Recently,
Senators Amy Klobuchar (D-MN), Charles Grassley (R-IA) and John McCain wrote a
letter to Health and Human Services(HHS) Secretary Tom Price asking him to
utilize legislation crafted 14 years ago to exercise his authority to ‘enable’
personal importation of prescription medicines under provisions of the Medicare
Prescription Drug Improvement and Modernization Act of 2003.
That such
a request to the Secretary is necessary is a reflection of the failure of
Congress to overcome the opposition of Pharma, which views personal importation
as a threat to its ability to impose the highest prescription drug prices in
the world upon American patients.
The
Senators are not alone in making such a request. A group of 33 Democrat members
of the House of Representatives sent a similar appeal to President Obama,
asking him to issue an executive order shortly before the end of his
Presidency.
Also,
throughout the last 14 years, advocates for personal importation have
challenged previous HHS Secretaries to act on specific portions of the
legislation, namely, requiring that …’The Secretary, in consultation with
appropriate government agencies, shall conduct a study on the importation of
drugs into the United States pursuant to section 804 of the Federal Food, Drug,
and Cosmetic Act (as added by section 1121 of this Act). Not later than 12
months after the date of the enactment of this Act, the Secretary shall submit
to the appropriate committees of the Congress a report providing the findings
of such study”; and, “…In particular, the Secretary shall by regulation grant
individuals a waiver to permit individuals to import into the United States a
prescription drug that— ‘‘(A) is imported from a licensed pharmacy for personal
use by an individual, not for resale, in quantities that do not exceed a 90-day
supply; ‘‘(B) is accompanied by a copy of a valid prescription; ‘‘(C) is
imported from Canada, from a seller registered with the Secretary; ‘‘(D) is a
prescription drug approved by the Secretary under chapter V; Regulations...”.
These
provisions are an early indication of the fact that there was—and remains
today—a realization by Congress that even in 2003, relief was needed for the
millions of Americans who were then—and today—denied access to safe, affordable
brand-name prescription medicines from licensed, registered pharmacies in Tier
One Countries whose standards of safety and efficacy meet or exceed those of
the U.S.
Significantly,
although the HHS Secretaries over the years chose to not act on the
legislation, American patients acted on their own initiative, and by so doing
have provided a de facto validation of the authenticity and validity of
personal importation of brand-name medicines from Tier One Countries of which
Canada is one.
But,
rather than relying upon 14-year old legislation, it is now time for Congress
to act to deal with the current state of and continuing needs of American
patients to incorporate personal importation into effective legislation as
reflected in the AmericanRxBillofRights which was submitted to the platform
committees of the Democrat and Republican Platform Committees of the 2016
conventions.
The need
for a new approach is because there exists the potential for one provision of
the 2003 Act to be not only unnecessary but actually harmful to personal
importation.
The provision
in the 2003 act would empower the HHS Secretary to establish wholesale
operations within the U.S., solely for the importation of medicines from Canada
to be resold in the U.S., as well as allowing specific pharmacies to engage in
personal importation.
This was
opposed by many proponents of personal importation when it was first presented
in the 2003 legislation.
There are
several reasons for concern about this segment of the 14-year-old bill:
·
One
of the debates that arose about personal importation from Canada in 2003, was a
reaction from some Canadian officials being fearful that Canada would become ‘America’s
drugstore’ which can be directly linked to the wholesaling provision;
·
Equally
pertinent, many American advocates of personal importation believed then, and
continue to do so today, that to grant such blanket authority to wholesalers
and individual pharmacies would defeat the very purpose of personal
importation, i.e., individual American patients’ access to safe, affordable
brand-name medicines;
·
That
is because we must be concerned about U.S. wholesalers gaining control over
large supplies or sources of lower-cost medicines, giving them a capability to
control prices in a manner similar to the abusive practices of Pharma, and
crippling the ability of Americans to make purchases of their meds from any
source other than the wholesalers and pharmacists.
It is time,
therefore, for Congress, especially those erstwhile supporters of personal importation
to come together to form a consensus on comprehensive legislation for personal
importation of prescription medicines as the only readily available avenue with
which to ensure that no American is denied their access to vital lifeline
medicines because they are unaffordable.
This
calls for consensus building in which Representatives and Senators of both
parties who support personal importation instruct their staffs to come together
to identify what opportunities—and obstacles—face enactment of new, current
legislation to lower prescription drug prices via personal importation; address such
problems caused by the one in ten Americans not being able to afford their medicines; to
restrain the Food and Drug Administration from the seizure and destruction of
medicines which can easily be identified as authentic, safe medicines.
By acting
in such a manner to meet their obligations to the American public, Congress can
develop legislation in which personal importation will have a major role and
will reflect the realities of the needs of Americans patients today, rather
than simply appealing for the HHS Secretary to carry the water on this issue.
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