Lilly Battles FDA Decision Over Compound Pharmacy Lawsuit

Eli Lilly seeks to defend its interests in a lawsuit challenging the FDA's decision on the supply status of its drugs Zepbound and Mounjaro. The lawsuit, filed by compounding pharmacies, aims to reverse the FDA's determination that these drugs are no longer in short supply.

Eli Lilly has moved to join a lawsuit filed by compounding pharmacies against the U.S. Food and Drug Administration, challenging the agency's ruling that Lilly's key drugs for weight-loss and diabetes are not in shortage.

Filed in Fort Worth, Texas federal court on Wednesday, the motion indicates Lilly's lack of confidence in the FDA's ability to protect its interests should the case conclude unfavorably. The lawsuit, led by the Outsourcing Facilities Association and a Texas compounding pharmacy, questions whether compounding pharmacies can produce cheaper versions of Lilly's drugs Zepbound and Mounjaro if shortages are acknowledged by the FDA.

The legality of producing compounded drugs hinges upon the FDA's shortage list. Recently, the FDA reaffirmed the absence of a shortage for tirzepatide drugs but committed to taking no enforcement action for 60 days. Eli Lilly insists on joining the lawsuit to ensure its business interests are safeguarded, while competitor Novo Nordisk's drug Wegovy remains labeled as in short supply.

(With inputs from agencies.)