Specialty pharmacies and online companies that have been selling off-brand copies of two blockbuster obesity and diabetes drugs will have to phase out their versions next year under a federal ruling issued Thursday.
The Food and Drug Administration said a nationwide shortage of Eli Lilly’s Zepbound and Mounjaro has been resolved, eliminating the need for copycat versions of the drugs that have become wildly popular with Americans trying to lose weight.
The decision is a victory for Lilly — which had been pushing the FDA to take the step for months — and is expected to affect how patients access drugs, including how much they pay.
Zepbound is FDA approved for the treatment of obesity and Mounjaro is approved for diabetes.
They use the same active ingredient, tirzepatide.
The FDA said Thursday that “Lilly’s supply is currently meeting or exceeding demand,” after two years of shortages.
Both drugs are part of the GLP-1 class that has shown unprecedented results in helping people lose weight by reducing appetite and increasing satiety.
Wegovy and Ozempic – competing drugs from Novo Nordisk – remain on the FDA shortage list.
With demand for GLP-1 drugs booming, pharmacies and telehealth companies like Hims and Ro have jumped into the market, selling cheaper versions online.
People can usually get a month’s supply for a few hundred dollars.
Thursday’s decision gives businesses between 60 and 90 days, depending on their size, to phase out their products.
The FDA allows compounded versions of brand-name drugs when they are in short supply, and switching to Lilly’s drugs could improve safety for consumers.
The FDA warned patients last year about problems with the ingredients and formulations of some GLP-1 drugs sold online.
The agency has limited oversight of compounding pharmacies, which are primarily overseen by state authorities.
Compounding pharmacies use raw drug ingredients to make customized versions of prescription drugs—for example, when patients have allergies to certain ingredients.
The industry has grown into a multibillion-dollar business over the past decade amid growing drug shortages.
Demand for off-brand GLP-1 drugs has been boosted by aggressive online promotions by telehealth companies, which are not subject to the same marketing rules as drug manufacturers.
The FDA previously declared the end of the Mounjaro and Zepbound shortages in early October, but reversed its decision after public outcry and a lawsuit filed by compounding pharmacies.
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