Lawsuit Against FDA Over Drug Shortages

By Brendan Pierson

(Reuters) – A drug compounding industry group has sued the U.S. Food and Drug Administration (FDA) for removing Eli Lilly’s weight loss and diabetes medications from its short supply list.

Shortages of drugs such as Lilly’s Mounjaro and Novo Nordisk’s Ozempic have increased demand for compounded versions from facilities.

In a Fort Worth, Texas federal court lawsuit, the Outsourcing Facilities Association argues the FDA’s decision to remove Lilly’s tirzepatide was unfounded as it remains in short supply. Lilly markets this drug under the brand names Zepbound for weight loss and Mounjaro for diabetes.

The lawsuit asserts that the FDA did not allow public commentary on its decision and relied on Lilly’s assurances that they could meet the demand. It describes the FDA’s action as “arbitrary, capricious, and contrary to law.”

Neither the FDA nor Lilly has commented on the lawsuit yet.

Mounjaro had been on the FDA’s shortage list since late 2022, with Zepbound added in April. Compounding facilities produce medications by mixing or modifying ingredients, permitted under federal regulations when a drug is in short supply. However, compounded drugs cannot be produced regularly or in large quantities if there is no shortage.

Novo Nordisk’s semaglutide remains on the shortage list.