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U.S. Department of Health and Human Services

Animal & Veterinary

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Welcome and Outline of Scope, Purpose and Objectives of Workshop

Dr. Stephen Sundlof

DR. SUNDLOF: My name is Steve Sundlof and I am the Director of FDA's Center for Veterinary Medicine. And it is my pleasure to be able to host this meeting. Before we get started, just a little bit of background as to where this meeting fits into the grand scheme of things.

Back in January of 1999, we held a Veterinary Medicine Advisory Committee. And at that committee, we discussed a document which we referred to as the Framework Document -- I think there are copies out on the table of that document -- which basically described the Agency's best thinking at that time as to what might be a rational approach to regulating antimicrobials as it pertains to the human food safety aspects of antimicrobial resistance.

And at that meeting, we said that there would be additional workshops to discuss specific issues, specific parts of that framework. And this is one of those meetings. And since the meeting in January, we have put in a great deal of effort, listened to a lot of what people had to say, read through many, many comments and tried to respond accordingly.

So today is the continuation of that process. And, as you might guess, it will not be the end. There will be additional meetings that will be held. I would like to start off with just a few philosophical points. And these are my own philosophical statements, but to try and set the tone for the meeting for the next two days.

(Laughter.)

We don't have to worry about OSHA I am sure.

(Laughter.)

FDA as an agency is a science-based, public health, regulatory agency. It has all those three things. It is science-based. It is decisions. And it is regulations. By law, I have to be based in science. It is a public health agency and a consumer protection agency. And it is also a regulatory agency. We do have the authority to take regulatory actions to support the decisions that we make.

I want to talk about the science part of it. It is very important to FDA and I think to society at large that our policies and our regulations are supported by the body of science as it is known at the time and at the same time, recognizing that there will always be uncertainties in that body of science.

The scientific method is by design contentious -- well, it is a messy process. It involves intense debate, critical scrutiny of underlying assumptions, experimental designs and interpretations of results. At times, it can become contentious and acrimonious. And for many people, it can become an uncomfortable event. But that is part of the scientific process. And in many cases, it is only through that emotionally charged process that science advances.

It is therefore important that we allow that process to play out and that we resist the temptation to cut off the debate prematurely. I am hopeful in the next two days that we will contribute positively to that debate. And that is my sincere hope for this meeting.

To help set the tone for the next two days, I would like to make a proposition with all of you. We at FDA will make a concerted effort to listen to you if you can all agree to listen to each other.

That doesn't mean that we shouldn't challenge one another to support his or her positions during the discourse. But it does mean that comments of a personal nature are off limits. And accordingly, that comments not be taken personally by those to whom they are directed. And I will try and set an example by intervening where appropriate.

But I think it is up to everyone to hold each other responsible for maintaining a high standard of conduct during the meeting. So that is a little bit of the philosophy. Now I will talk more about the meeting and I will try and set up what we hope to accomplish in the next two days.

(Slide.)

The objective of the meeting is to consider the merits of the risk assessment. We did do a risk assessment. It should be out on the front table. We apologize in advance for the short time that it has been available to the public. It has been available the same amount of time to us.

But we want to discuss the merits of the risk assessment as a potential model for evaluating the risk to human health from resistant food-borne pathogens associated with the use of antimicrobials in food animals. The risk assessment itself is very specific. It deals with one specific aspect of resistance. And we will discuss that considerably.

But what we really want to know, the real purpose of introducing the risk assessment is to ask the question is this a good approach; is this risk assessment applicable to dealing with the entire whole issue of antimicrobial resistance; where does it fit in. So those are the kind of issues that we would really like to get your opinions on. Not so much the specifics of that particular risk assessment, but how it might fit into a greater regulatory scheme.

And then what kind of criteria should CVM consider in evaluating the risk of certain pathogens; how do we define such things as an acceptable level of risk, as harm; what do we define as harm; what do we define as the population that we are considering protecting. These are questions that will come up during the course of this discussion.

(Slide.)

We started out a little more than a year ago. It was on November 18th. And we issued a guidance document in the Federal Register. And it said that -- it basically said that emerging scientific evidence indicates the therapeutic use of antimicrobials in food animals in addition to sub-therapeutic food uses may select for resistant bacteria of concern to human health.

It also said that the FDA believes that it is necessary to consider that potential harm, human health impact of microbial effects associated with all uses of antimicrobial drugs. So that is -- that started this process.

(Slide.)

That was followed last December, almost one year ago to the day, with a framework document that most people I think are familiar with. And that framework document said that it was an attempt for FDA, as I indicated earlier, to provide its thoughts on what might be a rational approach to dealing with the issue of antimicrobial resistance from a regulatory perspective.

And it says that FDA's position is that the regulatory system for antimicrobials for use in food animals should be modified to address the issue of microbial safety. And it should look at the importance of drugs. The framework document takes a risk-based approach in that it looks at the risk as it relates to the importance of the particular antimicrobial drug or class of antimicrobial drugs for human -- the importance in human medicine.

And it also talked about such things as setting acceptable levels of risk thresholds and those kinds of things that would be important from a regulatory standpoint.

(Slide.)

A number of comments were received. And I think one of the comments that we heard time and time again was that we, the FDA, before we take any regulatory action should conduct a risk assessment to determine exactly what the harm is from exposure to the public to resistant microbes.

And so we listened to that and we contracted with an expert in risk assessment. And you will hear from him later, Dr. David Vose. And he helped develop the model that you -- that we published last week. So CVM's risk assessment was really -- it was a pilot project. We weren't sure at the time when we entered into it if we would actually be able to pull it off. But I think we have.

We learned a tremendous amount just by going through the process. And we wanted to -- the risk assessment does model the risk associated with fluoroquinolone-resistant Campylobacter originating from chickens. That is the subject of that particular risk assessment. And we want to know if that model that we propose today in some form might be used as a model for looking at the whole entire issue of antimicrobial resistance.

(Slide.)

Some people had asked, well, why did we pick this particular microorganism and drug in chickens in this case as the model. Well, there were a number of reasons why we chose this particular combination of fluoroquinolones, chickens and Campylobacter. First of all, chickens are a reservoir of Campylobacter and Campylobacter is one of the most common of the food-borne diseases and Campylobacter -- excuse me -- Campylobacter do have the ability to develop resistance quickly to fluoroquinolones.

And fluoroquinolones are often used empirically in the treatment of patients that have food-borne disease. And probably as important as all of those other contributing factors is that we actually were able to obtain data, real data that we could use to model the risk.

So for all of those reasons, that is why Campylobacter was chosen as the first one. It is probably one of the simplest of the -- of all the food-borne diseases that we can model. And so that is why we chose that one.

(Slide.)

Let's talk a little bit about the agenda for the meeting. For this morning, we will have a general description of risk assessment tools, a discussion of the epidemiology of Campylobacter, and presentation of the risk assessment, the risk assessment that we published. This afternoon, we are going to talk about the use of risk assessment by various other agencies, looking at the issue of food safety or water safety.

The second part, we will have a discussion of the epidemiology of Campylobacter -- oops, not -- we will have a panel discussion looking at risk assessment. And we will adjourn at 5:30 sharp. That is what time our transcriber has indicated that she needs to leave. So we will try and, again, adjourn at 5:30 sharp. There is going to be a small reception that will occur at some other time, somewhere between 5:30 and 6:00 as I understand.

Okay, Friday. On Friday, we will meet again in the morning. Session 2 will look at the overview of the assessment of risk by U.S. regulatory agencies. In the afternoon, we will have a panel discussion on how based on all of the things that we have heard to that point, looking at what other agencies are doing, etcetera, how should CVM evaluate the risks; how should CVM look at antimicrobial resistance within the context of the other regulatory agencies.

And we are going to on both days seek public comments. We want a lot of public comments. Finally, we will end the session by talking a little bit about what the next steps are about how we might go about with the process of setting regulatory thresholds for resistance.

(Slide.)

Okay. In addition, because we are not going to be able to get everything decided here at this meeting, we think this meeting will provide a lot of food for thought and the people will want to go back home and reflect on what has occurred, read the risk assessment a little bit more carefully, look at the Framework Document, all of these things, and then provide comments on their own personal thoughts about what should be done.

And the comments can be sent to this docket. And we will provide a full transcript of this meeting. It will probably be put up on our home page sometime following the meeting so that everybody has the opportunity to determine -- to know what actually transpired at this meeting. We really do need a lot of public input on this.

(Slide.)

Before I turn the podium over to Dr. Beaulieu to introduce the first panel, I would like to take this opportunity to recognize some of the people in CVM who went way, way beyond the call of duty to bring us to this point where we could hold this meeting.

First and foremost, I would like to recognize Dr. Sharon Thompson, Associate Director for Veterinary Medical and International Affairs at the Center for Veterinary Medicine. Sharon is one of those exceptionally rare individuals that I can charge with an impossible assignment and know with complete confidence that she will accomplish it on time, under budget, and exceeding all expectations.

I would also like to recognize Kathy Hollinger. Kathy is a veterinarian and an epidemiologist par excellence. During the course of developing the risk assessment, we were told repeatedly by the experts that what we were trying to do was impossible because the data needed to support the model simply didn't exist. And Kathy proved all the experts wrong.

Through self-motivation and shear tenacity, she was able to obtain data that were thought to be unobtainable. And I believe the term that we use for that today is data-mining. And she is the best miner that we've got. So I want to recognize her.

Mary Bartholomew -- I put "Dr." up there, but it is pretty close to the truth now. Mary is our statistician who expended a great deal of effort in assisting our risk assessment consultant, David Vose, to develop the mathematical and statistical elements of the model. So we really want to recognize her.

Marsha Larkins is CVM's ombudsman. But in addition to her regulatory duties, she was responsible for coordinating CVM's response to the enumerable comments on the Framework Document. And, again, that should be available out on the table.

Alita Sindelar is the newest member of the CVM team. She assumed the responsibility for planning three public meetings on antimicrobial resistance including the one that you are attending here today. And this is how it worked, this is how the CVM management works. CVM management decided that to get to the point that we are today, we needed to respond to all the comments from the -- on the Framework Document, develop a risk assessment, and then through some miracle hold a public meeting before the millennium.

Marsha Larkins got the framework comments assignment. Sharon, Kathy and Mary got the risk assessment assignment. And Alita got the miracle assignment. And she has performed outstandingly.

Finally, I would like to recognize Ms. Linda Kawatch for her help in putting this meeting together. All the myriad of minute details that go into putting a meeting like this together are something that most of us never consider, but are so terribly important. And what Linda has done in the past few weeks alone is the kind of work that is usually done by whole staffs and other organizations. So we really wanted to make sure and recognize those people.

(Slide.)

I want to recognize a number of organizations that contributed to this. And we absolutely could not be where we are had we not had a tremendous amount of assistance from these various organizations: Centers for Disease Control and Preventions, especially the National Center for Infectious Diseases is a critical partner in our being able to not only obtain a lot of the data that went into the risk assessment, but also NARMS could not exist, absolutely could not exist without CDC's input. So an absolutely critical player.

A similar critical player is USDA's Agricultural Research Service who are -- whose laboratory is helping us in actually doing the antimicrobial resistance monitoring for the animal specimen. NARMS couldn't exist without ARS either.

Food Safety Inspection Service of the USDA has been wonderful in providing us with access to the animal isolates from the HACCP programs from the slaughter houses so that we can conduct the NARMS system. Economic Research Service, the Census Bureau, the National Chicken Council and the University of Pennsylvania all provided valuable information that went into the risk assessment.

(Slide.)

And finally, I would like to recognize the American Veterinary Medical Association for -- under the heading of risk management for their outstanding commitment to develop and promote judicious use of therapeutic antimicrobial drugs in veterinary medicine. They have supported it with their dollars. They have supported it with their resources and efforts and convening people. And I didn't want to get -- let the opportunity get away to express how important CVM thinks that committee is.

And with that, I am going to turn the meeting over to the Deputy Center Director for Veterinary Medicine, Dr. Andy Beaulieu.