National Consumers League Welcomes the Appeals Court Ruling Backing FDA’s Decision to Remove GLP-1 Drugs from the Shortage List
Media Contact: Lisa McDonald, Vice President of Communications, 202-207-2829
Washington, DC – As an organization focused on the safety of GLP-1 weight loss drugs, the National Consumers League welcomes the August 27 ruling by the US Court of Appeals for the Fifth Circuit affirming the Food and Drug Administration’s (FDA) decision to remove the popular GLP-1 weight loss drug semaglutide from its drug shortage list as lawful and correct.
The Court’s decision, which also applies to the FDA’s action removing tirzepatide from the shortage list, is especially important because it validates the legal framework for how the FDA regulates the sale of compounded drugs during shortage situations. Dating back to the passage of the Food and Drug Administration Modernization Act in 1977, this framework both allows compounders to produce temporary versions of commercially available drugs during shortages, but it also makes it illegal for the continued mass production and sale of compounded versions when the shortage has ended.
Yet, despite being in existence for almost 50 years, the framework for removing drugs from the shortage list was recently challenged, not because there are legal issues, but because the mass-marketing of compounded GLP-1s became big business for compounding pharmacies and direct-to-consumer telehealth platforms while the branded GLP-1 weight loss drugs were in short supply. In fact, in 2024, compounded versions accounted for an estimated 30% of the overall GLP-1 weight-loss market. Thus, the Outsourcing Facilities Association (OFA), an organization representing compounding pharmacies, sued the FDA for declaring an end to the shortages of semaglutide and tirzepatide, claiming the agency was “abruptly depriving patients of much needed treatment and artificially raising drug prices.”
Among OFA’s arguments were that the FDA ignored evidence that the shortages continued to exist, and that the agency did not give compounders reasonable notice of the planned determinations or allow them to weigh in with comments. But here is the good news: the Appeals Court reviewed the evidence and rejected these arguments, concluding that the FDA “followed the statutory framework, applying the statutory definition of shortage to the evidence before it.”
Importantly, the Court also endorsed FDA’s methodology and its reliance on actual supply data from the manufacturers to make the determination of the end of the shortage. Specifically, the Court declared that pharmacy screenshots, patient reports, articles, blog posts, and form letters submitted by compounders are less probative than “more specific, reliable, comprehensive, and current” data from the manufacturer – codifying common sense and the value of verifiable evidence.
At a time of growing concern over the need to improve the regulation of compounded drugs and restore compounding to its intended purpose, the Fifth Circuit’s ruling represents a line in the sand for policymakers and compounders. FDA’s time-tested regulatory framework for addressing shortage situations works and relies on a thorough review of the evidence that credits specific, reliable, comprehensive, and current information and data—up and down the product supply chain—over anecdotal, isolated, and unreliable reports.
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About the National Consumers League (NCL)
The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.
