Eli Lilly has requested to join a lawsuit filed by compounding pharmacies against the U.S. Food and Drug Administration (FDA). The lawsuit challenges the FDA’s decision that Lilly’s popular weight-loss and diabetes medications are no longer in short supply.
In a motion filed Wednesday in federal court in Fort Worth, Texas, Lilly argued that it could not depend solely on the FDA to protect its interests in the case. The lawsuit is centered on whether compounding pharmacies can continue selling cheaper versions of Lilly’s weight-loss drug, Zepbound, and its diabetes medication, Mounjaro. Both drugs contain the same active ingredient, tirzepatide.
The FDA has declined to comment on the matter. The Outsourcing Facilities Association, which filed the lawsuit with a Texas-based compounding pharmacy, also did not respond to requests for comment.
The compounded versions of the drugs, which are essentially unapproved copies of the branded medications, can only be produced in large quantities if there is a shortage. However, in October, the FDA determined that there was no longer a shortage of tirzepatide-based drugs.
In response to the lawsuit, the FDA agreed to reconsider its decision but reaffirmed its stance on December 19, stating that there was no shortage. The agency also announced that it would not take enforcement action for at least 60 days. Despite this, the compounding industry is still seeking a court order to overturn the FDA’s decision.
Lilly’s motion emphasized the need for the company to join the case to protect its interests, as it could not rely on the FDA to appeal a ruling that might go against the agency. Lilly also expressed concerns that compounding pharmacies, as opposed to larger outsourcing facilities, may not be able to produce compounded drugs even in the event of a shortage. This, Lilly suggested, could conflict with the FDA’s interpretation of the situation.
Meanwhile, Lilly’s competitor, Novo Nordisk, still faces shortages of its weight-loss drug Wegovy, which remains on the FDA’s shortage list. The Alliance for Pharmacy Compounding, another industry group, recently revealed in a survey that over 200,000 prescriptions for compounded versions of Wegovy are filled each month.
While insurers typically cover Lilly’s and Novo’s diabetes drugs, many do not cover the weight-loss treatments. This has led some patients to seek cheaper, compounded versions of the drugs, which are not FDA-approved.
In August, Lilly began sending cease-and-desist letters to telehealth companies, wellness centers, and medical spas selling compounded versions of Zepbound and Mounjaro. The company has also filed lawsuits against those falsely advertising FDA-approved versions of its drugs.
