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FDA Reassesses Decision on Weight-Loss and Diabetes Medications Amid Legal Challenge
In light of a recent lawsuit, the Food and Drug Administration (FDA) is re-evaluating its choice to remove popular weight-loss and diabetes medications from the national shortage list. This decision will enable compounding pharmacies to keep producing more affordable generic alternatives—at least for the time being.
A trade association representing compounding pharmacies filed a lawsuit against the FDA following its announcement on October 2, which stated that there was no longer a shortage of tirzepatide medications, marketed as Mounjaro for diabetes management and Zepbound for weight reduction. These drugs belong to the highly sought-after GLP-1 class, known for their effectiveness, and had been listed as in short supply since December 2022.
The inclusion on this list permitted compounding pharmacies—also referred to as outsourcing facilities—to legally produce “essentially copies” of these medications. The only circumstances under which these facilities can create imitation versions of approved pharmaceuticals like tirzepatide is when such products are recognized as being in short supply. Consequently, with the FDA’s recent announcement, these compounders were immediately prohibited from manufacturing any additional quantities of these profitable drugs while having just 60 days to complete outstanding orders.
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