A trade group representing large compounding pharmacies has sued the U.S. Food and Drug Administration for a “reckless and arbitrary” decision to remove a widely prescribed Eli Lilly drug for combating diabetes and obesity from an official shortages list.
The Outsourcing Facilities Association argued that a shortage of the drug, known as tirzepatide, actually still exists and the agency action was a coup for the company that came at the expense of the public. Moreover, the trade group maintained the FDA move was “unlawful,” because it failed to follow so-called rule-making procedures and provide proper notice of its plans.
The lawsuit follows an FDA announcement last week that Lilly determined its manufacturing capacity can meet “present and projected” national demand after a sustained shortage of the drug, which Lilly sells under the brand name Mounjaro for treating diabetes and as Zepbound for weight loss. The FDA noted, though, that a rival drug from Novo Nordisk called Wegovy remains on the shortages list.
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