Federal judge rules for FDA and Novo on the merits in the semaglutide shortage case

A federal district court ruled in favor of the Food and Drug Administration and Novo Nordisk in the lawsuit challenging the agency's decision to declare the semaglutide shortage over. The decision, entered June 13, 2025 and unsealed June 17, 2025, upheld the FDA's determination on the merits, which meant semaglutide would not go back on the shortage list — the legal trigger that had allowed compounders to make copies of the drug.

The case was brought by the Outsourcing Facilities Association (OFA), a group representing compounding pharmacies, which sued the FDA after the agency declared the semaglutide and tirzepatide shortages resolved. OFA argued the agency was "abruptly depriving patients of much needed treatment and artificially raising drug prices" ^[1].

The district court's ruling was not the last word. On August 27, 2025, the U.S. Court of Appeals for the Fifth Circuit affirmed the FDA's decision to remove semaglutide from its drug shortage list as lawful and correct, in a decision that also applies to the agency's action removing tirzepatide ^[1].

What the courts decided

OFA's main arguments were that the FDA ignored evidence that shortages were continuing, and that the agency did not give compounders reasonable notice of the planned determinations or a chance to comment ^[1]. The appeals court reviewed the evidence and rejected those arguments, concluding that the FDA "followed the statutory framework, applying the statutory definition of shortage to the evidence before it" ^[1].

The court also endorsed the FDA's methodology and its reliance on actual supply data from the manufacturers. It found that pharmacy screenshots, patient reports, articles, blog posts and form letters submitted by compounders were less probative than "more specific, reliable, comprehensive, and current" data coming from the manufacturer ^[1].

That matters because of how the law works. Under the framework dating to the Food and Drug Administration Modernization Act, compounders may produce temporary versions of a commercially available drug during a shortage, but continued mass production and sale of compounded versions becomes illegal once the shortage ends ^[1].

The scale of the business at stake was large. In 2024, compounded versions accounted for an estimated 30% of the overall GLP-1 weight-loss market, according to the National Consumers League, which welcomed the appellate ruling ^[1]. Compounded GLP-1s became big business for compounding pharmacies and direct-to-consumer telehealth platforms while the branded drugs were in short supply ^[1].

The specific reasoning in the June district court opinion, the name of the judge, and the exact deadlines the FDA set for compounders to stop producing semaglutide copies are not described in the sources available here.

Why it matters for patients

For people who were getting compounded semaglutide through a telehealth platform or a compounding pharmacy, the practical effect of these rulings is that the shortage-based legal pathway for those copies is closed. Semaglutide is sold in the U.S. as Ozempic and Rybelsus for type 2 diabetes and Wegovy for weight management; tirzepatide is sold as Mounjaro and Zepbound. The court decisions do not change how those FDA-approved products are prescribed or covered.

The rulings also settle a question that had been genuinely unclear for months: whether a court would second-guess the FDA's call on when a shortage ends. The Fifth Circuit said the agency's approach — leaning on manufacturer supply data rather than anecdotal reports — was the right one ^[1].

Cost is the piece the sources do not resolve. OFA claimed that ending the shortage designation would raise prices for patients ^[1], and the courts did not address whether that has happened. Nothing in the sources describes what patients who were using compounded versions are now paying or using instead.

What happens next

• June 13, 2025: District court rules for the FDA and Novo Nordisk on the merits; the decision is unsealed June 17, 2025.
• August 27, 2025: The Fifth Circuit affirms the FDA's removal of semaglutide from the shortage list, in a decision that also covers tirzepatide ^[1].

Whether OFA will seek further review is not stated in the sources. The National Consumers League framed the Fifth Circuit ruling as "a line in the sand for policymakers and compounders" at a time of growing concern over how compounded drugs are regulated ^[1].