Drug Compounders Challenge FDA Over Semaglutide Supply Decision

Drug compounders have filed a lawsuit against the FDA for removing Novo Nordisk's Wegovy and Ozempic from its shortage list. This decision restricts compounders from selling cheaper versions, despite ongoing drug shortages. The lawsuit claims FDA's decision was arbitrary, impacting those who rely on affordable alternatives.

Drug compounders have taken legal action against the U.S. Food and Drug Administration (FDA) following its decision to remove Novo Nordisk's weight-loss and diabetes medications, Wegovy and Ozempic, from the official shortage list. This removal significantly limits compounders' ability to provide cost-effective alternatives to these medications.

Filed in Fort Worth, Texas, by the Outsourcing Facilities Association and a Texas-based compounding pharmacy, the lawsuit argues that the FDA's conclusion about the supply of semaglutide, the active ingredient in these drugs, was both arbitrary and capricious. Similar legal action was previously taken for Eli Lilly's tirzepatide, with that case still pending.

The lawsuit emphasizes the continued scarcity of these drugs, challenging the FDA's reliance on manufacturers' assurances that they can meet demand. The FDA's decision to lift the shortage warning includes a grace period, but compounders insist shortages persist, affecting patients seeking less expensive options.