FDA Orders Pentagon To
Follow FDA Vaccine Rules
Pentagon Broke Rules In Giving Soldiers Vaccine

WASHINGTON (AP) -- The Pentagon violated federal rules in giving an encephalitis vaccine to American soldiers in Bosnia in 1996, raising questions about how the Defense Department performs medical research, the Food and Drug Administration says.
The FDA, already probing problems stemming from experimental drugs given to Gulf War soldiers, ordered the Pentagon last month to submit detailed procedures to ensure it will follow FDA safety rules.
The Pentagon missed the January 12 deadline, the FDA said Monday, but has promised a response soon.
"We want it resolved correctly and appropriately, because none of us knows when there will be the need to have another deployment" in which soldiers need experimental drugs, said FDA senior policy analyst Bonnie Lee.
The Pentagon is working "to improve compliance during such circumstances in the future," said Defense spokesman Lt. Col. Tom Begines. But he stressed that the violations were minor and that the encephalitis vaccine has been given safely to millions of Europeans as well as to the U.S. soldiers.
The issue first arose after Gulf War troops received two experimental drugs as protection against chemical and biological warfare, when the FDA waived usual requirements that let Americans choose unapproved therapies only after being fully informed of the risks.
But the FDA says the Pentagon violated its rules requiring that troops be told the drugs were experimental and that strict health records be maintained to catch side effects. The drugs now are under scrutiny for possible links to so-called Gulf War syndrome.
The Pentagon acknowledged problems, but in July the FDA said it had broken the rules again -- while vaccinating nearly 4,000 soldiers in Bosnia against tick-borne encephalitis.
The FDA does not consider the vaccine dangerous -- it is widely used in Europe but not here because tick-borne encephalitis is not a U.S. problem. Still, soldiers were inadequately warned about side effects and the fact that the vaccine was not FDA approved, and the 1996 vaccinations were not properly recorded in many soldiers' medical records, the FDA said.
It cited a pattern of violations that it will consider in debating how to regulate future Defense Department research.

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