Unreported / Non-Citable
Background
Mounjaro and Zepbound are Eli Lilly’s FDA-approved tirzepatide injection products for treating type-2 diabetes, obesity, and related conditions. After the FDA placed the products on its drug-shortage list, qualifying pharmacies and outsourcing facilities could compound tirzepatide products without ordinarily applicable restrictions on making copies of approved drugs.
The FDA announced in October 2024 that the shortage had ended, then reconsidered that decision during a voluntary remand. In December 2024, the agency issued a declaratory order confirming that Eli Lilly’s expanded capacity could meet or exceed projected demand. Two organizations representing compounders sued, arguing that the FDA improperly bypassed notice-and-comment rulemaking and that its shortage determination was arbitrary and capricious. The district court granted summary judgment to the FDA and intervenor Eli Lilly.
The Court’s Holding
The Fifth Circuit affirmed. It assumed without deciding that the FDA should have used notice-and-comment procedures but held that any procedural error was harmless because the compounders failed to show prejudice. They had actual notice of the FDA’s reconsideration, submitted information, and did not identify additional material that formal notice or a longer comment period would have produced. Patients, providers, pharmacies, and other interested parties also submitted information during the nearly 60-day reconsideration period.
The court also held that the delisting decision was not arbitrary or capricious. The FDA reasonably considered recent and projected supply-and-demand data, inventory, production capacity, distribution-channel supply, and newly approved vial forms. It explained why it credited Eli Lilly’s data over screenshots, surveys, news reports, form comments, and other contrary evidence that it found anecdotal, insufficiently specific, or affected by distribution, insurance, and pharmacy-level issues.
Key Takeaways
- The court did not decide whether removing tirzepatide products from the shortage list required notice-and-comment rulemaking; it resolved that challenge on harmless-error grounds.
- An APA challenger alleging deficient notice and comment must demonstrate prejudice, such as material information that a proper process likely would have placed before the agency.
- The FDA reasonably concluded that Eli Lilly’s tirzepatide supply would meet or exceed projected demand and adequately explained its treatment of competing evidence.
Why It Matters
The ruling leaves intact the FDA’s determination that the tirzepatide shortage was resolved, restoring the statutory restrictions on compounding products that are essentially copies of Mounjaro and Zepbound. It also illustrates that extensive actual participation in an agency’s decision-making process may make a potential notice-and-comment violation harmless when challengers cannot identify resulting prejudice.