Less than a week after the U.S. Food & Drug Administration (FDA) determined that the shortage of the tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been “resolved” and removed from the FDA’s shortage list, see our prior blog “ GLP-1 Drugs: FDA Removes Lilly’s Zepbound® and Mounjaro® (tirzepatide injection) from its Drug Shortage List ,” on October 8, 2024, the Outsourcing Facilities Association (OFA) – a trade association representing FDA-registered 503B outsourcing facilities – filed a lawsuit against the FDA relating to the agency’s removal of tirzepatide, from the FDA’s drug shortage list.
OFA’s lawsuit, filed in the U.S. District Court for the Northern District of Texas, seeks a determination that the FDA’s action was contrary to law and to have it vacated immediately.
OFA is also seeking a temporary restraining order (TRO) that would enjoin FDA from taking action against OFA’s members for making compounded versions of tirzepatide during the pendency of the lawsuit. On Friday, October 11th FDA filed an unopposed motion for voluntary remand and stay, stating that FDA wanted to “reevaluate the challenged decision” and canceling the hearing scheduled for October 15, 2024. FDA further stated that it would not take enforcement action against plaintiffs and its members while it reevaluated the decision and for two weeks beyond this period.
FDA proposed that a Joint Status report be scheduled for November 21, 2024. Key Ta.