BLOOD PRODUCTS
ADVISORY COMMITTEE
83nd Meeting – July 21, 2005
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, PhD, 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, FDA (15’)
-
Update on Safety of Albumin – Laurence
Landow, M.D., FDA (5’)
-
Summary of
June 2005 Workshop on Biological
Therapeutics for Rare Plasma Protein Disorders
– Mark Weinstein, Ph.D., FDA (10’)
-
Summary of July 2005 Workshop on Leukoreduction- Alan Williams, Ph.D.,
FDA (10’)
-
Update on West Nile Virus Guidance – Alan Williams,
PhD, FDA (10’)
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, MD, OBRR, FDA (15’)
B. Roche – Tom Clement (10’)
C. National Genetics
Institute – Dr. Richard Smith (10’)
10:15 a.m. BREAK
10:30 a.m. OPEN
PUBLIC HEARING
11:00 a.m. Open Committee Discussion
D. FDA
Perspective and Questions for the Committee
E. 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., FDA (10’)
B.
VZIG manufacture, potency
testing, and current supply status – D. Ambrosino, M.D., MPHBL (15’)
C.
Varicella Zoster Disease,
Indications for VZIG – P. La Russa, M.D., Columbia University (30’)
D.
VZIG licensure history
and clinical trials (FDA, Scott or Ko) (15’)
E.
ACIP Recommendations for
VZIG use – Mona Marin, M.D., CDC (10’)
F.
Vaccine trials,
correlates of protection, implications for donors of IGIV – Philip Krause,
M.D., FDA (10’)
2:30 p.m. OPEN
PUBLIC HEARING
3:00 p.m. Open
Committee Discussion
G. FDA Perspective and Questions for the Committee
H. 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 – Lawrence Landow, M.D., FDA (10’)
B.
Swedish Studies With
Dextran 1 – Ljungstrom M.D.(25’)
5:00 p.m. OPEN PUBLIC HEARING
5:30 p.m. Open
Committee Discussion
D.
FDA Perspective and Questions
for the Committee
6:30 p.m. Adjournment