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DR. DOYLE: Very well done, Janet. I'm curious to know a little bit more about the risk assessments that you're doing. Is the purpose of these risk assessments to identify what products are of greatest risk or what points in the process are riskiest, or where are you going with that?
DR. WOODCOCK: There are three kind of meanings to this, okay? And, yes, the first would be for our inspectional program, where are the greatest vulnerabilities to public health? Because as you saw, we're not the Department of Agriculture and we don't have an inspector in every plant. And the number of inspectors and the number of inspections that have been able to be done over the years have dwindled. So we need to figure out what are the most serious vulnerabilities with respect to public health, and make sure the resources are concentrated there. I want to make sure people understand that doesn't mean they would be exclusively focused on the highest risk. We would continue to have a presence throughout any risk categories, but the emphasis ought to be on the highest risk products.
Now, that doesn't mean we could say today, well, intravenous products for life-threatening diseases are highest risk. We think we probably need to construct a model that has to do with the firm's compliance history--I'm just making stuff up because I don't know the answer--the inherent difficulty in manufacturing the product. You know, sterile products obviously are of more concern than toothpaste or dandruff shampoo. There are other factors that go into this, but we need to construct such models and then test them and so forth. So that's what we're talking about for inspections.
For manufacturing, it's quite different, although it's conceptually the same issue. And Ajaz taught me a lot about this. So back when much of this was conceived, perhaps back in the '70s, we didn't have as much basically engineering and material science understanding, especially for solid oral dosage forms, about what the factor were that create vulnerabilities that make things go wrong. For example, a blender. Why is there an inhomogeneous blend? And we didn't have the ways of monitoring blend that we may be able to introduce today. So the approach was we need to check everything and control everything carefully and control the process extremely carefully, because we couldn't predict which factors mattered.
Now, as more knowledge has been generated, scientific knowledge, and you can predict, based on all sorts of things that I won't go into, certain failures because of certain parameters, those are the parameters that should be controlled the tightest and we may be able really to move to a system that really focuses on the risk or critical control points of vulnerability in the manufacture of many products. This would help everybody. It would help FDA because we wouldn't have so many records to inspect. There's a record burden for everyone here in all this testing and controlling and record keeping and everything, and it would help the manufacture because it would be more efficient, and it would help the consumer because you would have at least a high of assurance of fitness for use, maybe higher. So that's another meaning of risk. And we are exploring all of those parameters and thinking how do you apply this in a regulatory system.
DR. LANGER: Other questions or comments?
DR. LANGER: I just had a minor one. First, again, it's great progress. You had mentioned about--and this is really just to see if we can help in any way--getting chemical engineers involved and stuff like that. Is that going fine or is there any help you would like?
DR. WOODCOCK: This is H.S. Hussain from the Center for drugs.
MR. HUSSAIN: This is Friday, casual day, so.
MR. HUSSAIN: I think we have been able to recruit chemical engineers and enlisted pharmacists, and we actually have set up a position description for that, and we will have some challenges with respect to people trained in pharmaceutical engineering, and support for education I think is needed, so I think the Science Board has a voice in that regard with respect to making arrangements of this with NSF and so forth.
DR. WOODCOCK: Yes. We can come back to the Science Board at some point as we get to specific science issues. I think what H.S. was right now we're able to recruit, but there may be like more fundamental science issues that we really need to bring back to the Board and get some help, perhaps research support for certain kinds of research that really needs to be done.
DR. LANGER: That sounds great.
Any other questions from anybody in the audience or Board?
DR. LANGER: Janet, I think everybody thinks that's great progress. Thank you.
DR. WOODCOCK: Thank you.
DR. LANGER: So now, basically, this is the final session where we just make closing remarks and talk about future directions, so let me try to make some summary comments on each section. If I'm missing something or state something in any way someone would like me to change, correct me.
So the first topic was counterterrorism. The issues that came up there were to explore the issue of research priorities and counterterrorism and how the Agency's priorities--prioritizes those with limited resources, also to explore how the Board can help, for example, with respect to capturing expertise from academia, for example. Any changes on that?
DR. LANGER: The second area was in the Office of Cellular, Tissue and Gene Therapies. Let me go over what we talked about there. There was a lot of discussion with the following comments came up. First, that the Board believes that as part of its function, that if administrative changes are being considered which could potentially impact the science basis of the FDA, the Science Board should be asked for input, and that specifically on the proposed move of the therapeutic products from CBER to CDER, the Board's concerned that the science not get disrupted and wants to better understand the reason for the move.
Any comments, changes on that?
DR. LANGER: The next point was there was a--and that also came up in the open public comment.
The next topic was on pregnancy and labeling issues, here that the FDA will explore opportunities for further research with NIH and will consider how the Board can help and continue to discuss this issue at future meetings.
Any changes, modifications?
DR. LANGER: The next section was pharmaceutical cGMPs Initiatives that Janet just went over, and I think here everybody is really delighted with the progress and look forward to any way we can help at future meetings.
And finally, came up, just for the future, other proposed items that might be discussed at future meetings would include combination products. These are not to be meant exclusive in any means, but combination products, counterterrorism follow-up issues as aforementioned, antibiotic developments from the April meeting earlier this year, obesity issues, further exploration of the pregnancy labeling issues.
And Mike Doyle, as the new Chair in 2003 will work with Susan and Norris to prepare agenda items in consultation with other members of the Board.
Any other comments or addition to that?
DR. DOYLE: Did we want to include the topic about the Committee regarding reorganization at that meeting?
DR. LANGER: Yes. What would be the best thing to say about that? I guess that was kind of left--I don't think that was clear from what was said this morning, what was going to happen, but maybe that could be part of what's going to be--when you work with Susan and Norris on that agenda, that could certainly be a part of it. Whether we need to say it more explicitly, I don't know. What do you think?
DR. DOYLE: I just didn't want to lose the thought.
DR. LANGER: Do you want us to do that?
DR. ALDERSON: I would counsel you to go ahead and say that--what I hear from the Board members this is something we would really like to engage in if this is something the Agency wants to do, and offer your services for that.
DR. LANGER: So I'll put another item there. Basically discuss--what should I say? What would be the best way to say it?
DR. DOYLE: Restructuring of FDA.
DR. LANGER: Discuss restructuring of FDA from a science standpoint.
DR. DOYLE: Exactly.
DR. LANGER: From a science based standpoint. We'll put that down as a future item as well. Any others? Yes, Harold.
DR. DAVIS: I would like for Janet to consider--I really applaud the CFR part 11. I'm not sure the whole Board appreciates what that's all about. For those of us in the industry I mean it's just critical. And so I would like to consider in the future, especially as you get past February the 11th and about to make some comments, decisions or whatever, so I'd like to have you share those with us just because I do recognize how critical those are. And I'm very happy you're doing it, that's for sure.
DR. WOODCOCK: Yes. I would be glad to do that if the Board is interested. We are crashing on that part of the project because it is so critical, but we don't have anything to share right now. It's going to be a little while.
DR. DAVIS: whenever.
DR. WOODCOCK: When we have something, we can share it. Again, it's very technical, not that you guys can't understand it.
DR. LANGER: You have to tone it down for us.
DR. LANGER: So what I wrote, I basically just amended what I had said earlier. I just wrote, "Excellent progress on the pharmaceutical cGMPs, and we look forward to following this more appropriate at future meetings." I didn't add the fact that we want it to be very simple. Is that all right?
Anything else that anyone would like to add before we adjourn? Yes?
DR. SCHWETZ: I would for sure want to thank you, Bob, for not only a good meeting today but many of them, and the help that you have been to us, and we look forward to a similar performance by Mike.
DR. LANGER: Well, it's really the work of you all and the FDA, so it's been a pleasure.
DR. DOYLE: I want to second what Bern said, and the representative Board has really appreciated your leadership, Bob.
DR. LANGER: Well, thanks. It's been a pleasure to work with all of you.
DR. LANGER: With that, any other topics?
DR. LANGER: I guess we'll move to adjourn. We'll adjourn. Thank you all.
[Whereupon, at 3:18 p.m., the meeting was adjourned.]
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