Eli Lilly’s State Law Attempt to Halt Florida Compounding Pharmacy’s Tirzepatide Sales Dismissed

- Eli Lilly and Company (LLY) suffered a legal loss in their attempt to obstruct RXCompoundStore.com from marketing its version of the drug tirzepatide, which Eli Lilly markets as Mounjaro for diabetes and Zepbound for weight loss.
- U.S. District Court Judge Roy Altman dismissed the case, stating that Eli Lilly was perceived as attempting to circumvent federal law by using state law to enforce the provisions of the FDCA.
- The court asserted that the FDCA and its regulations grant the United States with nearly exclusive enforcement authority, and courts typically refrain from infringing on this authority by adjudicating claims concerning FDCA compliance.
- Eli Lilly had previously disclosed legal actions against ten entities in the U.S., including medical spas, wellness centers, and compounding pharmacies, for selling unauthorized, less expensive versions of Mounjaro in September 2023.
- Eli Lilly identified bacteria and elevated impurity levels in products falsely advertised as compounded versions of tirzepatide in March 2024.
- Novo Nordisk A/S (NVO), a competitor of Eli Lilly, had also taken legal action against compounding pharmacies and wellness clinics for selling altered versions of semaglutide.
- The court's decision highlights the principle that only the federal government, represented by the FDA, has the authority to enforce the FDCA.