by Pamela Hess
United Press International
April 13, 2000
WASHINGTON, April 13 (UPI) -- The Pentagon has awarded the troubled manufacturer of its anthrax vaccine another $12 million to help its new laboratory pass an inspection by the Food and Drug Administration, Defense Department officials acknowledged today.
This money comes on top of the $40 million the Pentagon gave the company to bail it out of financial trouble last fall.
BioPort, of Lansing, Mich., is the only potential source for the anthrax vaccine in the country. The military desperately needs it to succeed: It is trying to inoculate all its troops against anthrax, which is believed to be in the arsenals of at least 10 countries.
BioPort bought the manufacturing rights from a Michigan state-run laboratory in 1998, but failed to anticipate how difficult it would be to set up a new laboratory capable of producing more than three million doses a year.
"Neither on the government side nor on BioPort's did anyone fully understand what had to be done to build a new lab and start over again," said David Oliver in an interview with United Press International. Oliver is a senior Pentagon acquisition official now charged with getting the belabored program up and running.
"There's nobody bad here. Everybody's trying to do the right thing. But people are not used to start ups, they are not used to the problems. Then I had all my bureaucrats not thinking ahead and making it more difficult," said Oliver. "If the government understood what the hell it was doing... Well, this is not the most fiscally prudent approach."
But it is the approach the Pentagon is stuck with: BioPort won the contract from Michigan in 1998 without Pentagon participation in the process. It was expected the company would just expand operations and sell the vaccine to the government. It would then sell extra vaccine on the private market, banking on a growing fear of terrorists with biological weapons.
If a colorless, tasteless, almost microscopic anthrax spore is breathed in by an unsuspecting victim, death is almost a certainty in about 10 days.
But the program has had more than its share of bumps. About 350 soldiers are refusing to take the vaccine out of safety fears, which are only made worse by BioPort's troubles with the FDA.
The Pentagon funded the construction of a state-of-the-art new laboratory, but it has failed to pass a series of FDA inspections, the most recent in November, when it came up with more than 30 deficiencies.
Earlier last fall, BioPort informed the Pentagon that it would need to triple the price it charges for the vaccine because the formerly state-run facility had faulty accounting practices.
Finding itself in deep financial trouble, BioPort turned to the Defense Department for a bailout. It got one, of about $21 million, plus an $18.7 million advance, to be paid back when it finally begins selling the vaccine on the open market.
Awarded in February, the latest gift from the Pentagon is $12 million, which will be used to get the laboratory in shape so it can pass FDA inspection, as well as to pay consultants to establish test procedures and labeling practices.
It's not a good situation for the Pentagon to be in, but it's the only option it has for getting enough vaccine for the troops, explains Oliver. Defense Secretary William Cohen made inoculations mandatory in 1999.
"You only have one source. You don't have a near-term solution. You don't have an alternative, and so we have to focus on getting this done," Oliver told UPI.
Getting a second company to produce anthrax would take between five and 10 years, Oliver told the Senate Armed Services Committee today.
The Pentagon doesn't have nearly that much time: It only has enough approved vaccine to last until July. Another 273,000 doses are awaiting FDA approval, enough to last until November. BioPort's new facility is expected to be ready for inspection in September. If it gets a clean bill of health, it should be open for business just as current supplies are running out.
Oliver, however, says he has a small cushion of time. There remain vast stores of older vaccine that can be tested for purity, effectiveness and safety and given to troops if BioPort misses another deadline.
"I'll get more approved," he said.
And the vaccine program will be made to work, Oliver said -- no matter how much money it takes.
"If I need to put more money against this to make this work then we will probably determine a way that that's feasible," he told UPI.
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