Novo Nordisk is increasing its efforts to combat the compounded versions of its medication semaglutide. The company is lobbying the FDA to classify semaglutide as a substance with "Demonstrable Difficulties for Compounding" (DDC), which would effectively prohibit compounding pharmacies from producing their own versions of the drug. Novo Nordisk argues that the complexities involved in safely compounding semaglutide pose risks to patient safety.
The FDA is currently reviewing the request, which could have implications for the compounding industry and patients relying on these alternatives.
The compounded semaglutide market has gained traction due to shortages of injectable GLP-1 drugs. Compounded semaglutide is being sold online at significantly lower prices than the brand-name alternatives. However, compounded drugs do not require FDA approval, raising concerns about their safety and effectiveness. Reports of adverse side effects have fueled the debate over the safety of these alternatives.
Novo Nordisk has filed lawsuits against various entities involved in the sale of compounded products, alleging trademark infringement and unfair competition. The compounding sector has objected to Novo Nordisk's attempts to restrict access to compounded semaglutide, arguing that it can be compounded safely and effectively.
The FDA's recent declaration regarding the shortage of tirzepatide has added complexity to the situation. Compounding pharmacies were forced to cease production of their versions, and the manufacturer of tirzepatide has sent cease-and-desist letters to companies offering the drug. A trade group has filed a lawsuit against the FDA, claiming that the shortage persists and is depriving patients of essential treatments.
The battle between pharmaceutical companies and compounding pharmacies has significant implications for patients. If Novo Nordisk's petition is granted, individuals relying on compounded semaglutide may face increased costs and reduced access to these treatments. The future of compounded medications and their role in patient care remains uncertain, with financial implications for both the pharmaceutical industry and the compounding sector.