WASHINGTON — On Thursday, a significant federal ruling mandated that specialty pharmacies and online retailers must discontinue their off-brand alternatives to two highly sought-after medications for obesity and diabetes starting next year.
The Food and Drug Administration announced that the nationwide supply issues regarding Eli Lilly’s Zepbound and Mounjaro have been resolved, reducing the necessity for these unauthorized versions, which have gained immense popularity among individuals seeking weight loss solutions.
This ruling represents a substantial victory for Eli Lilly, which has been advocating for the FDA’s intervention over the past several months. The change is anticipated to affect patient access to these drugs and influence their financial costs.
Zepbound is specifically approved for obesity treatment, while Mounjaro is designated for diabetes management. Both medications share the same active component, tirzepatide. The FDA affirmed on Thursday that “Lilly’s supply is currently meeting or exceeding demand,” marking the end of two years of shortages.
Both Zepbound and Mounjaro belong to the GLP-1 medication class, which has demonstrated remarkable efficacy in aiding weight reduction by suppressing appetite and enhancing sensations of fullness. Competing medications such as Wegovy and Ozempic, produced by Novo Nordisk, are still listed under FDA shortages.
Given the soaring demand for GLP-1 drugs, compounding pharmacies and online health services, like Hims and Ro, have entered the fray, offering more affordable alternatives online. These off-brand options typically cost several hundred dollars for a month’s supply.
The FDA has granted businesses a window of 60 to 90 days, based on their size, to phase out these products. The agency allows compounded versions of name-brand drugs when they are in short supply; however, the transition back to Lilly’s original medications may enhance consumer safety. The FDA issued warnings last year concerning issues with the ingredients and formulations of some GLP-1 drugs sold online. The agency has limited oversight of compounding pharmacies, which are primarily regulated by state agencies.
Compounding pharmacies create tailored versions of prescription medications using raw drug ingredients, especially for patients with allergies to specific components. Over the past decade, this industry has evolved into a multibillion-dollar enterprise in response to increasing medication shortages.
The rising appeal of off-brand GLP-1 medications has been further boosted by robust online advertising campaigns from telehealth companies, which do not face the same marketing regulations as traditional drug manufacturers.
The FDA had previously declared an end to the shortages of Mounjaro and Zepbound in early October but reversed that decision following public dissent and a lawsuit initiated by compounding pharmacies.
