FDA partly to blame for EpiPen cost
Wow, can things change quickly.
I remember 20 years ago when the average person had never heard of severe anaphylactic shock from food allergies. Those times are far in the past, as proven by Wednesday’s news cycle. Major news sources and presidential candidates both publically shamed Mylan, a large pharmaceutical company with headquarters in Southpointe, for unnecessarily raising the price of their product the EpiPen.
The EpiPen is currently the only medicine approved by the Federal Drug Administration for stopping an anaphylactic reaction to severe food allergies. I have dealt with severe food allergies for almost 20 years, and also work in the public policy sector, so I have a few things to say on this topic.
To begin, all of the fingers should not be pointing toward Mylan. It is true that the EpiPen’s cost has increased over eightfold in the past nine years, which is controlled by Mylan. But the FDA and poor legislation have paved a yellow brick road allowing Mylan to increase the EpiPen’s price unconventionally. The FDA has created a virtual monopoly for Mylan through continual regulation. The average drug takes more than seven years to make it through the FDA’s intense clinical trials, and only 10 percent of these drugs succeed in getting approved by the FDA to take to market.
It is no surprise then the EpiPen only had one competitor at the start of this year, the Auvi-Q created by Sanofi, a French pharmaceutical company. Sadly, the Auvi-Q had an issue with dosage delivery and was put on major recall back in February. Sanofi has not produced any Auvi-Q’s since that recall.
Thus, there is no competition for the EpiPen, allowing for a price spike.
On top of the FDA creating barriers to entry for new and innovative competitors in the food allergy industry, the FDA also protects drugs for a period of time through a patent exclusivity system. Many parts of the EpiPen are patented, including its delivery form, making it even more difficult for new drugs to be brought to market that are similar to the EpiPen. Trust me, many pharmaceutical companies see the profit to be made by creating an EpiPen generic equivalent. Sadly it is the means, not the end that is the problem.
Yes, I do believe Mylan should take into consideration the impact that continually raising the cost of EpiPens will have on the average middle income family, especially since the negative media attention will hurt their brand. But the American people also need to call out the FDA and other regulators for creating the means for this problem to exist in the first place.
Stephen Strosko
Eighty Four
Strosko is a policy associate with the Mercatus Center, a think tank affiliated with George Mason University, though he said the letter “reflects my personal views and not that of Mercatus’s.”