# FDA Reexamines Its Choice to Remove Tirzepatide Drugs from Shortage List Following Lawsuit
The U.S. Food and Drug Administration (FDA) is reassessing its decision to take tirzepatide-based medications, including Eli Lilly’s Mounjaro (for diabetes) and Zepbound (for weight loss), off the national shortage list. This reexamination comes as a result of a lawsuit initiated by a trade organization advocating for compounding pharmacies, which asserts that the shortage of these medications continues even after the FDA’s prior announcement that supply issues had been addressed.
## Overview of Tirzepatide and Its Demand
Tirzepatide belongs to the glucagon-like peptide-1 (GLP-1) receptor agonist class of drugs, which has attracted significant attention due to its effectiveness in treating both type 2 diabetes and obesity. Mounjaro, originally approved for diabetes treatment, and Zepbound, utilized for weight management, have become extremely popular medications because of their effectiveness in helping patients control blood sugar levels and achieve substantial weight loss.
The high demand for these drugs has resulted in a notable increase in need, consequently leading to supply shortages. In December 2022, the FDA included tirzepatide medications on its national shortage list, thereby permitting compounding pharmacies to create more affordable, copycat versions of the drugs. Compounding pharmacies, or outsourcing facilities, can lawfully manufacture imitation versions of FDA-approved drugs only when those drugs are officially recognized as being in short supply.
## FDA’s Action to Delist Tirzepatide from the Shortage List
On October 2, 2024, the FDA declared that tirzepatide drugs were no longer deemed to be in short supply. The agency referenced assurances from Eli Lilly, the producer of Mounjaro and Zepbound, indicating that its production ability could satisfy both current and anticipated national needs. Nevertheless, the FDA did concede the possibility of “intermittent localized supply interruptions.”
The determination to remove tirzepatide from the shortage list meant that compounding pharmacies were instantly restricted from producing any additional quantities of the drug. They were granted a 60-day period to complete existing orders, after which they would be prohibited from manufacturing the compounded forms.
## Lawsuit and FDA’s Reassessment
Following the FDA’s decision, the Outsourcing Facilities Association (OFA), representing compounding pharmacies, initiated a lawsuit against the agency. The legal action contended that the shortage of tirzepatide drugs remained and that the FDA had relied exclusively on Eli Lilly’s assurances, which the OFA argued were self-serving and intended to monopolize the market.
The lawsuit prompted the FDA to reassess its determination. In a court submission on October 13, 2024, the FDA sought to pause the lawsuit to give the agency time to reexamine its decision regarding the removal of tirzepatide from the shortage list. The FDA referenced previous court decisions that allow agencies to rectify their own errors before further legal actions ensue.
As part of this review process, the FDA also committed to refraining from taking any regulatory enforcement measures against compounding pharmacies that continued to produce tirzepatide-based drugs while the review continued. This approach effectively permits compounding pharmacies to keep manufacturing the drugs until a conclusive decision is reached.
## Responses from Stakeholders
### Compounding Pharmacies and Patients
The FDA’s decision to revisit its position was positively received by the Outsourcing Facilities Association. OFA Chairperson Lee Rosebush expressed contentment with the outcome, stating, “We believe that this is a fair resolution in light of the agency’s hasty decision to remove the drug from the list when the agency has acknowledged ‘supply disruptions,’ which immediately created a significant access issue for patients everywhere.”
For patients dependent on the more affordable, compounded tirzepatide versions, the FDA’s reexamination is likely to be a relief. Numerous patients, particularly those lacking comprehensive insurance, have turned to compounded drugs as a cost-effective alternative to the brand-name options. For some, compounded formulations may have been their sole means of accessing tirzepatide.
Nonetheless, the FDA has consistently cautioned that compounded drugs lack FDA approval and do not undergo the same stringent safety, efficacy, and quality evaluations as their brand-name equivalents. The agency has expressed concerns regarding dosing mistakes and other safety challenges linked to compounded variations of GLP-1 medications.
### Eli Lilly’s Reaction
Eli Lilly, the developer of Mounjaro and Zepbound, has conveyed dissatisfaction with the FDA’s reconsideration. The company had previously issued cease-and-desist notices to compounding pharmacies, asserting that the shortage had been addressed and that there was no necessity for compounded iterations of the drugs.
In a statement to Ars Technica, a representative for Eli Lilly reiterated that the company’s supply of tirzepatide was adequate to meet demand and emphasized that compounded versions were unwarranted. The
