The Food and Drug Administration said in a court filing Friday that it would allow pharmacists to continue manufacturing a compounded version of tirzepatide — the active ingredient in Eli Lilly's diabetes and weight-loss drugs Mounjaro and Zepbound — as it reconsiders its decision. to remove the drug from its national shortage list.
The surprise move is a big win for pharmacists and patients who have been furious with the FDA ever since. Announced on October 2 This deficiency of tirzepatide has been resolved.
Deficiency of the drug, including semaglutide – its active ingredient Ozempic and Wegovi – There is unprecedented demand for fuel Compounding pharmacy to make their own versions of the drug, which patients say are often cheaper and easier to find than the brand.
During shortages declared by the FDA, Compounding is legal to make pharmaceutical versions of these include the lack of “basically a copy” of brand-name drugs, although drug manufacturers have strongly resisted the legality of this practice.
The FDA's October 2 announcement of the deficiency means that compounding pharmacists will have to stop filling tergepeptide prescriptions. It stated at the time that pharmacies that manufacture large batches of the drug will no longer be able to accept new orders for tergepeptide and will have 60 days to fulfill existing orders.
On October 7, the Outsourcing Benefits Association, an affiliated trade group, sued the FDA, stating that the drug is still in short supply and therefore should be on the shortage list.
The FDA's order Friday was a response to the group's lawsuit, saying its action was “effectively the relief that plaintiffs sought in their lawsuit.” In the filing, the agency said that for now, it “will not take action” against the plaintiffs and their members who manufacture manipulated versions of the drug while it reevaluates its decision.
Simone Williams, 50, of Spartanburg, South Carolina, said she was deeply disturbed by the FDA's decision. tirzepatide Not on the shortage list.
Williams began taking the weight-loss compound tirzepatide after his Mounjaro prescription expired last year. He couldn't afford $1,060 a month on brand-name medications.
Williams has to “make the switch” and get a prescription for the compound semaglutide, which is deficient.
The FDA's update is “good news,” Williams said, but he remains cautious.
“Until the FDA makes a firm decision, I'm still going to be nervous and angry about this, because they might come back and say, 'No, there's no deficiency,' and I'll be back to square one,” he said.
Is tirzepatide really deficient?
Tirzepatide has been on the FDA's drug shortage list for nearly two years. Initially approved as Mounjaro for the treatment of type 2 diabetes, many patients were prescribed tirzepatide off-label for weight loss. When it was officially approved last year, its popularity for weight loss grew – called Zipbound. Exacerbating the deficit.
Lilly has taken steps to increase production of tirzepatide, including committing billions to a new factory dedicated to producing more drugs.
Michael Ganio, senior director of pharmaceutical practice and quality at the American Society of Health-System Pharmacists, a group that monitors drug shortages in the United States, said the group is still hearing reports from patients and caregivers suggesting that the tergepeptide is difficult to find. . .
ASHP still lists tirzepatide as in short supply, although Ganio said that could change as pharmacists discover supplies are available.
“It could be something that takes weeks to deliver,” he said. “The distribution centers are refilled and then sent to the pharmacy. All pharmacies probably have backorders and have customers who probably got it at a compounding pharmacy and are now trying to get it at a retail pharmacy and a community pharmacy.”
Christopher McGowan, a gastroenterologist who runs a weight loss clinic in Cary, North Carolina, said he believes the case is less about whether there is a true drug shortage and more about the beneficial nature of GLP-1 compound drugs.
“It’s about money,” McGowan said. “The composites industry will argue that the supply chain is not yet stable enough, but there really are millions at risk. That’s the question.”
Lilly says there's no shortage of tirzepatide.
In a statement Monday, Lilly spokesman Jared Shapiro said all of its Mounjaro and Japbound doses are available, warning that it is important that patients “are not exposed to the risk of taking untested and unapproved imitations.” .
“Nothing changes the fact that, as the FDA has acknowledged, Mounjaro and Zepbound are available and the deficiency remains 'resolved,'” Shapiro said.
The FDA did not respond to requests for additional comment.
An FDA spokesperson said in a statement before the filing of the order Friday night that the agency understood patients' frustration with the decision to end the shortage, saying, “We understand that higher drug prices have a direct impact on patients.”
“Too many Americans have been overpriced for the medications they need,” the spokeswoman said. “However, the FDA does not have the legal authority to investigate or regulate prices set by manufacturers, distributors and retailers.”
The goal of the FDA's compounding program is to preserve access to “legally marketed compounding medications” for patients who need them, the spokeswoman said, although the agency generally advises patients to use FDA-approved medications when available.
'peace of mind'
Meanwhile, patients and compounding pharmacists are celebrating the FDA's decision to allow continued compounding of tirzepetide.
A spokesperson for the Outsourcing Facilities Association, which filed the lawsuit, said in a statement that this is “a relief for our members and the many patients they serve.”
“We believe this is a fair resolution in light of the agency's hasty decision to remove the drug from the list, while also recognizing the agency's 'disruption in supply'.” “More importantly, if the FDA repeats its removal decision when a deficiency still truly exists, we will be back in court.”
In a statement, the Alliance for Pharmacy Compounding, another industry group, called it a “tremendous victory” for the outsourcing benefits association.
The APC called reporters earlier this month, saying the FDA's initial decision caught complex pharmacies “off guard” and left patients “by surprise.”
Lily was the first to suggest in August that tripeptide shortages will be resolved soon, two months before the FDA's official decision.
APC said in an email to customers over the weekend that it is working with lawyers to clarify whether the new FDA order means Terzeptide will not be enforced against plaintiffs in the lawsuit.
“Our intent is to find out in writing that the FDA will have discretion with respect to all pharmacies handling copies of tirzepetide injection at this time,” APC wrote in an email.
For Elizabeth Kenley, 59, of Graham, North Carolina, the FDA's decision gives her “peace of mind.”
A compound version of tergepeptide was prescribed in March after Kenley had difficulty finding it because it was missing.
Last week, Kenley's compounding pharmacists informed him that since tirzepatide was no longer on the shortage list, they would have to stop manufacturing compounded versions or find another supplier. Pharmacists said they will distribute the remaining stock and hope to continue dispensing prescriptions to patients until the end of the year.
According to the document presented by the FDA on Friday, Kenley “does not need to struggle to come up with a plan B.”
Since starting the compound, he says he has lost 30 pounds and wants to lose another 25 pounds.
“The compounding pharmacy is my lifeline to continuing the therapy that has been so successful for me,” Kenley said. “I understand that research and development companies need to make money, but they need to work together with insurance companies to ensure fair and equitable access to these medicines.”
