A lawsuit has been filed by the Outsourcing Facilities Association (OFA) against the U.S. Food and Drug Administration (FDA) over its decision to remove semaglutide, the active ingredient in Novo Nordisk’s Ozempic and Wegovy, from its drug shortage list. Semaglutide has been on the list since March 2022, allowing pharmacies and healthcare providers to produce and sell compounded versions of the drug due to high demand and supply constraints.
The OFA claims that the FDA is ignoring evidence that the shortage persists, which will deprive patients of a vital treatment for type 2 diabetes, obesity, and other conditions. Semaglutide belongs to a class of drugs known as GLP-1s, which have become highly sought after for their weight loss effects, contributing to the soaring sales of Novo Nordisk and its rival Eli Lilly.
Background on Compounding
Compounding involves customizing approved drugs to fit individual patient needs. Typically, the Food, Drug, and Cosmetic Act prohibits compounding drugs that are copies of commercially available medications. However, during shortages, the FDA allows compounding as these drugs are not considered commercially available.
FDA’s Decision and Its Impact
The FDA has determined that the semaglutide shortage is resolved, citing Novo Nordisk’s increased manufacturing capacity and regular shipments to wholesalers. As a result, compounders must stop producing semaglutide by specific deadlines: April 22 for state-licensed pharmacies and May 22 for outsourcing facilities.
Not all compounders are challenging the FDA’s decision. The Alliance for Pharmacy Compounding has accepted the agency’s move, thanking them for providing an “off-ramp” to halt production.
This lawsuit is the second filed by the OFA against the FDA over compounded weight-loss drugs, following a similar suit in October regarding tirzepatide, the active ingredient in Eli Lilly’s Zepbound. The ongoing legal battle highlights tensions between the FDA, pharmaceutical companies, and compounders over access to these highly sought-after medications.
