As the battle over compounded tirzepatide continues, both the FDA and the Outsourcing Facilities Association (OFA) have filed their latest reports following Judge Pittman’s October 11th decision to grant the FDA’s request for a remand and stay. This move temporarily paused the lawsuit to allow the FDA to reassess its earlier decision that compounded tirzepatide was no longer necessary due to the availability of branded products like Mounjaro.
Here’s what’s happening now and what it could mean for patients relying on compounded tirzepatide as a more affordable or accessible option.
FDA’s Report: Progress but No Answers Yet
In its report to the court, the FDA claims to have made “substantial progress” in reevaluating its decision and continues to prioritize issuing a new ruling on remand. However, no timeline or definitive conclusion has been provided. For patients and providers, this lack of clarity leaves them in limbo, especially as demand for GLP-1 medications like tirzepatide remains at an all-time high.
OFA’s Report: Patients Still Can’t Access Branded Products
The OFA, which represents compounding pharmacies, paints a starkly different picture. According to their report, the branded supply of tirzepatide remains limited, with pharmacy distributors frequently listing products as “out-of-stock” or only available in small quantities. Survey data from this month reveals growing numbers of patients unable to access branded tirzepatide medications.
Meanwhile, the OFA asserts that compounded tirzepatide production has remained steady—or even increased—to meet the ongoing demand. This reflects a critical gap in the market where branded options fail to meet medical and financial needs for many patients.
Joint Agreement: Case Still Stayed, Updates Expected in December
Both parties agreed to keep the case on pause while the FDA works through its remand process. The next update is expected no later than December 19, 2024, or within seven days of the FDA issuing its decision. This timeline underscores the urgency of the situation, as patients and providers alike are watching closely for clarity on whether compounded tirzepatide will remain a viable option.
What Does This Mean for Patients?
For now, patients reliant on compounded tirzepatide continue to face an uncertain future. The FDA’s ultimate decision could either:
1. Reinstate tirzepatide on the shortage list, allowing compounders to continue producing it under federal law.
2. Maintain its position that the shortage is resolved, potentially halting 503b compounded production altogether.
3. Request further time for reevaluation, prolonging uncertainty. As was the case today.
Each of these outcomes carries significant implications for patients who have turned to compounded medications due to cost barriers, insurance limitations, or availability issues with branded products. In the meantime, status quo with the courts will rule the day and compounded versions will be permitted by the FDA until resolution is reached.
The Bigger Picture: Access and Affordability
This case continues to highlight systemic issues in access to GLP-1 medications. While branded products like Mounjaro and Zepbound dominate the headlines, compounded alternatives have been a lifeline for many, offering more affordable solutions to a rapidly growing patient population. Removing these options without resolving supply chain and affordability issues for branded medications would be devastating for countless individuals.
As we approach the FDA’s decision, one thing is clear: patients and providers need clear guidance and solutions to address the ongoing gaps in the system. Whether through compounded medications, improved access to branded products, or both, this issue remains critical for the millions affected by obesity and type 2 diabetes.
Stay Informed
For updates on this case and other developments in the world of GLP-1 medications, stay tuned to On The Pen. Sharing this article is a powerful form of advocacy—help spread the word in Facebook groups, Reddit forums, and your social networks. Together, we can bring attention to the policies that affect access to life-changing medications.
Production won't be halted immediately if there is an adverse order. In the previous agreement and stipulated order, the FDA agreed that it would treat tirzepatide as being in shortage for purposes of enforcement if the plaintiffs seek a preliminary injunction against the FDA's future ruling. The FDA agreed that the enforcement moratorium would remain in effect until the trial court rule on the injunction request.