Pentagon Appeals Decision Halting Anthrax Inoculations
By Deborah Funk, Times staff writer
Government lawyers representing the Pentagon and Department of Health and Human Services want to convince a federal appeals court that a U.S. District Court judge erred in halting the military’s mandatory anthrax vaccination program late last year.
In documents filed May 16 in the U.S. District Court of Appeals for the District of Columbia, government attorneys said the district court judge’s conclusion that the vaccine has never been licensed for to protect against anthrax exposure through inhalation is “without basis.”
When the National Institutes of Health licensed the vaccine in 1970, it did not differentiate the possible routes of exposure of the disease nor the possible uses of the vaccine, according to the government’s written argument.
The license remains in effect and the Food and Drug Administration has said repeatedly that the vaccine is effective against all forms of anthrax, to include contracting it through the skin.
But instead of relying on the original license and the FDA’s review, the court based its decision on a 1985 advisory panel that said the vaccine’s “efficacy against inhalation anthrax is not well documented,” stated the government’s written argument.
The government insists that the panel’s conclusion “was premised on a misunderstanding of the relevant data.”
Government lawyers also are arguing that the district court judge did not need to stop the military’s entire anthrax vaccine effort in order to protect the interests of the six men and women who sued the government over the mandatory program.
“The interests of thousands of members of the armed forces are not aligned with those of the six plaintiffs,” government lawyers wrote. “The court’s ruling jeopardizes the safety of the countless persons who have never been made part of this action.”
Oral arguments in the appeal are not yet scheduled.
Government lawyers representing the Pentagon and Department of Health and Human Services want to convince a federal appeals court that a U.S. District Court judge erred in halting the military’s mandatory anthrax vaccination program late last year.
In documents filed May 16 in the U.S. District Court of Appeals for the District of Columbia, government attorneys said the district court judge’s conclusion that the vaccine has never been licensed for to protect against anthrax exposure through inhalation is “without basis.”
When the National Institutes of Health licensed the vaccine in 1970, it did not differentiate the possible routes of exposure of the disease nor the possible uses of the vaccine, according to the government’s written argument.
The license remains in effect and the Food and Drug Administration has said repeatedly that the vaccine is effective against all forms of anthrax, to include contracting it through the skin.
But instead of relying on the original license and the FDA’s review, the court based its decision on a 1985 advisory panel that said the vaccine’s “efficacy against inhalation anthrax is not well documented,” stated the government’s written argument.
The government insists that the panel’s conclusion “was premised on a misunderstanding of the relevant data.”
Government lawyers also are arguing that the district court judge did not need to stop the military’s entire anthrax vaccine effort in order to protect the interests of the six men and women who sued the government over the mandatory program.
“The interests of thousands of members of the armed forces are not aligned with those of the six plaintiffs,” government lawyers wrote. “The court’s ruling jeopardizes the safety of the countless persons who have never been made part of this action.”
Oral arguments in the appeal are not yet scheduled.
