Food Safety Counterterrorism Initiatives




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We think that the reasons for it--we don't know what the reasons for it really are. But in fact I can tell you that for the new office to function, it's a bit of a bite. And I'll leave it at that.

But no matter how hard this may be, at the end of the day the question is "Is it all worth it?" and we say "yes." Learning the lessons of the past absolutely enables a future, and what can be imagined will be done. And as we move forward we always do this with hope, because we always hope next year it'll be a little bit better. We know for those X-SCID babies, even the parents who know that one of them may develop leukemia, they want to take that risk. We need to have appropriate humility. Far too often as we move forward, we kind of forget just basic things.

Originally 1902 Law for Biologics was because people kind of forget. Horses get sick too. A horse named Jim came down with tetanus before it was discovered. That was to create a diphtheria antitoxin. The diphtheria antitoxin was a wonderful therapeutic agent, but its use was being discredited because of that.

The 1938 Food, Drug, and Cosmetic Act. I don't know how many men, women, and children died because sulfonylmide was insoluble in water, so what did they use? They used antifreeze. They didn't even try it in animals first.

We need to remember that nature's been everywhere, she's done everything. And if it doesn't exist, there's a good reason why. And when we perturb that system, we need to tread with due caution with humility and not hubris. This is progess. The race is not to the swift or the battle to the strong, but as everybody in a manufacturing facility knows, time and chance happens to us all. And most of all, as we move forward, we need to move forward with compassion.

Thank you for your kind attention, and Dr. Zoon and I will be pleased to take any questions.

DR. LANGER: Thanks. So, we'll open it up to questions. Harold, why don't you go first?

DR. DAVIS: I actually have--the CBER/CDER reorganization, but I'm not sure if this is the time we want to do that in an open discussion, et cetera. I'm not sure how you--

DR. LANGER: I think that probably the best time to go over anything is now, unless people want to break things up, but it seems to me now we should go over any of the topics that Kathy or Bill raised.

DR. DAVIS: I guess I was a little confused about the fact that--procedures for recruiting somebody and then calling--recruiting. Are these internal recruits--are you recruiting--

DR. ZOON: Most of the recruits--when you establish a new office it takes time to write all the position descriptions and formally advertise them. So in order to implement a new office what we do is do an advertisement for a detail, which is an acting position. All those position descriptions can be written and then formally advertised. This is a method that helps the program get started and up and running, and clearly it's important to do that and get people--in this, but sometimes that could take anywhere from six months to a year to get all those position descriptions written, classified, and advertised and ultimately filled. We need to do this in order to get the operation up and running.

DR. DAVIS: --the child who came down with leukemia, how long post treatment--

DR. NOGUCHI: We don't know the exact date of the actual--there was a development of--we don't know, but it was at least two and a half to three years after the initial treatment.

DR. DAVIS: I guess my comment, and this comment ought to be taken from Harold as opposed from Amgen. In the time I've been on the panel, I don't think anything we've discussed as a science board, potentially--like the proposed--and I'm not --even good or bad, just the fact that it could potentially impact that. So I'm very surprised that the Science Advisory Board--considering being brought in to offer an opinion on that, or to view that, et cetera. If we are to review the issues around the science of the FDA, to me nothing we've looked at since I've been here potentially has an--impact like that. I was actually very happy to hear Dr. Crawford--say some members of the board or subcommittee or something would be set up. My concern around that is--did that come from--. Did BoB, did you and somebody else propose that? If that's an FDA thing--

DR. LANGER: Yes, I think I'll have to ask Lester about that. I don't know the answers to that. I think all of us probably want to do whatever we can to help in any way. So, probably what could happen on this is get a sense of how different members of the board feel and, you know, we could make some recommendations to Les. I'm not sure what else we can do. I mean I'm open to anything, myself. Yes?

DR. ROSENBERG: I also would like to comment. I spent yesterday, I just spent the afternoon, very enjoyable afternoon, listening to the science programs at CBER, and perhaps that combined with the fact that I've also had fifteen years of interaction with that organization from my prior experience in the pharmaceutical--and when Kathy was talking about this research or review model, what came across yesterday loud and clear was how important that model is and how well it works for the type of review they do, in terms of novel biological materials, and how integrated that process is and how it requires this kind of interrelationship, to be able to have the cutting-edge science in place to be able to look at those kinds of novel products.

And the case that was just explained, of course, is just one in terms of how therapeutic modalities intermix with cell tissue and gene therapy. I think it's even much more complex than that. I think there's interactions between adjuvants and vaccines, and the same cytokines that are being used therapeutically are being considered as adjuvants.

The whole process of what they do is so integrated, and it's integrated right from the point of view of helping companies to develop these things, in providing feedback to those companies, that assistance. Also in approving them and getting the right approval capabilities. And then regulating them, particularly regulating them from the manufacturing standpoint, and all the again kind of unique properties of these kinds of molecules and the science base it takes to monitor that.

So given that kind of background, I would like to certain support what Harold just said, and that we just heard about all this week. And given the importance of that science base to the ability to give feedback to the industry, to regulate this industry, to approve products in this industry, to monitor manufacturing processes across the divisions that were discussed--I really am very concerned that we do not disrupt that science, that we make sure that whatever gets done--and again, I don't enough about this to know the reasons for or against moving things, but I think before you move something, somebody's got to present a very logical and rational reason for doing that. And I certainly haven't heard that. As a member of the Science Board, nobody's presented that. It's never come up for discussion. And I'd like to hear more about why this is going on and where it came from and what its purpose it, because I know that its potential effect sounds like it could be pretty traumatic. And therefore, we'd like to know and help out if we can to do something.

DR. LANGER: I don't know if there are any comments from the FDA, or whether we should just--Les is not here--or whether we should just continue with comments from members of the Science Board, or questions.

Okay, Bob?

DR. NEREM: Several comments. Number one, this is not something that just happened. It's been in the news for at least a month, if not longer. But it was my understanding that in fact Lumpkin was going to give some background on that, and then unfortunately had to go down to the White House, or whatever. But certainly it is something that probably deserves further discussion, but it's unfortunate in a way that this has come up the way it has, without hearing first what the rationale of upper management is, and it's difficult for me to know to be pro or con, as probably most of the Science Board members. But I do think it's important.

Here, one of the things, which at least my understanding from Dr. Crawford was that this subcommittee talking was not to look at this specific issue, but to look in a broader way at the organization of the FDA, and certainly I would support the FDA thinking out of the box, in terms of how they should be organized with the products of the 21st Century. And I consider it a very positive thing. Because I would assume that a subcommittee would meet before the next board meeting and at least produce some homework. So I viewed that comment by Dr. Crawford as a very positive comment, but not something that was meant to address this particular issue, which doesn't mean that it shouldn't be addressed by some group.

I don't if Kathy--now, I like to come back to this office, and I would gather that you're probably not ready, you and David Feigal, to talk about some of your ideas, and you'd rather wait on that. Is that fair?

DR. ZOON: Yes, but I think in terms of conceptually, I think the discussions we have are going to very much reflect how we think. We can work together in a seamless fashion to deal with these products in a step-wise, risk-driven strategy, where the amount of oversight and regulation is coincident with the products and the issues surrounding the products, and that we do this in a way that is mindful of both the scientific underpinnings from both centers to make sure that we're coordinated timely and working in teams.

And so I won't go into more details 'til we work out the specifics, but I think much of the philosophy and the needs of this particular tissue engineering field have been heard loud and clear, and we're trying very hard to incorporate those ideas into the concepts of furthering the science in this area and to make sure that the centers do it in a coordinated fashion.

So right now we have our teams working very hard on this issue and coming up with a strategy. We will be presenting that to Dr. Crawford and others, and hopefully they will be pleased with what we come up with, or provide feedback that we can go back and work on. So my sense is there should a positive solution.

DR. NEREM: Just a couple of comments. You know, one of your slides--I think it was your slide--was expertise, and that list of expertise was actually striking in terms of what you have and equally striking in terms of what you don't have in terms of what you don't have when it comes to tissue engineering products, and that's why it's so important that there be a cooperative effort. And I would hope that in thinking out of the box, you would even be considering the possibility of a joint office that is jointly staffed. Having gone through the CDRH review a year ago, the idea of calling in consultants doesn't seem to be the optimum situation. You need people who are working side by side on a day-by-day basis, and that are helping to educate each other as to the problems that come from the different sides.

DR. ZOON: I totally agree with you, Bob. I think that we recognize that each of the centers has some very precious expertise. It does not serve either center well to duplicate expertise, but to coordinate and bring teams together that have responsibilities. And so that is what we are trying to achieve in our planning and our strategies to work together on these new products. And I think that teamwork and dedicated teamwork will be a reflection of the concepts that we are putting together.

DR. NEREM: The other thing I would suggest is that one probably should not be talking about a device approval process versus a biologics approval process, but sort of starting from scratch, what is the right approval process for these complex products. And I don't know whether a different process would require legislation, but if it requires legislation, so be it, because we need the right process, not some shoe-horning products into an existing process.

DR. ZOON: Yes, I think there's a way to approach this. And particularly because the centers have the opportunity to use all of our legislative authorities and regulatory schemes, we actually have a lot of flexibility on how to manage these products. And so my view is that we should give it a go, and use what the tools are we have to make it the very best we can. If after an evaluation, because I think it's important not only to act but to evaluate what you do and how effective it is. But to implement something, look at its effectiveness, talk to the people in the field, and then see is this effective.

And then once we can do that, we can do an iterative process as to how this should be best moved forward. But we have to start somewhere within the given tools, and I would say this field needs to move forward and not get tied up in knots. And then we can work together with the patients, with the industry, with the academic institutions to move it forward.

DR. DAVIS: Thanks, Bob, for clarifying that around the subcommittee. That's actually quite helpful.

But two points. One, I still believe if we're going to attack an issue or deal with an issue with the subcommittee, what I've seen to date with us is that the agency brings an issue to us they'd like for us to consider or wrestle with, and then this committee has sort of decided how to deal with it--to put a subcommittee together, et cetera, et cetera. So that doesn't allay all my concerns about the fact that there will be future subcommittees.

And you also made a point which I agree with. In the last few years we've actually reviewed issues around various individual centers, and I can't understand how we would deal with individual center issues around how they're structured. We've looked at the retention issues, the seniority issues, hiring people, where do you find people, et cetera--how those issues were any more scientific oriented for this Board than the potential issue around what's going to happen if we should merge CBER into CDER. And please understand, I'm not speaking for it or against it at all. It's just the fact that if the agency is going to that, I would say that my friends who would hold up and see that FDA has a science board, advisory board, and that my name is on that science board, would probably have assumed from a public standpoint that that was discussed at this board.

And we are very far along, there's a quick time to turn this whole thing around, et cetera, and I'm not sure of what the board can say or do or what will be discussed and what impact we can have, et cetera, and that concerns me.

DR. LANGER: Other comments or questions?

Yes?

DR. SCHWETZ: I can't speak for Dr. Crawford or Dr. Lumpkin, but in the absence of both of them--I know you're going to leave today--unless we have an opportunity to discuss this with Dr. Crawford yet today, which I don't have reason to believe is going to happen--I would predict you're going to go home with a feeling of nonclosure on this. And while I can't close it for Dr. Crawford, let me just say that you've made some very good points and I appreciate your effort to make this a generic issue as opposed to a very specific one, and I think your recommendations are good.

I would suggest a couple of ways that we might help to bring some closure to this, even if it isn't today, to do it in the near future. And that is--I think I can speak for Norris. Norris and I will relay the nature of the comments to Lester immediately, as soon as we can meet with him to share your concerns, because of the time lines of what is going on, that we don;t want to go in and talk to him after the fact.

So we will talk to him and relay the thoughts that you have put forward.
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