Unreported / Non-Citable
Background
Ozempic and Wegovy are Novo Nordisk’s FDA-approved semaglutide injection products for treating type-2 diabetes and obesity. The FDA placed the drugs on its shortage list in 2022, temporarily allowing qualifying pharmacies and outsourcing facilities to compound versions that otherwise could be prohibited as essentially copies of approved drugs.
In February 2025, after reviewing supply, inventory, demand, wholesaler, and other information, the FDA determined that the semaglutide injection shortage had resolved and removed the drugs from the list. Two compounders sued under the Administrative Procedure Act, arguing that the FDA unlawfully bypassed notice-and-comment rulemaking and acted arbitrarily and capriciously. The district court granted summary judgment to the FDA and intervenor Novo Nordisk.
The Court’s Holding
The Fifth Circuit affirmed. Without deciding whether the delisting action legally required notice-and-comment rulemaking, the court held that any procedural error was harmless. The compounders had actual notice that the FDA was monitoring semaglutide availability, submitted at least 34 comments over more than three months, and failed to identify additional information they would have supplied through formal notice and comment. The FDA also delayed enforcement for 60 or 90 days, depending on the type of compounder.
The court further held that the delisting action was not arbitrary or capricious. The FDA reasonably evaluated recent and projected supply-and-demand data, inventory and wholesaler information, dosage-specific ordering patterns, and expected demand from patients transitioning away from compounded products. It also reasonably found Novo Nordisk’s business data more probative than pharmacy screenshots, individual access reports, articles, and other submissions whose timing, scope, or connection to particular products and dosages was uncertain.
Key Takeaways
- The court did not decide whether the FDA’s drug-shortage delisting was rulemaking or adjudication, or whether notice and comment was legally required.
- Any assumed APA procedural error was harmless because the compounders had actual notice, repeatedly submitted information, and showed no prejudice from the absence of formal procedures.
- The FDA rationally concluded that Ozempic and Wegovy supply met or exceeded demand and adequately explained why contrary evidence was less probative.
Why It Matters
The decision preserves the FDA’s removal of Ozempic and Wegovy from the shortage list, thereby restoring the statutory restrictions on compounding products that are essentially copies of those approved drugs, subject to applicable federal requirements.
More broadly, the opinion shows that an APA notice-and-comment challenge may fail on harmless-error grounds when affected parties had actual notice, meaningfully participated, and cannot identify information or arguments that formal procedures would have added. It also illustrates the substantial latitude agencies retain when weighing conflicting technical evidence under arbitrary-and-capricious review.