Eli Lilly Files Lawsuits Against US Medical Spas and Pharmacies Selling Non-FDA Approved Products
Pharmaceutical company Eli Lilly has recently taken legal action against several medical spas, wellness centers, and compounding pharmacies in the United States. The lawsuits aim to cease the unlawful marketing and sale of non-FDA approved compounded products that these businesses are falsely claiming to be Eli Lilly’s medication, Mounjaro. The medication contains tirzepatide, an active ingredient. CNN reports that Lilly filed the complaints on Tuesday, specifying various businesses in several states.
In a statement released to CNN, Eli Lilly emphasized their intention to protect patients’ safety and well-being with these lawsuits. The company acknowledges that it cannot guarantee the safety or effectiveness of products falsely labeled as containing tirzepatide, which are not their own branded product. Mounjaro, approved for the treatment of Type 2 diabetes, is exclusively manufactured and commercially available through Eli Lilly. The company highlights that the medication is only available in prefilled single-dose pens.
The lawsuits filed by Eli Lilly assert that these entities must be prevented from violating consumer protection laws by providing drug products that claim to offer the same safety profile and clinical benefits as Mounjaro. The company urges that these businesses should be held accountable for their actions.
Earlier this year, the US Food and Drug Administration (FDA) issued a warning regarding some compounded versions of semaglutide, a similar type 2 diabetes drug marketed as Ozempic and Rybelsus. Novo Nordisk, the manufacturer of these medications, initiated legal proceedings to stop certain establishments from falsely advertising, trademark infringement, and the unlawful sales of non-FDA approved compounded products containing semaglutide.
While the FDA has not issued a compounding warning for tirzepatide, Mounjaro has been on the FDA’s Drug Shortages list since last year, alongside Ozempic and Wegovy. The FDA emphasizes that compounded versions of drugs may be prepared by compounders if they meet the requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act when the drug is experiencing a shortage. However, these compounded versions are not reviewed by the FDA for their safety, effectiveness, or quality.
Eli Lilly warns that compounded versions of tirzepatide pose potentially serious health risks to users. It emphasizes that products claiming to contain tirzepatide from compounding pharmacies or counterfeit sources have not undergone safety, quality, or efficacy reviews by the FDA or other regulatory agencies.
Overall, Eli Lilly’s lawsuits against these establishments highlight the importance of ensuring that patients have access to safe and legitimate medications approved by the FDA. By taking legal action, the company aims to protect patients from potential harm caused by non-FDA approved compounded products.