|
"More than four months ago, on Oct. 25,
2004, I reached out to you seeking approval for the state of
Illinois to import flu vaccine made by Aventis Pasteur and Glaxo
Smith Kline in Europe," the governor wrote. "My request came shortly
after your agency announced that nearly half of the United State's
flu vaccine supply had to be destroyed and warned public health
departments around the country to put in place tight emergency plans
for limiting the distribution of our country's limited supply of
vaccine. In an unbelievable display of utter disregard for the
citizens of our states and cities, the Food and Drug Administration
has yet to respond to our request for approval to import
additional supplies of vaccine. We are left in a very difficult
situation as a result: It is likely too late to get the vaccine to
our populations before flu season peaks, and it is also now
difficult to resell the vaccine on the European market because their
flu season is also waning."
The European vaccine secured for
Illinois, New Mexico, New York City and Cleveland is now being moved
back to the European wholesale market.
The governor pressed Crawford to
offer evidence that the FDA is better prepared for future flu
seasons and ready to work with states and cities in a timely manner
to address future shortages.
"The debacle of the 2004-2005 flu
season must serve as a lesson. A future vaccine shortage could prove
deadly if not handled more quickly and effectively by the FDA," said
Blagojevich.
* * *
Text of governor's letter:
Office of the Governor
Rod R. Blagojevich
JRTC, 100 West Randolph, Suite 16-100
Chicago, Illinois 60601
January 28, 2005
Hon. Lester M. Crawford, D.V.M., Ph.D.
Acting Commissioner of Food and Drug Administration
U. S. Food and Drug Administration
5600 Fishers Lane
Rockville MD 20857
Dear Commissioner Crawford:
More than four months ago, on October
25, 2004, I reached out to you seeking approval for the State of
Illinois to import flu vaccine made by Aventis Pasteur and Glaxo
Smith Kline in Europe. My request came shortly after your agency
announced that nearly half of the United State's flu vaccine supply
had to be destroyed, and warned public health departments around the
country to put in place tight, emergency plans for limiting the
distribution of our country's limited supply of vaccine. Soon after
I reached out to you, the State of New Mexico and the cities of New
York and Cleveland asked Illinois for assistance in securing
additional vaccine from abroad.
[to top of second column in
this article] |
We - Illinois, New Mexico, New York
City, and Cleveland - determined it was in the best interest of our
citizens to act immediately and find more vaccine quickly, before
the onset of flu season, rather than wait for a major public health
crisis to unfold. Just like the analogy, if your house is burning
down, you don't wait to get permission to park the fire truck, we
didn't want to wait and put the public's health at risk.
Upon hearing of the severe shortage, I
immediately asked my pharmaceutical experts to scour the foreign
markets for flu vaccine that was similar to what is used in the U.S.
We found vaccine that was the same as what is used in our country.
And we learned that, if we acted quickly, we could secure a supply
for our residents to help avoid a major health crisis.
That's when we reached out to you for
approval to bring the vaccine to the United States so it could be
distributed to our vulnerable residents before flu season was under
way. While the weeks passed and we waited for an FDA response, your
agency gave the federal Center for Disease Control permission to
import more than one-million doses of the same German-made Glaxo
Smith Kline vaccine we had secured and asked to import.
In an unbelievable display of utter
disregard for the citizens of our states and cities, the Food and
Drug Administration has yet to respond to our request for approval
to import additional supplies of vaccine. We are left in a very
difficult situation as a result: it is likely too late to get the
vaccine to our populations before flu season peaks, and it is also
now difficult to re-sell the vaccine on the European market because
their flu season is also waning.
Fortunately for all of us, the United
States has had an unusually mild flu season so far this year. I hate
to think of the disastrous consequences of your inaction had this
season been as severe as last year's.
The debacle of the 2004-2005 flu
season must serve as a lesson. A future vaccine shortage could prove
deadly if not handled more quickly and effectively by the FDA. What
is your agency doing to avoid subsequent shortages? How can we be
assured that we will not be left in a similar position if future
shortages do occur? What changes have been made at the FDA to ensure
states and cities receive timely responses?
I will continue to put the interests
of the people of Illinois first. When we face emergencies or threats
to the public's health in the future, I hope we can rely on the FDA
to join us in resolving the problems rather than looking the other
way.
Sincerely,
Rod Blagojevich
Governor of Illinois
[News release from the
governor's office] |
