The Outsourcing Facilities Association, a trade group representing compounders, filed a similar lawsuit in October last year after the FDA formally ended the tirzepaptide shortage.
A trade group of drug compounders sued the FDA on Monday after the regulatory agency last week declared that the shortage of Novo Nordisk’s GLP-1 best-seller semaglutide—sold as Ozempic and Wegovy—officially over.
The complaint—filed by the Outsourcing Facilities Association (OFA) with the U.S. District Court for the Northern District of Texas—claims that the FDA made a “reckless and arbitrary decision” to declare the shortage over.
The FDA’s move, the OFA contends, deprives patients “of a vital treatment for type 2 diabetes, obesity, cardiovascular disease, and other serious medical conditions.” The trade group is asking the court to declare the FDA’s action unlawful, vacate the declaration and prevent the regulator from taking action against any of the Association’s members for compounding semaglutide.
“Arbitrarily dismissing evidence that the shortage persists, FDA removed semaglutide from the shortage list without notice-and-comment rulemaking,” the lawsuit read. The OFA additionally argued that even producers of FDA-approved semaglutide revealed in a recent SEC filing that the “supply constraints’ and ‘drug shortage notifications’ will continue into the foreseeable future.”
Given these disclosures, the OFA said the FDA’s decision to end the shortage is “arbitrary, capricious, and contrary to law,” one that serves to “benefit special interests, raise drug prices, and deprive much of the public access to a needed medicine.”
Compounding—the process by which pharmacies and other parties produce their own formulations of FDA-approved drugs—can help physicians address specific needs of their patients. Congress allows the practice in case of drug shortage and, as per the OFA suit, deems compounding “an efficient, effective, and appropriate means” to maintain access to a drug despite supply constraints.
Monday’s lawsuit is the latest development in what has become a prolonged struggle over GLP-1 supply and drug compounding. The OFA has been at the forefront of the fight to enable compounding, filing a similar lawsuit against the FDA in October 2024 after the regulator formally ended the shortage of Eli Lilly’s tirzepatide.
In December, however, the FDA confirmed that tirzepatide would no longer be in shortage, giving compounders up to 90 days to cease their production of the GLP-1 therapy.
For their part, Novo and Lilly—undisputed leaders of the GLP-1 space—have put up a strong legal front against compounding. Separately, the pharmas have sued several pharmacies and clinics which they allege are illegally producing compounded versions of their incretin products.
Novo in October 2024 took the extra step of arguing to the FDA that semaglutide is too complex to compound, asking the regulator to include the drug in its Demonstrable Difficulties for Compounding (DDC) list—in turn keeping it out of reach for compounders even in times of shortage. In its own effort to fight off compounders, Lilly has started selling single-dose vials of its tirzepaptide drug Zepbound at multiple dosage levels.
