|VOLUME I:||Remarks||WWW 101||Group 1||Group 2||Presentations||Group 3|
|VOLUME II:||Remarks||Group 4||Presentations||Group 5|
October 17, 1996
Remarks: Stuart Nightingale, M.D.
P R O C E E D I N G S
DR. NIGHTINGALE: The presentations yesterday were very interesting, spirited discussions and we had, indeed, a real learning experience which is what we wanted to get out of the meeting. The discussions really were, I think, very valuable to all of us and there was no question that we are dealing with a powerful and evolving technology.
In short, yesterday's meeting surpassed our expectations and we do expect more of the same today and I am sure we will have that from this very distinguished group. We did keep on schedule which was no mean feat considering the very large size of our discussion group panelists. I am also pleased that we had, I think, quite a good audience participation, again, given the size that was extremely good.
In my long years of experience with Part 15 hearings, I don't think I have ever seen anything quite as good as this in terms of intense interaction among so many people. Also we had a slight problem yesterday with the air conditioning and I understand that has been fixed today so that should not be a concern.
Today we have two topic areas which are extremely important for our ongoing education and to help us in our decision making. What I would like to do before going any further, though, is to repeat and reemphasize a few of the comments that were made by Bill Schultz yesterday, to help those of you who were not here as well as to reemphasize some of those comments.
Remember, this public meeting grew out of a series of smaller meetings that we had with individual companies. It became very clear to us that the issues were really industry-wide concerns and there was a great desire to have some guidance from us in this area.
Although the individual meetings were interesting and valuable, we felt we really needed to have a very large session with major public input both here, in terms of the verbal comments, as well as an opportunity for written submissions on the record.
Let me reemphasize that this is not a meeting for FDA to announce its policy on advertising and promotion of medical products on the Internet. This was made clear in the Federal Register document. We are here to learn.
The questions that the Agency is posing to the discussion groups raised the issues and questions that have been most frequently asked about the dissemination of information about FDA-regulated medical products over the Internet. So these questions come from that and more than that should not be ascribed to what the questions are.
I think Bill emphasized that yesterday. To date, we have not set any policy on these issues although there have been some warning letters. I think he mentioned that as well. We want to wait to hear what you have to say, where the technology is and where it is going before we develop the guidance.
Following this meeting, the Agency intends to take what it has heard here along with the written comments that we receive and develop guidance. It is hard to say exactly when this will occur. It depends on what we hear at this meeting as well as the written comments that come in to the record.
Now, to repeat the actual running of the meeting. By the way, we will work as quickly as possible on developing the guidance. As the agenda states, there will be one discussion group at a time up here. Persons participating in the discussion group should not come to the stage area until called or told it is time to be seated. We have done this quite well here.
The moderator for the session will present the issues and questions for discussion. The moderator is, then, really going to be the master of ceremonies for what takes place. For the record, discussion-group participants should state their name before speaking.
Discussion-group participants should be considerate to their colleagues and limit the time for their comments. The moderator will tell you exactly what that is depending on where we are. There is a lot to discuss in a short period and we want to make sure that everybody has an opportunity to be heard.
The discussion groups will have roughly 75 minutes to discuss the issues. Some groups may have more or less time. After the group discussion is over, or in this case, I think, we are going to try to have FDA panel questions and comments at two times--this is what we did yesterday--in the middle of the session and at the end just prior to going to audience questions and comments.
Transcripts of the meeting will be available about two weeks after the meeting. You can get a copy through FDA's FOI Office. Also, we will try to put the transcript on FDA's website shortly after it is available.
The ground rules. The discussion group participants are not expected to make their own lengthy presentations and there is not time to do so. You will have an opportunity to comment on the record and you will also have an opportunity to ask questions from the audience when there are topics from other panels that you are interested in commenting on.
You are aware that there has been much public debate on FDA reform, and the Agency's policies related to advertising and promotion of medical products. The purpose of this meeting is, however, to discuss the issues as they relate to current law and Agency policy.
Please avoid discussions about how the law should be changed. This is not the appropriate forum for that type of discussion.