Federal judge upholds FDA’s decision to remove GLP-1 drugs from shortage list

• On June 18, a federal judge ruled that the Food and Drug Administration (FDA) acted lawfully when it removed semaglutide (Ozempic, Wegovy) from the drug shortage list, effectively ending legal mass compounding of the medication.
•  The Outsourcing Facilities Association (OFA) challenged the FDA’s decision, arguing it was abrupt, harmful to patient access and procedurally improper. The judge dismissed the case with prejudice, citing flawed arguments and misrepresented data from the OFA.
• Judge Mark Pittman found the FDA’s decision was based on legitimate data from Novo Nordisk and an internal review, not requiring public comment. He criticized the OFA for a pattern of factual misinterpretations.
• The FDA has advised pharmacies, telehealth providers and prescribers to urgently develop transition plans for patients relying on compounded semaglutide, as enforcement flexibility will soon end.
• With compounded 503B semaglutide now barred, patients may face access issues. Any continued sales are legally risky and the FDA has reiterated that compounded drugs are only allowed during verified shortages.

A federal judge ruled Wednesday, June 18, that the Food and Drug Administration (FDA) acted lawfully in its decision to remove popular GLP-1 medications from the national drug shortage list, effectively ending the legal sale of compounded versions of the weight loss and diabetes treatments.

In February, the FDA decided to officially remove semaglutide – sold under brand names such as Ozempic and Wegovy – from its drug shortage list. These drugs were previously in short supply, but the FDA determined that the situation improved enough to lift the designation, which had allowed compounding pharmacies to legally produce and sell alternatives. (Related: Ozempic users experiencing sudden blindness; experts warn of serious side effects.)

The Outsourcing Facilities Association (OFA), which represents 503A compounding pharmacies, challenged the action in court. It argued that the removal was abrupt and harmed patient access, citing industry estimates that compounded drugs met 20 percent of GLP-1 demand. The group added that the FDA’s removal of GLP-1 drugs like semaglutide was “arbitrary and capricious” and would limit patient access while driving up drug prices.

U.S. District Court Judge Mark Pittman dismissed the lawsuit. Pittman rejected the claims of the OFA, finding that the FDA’s decision was based on appropriate administrative procedures and that the plaintiffs presented flawed or misleading arguments.

Pittman also claimed the OFA misread the data it cited and introduced evidence, such as a 10-page chart and a survey from telehealth provider Hims and Hers, that had not been part of the FDA’s original review process. He noted that the Hims & Hers survey lacked transparency and reliability, offering no details on sample size or methodology to support claims of limited patient access.

“In cases where such mistakes can be attributed to either an accidental misread or an intentional mischaracterization, the Court prefers to attribute them to accident rather than malice,” Pittman wrote. “However, plaintiffs’ consistent and pervasive pattern of similar mistakes, in this case and OFA I, has made it increasingly difficult for the Court to assume they are the product of accident.”

The ruling dismisses the case with prejudice, meaning OFA cannot bring the same claim again in district court. However, the organization filed a notice of appeal to the U.S. Court of Appeals for the Fifth Circuit, signaling the legal fight may continue.

FDA urges pharmacies and providers to transition patients quickly

GLP-1 receptor agonists like semaglutide and tirzepatide have soared in popularity due to their effectiveness in managing Type 2 diabetes and promoting weight loss. Demand for these drugs has at times outpaced supply, prompting temporary shortages and a boom in the compounding industry.

FDA-approved versions of the drugs are manufactured by pharmaceutical giants such as Novo Nordisk and Eli Lilly, but compounded alternatives often made by smaller pharmacies became more common during the shortage window. The FDA has since reiterated that compounded medications are only permitted when a drug is officially deemed in short supply and must meet strict safety standards.

“As a result of the FDA’s action, community pharmacies, telehealth companies and other providers with a patient population relying on compounded semaglutide injection products will need to develop a transition plan. In its declaratory order, the FDA acknowledged that patients using these compounded products may face gaps in treatment and local shortages could persist.

The FDA’s reasoning for extending the enforcement discretion period was, in part, to enable local pharmacies the opportunity to assess inventory and adjust ordering patterns based on new patterns of patient demand. However, the window of opportunity the FDA describes will not remain open long. As a result, stakeholders prescribing, receiving or dispensing compounded semaglutide injection products need to take immediate action to plan and adapt accordingly.

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Watch Calley Means explaining how Ozempic causes stomach paralysis.

This video is from the Thrivetime Show channel on Brighteon.com.

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Sources include:

Reuters.com

TheHill.com

Brighteon.com