said companies cannot “claim that non-FDA-approved compounded products are generic versions or the same as drugs approved by FDA” and “cannot state compounded drugs use the same active ingredient as the FDA-approved drugs or that compounded drugs are clinically proven to produce results for the patient.”
Scott Brunner, CEO of the Alliance for Pharmacy Compounding, a trade group representing the makers of the compounded medicines, said Friday that “saying the API in the compounded drug is the same API as the FDA-approved drug – as Hims statement yesterday asserted – is a factual statement. Otherwise, the compounded drug would not meet the [Food, Drug & Cosmetic] Act requirement about what substances can be compounded.”
Mr. Brunner said that previously the FDA had not “asserted that the semaglutide (or tirzepatide) API the drugmakers are using is somehow superior or even different from that used by compounding pharmacies. So I’m curious to see what FDA’s beef may be.”
Tirzepatide is the active ingredient in Eli Lilly’s injectable medicines Mounjaro, which is prescribed for diabetes, and Zepbound which is prescribed for weight loss.
• Brad Matthews can be reached at bmatthews@washingtontimes.com.
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