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- Current Thinking on Draft Guidance for Nucleic Acid 173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

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

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.