As we reported last week, the US – following Canada and the UK – is now in the midst of a de facto EpiPen shortage. Though it is our understanding that Pfizer’s Meridian unit, the manufacturer of EpiPen for Mylan, is having production issues, there is little else we know because Pfizer is not forthcoming.
We reached out to the company with specific questions aimed at gaining a better understanding of the issue, but were met with a response from their Director of Corporate Affairs that was little better than opaque double-speak:
We are currently shipping product; however, supplies may vary from pharmacy to pharmacy. The FDA has not announced a shortage in the US.
We understand how important this potentially life-saving product is to patients, and we are working closely with Mylan to monitor supply levels so patients have access to epinephrine auto injector products.
We call “BS” on Pfizer’s response: If they truly “understood”, they would know that the food allergy community is up in arms over the shortage with many desperate to find supplies and many others concerned with Pfizer’s continued ability to produce a safe and reliable product.
Our readers vividly remember last year’s EpiPen recall and the FDA’s subsequent admonishment to Pfizer for numerous violations, including this gem:
You failed to thoroughly investigate multiple serious component and product failures for your EpiPen products, including failures associated with patient deaths and severe illness,” the warning read. “You also failed to expand the scope of your investigations into these serious and life-threatening failures or take appropriate corrective actions, until FDA’s inspection.
It is evident that Pfizer is dealing with significant issues in the wake of the FDA’s warning, but the firm feels little obligation to the consumers who have placed their trust in company’s ability to deliver a product that can be relied upon in a life-or-death emergency.
We call on Pfizer to come clean regarding the manufacturing issues currently plaguing EpiPen production. We demand to know what has transpired to date and the steps the company is taking to correct their processes to ensure their product can be relied upon when sufficient quantities return to pharmacies.
We also ask our readers to reach out to Pfizer and demand likewise. To make that process as simple as possible, click here for a pre-formatted mail message, add your signature and send it.
We are not a community that will allow itself to be treated like sheep, bound – as we were in the past – to a single provider of an indispensable drug. We demand accountability from the companies that produce the products that stand between life and death for ourselves and our families beginning with Pfizer.
I, too, was very suspicious of their vague explanations. After digging around, the only thing I could come up with was that they have a laundry list of FDA violations at their facilities. Why they can’t get their act together and fix them is beyond me. They need to be held accountable.