The move comes after a lawsuit from the Outsourcing Facilities Association, which represents the compounding industry, aimed to ensure patients maintain access to more affordable alternatives of the medication while the agency reviews the current drug shortage status. This decision also follows an earlier update from the FDA this month that said the drug was no longer in shortage after two years of limited availability.
Here are five things to know:
- The FDA agreed to reevaluate its decision, allowing compounding pharmacies to continue providing these medications while the agency continues to review whether there is an actual shortage of tirzepatide.
- The reconsideration follows an Oct. 11 lawsuit that prompted U.S. District Judge Mark Pittman to temporarily halt legal proceedings to give the FDA time to reassess its ruling.
- The initial FDA decision threatened patients who rely heavily on compounded versions of Mounjaro or Zepbound, which are typically cheaper than the name-brand versions of the drug.
- Tirzepatide has been on the FDA shortage list since late 2022, reflecting ongoing supply issues for Eli Lilly’s products and for other competitors, increasing the demand for compounded versions of the weight loss drugs.
- The FDA and Outsourcing Facilities Association are required to submit a joint status report by Nov. 21, and the next court hearing scheduled for Oct. 15 has been canceled, with the FDA encouraged to submit additional information regarding tirzepatide’s availability during the remand process.
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