The lawsuit, filed by the Outsourcing Facilities Association , FarmaKeio Custom Compounding and North American Custom Laboratories in the U.S. District Court for the Northern District of Texas, argues that the FDA acted arbitrarily and is depriving patients of critical medication, according to court documents reviewed by Becker’s.
The plaintiffs claim that despite the FDA’s decision, a shortage of semaglutide persists, and removing it from the list effectively blocks compounding pharmacies from producing the drug to meet patient demand.
The companies also argue that the FDA removed semaglutide from the shortage list without warning and evidentiary support.
The same companies sued the FDA in October over a similar decision the agency made with respect to tirzepatide; Eli Lilly has since joined that lawsuit.
Becker’s reached out to the FDA for comment and will update this article if more information becomes available.
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