An injection pen for Eli Lilly’s weight loss drug Zepbound is on display in New York City on December 11, 2023.
Brendan McDiarmid | Reuters
Eli Lilly Lilly’s blockbuster weight loss and diabetes drugs have been asked to join in opposing a lawsuit filed by compounding pharmacies against the U.S. Food and Drug Administration over the agency’s determination that Lilly’s blockbuster weight loss and diabetes drugs are no longer in short supply.
in motion Lilly Co. said in a lawsuit filed late Wednesday in federal court in Fort Worth, Texas, that the lawsuit, which will determine whether pharmacies and facilities can continue to sell cheaper versions of the company’s weight-loss drug, will completely eliminate FDA benefits. He said that he could not be asked to defend him. Zepbound and the diabetes drug Mounjaro contain the same active ingredient, tirzepatide.
The FDA declined to comment. Outsourcing Facility Association, General Incorporated Association filed a lawsuit Texas pharmacies also did not respond to requests for comment.
The combination drugs in question are essentially copies of brand-name prescription drugs, but they are not FDA-approved and can only be manufactured in large quantities if there is a shortage.
The FDA determined in October that the drug tirzepatide is no longer in short supply.
Although the agency agreed to reconsider its decision following the lawsuit, Affirmed on December 19th There is no shortage. At the time, the 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 FDA’s decision.
Lilly said in Wednesday’s motion that he needed to join the lawsuit to protect his interests because he does not know whether the FDA will appeal if the court rules against it. .
Lilly also said he believes compounding pharmacies, as opposed to large so-called outsourcing facilities, may not produce compounded drugs even if there is a shortage. He said that could be inconsistent with the FDA’s position.
Novo Nordisk’s rival weight loss drug Wegovy remains on the FDA’s shortage list. Another industry association, the Alliance for Pharmacy Compounding, held in November announced a study This represents more than 200,000 prescriptions for Wegovy’s combined version each month.
Insurance companies typically cover Lilly’s and Novo diabetes drugs, but many do not cover weight loss drugs. As a result, many patients ended up purchasing the usually cheaper combination version out of pocket.
august lily Began sending cease and desist letters. Telemedicine companies, wellness centers, medical spas, etc. that sell combined versions of Zepbound and Mounjaro. The company also filed a lawsuit against anyone falsely claiming to be selling an FDA-approved version of a drug.
