FDA Reconsiders Tirzepatide Shortage Status, Allowing Continued Access to Compounded Versions

Reevaluation of Shortage Status:
The FDA is reconsidering its decision to remove tirzepatide, a type 2 diabetes and weight loss medication, from its drug shortage list. This decision comes after a federal court granted the FDA's request for a voluntary remand and stay in a lawsuit challenging the removal.

Continued Access to Compounded Versions:
During the review period, compounding pharmacies will be allowed to continue selling their own versions of tirzepatide, ensuring that patients have access to the medication.

Legal Background:
The Outsourcing Facilities Association, a trade group for FDA-registered compounding pharmacies, filed a lawsuit arguing that the FDA's decision to end the shortage was "reckless" and "arbitrary," and lacked proper legal process.

Previous Shortage Resolution:
The FDA had previously declared the tirzepatide shortage resolved on October 2, 2024, stating that the drug's manufacturer, Eli Lilly, had sufficient supply to meet national demand.

Impact on Patients:
The reconsideration ensures temporary relief for patients and healthcare providers who rely on compounded tirzepatide, as pharmacies can continue filling prescriptions without facing immediate enforcement actions from the FDA.

Future Developments:
The FDA will submit a joint status report by November 21, 2024, updating the court on its progress, which will provide more clarity on the final decision and its impact on patients and healthcare providers.