Food Safety Counterterrorism Initiatives

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And it's been good fortune for us that some of these systems, as Joe mentioned, the OASIS computerized system for import entry that was developed a dozen years ago to facilitate product entry into the country with more people tuning in to their computer screens and taking a look at the products as they're coming across, and being at the border with that information, querying other data systems, has really given us an opportunity to do a lot more surveillance, and we're going to be cranking that up again next year, so it's been a dual win for us, actually.

MR. LEVITT: There's also, I would just add, an intangible element as well, and that is having enough presence, enough show of force that this does not come across as the weak link. And when we--when you stand up and say there are 300 ports of entry and the FDA has 150 import inspectors, how do you say that to the public if you're really worried? You know, the FDA had always seen the import program as a check, a small little check as opposed to a first line of defense. And so that difference, it's hard to measure exactly how much--what the impression is on the other side, but they'll see if it's harder to get through, if there is more scrutiny, then they are less prone to just think it's an easy mark.

DR. RIVIERE: Would the creation of a Department of Homeland Security impact any of what you just presented?

MR. LEVITT: I don't think so. One of the things that we have a done a lot over the last 5 or 10 years is work more closely with Customs Service, and while the U.S. Customs Service is to be part of the new Department of Homeland Security, I suspect they will remain much as they are, and therefore, our connections with them will remain much as they are.

DR. RIVIERE: Thank you.

DR. DOYLE: NIH has a major request out now for proposals addressing a foodborne and waterborne network, which I guess would try to line up several universities and perhaps other facilities throughout the country. Is FDA an integral part of this program?

MR. LEVITT: That really was part of what I was referring to before, and we have met with them. Actually some of the people working at NIH came from FDA. One of them actually came from CFSAN. And so I think they've made real overtures to try and understand what the needs are so they can respond properly. But as somebody said, it's not the same as having your own. We have to learn how to work within that system. We in the food area are not as familiar with the NIH system, the study sections, how they review the grants and so forth, as other folks may be, so it's a learning process for us.

DR. DOYLE: Following up on that, it seems to that FDA ought to be a highly important player in this approach, because as I read it, there's going to be kind of like an oversight, an overseer, whoever that may be--it didn't indicate in the grant proposals--but they're going to determine what additional testing may need to be done in the case of an event, and who would get involved in development of methods for detecting foodborne pathogens. This all seems to fit very closely to what your needs and interest would be. So I would hope that FDA could be a primary player, not only in the end product, the end results of all this, but also in the developmental stage in identifying besides the key players.

MR. LEVITT: I agree.

DR. LANGER: Are there other questions anyone in the audience or FDA would like to ask, or comments?

[No response.]

DR. LANGER: I guess not. Thank you very much. That was really very, very helpful. Is there anything that we can be helpful to you on?

MR. LEVITT: I think for us your words of encouragement on the research side and the method development side, as I said, funny things drive budget allocation, and while we like to think there is some cosmic risk based thing, that's there in part, but in part, certain projects require certain sums of money. You're going to put in an automated food registration prior notice system, that is going to take a chunk of money. But it has a definable amount. And so you can say, "This is what I need and I'm done." The area of research, methods development, is a little more amorphous. You can't say, "Give me $5 million and you will never see me again." In fact, the worry is there's a never-ending need, and so whatever I give you is okay because I can't satisfy you anyway.

Any help or advice you can give in how to help us frame research needs, relative importance to other things, so we can keep that high on the radar screen, I think would be very useful to us.

DR. DAVIS: That sort of goes back to my concern about the vast array of things that we put up earlier that the FDA saw it should be involved with around this topic, and the fact that there was only $150 million. Any organization has a mission, and people always look to see where they can be involved and have a real impact. So I think one of the things that FDA's going to have to do in the absence of being able to get real dollars, as you describe them, you're really going to have to prioritize the programs because there are a lot of things to do, as you put up in your list, but $150 million are not going to go very far unless you start to cut into programs that were already ongoing. And maybe you have to do that with something like this, but again, I simply say what last year, what was very important is no longer important, that you can get rid of it to carry out this program. And that's of concern.

MR. LEVITT: Just to give you some sense of the portion, in CFSAN's research program, we consciously decided we would redirect 15 percent of our research program to methods development for these areas. So from an inside viewpoint that's a lot, because it's not 1 or 2 percent, that it affects a number of different people in our center, but it also means 85 percent we didn't redirect. That will give you some sense of proportion that way.

DR. MEYERHOFF: If I could just make a couple of more comments on that. You're right, there is a lot to do, and I think there's a number of different tools we can bring to that. Some of these tasks are built into what we already do. We do a lot. If we had more, we could do more.

Secondly, we leverage across the government and other sectors of society, with industry, with academia, to get some of these jobs done.

Lastly, and probably what I think is really one of the most important things in counterterrorism, is understanding the need to be light on our feet. We are never going to be able to predict exactly what the next event is going to look like, but we need our systems to be elastic enough and moveable enough that we can respond, knowing what our job is but not knowing what the exact threat is going to be perhaps until very close to the time it happens or when it does.

But your points are very well taken. Thank you.

DR. LANGER: Other comments?

MR. LEVITT: I'm sorry. Could I add one other thing in response to your question.


MR. LEVITT: Another area that you could help us with, and maybe it might be a topic for the next meeting, is how we can better capture the expertise out in the many universities in the country. We are--I can't say starting because it started--to receive a series of visits from University X with their new Center for Food Safety and Security, and University Y with their Center for Food Safety and Security, and Z with, guess what, their new Center for Food Safety and Security. And while they're all coming hoping to get funding and are sorely disappointed when I describe our funding capabilities in the area, nevertheless, there are a lot of established universities with established expertise, which if there is a way to get that banded together--NIH often likes the phrase "Centers for excellence"--into a series of Centers for Excellence in Food Safety and Security devoted to these things, so we're not duplicating, so we can tap into the right people, and so we have more of a real forward-looking effort, that's something that I think would be worth further discussion.

DR. LANGER: I think that would be very useful to a future meeting.

Along those lines, one thought is--this is really only a partial answer to that--but is giving talks at scientific meetings in universities. I don't know to what extent that happens, and I would think that if there are scientific talks on these topics, they would probably make you much more visible and people would be interested in sharing things with you. I don't know if there are really programs aimed at that or not, but that's just like I say, one thought.

I'm sure the people here are all at universities and would certainly be happy to help. But if you let universities know, I mean I'm sure that there's some interest on the FDA's part. I'm sure that they'd be happy to invite you.

MR. LEVITT: Thank you.

DR. LANGER: Other comments?

[No response.]

DR. LANGER: Well, thank you very much. What we're going to do is take a break and then come back at 10:15, where we'll be discussing the Office of Cellular, Tissue and Gene Therapies at that time. Thank you very, very much.


DR. LANGER: The advice I'm getting is that when people want to speak, they need to press the button and make sure the red light's on, and then they can speak, reasonably close to the microphone.

With that, let me introduce Kathy Zoon, and she's going to discuss the Office of Cellular, Tissue and Gene Therapies. I'll let you lead the next discussion, Kathy.

DR. ZOON: Thank you.

I just want to say it's a pleasure to be here today and have the opportunity to discuss the Office of Cellular, Tissue and Gene Therapies and some related topics, and in doing so, before I get started, yesterday CBER had the wonderful opportunity of having a number of you from the Science Board visit our center, and we had just a great afternoon. For those of you who didn't get a chance to come this time, we're happy to have you all the next time, and we'll certainly be happy to host other visits to CBER, but we had a great discussion, a lot of very good input onto the programs that were presented, as well as some of the specific projects and initiatives going on in CBER. So thank you.

My presentation here today actually is a reflection of a lot of thinking that you all have done with respect to cell tissues and gene therapies, and the discussions we've had previously with this group on combination products. And CBER has taken to heart the discussions of this body. We've had a number of open public workshops regarding cells, tissues and tissue engineering with Dr. Feigal, David, and have spent a lot of time thinking about this.

And one of the fruits of our discussions and with the support of Dr. Crawford, has been the creation of the new Office of Cell, Tissue and Gene Therapies. And in saying this, one of the things that we are currently doing is working with David and CDRH on tissue engineered products, and we are currently working on a schema that we will hopefully have an opportunity to present to the Board at the next meeting that will look at the issues and how we are going to manage these as a seamless process between the two centers, so that these products of tomorrow can actually reach patients in a timely way.

So, David, I thank you and all your team, and we look forward to continuing to work together on this important area.

I just want to spend the time this morning discussing several issues, to talk about the regulation of biological products in general, and some of the philosophy which I think is really important for products of new technology, including the products that are in the new Office of Cell Tissues and Gene Therapy.

As you know, the regulation of our products is based on science, law and public health impact, and this has really been afforded us by two main laws. It's the Public Health Service Act, and the Food, Drug and Cosmetic Act. And I think one of the things that CBER has looked at over the years is the importance of science underpinning our regulation of these products as well as making sure they're safe and facilitating them to the public.

At the core of this you'll see research. Research I think of, there's two pieces of research. One is a laboratory based science and another is the research that one gives intellectual freedom to our scientists to think beyond the boundaries and to contribute to new ideas and new processes. So in our center this has been the core of our mission with the review process and our surveillance in policy and compliance.

In doing so, I think it's important for people to realize we have four main product offices within the Center for Biologics. We have the Office of Therapeutics Research and Review, the Office of Vaccines Research and Review, the Office of Blood Research and Review, and now the new Office of Cellular, Tissue and Gene Therapies.

While CBER is constructed on an office level, the dynamics and the interplay between our organizations is intense. We feed the science across our organization. We're not a stovepipe organization. We're actually a very cross-cutting organization with respect to sharing science among our agencies. We have focus groups. We have cross support for all our products, and I think I will come back to this because I think some of the reorganizational changes that have been proposed that we are working with Dr. Crawford on have raised grave concerns with me. And I think I will discuss those to some length during the course of my presentation before I turn it over to Phil, and perhaps this is something that the Committee will discuss with me. So with that, I will go on and talk about why we actually went in and established this office.

The first question is why did we actually create this new office, and one of the main reasons was because there was an increasing number of regulatory activities in this area of cell, tissue and gene therapy. In addition, we were looking at stem cells and tissue engineering, and how to incorporate these important products into our organization in a way that we could facilitate science.

Now, clearly in the area of stem cells, we have been working with stem cells for quite a while. We have had peripheral blood stem cells, cord blood stem cells, mesenchymal stem cells, a lot of different stem cells. However, most recently back in August of last year, President Bush allowed that embryonic stem cells created before August 9th, 2001 could now be used in the public forum to do research. So the opportunity to look at tissue engineering in a global sense, and really to try to understand the science and how we were going to move this area forward became a major new program for our center. We were also seeing that these products are getting more and more complex. Dr. Noguchi, who will be the Acting Director of the new office and will speak to you, will give you some examples. We're just not talking about a cell. We're talking about how these cells are grown, how they're manipulated, what are the factors that cause their differentiation, how do you stabilize these, how do you actually understand what the characteristics of these cells are that you can make products consistently? All of this requires a lot of science and a lot of direction in this new area.

And clearly, there's an evolution likewise within the Center for Devices, where new matrixes are being developed and new science is being developed that has to interdigitate where there are combination products. And so we recognize that this is an important area and needs serious attention and work by the FDA. And we are committed to do it, which leads to the seamless and transparent coordination and communication. I think we have heard loud and clear from our advisory boards, from the public comment, that we need to develop a process that is clear, transparent, logical, that imparts the best from CDRH and CBER to get these products reviewed in a timely way, and that we give timely guidance and instructions.
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