The Food and Drug Administration (FDA) said it will reconsider its decision to remove Eli Lilly’s blockbuster weight loss and diabetes drug from its official shortage list and allow compounding pharmacies to continue selling their own versions.
A federal court in Texas on Friday granted the FDA’s unopposed motion to stay litigation over the drug’s removal from shortage.
In a court filing late Friday, the FDA said it wouldn’t pursue regulatory action against the plaintiff compounding pharmacies for making copies of the drugs while it reconsiders the decision.
The FDA’s motion marked a significant reversal for the agency, which was sued last week by compounding pharmacies and a trade organization representing compounding pharmacies after removing tirzepatide from the shortage list.
At the time, the agency said removing the drug meant compounding pharmacies would no longer be legally allowed to continue making and dispensing their own versions.
In the lawsuit, the Outsourcing Facilities Association claimed the drug was still in short supply, and that the agency’s decision was “reckless and arbitrary.” The group asked a federal court in Texas to issue a 14-day temporary restraining order that would prevent the FDA from taking action against any of the plaintiffs for continuing to make copies of the drug.
Tirzepatide is sold as Mounjaro for diabetes and Zepbound for obesity.
In a statement to The Hill, a spokesperson for Lilly said all doses of Mounjaro and Zepbound are available and reiterated the branded drug industry’s view that compounded versions are risky for patients.
“All doses of Lilly’s FDA-approved medicines are available and it is important that patients not be exposed to the risks in taking untested, unapproved knockoffs,” the spokesperson said.
"FDA has rightly and repeatedly expressed concerns with unapproved GLP-1 drugs used for weight loss, and that such drugs are risky for patients, as unapproved versions do not undergo FDA’s review for safety, effectiveness and quality before they are marketed.”
Compounded anti-obesity drugs are sold at vastly lower prices than the branded versions and can give patients needed access to drugs that are in shortage. The lawsuit argued the FDA was taking away that access.
In the motion, the FDA asked the court to pause the lawsuit and remand the case back to the agency, which would allow it to “reevaluate the decision in light of Plaintiffs’ challenges to it.”
The agency said it would not take action against the compounders while it reconsiders, “which is effectively the relief that plaintiffs sought.”
The agency asked the plaintiffs to “submit additional information regarding tirzepatide’s availability” while it reconsiders.
U.S. District Judge Mark Pittman in Fort Worth, Texas, granted the motion and put the lawsuit on hold. A joint status report is due Nov. 21.
The FDA said its enforcement discretion will extend from the date of the order to two weeks beyond its reconsideration of the decision.
In a statement, Outsourcing Facilities Association chair Lee Rosebush called the move a “fair resolution” and said the group is “greatly relieved, for our members and the many patients that they serve, that the FDA has agreed to reconsider its decision."
He added that “should the FDA repeat its removal decision when a shortage still genuinely exists, we will return to court.”
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