DR. WYKOFF: Thank you very much.

Mr. Chairman, members of the Committee, invited guests, it is my pleasure and honor to welcome you on behalf of the Commissioner and on behalf of the entire FDA.

Over the next two days, you will be asked to deal with some complex and challenging public health issues. But this is not a situation that is new to this Committee.

Because of the nature of TSEs and because of their potential public health implications, this Committee has dealt with complex and challenging public health issues in the past and will likely do so for many meetings in the future.

The specific issues that you will be asked to advise us on are: the possible deferral of donors based on foodborne exposure in BSE countries, possible revisions in our guidance on processed human dura mater, and issues related to the safe sourcing of material of sheep and goat origin for use in FDA-regulated products.

The way we will ask you to advise us on these issues is by posing some questions to you. These questions have been developed by FDA's TSE working group. And I would like to take a moment to thank the working group for everything that they have done, not just in keeping up to date with the latest issues related to TSE science but also in putting together an outstanding agenda for this two-day meeting.

As a result of their agenda, you will have the opportunity to hear several distinguished presentations from around the world. You will hear presentations from FDA-regulated industry, from academia, from public health agencies in other countries, and from our sister agencies here in the United States.

It is our sincere hope that based on the information that you hear from those presentations, when combined with the knowledge that you already have and the discussions that you will have here over the next two days, that you will be able to answer and provide us with detailed and specific answers to the questions that we have posed to you.

More realistically, however, you will probably find that several of the questions are more difficult to answer and that you would really like to have additional information and that you don't have complete information upon which to answer the questions.

This, too, is not a situation that is unique to this Committee. Because of the information and lack of information about TSEs, this Committee has found itself having to provide advice to the FDA with less than all of the information than it might otherwise like to have. And I suspect that it will continue to do so for many meetings in the future.

Nonetheless, we have an absolute obligation to try to get these questions answered. And that obligation is our obligation to the American public to make certain that we carefully collect and systematically analyze all of the data that relate to TSEs and based on those data, incomplete though they may be, come up with the recommendations that are fair and balanced and in the best interest of the public health.

And, just as the American public looks to the FDA for advice and recommendations, we look to you for your thoughts, your counsel, and your recommendations.

The issues that you are dealing with are complex and challenging. And it is true that there is incomplete information upon which to make these recommendations. But I think you understand that we have an absolute obligation to take the information that we do have and based on that information make the best recommendations that we can to promote and protect the public health.

We sincerely appreciate your willingness to be a part of this process. We thank you for being here. We welcome you, and we wish you good luck. Thank you.


CHAIRMAN BROWN: Thank you very much, Dr. Wykoff. We'll do our best and start off with some background information provided by Dr. Mary Elizabeth Jacobs.