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A group representing companies that made copycat versions of Eli Lilly and Co.’s weight-loss drugs has sued the U.S. Food and Drug Administration over the agency’s decision to remove Lilly’s medications from its shortage list.
Indianapolis-based Lilly’s supply of Mounjaro, which is used to treat Type 2 diabetes, and popular weight-loss drug Zepbound, can now meet present and projected national demand, the FDA said last week in a statement.
The Outsourcing Facilities Association, which represents bulk compounders, alleged that the FDA’s decision was arbitrary, capricious, and “contrary to law,” in its complaint, filed in federal court in Texas. The plaintiffs, including compounding pharmacy FarmaKeio Custom Compounding, said the FDA should have given advance notice of its decision and solicited public comments.
The plaintiffs alleged that the shortage of Lilly’s drugs isn’t actually over, and that the agency’s decision deprives patients of important medicines by restricting compounding. The complaint asked the court to vacate or set aside the FDA’s removal of Lilly’s drugs from the shortage list.
The FDA did not immediately respond to a request for comment.
Lilly’s popular weight-loss drugs had been in shortage since 2022, a designation that allowed compounding pharmacies to make copies to be sold at cheaper prices than the brand-name products. Hundreds of thousands of patients have taken these off-brand drugs. But after the FDA decided the shortage was over last week, compounding was no longer broadly allowed.
That means many patients taking the compounded versions of Lilly’s drugs now have to look elsewhere for medicines: to the brand-name versions, which are usually more expensive; alternatives made by Novo Nordisk A/S; or compounded versions of Novo’s drugs, which are still in shortage.
Some compounding pharmacies have said they’ll continue making copies of Lilly’s drugs under a federal provision that allows compounding as long as the medicine is customized for a patient in order to meet a specific medical need, including by adding or subtracting ingredients or changing the dosing.
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