Drugmaker asks FDA to ban compounding pharmacies from making Ozempic’s key ingredient

The news: Novo Nordisk asked the FDA to prevent companies from making compounded versions of semaglutide, the drugmaker’s blockbuster injectable marketed as Ozempic and Wegovy.

• Novo argues that semaglutide should be added to a list of drugs that are too complex for compounding, even during shortages, due to potential safety risks.
• The FDA is reviewing Novo’s petition and will respond to the drugmaker directly.

For context, the FDA allows companies to make compounded drugs when branded versions are in shortage. While consumer demand for semaglutide remains high, its availability is struggling to keep pace.

How we got here: Last year, Novo took legal action against five spas and clinics selling obesity drugs allegedly purchased from compounding pharmacies and containing semaglutide, asserting the unlawful and deceptive use of Novo trademarks. Now, it wants to put a stop to compounded versions of the drug being made, even when companies aren't falsely advertising the product.

• But this has done little to slow down the tsunami of entrants like Hims & Hers, The Vitamin Shoppe, and Noom from offering compounded GLP-1s through their own weight loss programs.
• The murky situation led 34% of US healthcare professionals to predict that compounding pharmacies and the gray market would cause counterfeit concerns, per a May Venrock survey.

Why it matters: The FDA’s decision holds real consequences for both Novo and compounded GLP-1 sellers.