Food and Drug
BLOOD PRODUCTS ADVISORY COMMITTEE
87th Meeting – July 13, 2006
The Committee listened to the following briefings
and updates: Dr. Jerry Holmberg presented an overview of the
May 2006 DHHS Advisory Committee on Blood Safety and Availability.
Dr. Sanjai Kumar summarized the July 12, 2006 FDA Workshop
on Testing for Malarial Infections in Blood Donors. Dr. James
Allen, Chairman, BPAC, presented an overview of the findings
of the Subcommittee Report of the Office of Blood Research
and Review Site Visit, Review of Intramural Research. Dr.
Jesse Goodman, Director, CBER, then commented on the report
and emphasized the importance of research at CBER, a science-led
organization. The updates were concluded by Dr. Maria Rios’
presentation on West Nile Virus.
FDA Review of Nabi Biopharmaceutical’s Hepatitis
B IGIV for Prevention of Recurrent HBV Disease after Orthotopic
Dr. Charles Maplethorpe introduced the topic
with questions for the Committee. He was followed by Nabi’s
presentation by Dr. Henrik Rasmussen. Following Dr. Rasmussen’s
presentation, Dr. Maplethorpe presented the FDA clinical review
of Nabi’s submission. This was followed by FDA’s
statistical review by Dr. Jessica Kim. During the Open Public
Hearing, Dr. Imagawa presented findings from the University
of California, Irvine and summarized written statements provided
by the Hepatitis B Foundation, Dr. Fung of Cleveland Clinic
and Dr. Sher of USC School of Medicine, and Dr. Pruett of
University of Virginia. Additionally, Lisa Tobin of the American
Liver Foundation and Jan Gyn, a liver transplant recipient,
addressed the Committee.
The Committee then discussed and voted on the
1. Please comment
on Nabi’s post hoc inclusion and exclusion criteria
for the classification of subjects as successes or failures
following HBIG administration in the setting of orthotopic
liver transplantation (OLT).
The Committee noted that there is a wide
difference of opinion between FDA and Nabi regarding which
patients should be considered successes, failures or excluded
from the study criteria. Several Committee members considered
FDA’s inclusion and exclusion criteria too stringent.
2. Given the observational nature
of the information provided, the data limitations (including
a priori definitions), and the lack of analysis plan, is
inference about the outcomes of Nabi’s HBIG administration
in this setting appropriate?
The Committee stated it was not possible
to comment on this question since FDA and Nabi failed
to reach agreement on which patient treatments could be
considered as successes, failures or should be excluded.
3. Do the submitted data from retrospective
chart reviews, an uncontrolled PK assessment and an open
label access program demonstrate efficacy of Hepatitis B
Immune Globulin (H) (HBIG) (Nabi-HBTM) for the OLT HBV immunoprophylaxis
The Committee voted on question 3, as follows:
9 yes votes, 2 no votes and 3 abstained. Several committee
members noted their difficulty in voting on this question
in the absence of resolution of the uncertainty concerning
the outcomes of treatment in the study patients.
Review of the Research Programs in the
Laboratory of Bacterial, Parasitic and Unconventional Agents,
Division of Emerging and Transfusion Transmitted Diseases,
OBRR, CBER (May 25, 2006)
An overview of CBER research in the context
of FDA’s critical path was provided by Dr. Carbone.
Dr. Atreya then presented an overview of OBRR’s regulatory
responsibilities and research programs. Subsequently, Dr.
Nakhasi provided an overview of the Division of Emerging and
Transfusion Transmitted Diseases research program and Dr.
Asher reviewed the Laboratory of Bacterial, Parasitic and
Unconventional Agents research, as well as his own research
program. Dr. Piccardo, Dr. Nakhasi, Dr. Duncan, Dr. Selvapandiyan,
Dr. Debrabant and Dr. Kumar then provided overviews of their
respective research programs.
The Committee then met in closed session to
discuss the site visit report of the investigators included
in the May 25, 2006 review.
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