Compounding group sues FDA for removing obesity drug from shortages list

A commerce group representing giant compounding pharmacies has sued the U.S. Meals and Drug Administration for a “reckless and arbitrary” resolution to take away a extensively prescribed Eli Lilly drug for combating diabetes and weight problems from an official shortages checklist.

The Outsourcing Amenities Affiliation argued {that a} scarcity of the drug, often called tirzepatide, really nonetheless exists and the company motion was a coup for the corporate that got here on the expense of the general public. Furthermore, the commerce group maintained the FDA transfer was “illegal,” as a result of it did not comply with so-called rule-making procedures and supply correct discover of its plans.

The lawsuit follows an FDA announcement final week that Lilly decided its manufacturing capability can meet “current and projected” nationwide demand after a sustained scarcity of the drug, which Lilly sells below the model identify Mounjaro for treating diabetes and as Zepbound for weight reduction. The FDA famous, although, {that a} rival drug from Novo Nordisk known as Wegovy stays on the shortages checklist.