The U.S. Food and Drug Administration (FDA) has agreed to reconsider its recent decision to remove tirzepatide, Eli Lilly's type 2 diabetes and weight loss drug, from the drug shortage list. This reversal follows a lawsuit from the Outsourcing Facilities Association, a trade group representing compounding pharmacies, which argued that the decision was premature and lacked due process.
The FDA will now review whether tirzepatide is still in shortage, allowing compounding pharmacies to continue selling cheaper, compounded versions of the drug. This is significant for patients who have relied on these versions due to limited access to the brand-name drugs, Zepbound and Mounjaro, particularly for weight loss treatments not typically covered by insurance.
This reconsideration offers a reprieve for patients and compounding pharmacies as the FDA revisits the tirzepatide supply situation, while Eli Lilly continues to oppose the distribution of compounded versions, taking legal action against several sellers.
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