REQ FOR DETERMINATION INFORMED CONSENT DRUG AND VACCINES

File: 970101_sep96_decls31_0002.txt
Page: 0002
Total Pages: 16

Subject: REQ FOR DETERMINATION INFORMED CONSENT DRUG AND VACCINES        

Unit: OTSG        

Parent Organization: HSC         

Box  ID: BX003201

Folder Title: REQUESTS FOR DETERMINATION INFORMED CONSENT DRUGS                                               

Document Number:       1001

Folder Seq  #:         16






                         THE ASSISTANT SECRETARY OF' DEFENSE

                              WASHINGTON. D. C, 20301-1200











         David A. Kessler, M.D.
         commissioner of Food and Drugs
         Food and Drug Administration
         5600 Fishers Lane
         Rockville, Maryland 20857

         Dear Doctor Kessler:

             Under the provisions of 21 CFR 50.23(d)(1), as published in
         the Federal Register of December 21, 1990, 1 request a determi-
         nation that obtaining informed consent is not feasible for
         pentavalent botulinum toxoid (ABCDE), BB-IND 3723, because of
         military combat exigencies in operation Desert Shield. This
         determination would apply to the use of this drug by American
         military personnel at risk of exposure to botulinum toxins
         employed as biological warfare agents by enemy forces.

             As summarized in Enclosure 1 and supported in documentation
         in the IND file, available evidence supports the safety and
         effectiveness of pentavalent botulinum toxoid (ABCDE) for this
         purpose. The fatality rate among unvaccinated personnel exposed
         to botulinum toxins would be very high and many casualties would
         be expected. In such a situation, service members who became
         casualties would also pose a liability to their unit mission and
         the overall safety and well being of the other members of the
         unit. Pentavalent botulinum toxoid (ABCDE) is currently the only
         prophylactic measure available to persons who are exposed to
         botulinum toxins. During Operation Desert Shield, informed
         consent prior to vaccination with pentavalent botulinum toxoid
         (ABCDE) is neither feasible nor prudent for the foregoing reasons.
         The recommendation for use of pentavalent botulinum toxoid (ABCDE)
         without informed consent has been concurred in by a duly consti-
         tuted institutional review board (Enclosure 2).

Document 16 f:/Week-36/BX003201/REQUESTS FOR DETERMINATION INFORMED CONSENT DRUGS/req for determination informed consent drug and :12249609312932
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003201
Unit = OTSG
Parent Organization = HSC
Folder Title = REQUESTS FOR DETERMINATION INFORMED CONSENT DRUGS
Folder Seq # = 16
Subject = REQ FOR DETERMINATION INFORMED CONSENT DRUG AND
Document Seq # = 1001
Document Date =
Scan Date =
Queued for Declassification = 01-JAN-1980
Short Term Referral = 01-JAN-1980
Long Term Referral = 01-JAN-1980
Permanent Referral = 01-JAN-1980
Non-Health Related Document = 01-JAN-1980
Declassified = 24-DEC-1996