Critics of the pharmaceutical companies will use the Epi-Pen price hike as another example of corporate greed -- and so it is. Competition keeps corporate greed in check better than any form of legislative price control. But as Dr. Mary Ruwart points at in this article, the real culprit here is the FDA, which has delayed or killed Mylan's competition. 

By Dr. Mary Ruwart

Last October, Sanofi withdrew Epi-Pen’s last true competitor, Auvi-Q,  from the market after some suspected device malfunctions.  Without competition, Mylan, which acquired the Epi-Pen in 2007, when it was selling for around $57, raised their prices to $600 for a 2-pack.  I was actually quoted $800 at my pharmacy.

Teva had submitted an application for a generic version of the Epi-Pen to the FDA.  However, the agency felt “certain major deficiencies” needed to be addressed. Marketing of Epi-Pen’s new competitor will be delayed until at least 2017.

Adamis wants to market a syringe prefilled with epinephrine, the active drug in the Epi-Pen. Some diabetics must inject themselves with insulin, so use of a syringe, rather than an Epi-Pen-like device, is not unprecedented.  The FDA wouldn’t approve it without more studies on patient usability and product stress testing. Mylan is protected from still another competitor by regulatory delays.

Read the full article here.