The House of Representatives approved the $5.6 billion anti-
terrorism initiative Project Bioshield late Wednesday, ending more than a year
of delay in Congress over the Bush administration's plan to stockpile remedies
against deadly germs that could be used in a biological attack.
By a 414-2 vote, the House passed a bill creating a 10-year funding
reserve for large public supplies of drugs and vaccines to battle potential
bioterror weapons including anthrax, smallpox, plague and the Ebola virus. The
bill awaits only President Bush's signature.
"This is the largest first-responder program ever enacted in American
history,'' said Homeland Security Committee Chairman Christopher Cox, R-
Newport Beach (Orange County).
A Brisbane biotechnology firm, Vaxgen Inc., is among the leading bidders
for one of the largest government grants to be paid from Project Bioshield
money: a contract for about $700 million to produce 75 million doses of an
improved anthrax vaccine.
Vaxgen spokesman Lance Ignon said passage of the bill will encourage
companies to devote resources toward the development of anti-bioterror drugs
that might have no market outside of government contracts.
"The passage of Bioshield is important because it reaffirms the
government's commitment to purchase biodefense products, and that is an
important signal to the country as a whole and certainly to industry,'' Ignon
said.
Bioterrorism preparedness moved to the top of the national agenda in late
2001, when anthrax-laden letters were mailed to Congress and media offices
while the nation was still reeling from the Sept. 11 terrorist attacks. The
anthrax mailings -- an unsolved crime -- killed five people, sickened more
than a dozen others and required cleanup costing millions of dollars.
Bush proposed Project Bioshield in January 2003, but the proposal stalled
in Congress as legislators tangled over the ground rules for disbursements
from the huge fund.
A compromise version, approved by the Senate in May, resolves concerns by
some lawmakers that Congress would lose control over the bioterror allocations.
Under the original proposal, the fund would not have been subject to the
usual congressional appropriations process. That provision raised alarms,
coming under consideration just as the administration was under fire for large
cost overruns in military support contracts for the Iraq war that had been
awarded to Halliburton Co. Vice President Dick Cheney was formerly the chief
executive of the firm.
The final bill restores discretion to Congress over specific awards from
the fund. But it also guarantees that a full $5.6 billion will be dedicated to
anti-bioterror drug stockpiles and can't be diverted to other government
programs. That allays some of the concern among private drug developers that
federal government investment in anti-bioterror medicines might wane as the
anthrax attacks of 2001 fade into the past, said John Clerici, a Washington
attorney who worked on modifications to the bill as a representative of
several drug firms.
Bush said in a statement that he looked forward to signing the bill,
which would not only help protect Americans but also "break new ground in the
search for treatments and cures while strengthening our overall biotechnology
infrastructure.''
Government funding had already started flowing to companies like Vaxgen
while the Project Bioshield bill was on hold. Vaxgen has received several
grants to develop a next-generation anthrax vaccine based on Army research,
and to make an initial supply of 3 million doses.
Vaxgen is vying with one other leading contender, Avecia Group PLC of
Manchester, England, for an additional contract to manufacture 75 million
doses of the vaccine, enough to inoculate 27 million people or about 9 percent
of the U.S. population. The government's decision is expected by late summer.
The House bill passed Wednesday allows the government to distribute such
newly developed drugs in emergencies, even if they have not received FDA
approval. But nothing in the bill authorizes the government to force
individuals to take anti-bioterror drugs, Clerici said.
Clerici said he is working with members of Congress on "Bioshield II,''
which could address some industry concerns left unresolved by the bill passed
Wednesday. The final version includes no language relieving drug manufacturers
of any liability they might face if bioterror vaccines or drugs ordered by the
government turned out to cause injuries, Clerici said.
Such indemnification provisions are important if the government wants to
increase the participation of large pharmaceutical companies in bioterror
defense contracts, Clerici said. Many grants have gone to smaller firms that
have not insisted on such guarantees, he said.
"These (small firms) are great companies, and they're the innovative
engines of America,'' he said. On the other hand, he said, Project Bioshield
hasn't done enough to enlist the firms with the resources of "the
GlaxoSmithKlines, the Pfizers and the Mercks.''
"It's like fighting a war without Lockheed Martin, Boeing or Northrup
supplying the government,'' Clerici said.
Ignon rejected the argument that large firms are essential to bioterror
defense because smaller ones could be easily ruined by a single big liability
suit. He said Vaxgen has obtained private liability insurance, and the cost
will be factored into the price of its anthrax vaccine.
Project Bioshield, though huge, is just one element of the government's
expenditures on bioterror defense. For example, Sunnyvale biotech firm Cepheid
has helped develop biodetectors for the U.S. Postal Service that pick up signs
of mail tainted with pathogens such as anthrax. Lawrence Livermore National
Laboratory is spending $60 million in federal funds this year on advanced
biodetection systems and technologies to decontaminate buildings.
Public health agencies throughout the country have been receiving extra
federal grants to prepare for their role as the first line of defense against
a bioterror attack. Dr. Marty Fenstersheib, Santa Clara County public health
officer, said agencies like his are constantly training to handle the
responsibility of administering anti-bioterror vaccines supplied by the
government.
"Even though they may bring it to our doorstep, we then have to
distribute it to the community, and that's the real challenge,'' he said.