The Assistant Secretary of Defense
Washington, D.C.   20301-1200
Health Affairs

Mar 04 1997

Micheal A. Friedman, M.D.
Lead Deputy Commissioner of Food and Drugs
Food and Drug Administration
5600 Fishers Lane
Rockville,  Maryland  20857

Dear Dr. Friedman:

           As you know, during the Gulf War, the Department of Defense (DOD) employed fully licensed Anthrax vaccine to protect U.S. forces against the threat of an Iraqi biological warfare attack with Anthrax.

          Because Anthrax is the most lethal biological warfare threat today, and because a fully licensed vaccine is available, DOD is evaluating an immunization initiative to protect U,S, forces.   While the package insert for this vaccine is non-specific as to the route of exposure, DOD has long interpreted the scope of the license to include inhalation exposure,  including that which would occur in a biological warfare context.   Please advise whether the FDA has any objection to our interpretation of the scope of the licensure for the Anthrax vaccine.   In advance of this letter, I have spoken with Dr. Kathryn Zoon, Director, Center for Biologics Evaluation and Research, on this matter.

           I will follow up this letter with a telephone call in the next few days.   My point of contact for this matter is LTC Terry Rauch, 703-697-2111.

Sincerley,

Stephen C. Joseph, M.D., M.P.H.