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U.S. Department of Health and Human Services

Animal & Veterinary

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Welcome and Workshop Overview

Dr. Stephen Sundlof

DR. BABISH:  Good morning.  We will be trying to clear the halls in the back.  My name is John Babish.  I am the national coordinator for NRSP-7, the minor species and minor use program here in the United States.  This morning it is my pleasure to begin the program.  First I would like to make sure that everyone in here is interested in attending the International Workshop on Minor Use and Minor Species.  If you don’t have a booklet and you are not interested in this topic, you are on the wrong flight.  I mean you are in the wrong room.  You see I have been traveling way too much.

My purpose here this morning is to introduce a fellow that I have known since 1982 and have had the pleasure of working with and knowing since that time, and I believe there is no one single individual that is more qualified to begin a program on this topic.  From 1982 to 1984 Dr. Sundlof participated the NRSP-7 program as the southern regional coordinator, and in that capacity he developed enormous practical understanding of the problems and issues in minor species.  Whether it was touring in the alligator farm in southern Florida or listening to game bird stakeholders lament about the situation in game birds, Steve has a practical knowledge of minor uses and minor species.  Since 1994, he has had experience in the regulatory aspects of minor uses and minor species.  So for a 12-year period and a 10-year period respectively, Steve has been participating in and understanding the national and international issues of minor species.  So before I digress into some rather ripe old stories about nights in Gainesville, I would like to introduce Dr. Stephen Sundlof.

DR. SUNDLOF:  Thank you, John, for the introduction and the trip down memory lane.  I just want to welcome everybody, especially our international guests who have traveled so far to come and be with us today.  This is to my knowledge the first symposium of its kind where we brought the world together to address these varied issues that are common to all of our nations.  Also we want to welcome the representatives from the pharmaceutical industry because without them none of this would work; government representatives, not only from the US government, but from other governments as well; producers of minor species, and all of the interested citizens who share our passion for this issue.  As John was talking about this, it is evident that this particular issue, the need for drugs in minor species and the need for drugs in minor diseases has been more than just a professional interest.  It is a profound and personal interest of mine, and I am very happy to see that we have come as far as we have, that we can also get together and talk about the needs.

This workshop is jointly sponsored by the Food and Drug Administration’s, Center for Veterinary Medicine, which is my organization, and the US Department of Agriculture’s National Research Support Project No. 7, or NRSP-7.  Both of these groups have a strong interest in the development of new animal drugs for minor species, the FDA being the ultimate regulatory agency which approves the new medications so that they can be legally used.  The NRSP-7 program is designed specifically to fund the studies that are needed to generated the data so that FDA can review them and approve those products for minor species.

The purpose of the workshop today is to provide a global perspective on drug needs and drug approvals for minor species and minor uses.  Now a number of countries are struggling with these same issues that we have here in the United States.  These are animals and diseases that do not have sufficient numbers to provide economic incentives for drug development.  Sharing information about how different countries address this problem should be helpful to all of us as we develop policies and methods for assuring the legal availability of safe and effective treatments for minor species and for minor uses. 

So I want to thank all of you once again for coming and introduce our next speaker, Dr. Mac Lumpkin, who has been a true friend of the Center for Veterinary Medicine.  Just a little background, he told me to keep this very short, so I will.  Dr. Lumpkin is a physician and is currently the Acting Deputy Commissioner for International and Special Programs of the United States Food and Drug Administration within the Office of the Commissioner.  He is responsible for overseeing the Office of International Programs, the Office of Pediatric Therapeutics, the Office of Combination Products, and for coordinating the FDA responses to several national public and health issues that cut across several programmatic areas in the FDA; and we have lots of issues, so Mac is a very busy guy.  Mac, please join us.