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U.S. Department of Health and Human Services

Advisory Committees

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Welcome and Opening Remarks by Dr. Bernadette Dunham, Director, CVM

DR. DUNHAM: Good morning, everybody.  I am very thrilled to have you come to our FDA Center for Veterinary Medicine’s Veterinary Advisory Committee meeting this morning.  I am Dr. Bernadette Dunham, and I am the Director for the Center for Veterinary Medicine at the U.S. Food and Drug Administration.  And two acronyms throughout the day will be “CVM,” for the “Center for Veterinary Medicine,” and “VMAC,” for “Veterinary Advisory Committee Meeting.”

Today, through a series of presentations, we will discuss the current Risk Mitigation and Restricted Distribution Plan, called the “RiskMAP,” for ProHeart 6 and the data generated during the last 18 months that this product was marketed under this plan.  But before we start, I have the pleasure of introducing a number of people to you.

Seated on my left from the podium is Dr. Dan McChesney.  He is the Director for CVM’s Office of Surveillance and Compliance, and he will briefly explain the roles and responsibilities of the Office of Surveillance and Compliance. 

Next is Ms. Janice Steinschneider.  She is Regulatory Counsel, also from CVM’s Office of Surveillance and Compliance.  Ms. Steinschneider will discuss CVM’s regulatory framework with respect to FDA’s risk management activities.

Next we have Dr. Steve Sutherland, who is Senior Director for Regulatory Affairs with Pfizer, and Dr. Tatty Hodge, Director of Global Pharmacovigilance with Pfizer.

Then we have Dr. Hartogensis.  Martine Hartogensis is our Deputy Director for CVM’s Office of Surveillance and Compliance, and she, along with, beside her, Dr. John Baker, who is the Veterinary Medical Officer in CVM’s Division of Surveillance and who is also Medical Review and Pharmacovigilance Team Leader, both Dr. Baker and Dr. Hartogensis will be giving presentations later this morning. They are going to present the ProHeart RiskMAP labeling and some of CVM’s analysis of the data that has been generated during the last year and a half.

Now I have the delight of introducing to all of you the members of the VMAC.

Our Acting Chairman today is Dr. Michael Doyle, who is sitting at the front.  He is the Director for Food Safety as well as the Regents Professor of Food Microbiology at the University of Georgia.  He brings to us his expertise in risk assessment and microbiology.  And Dr. Doyle had also been our former Chair for the Science Board.

Beside is Dr. Craig Altier, Associate Professor, Department of Population Medicine and Diagnostic Sciences at the College of Veterinary Medicine at Cornell University.  Dr. Altier is also recognized for his expertise in microbiology.

Dr. Mike Apley is a Professor of Production Medicine and Clinical Pharmacology with the Department of Clinical Sciences, College of Veterinary Medicine, Kansas State University.  Dr. Apley’s expertise is in veterinary clinical pharmacology, food animal therapeutics, and antimicrobial resistance.

Next is Dr. Dee Griffin, Professor of Beef Cattle Production Management at the University of Nebraska-Lincoln.  Dr. Griffin’s expertise is in feedlot production management and medicine. 

And I am looking myself -- I need glasses!  Dr. Mathew!  Dr. Alan Gerard Mathew is Professor and head of the Department of Animal Science at the University of Tennessee in Knoxville.  He will provide his expertise in animal science during today’s discussion.

Beside him is Dr. James Daniel McKean, Professor and Extension Veterinarian with the Department of Veterinary Diagnostic and Production Animal Medicine at Iowa State University.  Dr. McKean’s area of expertise includes swine medicine, zoonotic disease food safety, and disease surveillance.

Beside him is Dr. Michael Murtaugh, an expert in immuno-toxicology, Professor of Molecular Biology at the University of Minnesota.

Then we have Dr. Robert Poppenga, Professor of Clinical Diagnostic Toxicology at the School of Veterinary Medicine, U.C. Davis, also joins us today.  His interests are clinical and diagnostic veterinary toxicology with a special focus in wildlife toxicology.

Then we have Dr. David Senior, Associate Dean of Advancement and Strategic Initiatives with the School of Veterinary Medicine at Louisiana State University.  Dr. Senior serves as our expert in companion animals today.

Finally, to round out our panel, Dr. Michael Wolf adds his expertise in Health Literacy and Medication Use.  Dr. Wolf also serves on FDA’s Risk Communication Advisory Committee and is an Assistant Professor with the Institute for Healthcare Studies at Northwestern University in Chicago and represents the pet owners’ interests in risk communication and labeling.

I welcome all of our distinguished experts to CVM’s VMAC today.

The purpose of today’s meeting, as I said, is to review and discuss the Risk Mitigation and Restricted Distribution Plan, called the RiskMAP, for ProHeart 6, an injectable heartworm preventative for use in dogs.  The meeting will focus on the data generated during the time that ProHeart 6 was marketed under this plan. 

We are seeking feedback from our Veterinary Medical Advisory Committee panel on our approach to the plan and/or any modifications they would recommend.  We are looking forward to today’s discussion and hope you will find it useful as we demonstrate the value and collaborative efforts involved in marketing a drug under a RiskMAP.

So before we start the actual full agenda, let me introduce to you Ms. Aleta Sindelar, our Executive Secretary for VMAC, and she will have a few comments to make and she will also make the Conflict of Interest Statement for the meeting.  Aleta?

MS. SINDELAR:  Thank you.  Welcome, everyone.  It is great to see everyone here. 

One of the most tedious things to begin with is reading the Conflict of Interest, which is a statement that must be read before every Advisory Committee meeting. 

(Whereupon, Ms. Sindelar read the Conflict of Interest Statement into the record.) (Luncheon logistics.)

DR. DUNHAM:  Thank you very much, Aleta.  So, with no further ado, we shall now begin the VMAC meeting.  It is my pleasure to have Dr. Dan McChesney give us the background.