Legal Battle Over Semaglutide Supply: Compounders vs FDA

Compounders have filed a lawsuit against the FDA challenging its decision to remove Novo Nordisk's Wegovy and Ozempic from the shortage list. The lawsuit claims the FDA's actions are arbitrary, impacting the sale of cheaper compounded versions. A previous lawsuit concerned Eli Lilly's similar drugs.

Drug compounders are taking legal action against the U.S. Food and Drug Administration, contesting the agency's recent decision to exclude Novo Nordisk's Wegovy and Ozempic from its drug shortage list.

This legal move, initiated by the Outsourcing Facilities Association and others in a Fort Worth, Texas federal court, argues that the FDA's ruling, which states no existing shortage of the active ingredient semaglutide, is deemed arbitrary and lacks justification.

The legal precedent is rooted in a similar lawsuit filed last year concerning Eli Lilly's products. Current U.S. regulations permit compounding pharmacies to replicate medications experiencing short supply, providing options for those unable to afford brand-name alternatives.

(With inputs from agencies.)