On December 19, 2024, the FDA finalized its reexamination of its initial decision (on October 2, 2024) that the tirzepatide shortage had been resolved. This comes after compounders of the drug ran to court to challenge the Agency’s initial decision. The latest notice of the shortage’s resolution came yesterday in a declaratory letter (here), issued by the FDA to Eli Lilly and Company, explaining its final decision that the shortage has been resolved.

This decision impacts pharmacies that compound tirzepatide based on individual prescriptions (known as 503A compounders) as well as outsourcing pharmacies that produce the product in bulk (known as 503B outsourcing facilities) that come under direct FDA scrutiny.

In its decisional letter, the FDA states, “Tirzepatide injection products were first added to FDA’s drug shortage list on December 15, 2022. The Agency determined that the shortage was resolved and removed tirzepatide injection products from FDA’s drug shortage list on October 2, 2024. FDA has now reevaluated that decision… This order revokes and replaces FDA’s October 2, 2024 decision on the same subject.”

In the letter, the FDA also notes that “We [the FDA] conclude that the information and data Lilly has provided to FDA demonstrate that Lilly’s supply is currently meeting or exceeding demand for these drug products, and that Lilly has developed reserves that it now holds in its finished product inventory, plus significant units of semi-finished product, and has scheduled substantial additional production over the coming months, such that supply will meet or exceed projected demand.”

While the “final” decision, at least this one, means that compounders will not be able to compound duplicate copies of FDA-approved tirzepatide products, the FDA’s decision (while final) will not be an immediately effective action-taking against such compounders; the FDA has provided a grace period during which it will exercise enforcement discretion prior to taking any action as follows:

  • For state-licensed pharmacists or physicians compounding under section 503A of the FD&C Act, 60 calendar days from the date of this order, until February 18, 2025; and
  • For outsourcing facilities under section 503B of the FD&C Act, 90 calendar days from the date of this order, until March 19, 2025.

The letter provides significant details as to how the FDA utilized certain data and facts in making its determination that this drug product was in shortage, and it describes the Agency’s process for evaluating that a product shortage is resolved. Please see the letter for additional details as to the FDA’s decisional process and the Agency’s discussion of its authority.

For more background, see our previous posts about this saga here, here, here, and here. Please note that there is still ongoing litigation by various parties concerning this issue. For now, we have the FDA’s position clearly outlined; however, the question is, will there be a third chapter to this story?

 

 

Photo by nosha from Pennington, New Jersey, USA – The big brass ring, CC BY-SA 2.0, https://commons.wikimedia.org/w/index.php?curid=62805793