The FDA has doubled down on its decision to remove Eli Lilly’s tirzepatide from its list of products that are in shortage. The agency’s move means that compounding pharmacies will have to halt production of their knockoff versions of diabetes drug Mounjaro and obesity treatment Zepbound.
During the shortage, compounders have suddenly thrived, flooding the market with their lower-cost copycats to meet the booming demand for Lilly and Novo Nordisk’s weight loss treatments.
With the FDA move, however, state-licensed pharmacies will be required to stop manufacturing these therapies by Feb. 18.
Meanwhile, outsourcing facilities that have been endorsed through the FDA’s 503B registration process will have until March 19 to produce tirzepatide treatments.
"Our determination is based on our conclusions that supply meets or exceeds current demand, and that, based on our best judgment looking at the available information with its limitations, supply will also meet or exceed projected demand," Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, wrote in a letter published on the agency's website.
The FDA decision is “not necessarily the end of the story," Alliance for Pharmacy Compounding CEO Scott Brunner said in a statement. Brunner added that he was not “persuaded” the regulator had the data necessary to determine whether the “shortage is really over.”
“We continue to hear from pharmacies that the FDA-approved tirzepatide drugs are not attainable from wholesalers in quantities needed to meet demand by patients transitioning from compounded to commercial versions of the drug,” Brunner explained.
In October, when the FDA initially erased tirzepatide from its shortage list, a compounding industry group sued the FDA days later, claiming the decision was “reckless and arbitrary” and “lacking any semblance of lawful process.”
Four days later, the FDA backed off its decision, saying it would take a second look. The move put on hold the lawsuit by the Outsourcing Facilities Association.
“Today’s statement from the agency certainly informs that litigation, but it’s not a decision by a court,” Brunner said. “It’s a unilateral action by the agency, so don’t confuse the two.”
In the U.S., when a drug goes on the shortage list, compounding pharmacies are allowed to produce knockoffs to fill the void. For decades, the production of compounded drugs has mostly been conducted on a small scale to fill existing prescriptions.
But, with the outsized demand for Mounjaro and Zepbound and Novo Nordisk’s GLP-1 drugs Ozempic and Wegovy, it has become a big business, with spas and online sellers attracting customers with prices that undercut those for branded versions of the drugs.
Compounders have been able to produce tirzepatide products since the drug went on the FDA shortage list in December 2022. Novo’s semaglutide entered the list in August 2022 and remains in shortage. In September, the Danish company said it expected its shortage of Ozempic to continue through the end of the year.
There are an estimated 2 million Americans taking compounded versions of the drugs, according to the Kaiser Family Foundation.