The shortage of tirzepatide, used by pharmaceutical giant Eli Lilly in diabetes medication Mounjaro and weight loss drug Zepbound, is officially over, the Food and Drug Administration said Wednesday.
During the shortage, which started in December 2022, other companies were legally allowed to make compounded versions of the medicine in order to make up the shortfall in supply. These versions of the medicine do not have to comply with the FDA safety and approval process, but once a shortage is resolved, making them is once again restricted.
The Alliance for Pharmacy Compounding trade group says that some patients could be left without medicine, and that enough patients may switch to the Eli Lilly-manufactured, FDA-approved medicine to cause another shortage.
“For Lilly, this is surely progress, but for many patients, at least in the near term, I’m not so sure,” APC CEO Scott Brunner said in a release. “I suspect plenty of patients taking compounded tirzepatide are going to be caught flat-footed by this. They are being cut-off cold-turkey, their prescription no longer fillable. They’ll need to get in to see their provider to get a new prescription, and that will take some time.”
APC had asked for a 60-day period to allow patients taking compounded tirzepatide to slowly be switched over to Zepbound or Mounjaro, but the FDA did not respond.
Eli Lilly says that it has ramped up production to meet demand.
“We know many people rely on our medicines, so we invested significantly to expand manufacturing and bring new options to the market,” Lilly USA President Patrik Jonsson told Bloomberg.
The company has decried the practice of compounding the drugs it produces.
“The entities currently mass-producing and mass-marketing compounded and counterfeit tirzepatide need to stop immediately,” Eli Lilly told the New York Times.
• Brad Matthews can be reached at bmatthews@washingtontimes.com.
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