Food Safety Counterterrorism Initiatives




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I would also volunteer that you might personally call him. There isn't reason by Science Board members can't call the acting commissioner and share off-line thoughts, raise questions, interact with the person to whom you are the advisor, outside of meetings. So I would encourage any one of you to ether speak on your own behalf or you and your fellow board members to the extent that you want to relay the discussion that went on here, and your concerns, and the discussion that went on yesterday over at CBER. I think it would be appropriate for you to share your feelings with him by telephone or by whatever means you would like.

Thank you. Norris?

DR. ALDERSON: I agree with what Bernard just said. Bob just gave me a draft of something that I think he's going to pose to the board to relay to Dr. Crawford. And I think that's very appropriate that you do that. I think he's captured here in a statement your concerns that I hear you saying. And I think the point that Bern made about this is not specific to this issue, but it's more of a generic issue which you are addressing, and I think that's the way you need to do it.

DR. LANGER: I want to see if there are comments from the audience. Anybody want to make any comments from the FDA or elsewhere around the table? Okay, sure.

MS. ROSENBERG: I'm Amy Rosenberg, and I'm the Director of the Division of Therapeutic Proteins in CEBR in the Office of Therapeutics. And I would like to make a comment that echos some of what I've heard around this table. And basically that is that we feel that this consolidation plan was formulated in the complete absence of what is regarded by the scientific community as critical input. That is, input from authorities responsible for oversight of FDA scientific programs. The Science Board to the FDA, the Biologic Response Modifiers Advisory Committee, or other subcommittees appointed through these committees.

The plan to move much of OTRR's research programs into CEDR contradicts recommendations previously made by a subcommittee of this Science Board that drafted a report finalized in October of 1998. It's now known as the Bennett Report. And in his report, the committee resoundingly reported the requirement of a high-quality intramural research program for regulation of biological products, including biological therapeutics, and the committee stated that "It is the consensus of the committee that CEBR requires a strong laboratory research focus and not a virtual science review process. Otherwise we risk the potential to damage not only the health of the population of the United States, but also the health of our economy."

They further stated in no uncertain terms that the culture of science, which is so strong at CEBR and necessary to the regulation of biological products, is specifically absent from other centers. In so stating, the committee stated that the review committee in expressing its strong support of the need of laboratory research in CEBR and other centers in FDA, recognizes that this position is contrary to the experience of the agency and the industry in the review and approval of drugs by the Center for Drug Evaluation and Research.

So among the many critical reasons that the committee offered in support of CEBR's and OTRR's intramural laboratory research programs were the following: one, regulators and policy makers require expert knowledge and firsthand experience with the latest technology being applied to biological products. And I think a group of you yesterday saw a presentation that highlighted the cutting edge proteomics, genomics, and other programs that we have at CEBR, and the fact that our scientists stay there. We have very low turnover. They stay there because they love what they do. They love they love the integration of science and regulation. And they're dedicated to it. These people could make much more money if they went elsewhere. But they're dedicated to this. But they're dedicated to it because the science is incredibly satisfying, as you all well know, and they're not going to go to a center wherein research will not be supported.

Secondly, the committee stated that an intramural research program is required to assess risks of new therapies, to develop assays and new approaches to increased efficacy, safety, and reduced risks.

The third comment was that a strong well-maintained intramural research program provides the basis for a climate of science and scientific communication within CEBR that enhances the ability of the agency to recruit and retain high-quality scientific staff. And in that light I would ask you to consider the presentations yesterday and also the bibliography that we passed out this morning of publications from the Office of Therapeutics. I believe that this shows that we have an outstanding publication record, and it's remarkably done so while over 50 percent of the time of these research reviewers is spent in regulatory responsibilities.

Furthermore I would highlight that the proposed consolidation poses a real threat to retention of the high quality scientific expertise. Recently we conducted an anonymous questionnaire of OTRR personnel, and found that about 90 percent of principal investigators and tenure track fellows, and staff fellows, will seek alternative employment if the consolidation plan goes forth as planned.

Fourth, the research program facilitates the ability of CEBR to address existing regulatory issues and anticipate future problems, to keep pace with rapidly emerging and complex cutting edge technology. And I have already alluded to the cutting edge science that we have at CEBR, which may not stay, should it be placed in an office where science is not supported and there's not a critical mass of scientists.

With regard to existing regulatory issues, we interact extensively with industry. We've organized many, many meetings to address what for biological therapeutics are critical issues, that of immunogenecity, comparability, and the prospect of generic biologics.

So in summarizing, because the conclusions of this report are so clear with regard to the requirement for research, we feel that the input of the Science Board to the FDA to this consolidation plan is of vital importance, and notably has been absent.

And we welcome your comments, we welcome further input of the Science Board, and really very much encourage your participation. Thank you.

DR. DAVIS: The questionnaire that you said was done? How many people are we talking about? How many people were sampled? You said 90 percent of the people responded one way or the other? Are we talking about ten people, 100 people?

MS. ROSENBERG: We're talking about, I believe it is 100, at least that we've so far gotten questionnaires back from. But the majority of persons are within DTP and DMA.

DR. DAVIS: That's 100 out of 140? 100 out of 300, or...

MS. ROSENBERG: Do we have the numbers? Dr. Max can speak to this.

DR. MAX: I believe there are approximately 140 to 150 people within OTRR. We had a response from about 86, so it's not complete. We don't know if it's representative, but that's what we got. We tried to assemble this so we could give you some idea at this meeting. We carried this out earlier this week and it was primarily in response to comments that Dr. Crawford had made, suggesting that the attrition rate that we could expect and that he's seen so far since the consolidation was announced was no greater than the normal attrition rate at the FDA.

Of course, it's only been announced for one month, and to allow people to seek alternate employment as professionals, we wouldn't expect to see any change in the attrition rate, even if they did have the intention of doing so.

DR. DAVIS: So the 90 percent is 90 percent of the 86?

MS. ROSENBERG: Yes.

DR. LANGER: Other questions or comments by anybody?

Thank you very much. Any other comments from anyone in the audience? Or the FDA?

I think that a number of good suggestions were made about how we can all individually collectively follow up. But I think probably it's also important to have something on the record for sort of capturing briefly what has been said here today. So I've made an attempt at that, based on Marty's and Harold's comments, and I wanted to just read that and then let people modify it, so that we could somehow capture the spirit of this briefly. So here's what I will say on the proposed move of therapeutic products from CBER to CDER. The board is concerned that the science not get disrupted and wants to better understand the reason for this move. I tried to just make it--that's actually taking a number of things that you said, but I just want to try to put something down that captures this in some way, and I just want that we can put it in at the end of the day.

Again, I want to open this up, so if anybody wants to modify that or just say it's fine. What do you think?

[No response.]

DR. LANGER: If there's nothing else at this point, we'll take a break for lunch, and we'll resume at 1 p.m. for the Open Public Comment.

[Whereupon, at 11:37 a.m., the proceedings were adjourned, to reconvene at 1:03 p.m., the same day.]

A F T E R N O O N S E S S I O N

1:03 p.m.

DR. LANGER: We'll get started with the 1 o'clock session, where there's Open Public Comment. So I just wanted to check to see if anyone from the public would like to make comments. Do we have any comments?

[No response.]

DR. LANGER: There is one written comment that's been submitted by a Dr. Kathryn Stein. Dr. Stein was unable to be here to present these comments, so I'd like to give these to the transcriber to incorporate them into the official transcripts and dockets for the meeting. This letter covers the proposed CDER/CBER move that we discussed earlier this morning. So let me give that.

[The statement of Dr. Kathryn Stein follows.]

DR. LANGER: Just in case anyone did walk in, are there any other, any public comments that anyone wants to make before we close this particular session?

[No response.]

DR. LANGER: So I'm checking with my colleagues about what we're going to do next. We're moving so quickly. Let me get the advice of my colleagues at the FDA, unless someone would like to tell some jokes.

DR. SCHWETZ: I don't tell jokes well, so I don't attempt to, but I would like to raise something serious that we might talk about in the few minutes before they arrive, and it is to take advantage of the transition in chairs and to have some discussion, either some thoughts from yourself or discussion from the board, on how we might do a better job of Science Board meetings, of keeping the Science Board members informed, while identifying issues to bring to the Science Board, how we might operate, whatever details you might like to raise.

And, Mike, as you look at filling this chair, there are things that aren't necessarily fixed in concrete in how this happens, and we would welcome some new thoughts. We'd welcome recommendations from people who have been on this for a long time and have obviously seen how we work. Bob, any thoughts on how we could do this better?

DR. LANGER: I think we can always do better, and really the only way is doing exactly what you said, just getting advice from people on the Board, at the FDA and from people here. I have no particular ideas. I do think, and we'll talk about this later in the day, you know, further defining the precise role of the Science Board is an important thing to all of us, and so I think that's something we discussed in the morning and at lunch a little bit more, and we'll go over that in one of the written statements at the end, but I think it's really just getting feedback from people to see how we can do it the best possible way.

Whatever we've tried to do the last few years has been based on, you know, what I've heard from different people, both at the FDA and on the Board. So I think it's just continuing to get feedback from everybody here. I don't have any specifics. I know we're going to be in great hands.

DR. DOYLE: Well, I think we have been in great hands for four years, so there's some big shoes to fill here.

But I guess one major question I have is how do we go about identifying agenda items for the Board, and I know many or not all of the agenda items come from the FDA, and are you receptive to having more input from Board members in terms of identifying agenda items and, if so, how do we go about that?

DR. SCHWETZ: Absolutely. We are interested in items that you would like to have on the agenda. We haven't had meetings between meetings, where you might have that as an agenda item to talk about what do you want to have in the next formal meeting, but, Norris, I think we should come up with some kind of a mechanism whereby we solicit comments, maybe halfway between meetings, a couple months after the meeting to get some ideas and then pass the agenda for the next meeting, maybe more than just in front of the Chair. We could pass it by in a draft form to the other members.

DR. ALDERSON: I'm personally open to anything you want to do relative to the agenda. The only thing I would tell you, it takes a while to put the program together, in terms of scheduling staff, so we need to start, you want to do this, tell me how you want to do it, Chairperson. So I'm perfectly open to any input you want to have on this.

DR. DOYLE: I think we'll have to talk about that as a group and get back to you.

DR. ALDERSON: Okay. That's good. It could be in the form of a conference call, for instance, and we could set that up or you could come with a number of list of proposals. You could give us some things that you'd like to see, and we can determine whether they're doable or not.

DR. DOYLE: And another point that has been discussed among the group is the idea of what Dr. Crawford had brought up about a subcommittee of the Science Board to address how the FDA might be reorganized, and the sense that I have from my conversations with the group is that they'd rather have everybody be invited, and some may be too busy, but they'd rather have it an entire Board activity, instead of just a subcommittee, if that would be acceptable.

DR. DAVIS: I guess my point, along that line, I think there might be times where a subcommittee is very appropriate to dig into something, get the ball rolling, bring it back to the Board, et cetera. I just think the Board ought to be, it ought to be up to the purview of the Board how to attack an issue on behalf of the Board, but I could see times when a subcommittee might be useful.

DR. SCHWETZ: I would remind you that in the past we have also used members of the Board of Scientific Counselors to be part of a larger subcommittee, that we would bring together with specific expertise to deal with a question, whether it was review of a center or the Korn report kind of thing or if we wanted to have a group of people, when you think of the IOM reviewing the structure of NIH, I would hate to be in your shoes as a member of the Science Board and be assigned the task of reviewing the structure of the FDA. That could be a huge task.

On the other hand, if there are parts of this that you would like to take on, it sure would be helpful, even if it meant just getting your opinions without doing a huge amount of homework on it would be valuable.

DR. DOYLE: Another question that comes to mind is the issue of obesity, which is a big issue today as we read in the paper, and it would be interesting to know what FDA is doing in regard to this public health issue.

DR. SCHWETZ: This is an issue that I have personally taken up as one that I want to, and being in this position of being the ex-acting Commissioner, I'm fortunate to have time to be able to devote to this issue. So I have been working within the Agency to raise the level of attention to nutrition and overnutrition, and obesity, and what other things might be all a part of that package.
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