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On approval bill format for Animal science

well good afternoon thank you too niaa for inviting me including me in this this symposium we certainly appreciate the efforts that niña has done in terms of bringing folks together on this important issue over the years I realized when I actually saw my proposed title in print in the agenda I realized I should probably clarify something right up front in terms of defining goals and objectives which is clearly important my primary intent of my you know comments are talked this afternoon is not to actually define those goals or presume that I would define those goals and objectives but primarily to get that issue on the table and to kind of focus on the fact that given the the theme of this symposium on stewardship given the discussions that occurred in the prior session on metrics that it seems important that we maybe pause and make sure that we are putting enough time and energy and focus on making sure that we're all clear on what the goals or objectives or what you know where what the desired outcomes really are and what is our you know sort of destination so to speak because that may help us quite a bit in terms of you know how we coordinate and and making sure that we're all kind of rowing in the same direction so to speak so with that in mind I guess there were several different topics I was going to try to touch on one just you know some things that I think many of you already know but I think it goes with worth it's worth saying that when we're talking about stewardship in veterinary settings there's a number of factors that we need to keep in mind in terms of how do we kind of sort through all those issues clearly the crux in my comments today is on this issue of uh what what more may we need to do in terms of clarifying what the goals or objectives are kind of where we are to date and then kind of how do we monitor and and some of the issues that have been raised in terms of monitoring our progress as we move forward so first off I guess you know I think in US for us to start talking about implementing stewardship or strategies intended to foster stewardship you know I think there's important that we look at you know particularly for focused on veterinary settings that we have a number of challenges that we need to keep in mind as we think through that clearly we're dealing with a wide variety of animal species that involve particularly in the in animal agriculture a wide variety of husbandry practices and settings and then clearly a quite a spectrum of stakeholders that have a role to play and how do we bring all of those together in terms of coming up with strategies that you know have a shot at being effectively implemented so first off again it was alluded to earlier that you know certainly in the veterinary sector or we have many many different species that we that we need to focus on in the spirit of the one health idea I think the notion is that we when talking about this issue that we need to look at all the different uses in all for all the different settings whether it's in the various human health care settings or whether it's in the various veterinary settings and you know here we're dealing with not only food animals the major food production species you know which you know we have to deal with situations where you have very small operations very small numbers of animals in you know local you know Farms there are in some cases just hobby farmer farmers everything all and foragers all the way up to multistate integrators and then sort of everything in between we have minor species a variety of the list goes on and on in terms of the different species including things like fish and honeybees where again another food species that we sometimes don't think about where there there are places or situations where antibiotic use is important and then clearly obviously companion animals is an element that we we also have to pay attention to in terms of are there things we need to be doing there and then the numbers of various species can go on and on but the point is is that we need to be cognizant of all these different settings when we're thinking about stewardship and then you know particularly looking at the animal production or food producing animals clearly animals are raised in a wide variety of different settings you know again that was mentioned earlier how do we factor that into the strategies that we are thinking about related to stewardship clearly inherent to animal production is the fact that we're raising and rearing animals in large groups that may be you know on the order of a pen a building a full you know when they have 30,000 broilers to animals raised in pastures to a variety of different settings where we have to manage disease and so antibiotic use becomes important as an important tool for not only treating sick animals but again given the the settings and the risk of disease outbreaks that there are important tools for helping us to prevent disease and control disease outbreaks and how is that how can that be done appropriately and judiciously again from FDA's perspective we we do recognize that antibiotics are not only important for treating disease but there there are important tools for preventing disease as well but we need to make sure that we're as you know establishing strategies and approaches for using those drugs to prevent disease in a way that optimizes their use and targets these as much as possible when it comes to the size of these different operations I think that's another factor that you know and sometimes it can be misleading it's not always the outcome that you think in the tendency of small you know farms is not necessarily always better while small operations may have lower densities of animals in some cases those those particular operations may not have perhaps as rigorous controls or biosecurity measures whereas say large facilities clearly have much higher concentrated animals and certainly a lot of challenges to deal with those higher densities of animals but on the other hand in some cases they actually have better controls in place or more strict biosecurity measures that can help control disease so there's a whole variety of different factors that we obviously need to be paying attention to oops and so clearly you know even the issue of sort of who that you know the various stakeholders it isn't the reason I sort of point this out is the fact that when it comes to stewardship it's really something that requires a collaboration across all all the variety of different stakeholders that have a role to play in the different settings where we see animals being raised and it's therefore important as we start talking about stewardship and identifying the goals and objectives with establishing certain priorities around stewardship that we make sure that we we bring these different stakeholders along as part of that process because in order for us to effectively implement these at the level of the of the actual farm or producer that we need to have all these folks involved in that process so turning then to this notion of you know goals and objectives you know I think clearly for you know I'm sure many folks here have been in many conferences and discussions around concepts of appropriate use judicious use prudent use or stewardship on there's a variety of terms that we talked about and I think it's you know important that we we also you know kind of step back and make sure that when we're all using those kinds of terms and terminologies that you know that there's some common thread and that we're actually have the same notions in mind because I think they are you know terms that may mean different things to different folks so I think there isn't an important you know that it's important that we you know you know make sure that we are working towards getting some common understanding of what what exactly we have in mind and so you know I think we've done a lot in terms of thinking about particular actions we need to take or how we measure those actions but you know I think it's important that we pause and sort of make sure we're clear and on the same page in terms of you know kind of what the outcomes are that we're trying to attain and I think that's you know important for bringing folks along for for you know why you know the sort of answering the why question you know why are we asking producers or veterinarians to do certain things or to implement certain measures what is the what is the goal or intended outcome of doing those things you know and what what is that is there a clear and consistent message that all the variety of stakeholders that are involved in this or are you know speaking tours or they or is there a confusing message because I think all those factors are important in terms of you know you know the success of us moving forward so again we have you know done a lot to talk about what things we should do and as was talked about in the last session you know what are their what metrics do we identify our measures to identify you know to track whether you know the you know whether those actions on you know have been implemented but I think perhaps focusing a bit more on sort of getting making sure were we have consensus around the y part of this in terms of what are the intended outcomes are the goals that we're setting for our cells and trying to get make sure there's there's clarity around goals and objectives in order for us to make you know positive progress moving forward and so I think the you know with this symposiums focus on stewardship you know I guess the one sort of key you know message that I was you know wanting to convey today was the you know putting energy and effort into focusing on can we reach some sort of agreement on common principles related to stewardship what what does that mean you know across the different veterinary sectors recognizing that you know whether it's you know in these different sectors whether it's in the various cattle environments poultry or swine there may be different clearly different pressures that apply and different challenges within each of those sectors and perhaps different strategies to implement stewardship in those different sectors but nonetheless are there some sort of common principles that were sort of rallying around in terms of sort of defining the goal in terms of what we're shooting for so graphics is not necessarily one of my my strong points but part of the reason I wanted to put this up was just sort of the to me giving sort of this notion of you know direction target that there's a destination and I think that when we talk about stewardship and all the things that we're trying to do in terms of adjusting practices and behaviors that you know clearly it's important that we keep our eye on the ball so to speak in terms of what the desired outcome is which is we're doing all these things with the notion in mind that we're trying to slow you know or mitigate resistance emergence the reality is that we probably can't prevent it we can't stop it from happening but there are things we can do to slow it down and to manage it i think that's you know you know an important notion they keep in mind but also that that when it comes to us looking at you know are not only our goals and our targets but also the measures or metrics that were identifying that we don't lose sight of the fact that we're doing these things and that the things we're doing are in fact meaningful to help chip away at that old ultimate goal of slowing resistance emergence so again just putting this idea out there and again you know my intent here is not to necessarily say that this is how we should define things just as a way of sort of illustrating the fact that you know can we focus in on some key ideas in other words what is what is antibiotic stewardship really mean what are the what are the core goals that we're trying to focus on within that concept with the intent being that though if we implement those goals or objectives that that they collectively help us slow down resistance emergence you know and sort of in a very simplistic way you know one way of thinking about it is you know and again this part of this gets to sort of clarity of message you know and are we speaking with one voice in terms of when we're talking to different stakeholders when we're talking to the general public about what is it what it is we're doing and why are we doing it and so you know in a very simple way his storage is stewardship and this sort of a question of is is it is it really simply the notion that you know we only use antibiotics when we really need to use them and when we find we need to reach for an antibiotic that we you that we optimize how we use that drug you know and so is that it sort of in a nutshell and if in fact that is it you know or some variation thereof then what are the things we can do to help support those basic ideas so I guess that's that's sort of an ideal just to put out there is that you know again around the message of can we distill listen to a clear message of what our goal is you know and and sort of put some ideas on the table that you know there's some consensus around yes that makes sense that that's what we're striving for and then we we sort of work to identify further details around you know how do we support those ideals so again this is just meant to be for illustrative purposes if you sort of take that a level further you know and think about those sort of two basic ideas at the top meaning that you know in one respect we're looking to do things that help us you know support the idea that we only really that we use or we minimize when we use antibiotics or when antibiotics are needed because it does seem as just the basic principle of stewardship that fundamentally not reaching for an antibiotic at all is really a good way to you know limit you know and be judicious about using an antibiotic that that are there other things we can do to manage a particular disease you know through a variety of different strategies that helps meet that goal recognizing that ultimately we may still need to reach for that antibiotic in certain circumstances so again some of the things that we're already working on in that arena and that's some of the logic and idea behind why we think that nur oversight is important you know is that they're they're making sure that that expertise is there in that decision-making process do I really need to reach for an antibiotic or not and I think veterinarian can play important role in helping advise producers on that idea certainly was the idea when we initiated action under the current strategy to eliminate production purpose production uses is that I think in the end we don't really think we need to be using particularly medically important antibiotics for that kind of purpose because they're not really being used to manage the disease so is that really necessary that we reaching for antibiotics in that case so it's really those kinds of ideas or other things we can do to more effectively manage disease and and reduce incidence of disease and again some of these are issues that go beyond you know different stakeholders have a clearly have a role to play but again that these actions and these different actions have a certain outcome that we're trying to shoot for you know and whether it's you know putting in place more rigorous or looking for alternative disease control strategies whether it's are we maximizing the way we're using vaccination or vaccination programs is there more that we need to be doing to try to look for and develop more effective vaccines or other other strategies in terms of how animal animals are raised or how we're using diagnostics and other things in terms of a deciding winner when not when of antibiotic use is really necessary or not and then on the other side of course is when we do need to reach for an antibiotic are the things that more that we can do to make sure that that we're sort of optimizing our values now maybe that's not the best word but it's the notion that you know you know and again I think the brain mention it it's sort of that notion of the right drug the right dose you know you know for the right indication and that are there's more is there more we can do there and and certainly some of it has to do with some of the things that that we're doing at FDA in terms of looking at the products the labels of those products how you know what are the use conditions on those products and other improvements or enhancements that really need to be made there but then this goes beyond that I mean it's you know do veterinarians to veterinary students do others have the training and information they need to help them utilize these drugs you know in sort of that optimal way and again there is you know intended outcomes what are the intended outcomes of those of those actions you know the some of which is is sort of the intent being you know down in that bottom right corner is that these things ultimately or pushing in the direction of things that are helping this low resistance emergence so again there's nothing necessarily new or you know particularly enlightening and this slide other than just trying to I guess we emphasize or emphasize the fact that you know I think putting a little bit more are they focus on building consensus around you know what is the message what is our goal gear and how are the things we're doing helping us move towards in and attain that goal and when it comes to the idea metrics then what are the kinds of indicators that we need to be tracking they'll tell us whether we're accomplishing those those different actions with which are meant in sum total to help us combat antibiotic resistance so clearly there are some things and I think the good news is i think we are making some meaningful progress moving forward i think some of the ways I or I kind of look at it that we've been up to this point anyway kind of focused in three areas at least I'm speaking from kind of FDA's perspective you know activities are things that we're doing their focus on the products themselves meeting the antibiotic products the medically important antibiotics are the what are the other things we need to do relative those products to make sure that they're aligning with what we think about today is again judicious use or good stewardship there's activities that are focused on sort of behavior or practices at the farm level and I think there in that arena we're talking about a much broader set of stakeholders that really needs to be involved in that area and then third is the prior you know monitoring progress we need to be identifying some kind of measures you know it again I think this is a collaborative effort certainly federal agencies have been looking for mechanisms by which and we already collect some information that helps us in this regard but i think was mentioned earlier that you know there there there may be opportunities that you know for more of a public-private partnership in this area to to really get at the type of information that it's going to be most meaningful so clearly you know on the product side you know there's there's you know to date the focus has been on the things we've been doing under under the guidance to 13 initiative which again I think are really important and critical steps forward and sometimes that I think gets glossed over a little bit in terms of the significance of the changes that are happening under that process and I think I think the fact that we've seen the the positive engagement across the AG industry not to say that there aren't some significant challenges that folks are having to contend with but nonetheless I think the fact that we've seen a real positive shift towards folks really looking for solutions and as we we try to move forward and meet our target of January one to eliminate growth promotion use and brain the remaining uses under vet oversight but given the significance of that I think you know there are still you know additional measures we need to take it doesn't we're not finished you know on january one and you know our goal is to sort of build on the you know progress we've made under the guidance to 13 process you know and collect and continue that collaborative effort to identify are there additional things we need to do in them on the product arena so to speak you know are there distal enhancements or changes or improvements we need to make in terms of how these products the medically important antibiotics are are being are labeled the use condition is how they're being sold distributed and again you know we've already initiated one step to just begin the process of seeking input on the issue of some of these products having therapeutic uses or prevention uses that don't have defined use durations and again the primary goal here is to really look at how you know what are the situations in which those products are being used to control or prevent disease we're very interested in hearing from producers about those disease conditions how are they being managed or they're better other strategies additional strategies or that can be done to manage those disease more diseases more effectively without necessarily using the antibiotics continuously recognizing that you know those are important tools the intent is not to eliminate those products as tools for preventing those diseases but are there ways we can use them in a more targeted way and I think the notice we put out was really just to start the process of getting that conversation going giving input on how do we map out a strategy forward and try to identify you know improvements that can be made in that arena there are clearly and also as dr. Murphy mentioned earlier the guidance to 13 processes focused on the feet and water products you know our primer you know the reason we were focused there is because of the fact that feeding water products clearly by design are meant to be administered to large groups of animals so there's certainly a greater exposure potential in terms of the use of those products in comparison to other dosage forms like injectable products so our primary you know priority was to look at the feedwater products particularly in terms of transitioning those products from over-the-counter availability to vendor oversight there still are and will be as of January one some other dosage forms that are available still remain available OTC and I think in the long you know we need to be thinking about you know setting your designing or developing a strategy for transitioning those products you know the medically important antibiotics that are available is over the counter to veterinary oversight as well and again that's no timelines yet been set for that but I think we need to sort of have that on the horizon that's something else we need to be working towards and then we need to look at other areas where are there other areas we've not focused on like companion animals and I think there's that's another area where we need to determine whether it's additional strategies we need to be focused on a nut in that area as well so when it comes to the stewardship or sort of behaviors or activities at the farm level you know this is where I think many many different stakeholders have a role to play and it's really critical that we work collaboratively certainly we've been working in collaboration with other agencies with USDA and CDC but clearly this is something that really necessitates that the different stakeholder groups work in collaboration with the federal agencies about what can be done in terms of designing strategies as relates to stewardship and and because implementation is going to require you know involvement by the different producer organizations veterinary associations and others to affect change in that in that area and clearly as I noted that the challenge is you know how do we work across all the very you know sectors and find strategies that that can be applied effectively in those different settings and certainly a lot of progress has been made you know to date i would say in in response to the guidance to 13 initiative we've been very encouraged by the engagement we've seen from a variety of you know stakeholder groups who have been you know actively working to get information out to veterinarians producers and i and i think it's very encouraging by the fact that you know we did set up a CVM ask CVM site to sort of funnel all questions in and you know the the detail and the number of questions that we've been getting you know it's rather it's rather impressive and that and the one thing it does tell me is that people are really trying to get it right you know which is really encouraging I mean there were you know we're coming up with all kinds of things that you know we never really thought of and that's the challenge with implementing these kind of changes is you know what do we do in this situation or that situation but i think the encouraging thing is we've gotten over probably up to what 300 or so questions that have come in specifically just like say on the VFD rule but i think the encouraging thing errors are is that is the sense that folks are really trying to understand it and their desire to really get it right and i think that's that's important and that's a very encouraging sign and we recognize it's it's a challenge and if there's going to be there is certainly a learning curve that we need to work through and a lot of challenges to get through you know as we move into the new year in january and certainly as it relates to stewardship again it certainly goes beyond the federal agencies i mean we we've seen engagement by different academic organizations about you know stepping back and looking at veterinary curricula is there more we need to be doing there that new veterinarians coming in to the practice environment you know have additional skills or information regarding antibiotics and and even to date you know we've seen the producer organizations you know have incorporated judicious use ideas into their Quality Assurance programs but again I think there may be more we can do in that arena in terms of really focusing in on again what our primary goals and objectives are related to stewardship so sorry kk used to the delay tins so again as was discussed in the last session clearly you know defining metrics or measures is is going to be is important or as critical as we move forward with all these different efforts so as we have some understanding as to whether the things we're doing are actually having the desired you know impact and I think it's it's clear that we need to focus and get clarity around what again what our goal is I think it's and in terms of what you know success looks like and certainly reduction in overall use of antibiotics it's not necessarily the the only you know the endpoint in mind but we expect that you know buying by putting an emphasis on implementing good stewardship practices on reducing unnecessary or inappropriate use that the outcome will likely be that we're going to have an effect on reducing overall use but but the driver really is focused on you know how we're using antibiotics are we using or we are we using them in situations where we don't really need to use them and when we are using them are we using them in an optimal and I think the outcome of that is going to be some effect on you know modulating overall use and that how these drugs that are used or you know the desire is that they're being used in a way that's less likely to be driving resistance again are we going to prevent resistance not likely but can we slow it you know the goal is slowing it down again we can't lose sight that that's really the goal that we have in mind is that the things we're doing are helping the mitigating resistance so again my knots my brother simplistic graphic here but and this tying into the notion of metrics is the idea that again trying to keep our you know tethered to the idea that what we're trying to do is slow resistance emergence but but there's which again is sort of the ultimate indicator of our all the things we're doing across all sectors where antibiotics are being used are we moving the needle so to speak in terms of slowing resistance clearly that's a that's the root of it but we really need to be identifying kind of intermediate you know indicators so if we're identifying certain actions that we think are important again in this model and I'm just saying in this model for argument's sake actions that we're taking to try to you know avoid use or minimize use and limited to only when we need to are there what are those actions and are the things we can track they give us an understanding as to whether those kinds of actions are actually being implemented and and that gives us an indicator of whether or not if that's what those what adds up to stewardship then it's a way of us sort of tracking whether we're actually making progress in terms of how we're actually using these products at the ground level so again there clearly are a lot of challenges on the modern and the impact issue as we've already mentioned there's a quite a wide variety of settings that we have to take into account I think it's you know clearly as dr. Braden mentioned earlier there's a lot of work going on within the human medical community in terms of implementing stewardship programs tracking their effectiveness and and certainly it's reasonable that folks look at the human medical community and CEO k we see what's happening in those sectors you know what's happening in the bit you know what it's comparable you know in the veterinary sector so I think how do we respond to that and how do we address that and I think some of the challenges just be a reality but when the things we have to work through is clearly the the you know the the infrastructure that exists in terms of healthcare infrastructure so to speak is vastly different clearly on the human medical side and it isn't vendor side certainly that is a challenge that we we have to deal with whether it's in way that things that can help support implementing standards or stewardship ideas or principles in different settings or whether it's being able to tap into information that helps us measure or track impacts you know we don't have that infrastructure much of that same kind of infrastructure in the veterinary side so it's it's certainly a challenge I mean I'm not saying that as an excuse that we can't do something but I'm just saying it's a it's a real challenge that we have to figure out how do we how do we work through that to get at the information we need and but i think we are making progress and certainly fda has been working with usda as it relates to mechanisms for fur gathering use information and certainly we we hope that funding becomes available it enables some of the survey work that usda has been working on with that can move ahead FDA recently awarded several grants working with several researchers in academia to look at strategies for collecting use information and am I there's that would be a good example of you know an opportunity for you know public-private partnership together the information we need so in closing again I think significant progress has been made to date I think the engagement we received from the industry is very encouraging and we clearly have an important milestone coming up January one but stewardship random acromial stewardship you know it's something that we need to be sure we sort of have clarity around how we define that is an ongoing process and something that we have to continue to work on and really realistically take move it forward and incremental steps and phasing in changes over time as those changes are determined to be needed and again it can't be successful without engagement of all stakeholders including veterinary producers and others and again my main message for this talk was just that we continue to strive for seeking a common understanding as to you know what the goals and objectives are of of the notion of implementing antimicrobial stewardship so thank you you