FDA to Reassess Tirzepatide Shortage Status Amidst Compounding Dispute
Key Insights
The FDA will re-evaluate the shortage status of tirzepatide, the active ingredient in Zepbound and Mounjaro, following a lawsuit from compounding pharmacies.
A court ruling allows compounders to continue producing tirzepatide medications while the FDA reviews its earlier declaration that the shortage was resolved.
The Outsourcing Facilities Association argued the FDA's decision to remove tirzepatide from the shortage list was a substantive rule change without proper notice.
The Food and Drug Administration (FDA) has agreed to re-evaluate its stance on the shortage status of tirzepatide, the active ingredient in Eli Lilly's Zepbound and Mounjaro, following legal challenges from compounding pharmacies. This decision comes after the FDA temporarily removed Zepbound and Mounjaro from its agency shortage list, prompting a lawsuit alleging violations of federal law.
A recent ruling in the U.S. District Court for the Northern District of Texas allows manufacturers of compounded tirzepatide versions to continue selling their medications while negotiations between the FDA and the Outsourcing Facilities Association (OFA) proceed. A status report is expected on Nov. 21.
The FDA's initial declaration on October 2 stated that "product availability and manufacturing capacity can meet the present and projected national demand," effectively reinstating restrictions on the mass production of compounded copycats. However, the OFA argued that this decision was a "substantive" rule change that contradicted available evidence, citing ongoing supply chain issues that prevent patients from immediately filling prescriptions.
The lawsuit filed by the OFA contested that the FDA should have provided prior notification of the shortage's end, allowing affected parties to comment. In response, the FDA sought to stay the case but agreed to permit compounders to continue manufacturing tirzepatide while reassessing the shortage situation. This motion was subsequently confirmed by the court.
Impact on GLP-1 Agonist Market
The market for GLP-1 receptor agonists like Zepbound, Mounjaro, and Novo Nordisk’s Wegovy has experienced significant demand, leading to manufacturing shortages and the emergence of compounded alternatives. Eli Lilly and Novo Nordisk have invested billions to increase manufacturing capacity to meet the growing demand, projected to exceed $100 billion annually in the next decade. While the FDA has resolved the shortage of tirzepatide, one formulation of semaglutide, the active ingredient in Novo’s Ozempic and Wegovy, remains in shortage, specifically the low "starter" dose of Wegovy.