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FOOD AND DRUG ADMINISTRATION


TRANSMISSIBLE SPONGIFORM

ENCEPHALOPHATHIES

ADVISORY COMMITTEE

October 25, 2001


Holiday Inn

8777 Georgia Avenue

Silver Spring, Maryland


Reported and Transcribed by:

CASET Associates, Ltd.

10201 Lee Highway

Fairfax, Virginia 22030

(703) 352-0091

PARTICIPANTS

Freas, William, PhD, Exec. Sec.

Bolton, David C. PhD, Chairman

Members

Belay, Ermias D. MD

Cliver, Dean O., PhD

DeArmond, Stephen J., MD, PhD

Ewenstein, Bruce M. MD, PhD

Ferguson, Lisa A., DVM

Gambetti, Pierluigi, MD

Lurie, Peter G. MD

McCullough, J. Jeffrey, MD

Piccardo, Pedro, MD

Priola, Suzette A, PhD

Williams, Elizabeth S. DVM, PhD

Walker, Shirley Jean, Consumer Rep.

Petteway, Stephen R., Jr., PhD

Consultants

William C. Blackwelder

Paul Brown, MD

Lester M. Crawford, Jr., DVM, PhD

Susan F. Leitman, MD

George Nemo, PhD

Raymond P. Roos, MD

David Stroncek, MD


CONTENTS


PAGE


Administrative Remarks - William Freas, MD. Exec. Sec. 1


Opening Remarks - David Bolton, PhD, Committee Chairman 6


TOPIC 1. FDA's Draft Guidance on Revised Preventive Measures to Reduce the Possible Risk of Transmission of

Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-

Jakob Disease (vCJD) by Blood and Blood Products

(published in the Federal Register on August 29, 2001,

http://www.fda.gov/cber/gdins/cjdvcjd.htm)


Topic Overview - Dr. Dorothy Scott, MD, OBRR, FDA 7

Update: Current State of the Blood Monitoring Project

and Plans to Extend Monitoring to the Supply of Plasma

Derivatives and their Recombinant Analogs

Stephen D. Nightingale, MD, Exec. Sec., DHHS Advisory

Committee on Blood Safety and Availability 26

Update: Dhhs Meeting held on September 24, 2001

Stephen D. Nightingale, MD 50


Update: Anticipated Implementation of New Donor

Deferral Policies

Celso Bianco, MD, Exec. VP, America's Blood Centers 55


Ms. Jacquelyn Fredrick, Senior VP, Biomedical Services

and COO Donor Enterprise Unit, American Red Cross 62


Robert Jones, MD, President, New York Blood Center 68


G. Michael Fitzpatrick, PhD, Col. MS, USA, Director

Armed Services Blood Program Office 73


Open Public Hearing 81


Committee Discussion 87


TOPIC 2: Discussion of Amino Acid Sourcing and

Production and the Theoretical Risk of Transmission

of the BSE Agent Through Their Use in Biopharmaceutical

Products


Topic Introduction and Overview

Dr. Gerald Feldman, OTRR, CBER 105

Degussa-Rexim's Amino Acid Production Process

Mr. Gerard Richet

R&D Director, Deputy Plan Manger

Degussa-Rexim, France 124


Ajinomoto's Amino Acid Production Process

Mr. Mike McLean, Quality Assurance Director, NC Plant 137


Open Session - Open Public Hearing 144


Committee Discussion and Votes 151

P R O C E E D I N G S 8:05 AM

DR. FREAS: Mr. Chairman, members of the Committee, invited guests, public participants, I would like to welcome you to this, our tenth meeting of the Transmissible Spongiform Encephalopathies Advisory Committee.

I am Bill Freas, the Executive Secretary for this Committee. Both days of this meeting will be open to the public with the exception of one short closed committee session around lunchtime today.

As stated in the Federal Register this session will be closed to the public in order for the manufacturers to present trade secret and confidential information to the Committee.

After this short closed presentation the rest of the meeting today and all of tomorrow will be open to the public.

At this time I would like to go around and introduce the members seated at the head table. Will the members please raise their hands as the name is called?

Starting on the right-hand side of the room, that is the audience's right, the first chair is occupied by Dr. Raymond Roos, Chairman, Department of Neurology, University of Chicago.

Next is a standing Committee member, Dr. Bruce Ewenstein, Director, Boston Hemophilia Center, Brigham and Women's Hospital.

Next is a standing Committee member, Dr. Pedro Piccardo, associate professor, Indiana University School of Medicine.

Next is a temporary voting member, Dr. Lester Crawford, Executive Director, Association of American Veterinary Medical Colleges, Washington, D.C.

Next is a standing Committee member, Dr. Ermias Belay, medical epidemiologist, Centers for Disease Control and Prevention.

Next is a standing Committee member, Dr. Elizabeth Williams, professor, Department of Veterinary Service, University of Wyoming.

Next is a temporary voting member, Dr. George Nemo, Chief, Blood Resources Section, Division of Blood Diseases and Resources, National Heart, Lung and Blood Institute.

At the front of the table is a standing Committee member, Dr. Pierluigi Gambetti, Professor and Director, Division of Neuropathy, Case Western Reserve.

Next is an chair where we will soon be joined by Dr. William Blackwelder, biostatistical consultant, Biologics Consulting Group, Alexandria, Virginia.

Next is a temporary voting member and also a representative from FDA's Blood Product Advisory Committee, Dr. David Stroncek, Chief, Laboratory Service Section, Department of Transfusion Medicine, NIH.

Next is the Chairman of this Committee, Dr. David Bolton, head of the Laboratory of Molecular Structure and Function, New York State Institute for Basic Research.

At the corner of the table is a standing Committee member, Dr. Peter Lurie, a medical researcher for Public Citizen's Health Research Group, Washington, D.C.

Around the corner is a standing Committee member, Dr. Stephen DeArmond, professor, Department of Pathology, University of California, San Francisco.

In the empty seat we will soon be joined by Shirley Walker, our consumer representative for today, Vice President of the Health and Human Services, Dallas Urban League.

The next occupied seat is a standing Committee member, Dr. Suzette Priola, investigator, Laboratory of Persistent and Viral Diseases, Rocky Mountain Laboratories, and the next empty seat we should be joined later today by Dr. Paul Brown, Medical Director, Laboratory of Central Nervous System Studies, National Institute of Neurological Disorders and Strokes.

Next is a standing Committee member, Dr. Jeffrey McCullough, professor, Department of Laboratory Medicine and Pathology, University of Minnesota.

Next is a temporary voting member for today, Dr. Susan Leitman, Chief, Blood Services Section, Department of Transfusion Medicine, NIH.

Next is a standing Committee member, Dr. Dean Cliver, professor, School of Veterinary Medicine, University of California at Davis.

Next is a standing Committee member, Dr. Lisa Ferguson, Senior Staff Veterinarian, US Department of Agriculture.

Next is our industry representative, Dr. Stephen Petteway, Director of Pathogen Safety and Research, Bayer Corporation.

There were two Committee members who could not be with us today. They are Dr. Donald Burke and Dr. John Bailar.

I would like to thank everybody else for coming, and I would now like to read the conflict of interest statement into the public record.

The following announcement is made part of the public record to preclude even the appearance of a conflict of interest at this meeting.

Pursuant to the authority granted under the Committee charter, the Director, Center for Biologics Evaluation and Research has appointed, Drs. Paul Brown, William Blackwelder, Lester Crawford, Susan Leitman, George Nemo, Raymond Roos and David Stroncek as temporary voting members for this meeting.

Based on the agenda made available it has been determined that the agenda addresses general matters only.

General matters waivers have been approved by the agency for all members of the TSE Advisory Committee as well as consultants to this meeting.

The general nature of the matters to be discussed by the Committee will not have a unique and distinct effect on any of the matters, personal or imputed, financial interests.

Dr. Stephen Petteway is serving as a non-voting industry representative for this Committee. He is employed by Bayer and thus he has interests as employers and other regulated firms.

In addition, listed on the agenda are speakers making industry presentations. These speakers are employed by industry and thus have interests in their employers and other regulated firms.

The speakers for topic 1 were invited to present their comments on the implementation of new donor deferral policies and the speakers for topic 2 were invited to talk about their company's manufacturing or production processes.

All Committee discussions are general matters discussions only.

In the event that discussions involve specific products or specific firms in which the FDA participants have a financial interest the participants are aware of the need to exclude themselves from these discussions, and their exclusion will be noted in the public record.

A copy of the waivers is available by written request under the Freedom of Information Act.

With respect to all other meeting participants we ask in the interest of fairness that they address any current or previous financial involvement with any firm whose product they may wish to comment upon.

So ends the reading of the conflict of interest statement.

Dr. Bolton, I turn the meeting over to you.

DR. BOLTON: Thank you, Dr. Freas. I have very few remarks this morning. I would like to thank all the Committee members for returning after our epic meeting in June. You are congratulated for surviving that ordeal, and I would, also, like to thank all the industry representatives and those members of the public who are at the meeting today.

We have a very relaxed schedule for this meeting as opposed to our last meeting and one clear indication of that is that Bill told me that he left the timer out. So, I think we will be able to have free discussion and still be able to do a reasonable job of meeting our agenda targets.

With that I think we should begin. Our first topic today is the FDA's draft guidance on revised preventative measures to reduce the possible risk of transmission of Creutzfeldt-Jakob disease and variant Creutzfeldt-Jakob disease by blood and blood products as published in the Federal Register August 29, 2001, and our first speaker is Dr. Dorothy Scott who will give the topic overview.

Dorothy?

DR. SCOTT: Good morning. I think I will be presenting the results of all your hard work from the last long session that we had.

For the first topic I am going to review the FDA draft guidance entitled Revised Preventive Measures to Reduce the Possible Risk of Transmission of CJD and vCJD by blood and blood products.

This was issued on August 27, of this year. Just to very briefly let you know what the previous guidance said with regard to donor deferrals, the previous guidance recommended deferral of donor who had vCJD or CJD, risk factors for classical CJD as listed here and a geographic donor deferral for BSE exposure risk and this was for travel or residence in the United Kingdom for a cumulative period of 6 months or more between 1980 and 1996, or injection of bovine insulin that may have been sourced in the UK.

Since the 1999 guidance there has been an increasing rate of the vCJD epidemic in the United Kingdom. This appears to continue statistically speaking. There has been an increased BSE epidemic detected in Europe. that is

more countries have been identified with BSE and more cattle in some countries have been identified.

So, in some cases it is difficult to say that the epidemic is decreasing there. There was the often cited sheep transfusion transmission of BSE. So far we only know that one sheep had a transmission. However, the experiment is ongoing, and that particular report was a very preliminary report. So, we wait to see if more sheep come down with BSE, and finally there has been a continued scientific uncertainty as to whether variant CJD can be transmitted by human blood.

So, all of this triggered the question whether we needed additional donor deferrals if they can be tolerated for risk of vCJD.

This Committee considered increased donor deferrals for vCJD risk, that is BSE exposure at the last meeting as I am sure you remember. You weighed the risk of shortage of blood and the need for precautionary measures against each other, and I just wanted to point out some of the aspects of this that make the whole decision-making process for many donor deferrals so difficult.

The long incubation period of TSEs in general in humans and presumably vCJD although we don't know that, when we see epidemiological studies that are variable that might assure us that transmission with vCJD by human blood is unlikely, if transmission is possible, however, deferrals have current importance and it would be useful to implement them now instead of to wait for this evidence to come to light.

Studies on the infectivity of vCJD food are, also, quite limited to date. There are certainly a number of experiments ongoing, but we don't have those results.

Formerly as you saw in the last meeting blood shortages are considered possible if longstanding deferrals are recommended.

So, you considered options for donor deferrals at the last meeting, and the options that you voted for were incorporated into the FDA draft guidance that was issued.

The new donor deferrals which I will review in a minute decrease the total risk based upon exposure to BSE by about 90 percent and a 5 percent donor loss is anticipated for blood based on the web survey data that Alan Williams presented last time.

I just want to highlight a couple of aspects of the guidance for you in addition to the donor deferrals. I will go through each of these, the first, implementation of the donor deferrals, pilot studies that are recommended for more stringent donor deferrals than the FDA recommended deferrals, the distinction that we are drawing between blood and plasma for the European donor deferral and finally a little bit about blood supply monitoring, but you are going to hear a lot more about that after I speak.

There are two phases recommended in the draft guidance for donor deferrals, Phase I and Phase II, and these will be implemented at different times.

Phase I, May 31, 2002 is the proposed data, and Phase II by October 31, 2002, and the purpose of this is to attempt to attenuate any impact of a sudden large deferral on the blood supply.

So, the first set of deferrals is for residents in the UK for 3 months and more between 1980 and 1996. I will talk about that 1996 time period next because the Committee had some questions about that last time.
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