Sunday, August 28, 2016

The Outrage over the EPIPEN Cost Increase, and Why it’s the Administration’s Fault

By now almost everyone with a computer is aware of the following facts.
  • The EPIPEN is a critical, as in life saving, delivery tool to provide epinephrine in a measured dose to someone entering into anaphylaxis shock from a severe allergic reaction.
  • Mylan Pharmaceutical increased the cost of the its EPIPEN by 400%, potentially eliminating access of this medical tool to the most needy.
  • There is nothing proprietary in the medicine (epinephrine).
  • The CEO of Mylan is Heather Bresch, a Clinton donor, and the daughter of Joe Manchin -- the senior democratic senator from WV
When this price increase became public there was a huge outcry over the greed of these pharmaceutical companies (going back to the previous outrageous increase in generic HIV medications by Turning), and how the government needs to crack down on them and implement price controls so this can’t happen.
Well let’s look at some other relevant facts about this whole affair, starting with the Patient Protection and Affordable Care Act (AKA Obamacare).  You all remember that don’t you?  Isn’t this an affordable care issue?  Of course it is, and Obamacare actually addresses the solution to this, but the administration has been so busy campaigning it really hasn’t done what its own law says it should do.
The ACA called for the FDA to issue guidance and to expedite the approval of generic drugs and to introduce competition to the drug market.  In the six years since the ACA was signed what has the FDA done to approve alternatives to these medicines?
Well according to the Regulatory Affairs Professionals Society website[i] as of January of this year there were over 6,000 applications pending FDA review and approval/disapproval.  The average response time from the FDA has increased from 30 months to 48 months.  So much for speeding up the process!  Also noted in this article is the fact the FDA does not even have a process for determining what acceptable pricing ranges are for the generic drugs it has approved.
So now let’s talk about capitalism and greed.  The socialists of the left love to talk about our capitalist system and greed, as if greed only existed in a capitalist market.  But here we have something other than a free market system where a drug company must be concerned with competition, because the government has interjected itself into the market place through the approval of the drugs, and the governments concern about keeping drug companies profitable by limiting the approval of competitive drugs.  It has also dramatically reduced free market competition through the approval of mergers and acquisitions of the various companies by other companies further narrowing the competition. 
For those who will answer that the FDA existed under the Bush administration my response is so what?  The A in the ACA is affordable, and the ACA didn’t exist under Bush, the President promised to reduce the cost of health care.  What has this administration done to improve affordability, other than complain about Republicans, Capitalists, Bankers and the greedy drug companies.  The power to affect the changes are in the law, and the FDA, responsible to the President through the Department of Health and Human Services has created the climate where a company like Mylan and its Democratic CEO are empowered to gouge the public because they have political top cover by the President and the Democratic candidate.


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