A Texas judge denied a motion from compounders to keep making versions of Ozempic and Wegovy, clearing the way for FDA enforcement and other lawsuits.
A federal court in Texas has ruled against a trade group representing compounding pharmacies, siding with the Food and Drug Administration (FDA) and pharmaceutical company Novo Nordisk in a dispute over copies of the popular weight-loss and diabetes drugs Ozempic and Wegovy.
The ruling, issued April 24 in the U.S. District Court for the Northern District of Texas, denied a request from the Outsourcing Facilities Association (OFA) to block the FDA’s recent decision to remove semaglutide from its drug shortage list.
That decision effectively ended a temporary allowance for pharmacies to compound semaglutide-based drugs for patients. Semaglutide is the active ingredient in Ozempic and Wegovy. Court documents remain sealed, but the outcome was confirmed by two related parties from a Novo Nordisk statement and an OFA statement.
According to a KFF study last year, one in eight adults say they have taken one of the drugs before, and as many as four in 10 of those who have been told by a doctor they have diabetes have taken it.
Without the shortage designation, pharmacies may no longer produce compounded versions of semaglutide except in rare circumstances. Smaller 503A pharmacies must stop immediately, while larger outsourcing facilities have until May 22 before facing FDA enforcement.
The FDA said in February that it had “determined the shortage of semaglutide injection products, a glucagon-like peptide 1 (GLP-1) medication, is resolved,” adding that it had been in shortage since 2022 due to “increased demand.”
Several other lawsuits regarding another popular weight loss medication called tirzepatide [brand name Zepbound and Mounjaro] are also ongoing, as its manufacturer, Eli Lilly, has taken a similar legal approach as Novo Nordisk. The FDA declared that the drug’s shortage was resolved in December.
In an emailed statement to The Epoch Times on Friday, the Outsourcing Facilities Association said it was “deeply disappointed” by the court’s decision.
By Chase Smith
