Zepbound and Mounjaro Shortages Are Over: What This Means for Compounds

According to the latest update from the FDA shortage website, all strengths of Zepbound and Mounjaro are listed as “available”. Does this mean that the shortages are over? And what does this mean for the compounded versions that the FDA authorizes during times of shortages?

WHAT IS THE FDA SHORTAGE LIST

In order to understand the significance of this update, it is important to have the context of what this FDA shortage tool is and how it works. The FDA drug shortage list is a critical resource managed by the U.S. Food and Drug Administration to monitor and address the availability of essential medications in the United States. This list includes drugs that are currently in short supply, providing transparency and updates to healthcare providers, patients, and stakeholders. The FDA identifies (via self-reporting tools offered to manufacturers) a drug shortage when the demand for a medication exceeds its supply, which can happen due to various reasons such as manufacturing issues, supply chain disruptions, or unexpected increases in demand. In the case of Zepbound and Mounjaro, the injector pens (not the ingredients) have been identified as the reason for the shortage.

When a shortage is reported by the manufacturer, the FDA collaborates with the manufacturers to understand the root cause and work towards resolving the issue. This might involve expediting inspections and reviews, finding alternative manufacturers, or coordinating with international suppliers. The agency also prioritizes the communication of shortages, offering regular updates through its website to keep the public informed about the status of affected drugs and potential mitigation strategies.

WHY IT MATTERS

Once a drug is identified and reported by the FDA as being in short supply, legislation from 2013 allows 503B compounding pharmacies to manufacture "copy-cat" drugs to help ease the shortage. This means straight API copies of drugs like tirzepatide can be prescribed and filled, primarily by telehealth companies.

503A pharmacies have always been allowed to fill off-brand prescriptions for patients needing compounded formulations of brand-name drugs based on medical necessity. For instance, a patient allergic to a dye or preservative in a brand-name drug may require a variant of the active pharmaceutical ingredient to be compounded.

In contrast, 503B pharmacies have a different mandate focused on easing drug shortages by mass-manufacturing drugs, whereas 503A pharmacies compound individual prescriptions. Once a drug is removed from the shortage list, the FDA offers a 60 day grace period to 503B pharmacies to fulfill remaining large orders, before enforcement begins. 503A pharmacies are not offered the same grace period, and must return to manufacturing truly compounded versions, only when a medical requirement precipitates the need.

SO WHAT DOES THIS MEAN FOR COMPOUND TIRZEPATIDE’S IMMEDIATE FUTURE

As of today, 8/2/24, all doses have been reported as “available”. This does not mean, however, that Mounjaro and Zepbound are no longer considered “in shortage” by the FDA. Mounjaro and Zepbound (tirzepatide) still remains on the master shortage list. If Eli Lilly continues to report all doses as available, they can then work with the FDA to remove tirzepatide from the shortage list entirely, at which point the 60 grace period would begin for the 503B pharmacies.

The issue, as I see it, is that the shortage list is by and large a self-reporting tool. We are relying on the good faith of the manufacturers to provide accuracy in their reporting, even when there is great financial incentive for them to report otherwise. A successful removal of tirzepatide from the FDA shortage would effectively end the legal work around the patents, and compounded tirzepatide would become much less accessible. If the shortages are truly over, great. But thousands of patients making their voices heard online would argue otherwise.

Based upon messaging from Lilly executives on recent earnings calls, Zepbound and Mounjaro shortages would likely last through 2026 when Orforglipron, Lilly’s oral GLP-1 candidate, is predicted to come to market. Based upon their own words, it would be infathomable that a nearly $800 billion dollar company could miscalculate supply and demand that badly. More likely, this is a temporary repreave that will not effect compounds long-term. That is unless Eli Lilly plans to implement the calls to #releasethevials and brings more product to market, and soon.

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