Document Page: First | Prev | Next | All | Image | This Release | Search

Subject: JUSTIFICATION  APPROVAL FOR CIPROFLOXACIN FOR ODS  18 JAN 91    

Unit: OTSG        

Parent Organization: HSC         

Box  ID: BX003201

Folder Title: APPROVAL FOR ANTIBIOTIC CIPROFLOXACIN FOR DESERT SHIELD                                         

Document Number:       1001

Folder Seq  #:          6





                                              Antibiotic Ciprofloxacin
                                              DAMD17-91-C-1032




        by FDA has not been successful in Operation Desert Shield due to
        the requirement of FDA for individual informed consent for use of
        vaccines and drugs produced under Investigational New Drug
        regulations. Accordingly, no attempt was made to contract for an
        unlicensed product.

            b. Meetings were conducted with representatives of the
                                          to discuss medical issues
        resulting from Operation Desert Shield. It was learned that the
        = is utilizing doxycycline for therapeutic treatment of
        diarrhea. Ciprofloxacin was recommended by the Armed Forces
        Epidemiology Board for immediate acquisition rather than
        doxycycline because it is effective against antibiotic-resistant
        diarrhea, and may be an effective treatment for certain biological
        warfare agents.

        7. Actions to Increase Co=etition - It is not anticipated that
        the U.S. Army Medical Research and Development Command will
        acquire ciprofloxacin in the future; see paragraph 10 below.

        8. Market Survey - No market survey was conducted; FDA has not
        licensed any other pharmaceutical firm to produce ciprofloxacin.

        9. Interested Sources - A Commerce Business Daily (CBD) notice
        was not published since pursuant to FAR 5.202(a)(2) the
        contracting officer determined that the Government would be
        seriously injured if the time periods in FAR 5.203 were complied
        with for this acquisition.

        10. Other Factors


            a. Procurement History. DPSC and the Veterans Administration
        contracted with Miles, Inc. in 1988 for delivery of ciprofloxacin.
        It has not been possible to review the history of the contracting
        process; however, the current contracts expire Dec 90 and the
s $1.50. The negotiated price is considered
        reasonable, since the published price, and that proposed to the
        Government, for future acquisitions, is $1.9460 per tablet. In
        addition, one-half the quantity, 15 million tablets, will be
        packaged in blistered cards for individual soldier use. This type
        packaging was not previously required by the Government, and
        increased the cost to the contractor to meet the required delivery
        schedule.


            b. Pursuant to DFARS 208.7100-2, DPSC was informed that
        USAMRDC was contracting for ciprofloxacin, and that a copy of the
        contract and Business Clearance Memorandum would be provided to
        them.





                                          3

Document Page: First | Prev | Next | All | Image | This Release | Search

Document 6 f:/Week-36/BX003201/APPROVAL FOR ANTIBIOTIC CIPROFLOXACIN FOR DESERT SHIELD/justification approval for ciprofloxacin for od:01029715474559
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003201
Unit = OTSG
Parent Organization = HSC
Folder Title = APPROVAL FOR ANTIBIOTIC CIPROFLOXACIN FOR DESERT SHIELD
Folder Seq # = 6
Subject = JUSTIFICATION APPROVAL FOR CIPROFLOXACIN FOR OD
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 = 02-JAN-1997