Mylan confirms EpiPen “supply disruption” (i.e. shortage) and more
A few things happened today that shed more light on the shortage of EpiPens in the U.S. market since I last shared my point of view (though, again, Mylan and Pfizer – who manufactures the product – continue to point out that the FDA is NOT calling this a shortage, but rather, an “intermittent supply”).
First, the FDA DID today add Mylan’s branded and generic versions of the regular and junior EpiPens to their drug shortage list. The stated reason is “manufacturing delays.” The following is under “relation information.”
There are intermittent supply constraints due to manufacturing delays from the manufacturing partner, Meridian Medical Technologies, a Pfizer company. Mylan is receiving continual supply from MMT and expediting shipment to wholesalers upon receipt. Supply levels may vary across wholesalers and pharmacies. Patients who are experiencing difficulty accessing product should contact Mylan Customer Relations at 800-796-9526 for assistance in locating alternative pharmacies.
So here we see those same words both Mylan and Pfizer are using – “intermittent supply.” What does that mean? Means you may not be able to find these products easily. Why does that occur? It occurs because there’s a shortage. That’s how I translate legal language to common sense language. It doesn’t mean they’re in such short supply that we need to storm the pharmacies before they’re all gone, but they’re still not satisfying the market’s need.
The second occurrence today was the release of Mylan’s 1stquarter financial results and association investor conference call. First off, Mylan’s revenues from EpiPens declined significantly once again. My best estimate parsing their words was that EpiPen revenues were down roughly $50-100M in the quarter alone! Now, during the investor day they held last month – in which they only mentioned EpiPen once in a 108-slide presentation – they said that “competitive market dynamics” were causing a decline in EpiPen sales. (This follows a year in which EpiPen revenues were down dramatically – by $655 million!!!) While a large part of this is likely related to the shift in sales from the $600 branded EpiPen to the $300 generic, and an unknown amount must have been lost from the manufacturing problems causing Canadian, and now U.S., shortages, we know Mylan is losing share as well. But how much? How much share is AUVI-Q stealing? How much is CVS getting with their generic?
Related to the shortage, Mylan confirmed “supply disruption” and “intermittent supply,” noting Pfizer’s “manufacturing setbacks.” They say that Pfizer’s supply is increasing each month, but did not specify how substantially. Notably absent was any confidence that this issue would be resolved soon. Remember that when we reported on the Canadian supply shortage, the company was confident about when the shortage would end. They turned out to be very wrong, but still thought they had an answer. So is Mylan just being cautious now after the Canadian experience or do they lack enough visibility to give a time frame?
Judging by our research and contacts with the companies, as well as those by others, I’d say no one knows when the shortage will be resolved.
And yes, I still call it a shortage.
What are your thoughts? Where have you experienced a lack of supply? Has it been related to branded EpiPens, the generics, or both? Are you switching your epinephrine autoinjector supplier (and, if so, to who)? Share, share, share! We need your feedback!