Dallas — In a significant legal setback for compounding pharmacies, a U.S. judge has denied their request to continue producing copies of Novo Nordisk’s widely used diabetes and weight-loss medications,Ozempic and Wegovy. The ruling hinges on an ongoing legal dispute concerning alleged drug shortages, according to court records.

The decision by U.S. District Judge Mark Pittman in Texas effectively upholds the Food and Drug Management’s (FDA) determination that the active ingredient in these drugs, semaglutide, is no longer in short supply.Judge Pittman’s legal reasoning remains under seal.

The Lawsuit and Its Implications

The legal battle originated from a February lawsuit filed by a compounding industry group challenging the FDA’s assertion that the semaglutide shortage had ended. This designation had previously allowed compounders to manufacture and distribute copies of Novo Nordisk’s drugs.

• Background: Compounding pharmacies where permitted to produce copies of Ozempic and Wegovy due to reported shortages.
• Impact: Many of these compounded drugs are sold through large telehealth companies, including Hims & Hers.
• Current Status: With the denial of the preliminary injunction, the FDA’s timeline for larger U.S. compounders to exit the market remains in effect, starting in May.

Precedent Set Earlier This Year

This ruling echoes a previous decision by Judge Pittman, who earlier this year refused to allow compounding pharmacies to continue making copies of Eli Lilly’s weight-loss and diabetes drugs, Zepbound and Mounjaro. This consistent stance underscores the court’s deference to the FDA’s regulatory authority in this area.

Industry Response and Ongoing Concerns

Lee Rosebush, chairman of the Outsourcing Facilities Association, the lead plaintiff in the case, expressed disappointment with the court’s decision. He stated that his institution presented evidence of an ongoing semaglutide shortage, gathered after the initial lawsuit filing. Though, the judge declined to consider it, finding that it was filed late.

FDA Enforcement and Compliance Timeline

The FDA has outlined a specific timeline for enforcement. The agency stated it would not take action against compounders before the court’s ruling. Now that the ruling is in place:

• Larger Outsourcing Facilities: These facilities, which produce compounded drugs in bulk and are regulated by the FDA, have untill May 22 to comply.
• Smaller Compounding Pharmacies: These pharmacies, which primarily serve individual patient prescriptions and are overseen by state authorities, must promptly cease making copies of semaglutide.

Official Statements Awaited

As of the time of reporting, neither the FDA nor Novo Nordisk had issued official statements regarding the court’s decision. The industry awaits further clarification on the implications and next steps.