Published: Jun 20, 2024
By Tristan Manalac
BioSpace
Eli Lilly on Thursday announced it has filed additional lawsuits against medical spas, wellness centers and other similar entities, which allegedly have been selling unapproved compounded versions of the pharma’s best-selling GLP-1 receptor agonist tirzepatide.
According to Lilly, the defendants in the lawsuits have misrepresented their products as either Mounjaro or Zepbound—the only two FDA-approved brands for tirzepatide—indicated for type 2 diabetes and chronic weight management, respectively. The defendants also refer to these FDA approvals to mislead customers to believe that these compounded products have cleared regulatory scrutiny, Lilly contends.
In addition, the defendants use Lilly’s study data in their advertising which is “deceiving consumers to believe the defendants’ compounded drugs were part of Lilly’s clinical trials,” the pharma alleges.
Lilly also published a lengthy open letter on Thursday, warning patients of the harms of compounded and counterfeit pharmaceutical products—as well as blasting “certain practices” of other clinics and spas regarding Mounjaro and Zepbound.
In the open letter, Lilly emphasized that its GLP-1 products “are indicated for the treatment of serious diseases” and are “not approved for—and should not be used for—cosmetic weight loss.” The pharma also said that it does not endorse the use of Mounjaro and Zepbound outside of its approved indications, and that patients should only use these medications following the prescription of a licensed healthcare professional.
Lilly also took aim at the increasingly common sales of Mounjaro and Zepbound online, particularly on social media which the pharma says involves counterfeit, fake or compounded versions of these treatments. “Social media is not a replacement for a healthcare professional,” Lilly warned, noting that purchasing these products through unregulated channels could put patients at risk.
In September and October 2023, Lilly sued several medical spas and wellness clinics for compounded versions of Mounjaro and Zepbound. The lawsuits alleged that these defendants infringed on Lilly’s trademark and violated federal and state consumer protection laws.
However, in April 2024, a Florida judge dismissed Lilly’s case against one compounding pharmacy, ruling the pharma was arguing to use state law to implement federal regulations—the Federal Food, Drug, and Cosmetic Act. In doing so, Lilly was trying to pre-empt federal law, U.S. District Judge Roy Altman ruled.
Novo Nordisk, Lilly’s main competitor in the lucrative obesity market, is also clamping down on compounded and counterfeit version of its own GLP-1 analog semaglutide, which are sold under the brand names Ozempic and Wegovy. The Danish drugmaker began its legal campaign in June and July 2023, claiming early victory in February 2024 with a Florida court issuing a permanent injunction against one of the defendants.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at [email protected] or [email protected].
Source: BioSpace
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