Compounding pharmacies have filed a lawsuit against the Food and Drug Administration following its removal of Novo Nordisk's semaglutide, a type of glucagon-like peptide-1, from a drug shortage list.
Outsourcing Facilities Association, a trade organization that represents compounding pharmacies, and North American Custom Laboratories, which operates as FarmaKeio Superior Custom Compounding, filed the suit Monday in the U.S. District Court of Northern Texas. The two organizations filed a similar lawsuit against the agency in October after it removed Eli Lilly's tirzepatide, another GLP-1, from its shortage list.
Related: Hims & Hers pivots as semaglutide shortage ends
In the suit, the association and the company allege the FDA's announcement last week was premature and was made without proper notification. They did not respond to a request for comment.
The FDA's announcement that the shortage of Novo Nordisk’s Wegovy and Ozempic drugs is resolved has affected providers of the drug, particularly companies like Hims & Her Health, that benefited from selling consumers compounded versions during the past two years. Hims & Hers saw a sizable drop in its stock price following the agency's announcement.
Other compounded or copycat versions of various weight-loss and diabetes medications have also been on the rise as brand name-versions go on and off the FDA's shortage list. Eli Lilly, the manufacturer of GLP-1s like Mounjaro and Zepbound, filed several cease-and-desist letters to providers in August demanding they stop promoting copycat drugs.
The FDA declined to comment.
In a regulatory filing earlier this month, Novo Nordisk said periodic supply constraints and drug shortage notifications regarding various drugs including glucagon-like peptide-1s were expected to continue this year. The company's filing was referenced in the lawsuit.
