FDA to Reconsider Ban on Compounded Versions of Lilly's Weight Loss Drug

Key Insights

• The FDA will reconsider its decision to bar drug compounders from selling versions of Eli Lilly's Zepbound and Mounjaro, following a lawsuit by the Outsourcing Facilities Association.
• The agency will allow compounding pharmacies to continue providing compounded tirzepatide while reviewing whether a shortage of the active ingredient exists.
• The initial decision to remove tirzepatide from the FDA's shortage list endangered access to cheaper compounded versions of the drugs for many patients.

The U.S. Food and Drug Administration (FDA) has agreed to reconsider its recent decision to prevent drug compounders from selling their own versions of Eli Lilly's blockbuster weight loss and diabetes drugs, Zepbound and Mounjaro. This decision comes in response to a lawsuit filed by the Outsourcing Facilities Association, an industry group representing compounding pharmacies.

The FDA stated in a court filing that it will now permit compounding pharmacies and facilities to continue providing compounded versions of tirzepatide, the active ingredient in Zepbound and Mounjaro, while it reviews whether a shortage of the drug actually exists. Compounded versions of these drugs are typically more affordable for patients than the brand-name versions.

The Outsourcing Facilities Association filed its lawsuit after the FDA's September 30 decision to remove tirzepatide from its list of drugs experiencing shortages. This action would have effectively cut off access for many patients who rely on compounded versions due to their lower cost, particularly since many insurers do not cover drugs like tirzepatide for weight loss, though they often do for diabetes.

Lee Rosebush, Chairman of the Outsourcing Facilities Association, expressed relief at the FDA's decision to reconsider, stating it was beneficial for both their members and the patients they serve.

Federal regulations permit the sale of compounded versions of an FDA-approved drug to meet demand if the drug is in short supply. However, if no shortage exists, compounded versions cannot be produced regularly or in large quantities. The Outsourcing Facilities Association argued in its lawsuit that the FDA removed tirzepatide from the shortage list despite its continued scarcity.

Eli Lilly has been actively combating the sale of compounded versions of its drugs. In August, the company began sending cease-and-desist letters to telehealth companies, wellness centers, and medical spas selling these versions. Lilly has also filed lawsuits against sellers falsely claiming to offer FDA-approved versions of Mounjaro.

It's noteworthy that the active ingredient in Novo Nordisk's weight loss and diabetes drugs, semaglutide, remains on the FDA's shortage list.