GLP-1 Drugs: FDA Sued Over Removing Tirzepatide from the Drug Shortage List

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 Takeaways. This unexpected development where FDA is reevaluating its position with respect to removing a product from the drug shortage list is a major backtrack from FDA’s prior position and likely suggests that this issue (whether the product is or is not in short supply) will remain unresolved until perhaps the end of the year or even later. No one in the past has legally challenged FDA’s procedure for removing a product from the drug shortage list. However, the price of the product has not been a consideration when FDA removes a product from the drug shortage list. While it is unclear what Lilly will do in light of this development, we expect some if not most compounders will see this as an opportunity for at least temporarily continuing to compound tirzepatide.

Foley will continue to monitor these developments. Foley is here to help you address the short and long-term impacts in the wake of regulatory changes. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out to the authors, your Foley relationship partner, or to our Health Care Practice Group and Health Care & Life Sciences Sector with any questions.