Another legal battle between OFA and FDA
On February 24, 2025, the Outsourcing Facilities Association, a compounding group, filed a new lawsuit against the Food and Drug Administration.
This lawsuit came in response to the FDA's recent removal of semaglutide injections from its drug shortage list. Semaglutide, the active ingredient in popular weight loss drugs Wegovy and Ozempic, has been on the FDA's drug shortage list since 2022. Since then, compounders have been able to manufacture and sell generic versions of the drug while it has been in short supply.
This, of course, is not the only ongoing lawsuit between the OFA and FDA. In October 2024, the OFA sued the FDA when it removed tirzepatide from the drug shortage list. Tirzepatide is another popular GLP-1 and the active ingredient in Mounjaro and Zepbound.
OFA Challenges Major Manufacturers Along with FDA
The FDA’s decision to resolve the semaglutide shortage, announced unexpectedly on Friday, February 21, 2025, caught many by surprise. Especially given the heightened attention surrounding OFA’s ongoing litigation with the FDA and Eli Lilly.
Eli Lilly joined the FDA as a co-defendant in the OFA's first lawsuit against the FDA on New Year’s Day 2025. Novo Nordisk, the pharmaceutical company behind Ozempic and Wegovy, had previously remained silent during the proceedings regarding tirzepatide.
Last week, Novo Nordisk entered the legal fray by filing an amicus brief supporting the defendants. In hindsight, the company’s amicus filing may have been a strategic move anticipating the FDA’s decision and the subsequent legal challenges.
The case has been assigned to Judge Reed O’Connor of the U.S. District Court for the Northern District of Texas. The OFA alleges that the FDA's actions violate the Administrative Procedure Act (APA).
Stay tuned for a breakdown of the legal arguments.