Compounding Group Sues FDA for Removing Lilly’s Weight Loss Drug From Shortage List

(Reuters) -A drug compounding industry group on Monday sued the U.S. Food and Drug Administration over its decision to take Eli Lilly’s blockbuster weight loss and diabetes drugs off its list of medicines in short supply last week.
Shortages of drugs such as Lilly’s Mounjaro and Novo Nordisk’s Ozempic have fueled demand for compounding facilities’ own versions of the medicines.
In a lawsuit in Fort Worth, Texas federal court, the Outsourcing Facilities Association claims the FDA removed Lilly’s tirzepatide from the list even though it remains in short supply. Lilly sells the drug under the brand names Zepbound for weight loss and Mounjaro for diabetes.
The FDA did not give the public a chance to weigh in on its decision and trusted assurances from Lilly, “the company that is self-interested in monopolizing the market,” that it could meet projected demand, the lawsuit said.
It called the FDA’s action “arbitrary, capricious and contrary to law.”
The FDA and Lilly did not immediately respond to requests for comment.
Mounjaro had been on the FDA’s list of drugs in short supply since late 2022, while Zepbound was added in April.
Compounding facilities create medicines by combining, mixing or altering drug ingredients. Federal regulations allow compounded versions to be sold to meet demand if a drug is in short supply.
If there is no shortage, federal law states that compounded drugs cannot be made “regularly or in inordinate amounts.”
The active ingredient in Novo Nordisk’s drugs, semaglutide, remains on the shortage list.
(Reporting in New York; Editing by Chris Reese and Sonali Paul)
 
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