Food Safety Counterterrorism Initiatives

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8:08 a.m.

Friday, October 25, 2002

5630 Fishers Lane

Room 1066

Rockville, Maryland


FDA Science Board

Robert Langer, Sc.D., Chair

Susan M. Bond, Executive Secretary

Martin Rosenberg, Ph.D.

Michael Patrick Doyle, Ph.D.

Robert Nerem, Ph.D.

Harold Davis, D.V.M., Ph.D.

Jim Riviere, D.V.M., Ph.D.

Josephine Grima, Ph.D.

Lester Crawford, D.V.M., Ph.D., FDA

Norris E. Alderson, Ph.D., FDA


Joseph Levitt, Esq.

Andrea Meyerhoff, M.D.

Margaret Miller, Ph.D.

Philip Noguchi, M.D.

Kathleen Uhl, M.D.

Susan Wood, Ph.D.

Janet Woodcock, M.D.

Kathryn Zoon, Ph.D.

Also Present:

Daniel Casciano, Ph.D.

David Feigal, M.D.

Steven Galson, M.D.

John Marzilli

Betsy Natz

Bernard Schwetz, D.V.M., Ph.D.

Stephen Sundlof, D.V.M., Ph.D.



Call to Order - Robert S. Langer, Sc.D.,

Science Board Chair 5

Introductory Remarks - Lester Crawford,

D.V.M., Ph.D., Deputy Commissioner, FDA 7

Introductory Remarks - Norris E. Alderson,

Ph.D., Senior Associate Commissioner for

Science and Health 13

Counterterrorism Initiatives at FDA - Andrea Meyerhoff, M.D., Director, Counterterrorism Programs, Office of the Commissioner 17

Food Safety - Counterterrorism Initiatives -

Joseph Levitt, Esq., Director, Center for

Food Safety and Applied Nutrition 38

Discussion - Science Board Members 66

Office of Cellular, Tissue, and Gene

Therapies (OCTGT)

- Kathryn Zoon, Ph.D., Director, Center

for Biologics Evaluation & Research

(CBER) 92

- Philip Noguchi, M.D., Director, OCTGT 107

Open Public Comment 156

Pregnancy Labeling/Research & Study Design on Medications Used by Pregnant Women

- Susan Wood, Ph.D., Director, Office of Women's

Health (OWH), Office of the Commissioner 164

- Margaret Miller, Ph.D., Manager, Science

Programs, OWH 178

- Kathleen Uhl, M.D., Medical Officer,

Pregnancy Labeling Team, CDER 171

Discussion - Science Board Members 192

C O N T E N T S (Continued)


Pharmaceutical cGMPs Initiative (Update)

- Janet Woodcock, M.D., Director, Center

for Drug Evaluation & Research (CDER) 234

Discussion - Science Board Members 257

Science Board Closing Remarks/Future

Direction 266


DR. LANGER: Good morning. My name is Bob Langer. We'll just call the meeting to order. I just want to make one announcement and then have people go around and introduce themselves.

The announcement is, if you looked at the original schedule that was posted, there's going to be one change. Dr. Lumpkin can't be here today. So the schedule will be--there's a new handout that people hopefully have, so there will probably be a little bit earlier break for lunch so people can eat more.

So, with that, why don't we start and we'll just go around and introduce ourselves.

DR. RIVIERE: Jim Riviere, North Carolina State University.

DR. LANGER: And you're a member of the Science Board.

DR. RIVIERE: Member of the Science Board.

DR. GRIMA: Josephine Grima. I'm the consumer representative for the Science Board. I am now with the National Marfan Foundation.

DR. NEREM: This is Bob Nerem. I'm from Georgia Tech, a member of the Science Board.

DR. DAVIS: Harold Davis from Amgen, member of the Science Board.

DR. ROSENBERG: Marty Rosenberg. I'm also a member of the Science Board, and I'm on sabbatical, teaching at the University of Wisconsin.

DR. DOYLE: I'm Mike Doyle with the University of Georgia, and I'm also a member of the Science Board.

DR. SCHWETZ: Bernard Schwetz, Senior Advisor for Science at the FDA.

DR. LANGER: I'm Bob Langer, Science Board. I'm from MIT.

DR. ALDERSON: I'm Norris Alderson, Senior Associate Commissioner for Science at FDA.

MS. BOND: Susan Bond, Executive Secretary to the Board.

MR. MARZILLI: I'm John Marzilli. I'm with the Office of Regulatory Affairs.

MR. LEVITT: I'm Joe Levitt, Center for Food Safety and Applied Nutrition, FDA.

DR. ZOON: Kathy Zoon, Director of Center for Biologics.

DR. CASCIANO: Dan Casciano, National Center for Toxicologic Research.

DR. SUNDLOF: Stephen Sundlof, Director of the Center for Veterinary Medicine.

DR. GALSON: Steve Galson. I'm the Deputy Director of the Center for Drug Evaluation and Research.

MS. NATZ: Betsy Natz. I'm with the Office of External Affairs.

DR. LANGER: Thank you all. I did want to make one other announcement. Kathy Zoon, who introduced herself a minute ago, was elected two weeks ago to the Institute of Medicine of the National Academy of Science.


DR. LANGER: Anyhow, with that, let's turn it to Dr. Crawford for introductory comments.

DR. CRAWFORD: Thank you, Dr. Langer.

We have four members of the Science Board that have served long, well, hard, and painfully who will be retiring from the Board. All of them have to be recognized, and must be, starting with Owen Fennema, Ed Scolnick; Rita Colwell actually has called from Stockholm. We can only imagine what she's doing in Stockholm. She may be trying to one-up Dr. Zoon. [Laughter.]

And, finally, the long-suffering but brilliant Chairman of the Science Board, Dr. Bob Langer, and all of you who are devotees of Time Magazine may recall on August 20, 2001, that our man Langer was featured. And there is a very large picture of him, which I'm going to embarrass him with, and it does not show a defective ocular situation. It shows him looking for the optimal drug delivery system, and it indicates some essentials which I am going to embarrass him with. You may not leave the room. It says he was born August 29, 1948, in Albany, New York. What got him started was a Gilbert chemistry set, which he received when he was 11 years old, that he still has and plays with most evenings. [Laughter.]

The turning point in his life was a post-doctoral fellowship with cancer researcher Judah Folkman, which took him off the chemical-engineering career track. And his modus operandi, he looks at problems upside down and inside out. And that's why he's so comfortable working with FDA.

So I have the honor of presenting the award, which I hope you will enjoy and hope you will open now. At the University of Georgia where I worked for about 20 years, we got a Gruen watch. This is a Gruen watch. This is a big one.


DR. LANGER: Thank you very much.

DR. CRAWFORD: Take a moment.

DR. LANGER: It's not going to blow up, I hope.


DR. LANGER: It does look a little something like a watch. Well, thank you very much.

DR. CRAWFORD: Well done.


DR. CRAWFORD: Now, at this point I would also like to announce the new Chair for the Science Board beginning with the term of January 1st of next year, and it will last longer than that, depending on his performance, Dr. Michael Doyle of the University of Georgia. Mike?


DR. CRAWFORD: All of us are a bit--we have a couple of changes to the program. First, Dr. Mark McClellan is unable to be here. As some of you know, he is still doing his White House duties as one of the three members of the Economic Council that advises the President on the nation's economy. Dr. McClellan will be sworn in probably on November 8th and will show up here, we all hope, and especially me, within a few minutes after that. His replacement at the White House--actually, that is his starting date, so we believe that things will happen at that point. He's already been confirmed by the Senate and, therefore, is called Commissioner Designate until President Bush swears him in.

Let it be said for the record that Dr. McClellan, if he does make it by November 8th, will be the youngest FDA Commissioner ever at the age of 39-plus, but 40-less. But if it goes as late as November 12th, David Kessler will still maintain that honor.


DR. CRAWFORD: So we're working with POTUS to get him sworn in before then because that is a notable distinction, and Dr. McClellan has begun his process of getting oriented to FDA, and we are all very, very impressed.

He has been our primary White House liaison during the time that I've been here, which is now eight months, and he will be very familiar with all of FDA's matters. Anyhow, I think it is going to be a little bit dangerous to orient him, and I'm trying not to be involved in that process because he's already oriented, I can assure you of that.

Now, one other thing we want to mention, and that is that Dr. Lumpkin is with Dr. McClellan and, therefore, both of them are unable to be here. If that makes sense to you, then I'd like to speak to you after this meeting. But big things are happening, so we had to take off--we had to change the program both to reflect Dr. McClellan's inability to make opening remarks and also for Mack's inability to talk about the CBER/CDER switch.

Dr. Lumpkin has been Chairman of the Implementation Team that has put that into place. I now have before me the recommended approach. This has been shared with CBER, and we are now in the process of discussing with them the fine-tuning of that.

Last night at the dinner, I discussed some aspects of that, and also the idea that there would be some other organizational considerations, and the Science Board, at least one of you and hopefully two or three, have agreed to form a subcommittee to look at future changes, and we may need a permanent subcommittee, Mr. Chairman and Mr. New Chairman. So we'll be looking forward to working with you on that. And this kind of input would be very useful to us for future changes.

So, with that, I will turn the meeting back over to Norris Alderson to make other comments, and I look forward to being with you until the lunch, where I have to also go to the White House. And I have not been told what it's about, so that's life.

DR. ALDERSON: Thank you, Dr. Crawford.

I would like to second Dr. Crawford's comments regarding Dr. Langer. It's been a real pleasure for me to work with Bob since I've been in this position, and I really appreciate, Bob, the guidance you've given us over that period.

As Les mentioned, we are in the process of getting four new Board members beginning in January. They've been selected. They're going through the clearance process, and as soon as they've made the clearance, we will be making an announcement of those individuals.

I do want to point out that the FDA Science Forum for 2003 has been scheduled. There are copies of the announcement outside on the table. It's scheduled for April 24th and 25th at the Washington Convention Center. We encourage Board members to attend that if they can.

This is one of the premier science activities of FDA. It's becoming of more significance in the science arena for FDA than ever before. Last year we had over 1,200 registered for it.

This year's theme will have three areas: one, risk management; second, novel science initiatives at FDA; and, third, public health initiatives post-9/11. So we think we've got an outstanding program planned with outstanding speakers, and we certainly encourage everyone to attend.

As a note of follow-up items to the April meeting, you'll remember we had considerable discussion regarding the development, or lack thereof, of antibiotics that is going on in the industry. Dr. Crawford is pursuing with us the additional time at the April meeting of this Board to pursue that further, and I'll be talking with many of you in the next few months about your view on how we need to address that as a program for the Science Board. But I just want to alert you to that.

That's all I have, and I think Sue has some administrative requirements she needs to tell everyone about.

MS. BOND: I have to make comments for the public record, if you'll bear with me here.

The following announcement addresses the conflict of interest with respect to this meeting and is made part of the record to preclude the appearance of such at the meeting. The Food and Drug Administration has prepared general matter waivers for Drs. Nerem, Davis, Grima, Riviere, Langer, Rosenberg, and Doyle. A copy of these waiver statements may be obtained by submitting a written request to the agency's Freedom of Information Office in the Parklawn Building, Room 12A30. The waivers permit them to participate in today's discussion of counterterrorism initiatives, the new CBER Office of Cellular, Tissue, and Gene Therapies, Pregnancy Labeling Study issues, and the agency's Pharmaceutical Manufacturing Initiative.

The topics of today's meeting are of broad applicability. Unlike issues before a committee in which a particular product is discussed, issues of broader applicability involve many industrial sponsors and academic institutions. The participating committee members have been screened for their financial interests as they apply to these general topics. Because the topics impact so many institutions, it is not prudent or practical to list all of them at this time.

We acknowledge there may be potential conflicts of interest where, because of the general nature of the discussion before the committee, these potential interests are mitigated.

Now, to the important other housekeeping things, just for the public we invite everybody to have coffee and Danish up in front of the room here. There are phones outside behind the guard station. The rest rooms are right outside the door. We'll be breaking for lunch--well, Bob will call the lunch. We may be breaking a little bit early. And there's a list of restaurants outside on the table for those of you that want to go somewhere.

Public comment will start at 1 o'clock, and remember to push the microphones on when you talk. And that's all.

DR. LANGER: Thank you very much.

So now I guess we're ready to start, and the first discussion will be counterterrorism initiatives at the FDA, and Andrea Meyerhoff is going to lead that.

DR. MEYERHOFF: Good morning. Thank you very much for asking me here today. Can you hear me?


DR. MEYERHOFF: Thanks. Good morning. I'll say again thank you very much for asking me here today. What I'd like to do is provide something of an overview of our counterterrorism programs and then--it went off and on here. I'll stay away from the microphone--and then present something of a sampling of scientific issues that have arisen in this area for the consideration of the Science Board.
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