Eli Lilly, a prominent diabetes drug manufacturer, has initiated legal action against various businesses across multiple states. Their claim alleges that these entities are engaging in fraudulent practices by falsely representing their compounded products as equivalent to Eli Lilly’s medication, Mounjaro. Mounjaro is an FDA-approved drug containing tirzepatide and is intended for the treatment of type 2 diabetes.
The lawsuits, filed recently, aim to put an end to what Eli Lilly considers the unlawful marketing and sale of non-FDA approved compounded products by these medical spas, wellness centers, and compounding pharmacies.
In a statement, Eli Lilly emphasized that they filed the lawsuit to safeguard the interests of patients. They stressed their inability to validate the safety or effectiveness of products claiming to contain tirzepatide that are not their own branded Mounjaro. Eli Lilly exclusively markets Mounjaro in prefilled single-dose pens.
The statement further highlighted the importance of halting these entities from providing drug products that contravene consumer protection laws, particularly when they make claims to their patients that their drugs offer the same safety profile and clinical benefits as Mounjaro.
This legal action by Eli Lilly follows a similar pattern in the pharmaceutical industry. In June, Novo Nordisk also sued businesses for producing compounded versions of semaglutide, which is utilized in Novo Nordisk’s type 2 diabetes drugs Ozempic and Rybelsus, as well as in obesity treatment under the brand name Wegovy. Novo Nordisk’s cases revolve around false advertising, trademark infringement, and the unlawful sale of non-FDA-approved compounded products containing semaglutide.
Eli Lilly raised concerns about compounded versions of tirzepatide, stating that they can pose potentially serious health risks. These products, allegedly containing tirzepatide and made or distributed by compounding pharmacies or counterfeit sources, have not undergone safety, quality, or efficacy evaluations by the U.S. FDA or global regulatory agencies, as per Eli Lilly.
The FDA has previously received reports of adverse events associated with compounded semaglutide. In response, the FDA advised patients not to use compounded drugs if an approved drug is available. However, it’s worth noting that both Mounjaro and Novo Nordisk’s drugs Ozempic and Wegovy have been listed on the FDA’s drug shortages list since last year. During drug shortages, compounding pharmacies may be permitted to create compounded versions of the drug if they meet certain requirements outlined in the Federal Food, Drug, and Cosmetic (FD&C) Act, according to the FDA.