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 Wegovy on its drug-shortage list in March 2022 and Ozempic on the list in August 2022. While the products remained listed, qualifying pharmacies and outsourcing facilities could compound semaglutide products without certain statutory restrictions that ordinarily prohibit compounding drugs that are essentially copies of approved products.
In February 2025, after reviewing supply, inventory, demand, and other information from Novo Nordisk, compounders, telehealth companies, industry groups, and individuals, the FDA determined that the semaglutide injection shortage had resolved and removed Ozempic and Wegovy from the list. The Outsourcing Facilities Association and FarmaKeio challenged that delisting under the Administrative Procedure Act, arguing that the FDA was required to use notice-and-comment rulemaking and that its decision was arbitrary and capricious. 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. Without deciding whether the FDA was required to proceed through notice-and-comment rulemaking, the court held that any procedural error was harmless. The compounders had actual notice that the FDA was monitoring the semaglutide shortage, submitted at least 34 comments over more than three months, and did not identify additional information they would have provided through a formal notice-and-comment process. The FDA also delayed enforcement for 60 or 90 days, depending on the type of compounder.
The court also held that the delisting was not arbitrary or capricious. The FDA examined recent and projected supply-and-demand data, explained its reliance on Novo Nordisk’s inventory and distribution information, considered the expected transition from compounded products, and reasonably found anecdotal reports and pharmacy screenshots less probative than Novo Nordisk’s more specific and current business data. The record supplied a rational connection between the evidence and the FDA’s conclusion that Novo Nordisk could meet or exceed demand for Ozempic and Wegovy.
Key Takeaways
- The court left unresolved whether removing drugs from the FDA shortage list required notice-and-comment rulemaking because any procedural error was harmless on this record.
- Actual notice, extensive opportunities to submit information, and the failure to identify omitted arguments defeated the compounders’ claim of prejudice.
- The FDA reasonably relied on manufacturer supply, inventory, wholesaler, and projected-demand data while discounting less specific anecdotal evidence of localized access problems.
Why It Matters
The decision preserves the FDA’s removal of Ozempic and Wegovy from the drug-shortage list, restoring the federal restrictions on compounding products that are essentially copies of those approved drugs, subject to the agency’s transition periods and applicable statutory exceptions.
The opinion also demonstrates that an APA procedural challenge may fail as harmless when affected parties had actual notice and a meaningful opportunity to present evidence, even if the court does not decide whether the agency selected the correct procedural mechanism.