The Outsourcing Facilities Association (OFA) and Texas-based FarmaKeio Custom Compounding have filed a lawsuit against the FDA over its decision to remove Novo Nordisk’s semaglutide products—Ozempic and Wegovy—from the drug shortage list. The complaint, filed in the U.S. District Court for the Northern District of Texas, argues that the agency’s ruling is arbitrary and disregards ongoing supply constraints.
The FDA’s move, announced last week, effectively limits the ability of compounders to produce lower-cost versions of semaglutide, which has seen skyrocketing demand for diabetes and obesity treatment. Under U.S. regulations, compounding pharmacies can only manufacture alternative formulations of FDA-approved drugs when the original products are in short supply.
The OFA claims that the FDA’s decision benefits pharmaceutical manufacturers while depriving patients of affordable treatment options. Citing continued supply challenges, the lawsuit alleges that Novo Nordisk itself acknowledged ongoing “supply constraints” in recent SEC filings. The compounders argue that patients still struggle to access the branded versions, making the FDA’s declaration premature.
This legal action follows a similar lawsuit the OFA filed last year after the FDA removed Eli Lilly’s tirzepatide (Mounjaro, Zepbound) from the shortage list. That case remains unresolved. The FDA has given compounders 60 to 90 days to halt semaglutide production, a move expected to push many patients back toward higher-cost branded medications.
Meanwhile, industry reactions remain divided. The Alliance for Pharmacy Compounding (APC) has accepted the FDA’s ruling, while telehealth companies like Hims & Hers have announced plans to discontinue compounded semaglutide sales by the end of the first quarter.
Novo Nordisk’s stock surged 10% following the FDA’s decision, while Hims & Hers’ stock dropped 27% after announcing it would cease compounded semaglutide sales.
The lawsuit is the latest escalation in the ongoing battle between pharmaceutical manufacturers and compounding pharmacies over access to GLP-1 medications.
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LinkedIn Commentary: Accessible Evidence-Based Treatments
Florencia Halperin, Chief Medical Officer at Form Health, emphasized the importance of accessible, evidence-based treatments:
"If Americans had reliable access to safe, effective, evidence-based care for their metabolic disease, then they would not need to turn to cash pay options that lack clinical trial testing."
Dr. Halperin also highlighted concerns about the potential for companies to exploit regulatory loopholes, stating that some are marketing their products as "personalized treatments" without proper medical evaluations. She expressed hope that the FDA will enforce its mandates to protect public health.
Edward C. La Cava, MD, FACE, Chair of the Executive Board of Directors at Pacific Diabetes Technologies Inc, voiced support for making evidence-based treatments more accessible:
"This is something we can all get behind, the best products, evidenced based, available for those who would need the most."
Dr. La Cava noted that recent price reductions are a positive step toward increasing accessibility to high-demand GLP-1 receptor agonists and related pharmaceuticals.
These insights demonstrate the ongoing need to balance regulatory actions with patient access to safe and effective treatments for metabolic diseases.
