Miami, FL – December 2, 2023
Novo Nordisk (NOVOb.CO) has initiated legal proceedings against two compounding pharmacies in Florida, alleging that their products claiming to contain the active ingredient for the popular weight-loss drug Wegovy were found to be impure, with some samples showing impurities as high as 33%. The Danish pharmaceutical company has filed a new lawsuit against one pharmacy and refiled a previous lawsuit against another, as reported by Fidelity on Thursday.
The legal action comes after Novo Nordisk discovered impurities in all the drugs tested from Wells Pharmacy and Brooksville Pharmaceuticals in Florida. Brooksville had previously been sued by Novo in July, and during subsequent testing, a substance called BPC-157 was identified in samples from Wells.
In September, the “U.S. Food and Drug Administration (FDA)” banned BPC-157 from use in compounded drugs, citing insufficient data to determine its potential harm to humans and the risk of dangerous immune system reactions.
Novo Nordisk revealed that compounded versions of Wegovy from Brooksville were not only impure but also less potent than advertised, with one sample showing a potency at least 19% weaker than indicated.
Jason Brett, an executive at Novo Nordisk, emphasized the potential health risks associated with compounded drugs, stating, “Compounded products do not have the same safety, quality, and effectiveness assurances as FDA-approved drugs, and adulterated and misbranded injectable compounded drugs may expose patients to significant health risks.”
The lawsuits filed on Wednesday aim to prevent the two pharmacies from selling products claiming to contain semaglutide, the main ingredient in Wegovy and Ozempic. Additionally, the legal action seeks to prohibit Wells Pharmacy from asserting that its products are FDA-approved or that BPC-157 offers health benefits without adequately informing customers of associated safety risks.
Terry Myers, managing partner at Brooksville, disputed the new allegations, stating that the company plans to file another motion to dismiss. Wells Pharmacy has not yet responded to requests for comment.
Novo Nordisk has been actively pursuing legal action against weight-loss clinics, medical spas, and compounding pharmacies offering products claiming to contain semaglutide. The company has secured temporary orders against six of these entities to prevent false claims about product authenticity, FDA approval, or association with Novo Nordisk.
The legal cases against Wells and Brooksville have been filed in the “U.S. District Court, Middle District of Florida,” with the Wells case in the Ocala division and the Brooksville case in the Tampa division. As the legal battle unfolds, it is expected to shed light on the regulatory challenges and potential risks associated with compounded drugs in the weight-loss pharmaceutical market.