At the same facility producing the EpiPen, which earlier in the year had been recalled following a pair of reports of the misfiring of the auto-injector devices, when that recall ended, which is in the FDA letter, there were not any reports released to the public of any deaths associated with the use of the EpiPens.
The manufacturing issues have been yet another setback for Mylan in its quest to maintain EpiPen as a big-selling product.
On March 31, 2017, Mylan announced that a voluntary recall, which began in Europe, Australia and Japan, was expanded to include certain lots of U.S. EpiPens “as a precautionary measure out of an abundance of caution”.
It also narrows their blood vessels.
“Pfizer is continuing to work with FDA to resolve the points raised in the letter regarding Pfizer’s manufacturing of EpiPen Auto-Injector and Mylan will do whatever it can to support this process”, Mylan said in an emailed statement to BioPharma Dive. The device is created to inject epinephrine to halt risky allergic reactions.
This pricing was up 500 percent from the cost of a two pack ten years ago.
It wasn’t until the FDA urged the company to look at the issue more closely, the warning letter says, that the Pfizer operation discovered that its supplier had produced a “deformed” part that was used in multiple lots of EpiPen products, 13 of which had been distributed in the U.S. It was only at that point the Meridian recalled the potentially defective units. Meridian received another complaint on April 28, 2016 about an device that didn’t activate properly, and ultimately determined it was because of the same defective parts. It rejected the lot and one other, but “did not examine any units from the associated lot to determine whether additional units were affected by the same or similar manufacturing defects”. In particular, the agency questioned why Meridian grouped complaints about autoinjectors that didn’t activate as “expedite” while complaints about autoinjectors that dispensed epinephrine before it was actually used were billed as “normal”.
Pfizer was aware of these complaints but did nothing to address them, according to the letter.
In fact, your own data show that you received hundreds of complaints that your EpiPen products failed to operate during life-threatening emergencies, including some situations in which patients subsequently died.
Mylan responded by launching an authorized generic for $300.
The company also said that the chance that an EpiPen is used incorrectly is great since most people who use them – to inject themselves – are not doctors.
A spokeswoman for Pfizer, Kim Bencker, said in a statement that the company was “very confident in the safety and efficacy of EpiPen products being produced at the site” and noted that it has shipped more than 30 million EpiPens since 2015.
The company added that they do not anticipate any supply issues as a result of the FDA’s warning letter.