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The FDA’s reconsideration of its decision to remove tirzepatide from the drug shortage list has given patients and compounding pharmacies a reason to celebrate. After facing significant backlash from industry stakeholders and a lawsuit filed by the Outsourcing Facilities Association (OFA), the FDA filed an unopposed motion for voluntary remand on October 11, 2024, agreeing to reevaluate the decision in light of these challenges.
Background on the Case
Tirzepatide, known under brand names such as Mounjaro and Zepbound, has been a critical drug in treating diabetes and aiding weight management for those with related health conditions. The FDA initially placed tirzepatide on its shortage list in December 2022 due to widespread supply issues. This allowed compounding pharmacies to produce compounded versions of the drug, providing an affordable alternative for patients who couldn’t access or afford the branded versions.
However, on October 2, 2024, the FDA determined that the tirzepatide shortage was "resolved" and subsequently removed it from the shortage list. This decision came as a shock to compounding pharmacies and patients, many of whom were still facing difficulties obtaining the medication. OFA quickly responded by filing a lawsuit against the FDA, challenging the removal of tirzepatide from the list under the Administrative Procedure Act (APA). OFA argued that the decision was made without proper public notice and was arbitrary and capricious given the ongoing supply challenges.
The FDA’s Motion for Voluntary Remand
On October 11, 2024, the FDA filed a motion for voluntary remand, asking the court to send the issue back to the agency for reconsideration. The FDA stated that a remand would allow it to reevaluate its decision in light of the plaintiffs’ concerns and preserve judicial resources by potentially avoiding unnecessary litigation. This motion effectively pauses the lawsuit and gives the FDA time to address the legal and practical issues surrounding tirzepatide’s availability.
The FDA's filing also highlighted that, during the remand period, it will exercise enforcement discretion, allowing compounding pharmacies to continue producing tirzepatide without fear of legal repercussions. This is particularly crucial for patients who have come to rely on compounded versions of the drug for affordable treatment.
Why Did the FDA Reconsider?
Several key factors likely influenced the FDA’s decision to reconsider the removal of tirzepatide from the shortage list:
Lack of Notice and Public Input: The OFA’s lawsuit argued that the FDA failed to provide public notice before removing tirzepatide from the list, which is a violation of the APA. By not allowing stakeholders to weigh in, the FDA left many patients and pharmacies in a difficult position, especially considering the continued challenges in accessing the drug.
Ongoing Supply Issues: Despite the FDA’s initial decision to declare the shortage resolved, reports from pharmacies and healthcare providers indicate that many patients still struggle to access tirzepatide in a timely and affordable manner. These ongoing supply challenges make compounded versions of the drug an essential part of the treatment landscape (Business Wire)(Cardiovascular Business)
Patient Impact: The FDA’s original decision could have left patients without access to affordable versions of tirzepatide. Stories of patients who would no longer be able to afford treatment without the compounded versions likely played a significant role in the FDA’s decision to reconsider.
What’s Next?
The FDA’s reconsideration is an important step toward ensuring continued access to tirzepatide for those who need it. As the agency reviews its decision, compounding pharmacies can continue to meet patient demand without fear of enforcement action. The FDA has committed to allowing these pharmacies to operate under existing guidelines during the remand period and will provide further updates once the reevaluation is complete.
The remand process will also allow stakeholders, including the OFA and compounding pharmacies, to provide additional input on the availability of tirzepatide. This input could shape the FDA’s final decision and ensure that any future actions are better aligned with the realities of the drug’s supply and demand.
In the meantime, patients who rely on compounded tirzepatide can breathe a sigh of relief, knowing that their treatment options will remain available for the foreseeable future.
To read the full motion, look here.
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