Drug compounding organizations filed a lawsuit against the Food and Drug Administration on Monday, challenging the agency’s recent decision to remove Novo Nordisk’s semaglutide from its shortage list, arguing the move will prevent patients from accessing crucial treatment options.
The legal action, filed in the Northern District of Texas federal court, follows a similar lawsuit regarding Eli Lilly’s tirzepatide, which remains under judicial review. The Outsourcing Facilities Association and North American Custom Laboratories claim the FDA’s February 21 declaration was made without proper advance notification to compounders and lacked opportunity for public input.
The FDA’s decision establishes deadlines of April 22 or May 22 – depending on authorization type – for compounders to cease production of semaglutide versions. The drug is marketed as Wegovy for weight management and Ozempic for diabetes treatment.
Compounders contest that a shortage persists, citing the FDA’s own acknowledgment of possible “intermittent and limited localized supply disruptions” and Novo’s admission of continuing “supply constraints.” The lawsuit characterizes the FDA’s action as favoring special interests while potentially increasing drug costs and limiting public access.
Major online healthcare provider Hims & Hers, which generated $225 million from compounded semaglutide and related GLP-1 drugs in 2024, announced plans to comply with the FDA’s directive. CEO Andrew Dudum informed analysts that customers will be advised to seek “alternative options on the commercial dosing” in coming months. The company’s stock value has declined by more than 33% since the FDA’s
announcement.
Despite this setback, Hims & Hers projects $725 million in weight loss drug revenue as part of an anticipated $2.3-2.4 billion total revenue for the year, with projected profits between $270-320 million. The company plans to maintain growth through legally permitted
“personalization” of semaglutide doses to help manage side effects and improve patient adherence.
Meanwhile, both Novo Nordisk and Eli Lilly have actively opposed compounding through legal measures and public communications highlighting potential risks of compounded medications.
In a separate development, Lilly announced Tuesday new pricing strategies for its self-pay program, including reduced costs for Zepbound doses and additional dosage options. The company decreased the monthly price of its 2.5-milligram dose from $399 to $349 and its 5-milligram dose from $549 to $499. New 7.5 and 10-milligram doses will be offered at $499 monthly for initial prescriptions and refills completed within 45 days, down from previous prices of $599 and $699 respectively. These medications will be supplied in vials rather than standard autoinjectors.
The legal dispute highlights ongoing tensions between traditional pharmaceutical manufacturers and compounding facilities over access to popular weight loss and diabetes medications. Compounders argue the FDA’s decision was “arbitrary, capricious, and contrary to law,” while pharmaceutical companies maintain concerns about compounded versions of their products. The outcome of this legal challenge could significantly impact patient access to these medications and shape the future landscape of drug compounding practices in the United States.
The situation continues to evolve as companies adapt their strategies, with Hims & Hers pursuing alternative revenue streams and Lilly implementing new pricing structures to maintain market position in the competitive weight loss drug sector.