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U.S. Department of Health and Human Services

Animal & Veterinary

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Dr. Murray Lumpkin 

DR. LUMPKIN:  Thank you, Steve, and I am only going to take a few minutes here because I know you have got, just looking at the program this morning, a tremendous amount of interesting material to cover today.  But I do appreciate the opportunity just to be able to have a few minutes on behalf of Commissioner Crawford and myself to welcome you here and to say how appreciative we are that you have taken time out of your schedule to come and join us to have these very, very critical and very important discussions. 

As Steve said, one of my portfolios right now is the international portfolio for the US Food and Drug Administration, and I am extremely pleased to see the very, very broad international participation that we have here.  I think we have got people literally from all of the continents here talking about what they are trying to do to address the issue that is the major theme of this conference.  As many of you know, back in 1983 the US Congress passed what became known as the Orphan Drug Act of 1983, and this was the first time that our Congress looked at the issue of how one can create incentives for a public good when the normal market forces do not present those incentives to the private sector.  I think as we look back on the human drug side of our experience and see what has happened with orphan drugs over the past 20 years, we can look at the decade of the ‘70s before the Orphan Drugs Act.  I think as we have gone back and looked at the data there were less than 10 drugs that were developed and brought to authorization in the United States for diseases that are called orphan diseases on the human side of our responsibilities.  If you look at the 20 years since 1983, we have had 1,300 different human drugs designated as potential orphan drugs in the United States, and 250 of those have been fully developed and have been authorized for sale and use in the United States for treating human orphan diseases. 

I think we have also looked at other issues such as pediatrics and how we could address the need we have in this country for developing drugs for children.  Again, an area where the market forces did not give us the incentive that we needed.  We have also looked, for example, at the development of agents to be used in situations were we to have a bioterrorist attack of some kind.  Again, a situation where we all hope and pray we never have to use the products, so there is clearly not a market-driven incentive for people to develop those kinds of products, and you are in the same situation here.  People looked at minor issues and minor species, and I think we were all delighted particularly with the work of people like Steve Sundlof and people in our Center for Veterinary Medicine within the USA and within the larger animal drug community to work together to put this particular piece of legislation into effect.  I think we have all the high hopes for this piece of legislation as we have seen manifest on the human drug side of the house with the Orphan Drugs Act back 20 years ago.

So with that, I don’t want to delay any further you getting into the crux of your work here.  It is extremely important work, and we are extremely pleased to have you here and thank you for coming.  I will now turn it back over to -- yes, right there.  Coming up.  Thank you very much.

DR. WEBB:  Well, welcome to our workshop.  Just some preliminary information.  In case the speakers look nervous, it is because they have been threatened with all sort of death and torture if they exceed their time.  What we are planning is if they finish early they can take questions.  Otherwise the questions will be rolled over to the group discussions, which we think will be far more interesting because it is an interaction of the workshop, not a conference.  That is the first thing.  Second thing, warning to the speakers, this program is being recorded.  Every word you say will end up in proceedings or transcripts that will eventually appear on the web after you have had a chance to delete your explicatives, and we will then have them available.  There will be a CD produced which all of you who attend and sign up will receive.  Don’t hold your breath, but it will come eventually.
  (Audio difficulties.)

The first speaker this morning is not Dr. Babish.  We are going up the agenda.  Okay.  First speaker this morning is Dr. Andrew Beaulieu or FDA/CVM.  Many of you know him as well.  He is currently, and I have got in parenthesis Acting Director of the Office of Minor Uses and Minor Species.  He may be acting, but he is probably one of the prime people who have worked with the coalition for MUMS and it is for this he has accepted our invitation to speak and to talk about the bill and to talk about FDA efforts in minor species.  I think he has been employed at FDA since 1974.  I tried to glean this background information.  The good thing is he came from the University of Miami.  He was blown up here in a hurricane back then after getting his baccalaureate degree.  He went to Ohio State University for Veterinary School and he was, as I said, very significant in the MUMS work, but also in the Drug Availability Act, which actually set the stage by telling FDA that they should be looking for a solution for minor species and minor uses.  I don’t want to take any more of his time, because I don’t want him to get nervous, so I will ask him to come forward.