As
the 112th Congress concludes its business and we prepare for the
launch of the 113th Congress, it is appropriate to call attention to
one of the continuing major drivers of healthcare costs—the fact that Americans
pay the highest prices for prescription medicines in the world.
It
is these prices that have led millions of Americans to turn to personal
importation of safe, affordable medicines from licensed, reputable pharmacies
in Tier One Countries that have standards of efficacy and safety that meet or
exceed those of the United States.
Many
members of Congress have repeatedly recognized the importance of this lifeline
to vital medicines for Americans by its support of personal importation. Unfortunately, even when legislation to facilitate
personal importation was passed, Pharma-backed groups of Senators and
Representatives thwarted the will of Congress and the American public by the
addition of ‘poison pill’ amendments requiring ‘certification’ of each and
every imported medicine by the Secretary of Health and Human Services (HHS).
In
2012, Pharma stepped up its activities to curtail the right and ability of
Americans to engage in personal importation of their medicines with such legislation
as the Protect Intellectual Property Act (PIPA) and the Stop Online Piracy Act
(SOPA) , both of which would have given Pharma intellectual property rights
that would have branded all imports as ‘counterfeit—ironically, including some of
the very same medicines manufactured by Pharma members outside the United
States and sold in this country.
Fortunately,
these bills were turned aside , the SOPA bill being particularly significant
because it actually led to an Internet ‘blackout,’ a recognition of the onerous
provisions of the legislation that would infringe upon a number of American
rights.
However,
with the passage of the PDUFA legislation—considered a ‘must pass’ piece of
legislation to allow the Food and Drug Administration (FDA) to conduct its
operations, Pharma again saw an opportunity—Section 708 which unfairly and
inaccurately portrays personal importation of medicines from reputable
pharmacies as being one and the same with the many bogus pharmacies selling
unsafe, counterfeit medicines. A summary of our concerns follows:
a. In
2006, a bi-partisan effort stopped Customs from seizing vital medicines
personally imported by Seniors and others.
Seniors personally importing their medicines had been coerced to sign
letters acknowledging their guilt in violating US law, and agreeing that the
letter could be used against them in criminal prosecution if they (the Seniors)
continued to practice personal importation. Congress found this unacceptable.
b. We
fear there may be some confusion about the actions taken in 2006 to block
arbitrary seizures in response to such an abuse of power by Customs and the
FDA. It has come to our attention that
there are those supporters of personal importation in Congress who seem to
believe that the previous legislation will prevent such arbitrary
seizures. To them, we voice our
gratitude for their past support.
However, we must caution that they do not confuse actions taken in 2006
as being binding upon Section 708.
c. Section
708 is different. It allows the Secretaries of HHS and Homeland Security to
arbitrarily make seizures of medicines valued at $2500 or less if they are
deemed to be potentially dangerous to Americans’ health. Unfortunately, this
highly commendable goal has been co-opted by Pharma to be likely construed to
extend to seizures of legitimate, safe medications.
d. While
the House version of PDUFA did not include any process for due process review,
the Senate Leadership was able to get such a provision in the final bill. The
following describes our understanding of the provisions:
i. From
the viewpoint of personal importation the structure of the review is based upon
an individual initiating a request for a review within 30 days.
ii. If
there is no appeal, the seized medicines are subject to destruction.
iii. If
there is an appeal, and it is not upheld, the individual making the appeal is
liable for any costs incurred by the Government during the appeal process.
e. The
authority to make seizures is granted to a wide number of individual Customs agents.
f. The
reasons for seizures include, but are not limited to : Safety, unregistered
medicine, new non-approved medicine lacking FDA review/approval (this would
immediately make all personally imported medicines subject to seizure since
they are approved by the regulatory agency of the country of origin),
misbranding (this could include medicines identical to those sold in the US being
subject to seizure because of labeling requirements of the country of origin.)
II.
It is our belief that the intent of the
legislation as written is evident, creating an authority to grant seizure
powers not only of bogus , dangerous and counterfeit drugs, but to expand
the scope to seize vital medicines personally imported from sources outside the
United States that have a proven record of safety and efficacy.
III.
When the bill was being considered, we made
contact with staff on the Senate Health Committee, and were told by Majority
Staff that this was not the ‘intent’ of the bill, and that Senate Majority
leadership, notably Senator Harkin, was committed to the concept of personal
importation of vital medicines, seeking assurances from the FDA that personally
imported medicines were not the ‘target’ of the Section.
a. Significantly,
however, when asked further, Staff said that the assurances given to the
Senator by FDA were adequate. We fear this might be the impression given to
Congressional supporters
b. Our
review of Section 708 has not given us any reason to believe that such good will
or intent without being addressed specifically in the legislative language,
will prevent unwarranted seizures from occurring, or that
individuals—especially seniors—will be able to navigate the complexities of the
appeals process and face the risk of the potential costs of an appeal.
In
summary, we believe that (a) Section 708 is written in such a manner as to
enable arbitrary seizures of legitimate, safe, affordable , and vital medicines
that provide a life-line to untold numbers of Americans (b) that even with the
stated intent of supporters of personal importation that such seizures will not
occur, without specific language excluding such seizures, and that the section
, as written, leaves no room for interpretation to the contrary (c) our
understanding of the provision is that there is not such exception in the bill.
The result will be that untold numbers of
Americans will be forced to either pay higher costs for the very same medicines
denied by the seizures, or more tragically imperil their health and well-being
by not purchasing vital medicines. The
consequences will be tragic.
That is why we call upon Congress to be alert
to what will admittedly be unintended consequences of actions that, on the
surface, appear to have merit, but really are nothing more than yet another
effort by Pharma-driven forces to solidify the United States as a safe haven
for the highest prescription medicine prices in the world, and a major driver
of the continuing rise in healthcare costs.
Thank you for your consideration of this
letter.
Sincerely,
Daniel Hines
Daniel Hines
Publisher
www.TodaysSeniorsNetwork.com
TodaysSeniorsNetwork
is comprised of www.TodaysSeniorsNetwork.com,
a leading informational website for the challenges and opportunities of dealing
with issues facing an Aging America attracting more than two million visitors
annually across the nation, http://RxforAmericanHealth.blogspot.com,
www.BoomersNewsOnline.com, and www.RxforAmericanHealth.com .
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