In a stunning, yet what some may call unsurprising move, the FDA put out a press release early this morning stating that they have officially removed tirzepatide from their master shortage list. This decision comes after a lawsuit brought by the OFA in October challenged the FDA's decsision, forcing the FDA to take a closer look at the supply of branded versions Zepbound and Mounjaro.
The FDA re-evaluated its determination from October 2, 2024, regarding the tirzepatide shortage and issued a new decision today, declaring the shortage resolved. According to the FDA, this determination was based on an analysis of all available information about the supply of branded tirzepatide injections.
However, this resolution has direct implications for patients relying on compounded tirzepatide. In connection with ongoing litigation, the FDA clarified that it does not intend to enforce violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to tirzepatide’s compounding for a limited time to prevent unnecessary treatment disruptions:
State-licensed pharmacies (Section 503A): Permitted to compound, distribute, or dispense tirzepatide injections until February 18, 2025 (60 calendar days from today’s announcement).
Outsourcing facilities (Section 503B): Permitted to compound, distribute, or dispense tirzepatide injections until March 19, 2025 (90 calendar days from today’s announcement).
Despite this temporary allowance, the FDA emphasized that it could still take action against compounded products that are found to be of substandard quality or unsafe. This announcement leaves patients with a narrow window to access compounded tirzepatide before stricter enforcement resumes.
The FDA underscored that semaglutide products still remain in shortage, and thus outsourcing faciliteis may continue to produce what amounts to "essentially a copy" of branded versions. The FDA noted that the patent holder of semaglutide, Novo Nordisk, has reported that all of the doses of their commercial versions of semaglutide (Wegovy and Ozempic) are available.
WHAT ABOUT THE LAWSUIT
As for the lawsuit between the OFA and the FDA, status reports are due to the court today. While nothing has been filed at the writing of this article, the OFA has yet to respond to our inquires on the future of the case, but has since issued a statement from their official Linkedin page:
It is made abundantly clear in the statement from the OFA, that they intend to continue their efforts to hold the FDA accountable for what they are claiming "ignores the facts" about the shortages patients are facing.
In a statement of their own, Scott Brunner (CEO of the Alliance for Pharmacy Compounding), had this to say:
WHAT ARE THE NEXT MOVES
Here are the next moves we will be closely watching at On The Pen:
How does the OFA respond in court to the FDA's update today?
If the OFA moves forward with their litigation, will the judge issue a stay on the enforcement of compound tirzepatide?
Who will be on the receiving end of what is sure to be another avalanche of cease and desist letters from Eli Lilly in the coming days?
How will those letters dictate the future willingness of prescribers/telehealths/and compounders to continue their offerings?
We will be following all this and more, so make sure you are subscribed to our emails for alerts!