DRAFT Agenda 01/25/05

FOOD AND DRUG ADMINISTRATION

TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES

ADVISORY COMMITTEE

February 8, 2005

Hilton Hotel

8727 Colesville Road

Silver Spring, MD

8:00 a.m. Administrative Remarks (10’)

8:10 Opening Remarks

Chairperson (10’)

8:30 Informational Presentation

Update on BSE surveillance in the U.S. (10’) Lisa Ferguson, DVM, USDA

8:55

8:40 Topic # 1 - Possible vCJD Risk from Investigational Coagulation Factor XI Manufactured in the 1990’s from Plasma of Donors Residing in the United Kingdom

A. Introduction (10’) M. Weinstein, Ph.D., OBRR, FDA

B. Elements of TSE risk assessments and risk assessment for

U.K. FXI (45’) S. Anderson, Ph.D., OBE, FDA

C. Current public health recommendations on management of surgical instruments used on patients with TSE or TSE risk (10’) Lynne Sehulster, Ph.D., CDC

9:45 Open public hearing (15’)

10:00 Committee Discussion and Vote (40’)

10:40 Break (20’)

11:00 Topic # 2 – Risk Assessment Models for Potential Risk of Exposure to variant Creutzfeldt-Jakob Disease (vCJD) Agent in Plasma Products

A. Introduction – rationale for risk assessments; question to committee (10’) D. Scott, M.D., OBRR, FDA

B. Risk Assessment – U.K. plasma derivatives

Risk assessment methods and assumptions and U.K. actions based on risk assessment (40’) Kate Soldan, Ph.D., and Anna Molesworth, MSc, U.K. Health Protection Agency

C. Preliminary Risk Assessment – U.S.

i. Potential TSE clearance steps in U.S. products - FVIII, FIX, IGIV (10’) D. Scott, M.D., OBRR, FDA

ii. Risk Assessment Model for U.S. plasma derivatives (40’) Steve Anderson, Ph.D., OBE, FDA

12:40 Questions for speakers (10’)

12:50 Lunch

1:50 Open Public Hearing (40’)

2:30 p.m. Committee Discussion and Vote (45’)

3:15 Break

3:25 Topic # 3 – Potential Deferral of Blood and Plasma Donors for History of Transfusion in European Countries

A. Introduction (10’) A. Williams, Ph.D., OBRR, FDA

B. Epidemiology of vCJD in France and risk assessments for blood and plasma derivatives (25’) Dr. Jean-Philippe Brandel, Neurologist, Epidemiosurveillance Network

C. Estimates of blood-borne vCJD risk in the U.K. and other European populations (20’) Sheila M. Bird, M.A., Ph.D, Medical Research Council Biostatistics Unit, Institute of Public Health, Cambridge University, UK

D. Risks and benefits of deferring donors transfused in France and other European countries: potential impact on blood and plasma supplies, and presentation of question for the committee (20’) A. Williams, Ph.D.

4:40 Open public hearing (20’)

5:00 Committee Discussion and Vote (35’)

5:35 p.m. Adjourn