Eli Lilly Takes Legal Action Against Medical Spas and Compounding Pharmacies for Selling Products with Tirzepatide
Eli Lilly, a leading pharmaceutical company, announced on Tuesday that it has initiated legal action against several medical spas, wellness centers, and compounding pharmacies in the United States for selling products containing tirzepatide. Tirzepatide is the active ingredient in Lilly’s blockbuster drug, Mounjaro, which is approved by the FDA for the treatment of type 2 diabetes.
Currently, Mounjaro is exclusively available through Lilly and can only be obtained in prefilled single-dose pens. In its statement, the company emphasized that it cannot vouch for the safety or effectiveness of products claiming to contain tirzepatide that are not their own branded product. Consequently, Lilly has filed lawsuits to protect patient safety and halt the unlawful marketing and sale of non-FDA approved compounded products fraudulently claiming to be Mounjaro.
Lilly has filed four separate lawsuits in federal courts in Florida and Texas, seeking to ban Better Life Pharmacy, ReviveRX, Rx Compound Store, and Wells Pharmacy Network from selling tirzepatide. The company is also seeking unspecified damages.
The lawsuits accuse these compounding pharmacies of violating federal and state consumer production and competition laws by selling unregulated and unapproved versions of Mounjaro. In addition, Lilly has accused six medical spas and wellness centers in various states of infringing on its trademark by marketing compounded tirzepatide as Mounjaro.
Lilly asserts that the defendants use their trademark to attract customers and generate revenues by passing off their own unapproved compounded drugs purporting to contain tirzepatide as Mounjaro. Moreover, they allege that these entities market the drugs for off-label use, specifically for weight loss, which is not an approved indication for Mounjaro. Lilly argues that these entities should be stopped from providing drug products that violate consumer protection laws, particularly when they falsely claim to offer the same safety profile and clinical benefits as Mounjaro.
These lawsuits come in the wake of a similar legal action by Novo Nordisk, a rival pharmaceutical company, which sued medical spas and compounding pharmacies for selling products claiming to contain semaglutide, the active compound found in their obesity treatment drug Wegovy and diabetes drug Ozempic. The FDA has previously warned against the use of compounded drugs when approved alternatives are available due to adverse events associated with them.
Lilly’s decision to take legal action is not only meant to protect its own interests but also to safeguard the health and well-being of their patients. The company believes that compounded versions of tirzepatide can pose potentially serious health risks.
Products claiming to contain tirzepatide that are distributed by compounding pharmacies or counterfeit sources have not been reviewed by the FDA or global regulatory agencies for safety, quality, or efficacy. They lack FDA approval, unlike Mounjaro, and may expose patients to significant health risks.
In conclusion, Eli Lilly’s legal action against medical spas, wellness centers, and compounding pharmacies demonstrates its commitment to patient safety and protecting its intellectual property. By preventing the sale of unapproved and potentially harmful products, Lilly aims to ensure that patients receive medications that have undergone rigorous regulatory scrutiny and meet the high standards of safety and efficacy.