by Daniel Hines, Publisher
Hillary Clinton’s strategy to deal with lowering prescription
prices is the most comprehensive approach employing several action steps that
have previously been introduced only as individual actions reliant upon
reaction to a series of Pharma price abuses.
As such, it represents hopefully an end to Pharma’s actions
that have been based on its confidence that it can charge what the traffic will
bear, thumbing its Collective nose at Congress and the American public.
Most importantly, its stand on imported medicines proves that
the Food and Drug Administration Pharma and
Pharma supporters have misled the American Public on the ability to ascertain
the authenticity and safety of personally imported medicines!
While GOP Candidate Donald
Trump has indicated his support for strategies to lower prescription drug costs, he has yet to come forth with specifics to lower prescription drug prices.
Also,
while the Democratic Party Platform specifically endorsed and supported a role
for Personal Importation, an end-to-pay to delay and other steps to lower prescription
drug prices, the GOP Platform had no mention of healthcare except for a call
for repeal of the Affordable Care Act (ACA).
Additionally, former GOP Speaker of the House Newt Gingrich
recently touted the GOP Platform as supporting ‘Pharma innovation and research
and development’. Gingrich specifically
attacked the role of Personal Importation of brand-name medicines from Tier One
Countries, asking only that the American public adopt a ‘trust us’ attitude
towards Pharma.
An examination of Ms. Clinton’s proposal is triggered by a realization
of the fact that unaffordable medicines are, in and of themselves, unavailable
because of their unaffordability.
At the same time, it is limited because it deals with ‘emergency-like’
crises that continue to occur with a disturbing frequency as Pharma continue
its pricing abuses. That’s why it is
time that the Presidential candidates take a strong stand to enact permanent—not
just temporary or emergency-related incidents.
Some thoughts on her plan follow:
- · Her plan calls for implementation when drug prices are ‘threatening’ the health of Americans because the drugs are unavailable due to their price. This should be extended to unaffordable ‘maintenance’ brand-name drugs that millions of Americans rely upon as a vital link to their health and well-being;
- · While her plan calls for ‘temporary,’ personal importation, if she were elected, she likely would have to use executive orders to implement and utilize such a ‘temporary’ role for importation. That’s why Congress should end its seemingly endless delays, investigations, statements, and business as usual;
- · Her stance clearly calls upon medicines from what can only be construed as a reliance upon Tier One Countries with proven standards of safety and efficacy that meet of extend those of the U.S.;
- · She points out that the Food and Drug Administration has in the past allowed such ‘emergency’ importation;
- · This is a tacit admission and recognition of the fact that, contrary to repeated claims of the Food and Drug Administration regarding personal importation that :
- o It is indeed possible to monitor and certify the safety, authenticity of brand name medicines ‘imported’ to the U.S.;
o
The
fact that such ‘importation’ would have to be implemented quickly to be of
benefit indicates that the FDA also is capable of such validation of the
sourcing, manufacture, packaging, safety and efficacy of imported medicines,
particularly since it has for years cooperated with foreign sources for
ingredients' oversight, and it has worked with regulatory agencies in other
countries during previous ‘emergency’ importation;
o
The
implementation of even a temporary importation’ program would be proof positive
of the safety and efficacy of imported medicines as well as their immediate
economic benefit, and, in the long-term, their favorable impact upon American’s
health. The lie to claims by Pharma and
the FDA that a medicine allowed to be imported from a Tier One Country cannot
be validated would be repudiated. A medicine that is imported in an ‘emergency’
situation that is safe and authentic cannot become fraudulent after the ‘emergency’
is over. Simply put, when a medicine—any
medicine—is unaffordable, it is unavailable, and that unavailability creates a
crisis and emergency situation for the individual denied access to vital
medicines;
o
A
‘temporary importation’ would illustrate the contradiction of a policy that
raises questions about the ‘legality’ of personal importation, since it clearly
illustrates that the Federal Government is willing to consider importation as a
part of a national policy to lower prescription drug costs to protect the
health of Americans;
o
That
benefit to medicines and the right to purchase them via personal importation
should be extended to the millions of Americans who are unable to afford not
only their specialty medicines, but their highly important maintenance medicines—maintenance
medicines that have been proven in the Rand study of enrollees in the
Affordable Care Act to improve patient health and lower total drug spending;
o
The
Clinton plan calls for consumer involvement and representation in an oversight
group to monitor and determine when price abuses by Pharma have occurred, one
of the key articles of the American Rx Bill of Rights. The key to the effectiveness of such a group
will be based on a determination of the members of the ‘consumer’ advocacy segment
and how they will be selected. The concept is a valid approach, but only if
implemented in such a fashion as to include truly representative advocacy
groups that represent patients’ rights and needs;
o There is a strong emphasis
in the Clinton plan on the role of generics.
But, in what is can only be construed as an admission of the failure of
such a previous reliance upon generics to lower drug costs because of their
being co-opted for many of the price increases in the past 18 months, the
Clinton plan calls for fines and penalties to be assessed against Pharma and
generic industry firms that are found to profit from excessive price increases;
o
The
plan calls for an end to several key elements of Pharma strategies: One is pay-to-delay, a tactic to delay the
introduction of generics to replace brand-name drugs scheduled to lose patent
protection; another is a call for negotiating Medicare Drug prices; The plan
would also call for an end to the backlog of generic applications awaiting
approval at the FDA; and, in one of the most dramatic recommendations, it calls
for an end to direct-to-consumer (DTC) advertising by Pharma, with the money spent on DTC being redirected
to Research and Development.
If any strategy—be it that of Ms.
Clinton or Candidate Trump—is to succeed, both candidates would be well-served
to remember that years ago, at a press conference after a Pfizer Board meeting,
then CEO Henry McKinnell commenting on remarks by Minnesota Governor Tim
Pawlenty said that efforts to lower prescription prices were nothing more than
“a Prairie Fire that breaks about every four years as an election issue
and then burns out.’’
Such a statement shows the contempt
that Pharma has long held for the American political process—a contempt based
upon Pharma’s extensive lobbying and millions of dollars in campaign
contributions, including to Ms. Clinton.
It is time to end the pricing
abuses of Pharma and to implement policies that will lead to the health
benefits that only access to safe, affordable prescription medicines can
provide. Failure to do so will once
again leave the rights of Americans to enjoy the benefits of good health such
access can provide in the ‘ashes of yet another Prairie Fire.’
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