On January 14, 2025, a significant development emerged from the ongoing legal battle between the Outsourcing Facilities Association (OFA), North American Custom Laboratories LLC (FarmaKeio Custom Compounding), and the United States Food and Drug Administration (FDA). Eli Lilly, the pharmaceutical giant behind Mounjaro and Zepbound, has joined the case as an interested party, adding weight to an already complex legal landscape. Presiding over the case is Judge Mark Pittman of the U.S. District Court in Fort Worth, Texas.
The OFA and FarmaKeio filed a motion to reopen their case against the FDA on January 13. Their goal? To challenge the FDA’s declaration that the shortage of tirzepatide—a key ingredient in Mounjaro and Zepbound—has ended. A hearing on the matter was held on January 14, during which the OFA successfully argued for a preliminary injunction rather than a summary judgment. This pivotal decision could extend the timeline of the case, allowing the OFA to delve deeper into the FDA’s evidence and Eli Lilly’s proprietary information.
Why A Potential Preliminary Injunction Matters
A summary judgment would have fast-tracked the case, with Judge Pittman reviewing the submitted evidence and issuing a ruling without further examination. However, the preliminary injunction grants the OFA the opportunity to scrutinize critical documents—many of which have been heavily redacted due to Eli Lilly’s claims of proprietary confidentiality. Lilly has argued that sharing these documents with the OFA’s general counsel poses a conflict, as the information could inadvertently influence the counsel’s daily advisory role for the OFA. Reports suggest that this tension led to discussions about the potential resignation of the OFA’s general counsel to safeguard the integrity of the process.
With a potential preliminary injunction in place, the OFA could continue to challenge the FDA’s decision to remove tirzepatide from the shortage list. This decision directly impacts access to compounded versions of tirzepatide, which are relied upon by hundreds of thousands of patients. If an injunction held, it could delay the FDA’s enforcement actions against compounders, offering temporary relief to those dependent on compounded medications.
Court-Ordered Filing Schedule
Following the January 14 hearing, Judge Pittman issued an order outlining the next steps in the case:
Plaintiffs must file their motion for a preliminary injunction two weeks after receiving the Decision Memorandum under the protective order entered on the same day.
Defendants and Eli Lilly, as the intervenor defendant, must file their responses three weeks after the plaintiffs' motion is filed.
Plaintiffs must file their reply one week after the defendants' responses are filed.
The court emphasized that after determining the motion for a preliminary injunction, parties will likely be required to brief their summary judgment motions on an expedited basis. The FDA has been tasked with compiling the administrative record for the case within three weeks, as represented at the hearing.
Protective Order Details
A stipulated protective order was also entered on January 14, 2025, to safeguard sensitive information in the case. Under this order:
Confidential Information: Documents submitted as part of the administrative record are classified as confidential if they include proprietary or trade secret data, information subject to the Privacy Act, or other exempt material under federal law.
Restrictions on Disclosure: Confidential information can only be disclosed to authorized individuals, including court personnel, attorneys of record, and designated experts. Unauthorized disclosure or use of this information is strictly prohibited.
Document Handling: Parties are required to handle and file confidential information under seal, adhering to strict guidelines. Any inadvertent disclosure must be promptly corrected.
Termination Protocol: Upon the case’s conclusion, all confidential information must be destroyed or returned, except for archival copies retained by counsel of record.
Implications of the Case
This legal battle comes at a critical time for Eli Lilly. On the same day as the hearing, Lilly’s stock dropped 8%, driven in part by lower-than-expected supply and sales of Mounjaro and Zepbound in 2024. In recent statements, Lilly’s President of Diabetes, Patrick Johnson, acknowledged ongoing supply constraints for injectable GLP-1 medications, projecting these issues to persist until the company’s oral GLP-1 drug launches in 2026. These admissions have fueled skepticism about the FDA’s decision to declare the tirzepatide shortage over, further complicating Lilly’s legal and public relations challenges.
Key Takeaways from the Hearing
Timeline Extension: The preliminary injunction pathway sets the stage for a prolonged legal process, with a new schedule for filings and responses expected soon. The next major hearing could take place in late February, providing both sides additional time to prepare.
FDA’s Data Scrutiny: During the hearing, the FDA presented data indicating that 217 deaths were associated with compounded tirzepatide. While the OFA sought to address these figures, the judge emphasized that the hearing’s purpose was to establish a briefing schedule, not to debate the merits of the case.
Compounding’s Future: The case highlights the precarious position of 503A and 503B compounders. With the FDA’s enforcement deadlines approaching in February and March, access to compounded tirzepatide could face significant restrictions. This raises questions about whether tradional compounding in small-scale custom formulations can meet patient demand.
Transparency Concerns: Critics argue that Eli Lilly’s public statements about supply constraints conflict with its legal stance that the shortage has ended. This inconsistency underscores the need for greater transparency in both regulatory and corporate practices.
What’s Next?
The preliminary injunction pathway is a small but significant win for the OFA, as it provides more time to build their case and challenge the FDA’s and Lilly’s assertions. However, this victory is far from final. The ultimate outcome of this case will have far-reaching implications for the availability of compounded GLP-1 medications and the FDA’s authority over drug shortages.
Stay tuned to OnThePen.com for further updates as court filings become available. Sharing this article within your networks, especially in Facebook groups and Reddit forums dedicated to GLP-1 medications, helps spread awareness of these critical issues. Together, we can advocate for greater transparency and access to life-changing treatments.
UPDATE 1/14/25 7:14 PM to accurately attribute the recent comment regarding demand for injectable weight loss drugs to Lilly President of Diabetes, Patrick Johnsson, not Lilly CEO, Dave Ricks.