DEPARTMENT OF HEALTH
AND HUMAN SERVICES
FOOD AND DRUG
ADMINISTRATION
This transcript has
not been edited or corrected, but appears as received from the commercial
transcribing service. Accordingly the
Food and Drug Administration makes no representation as to its accuracy.
79th Meeting of:
BLOOD PRODUCTS
ADVISORY
COMMITTEE
March 18, 2004
Holiday Inn
2 Montgomery
Village Avenue
Gaithersburg, Maryland
Reported By:
CASET Associates
10201 Lee Highway, Suite
160
Fairfax, Virginia 22030
(703) 352-0091
TABLE OF CONTENTS
Page
Welcome, State of Conflict of Interest, Announcements 1
Open Committee
Discussion
Clinical Trials
for Licensing hepatitis B Immune Globulin Intravenous as Treatment to Prevent
HBV Liver Disease Following Liver Transplantation in HBV+ Recipients.
- Introduction and Background - Basil Golding, MD 6
- Presentation - Anna S. Lok, MD 11
Open Public Hearing 74
Open Committee
Discussion (Continued)
- FDA Current Thinking and Questions for Committee 99
- Committee
Discussion and Recommendations
Committee Updates:
- Current thinking on Variances to Address the 136
Specificity of Ortho HBsAg 3.0 Assays
- Gerardo Kaplan, PhD
- Summary of meeting of PHS Advisory Committee on 155
Blood Safety Availability - Jerry Holmberg,
MD
- Summary of Meeting of Transmissible Spongiform 163
Encephalopathies Advisory Committee Meeting
- David Asher, MC
- Current Thinking on Draft Guidance for Nucleic Acid 173
Testing for HIV and HCV: Testing, Product
Disposition
and Donor Deferral and Re-entry - Paul Mied,
PhD
- Current thinking on Final Guidance for Use of Nucleic 191
Aid Testing on Pooled and Individual Samples
from Donors
of Whole Blood and Blood Components to
Adequately and
Appropriately Reduce the Risk of
Transmission of HIV-1 and HCV -
Pradip Akolkar, PhD, Judy Ciaraldi, BS, MT
Open Committee
Discussion:
Supplemental
Testing for Human Immune Deficiency Virus
and Hepatitis C
Virus.
- Introduction and Background, Robin Biswas, MD 203
Indira Hewlett, PhD
- Performance of HIV and HCV Supplemental Assays
- Wendi Kuhnert, PhD 208
- Dale J. Hu, MD, MPH 224
- Susan Stramer, PhD 231
- Michael Busch, MD, PhD 255
Open Public Hearing 282
Open Committee Discussion 287
- Questions for the Committee
- Committee Discussion and Recommendations
COMMITTEE
MEMBERS:
KENRAD NELSON,
MD, Chair. Johns Hopkins
University, School of Hygiene and Public Health, Baltimore, Maryland
LINDA SMALLWOOD,
PhD, Executive Secretary.
CBER, FDA
PERLINE K.
MUCKELVENE, Committee Management Specialist. Scientific Advisors and Consultants Staff, CBER, FDA
JAMES R. ALLEN,
MD, MPH, American Social
Health Association, Research Triangle Park, North Carolina
CHARLOTTE
CUNNINGHAM-RUNDLES, MD, PhD, Mount
Sinai Medical Center, New York, New York
KENNETH DAVIS, JR,
MD, University of Cincinnati
Medical Center, Cincinnati, Ohio
DONNA M. DI
MICHELE, MD, Weill Medical
College and Graduate School of Medical Sciences, Cornell University, NY, New
York
SAMUEL DOPPELT,
MD, The Cambridge Hospital,
Cambridge, MA
JONATHAN GOLDSMITH,
MD, Immune Deficiency
Foundation, Towson, Maryland
HARVEY KLEIN, MD,
Magnuson Clinical Center,
NIH, Bethesda MD
SUMAN LAAL, PhD, New York University School of Medicine, NYC
JUDY LEW, MD, University of Florida, Gainesville, Florida
NON-VOTING INDUSTRY
REPRESENTATIVE.
MICHAEL STRONG,
PhD, BCLD, Puget Sound Blood
Ctr, Seattle WA
TEMPORARY VOTING
MEMBERS:
MARY CHAMBERLAND,
MD, MPH. NCID, CDC, Atlanta,
Georgia
LIANA HARVATH,
PhD, NHLBI, NIH, Bethesda,
Maryland
BLAINE F.
HOLLINGER, MD, Baylor
College of Medicine, Houston, Texas
JAY HOOFNAGLE,
MD, NIDDK, NIH, Bethesda,
Maryland
KATHARINE
KNOWLES, Health Information
Network, Seattle, WA
T. JAKE LIANG,
MD, NIDDK, NIH, Bethesda,
Maryland
JEANNE V. LINDEN,
MD, MPH, New York State
Department of Health, Albany, New York
DANIEL MC GEE,
PhD, Florida State
University, Tallahassee FL
KEITH C. QUIROLO,
MD, Children's Hospital and
Research Center at Oakland, Oakland, California
GEORGE B. SCHREIBER, ScD, Westat, Rockville, Maryland
DONNA S.
WHITTAKER, PhD, Lt. Colonel,
United States Army, Brooke Army Medical Service, Fort Sam Houston, Texas
P
R O C E E D I N G S (8:00 a.m.)
Agenda Item:
Welcome, Statement of Conflict of Interest, Announcements.
DR. SMALLWOOD: Good morning, and welcome to the 79th meeting of the Blood
Products Advisory Committee. I am Linda Smallwood, the executive secretary.
At this time, I will read the conflict of
interest statement regarding this meeting.
This announcement is part of the public record for the Blood Products
Advisory Committee meeting on March 18 and 19, 2004.
Pursuant to the authority granted under the
committee charter, the director of FDA's Center for Biologics Evaluation and
Research has appointed the following individuals as temporary voting members:
Drs. Mary Chamberland, Liana Harvath, Jay
Hoofnagle, Blaine Hollinger, Jake Liang, Jeanne Linden, Daniel McGee, Keith
Quirolo, George Shreiber, Donna Whittaker, and Ms. Katherine Knowles.
Based on the agenda, it has been determined
that there are no specific products being considered for approval at this
meeting.
The committee participants have been screened
for their financial interests. To
determine if any conflicts of interest existed, the agency reviewed the agenda
and all relevant financial interests reported by the leading participants.
The Food and Drug Administration has prepared
general matters waivers for the special government employees participating in
this meeting who required a waiver under Title XVIII, United States Code 208.
Because general topics impact on so many
entities, it is not prudent to recite all potential conflicts of interest at
they apply to each member.
FDA acknowledges that there may be potential
conflicts of interest but, because of the general nature of the discussions
before the committee, these potential conflicts are mitigated.
We would like to note for the record that
Dr. Michael Strong is participating in this meeting as the non-voting
industry representative, acting on behalf of the regulated industry.
Dr. Strong's appointment is not subject to
Title XVIII United States Code 208. He
is employed by Puget Sound Blood Center and, thus, has a financial interest in
his employer. He is also a researcher
for two firms that could be affected by the committee discussions.
In addition, in the interests of fairness,
FDA is disclosing that his employer, Puget Sound Blood Center, has associations
with regional hospitals and medical centers.
With regard to FDA's invited guests, the
agency has determined that the services of these guests are essential.
These are interests that are being made
public to allow meeting participants to objectively evaluate any presentations
and/or comments made by the guests.
For the discussions of topic one, related to
clinical trials for licensing hepatitis B immune globulin as a treatment to
prevent hepatitis B virus liver disease, Dr. Anna Lok is employed by the
University of Michigan Medical Center.
She is a researcher with the National
Institute of Diabetes and Digestive and Kidney Diseases, that collaborates with
NABI.
She also consults with, and is a scientific
advisor for two firms that could be affected by the committee discussions.
For the discussion of topic two, on the
effectiveness of supplemental testing, methodologies for human immune
deficiency virus, and hepatitis C virus, Dr. Susan Stramer is employed by
the American Red Cross, National Reference Laboratory of Infectious Disease.
She is a researcher, a scientific advisor,
and has financial interests in firms that could be affected by the discussions.
Dr. Wendi Kuhnert is employed by the CDC in
Atlanta, Georgia.
Dr. Michael Busch is employed by the Blood
Center of the Pacific. He is a
scientific advisor for firms that could be affected by the discussions. He also receives speaker and consulting fees
and is a principal investigator on contracts and grants with firms that could
be affected.