Veterinary medicine advisory committee




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DEPARTMENT OF HEALTH AND HUMAN SERVICES


FOOD AND DRUG ADMINISTRATION


CENTER FOR VETERINARY MEDICINE


VETERINARY MEDICINE ADVISORY COMMITTEE


Monday, January 25, 1999


8:30 a.m.


Holiday Inn Gaithersburg

Ballroom

Two Montgomery Village

Gaithersburg, Maryland

PARTICIPANTS


Keith Sterner, D.V.M., Chairperson

Richard Geyer, Executive Secretary


MEMBERS

Frederick Angulo, D.V.M.

Steven Barker, Ph.D.

Oscar Fletcher, D.V.M.

Wanda Haschek Hock. B.V.Sc., Ph.D.

Robert Holland, D.V.M.

Vernon Langston, D.V.M., Ph.D.

Richard Wood


CONSULTANTS

Peter Galbraith, D.M.D., M.P.H.

Diane Gerken, D.V.M.

Donald Lein, D.V.M., Ph.D.

Carl Norden, M.D.

Thomas O'Brien, M.D.


FDA and USDA

CVM

Stephen F. Sundlof, D.V.M., Ph.D.

Linda Tollefson, D.V.M., M.P.H.

Margaret Miller, Ph.D.


CDER

Mark Goldberger, M.D., M.P.H.

Albert P. Sheldon, Ph.D.


Office of Policy

Eric Flamm, Ph.D.


DHHS

Nicole Lurie, M.D., M.S.P.H.

I. Kaye Wachsmuth, Ph.D.


Office of the Commissioner

Michael Friedman, M.D.

Jesse L. Goodman, M.D., M.P.H.


Office of Chief Counsel

Joy Whetstone Dawson, Esq.


GUEST SPEAKERS

David Bell, M.D.

Sherwood Gorbach, M.D.

Patricia Lieberman, Ph.D.

Scott McEwen, D.V.M., D.V. Sc.

J.M. Rutter, D.V.M.

Abigail Salyers, Ph.D.

Lyle Vogel, D.V.M., M.P.H.


C O N T E N T S


Introductory Remarks: Keith Sterner, D.V.M. 5


Introductory Remarks: Michael Friedman, M.D. 9

Nicole Lurie, M.D., M.S.P.H. 12


A Proposed Framework for Evaluating and Assuring the

Human Safety of the Microbial Effects of Antimicrobial

New Animal Drugs Intended for Use in Food Producing

Animals:

Stephen F. Sundlof, D.V.M., Ph.D. 17


The Importance of Antimicrobial Drugs for Human

Medicine:

Mark Goldberger, M.D., M.P.H. 36


The Animal Drug Approval Process for Antimicrobial

Agents:

Margaret A. Miller, Ph.D. 50


Post Approval Surveillance Issues:

Linda Tollefson, D.V.M., M.P.H. 66


GUEST SPEAKERS


Need for Addressing Issue and Benefits of Establishing

Threshold Levels:

David Bell, M.D., CDC 79


Risk Assessment:

Scott McEwen, D.V.M., D.V. Sc., University 94

of Guelph


Overview of CSPI Report Recommendations Relevant to

Use of Antimicrobials in Food Animals:

Patricia Lieberman, Ph.D., CSPI 109


Need for Safe and Effective Antimicrobials for Food

Animals and AVMA Efforts on Prudent Use:

Lyle Vogel, D.V.M., M.P.H., AVMA 122


The Authorization of Antimicrobial Products in the

European Union:

J.M. Rutter, D.V.M., Veterinary Medicine

Directorate, U.K. 145


Importance of Commensals in the Transfer of Resistance

from Animals to Humans:

Abigail Salyers, Ph.D., University of

Illinois 159


C O N T E N T S (Continued)


Importance of In Vitro Resistance Compromising Therapy

for Diarrheal Disease:

Sherwood Gorbach, M.D., Tufts University 175


Testimony of Animal Health Institute:

Dr. Brendan Fox 191

Dr. Richard Carnevale 210

Alex Mathews 225


PUBLIC SPEAKERS


Margaret Mellon, Union of Concerned Scientists 252


Dr. Rebecca Goldberg, Environmental Defense Fund 258


Dr. Tom Burkgren, American Association of Swine

Practitioners 264


Dr. Diane J. Fagerberg, Colorado Animal Research

Enterprises 273


Thomas Shryock, Ph.D., National Committee for

Clinical Laboratory Standards and Elanco

Animal Health 282


Barb Determan, National Pork Producers Council 291


Dr. Lester Crawford, Georgetown University 305


Joel Brandenberger, Coalition for Animal Health 310


Dr. Clyde Thornsberry, MRL Pharmaceutical Services 319


Harless A. McDaniel, AVID 329


Dr. Dennis Wages, American Association of Avian

Pathologists 332


Dr. Mike Apley, Academy of Veterinary Consultants 339


Dr. Robert Walker, Michigan State University 354


Dr. Larry Glickman, Purdue University 362


James S. Cullor, U.C. Davis 371


Dr. Barbara Glenn, Federation of Animal Science

Societies 381

P R O C E E D I N G S

Introductions

DR. STERNER: If you would take your seats, we have a very long and busy day. I would ask that we convene the meeting of VMAC.

By way of introduction, I am Keith Sterner, a private veterinary practitioner from Ionia, Michigan. I am in a nine person mixed, large animal practice. I am this year's Veterinary Medicine Advisory Committee Chair. I am going to start by introducing VMAC members. Dr. Angulo, if you would start by introducing yourself, and a bit about where you are from and what you do?

DR. ANGULO: Good morning. My name is Fred Angulo. I am with the Foodborne and Diarrheal Diseases Branch in the Center for Infectious Diseases at CDC.

DR. NORDEN: I am Carl Norden. I am a Professor of Medicine and Head of Infectious Diseases at Cooper Hospital in Camden, New Jersey, and I am on the FDA Anti Infective Advisory Committee.

DR. BARKER: Steven Barker, Louisiana State University, Department of Physiology, Pharmacology and Toxicology, representing the analytical sciences.

DR. GALBRAITH: Peter Galbraith. I am the State Epidemiologist for the Vermont Health Department, and I have done environmental risk assessment and infectious disease epidemiology.

DR. FLETCHER: Oscar Fletcher, Dean of the College of Veterinary Medicine in NC State University, representing poultry.

DR. HASCHEK HOCK: Wanda Haschek Hock, University of Illinois. I am Professor and Head of the Department of Veterinary Pathobiology, and I am representing pathology.

DR. HOLLAND: I am Robert Holland, Michigan State University, representing Minor Animal Program.

DR. DIANE GERKEN: I am Diane Gerken, College of Veterinary Medicine, Ohio State University, representing toxicology.

DR. LANGSTON: Corey Langston, clinical pharmacologist in Mississippi State University, representing pharmacology.

DR. LEIN: Don Lein, past chair of this group and a consultant, Chair of Cornell University Department of Population Medicine and Diagnostic Science, and Director of the Diagnostic Lab for the State of New York.

MR. WOOD: I am Richard Wood, Executive Director of Food Animal Concerns Trust, and I am the consumer representative on the committee.

DR. O'BRIEN: I am Tom O'Brien from Brigham and Women's Hospital and Harvard Medical School in Boston, and a consultant to the committee.

DR. STERNER: We have two members of VMAC who will not be here. One is George Cooper and the other is Calvin Koong. I don't believe that Calvin will be here for the entire meeting due to other commitments.

DR. GEYER: I am Dick Geyer. I am the Executive Secretary of VMAC. And Dr. Cooper will be with us tomorrow.

I have just two brief announcements before we move into our scheduled program. First, you will notice on the agenda that we are going to begin with the public speakers at five o'clock today. That is a change from the announcement in the Federal Register. We wanted to make sure that everyone knows this up front. We plan to have most of the speakers in the public session speak this afternoon or this evening. There will be a few who will be speaking in the morning.

If any of you who are public speakers have a difficulty with the time that you are scheduled for, please see me sometime today.

There is just one other thing. I would like to ask that everyone who speaks today be sure to speak into the microphone and, if you have not been introduced or if your name has not been mentioned, as you start to talk please state your name so that our reporter will be able to get your name correctly. Keith?

DR. STERNER: I think that the turnout at this meeting says it all with regard to the issue of antimicrobial resistance.

Just to set the tenor a bit, Veterinary Medicine Advisory Committee is just that, an advisory committee to the Food and Drug Administration's Center of Veterinary Medicine. And, they have prepared a framework document that deals with the issue of antimicrobial resistance as it involves approval and usage of antimicrobial agents in veterinary medicine. To that end, this document deals with an increasing level of both public and professional concern over the issue of emerging antibiotic resistance.

With that said, I need to tell you that VMAC is not here today and tomorrow to debate the issue of antibiotic resistance but, rather, to pass judgment on the framework document that deals with this issue, and to answer those five questions. So, those of you who are here to hear a definitive answer to antimicrobial resistance, I am afraid that VMAC will disappoint you in its deliberations.

I also would point out to you that people coming to this discussion all hold very strong views, many times from polar opposites on a very contentious issue. I think that the great thinking that you are going to hear in the presentations today will point out just how dramatically opposed some of those views happen to be.

But with that in mind, we will introduce our first speaker, Dr. Michael Friedman, who is the Deputy Commissioner for our Operations from the Food and Drug Administration.

Introductory Remarks

DR. FRIEDMAN: I appreciate the chance to make a few introductory remarks. Let me reinforce a couple of themes that you have mentioned and that will again be mentioned after me.

This is a very important meeting. It deals with the sort of exemplary, complex subject that affects many different communities in very important ways.

The mission of the Food and Drug Administration is to both promote and protect the public health. As an integral part of FDA, the Center for Veterinary Medicine is charged with these tasks: It protects, it promotes the public health through every decision that it makes whether that is in respect to food safety or whether it is in respect to animal health issues that are very important.

Today's issues represent, I think, a competition between a variety of different areas where there are competing needs and competing expectations. There are very legitimate, important veterinarian and animal owner needs. Antimicrobials are important drugs for veterinary use as well as for human use, obviously.

FDA recognizes the critical need for antimicrobials in veterinary medicine to treat animal diseases; to improve the health of animals and prevent suffering; to help ensure that animals raised for food production are health.

In addition though, concerns have to do with attempts to minimize the transmission of zoonotic pathogens. This is a highly dynamic situation. It is a situation in which we have incomplete scientific data, and I feel that at the end of the day, no matter how clever or how appropriate an overall scheme is devised, we will not have all the scientific information necessary to make a perfect decision, nonetheless, we must at some point make a decision.

There is a balance that is necessary. FDA's goal is to find the balance that protects human health and gives veterinarians the tools they need to treat animals.

The framework document that you have for your consideration and which will be discussed today represents a proposal for a conceptual regulatory framework, an approach toward balancing the needs for safe and effective animal health products against the potential impact on human health that would result if pathogens acquire resistance to important antimicrobials.

This is a document for your discussion and consideration. This is a framework document. It represents FDA's current thinking. It represents a synthesis of different opinions from within the agency, but please let me reinforce the idea that none of this document is etched in stone. The discussion here is no mere empty exercise but a serious, thoughtful debate that will be considered very carefully by the agency. We honestly desire input from stakeholders as we move forward to implement the concepts embodied in the document. We will take very seriously this input. We will use it to help guide us in developing a rational science based process for regulating antimicrobial drugs intended for use in food producing animals.

I want to appreciate the participation of the panel members, of the others who are represented here, of the people who will speak later, of all who participate in this very important exercise. This is not an easy issue but it is a very important issue.

Our goal is to articulate a public policy based on the best science that positions us well for today and positions us well for the future. And, as we search for a formulation that is both practical and one supported by the optimal public health position, we deeply appreciate all of your contributions and help. Thank you.

DR. STERNER: Thank you, Dr. Friedman and, in particular, I will personally thank you for keeping us on time.

Our next speaker this morning is Dr. Nicole Lurie, who is the Principal Deputy Assistant Secretary for Health at the U.S. Department of Health and Human Services. Her background includes her degree from the Minnesota School of Medicine where she held the post of Director of Primary Care Research and Education, Director of the Division of General Internal Medicine. She has taught within the University of Minnesota system since 1985, and serves currently in her capacity as Deputy Assistant Secretary since September of 1998. Dr. Lurie?

Introductory Remarks

DR. LURIE: Thank you. I can only observe that the room is so cold because the seats are already so hot.

[Laughter]

I am pleased to be here today on behalf of the Surgeon General and Assistant Secretary for Health to welcome you here, and pleased    very pleased that you are meeting together to address this very important and timely public health concern about antibiotic resistance, treating sick animals and its relationship to veterinary use.

I am going to take you back a step from what our introduction told us, and make a couple of comments about antibiotic resistance since you will spend the rest of the day working on this framework document.

As you may know, not only has antibiotic resistance been designated by the CDC as a high priority in its emerging health concern, but the World Health Organization has also designated it as a very high priority, and in its focus on emerging and re emerging infections it is right up there with our concerns about multi drug resistant tuberculosis.

In addition, Dr. Satcher has identified five priorities for his term as Surgeon General and Assistant Secretary for Health, one of which is global health. Again, antibiotic resistance is identified squarely as a global health concern in that framework. It is not only a concern in this country, as most of you know.

Everywhere I go I hear now about this issue. I hear about it from health plans and insurers, including people in the healthcare financing organizations and managed care organizations, who are concerned not only about antibiotic costs and provider prescribing behavior but about the morbidity and mortality of antibiotic resistance. Among doctors the concerns span the range from pediatricians to geriatricians.

I hear constantly now from state and local public health officials. I hear also from ordinary citizens with considerable frequency. Interestingly, their questions are not limited to the ones of human use. They are quick to recognize the many links between human and animal uses of antibiotics.

I am also pretty fascinated by the sophistication out there. The distinction between antibiotic use to ensure growth versus the distinctions between antibiotic use to treat sick animals are the ones that the public is increasingly able to make. Just last week, in fact, the public health officer in a large Midwestern city    and not Minnesota    asked me about antibiotics in groundwater for example, and asked again what we are going to do about it.

The questions I get asked are the questions you are going to help address today: What is the government going to do about this problem? What is the right mix of regulation and voluntary effort? What kinds of partnerships, both between government entities and between government and private sector organizations and businesses, can produce the best public health outcome?

I want to stress, as Mike did, the term "public health outcome" because our job here is to protect the health of the public. One of our overriding principles is that prevention is the best alternative. Another is that, to the extent possible, we use the best possible science to do so. Often the emotion surrounding an issue and the scientific evidence leads us to alternative conclusions, and I am sure there will be a long period today where that will appear to be the case. But we also understand that science does not yet have all the answers. So, we need to consider in this equation not only the potential risks and benefits but also public confidence in our public health decision making.

We also have here an obligation to define where scientific work remains to be done, and to get it going. In this case, we recognize full well that risk assessment is an imperfect science and we must strive to improve it.

We also recognize that for uncommon events surveillance systems alert us to problems often later than we wish they would. We must strive to improve those too. In both cases we hold ourselves to a commitment that when the science improves, or when the evidence changes, we may need to make different public health decisions than we might today. But we certainly don't want to wake up five or ten years from now with a massive problem of resistance and ask where were we; where was the FDA; where was the CDC where was agribusiness; where was the pharmaceutical industry; where was the Public Health Service to allow this to happen? This is why prevention is so absolutely critical.

We recognize, as you have been reminded twice already this morning, that we are dealing with a difficult issue. The science will get us a good part of the way there but not all the way. There are competing views of risk and sometimes competing goals for government, business and the public. Yet, I believe that it is not only possible but that we must find a common ground here, and I think it will be easier to find a common ground if we remember our common overriding goal    protecting the public's health.

I wish you the best in your deliberations and debate today, and I certainly look forward to the outcome and to hearing your best advice about dealing with this challenging issue.

I only want to comment in closing that I have had a very interesting discussion with my three boys over the past week about the availability of antidepressants now for dogs.

[Laughter]

And, one of the things I started wondering as I started thinking about antibiotics in groundwater is when we will see the mood of the public improve.

[Laughter]

So, let me wish you all a good day and the best of luck!

DR. STERNER: Thank you, Dr. Lurie. Our next speaker I think is known to each and every one of us in the room. I consider him a personal friend, and in my comments to him yesterday I said he must be doing a particularly good job as director of the CVM because he has made lots of enemies and usually that is a sign that, if you have made enough, you are doing something right.

Dr. Sundlof is Director of the Center of Veterinary Medicine, and he is going to set the ground rules for VMAC and give us additional background. Steve?

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