OFA Provides EXCLUSIVE Statement to OTP on Tirzepatide Ruling + Viewers Provide More Proof of Continued Shortages

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Yesterday, a federal judge in the Northern District of Texas issued a sealed ruling in the case between the Outsourcing Facilities Association, or OFA, and the FDA, denying OFA’s motion to reinstate tirzepatide to the official drug shortage list.

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While the full ruling has not been made public, OFA Chairman Lee Rosebush confirmed the outcome with the following statement:

“We are disappointed with yesterday’s decision by the U.S. District Court for the Northern District of Texas upholding the FDA’s determination that tirzepatide drugs are no longer in shortage. Drug shortage determinations affect patient access to medical treatment and should be based on sound reasoning and verifiable data, not the say so of self interested manufacturers seeking to push competitors out of the market. We continue to hear from patients who cannot access tirzepatide. We will not stop in our efforts to ensure that patients can obtain these vital medications and intend to appeal.”

This decision keeps the FDA’s current position intact. Tirzepatide is no longer considered officially in shortage. That has immediate consequences for patients, especially those who rely on compounded medications. With the exemption removed, pharmacies that were previously allowed to prepare compounded tirzepatide will now be prohibited from doing so under federal law.

But even as the FDA steps away from the shortage label, real world signs point to ongoing problems.

This week, Anthem and CarelonRx informed members that GLP-1 medications, including branded tirzepatide, are temporarily unavailable for home delivery due to what they described as a nationwide shortage. Their announcement is available here.

On the actual day of the ruling, a viewer forwarded me an email they received from Eli Lilly, after signing up for updates about Zepbound availability. The message said:

“While Lilly continues to manufacture and ship all doses of our medicines, over the next few months, you may experience difficulty when trying to fill your prescription. We are working with purpose and urgency to help meet the surge in demand and to minimize disruptions in the treatment plans for everyone who relies on our medicines.”

That statement, from the manufacturer itself, clearly acknowledges a supply strain.

On top of that, not all vial strengths are available. As of this writing, only the 2.5mg-10mg Zepbound vial is currently offered through LillyDirect. The upper doses of 12.5mg/15mg have not yet been released (#ReleaseAllTheVials).

So even if you have a prescription, and even if you are going through official channels, your treatment plan may not be supported with the product you actually need.

The court may have ruled, but real-world evidence suggests the underlying issues are not resolved.

You can hear more about the OFA’s position and legal strategy in my recent interview with Lee Rosebush in our recent interview. As he said in his statement, the association plans to appeal.

The fight may have shifted to a new phase. But for patients, the challenge of access remains very much in the present.

Stay tuned to our Substack for ongoing updates and original reporting on GLP-1 medications and access challenges. If this story resonates with you or someone you know, please share it. Together, we can keep pushing for accountability, clarity, and care that reflects reality.