In a significant development within the pharmaceutical compounding industry, the Outsourcing Facilities Association (OFA) has filed an interlocutory appeal to the Fifth Circuit Court of Appeals. This action challenges a recent decision by a federal judge to deny OFA’s motion for a preliminary injunction against the U.S. Food and Drug Administration (FDA). The injunction sought to allow compounding pharmacies to continue producing versions of Eli Lilly’s weight-loss and diabetes medications, Zepbound and Mounjaro, which contain the active ingredient tirzepatide.
Background on Tirzepatide and Its Compounded Versions
Tirzepatide, marketed under the brand names Zepbound and Mounjaro, has been widely used for managing type 2 diabetes and obesity. Due to previous shortages, compounding pharmacies were permitted to produce and distribute compounded versions of tirzepatide to meet patient demand. However, in December 2024, the FDA declared that the shortage of tirzepatide had been resolved, thereby restricting compounding pharmacies from continuing to produce these versions.
Legal Proceedings and Recent Developments
In response to the FDA’s declaration, the OFA filed a lawsuit in October 2024, challenging the FDA’s decision to remove tirzepatide from the drug shortages list. The association argued that patients still faced difficulties accessing the medication and that the FDA had relied solely on statements by Eli Lilly in determining that there was no shortage.
On March 6, 2025, U.S. District Judge Mark Pittman denied the OFA’s motion for a preliminary injunction, which would have allowed compounding pharmacies to continue producing tirzepatide during the ongoing litigation. The judge’s order was sealed, leaving the OFA and other parties without access to the reasoning behind the decision. Lee Rosebush, chairman of the OFA, expressed surprise at the ruling and indicated that the association was considering its options.
Implications for Compounding Pharmacies and Patients
The denial of the preliminary injunction means that smaller compounding pharmacies must immediately cease the production of compounded tirzepatide. Larger outsourcing facilities have been granted until March 19, 2025, to comply with the FDA’s directive. This development has significant implications for patients who have relied on more affordable compounded versions of tirzepatide, as they may now face higher costs for the brand-name medications, which can be around $1,000 per month without insurance coverage.
Next Steps in the Legal Process
The OFA’s interlocutory appeal to the Fifth Circuit seeks to overturn the district court’s denial of the preliminary injunction. The outcome of this appeal will be closely watched by stakeholders in the pharmaceutical and healthcare industries, as it may set a precedent for the role of compounding pharmacies in addressing drug shortages and the balance between regulatory oversight and patient access to medications.
As this legal battle unfolds, patients and healthcare providers are advised to stay informed about the availability of tirzepatide and consult with medical professionals to explore alternative treatment options if necessary.