The FDA said it will reconsider the removal of Eli Lilly’s GLP-1 drug tirzepatide from its official shortage list, after a trade group representing large compounding pharmacies challenged the move.
A federal court in Texas on Friday granted the FDA’s unopposed motion to stay litigation over the drug’s removal from shortage. The agency’s declaration that the shortage was over ended certain pharmacies’ ability to mix their own versions of Lilly’s popular obesity drug.
The legal development will send the matter back to the FDA for reevaluation, according to a court filing, and could reopen the door to some compounding pharmacies dispensing their versions of the drug. The FDA also said it would not take enforcement action against certain pharmacies for compounding tirzepatide during that time.
Lilly, which reportedly sent hundreds of cease and desist letters to compounders and telehealth companies this week, didn’t immediately respond to a request for comment.
On Oct. 2, the FDA said the shortage of tirzepatide, sold by Lilly as Mounjaro for diabetes and Zepbound for obesity, had been resolved after nearly two years. The move meant that compounding pharmacies would have to stop creating copies of those drugs, a practice that’s permitted only during official shortages.
Patients that have relied on compounded tirzepatide — often sold online — for weight loss have been scrambling to figure out how to keep accessing the drug. While not approved by the FDA, the alternative versions can be a fraction of the cost of the brand-name treatments.
Lilly’s list price for Zepbound is about $1,000 a month, though many patients pay less through insurance or other discounts.
On Monday, the Outsourcing Facilities Association, which represents a type of compounding pharmacy known as a 503B, sued the FDA over its decision to end the shortage. The association argued that the agency violated the Administrative Procedure Act when it didn’t give notice or allow for public comment, and failed to consider all relevant data. The association also argued that the FDA ignored evidence that the drugs remain hard to get for many patients and deprives them of their treatments.
The FDA said in its motion that the association could submit additional information on tirzepatide’s availability for consideration while the case is on remand.