BLOOD PRODUCTS
ADVISORY COMMITTEE
83rd Meeting
Gaithersburg,
MD 20877
Thursday, July 21, 2005
8:00 a.m. Welcome, Statement of Conflict of
Interest, Announcements
8:10 a.m. Committee Updates
-
Summary of May 2005
Meeting of the DHHS Advisory Committee on Blood Safety and Availability – Jerry
Holmberg, Ph.D., Executive
Secretary, Advisory Committee on Blood Safety and
Availability (10’)
-
Disseminated Intravascular Coagulation Associated with Acute
Hemoglobinemia Following Anti-D IGIV Administration for Idiopathic
Thrombocytopenic Purpura – Ann Gaines, Ph.D., OBE, FDA (15’)
-
Update on Safety of Albumin – Laurence
Landow, M.D., OBRR, FDA (5’)
-
Summary of
June 2005 Workshop on Biological
Therapeutics for Rare Plasma Protein Disorders
– Mark Weinstein, Ph.D., OBRR, FDA (10’)
-
Summary of July 2005 Workshop on Leukoreduction - Alan Williams,
Ph.D., OBRR, FDA (10’)
-
Update on West Nile Virus Guidance – Alan Williams,
Ph.D., Maria Rios, Ph.D., OBRR, FDA and CDR Matthew Kuehnert, Ph.D, CDC (15’)
9:30
a.m. Open Committee
Discussion
I.
Management of Donors and
Units that Test Positive for Hepatitis B Virus (HBV) DNA by Nucleic Acid Tests
(NAT)
A. Introduction and
Background – Robin Biswas, M.D., OBRR, FDA (15’)
B. HBV Seroconversion
Panel Results and HBV NAT Positive/Serology Negative Donors - Larry Pietrelli,
Roche Molecular Diagnostics (10’)
C. Temporal
Association of HBV NAT and HBsAg Reactivity in Prospectively Screened Source
Plasma Donations and Retrospectively Screened Seroconversion Panels – Richard
Smith, Ph.D., National Genetics Institute (10’)
D. Window Period
Detection of HBV with the Procleix Ultrio Assay – Larry Mimms, Ph.D., Gen-Probe
(10’)
10:15 a.m. BREAK
10:30 a.m. OPEN
PUBLIC HEARING
11:00 a.m. Open Committee Discussion
E. FDA
Perspective and Questions for the Committee
F. Committee
Discussion and Recommendations
12:00 p.m. LUNCH
1:00 p.m.
II.
Scientific Basis for
Review of Varicella Zoster Immune Globulin
A.
Background – Dorothy Scott,
M.D., OBRR, FDA (15’)
B.
VZIG Manufacture, Potency
Testing and Current Supply Status – Donna Ambrosino, M.D., MPHBL; Catherine A.
Hay, Ph.D, MPHBL (15’)
C.
Severe Varicella Zoster
Disease, Correlates of Protection and Post-Exposure Prophylaxis Options – Philip
La Russa, M.D., Professor Clinical Pediatrics, Columbia University (45’)
D.
Advisory Committee for
Immunization Practices Recommendations for Post-Exposure Prophylaxis of Severe
Varicella Infections – Mona Marin, M.D., Medical Epidemiologist, National Immunization
Program, Center for Disease Control (15’)
2:30 p.m. OPEN
PUBLIC HEARING
3:00 p.m. Open
Committee Discussion
E. FDA Perspective and Questions for the Committee
F. Committee Discussion and Recommendations
3:45 p.m. Break
4:00 p.m.
III.
Dextran
1 Pre-treatment For Safe Use of Dextran 40/70
A.
Introduction and
Background – Laurence Landow, M.D., OBRR, FDA (10’)
B.
Prevention of Adverse
Reactions to Dextran –
Karl-Gösta Ljungström M.D., Ph.D., Consultant Vascular
Surgeon, Associate Professor of Surgery, Karolinska Institute, Department of
Surgery, Danderyd Hospital, Sweden (25’)
5:00 p.m. OPEN
PUBLIC HEARING
5:30 p.m. Open
Committee Discussion
C.
FDA Perspective and Questions
for the Committee
6:30 p.m. Adjournment