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.
[i] http://www.raps.org/Regulatory-Focus/News/2016/01/28/24195/FDA%E2%80%99s-Woodcock-Generic-Drug-Application-Backlog-Will-be-Eliminated-Before-GDUFA-II/
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