A Florida compounding pharmacy is among the companies that were sued last week by Eli Lilly for allegedly selling unregulated and unapproved versions of a weight loss drug.
The Wells Pharmacy Network along with 9 other medical spas, wellness centers and compounding pharmacies are accused of selling drug preparations that contain Tirzepatide, according to media reports.
“These entities should be stopped from providing drug products in violation of consumer protection laws, particularly where they promise their patients that their drugs offer the same safety profile and clinical benefits as Mounjaro,” an Eli Lilly spokesperson said.
Tirzepatide is an ingredient in Mounjaro, a diabetes drug that has not yet been approved but is expected to be approved for weight loss next year.
As previously reported by Reuters, the U.S. Food and Drug Administration has only approved Eli Lilly to sell drugs made with Tirzepatide.
“Mounjaro, approved for type 2 diabetes, is only available from and manufactured by Lilly and is only commercially available in a pre-filled single-dose pen,” the spokesperson told the Florida Record. “Products claiming to contain tirzepatide that are made and/or distributed by compounding pharmacies or distributed by counterfeit sources have not been reviewed by the U.S. FDA or global regulatory agencies for safety, quality, or efficacy; are not FDA-approved like Mounjaro; and may expose patients to potentially serious health risks.”
The lawsuit was filed in the U.S. District Courot of Florida for the Middle District on Sept. 19. In the complaint, Eli Lilly alleges that Wells Pharmacy Network is violating the Florida Drug and Cosmetic Act, which prohibits the sale of drugs not approved by the FDA.
"Testing new drugs and obtaining the legally required regulatory approval to sell them is time-consuming and very costly. Ignoring drug-approval requirements provides Defendant an unfair competitive advantage over law-abiding pharmaceutical manufacturers like Lilly," wrote Plaintiff's attorney Brian P. Miller in the complaint. "Worse, it puts patients at risk by exposing them to drugs that have not been shown to be safe or effective."
The Wells Pharmacy Network has locations in Ocala, Wellington and Dyersburg, Tennessee, according to their website.
The pharmacy did not immediately respond to requests for comment.
“Lilly filed this lawsuit to protect patients,” the spokesperson stated. “Lilly cannot validate the safety or effectiveness of products claiming to contain tirzepatide that are not our own branded product. Because of this, Lilly filed lawsuits to protect patient safety and stop the unlawful marketing and sale of non-FDA approved compounded products fraudulently claiming to be Mounjaro® (tirzepatide) by medical spas, wellness centers and compounding pharmacies.”