Novo Nordisk, a Danish pharmaceutical company, is seeking to restrict the production of compounded semaglutide, a popular weight-loss drug, by lobbying the US Food and Drug Administration (FDA) to add it to the agency’s Demonstrable Difficulties for Compounding (DDC) lists. This move would prevent compounding pharmacies from producing copies of the drug, which are often sold at lower prices. Novo Nordisk argues that semaglutide is too complex to be safely compounded and poses a risk to patient safety. If granted, this designation would have significant implications for the compounding industry and the millions of people currently taking compounded GLP-1 drugs. The shortage of injectable GLP-1 drugs, including semaglutide, has led to the rise of telehealth providers offering compounded versions to patients. This has caused tension with pharmaceutical companies, as compounded versions are sold at much lower prices. However, unlike generic medications, compounded drugs are not subject to FDA approval, raising concerns about their safety and effectiveness. The FDA has received reports of adverse side effects related to possible dosing errors associated with compounded semaglutide products. The compounding industry has objected to Novo Nordisk’s attempt to place the drug on the DDC lists, calling it a desperate move to protect their revenue stream.
