Eli Lilly Takes Legal Action Against Medical Spas and Clinics for Selling Unauthorized Diabetes Drug
Eli Lilly, a pharmaceutical giant, has initiated legal proceedings against 10 medical spas, wellness clinics, and compounding pharmacies located throughout the United States. The lawsuits allege that these entities have been selling unauthorized, cheaper versions of Eli Lilly's diabetes drug, Mounjaro.
The legal actions come amid a challenging situation for Eli Lilly, as there is a shortage of Mounjaro in the U.S. due to surging demand. A significant portion of the drug's popularity arises from its off-label use in helping patients shed excess weight.
Eli Lilly has filed multiple lawsuits in federal courts in states such as Florida, Texas, Arizona, Georgia, Minnesota, South Carolina, and Utah. These legal actions seek court orders to halt the sale of counterfeit versions of Mounjaro and also claim monetary damages.
The pharmaceutical company specifically accuses the medical spas, clinics, and compounding pharmacies of marketing and selling "compounded" drug products that purportedly contain tirzepatide, the active ingredient in Mounjaro. Compounded drugs are custom-made versions of treatments that have not received approval from the U.S. Food and Drug Administration (FDA).
Eli Lilly holds the sole patent for tirzepatide and does not supply this ingredient to external entities. It remains unclear what these spas and clinics are actually offering to consumers.
In one lawsuit against Rx Compound Store, a compound pharmacy in Florida, Eli Lilly stated that instead of investing the necessary time and resources in researching, developing, and testing their products to ensure safety and efficacy and obtaining regulatory approval, the defendant is simply creating, marketing, selling, and distributing unapproved new drugs for unapproved purposes.
Eli Lilly emphasizes that the sale of counterfeit Mounjaro versions poses a risk to patients by exposing them to drugs that have not undergone safety or efficacy testing.
As of now, Rx Compound Store has not responded to requests for comment on the lawsuit from CNBC.
These legal actions by Eli Lilly come several months after Novo Nordisk filed lawsuits against medical spas and clinics for selling compounded versions of its popular weight-loss drugs, Ozempic and Wegovy.
The FDA issued warnings in May regarding the safety risks associated with unauthorized versions of Ozempic and Wegovy after reports of adverse reactions to compounded versions of these drugs.
Although the FDA has not issued warnings about compounded versions of tirzepatide, it is worth noting that Mounjaro, Ozempic, and Wegovy have all experienced shortages in the U.S. since the previous year, according to the FDA's database.
Industry analysts and executives anticipate that annual sales of these drugs and similar weight loss treatments could reach $100 billion within the next decade.