The Food and Drug Administration (FDA) announced it would 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 halt litigation over the drug shortage.
The FDA said in a court filing late Friday that it does not intend to take regulatory action against the plaintiffs' pharmacies for making copies of the drugs while it reconsiders its decision.
The FDA's complaint is a significant reversal for the agency, which was sued last week by compounding pharmacies and trade groups representing compounding pharmacies after it removed tirzepatide from the shortage list.
At the time, officials said removing the drug meant compounding pharmacies would no longer be legally allowed to continue manufacturing and dispensing their own versions.
In its lawsuit, the Outsourcing Facilities Association argued that the drug remains 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 barring the FDA from taking action against the plaintiffs who continued to make copies of the drug.
Tilzepatide is sold as Mounjaro for diabetes and Zepbound for obesity.
In a statement to The Hill, a Lilly spokesperson said all doses of Munjaro and Zepbound are available, reiterating the branded drug industry's view that combination drugs pose a risk to patients.
“It is important that all doses of Lilly's FDA-approved medicines are available and that patients are not at risk of taking untested and unapproved counterfeit products,” the spokesperson said.
“The FDA has rightly and repeatedly expressed concerns about unapproved GLP-1 drugs used for weight loss purposes, and unapproved versions undergo FDA review for safety, efficacy, and quality before being marketed. have expressed concern that such drugs are dangerous for patients.
Compounded anti-obesity drugs are sold at significantly lower prices than branded products, giving patients access to the medicines they need when they are in short supply. The lawsuit claimed the FDA was depriving it of that access.
In its motion, the FDA asked the court to suspend the lawsuit and send the case back to the FDA. That would allow the FDA to “re-evaluate its decision in light of plaintiffs' challenges.”
The agency said it would not take action against the compounders while it reconsidered, saying, “This is, in effect, the relief plaintiffs sought.”
The agency asked plaintiffs to “submit additional information regarding the availability of tirzepatide” during its review.
U.S. District Judge Mark Pittman in Fort Worth, Texas, granted the motion and put the case on hold. A joint status report is scheduled for November 21st.
FDA said its enforcement discretion extends from the date of the order to two weeks after review of the decision.
Lee Rosebush, president of the Outsourcing Facilities Association, called the move a “fair resolution” in a statement. “It's a great relief for patients.”
He added, “If FDA repeats its removal decision when a shortage truly exists, we will return to court.”
