LATEST UPDATE, READ FIRST:
TL;DR for Today’s Proceedings [7:40om central January 2, 2025]:
Updated TL;DR for January 2, 2025:
Eli Lilly filed a motion to intervene in the OFA vs. FDA case, and the court has now expedited certain parts of the process. While plaintiffs initially had until January 15 to respond and Lilly until January 21 to reply, the new order fast-tracks the timeline:
• Hearing Scheduled: A hearing on Lilly’s motion to intervene is set for January 10, 2025.
• Broader Scope: The January 10 hearing will also address the joint motion to reopen the case and establish the timeline for sharing unredacted FDA documents and the preliminary injunction process.
• Protective Order Deadline: Parties are still expected to agree on a protective order by January 15, which will allow OFA access to classified FDA materials.
While the timeline for the preliminary injunction motion remains dependent on the protective order, the court’s actions signal urgency in resolving key issues, further accelerating a case with significant implications for tirzepatide access.
Original Article:
In a pivotal legal development, Eli Lilly has filed a motion to intervene in the ongoing lawsuit between the Outsourcing Facilities Association (OFA) and the FDA. The case hinges on whether tirzepatide, the active ingredient in Lilly’s Mounjaro® and Zepbound®, should remain off the FDA’s drug shortage list—a determination the FDA affirmed in December 2024 after an months long review.
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Lilly’s intervention underscores the pharmaceutical giant’s stakes in preserving its market exclusivity and ensuring the integrity of FDA’s safety standards. The lawsuit, initiated by the OFA, seeks to challenge the FDA’s decision, alleging it unfairly curtails the ability of compounders to produce versions of tirzepatide.
This motion marks Lilly’s formal entry into the courtroom, citing it’s belief that there are inherent risks associated with compounded tirzepatide, which it argues are not subjected to FDA’s rigorous approval process. Lilly emphasized its significant investments—billions in research, manufacturing, and regulatory compliance—and the danger posed by unregulated copies.
While the FDA maintains its position, Lilly’s potential involvement may intensify the legal battle, with a huge potential to impact compounded tirzepatide access for patients. The broader implications of this case could reshape regulatory enforcement and patient access to compounded medications nationwide.
Stay tuned as we track this evolving legal showdown and its impact on GLP-1 medications and patient safety.
For further details, follow OnThePen.com, where we bring you timely updates and analysis on GLP-1 developments.
UPDATE 1 [January 2, 2025]: U.S. District Judge Mark T. Pittman has ordered expedited briefing on Eli Lilly’s motion to intervene in the lawsuit over compounded tirzepatide. Plaintiffs must file their responses by January 15, 2025, with Lilly’s reply due by January 21, 2025. This move underscores the court’s prioritization of resolving the dispute swiftly.
UPDATE 2 [3:49pm Central, January 2, 2025]: Judge Mark T. Pittman has reopened the case between the Outsourcing Facilities Association and the FDA. By January 15, 2025, the parties need to agree on sharing certain FDA documents with the plaintiffs. The plaintiffs are also preparing to ask for a preliminary injunction, which would temporarily pause the FDA’s decision about tirzepatide while the case is being decided. More updates to come as this unfolds.
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