In what may be one of the biggest news stories of 2015, and
one with the potential for long-range health and financial benefits for untold
numbers of Americans is that the harmful effects of Pharma pricing strategies has
seemingly become an issue of primary importance to the U.S. Congress.
But, after the many hearings are held, after the Forums are
over, after the Task Forces disband, after Pharma and its front groups launch
their counterattack using the vast financial support of literally dozens of
members of Congress and the army of lobbyists that will be turned loose on
Capitol Hill, the question remains:
Will this be, as Henry A. McKinnell,, the then-chairman of Pfizer
scolded then-Governor Tim Pawlenty of Minnesota in a press conference following
a shareholders’ meeting in St. Louis, the seeming outrage would
be nothing more than a ‘Prairie Fire that comes along every four years as a
product of the elections and then ‘burns itself out.’
That is why it is crucial that Congress acts to ensure that
the U.S. joins the rest of the industrialized world to ensure that our citizens
have access to affordable, safe, and innovative medicines that will enhance the
health and well-being of all Americans.
As a long-time supporter and advocate for personal importation
of brand name medicines, acting as a consultant on personal importation issues,
I have previously expressed
my support for a Congressional Caucus of Congressional supporters of personally
imported brand name medications.
Now, the furor over the Pharma practice of ‘charging what the
traffic will bear’ has led to a
number of Senators and members of the House
of Representatives of both political parties supporting legislation on
behalf of a range of issues such as ‘pay to delay’; personal importation;
patent rights of U.S. citizens as ‘stakeholders’ because of their dual role as
patients and as major providers of the fiscal support of Research and
Development costs of developing new medicines; and, measures to allow
negotiation of prices for Medicare and Medicaid, a practice already in place
for the Veterans’ Administration.
While all of these initiatives are encouraging, we believe it
is time for a coalition of Senators and Representatives and their staffs to
come together to reach consensus on a single comprehensive bill incorporating
all of the points listed above, and to be prepared to offer their bill
immediately with the reconvening of the 114th Congress in January 2015.
By so doing, Congress will assume its rightful role as the determinant
of policies affecting prescription medicine safety, cost and availability with
a bill that will favorably provide physical and fiscal benefits to untold
numbers of Americans. It will also end
the ‘Safe Haven’ that Pharma has created in the U.S. for its predatory pricing
practices.
It was in August 2014 that I wrote how Pharma
was developing ‘The Perfect Storm” to advance its agenda employing a number of
techniques to ensure that America remained its ‘Safe Haven’.
An exploration of the many aspects of Pharma’s strategy led us
to “…The conclusion is that whereas previous Pharma efforts had been
characterized as admittedly potentially harmful, they were ‘individual’ in
nature and lacked what can be determined in the present circumstance to be
‘cumulative’…”
We noted that “The current Pharma effort on a number of fronts
reflects a comprehensive, coordinated strategy that by its breadth threatens
the health and fiscal interests of the American patient/client…”
We cited the strong support of Pharma’s agenda by members of Congress
who received millions of dollars of contributions from Pharma, noting that there
existed “…An attitude inside the Beltway
by elected Senators and Representatives who are beneficiaries of huge donations
from Pharma interests that is described as a ‘By Invitation Only’ (BIO)
attitude. The BIO-approach limits the opportunity for advocates of
personal importation to testify before Congressional hearings on issues that
affect the role of personal importation while including only Pharma interest
spokespersons.”
The situation was bleak, but at the same time, I observed to
colleagues that there were always certain things that we could count on from
Pharma.
The first was the arrogance of the industry which had led over
many years and instances to a hubris that exposed Pharma’s primary motive, i.e.
to charge the highest prices possible and whatever ‘the traffic will bear’.
I followed that with the observation that perhaps Pharma was
not as smart as we gave them credit for being, noting the comment of a Pharma
lawyer during the submission of comments on Section 708 of the Food and Drug
Administration Safety Innovation Act (FDASIA) in which she called for the
criminalization of individuals who were personally importing their authentic
medicines from Tier One Countries, a policy move that was contrary to all
previous FDA actions.
I have always hoped that the public, policy makers and media
would someday recognize the merits of the mantra published so many times in
these blogs: A medicine that is
unaffordable is equally unavailable, and, by extension, a medicine that is
unavailable is equally incapable of providing any health benefit.
Now, that day has come, and it is Pharma
that is attempting a pushback to overcome the wrath of the public and policy
makers by claims that treatments that cost $80,000 to $100,000 are ‘worth it’
when compared to the alternative of dying.
But the highly expensive, overly priced specialty medicines were
only the tip of the iceberg. One need to
only consider the spike
in Generic prices in the last year.
There is finally a recognition of the problem of the predatory
pricing policies at a national level as the two
Democrat candidates for President have offered comprehensive legislation
that for the first time combines all the elements that have contributed to
Pharma abuse in proposed legislation.
The proposals include dealing with ‘pay
to delay’ tactics that keep lower-cost medications from being introduced; a
recognition of the ‘stakeholder’ role of U.S.
citizens and taxpayers who provide much of the funding for Pharmaceutical research
in the U.S. through their support of the National Institute of Health; a
call for changes in the prosecution of criminal activity by Pharma members that
would hold not merely the companies liable, but would subject the offending
officers of the firms to criminal action; and, a strategy that would allow the
ending of patent protections with the ‘ownership’ of the patents ‘returning’ to
American citizens; finally, there are many bi-partisan bills in the U.S.
Congress dealing with one or another aspect of Pharma practices including ‘pay
to delay’, personal importation of Brand Name medicines from Tier One
Countries, promotion of the broader use of generics,
The result is that whereas a year ago, Pharma was creating ‘The
Perfect Storm’, it today is in an unprecedented situation in which it is not
the determiner of the debate, but is instead is engaged in the middle of the
storm with lightning bolts directed at them by hospitals, insurance companies,
patients, Presidential candidates, and Congressional investigations.
This creates a climate of opportunity for long-suffering
Americans who have paid steadily increasing prices for their medications. It creates
a climate of opportunity to end Pharma actions that create costly—and too often
unaffordable medicines—that are a major driver of health care costs. It creates a climate of opportunity to
recognize the role of the American patient, caregiver, family member as having ‘stakeholder’
rights that merit a seat at the table in the form of ordinary citizens and/or
their advocates.
Most importantly, it creates a climate in which the totality of
the harmful effects of Pharma pricing strategies has been exposed.
The challenge: Will Congress exercise leadership
to take the steps that will ensure success, or, will we witness another Prairie
Fire burning out?
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