As the FDA faces legal challenges from the Outsourcing Facilities Association (OFA), a key question emerges: did the agency thoroughly verify Eli Lilly’s ability to meet market demand for tirzepatide before removing it from the drug shortage list? The answer to this question could determine the future of compounded tirzepatide and the role of compounding pharmacies in addressing patient access to life-changing medications.
Judge Mark Pittman, who is presiding over the case, has a history of demanding transparency and accountability from federal agencies. If evidence shows that the FDA acted without properly verifying supply capacity, it could strengthen OFA’s argument that compounded medications remain a critical necessity.
The Real Issue: Verifying Market Readiness
The FDA’s decision to remove tirzepatide from the shortage list effectively barred compounding pharmacies from producing the medication. The agency’s rationale rested on the claim that the shortage had been resolved—implying that Eli Lilly, the manufacturer of branded tirzepatide (Mounjaro), could meet market demand.
However, the OFA argues that the FDA did not adequately verify this claim. Patients and providers continue to report gaps in availability, leaving many without affordable access to GLP-1 medications. The crux of the case may not be whether the FDA overstepped its authority, but whether it fulfilled its due diligence in assessing Eli Lilly’s supply capacity before taking action.
What Due Diligence Should Look Like
For the FDA to justify its removal of tirzepatide from the shortage list, it would need to demonstrate that it:
Thoroughly Assessed Supply Chains
Did the FDA confirm that Eli Lilly could produce enough tirzepatide to meet demand across all patient demographics?
Monitored Regional Availability
Drug shortages often vary by region. Did the FDA account for disparities in availability across different parts of the country, or did it rely solely on national-level data?
Anticipated Demand Trends
GLP-1 medications are experiencing unprecedented demand due to their effectiveness in treating obesity and type 2 diabetes. Did the FDA consider how this growing demand would impact Eli Lilly’s ability to maintain consistent supply? Furthermore, the FDA granted Zepbound an indication for treating obstructive sleep apnea, the only medication approved for the condition. How will this new indication effect supply?
If the FDA cannot provide clear evidence of these steps, it could bolster the OFA’s case that compounded tirzepatide remains necessary to fill gaps in availability.
Judge Pittman’s Likely Approach
Judge Pittman’s prior rulings suggest he will focus heavily on the evidence—or lack thereof—behind the FDA’s decision. He has a track record of demanding transparency and scrutinizing whether federal agencies adequately justify their actions.
In this case, Pittman may ask:
• Did the FDA have concrete evidence that Eli Lilly could meet market demand?
• Were patient and provider reports of shortages ignored or dismissed too quickly?
• Did the FDA act prematurely in removing tirzepatide from the shortage list, given the growing demand for GLP-1 medications?
If the OFA can demonstrate that the FDA failed to fully assess Eli Lilly’s supply readiness, Pittman may rule to extend the suspension of FDA enforcement or even issue a preliminary injunction that protects compounded tirzepatide during the trial.
The Voluntary Suspension of Enforcement
For now, the FDA has voluntarily delayed enforcement actions against compounded versions of tirzepatide. This move acknowledges the stakes of the case while avoiding immediate disruptions for patients. However, this suspension is not permanent, and expires:
503A compounders: Stop distributing or dispensing tirzepatide injections by February 18, 2025
503B compounders: Stop producing tirzepatide injections by March 19, 2025
Implications for Patients
For patients relying on compounded tirzepatide, the outcome of this case could mean the difference between access and affordability—or being forced to go without treatment. If the court determines that Eli Lilly cannot meet demand and the FDA acted prematurely, it could result in prolonged access to compounded medications as a necessary safety net.
The Bigger Picture
This case highlights a critical tension in healthcare: the balance between protecting branded medications and ensuring patient access. While Eli Lilly’s exclusivity over tirzepatide is legally protected, the FDA also has a responsibility to ensure that patients are not left behind by disingenuous reporting of FDA approved branded medications.
By focusing on whether the FDA adequately verified Eli Lilly’s ability to meet demand, this trial underscores the need for accountability in regulatory decisions that directly impact patient care. In fact, On The Pen has proposed a policy change here, that we could use your “vote” on here.
What’s Next?
Judge Pittman’s decision will likely hinge on the evidence presented by both sides. If the FDA cannot demonstrate that it thoroughly assessed Eli Lilly’s supply readiness, it may face additional scrutiny—and patients relying on compounded tirzepatide may gain a crucial victory.
At On The Pen, we’ll continue to follow this story closely, breaking down what these developments mean for patients and providers. If you found this analysis helpful, please share it with others—because advocacy starts with awareness, and together, we can ensure that patient needs remain at the forefront of these critical decisions.
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