The FDA has declared the shortage of Eli Lilly's obesity and diabetes drugs, Zepbound and Mounjaro, resolved, requiring pharmacies to phase out generic versions. This impacts patient access and pricing.
Specialty pharmacies and online companies that have been selling off-brand copies of two blockbuster drugs for obesity and diabetes will need to phase out their versions next year under a federal decision issued Thursday. The Food and Drug Administration said that a nationwide shortage of Eli Lilly’s Zepbound and Mounjaro has been resolved, eliminating the need for the cheaper alternatives.
The decision is a win for Lilly — which had been pressing the FDA to take the step for months — and is expected to impact how patients access the drugs, including how much they pay.Wegovy and Ozempic — competing drugs from Novo Nordisk — remain on the FDA’s shortage list. With demand for GLP-1 drugs booming, compounding pharmacies and telehealth companies like Hims and Ro have jumped into the market, selling cheaper versions online.The FDA permits compounded versions of brand name drugs when they are in shortage, and the shift back to Lilly’s medications could improve safety for consumers.The agency has limited oversight of compounding pharmacies, which are primarily overseen by state authorities. Compounding pharmacies use raw drug ingredients to produce customized versions of prescription medications — for instance, when patients have allergies to certain ingredients. The industry has grown into a multibillion-dollar business over the past decade amid increasing drug shortages. Demand for off-brand GLP-1 drugs has been amplified by aggressive online promotions from telehealth companies, which aren’t subject to the same marketing rules as drugmakers. The FDA previously declared an end to the shortage of Mounjaro and Zepbound in early October, but reversed its decision after public pushback and a lawsuit filed by compounding pharmacie
FDA Drug Shortage Obesity Drugs Generics Compounding Pharmacies
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