A legal battle has erupted following the Food and Drug
Administration’s recent announcement declaring an end to the Wegovy shortage, with drug compounders filing a lawsuit against the agency on Monday. The compounders claim the FDA’s February 21, 2025 decision will negatively impact patient access to crucial treatment options.
The lawsuit, filed by the Outsourcing Facilities Association and North American Custom Laboratories in the Northern District of Texas federal court, challenges the FDA’s directive that will force compounders to cease production of alternative semaglutide versions by April 22 or May 22, depending on their authorization type. This marks the second such legal challenge, following a previous lawsuit regarding Eli Lilly’s tirzepatide, which remains pending in federal court.
The compounders’ legal complaint argues that the FDA’s decision was made without proper advance notification or public comment period. They maintain that a shortage still exists, citing the FDA’s own acknowledgment of possible “intermittent and limited localized supply disruptions” and Novo Nordisk’s statement about continuing “supply constraints.”
The impact of this decision has already affected major market players, including online healthcare provider Hims & Hers, whose stock value has declined by more than 33% since the FDA’s announcement. The company’s CEO, Andrew Dudum, announced plans to advise customers to seek alternative commercial dosing options in the coming months.
Despite the setback, Hims & Hers remains optimistic about its financial outlook. The company, which generated $225 million in revenue from compounded semaglutide and related GLP-1 drugs in 2024, projects total revenue between $2.3 and $2.4 billion for the upcoming year, with $725 million expected from weight loss medications. Their profit forecast ranges from $270 million to $320 million, with plans to maintain growth through legally permitted “personalization” of semaglutide doses.
Meanwhile, Eli Lilly has announced new pricing strategies for its Zepbound medication. The company is reducing prices across various dosage strengths and introducing new dose options. The 2.5 milligram dose will now cost $349 monthly, down from $399, while the 5 milligram dose has been reduced to $499 from $549. New 7.5 and 10 milligram doses will be offered at $499 for initial fills and refills completed within 45 days, representing significant reductions from previous prices of $599 and $699.
The ongoing dispute between compounders and the FDA has been further complicated by both Novo Nordisk and Eli Lilly’s active opposition to compounded versions of their drugs. These pharmaceutical giants have employed various tactics, including legal actions and public communications, to highlight potential risks associated with compounded medications.
The compounders’ lawsuit characterizes the FDA’s decision as “arbitrary, capricious, and contrary to law,” suggesting the agency’s actions favor special interests while potentially increasing drug prices and limiting public access to necessary medications. This legal challenge represents the latest development in an ongoing controversy surrounding the availability and regulation of weight loss and diabetes medications, as pharmaceutical companies, compounders, and regulatory authorities continue to navigate the complex landscape of drug supply and patient access.