UPDATE: FDA to reconsider tirzepatide shortage decision in response to litigation from Industry

On October 7, 2024, the Outsourcing Facilities Association (OFA) filed litigation against FDA in the Northern District of Texas challenging FDA’s decision to remove Eli Lilly’s GLP-1 weight loss drug, tirzepatide, from FDA’s shortage list. As reported in a previous blog post, on October 2, 2024, FDA removed Lilly’s tirzepatide from FDA’s drug shortage list, and also issued a release the same day reminding compounding pharmacies and outsourcing facilities of limitations on continuing to accept prescriptions or orders for a drug removed from the drug shortage list. In response, the Outsourcing Facilities Association sued FDA and filed an Emergency Motion for Temporary Restraining Order and Preliminary Injunction. Instead of facing a hearing that had been scheduled for Tuesday, October 15, FDA requested a voluntary stay with remand to FDA for the agency to reconsider its decision to remove tirzepatide from the drug shortage list. FDA promised not to take enforcement action against members of the Outsourcing Facilities Association until two weeks after FDA’s decision on reconsideration or after a ruling on motion for preliminary injunction, whichever is longer.

In Court filings, FDA does not specifically address allegations in the complaint that FDA failed to comply with notice-and-comment requirements under the Administrative Procedures Act before making the decision to remove tirzepatide from the drug shortage list. FDA commits to reconsidering its decision to remove tirzepatide form the shortage list, but does not yet address how that reconsideration will be undertaken. In the short term, it appears outsourcing facilities (and presumably compounders) will be able to continue to accept prescriptions or orders for tirzepatide at least until FDA issues a decision after reconsideration. A looming underlying issue will be whether FDA agrees to follow notice-and-comment procedures with input from industry in its reconsideration, or whether FDA makes a reconsideration decision on its own without benefit for industry of notice and comment.