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U.S. Department of Health and Human Services

Animal & Veterinary

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Coordination of Programs

Workshop Review: Action Items

Seeing none, what I would like to do now in the next half hour is to actually address the question I would like to pose to everyone here because we have a large group of people who are devoted and interested in this topic, is what practical things can we individually and collectively do to coordinate work towards MUMS approvals internationally.  Are there ideas?  I would like to have this in a brainstorming session.  How can we actually progress without trying to form a VICH committee?  What in the meantime can we do to actually help make progress in this field?  Elaine Jetté, and we are going to be taking extensive notes on this.
  
DR. JETTÉ:  Since the VICH is not meeting until next year and since VICH is already structured, Canada is an observer and I don’t know where -- what is the term of reference of this working group.  I am sorry for not knowing more about it, but perhaps like most of the countries represented here are either observer or members, and perhaps we could set up a working group to prepare for that meeting and do -- be better prepared to lobby the official VICH group to work more aggressively on MUMS.
  
DR. CRAIGMILL:  Do I have a second?  That is a good idea.  We had one suggestion from a gentlemen yesterday suggesting that when there is a major species approval in one country for an approval, then that species could be considered as a minor species in another country.
  
DR. DODEMAIDE:  Robert Dodemaide, Eco Animal Health, Princeton, New Jersey.  What I said yesterday was that I used the example of sheep and turkeys.  Sheep are major species in Australia, New Zealand and the UK or the EU, and turkeys are major species in the United States and they are minor species in other jurisdictions.  What I said yesterday was that if, for example, a complete package is provided to the authorities in the UK for the use of a given drug in sheep and that application goes through a rigorous review and the product finally gets a marketing authorization, I think the sponsor at that time should then be able to present those exact same data to another jurisdiction where it is a minor use, such as the US, and Steve and his boys and girls would review the package according to their rigorous standards and make a determination of what the US tolerances and the withdrawal period should be. 
  
But I think because it is a minor use it should be approved really without further requests for further data.  I think the package from the UK should be pretty well accepted as is unless there are really valid scientific reasons.  I mean, the parasite for example might be quite different in the US to the UK, so perhaps a small confirmatory field study may be required to provide some US data for the studies, but otherwise I think because it is a minor use I think a package such as that would be far more beneficial and provide far more information than just going through the MUMS procedure locally where the data package would be far less complete and would not have already been through this rigorous approval process where it is a major use.  Thank you.
  
DR. CRAIGMILL:  Thank you.  Dr. Jones.
  
DR. JONES:  Thanks.  Peter Jones again, EMEA.  There will be plenty of opportunity to say thank you and to congratulate these guys for the excellent jobs they have done, but one of the things that has really impressed me being here this week is the collaboration that has taken place between the various parties.  Regulators, veterinarians, extension scientists, academics, and I just wonder whether we can’t get that to infect other regions of the world.  I think what I was saying yesterday in my talk was that we have a frustration back home, but those people at the sharp end, the veterinarians and producers, don’t seem to be doing enough.  I want to put on the record my appreciation for what the industry has done in the EU.  Rick gave a very good talk about what they have been doing in IFAH*, and as he said, maybe his management is saying, "Well, why would we want to take this thing up as a campaign and do something with it?"  To their credit, the industry group in Europe has been really very supportive, has been driving this thing forward, but it has been disappointing I think that the vets have not done more and the producers have done little enough.
  
The FVE, the Federation of Vets in Europe, has been becoming more active.  They have had some major restructuring in that organization, but I just wonder through some forum like the World Veterinary Association, WVA, I don’t have much to do with that since some considerable time now.  But whether we could take what you have done in the US and sort of the collaboration that has taken place between veterinarians and animal scientists at all levels and somehow get that -- you know, the infectious spirit of enthusiasm that you guys have clearly got here and sort of help us in other areas to have that happen so that there is a portion of drive coming from elsewhere.  Because when that sort of thing takes off with a head of stem as it clearly has over here, then I think that in other areas, politicians, those that draft the legislation, will maybe listen some more.  So that was on suggestion.
  
If while I might have the floor I might just address something else very briefly.  Rick in his closing remarks yesterday talked about access to regulators, and I know that he was making the point that on a particular idea that he had that he hadn’t felt able to discuss that with the CVMP --- EMEA in sufficient depth.  I just wanted -- and he knows that I might say this because we talked about last evening.  I just didn’t want anybody going away with the fact that at the EMEA the doors are always shut and we are not open to people coming in and folks coming in.  Transparency is our byword really.  We really encourage people to come and talk and talk to us, and we try to facilitate that. 
  
We have meetings between the CVMP and the interested parties two or three times a year when any representatives can come in at fixed times when the committee is in session or after they close their session but then a post-meeting.  An agenda is fixed.  Two or three items can be on there, and we have a real good dialog and a good debate.  We have focus groups.  We have info days twice a year.  We have got one coming up in December, and indeed we have got a document going back to the committee next week which is really all about transparency and opportunities for how interested parties can come and talk to the committee, can come and talk to EMEA, to the working party experts when they are drafting guidelines.  So I want people to know that we are a very open organization in case anybody got the idea to the contrary.  Thanks for letting me say it.
  
DR. CRAIGMILL:  Thank you.
  
DR. SCARFE:  David Scarfe again.  To use Peter’s segue way, thank you, it is more a concept or an idea, but certainly I was going to wait until near the end of this discussion because one has to ask the next steps.  I truly believe, number one, next step is beginning to share information in an open forum, and that can obviously come in terms of publications, and I know there will be at least a CD that comes from this.  But the other is actually getting the heads together to start discussing.  Usually those come in the shape of workshops and symposia and such like, and I am certain this group probably will end up to conclude that we need the next steps.
  
Peter specifically mentioned the veterinary profession and the producers, and he also mentioned the World Veterinary Association.  I don’t know the feasibility.  I would have to investigate if there was any interest in this, and we would need interest clearly expressed, but 2005 World Veterinary Congress is being hosted by the United States and specifically by AVMA in Minneapolis next year.  This is intended as a global perspective as is every annual World Veterinary meeting or every World Veterinary Association meeting, usually hosted by different countries.  
 
I don’t know what the opportunities are, but we certainly could look into a forum such as that, whether there are special sessions that address minor species.  I do know that we will focus on a lot of drug issues.  We generally refer to them as therapeutic agents because it is a catch-all, but we also specifically look at certain minor species.  Things like sheep and goats, small ruminants, the aquatic animal sessions are fairly extensive.  Whether something else can be built on as an ancillary or addendum to the whole World Veterinary Congress approach I don’t know.  I will perhaps leave this all open to discussion.

I would point out very clearly that even though these meetings, even AVMA’s annual convention, typically consider, you know, favoring the veterinary profession.  These meetings are open to all, and in fact in some cases we actually go out of our way to invite industries in because the veterinary profession does not live in isolation.  We do interact intimately with all levels, from governments at the international level, all the way down to the producer and producer organizations.  I just open some of this up for potential discussion. 
  
DR. CRAIGMILL:  Sounds like a great opportunity, Dave, if that is possible to set up something there.
  
DR. JETTÉ:  I am just talking as a freelancer.  I have experience in the World Veterinary Congress.  I know that for example OIE organizes sessions, so I don’t see why such a session could not be organized under the VICH umbrella or Codex umbrella. 
  
DR. CRAIGMILL:  We will take that as a second for the motion.  I would like to ask a question as to whether or not people think that the establishment and posting of a global compendium of drugs that are available for minor species might be a useful thing.
  
DR. HALEY:  I have a question about that.
  
DR. CRAIGMILL:  Yes.
  
DR. HALEY:  Carol Haley again.  A question, who would put that together and how would you get the information to go into it?
  
DR. WEBB:  FARAD has started doing that.  We are accumulating labels from overseas countries and putting them into a standard database, but it is extremely hard to do without active cooperation from the countries.  So we will be soliciting help of people.  I think it is well worthwhile because you can see the commonality, the differences, and the gaps, and it helps guide researchers and regulators into filling those differences and gaps.
  
DR. CRAIGMILL:  In fact, those were the two followup questions.  The first was would this be a nice idea, and then the second, who is going to do it and where is it going to reside and who would be running it I also think that there -- it is not just the country regulatory agencies or registration agencies.  The pharmaceutical manufacturers also have to assist heavily in us getting these data.
  
DR. HALEY:  This is Carol Haley again.  This gets back to my point that I made earlier about all the other influences going on or all the other people who have an interest, stakeholders who have an interest in what pharmaceutical companies do.  I would guess that if a pharmaceutical company were to give you a list of their products that were approved in other countries to put on a compendium that people in US might use to decide whether to use a drug extra-labelly, that the pharmaceutical companies would not do that because they would be concerned about being not in compliance with what promotion of off-label use was.
  
DR. WEBB:  Having spoken of FARAD, one thing we haven’t said in case any of you have a feeling FARAD is not funding by FDA.  It is funded by USDA, which is the farmers’ friend and not --- up the back, so I am paying due credit.
  
DR. CRAIGMILL:  Yes.  That is an interesting question about whether or not to provide information about the availability of drugs in another country.  If you were to post those information on your website I believe that would probably be construed in that fashion.  If, however, someone like NRSP-7 were to take that information, launder it very nicely, and to represent it in a standardized format -- which is actually the basis behind our compendium.  Alistair, which countries have we started with on this?
  
DR. WEBB:  We have Australia and the UK because they speak a language I can understand.
  (Laughter.)
  
DR. CRAIGMILL:  But in two weeks we are having a Chinese delegation come, and we will be providing them with the software in order to have them start developing a compendium of their veterinary products.  Which is kind of exciting because they will probably take the format which we have developed and using what are called lookup tables in these databases, they can look at it and read it in Chinese and we can look at it and read the exact same information in English when it comes to withdrawal times, doses, species, et cetera.  Kornelia Grein.
  
DR. GREIN:  Kornelia Grein, EMEA.  I just want to inform about the situation in the EU, again I cannot give you a commitment to provide you these data for all EU member states because it is 25 countries and not all of the products are available.  In some countries there are public list of the products, in others there are not.  But there is a project at the EMEA in the new legislation, under which we will have one list of all products in the EU, but this is a huge task.  This will take time.  Then once this will be available, and I can of course then take for the EU those for the minor species.  But it is not something that will be available in the next year or two-years time.  I am sure about that.
  
DR. CRAIGMILL:  In that regard, can I ask a quick question?  Will those uses which are considered minor or minor species be indicated as such, or will there be no differentiation?
  
DR. JETTÉ:  I think I cannot.  I am not in a position to explain exactly what type of details will be given, but I would assume that we would have the species indication and when it is approved in the different member states.  At the moment if there would be an issue, we would be looking at for example Peter mentioned in his presentation yesterday that we were looking on a kind of list of essential products together with this coalition and industry that are really missing essential products.  We need really to go to all EU member states and ask what we have for these types of thing, for this indication, for this substance, other products, etc.  It has to be done in a tedious way at the moment because no EU-wide database is available right now.
  
DR. CRAIGMILL:  We are aware of compendia or lists of products that are approved in the EU, Australia.  Switzerland has a very nice compendium on their website that is even translated into our language for the most part.
  
DR. SCARFE:  David Scarfe again, AVMA.  Just to take that lead and perhaps another invitation, I believe at least some sort of compendium of what drugs are approved in different countries is an exceptionally useful tool.  But the pivotal part of that is the data that --- decision is vital.  I cannot emphasize that enough, and I would suggest that we in fact have some call it government-neutral mechanism to actually collect and to some degree utilize that data.  That is again, and I am not trying to sell their program, Global FARAD.  That data is vitally important for them to do assessments to provide information, and for their benefit I again emphasize free information, at least in most cases, that they cannot function without these data.  They need the data. 
  
I think we all respect the problems in federal agencies, irrespective of where their jurisdiction is, listing series of drugs that are approved outside of one geopolitical entity.  But if this has any merit, that may be a superb repository for this data, which is useful, can be reported in an independent fashion, can be identified clearly whether under certain jurisdictions it is legal to use or not legal.  But to many of us I think the important part is the data that comes from that can immediately be used.  So you have the key individuals here if there is any interest.  I would suggest very strongly making those contacts and seeing if you could support and at least build something along that line.
  
DR. CLAYTON:  I just wanted to expand a little bit on what Kornelia said and the availability of databases.  As she mentioned, there will be an EU product database which will start off listing the centralized procedure products and then for the nationally registered products, and that is a long-term program.  But a lot of this information is available already on the European Commission website.  You have an index of centrally-authorized products, and that is in English; and for products that have been registered through the mutual recognition procedure the heads of all European veterinarian agencies have a common website, and there is a product index.  I cannot guarantee -- well, I know it is not complete, but it does have a very large number of the mutually-recognized products on there.  The gap that is missing is all the products from the past that are registered nationally and haven’t been taken through the mutual recognition procedure.
  
DR. JETTÉ:  Speaking as a freelancer again because I don’t have the authority to suggest that as a Canadian representative.  Like Peter said, that regulatory authorities cannot do it all on their own and I agree with him.  I think the key is collaboration.  I think also another key is to look at the MUMS issue in little pieces rather than as a big piece and a very complex problem.  So what I would suggest is that I know most of us do not have the authority to make a decision today, but if we would go back as regulatory people and talk to those who can make a decision and propose to them that each country could act as champion of a species well, if we agree with the idea, that it could take one species and act as the clearinghouse for that species and as the facilitator for that species.  I am using the example of Australia with sheep.  Many countries could act on aquaculture because there is a big industry there, and although it is a minor species there is a lot of expertise going around.  So this clearing house would gather information, facilitate contacts, be responsible for coordination so that at the end of the day there would be something precise, and something concise, and something that we could work on, you know.  Because right now we have got all kinds of concepts and we have got all kinds of ideas, but how do we channel them into a digestible package?
  
DR. CRAIGMILL:  Thanks.  That is a great idea.  Well, as people approach hypoglycemia, Meg, did you want to speak?
  
DR. OELLER:  Okay.  This isn’t a new idea.  This is Meg Oeller from FDA CVM.  I just wanted to say, following up on what Peter Jones was saying about what his group does with outreach to industry and since no one laughed at my joke where I said we like to be hard on industry I better be clear that we are very much interested in working with industry, always have been, that companies can, bring in applications that they have submitted in other countries.   We already have everything in place to try to take whatever we can use out of those packages.  Sometimes when we are dealing with old applications it is not a lot, but with Andy Beaulieu and I now working in the new Office of Minor Use and Minor Species we are really hoping that people will come in and work with us and we can use all of our old mechanisms and our new ones to try and help get more drug availability for MUMS species and thanks to everyone who came and made this such a great workshop.
  
DR. CRAIGMILL:  Thank you, Meg.  Well, I think we have just about reached the end, and I think we should call upon the person who paid for most of this or who arranged for the payment to give us a quick summation.  Steve, would you like to say a few final words?
  
DR. SUNDLOF:  Sure. 
  (Laughter.)
  
DR. CRAIGMILL:  Put a mic and his hand and he will just go.
  
DR. SUNDLOF:  Well, I just want to say thank you as well, and echo Meg’s words and Peter’s words that this whole thing works because there are a lot of people that feel passionate about this issue and have come together, and when you have that kind of momentum good things happen.  Good things have been happening in this area of minor use, minor species.  Not nearly as quickly as we would all like it to happen, but it is.  I think it is a momentum that will continue on and gain in strength as we go on.  Having this as an international issue certainly I think will help that process out a lot.  I hope we have more of these.  This has been very enlightening to me and we also are going to be looking at some of the suggestions that we just heard here today and looking for ways that we can take advantage of these new ideas to advance the minor species and minor use issues that we are dealing with.  So just in closing again we at CVM were very proud to be one of the sponsors of this symposium and thank you all for making it such a wonderful success.
  (Applause.)
  
DR. CRAIGMILL:  And I think unless Alistair has anything else to add to this since --
  
DR. WEBB:  Well, I would particularly like to thank the people who helped us.  Joanne Kla, Kandi Crosier, Carolyn Whitford, Sandy Ogletree, Carol Rupert* and others who helped keep things going on and kept everything going fun; and the two people who logistically got everyone here and paid the bills, paid the airline fares and everything else, Meg Oeller and Aleta Sindelar.  We thank them very much.
  (Applause.)
  
DR. CRAIGMILL:  So thank you all very much.  A special thanks to all of our invited speakers who traveled so far to come and share their expertise.
  
DR. WEBB:  And have a good trip back.
  
DR. CRAIGMILL:  And have a safe trip home.
  (Whereupon, the meeting adjourned at 12:04 p.m.)