Eli Lilly and Company, pharmaceutical company headquarters in Alcobendas, Madrid, Spain.
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The US Food and Drug Administration on Friday agreed to reconsider its decision last month to bar drug compounders from selling their versions. by Eli Lilly blockbuster weight loss and diabetes drugs.
The agency said in a court filing that it would now allow compounding pharmacies and facilities to continue dispensing the drugs while it investigates whether there is a shortage of their active ingredient. Compounding versions of drugs are less expensive for patients than brand-name versions.
The decision gave him the answer a lawsuit It was brought up Monday by the Outsourcing Facilities Association, a composite industry group. After the FDA’s decision to reconsider Friday, U.S. District Judge Mark Pittman in Fort Worth, Texas, dismissed the case.
The FDA’s Sept. 30 decision jeopardized the compounders’ ability to sell versions of Lilly’s weight-loss drug Zepbound and diabetes drug Mounjaro. FDA decision they removed the active ingredienttirzepatide, from the list of drugs with shortages.
That would cut off access for many patients to the compounded versions they relied on during the shortage, which are cheaper than brand-name drugs. Insurance generally covers drugs like tirzepatide to treat diabetes, but many don’t cover them for weight loss.
Lee Rosebush, president of the Outsourcing Facilities Association, said in a statement that the group was “very relieved, for our members and the many patients they serve, that the FDA has agreed to reconsider its decision.”
Federal regulations allow compounded versions of an FDA-approved drug to be sold to meet demand if the drug is in short supply. If there is no shortage of drugs, compound versions of it cannot be made regularly or in large quantities.
The Outsourcing Facilities Association claimed in its lawsuit that the FDA removed tirzepatide from its shortage list even though it was in short supply.
Lilly in August he stopped and started sending desperate letters Selling composite versions of Zepbound and Mounjaro to telehealth companies, wellness centers and medical spas. The company has it too filed lawsuits Against vendors who claim to sell FDA-approved versions of the drug.
Active ingredient at Novo Nordisk the drug, semaglutide, remains on the FDA’s shortage list.
