Compounders Sue FDA Over Removal of Semaglutide from Drug Shortage List
The Outsourcing Facilities Association (OFA), a trade group representing drug compounders, filed a lawsuit against the FDA on February 25, 202513.
The lawsuit challenges the FDA's decision to remove semaglutide (Ozempic/Wegovy) from its drug shortage list on February 21, 202524.
The OFA claims the FDA's decision was "reckless and arbitrary" and will deprive patients of vital treatment for type 2 diabetes, obesity, and other conditions13.
The FDA's removal of semaglutide from the shortage list means compounders will no longer be legally permitted to manufacture and distribute their own versions of the drug4.
The FDA has provided a grace period for compounders to comply:
pharmacies have until April and outsourcing facilities until May to stop production4.
This lawsuit follows a similar case filed by the OFA in October 2024 regarding the removal of tirzepatide (Mounjaro/Zepbound) from the shortage list13.
Novo Nordisk, the manufacturer of Ozempic and Wegovy, stated that it is now shipping all doses regularly to meet demand2.
The FDA's decision comes after Novo Nordisk made significant investments to increase its manufacturing capacity4.
The lawsuit alleges that the FDA dismissed evidence of ongoing shortages and made its decision without proper notice-and-comment rulemaking13.
The compounders are asking the court to vacate the FDA's decision and prevent enforcement actions against OFA members for compounding semaglutide1.
Sources:
1. https://www.biospace.com/policy/compounders-sue-fda-for-declaring-ozempic-wegovy-shortage-over
2. https://www.healio.com/news/endocrinology/20250221/fda-removes-semaglutide-from-drug-shortage-list
3. https://www.pharmamanufacturing.com/industry-news/news/55270467/drug-compounders-sue-fda-for-removing-novo-nordisks-ozempic-wegovy-from-shortage-list
4. https://www.pharmaceutical-technology.com/news/semaglutide-shortage-ends-as-fda-sets-deadline-for-compounders/