Compounding Industry Group Sues FDA Over Drug Shortage List

A compounding industry group initiated legal action against the U.S. Food and Drug Administration (FDA), accusing the agency of improperly removing Eli Lilly‘s diabetes and weight loss medications from its list of drugs in short supply. The lawsuit was filed on Monday in a federal court in Fort Worth, Texas.

The Outsourcing Facilities Association claims that the FDA eliminated Lilly’s tirzepatide, sold under brand names such as Mounjaro for diabetes and Zepbound for weight loss, from the shortage list despite ongoing supply issues. According to the lawsuit, the FDA’s decision bypassed public input and relied solely on Lilly’s assurances of their capability to meet demand, an action the group describes as “arbitrary, capricious, and contrary to law.”

Drug shortages have heightened the demand for compounded versions of these medications, with compounding facilities stepping in to supply alternatives to popular prescriptions like Novo Nordisk‘s Ozempic and Lilly’s Mounjaro. These facilities manufacture medicines by combining or altering drug ingredients and are legally allowed to do so in response to short supply conditions.

Federal regulations stipulate that compounding facilities can produce alternative medicines only while a shortage persists. Otherwise, law prohibits the regular production or “inordinate amounts” of compounded drugs.

The FDA has not yet responded to requests for comment on the lawsuit. Eli Lilly also remains unavailable for immediate comment. The active ingredient in Novo Nordisk’s semaglutide, used in Ozempic, continues to appear on the FDA’s shortage list.

Brendan Pierson, who reports on product liability litigation and health care law, contributed to this report from New York, with editing by Chris Reese and Sonali Paul for Thomson Reuters.