U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only.

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U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated.

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  John McGlone  Katrina Mealey  Lisa Nolan  Mark Papich  Richard A. Sams  Arthur Craigmill Chairman  Susanne Aref  Corrie Brown  Sherman (Skip) Jack  Gregory Jaffe

VMAC Consultants  Charles Bennett  John Glisson  Sam Groseclose  Michael Luster  Tom Nelson  Michael Peterson  M. Gatz Riddell Jr.  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