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DoD Implements Policy for Emergency Use Authorizations and Use of Investigational New Drugs in Force Health Protection Programs<TABLE width="100%"><TBODY><TR><FORM action=search.jsp method=get><TD vAlign=bottom align=right>Last updated on 2008-04-04 10:52:07 </FORM></TD></TR></TBODY></TABLE><TABLE align=center border=0><TBODY><TR><TD vAlign=top>
</TD><TD vAlign=top>DoD Implements Policy for Emergency Use Authorizations and Use of Investigational New Drugs in Force Health Protection Programs
Military personnel deployed in some military operations could potentially be exposed to a range of chemical, biological, and radiological weapons as well as diseases endemic to an area of operations. It is policy of the United States Government to provide military personnel with safe and effective vaccines, antidotes, and treatment that will negate or minimize the effects of these health threats. However, in the wake of September 11th, concerns arose that the U.S. military might not be able to use countermeasures believed to be the best available.
If no safe and effective FDA-approved drug or biological product is available to meet a foreseeable threat at the time of need under a force health protection program, DoD may seek FDA authorization to use a product that has not been approved for general commercial marketing or that has been approved for some purposes but not for the same purpose for which it is needed for force health protection.
Understanding the drawbacks and delays in the use of Investigational New Drug (IND) procedures, Congress has approved a separate approach. With the implementation of Department of Defense Instruction 6200.02, items may be authorized by the FDA for use through an Emergency Use Authorization (EUA) when the intent is to use the drug/vaccine solely for emergency prophylaxis or treatment of military forces or civilians when there is no available approved product. EUAs may be requested to protect against chemical, biological, and radiological attacks.
Requests for approvals by the assistant secretary of defense for health affairs must be justified based on the available evidence of the safety and efficacy of the medical product and the nature and degree of the threat to personnel.
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http://fhp.osd.mil/new.jsp?newsID=32
</TD><TD vAlign=top>DoD Implements Policy for Emergency Use Authorizations and Use of Investigational New Drugs in Force Health Protection Programs
Military personnel deployed in some military operations could potentially be exposed to a range of chemical, biological, and radiological weapons as well as diseases endemic to an area of operations. It is policy of the United States Government to provide military personnel with safe and effective vaccines, antidotes, and treatment that will negate or minimize the effects of these health threats. However, in the wake of September 11th, concerns arose that the U.S. military might not be able to use countermeasures believed to be the best available.
If no safe and effective FDA-approved drug or biological product is available to meet a foreseeable threat at the time of need under a force health protection program, DoD may seek FDA authorization to use a product that has not been approved for general commercial marketing or that has been approved for some purposes but not for the same purpose for which it is needed for force health protection.
Understanding the drawbacks and delays in the use of Investigational New Drug (IND) procedures, Congress has approved a separate approach. With the implementation of Department of Defense Instruction 6200.02, items may be authorized by the FDA for use through an Emergency Use Authorization (EUA) when the intent is to use the drug/vaccine solely for emergency prophylaxis or treatment of military forces or civilians when there is no available approved product. EUAs may be requested to protect against chemical, biological, and radiological attacks.
Requests for approvals by the assistant secretary of defense for health affairs must be justified based on the available evidence of the safety and efficacy of the medical product and the nature and degree of the threat to personnel.
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http://fhp.osd.mil/new.jsp?newsID=32
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