Eli Lilly is intervening in a lawsuit filed by a trade group representing compounding pharmacies, aiming to block the FDA's determination that the shortage of its GLP-1 medications, Mounjaro and Zepbound, has ended.
Here are four things to know:
- Eli Lilly is joining in a lawsuit filed by the Outsourcing Facilities against the FDA, aiming to reverse the FDA's October 2024 determination that the shortage has been resolved, which would allow compounding pharmacies to continue selling unapproved versions of the drugs, according to court documents obtained by Becker's.
- Mounjaro and Zepbound, both containing the drug tirzepatide, are exclusive to Eli Lilly but were temporarily added to the FDA's drug shortage list due to overwhelming demand. During the shortage, some 503B compounding pharmacies began manufacturing and marketing knockoff versions of the medications, according to the Jan. 1 motion.
- Eli Lilly has invested billions of dollars in the development and manufacturing of the drugs, with the company emphasizing its commitment to meeting demand through increased production capacity, The Hill reported Jan. 2. Eli Lilly's $23 billion investment in manufacturing expansion aims to ensure that drugs remain available in sufficient quantities, negating justification of compounded alternatives. The company argued in the motion that these investments allow it to meet market demand, making the shortage no longer an issue.
- The FDA has repeatedly warned against the use of compounded versions of GLP-1 medications, citing significant safety concerns. Despite these warnings, compounding pharmacies have continued to produce and distribute the unapproved versions of the drugs. As of December 2024, the FDA reaffirmed that the shortage is over, rejecting evidence from compounding pharmacies.