[Congressional Record (Bound Edition), Volume 146 (2000), Part 17]
[Senate]
[Pages 25490-25491]
[From the U.S. Government Publishing Office, www.gpo.gov]



           DEPARTMENT OF DEFENSE VACCINE ACQUISITION STRATEGY

  Mr. HUTCHINSON. Mr. President, I rise today to notify my colleagues 
of my efforts to change the Department of Defense's vaccine acquisition 
strategy. You see, it is my belief that the BioPort/anthrax debacle 
provides lawmakers with an excellent case study, one which illustrates 
that the Department's present policy of relying on the private sector 
to provide vaccines critical to the protection of our men and women in 
uniform is fatally flawed and must be changed. There exists a growing 
consensus that the Department of Defense must shoulder the 
responsibility and begin to produce biological warfare vaccines for 
itself.
  In the early 1990's, in the aftermath of the gulf war, 
recommendations were presented to senior Defense Department acquisition 
officials to fulfill the urgent demands of war-fighters to develop 
vaccines against biological agents. One of the principal 
recommendations was for the construction of a Government-owned, 
contractor-operated (GOCO) vaccine production facility. Detailed and 
thoughtful studies presented many merits to the GOCO approach. Without 
listing all of its merits, I will point out that the GOCO option would 
guarantee the country access to a vaccine supply immune from the 
foibles of a profit-driven pharmaceuticals industry.
  For reasons that remain a mystery to this day, the Defense Department 
did not elect to pursue the safer, GOCO option. Rather, the Department 
chose to contract with a private-sector entity we now know as BioPort, 
for the vaccine against the biological agent anthrax.
  Since embarking on this acquisition strategy, events have proceeded 
as many had feared they would; disastrously. Last summer, the Defense 
Department awarded the BioPort corporation extraordinary contract 
relief to a previous contract for the production and vulnerable storage 
of the anthrax vaccine. The terms of the contract relief reduced the 
number of doses of vaccine to be produced by one-half, charged the U.S. 
taxpayer almost three times as much as was originally negotiated, and 
provided BioPort with an interest-free loan of almost $20 million. 
BioPort officials have stated that even this may not constitute enough 
support. I question the fitness of whoever negotiated such a horrendous 
arrangement on behalf of the American taxpayer.
  In July, because of BioPort's continuing troubles, the Department was 
forced to dramatically scale back the scope of Phase One of the 
immunization program because the rapid rate of vaccinations threatened 
to consume the last of the Department's stockpile of FDA approved 
vaccine. Now, only those personnel who are deployed to high-threat 
regions, such as the Persian Gulf and the Korean Peninsula, will 
receive vaccinations. As it appears increasingly apparent that neither 
additional lots of vaccine, nor the new production line in East 
Lansing, will receive FDA approval anytime soon even this dramatically 
reduced effort may completely exhaust the Department's supply of 
vaccine, leaving our troops vulnerable.
  As the Department is preparing to transition into production of the 
first of more than a dozen new bio-war vaccines developed under the 
Joint Vaccine Acquisition Program, it was apparent to me that unless we 
wish to repeat the mistakes of the past, a new acquisition strategy is 
urgently needed.
  My colleagues and I on the Senate Armed Service Committee are making 
efforts to prevent the Defense Department from continuing to pursue a 
flawed acquisition strategy. Through oversight hearings and legislative 
provisions within the national defense authorization bill, we are 
actively providing the Department with some much needed guidance.
  On April 14, I chaired the second of three committee hearings on the 
topic of vaccine production. During that hearing, DOD personnel who had 
advocated the GOCO route in the early Nineties, and were overruled, 
were given the opportunity to testify. Their testimony is perhaps the 
most important the committee has received all year on this topic.
  At a third committee hearing, conducted in July, the Department 
announced that it had published a solicitation for a second-source of 
the Anthrax vaccine. As the Department received only cursory inquiries 
from the pharmaceutical industry during the required thirty day period, 
this effort appears to have failed.
  In response to the testimony received by the committee, I drafted 
section 221

[[Page 25491]]

of the Senate's fiscal year 2001 national defense authorization bill. 
Section 221 requires the Secretary of Defense to conduct a reevaluation 
of the present vaccine acquisition. The report will include an 
evaluation of the commercial sector to meet DOD's vaccine requirements 
and a design for a Government-owned, contractor-operated vaccine 
production facility.
  Section 221 also notes that a significant body of work regarding this 
topic was assembled in the early 1990's including Project Badger, which 
recommended that a GOCO vaccine production facility be constructed at 
the Pine Bluff Arsenal in my home state of Arkansas.
  I am pleased to report that the provision was retained in the 
conference report which the Congress voted to send to the President for 
his signature.
  In addition to hearings and legislative provisions, I have begun a 
dialog with numerous personnel within the Office of the Secretary of 
Defense. I would be remiss if I did not mention the many productive 
conversations I have had with the Under Secretary of Defense, Rudy 
deLeon. Because Secretary deLeon is relatively new to his position and 
has little ownership over the flawed decisions of the past, he has been 
very willing to explore alternative acquisition strategies including 
the solution I favor: construction of a Government-owned, contractor-
operated vaccine production facility. As evidence of his commitment to 
find a solution, vaccine production was the first topic discussed by 
the Defense Resources Board, which Secretary deLeon chairs, when it met 
to begin its preparation of the Defense budget submission for fiscal 
year 2001.
  I have encouraged Secretary deLeon to include $25 million in the 
fiscal year 2002 Defense budget submission for R&D, in addition to $400 
million in the next version of the Department's Fiscal Years 
Development Plan, to cover construction costs. To ensure that funding 
for this project does not come at the expense of other critically 
needed bio-defense programs, I will soon meet with the Director of OMB. 
I am hopeful that I can explore with Mr. Lew ways to increase the top-
line of the Defense budget to cover the expense of this project.
  For too long DOD has pursued a flawed acquisition strategy that is a 
disservice to both the American taxpayer and our men and women in 
uniform. The Department must be weaned from its dependence on the 
private sector for the provision of critical biological warfare 
vaccines.

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