Much has been written about the EpiPen shortage. I predicted in this article last year that the recalls would spread worldwide, and sure enough, the shortages spread to Canada last month. The way the recalls and shortages have rolled out reminds me of when you find the beach you normally go to open, but the one right down the shoreline has been inspected and is closed due to E. coli contamination. One week later, the contaminated beach has reopened, but your beach has now been inspected and closed. The truth is, like EpiPens, your beach didn’t suddenly get shitty that week. The beaches were both shitty the entire time, you just hadn’t been notified about it yet.
To explain, the EpiPen shortage exists because in 2017 the FDA inspected Meridian Medical Technologies (the company owned by Pfizer that manufactures EpiPens) and found that due to violations of good manufacturing processes, they were producing adulterated products. The result of its investigation is contained in this letter. You will see in that letter that similar violations were found three years earlier in a 2014 inspection, which were not rectified by Mylan. Instead, Mylan continued selling EpiPens to you for three more years without rectifying the deficiencies. It also raised the price of EpiPen two packs from $300.00 to $608.00 during that period.
While researching this article, I came across a fun fact contained in this article: “Meridian has run into federal trouble before. In 2013, it had to replace injectors sold to the military that were to be used in case of a sarin gas attack. Pfizer had discovered that about 7 out of 1,000 of its DuoDote autoinjectors containing atropine and pralidoxime didn’t contain enough of one or both of the drugs.”
To make matters worse, there is a 2013 report of the FDA that will make your hair stand on end. EpiPens and EpiPen Juniors that were inspected were found to have crooked needles, empty cartridges, 126(!) of them failed to activate and 48(!) were found defective for providing a slow dose. There was foreign matter in some tubes, missing or unclear labeling, loose safety pins, missing components, and 93(!) of the inspected pens spontaneously activated. How badly do you want EpiPens to come back now?
If you live in a country where alternative auto-injectors exist, this break from EpiPen availability is a good thing, in my submission. I would run not walk to those alternatives. If you’re lucky enough to live in the United States, you have access to Auvi-Q, which I think is the best product for a few reasons.
The Auvi-Q is small and rectangular, so it fits neatly in your pocket. You should carry two doses of epinephrine on your body, and the size of an Auvi-Q really encourages self carrying, since it couldn’t be smaller and eliminates the need for an EpiPen belt or holster.
Due to the Auvi-Q’s design, the injection is painless. The needle enters your body at exactly a ninety degree angle, which causes less tissue damage than an EpiPen. Although you hold the Auvi-Q in place for five seconds, the needle leaves your body within a fraction of one second, again causing less tissue damage than an EpiPen, which requires you to hold the extended needle in your leg for five seconds.
To satisfy the FDA concerns, Mylan must have the line shut down for a period of time. I suspect they are revalidating the line and will focus on supplying the US (higher profit) before other less profitable markets. In other words, I predict that you will be able to buy EpiPens in the United States before the shortages in the rest of the world are rectified.
The leaders of Mylan have exploited their allergic customers in every conceivable way for long enough, and the end of the EpiPen monopoly is long overdue. Please ask yourself if you really want to buy an EpiPen now, given Mylan’s manufacturing history and greed.
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Thank you for the info Ms Goldenberg. I will most definitely inform my kids about Audi-Q. Now that they are both working adults, having choices is a better option. Also I think having to choose a compact epipen and carrying both with them is smarter than just bringing one in a small purse. FYI, both my kids had to deal with allergies since birth and I develop allergic reaction to tree nuts and peanuts after age 40. I have been carrying epipen for almost 20 years and the cost keeps on increasing and expiration date decreasing. After reading this, I shudder to think how reliable are the ones I have. I hope that there will be more better competition against a company that only cares about their own agenda. And every time I had to throw away an unused epipen for the past almost 20 years, I get mad because of the waste. We are living in the 21st century and yet we are producing more waste and waste more resources because apparently some companies just can’t seem to help themselves. And that’s shitty!
08-21-2018
Hello, Ms. Goldenberg;
thx 4 yer comments. I am always interested in your reading the postings on your blog via email.
Concerning the recall situation for Mylan’s Epi-Pen, yes, the current situation is serious and deplorable. Our association fully supports Rx for all alternative epinephrine auto-injector devices including Auvi-Q and particularly generic devices. The recent approval by the FDA of the new generic EAI device from TEVA is an encouraging development; more competition in the consumer patient epinephrine market place will help drive down the cost of the medication.
And another thing. Please don’t use profane language in your messages. It is my opinion that posting ugly four letter words so carelessly detracts from the important thoughts and ideas you are sharing with your readers.
Thank you for your time and attention. Best wishes, Elizabeth..