U.S. Judge Upholds FDA's Removal of Eli Lilly Drugs from Shortage List

A U.S. federal judge has upheld the FDA's decision to remove Eli Lilly's weight loss and diabetes drugs, including tirzepatide (Zepbound) and Mounjaro, from the drug shortage list, effectively barring compounding pharmacies from producing cheaper compounded versions. This ruling supports the FDA’s prior declaration that these drugs are no longer in shortage, despite opposition from compounding pharmacies represented by the Outsourcing Facilities Association (OFA), which argued that the FDA based its decision solely on Lilly's statements and that patients still face access difficulties. The judge, Mark Pittman, previously denied requests from compounders to continue producing these drugs while legal challenges proceeded and rejected similar injunctions related to Novo Nordisk’s GLP-1 drugs. The decision impacts patient access to lower-cost alternatives, as compounded versions were allowed only during the official shortage. The OFA criticized the ruling, emphasizing that shortage determinations should rely on verifiable data rather than manufacturer claims. The FDA and Lilly have not publicly responded to the court ruling at this time.