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					                       Welcome to
                            VMAC
Comments by Stephen F. Sundlof, D.V.M., Ph.D.
                 Director, Center for Veterinary Medicine
For the Veterinary Medicine Advisory Committee Meeting
                                      Rockville, Maryland
                                         January 31, 2005
Purpose of Meeting
          Review safety of
           ProHeart 6
          Product recall prompted
           by information from
           Adverse Drug Experience
           reporting system
          We will ask for your
           opinion of safety
           information
     VMAC Members
   Arthur Craigmill         John McGlone
    Chairman
                             Katrina Mealey
   Susanne Aref
                             Lisa Nolan
   Corrie Brown
                             Mark Papich
   Sherman (Skip) Jack
                             Richard A. Sams
   Gregory Jaffe
VMAC Consultants
   Charles Bennett      Tom Nelson
   John Glisson         Michael Peterson
   Sam Groseclose       M. Gatz Riddell Jr.
   Michael Luster       Lauren Trepanier
Protect Animal Health
   CVM Mission Statement
    “We foster public and animal health by
    approving safe and effective products for
    animals and by enforcing other applicable
    provisions of the Federal Food, Drug, and
    Cosmetic Act and other authorities”
Adverse Drug Experience
   Responsibility for safety continues after
    drug review
   Data collected, analyzed to detect
    problems
   Information from ADEs raised concerns
    about ProHeart 6
ADE System
   ADE information carefully analyzed
   We use an established system that is
    ordered, structured
   Results in unbiased decisions about
    product safety
Addressing Concerns
   Questions raised by ADE reports led first
    to label changes – then product recall
   Subsequent ADE data reviews have not
    changed our conclusions about safety of
    ProHeart 6
VMAC Review
   Present case in public forum
   Thorough review of all ProHeart 6
    information by VMAC
     advisory committee review of data is a
      common approach throughout FDA
Conclusion

       CVM responsible for safety of
        animal drugs
       ADE report information integral
       We appreciate assistance of
        VMAC members

				
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