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December 22, 2003
The Honorable Tommy Thompson
Secretary
United States Department of Health & Human
Services
200 Independence Avenue, S.W.
Washington, DC 20201
Dear Secretary Thompson:
As
you are aware, I have been working for several months
to find ways to help the people of Illinois save
money on the high cost of prescription drugs. I
was encouraged by your recent statements regarding
your willingness to approve a small-scale demonstration
project around the issue of reimportation of prescription
drugs from Canada. We would like to work with
you to design an effective pilot program that complies
with the law. I am writing today to request
your authorization for the State of Illinois to launch
the first reimportation demonstration program.
As
Justice Brandeis eloquently articulated in 1932, “[i]t
is one of the happy incidents of the federal system
that a single courageous State may, if its citizens
choose, serve as a laboratory; and try novel social
and economic experiments.” Few know the wisdom
of this tenet better than you. As the Governor
of Wisconsin, you responded to a crisis of escalating
welfare costs by creating an innovative welfare to
work program, and effectively lobbied Washington
to allow its implementation, despite apparent conflicts
with federal law.
All told, under your stewardship,
the State of Wisconsin obtained over 75 waivers for
purposes of implementing experimental programs in
the welfare arena. Your innovation in Wisconsin’s
approach to welfare reform demonstrates that when
given the chance to do so, states can often successfully
use their own ideas to meet the major challenges
of the day. That kind of innovation is clearly
needed when it comes to bringing down the price of
prescription drugs.
Last year, Illinois spent over $340
million on prescription drugs for its 230,000 employees
and retirees, and a total of $1.8 billion on prescription
drugs for all of the state’s health programs combined. With
the cost of prescription drugs continuing to soar,
this year, we’ll spend even more.
Citizens in Illinois, and across
the nation, pay 30-80% more for many of the same
prescription drugs sold in Canada. In the face
of a state fiscal crisis, an economy that continues
to falter, and the ever-increasing cost of prescription
drugs, as Governor, I have no choice but to explore
different options that can help the consumers and
taxpayers of Illinois.
Under
the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (“the Act”), Congress has
granted you the power, and authorized the necessary
appropriations, to permit Illinois’ implementation
of the first reimportation pilot program. First,
you could certify to Congress, under Section 804,
subsection (l), of the Act that for the narrow purposes
of Illinois’ pilot program, reimportation poses no
additional risk to the public’s health and safety,
and would result in a significant reduction in the
cost of prescription drugs to consumers. You
may then utilize the authority Congress granted you
under section (j) of the Act, which authorizes you
to grant waivers of the prohibition on reimportation,
to grant Illinois a waiver authorizing the reimportation
of an agreed list of prescription drugs. Additionally,
because Congress authorized the appropriation of
such funds as are necessary to oversee any reimportation
program, funding concerns should not bar your consideration
of our request.
With your approval, we will work
with your staff and the FDA to implement a pilot
reimportation program. The principle tenets
and requisite safeguards of our proposal are as follows:
- The State of Illinois, Office of Special Advocates
for Prescription Drugs, in conjunction with the
FDA, will develop a preferred drug list, detailing
those drugs that can be safely obtained from
Canadian sources.
- The list will be comprised of predominately
brand-name drugs for long-term usage.
- Only drugs that can be obtained more cost-effectively
from Canada than from the United States will
be included.
- The list will be periodically updated to ensure
continued cost-savings.
- Only FDA-approved drugs in FDA-approved dosages
will be eligible for inclusion on the list.
- The State will implement the following additional
protections to ensure patient safety.
- No first-fill. Plan participants must
first have an eligible prescription filled by
an Illinois pharmacy with a 30-day supply before
obtaining a refill for that drug through the
importation program.
- Illinois will implement a Primary Care Pharmacist
model, whereby every participant in the program
would have the opportunity to choose an Illinois
pharmacist to coordinate and monitor his or her
drug therapy.
- In collaboration with the University of Illinois
College of Pharmacy, Illinois will implement
a monitoring program to evaluate the safety/efficacy
of drugs received by plan participants from all
sources.
- All drugs distributed through the program will
be dispensed in manufacturer-sealed containers
with child-resistant caps or an equivalent safeguard.
- Illinois will contract with a private entity
to maintain a toll-free number with a pharmacist
available 24 hours a day, 7 days a week, to answer
any medication-related questions by plan participants.
- In addition to oversight by the State of Illinois,
all wholesalers and pharmacies involved in filling
prescriptions under the program will be licensed
and regulated either by authorities in Canada
or by authorities in the United States.
- Prescriptions will be dispensed only pursuant
to a valid prescription.
- Reporting
- Illinois will periodically report to the United
States Department of Health and Human Services
regarding the effectiveness and cost-savings
of the program.
This program, subject to your approval,
could be implemented through one of two plan designs. As
described in our recently-released study on this
issue, Illinois could contract with a Canadian Pharmacy
Benefit Manager (“PBM”) to administer the program
by mail-order, distributing prescriptions to patients
directly from the Canadian PBM. Or, Illinois
could work with Canadian sources to obtain eligible
prescription drugs in bulk. The drugs would
then be sent to a mail-order facility in Illinois
for distribution. In both of the scenarios
described, the State would stipulate performance
and safety standards for facilities in Canada and
in Illinois and would regularly inspect all facilities
for adherence to those standards.
Finally, the program proposed by
Illinois would be instituted as a pilot program,
involving only a small population of participants
at the outset. As described in our study, we
would begin by instituting a program, on a voluntary
basis, for state employees and retirees. The
scope of the study would be further narrowed in its
initial stages by limiting the number of eligible
drugs to those agreed to by the State and the FDA. If
successful, the program could later be expanded to
include additional drugs and/or additional populations
in Illinois.
I believe that we have a unique opportunity
to test the concept of importation with the implementation
of a pilot program in Illinois. Our program
will allow HHS and the FDA to gauge, on a small-scale,
the feasibility of drug importation, while authorizing
Illinois to obtain safe, effective, and affordable
prescription drugs for its employees and retirees
in a controlled setting.
The State of Illinois very much wants
to import prescription drugs from Canada in a way
that is fully compatible with current regulations,
and meets with your approval. Designating Illinois
as a demonstration project would allow us to do just
that, and provide a model that other states could
follow.
I would appreciate it if you could
let us know whether you will authorize Illinois to
launch a reimportation demonstration program within
thirty days. Thank you for your consideration.
Respectfully,
Rod R. Blagojevich
cc: Mark
B. McClellan
Office
of the Commissioner
United
States Food and Drug Administration
5600
Fishers Lane
Rockville,
Maryland 20857
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