Novo Nordisk sues med spas and compounders over semaglutide marketing and sales
Novo Nordisk has started legal proceedings against med spas, clinics and compounders it says sell compounded products claiming to contain semaglutide, as the FDA warns about unapproved versions.
Novo Nordisk said on June 20, 2023 that it has begun legal proceedings against certain US medical spas, weight-loss and wellness clinics and compounding pharmacies, citing false advertising, trademark infringement and unlawful sales of compounded products claiming to contain semaglutide [1].
The announcement named categories of businesses, not specific companies, and gave no count of the actions filed [1]. Semaglutide is the active ingredient in Novo Nordisk's own medicines: Ozempic and Rybelsus, both approved for type 2 diabetes, and Wegovy, approved for overweight and obesity [1].
Novo Nordisk said the marketing and sales practices it is challenging have created "a high risk of consumer confusion and deception" along with potential safety concerns [1]. In a statement to CNN the next day, the company said the proceedings are meant to stop entities from misleading or false advertising, from "infringing our trademarks," or from illegally distributing compounded products claiming to contain semaglutide [1]. Novo Nordisk added that it will keep weighing further action against parties it believes violate its intellectual property rights through sales of such products [1].
The drugmaker also set up a website, semaglutide.com, with information on telling FDA-approved products apart from what it called counterfeit versions, and said people holding a semaglutide prescription "should be vigilant in checking their medicine to ensure they are taking an authentic" one [1].
What the FDA had already said
In May 2023, the FDA cautioned about some compounded versions of semaglutide and said it had received reports of adverse events in people who used them [1]. Its advice: patients "should not use a compounded drug if an approved drug is available" [1].
Compounding, as the agency defines it, is the process of combining, mixing or altering ingredients to create a medication tailored to an individual patient, and it can include combining two or more drugs [1]. Ozempic and Wegovy have appeared on the FDA's Drug Shortages list since 2022 [1]. During a shortage, compounders may be able to prepare a compounded version if they meet certain requirements of the Federal Food, Drug, and Cosmetic Act, but the FDA does not review those compounded versions for safety, effectiveness or quality, the agency said [1].
The FDA also flagged salt forms — semaglutide sodium and semaglutide acetate — noting they contain different active ingredients from those in the approved drugs [1]. The agency said it was not aware of any basis for compounding with those salts that would meet federal requirements, and that products containing them have not been shown to be safe and effective [1].
Why it matters for patients
For anyone filling a semaglutide prescription, the dispute sharpens a question that already existed: whether the product being dispensed is an FDA-approved medicine or a compounded version the agency has not reviewed for safety, effectiveness or quality [1].
Novo Nordisk's complaint is about how such products are advertised and sold, and the company says the practices it is challenging create confusion for consumers [1]. The FDA, for its part, has said it received reports of adverse events tied to compounded semaglutide [1]. Whether any particular clinic, med spa or pharmacy changes what it offers because of the proceedings has not been disclosed [1].
A related issue is what is actually in a product. If a label lists semaglutide sodium or semaglutide acetate, that is not the same active ingredient as in Ozempic, Wegovy or Rybelsus, according to the FDA, which says the salts have not been shown to be safe and effective [1].
Supply is part of the backdrop. On an earnings call the same day as the announcement, Novo Nordisk said it has been building up Wegovy production capacity and had limited doses for new US patients in May so it could meet the needs of people already taking the medicine [1].
What happens next
No case names, courts, filing dates or named defendants have been reported [1]. Novo Nordisk says it will continue evaluating appropriate actions against entities it believes infringe its rights in connection with compounded products purporting to contain semaglutide [1]. The FDA's May 2023 warning and its position on semaglutide salts remain in place [1].
Separately, Novo Nordisk said it plans to study whether patients can hold onto weight loss after stopping treatment, while expecting semaglutide to be a chronic therapy for the foreseeable future [1]. Dr. Martin Holst Lange, executive vice president of development, said, "Based on the knowledge we have today, we're talking about a chronic treatment in order to maintain weight loss" [1]. The company has shown maintenance of about 15% weight loss over two years while staying on Wegovy, with weight regained by those who stop, according to the report [1].
Sources
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