As the articles above point out, there are several mechanisms in place for Mylan to support the high price of the Epipen. One thing about the case that I wanted to find out is why the FDA keeps rejecting competitors. The rejection that stands out is that of Teva Pharmaceuticals’ application, which was rejected February 23, 2016. The only thing that were reported as the cause was “major deficiencies.” There is little visibility into FDA rejections.
Mylan spent $1.5 million on lobbying in 2015. Much as I the am against the costly FDA approval process and lament the distasteful (yet successful) lobbying by Mylan, I don’t really see how their influence could reach inside the FDA. The rejection of Teva’s application is unfortunate, and the process should be more transparent, but there is no discernible link between Mylan and FDA.
Nevertheless, I have filed a FOIA request with the FDA. I will report again if I get any information regarding the rejection.