Eli Lilly, maker of popular diabetes medications Mounjaro and Zepbound, is taking legal action against the US Food and Drug Administration (FDA) over a rule change that allows compounding pharmacies to continue producing counterfeit versions of its drugs.
Lilly filed a motion to intervene in a lawsuit brought by the Outsourcing Facilities Association (OFA) and compounder FarmaKeio Custom Compounding. The OFA claims the FDA’s decision to formally declare the shortage of Lilly’s dual GIP/GLP-1 meds resolved was “reckless and arbitrary.”
However, Lilly argues that compounding pharmacies producing knock-off versions of its medications are not subject to the same safety and quality standards as branded medicines. The company warns that this could pose significant patient safety risks.
Lilly is seeking to protect its investment in manufacturing and help bring an end to the lawsuit. The company’s lawyers claim that the OFA’s position challenges the integrity of the FDA’s regulatory framework and directly affects Lilly’s exclusive right to sell its FDA-approved medicines.
The move comes as multiple other compounding outfits and organizations have protested the FDA’s decision to formally declare the US tirzepatide shortage resolved. Novo Nordisk, a rival company to Mounjaro and Zepbound, is also struggling to keep up with demand for its GLP-1 rivals.
Source: https://www.fiercepharma.com/pharma/lilly-looks-wade-legal-fracas-between-fda-and-compounders-following-end-tirzepatide-shortage