The U.S. Food and Drug Administration has removed Novo Nordisk's popular diabetes and weight loss medications, Ozempic and Wegovy, from its drug shortage list, marking a significant shift in the availability of these crucial treatments. The decision comes after nearly two years of supply constraints, with Wegovy first being listed in March 2022 and Ozempic following in August of the same year.
The FDA's decision has prompted immediate legal action from compounding organizations, highlighting ongoing tensions in the pharmaceutical supply chain. The Outsourcing Facilities Association (OFA) and North American Custom Laboratories (operating as FarmaKeio Superior Custom Compounding) have filed a lawsuit challenging the regulatory body's move.
Legal Challenge Details
The plaintiffs argue that the FDA's decision was made without proper adherence to the Administrative Procedure Act (APA), which requires federal agencies to engage in formal notice-and-comment rulemaking processes. They contend that the removal was "arbitrary, unlawful, and detrimental" to patients who depend on compounded semaglutide for various health conditions.
Adding weight to their argument, the compounding groups point out that Novo Nordisk itself has acknowledged ongoing supply challenges in recent earnings releases, raising questions about the timing and basis of the FDA's decision.
Broader Industry Impact
The controversy extends beyond the immediate shortage status, touching on larger issues of pharmaceutical manufacturing and compounding. In December, Novo Nordisk submitted a Citizen Petition requesting the FDA exclude liraglutide from the 503B Bulks List, which governs substances that compounding facilities can use. The company argues that its FDA-approved products – Victoza, Saxenda, and Xultophy – adequately meet patient needs without requiring compounded alternatives.
Similar Precedent
This situation mirrors a recent case involving Eli Lilly's tirzepatide injection, where the FDA also determined the shortage had been resolved. In that instance, compounding groups similarly contested the decision, arguing it was based solely on manufacturer production capabilities rather than actual market availability.
The dispute has drawn additional attention from major industry players, with Eli Lilly filing a motion to intervene as a defendant in the case against the FDA, demonstrating the significant commercial and regulatory interests at stake in these decisions.
