Novo Nordisk begins legal action against med spas and compounders

Novo Nordisk announced on June 20, 2023 that it has started legal proceedings against certain US medical spas, weight loss or wellness clinics and compounding pharmacies, asking them "to cease and desist from false advertising, trademark infringement and/or unlawful sales of non-FDA approved compounded products claiming to contain semaglutide" ^[1]. Semaglutide is the active ingredient in the company's Ozempic and Rybelsus, approved for type 2 diabetes, and Wegovy, approved for overweight and obesity ^[1].

In a news release, the drugmaker said those "unlawful marketing and sales practices … have created a high risk of consumer confusion and deception as well as potential safety concerns" ^[1]. The company did not name the targeted businesses or describe their specific practices ^[1].

In a statement to CNN, Novo Nordisk said its "legal actions are focused on preventing entities in the marketplace from engaging in misleading or false advertising, infringing our trademarks, or illegal distributing compounded products claiming to contain semaglutide," and added that it "will continue to evaluate any and all appropriate actions against entities that violate Novo Nordisk's intellectual property rights in connection with their sale of compounded drug products purporting to contain semaglutide" ^[1].

What compounding is, and why it is happening now

The move follows a US Food and Drug Administration warning issued the previous month about some compounded versions of semaglutide ^[1]. The FDA describes compounding as "the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient," including combining two or more drugs ^[1].

Both Ozempic and Wegovy have been on the FDA's Drug Shortages list since 2022 ^[1]. When a drug is in shortage, the agency says, 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 ^[1].

The FDA also said it has received reports of adverse events in people who used compounded semaglutide, and that patients "should not use a compounded drug if an approved drug is available" ^[1]. A separate concern the agency raised involves salt forms of the drug, such as semaglutide sodium and semaglutide acetate, which have different active ingredients from those in the approved products. According to the FDA, "The agency is not aware of any basis for compounding using the salt forms that would meet the FD&C requirements. … Products containing these salts, such as semaglutide sodium and semaglutide acetate, have not been shown to be safe and effective" ^[1].

Novo Nordisk said people who have a prescription for semaglutide "should be vigilant in checking their medicine to ensure they are taking an authentic" version, and pointed to a new website, semaglutide.com, with information on telling FDA-approved products from "counterfeit" ones ^[1].

Why it matters for patients

Shortages have pushed many people toward clinics and pharmacies offering cheaper or more available versions of semaglutide. The practical issue the FDA raises is that a compounded product is not reviewed by the agency for safety, effectiveness or quality, so a buyer cannot assume it matches what is in Ozempic or Wegovy ^[1]. Some products may contain salt forms that the FDA says have not been shown to be safe and effective ^[1].

There is also a branding question. Novo Nordisk's complaint centers in part on trademark infringement and false advertising — in other words, sellers presenting their products in ways that could lead consumers to think they are getting the approved medicine ^[1]. That is why the company is telling patients to check what they are actually being given ^[1].

The sources do not say how many businesses were targeted, where the cases were filed, or what remedies Novo Nordisk is seeking, and those details are not yet known from this reporting ^[1].

Supply and long-term use

On an earnings call the same day, Novo Nordisk said it has been ramping up production capacity for Wegovy after struggling to keep up with demand, and that it limited doses for new US patients the previous month so it could meet the needs of people already on the medicine ^[1].

The company also said it plans to study whether patients can maintain weight loss after stopping the medication, but expects it to be a chronic therapy for the foreseeable future ^[1]. "Based on the knowledge we have today, we're talking about a chronic treatment in order to maintain weight loss," said Dr. Martin Holst Lange, executive vice president of development at Novo Nordisk ^[1]. He said the company has shown patients can maintain weight loss of about 15% over two years while staying on Wegovy, but that those who stop the drug regain weight ^[1].