FDA Set To Reconsider Ban On Compounded Versions Of Lilly’s Popular Weight Loss Drugs

The U.S. FDA has accepted the reconsideration of its current decision that blocked drug compounders from selling their versions of Eli Lilly's widespread weight loss and diabetes medications. This step came as a reply to a lawsuit filed by the Outsourcing Facilities Association, a group representing the compounding industry. The FDA previously removed the active ingredient, tirzepatide, from the agency’s drug shortage list to stop the compounders from selling versions of Lilly's Zepbound and Mounjaro therapies for weight loss and diabetes, respectively. 

The re-evaluation statement from the FDA allows the compounding pharmacies to proceed with these versions while the agency re-analyses whether there is a shortage of tirzepatide. Compared to brand-name drugs, compounded versions are generally cheaper and more affordable. During the scarcity of drugs, the patients relied on the compounded drug versions since some insurance companies consider tirzepatide for diabetes but not for weight loss.

 Lee Rosebush, Outsourcing Facilities Association Chairman mentioned, “greatly relieved, for our members and the many patients that they serve, that the FDA has agreed to reconsider its decision.”

The scarcity of Eli Lilly’s drugs and opponent drugs like Novo Nordisk's Ozempic has increased demand for compounded alternatives. FDA listed Mounjaro as a drug in short supply since late 2022, with Zepbound added to the list in April. In contrast to generic or brand drugs, compounded medications are made without prior FDA approval. 

Compounded versions of FDA-approved drugs can be sold to fulfill unmet needs if the drug is in short supply; however, if there is a sufficient supply, the production and sale of compounded versions are unrestricted, according to federal rules. Eli Lilly had also taken legal action, sending cease-and-desist letters to companies selling compounded versions of Zepbound and Mounjaro and filing lawsuits against those falsely marketing these products as FDA-approved.