Biotech
Friday, December 1st, 2023 4:48 pm EDT
Key Points
- Novo Nordisk Sues Compounding Pharmacies Over Impure Drugs: Novo Nordisk has filed lawsuits against two compounding pharmacies in Florida, Wells Pharmacy Network and Brooksville Pharmaceuticals. The pharmaceutical company alleges that these pharmacies are selling impure and potentially unsafe drugs falsely claiming to contain semaglutide, the active ingredient in Novo Nordisk’s popular weight loss treatment Wegovy and diabetes medication Ozempic.
- Shortages of Wegovy and Ozempic Amidst Rising Demand: Novo Nordisk’s legal actions coincide with challenges related to shortages of Wegovy and Ozempic in the U.S. The demand for these drugs, known for their significant weight loss effects, has surged, leaving patients in search of alternatives. The scarcity has prompted individuals to explore potentially dangerous and unproven methods for weight reduction.
- Concerns About Impurities and Safety Risks: Novo Nordisk, the sole patent holder of semaglutide, asserts that all tested products from Wells Pharmacy Network and Brooksville Pharmaceuticals were impure, containing unknown and unauthorized substances beyond semaglutide. The lawsuits claim that these unknown impurities pose potential safety risks, including possibly serious and life-threatening reactions for consumers. Despite not seeking monetary damages, Novo Nordisk aims to prevent the pharmacies from selling their products through legal intervention.
Novo Nordisk has filed lawsuits against two compounding pharmacies in Florida, Wells Pharmacy Network and Brooksville Pharmaceuticals, accusing them of selling impure and potentially unsafe drugs claiming to contain semaglutide, the active ingredient in Novo Nordisk’s blockbuster weight loss treatment Wegovy and diabetes medication Ozempic. The legal actions come amid shortages of Wegovy and Ozempic in the U.S. due to surging demand for these drugs known for their significant weight loss effects, prompting patients to explore alternative, albeit sometimes dangerous and unproven, methods for weight reduction.
Novo Nordisk, holding the sole patent for semaglutide, does not sell this ingredient to external entities, raising concerns about the substances being sold by compounding pharmacies. Compounding pharmacies customize versions of commercially available treatments to meet specific patient needs. Novo Nordisk alleges that all products tested from Wells Pharmacy Network and Brooksville Pharmaceuticals were impure, containing unknown and unauthorized substances in addition to semaglutide. In one product, the level of unknown impurities reached 33%.
The impurities in these products, as per Novo Nordisk’s lawsuits filed in federal court in Florida, pose potential safety risks, including possibly serious and life-threatening reactions. The lawsuits do not seek monetary damages but request the court to prevent the pharmacies from selling their products.
This isn’t the first legal action by Novo Nordisk against Brooksville Pharmaceuticals, as the company previously sued the pharmacy in July for copycat versions of Wegovy and Ozempic. Although a federal judge dismissed the suit in October, Novo Nordisk has now refiled the complaint.
Including these recent lawsuits, Novo Nordisk has initiated 12 legal actions against compounding pharmacies, medical spas, and weight loss clinics allegedly selling counterfeit versions of Wegovy and Ozempic. The company claims to have obtained preliminary injunctions in six of these cases.
Rival company Eli Lilly has also taken similar measures against businesses selling knockoffs of its popular diabetes drug Mounjaro, including a lawsuit against Wells Pharmacy Network.
The new lawsuit against Wells Pharmacy Network alleges that its products contained a substance called BPC-157, banned by the U.S. Food and Drug Administration (FDA) in September. The FDA, citing insufficient data on its potential harm to humans, noted the substance could cause dangerous immune system reactions. Novo Nordisk’s lawsuit against Brooksville Pharmaceuticals asserts that its products had lower levels of semaglutide than advertised, putting patients at risk of receiving less effective drug products.
Novo Nordisk emphasizes the disparities in safety, quality, and effectiveness assurances between FDA-approved drugs and compounded products. Jason Brett, Novo Nordisk’s executive director of medical affairs, emphasizes the health risks associated with adulterated and misbranded injectable compounded drugs.
The FDA had previously issued warnings in May regarding the safety risks of unauthorized versions of Ozempic and Wegovy, following reports of adverse health reactions to compounded versions. Several states have also threatened legal action against compounding pharmacies involved in the production or distribution of unapproved variations of Novo Nordisk’s weight loss treatments.
For the full original article on CNBC, please click here: https://www.cnbc.com/2023/11/30/novo-nordisk-sues-pharmacies-over-impure-wegovy-ozempic-dupes.html
