FDA Ends Sales of Off-Brand GLP-1 Medications Like Ozempic

The U.S. Food and Drug Administration (FDA) has announced the cessation of sales for off-brand versions of popular GLP-1 medications such as semaglutide (commonly known as Ozempic and Wegovy) and tirzepatide (Zepbound and Mounjaro). This decision effectively bans the production and distribution of compounded medicines made by smaller pharmacies that were sold without FDA approval, after deadlines passed for their cessation—March for tirzepatide and Thursday for semaglutide.

Prior to this, many patients relied on compounded versions as a more affordable alternative to the brand-name drugs. For example, Olympia Pharmaceuticals supplied over 70,000 individuals weekly with compounded semaglutide. Patients like Michelle Pierce from Texas, who credited compounded semaglutide for helping lower her blood sugar and avoiding surgery, now face limited options due to the new restrictions, which she finds financially burdensome.

Healthcare professionals express concerns about safety and efficacy. Dr. Jody Dushay from Beth Israel Deaconess emphasized the risks, noting a lack of regulation, unknown ingredient composition, safety, dosing accuracy, and potential drug interactions with compounded medications. While some predict that these restrictions might strain the supply of FDA-approved medications during the initial dosing phases, manufacturers like Novo Nordisk and Eli Lilly remain confident in their supply chains and warn against the dangers of unapproved, knockoff drugs.

Both pharmaceutical companies have introduced online platforms and single-dose vials to improve access, but high costs and limited insurance coverage continue to hinder many patients. Industry experts like Lee Rosebush, chair of the Outsourcing Facilities Association, have filed lawsuits against the FDA’s decisions, though these efforts have been unsuccessful. Patients who stockpiled medication, like Pierce, are now concerned about those unaware of the impending loss of access.

This development highlights ongoing challenges in medication access, safety concerns, and regulatory efforts to ensure product efficacy and patient safety. For more information, visit Brown University Health’s detailed analysis on compounded weight-loss medications.