Background
Ozempic and Wegovy are Novo Nordisk’s FDA-approved semaglutide injection products for treating type-2 diabetes and obesity. The FDA placed Wegovy on its drug-shortage list in March 2022 and Ozempic on the list in August 2022. That designation allowed qualifying pharmacies and outsourcing facilities temporarily to compound semaglutide products despite statutory restrictions on compounding products that are 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 Ozempic and Wegovy from the list. The Outsourcing Facilities Association and a compounding business challenged that action under the Administrative Procedure Act, arguing that the FDA unlawfully avoided notice-and-comment rulemaking and acted arbitrarily and capriciously. The district court entered summary judgment for the FDA and intervenor Novo Nordisk, and the compounders appealed.
The Court’s Holding
The Fifth Circuit affirmed. It did not decide whether the FDA was required to use notice-and-comment procedures, whether the delisting was properly characterized as rulemaking or adjudication, or how much deference was owed to the FDA’s characterization of its action. Instead, the court held that any procedural error was harmless because the compounders had actual notice, submitted at least 34 comments over more than three months, received a 60- or 90-day transition period, and identified no additional information they would have submitted through formal notice and comment.
The court also held that the delisting was not arbitrary or capricious. The FDA reasonably relied on recent and projected supply-and-demand data, explained its inventory and demand measures, accounted for wholesaler overordering and transitional demand from compounded products, and recognized limitations in the available evidence. It also reasonably found Novo Nordisk’s detailed business data more probative than pharmacy screenshots, patient reports, articles, and blog posts that often lacked dates, dosage information, duration, or other context.
Key Takeaways
- The court left unresolved whether removing drugs from the FDA shortage list required notice-and-comment rulemaking.
- Any procedural error was harmless because the challengers had actual notice, ample opportunity to submit information, and failed to show prejudice.
- The FDA rationally connected the administrative record to its conclusion that Novo Nordisk’s supply of Ozempic and Wegovy met or exceeded current and projected demand.
Why It Matters
The decision preserves the FDA’s February 2025 determination that the semaglutide injection shortage had ended, thereby restoring federal restrictions on routinely compounding products that are essentially copies of Ozempic and Wegovy, subject to the transition periods the agency provided.
The opinion also illustrates the difficulty of overturning agency action based on an alleged notice-and-comment violation when affected parties had actual notice, submitted extensive materials, and cannot identify what formal procedures would have added. At the same time, because the court resolved the procedural challenge through harmless-error review, it did not settle whether future drug-shortage delistings must undergo notice and comment.