Inside the Tirzepatide Supply Number That Could Bring The FDA Lawsuit Crashing Down

There is a moment buried in the April 24 court transcript that deserves much more attention.

At the heart of the lawsuit over compounded tirzepatide lies a simple but explosive discrepancy. The FDA removed tirzepatide from the drug shortage list based on a supply figure provided by Eli Lilly. That figure was used to justify cutting off access to compounded versions of the drug, effectively handing full market control back to Lilly.

But here is the problem…

In Lilly’s own court filings, they admit they never actually hit that supply number.

Read that again.

The FDA ended the shortage designation based on a supply projection Lilly never reached. That means one of two things happened:

Either the FDA misrepresented what Lilly told them,

or Lilly overstated what they could do.

Neither is a good look.

And it raises a bigger question:

What did Lilly report in their financial statements?

If they told the FDA they were hitting a certain production threshold,

but told Wall Street something else entirely…

That is not just a policy issue.

That is a regulatory issue.

And the judge noticed.

At one point during the hearing, Judge Mark Pittman asked FDA counsel directly why the agency accepted Lilly’s numbers at face value, especially since they were contradicted by Lilly’s own filings. He later circled back to that exact issue, noting that the agency’s lack of reasoned explanation might be the cleanest legal basis for vacating the FDA’s decision.

In other words, this is not just a compounding issue.

It is not just about access.

It is about credibility, and the court knows it.

We are not just talking about the Administrative Procedure Act anymore.

We are talking about trust.

We are talking about transparency.

And maybe, we are talking about the SEC.