By Brendan Pierson
(Reuters) – Eli Lilly has asked to join in opposing a lawsuit brought by compounding pharmacies against the U.S. Food and Drug Administration over the agency’s decision that Lilly’s blockbuster weight-loss and diabetes drugs are no longer in short supply.
In a motion filed in Fort Worth, Texas federal court late on Wednesday, Lilly said it could not rely on the FDA to fully defend its interests in the case, which will determine whether compounding pharmacies and facilities can keep selling cheaper versions of the company’s weight-loss drug Zepbound and diabetes medicine Mounjaro, which have the same active ingredient, tirzepatide.
The FDA declined to comment. The Outsourcing Facilities Association, which brought the lawsuit along with a Texas compounding pharmacy did not immediately respond to requests for comment.
The compounded drugs at issue, which are essentially copies of the branded prescription medicines but not approved by the FDA, can only be made in significant amounts if there is a shortage.
The FDA decided in October that there was no longer a shortage of the tirzepatide drugs.
In response to the lawsuit, the agency agreed to reconsider its decision but on Dec. 19 affirmed that there is no shortage. At the time, FDA said it would not take any enforcement action for at least 60 days, and the compounding industry is still seeking a court order reversing the agency’s decision.
Lilly said in Wednesday’s motion that it needed to join the case to defend its own interests because it could not be sure that the FDA would appeal if the court ruled against it.
Lilly also said it believed compounding pharmacies, as opposed to larger so-called outsourcing facilities, may not manufacture compounded drugs even if there is a shortage. It said that may be at odds with the FDA’s view.
Novo Nordisk’s rival weight-loss drug Wegovy remains on the FDA’s shortage list. The Alliance for Pharmacy Compounding, another industry group, in November announced a survey showing that more than 200,000 prescriptions for compounded versions of Wegovy were being filled each month.
Insurers generally cover Lilly’s and Novo’s drugs for diabetes, but many do not cover the weight-loss medications. That has led many patients to pay out of pocket for compounded versions, which are typically cheaper.
Lilly in August 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 claiming to sell FDA-approved versions of the drug.
(Reporting By Brendan Pierson in New York, Editing by Alexia Garamfalvi and Bill Berkrot)
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