An injection pen of Zepbound, Eli Lilly’s weight reduction drug, is displayed in New York City on Dec. 11, 2023.
Brendan McDermid | Reuters
Eli Lilly has requested to hitch in opposing a lawsuit introduced by compounding pharmacies towards the U.S. Food and Drug Administration over the company’s resolution that Lilly’s blockbuster weight-loss and diabetes medication are not briefly provide.
In a motion filed in Fort Worth, Texas federal court docket late on Wednesday, Lilly stated it couldn’t depend on the FDA to completely defend its pursuits within the case, which is able to decide whether or not compounding pharmacies and amenities can maintain promoting cheaper variations of the corporate’s weight-loss drug Zepbound and diabetes drugs Mounjaro, which have the identical energetic ingredient, tirzepatide.
The FDA declined to remark. The Outsourcing Facilities Association, which brought the lawsuit together with a Texas compounding pharmacy didn’t instantly reply to requests for remark.
The compounded medication at concern, that are basically copies of the branded prescription medicines however not authorised by the FDA, can solely be made in important quantities if there’s a scarcity.
The FDA determined in October that there was not a scarcity of the tirzepatide medication.
In response to the lawsuit, the company agreed to rethink its resolution however on Dec. 19 affirmed that there isn’t a scarcity. At the time, FDA stated it might not take any enforcement motion for at the least 60 days, and the compounding trade remains to be looking for a court docket order reversing the company’s resolution.
Lilly stated in Wednesday’s movement that it wanted to hitch the case to defend its personal pursuits as a result of it couldn’t ensure that the FDA would attraction if the court docket dominated towards it.
Lilly additionally stated it believed compounding pharmacies, versus bigger so-called outsourcing amenities, might not manufacture compounded medication even when there’s a scarcity. It stated that could be at odds with the FDA’s view.
Novo Nordisk’s rival weight-loss drug Wegovy stays on the FDA’s scarcity record. The Alliance for Pharmacy Compounding, one other trade group, in November announced a survey exhibiting that greater than 200,000 prescriptions for compounded variations of Wegovy have been being stuffed every month.
Insurers typically cowl Lilly’s and Novo’s medication for diabetes, however many don’t cowl the weight-loss medicines. That has led many sufferers to pay out of pocket for compounded variations, that are usually cheaper.
Lilly in August began sending cease-and-desist letters to telehealth firms, wellness facilities and medical spas promoting compounded variations of Zepbound and Mounjaro. The firm has additionally filed lawsuits towards these falsely claiming to promote FDA-approved variations of the drug.
