Animal & Veterinary
Open Public Comments I
DR. CRAIGMILL: We have titled a forum, and forum is an Australian word. Phil will recognize this. A forum is Australian for a brawl, a free for all. Actually in the process of putting together the workshop, one of the things we wanted to do, first we all recognize that we have a tremendous amount of expertise in the room; and probably we have 70 people that could give 25-minute to one-hour presentations, and only half of us would fall asleep. Just kidding. Most of us have a lot to say, and rather than putting up a panel of five people who would probably field most of the questions and answers, we wanted everyone to have that opportunity. So what we are going to do is we are going to experiment with this forum format. We want people to ask questions of the speakers, and we will give them the opportunity to respond, but we also want other people to chime in.
Additionally at this time, one of the things that we are mandated to do, it was mentioned at the beginning of the conference, is to have a short -- actually we need to have an entire hour devoted to or available for public comments during this two-day meeting. Now we have had no one who has registered who wants to give public comments. This is done at other CVM Advisory Committee meetings. It is a chance for people to just get up and give their opinion of the matter that is involved. I think almost everybody here may not have public comments, but you have that opportunity. No one has registered to give public comments at the desk. However, at this time we would like to give people the opportunity to have from three to five minutes. Come up, read a statement, talk about your kids, you know, your latest vacation, anything else that you want. Basically it is wide open for public comments.
If we have no public comments, we will move directly into the forum and the discussion of efficacy concerns. So at this time officially and for the record, is there anyone who has public comments? Yes. Please identify yourself, your affiliation, and your name please for the record; and, Sandy, could you punch in -- anybody else before we start? Is there anyone else?
DR. CRAIGMILL: We will give you five minutes, sir.
DR. DODEMAIDE: Good afternoon. My name is Robert Dodemaide. I work for Eco Animal Health, and my office is located in Princeton, New Jersey. Headquarters is in London, UK. Comments on two different subjects. Firstly about what should be the title of the person who could be Steve Sundlof in the EU, and the title suggested was a MUMS Czar. My suggestion is Big MUMA.
DR. CRAIGMILL: You might be earning yourself 10. Keep going.
DR. DODEMAIDE: My second subject is about MUMS and I have sort of entitled it data package transfer from jurisdictions where a use is a major use to a jurisdiction where a use is a minor use. There have been several examples shown during the course of the day. For example, sheep is a major use in the UK; sheep is a minor use in the US. Turkeys is a major use in the US, but a minor use in Europe. So I will just read some comments that I jotted down, and I will give these to the recorder over there when I’m finished if that makes it easy.
All regulators want products which are safe and effective, and to insure that we have VICH guidelines, we have Codex procedures, we have JECFA to make various determinations to insure that this happens more or less on a global and a harmonized scope. Products for major uses go through a rigorous review process for quality, safety, and efficacy. We all know that. Major uses in one country may only be a minor use in another, and I gave a couple of examples of that. Turkeys in the US, major, minor in Europe. Sheep in the UK are major, minor in the US.
A data package from a major-use country should be accepted in a minor-use country. I think really accepted in fact because this package which has come from a major-use country has gone through a rigorous review process. I am using those two examples of sheep in the UK and turkeys in the US for those products that have an approval where they are a major use. They have gone through a very rigorous process, and I think the package should be able to simply be transferred post-approval in the major-use jurisdiction to the jurisdiction where it is a minor use.
I think this system would provide a package of data that is of good quality data that might otherwise not be available in a minor-use jurisdiction. So for example, if we ignored what happened in Europe and wanted a sheep approval, you would have to go through the MUMS procedure here and perhaps generate data which are not complete in the normal sense. Whereas in the UK, there would be a complete data package available for say an anti-parasitic drug for use in sheep. So under this proposal I would say the quality and safety should not be a problem. The manufacturing of this product would already be underway in the country where it is a major use beyond the CGMP, and that probably could be exported to the country where it is a minor-use jurisdiction. Safety should not be a problem because in the major-use jurisdiction it has gone through this rigorous process. There has been an ADI, a safe concentration, safe MRL, et cetera, and really what is acceptable in one jurisdiction where it has a rigorous review process I think should be accepted without too much question where the minor-use is proposed.
There might be some problems with it, but I think the quality of the data generated under this sort of a standard would be far superior to that which might be generated under the MUMS proposals that we have been sort of talking about today. I think a sheep anti-parasitic drug efficacy package generated in the UK would be a rigorous package which would cover several species, and it would be a much more complete and thorough package than might be generated in the US under the MUMS procedure.
I think my final bullet point here would be the label for a drug approved under this data transfer, data package transfer scheme, could be a new label if it was the first time the product had been approved, or it could be added to a current label. I am not sure if that would raise any legal questions, but perhaps it could read “approved, FDA in parens, MUMS” or something like that, just to show to the consumer that the full safety and efficacy package was not generated in the minor-use jurisdiction. All that data came from overseas. So that is just my thought on a data package transfer from a major-use jurisdiction to a minor-use jurisdiction.
DR. CRAIGMILL: Okay. Thank you very much, and you also have the opportunity to participate in the discussion with respect to all the other things. Was there anyone else who wishes a public comment? We have two, so what is our time? I guess we will have to give you each three minutes this time. Roz? Sandy, would you set it for three?
DR. SCHNICK: I am Roz Schnick. I’m a national coordinator for aquaculture drug approvals in the United States, and having done several international seminars throughout the world, I think I probably am unique in that I am the only person I know of that has this position in the world.
We have been very fortunate in the United States in having a wonderful partnership with the federal government and the state governments to develop a lot of the data that are needed for the drugs for approval for fin fish species. I am dealing mainly with that. We have some issues, but they are minor. The major part is for fin fish, particularly for fresh water fin fish. These data are very much nearing approval, and our companies that are involved in this I think if they knew that there was a worldwide market for this -- and obviously from every speaker from every part of the world that stood up today, this became very apparent. And to make the effort that we have extended to extend this worldwide for these companies will be really a tremendous asset, and it may help us attract additional companies if they can see how this can be leveraged worldwide.
So I encourage those of you that are from other countries and you interested in the aquaculture drug development in your sphere of influence that you get in touch with me so that I can help you and help the companies get together to really make the effort that we made to develop the data to benefit the world.
DR. CRAIGMILL: Thank you, Roz. Dr. Rao.
DR. RAO: Thank you for giving me an opportunity. I am GPS Rao from the University of Agricultural Sciences, in India. I do not know whether I could ask this specific question because this is a small topic for minor use and minor species. My interest is gender manipulation in fishes for ---. It is an accepted fact the Joint Expert Committee on Food Additives (JECFA) consisting of --- and WHO --- have given their report, and according to that two micrograms --- is ---. Similarly, for 17-beta estradiol is five micrograms --- is admissible limit. If this is the case, you don’t have one microgram ---. But in --- proper ban on the use of steroid hormones, and particularly ---. At that time during the ‘90s I was there in ---. I asked my guide, Dr. ---. She said it was more a political one rather than a scientific plan, and she --- and it proved right. These --- with the European Union, and some people --- in ‘99 --- report --- the 52nd Joint Economic Committee, Joint Expert Committee on ---, which is coming out as serial number --- by WHO.
So under these circumstances how are we going about this problem? This has proved that it has no adverse effects. The basically limited --- on the animal that --- 60 micrograms ---. I would like to know what exactly --- the FDA thinks about the WHO/FAO Joint Expert Committee on Fod Additives (JECFA) and what decision it is going to take a position on this issue. It is a common knowledge how that every man and the women through the urine discharge excrete about 15 - 20 milligrams of 17 keto steroids per day --- of
---, and this has been happening by millions of people for the past thousands of years. It is not — definitely getting accumulated in the Environment. Water and soil have some microbes which metabolize them. Water and --- not a good thing.
DR. CRAIGMILL: Thank you, Dr. Rao. I am going to have to move on
DR. RAO: Thank you.