Congress authorized the FDA to determine whether a drug is “in shortage in the United States.” The FDA’s determination of a drug shortage triggers mechanisms designed to alleviate the shortage. For example, a determination of drug shortage enables compounding pharmacies to make copies of the drug that is in short supply.
In Outsourcing Facilities Association et al. v. U.S. Food and Drug Administration et al., No. 4:24-cv-00953 (N.D. Tex.), compounding pharmacy plaintiffs argued that the FDA arbitrarily removed Eli Lilly’s weight loss drug tirzepatide from the drug shortage list. The compounding pharmacies sought a preliminary injunction to allow them to produce copies of tirzepatide.
On March 5, 2025, the district court denied the pharmacies’ request for a preliminary injunction. First, the court agreed with the FDA that the decision to remove Eli Lilly’s tirzepatide from the drug shortage list was an “adjudication” under the Administrative Procedure Act, rather than notice-and-comment rulemaking. Accordingly, “the FDA was not required to submit the Delisting Action to notice and comment or publish it in the Federal Registry.” Next, the court found that the FDA’s de-listing decision was reasonable in light of Eli Lilly’s production and inventory data, which showed that Eli Lilly was meeting or exceeding demand for the drug.
The court thus found that the compounding pharmacies are unlikely to succeed on their claims that FDA’s de-listing decision was (1) procedurally improper under the APA and (2) arbitrary and capricious. Accordingly, the court denied the pharmacies’ request for a preliminary injunction.
Editor: Brenden S. Gingrich, Ph.D.
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