When and Where It's Happening
In the backdrop of a widespread shortage of weight-loss drugs and rising demand, pharmaceutical giant Novo Nordisk is taking significant steps in the United States to restrict compounded versions of its well-known weight-loss drugs, Ozempic and Wegovy. The Danish company is actively engaging with the US Food and Drug Administration (FDA) to crack down on these more affordable imitations.

Why It Matters and Who's Involved
Novo Nordisk is lobbying to have semaglutide, the active ingredient in Ozempic and Wegovy, added to the FDA’s Demonstrable Difficulties for Compounding (DDC) list. This move aims to prevent compounding pharmacies from creating duplicates without FDA approval, ultimately affecting patients seeking cost-effective alternatives. Jamie Bennett of Novo Nordisk emphasized the intricacies of safe compounding, stressing the inherent risks to patient safety. The FDA is currently reviewing this proposal.

How It Could Change the Market
If Novo Nordisk's petition is approved, the impact on the compounding industry and the millions reliant on lower-cost compounded drugs could be significant. With the originals often priced around $1,000 per month without insurance, compounded versions, marketed as low as $100 monthly, have become an attractive option. This has created a burgeoning market driven by telehealth services offering quick access to these medications through virtual consultations.

The Underlying Issues with Compounding
Compounded drugs are not generics. Unlike generics, which the FDA approves post-patent expiration, compounded medications bypass pre-market safety and effectiveness checks. This has resulted in reported adverse side effects, necessitating hospitalization due to potential dosing errors.

Existing Drug Shortages
Since 2022, the popularity of GLP-1 injectables like semaglutide has led to persistent shortages. In such times, licensed pharmacies in the US can produce compounded versions containing the same active components. However, this has accelerated tensions between compounding pharmacies, telehealth providers, and pharmaceutical companies like Novo Nordisk.

For more detailed information, you can view the original article on Wired.