Compounders lose legal battle with FDA over removal of Eli Lilly’s weight loss drug from a shortage list

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A federal judge has sided with the U.S. Food and Drug Administration over a decision last year to remove two Eli Lilly drugs — the Zepbound weight loss medicine and the Mounjaro diabetes treatment — from a shortages list kept by the agency. The move means that patients will no longer have access to cheaper versions from compounding pharmacies.

Due to ongoing shortages of the Lilly drugs, compounding pharmacies were permitted to make copies that sold for substantially less. But once the FDA determined the drugs were no longer in short supply, the compounders could no longer satisfy patient demand, which swelled exponentially and created the equivalent of a gold rush for the manufacturer and investors.

However, the Outsourcing Facility Association, a trade group for compounding pharmacies, filed a lawsuit against the FDA, arguing the decision last year to remove the Lilly drugs from its shortages list was arbitrary and unlawful. The trade group maintained the FDA relied solely on statements by Lilly to determine that shortages had ended, even though patients still had difficulty obtaining the drugs.