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Committee to Study the Use of Advisory Committees - Food and Drug Administration Advisory Committees

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Like many other agencies of the federal government, the Food and Drug Administration (FDA) relies extensively on external advisory committees for independent scientific and technical advice. Recognizing that the existing advisory committee system is essentially sound, this volume recommends ways of enhancing the use of these committees in the evaluation of drugs, biological materials, and medical devices; strengthening the agencys management of the system; and increasing the accountability of the system to the public. In doing so, it examines and makes recommendations on such issues as the recruitment of committee members, the FDAs management of financial conflict of interest and intellectual bias among members, and the operations and management of the advisory committee system.

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title Food and Drug Administration Advisory Committees author - photo 1

title:Food and Drug Administration Advisory Committees
author:Rettig, Richard A.
publisher:National Academies Press
isbn10 | asin:0309048370
print isbn13:9780309048378
ebook isbn13:9780585085500
language:English
subjectInstitute of Medicine (U.S.).--Committee to Study the Use of Advisory Committees by the Food and Drug Administration, Public health advisory groups--United States--Evaluation.
publication date:1992
lcc:RA395.A3I56 1992eb
ddc:353.0077/8
subject:Institute of Medicine (U.S.).--Committee to Study the Use of Advisory Committees by the Food and Drug Administration, Public health advisory groups--United States--Evaluation.
Page i
Food and Drug Administration Advisory Committees
Committee To Study the Use of Advisory Committees by the Food and Drug Administration
Richard A. Rettig, Laurence E. Earley, and Richard A. Merrill, Editors
Division of Health Care Policy
Institute of Medicine
NATIONAL ACADEMY PRESS
Washington, D.C. 1992
Page ii
NATIONAL ACADEMY PRESS 2101 Constitution Avenue, N.W., Washington, DC 20418
NOTICE: The project that is the subject of this report was approved by the governing board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competencies and with regard to appropriate balance.
This report has been reviewed by a group other than the authors according to procedures approved by a report review committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.
The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this the Institute acts under both the Academy's 1863 congressional charter responsibility to be an advisor to the federal government and its own initiative in identifying issues of medical care, research, and education.
Support for this project was provided by the Food and Drug Administration pursuant to Contract No. 223-91-8050.
Library of Congress Catalog Card No. 92-62633
ISBN 0-309-04837-0
Copyright 1992 by the National Academy of Sciences. All rights reserved.
Printed in the United States of America
No part of this book may be reproduced by any mechanical, photographic, or electronic process, or in the form of a phonographic recording, nor may it be stored in a retrieval system, transmitted, or otherwise copied for public or private use, without written permission from the publisher, except for the purpose of official use by the United States government.
Additional copies of the report are available from:
National Academy Press
2101 Constitution Avenue, N.W.
Washington, DC 20418
B058
The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The image adopted as a logotype by the Institute of Medicine is based on a relief carving from ancient Greece, now held at the Staatlichemuseen in Berlin.
First Printing, October 1992
Second Printing, March 1993
Page iii
Committee to Study the Use of Advisory Committees by the Food and Drug Administration
LAURENCE E. EARLEY,*Chair, Francis C. Wood Professor of Medicine, Department of Medicine, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania
ROBERT S. ADLER, Associate Professor of Legal Studies, Graduate School of Business Administration, University of North Carolina, Chapel Hill, North Carolina
RICHARD A. BERMAN,* President, Howe Lewis International, New York, New York
RICHARD E. CLARK, Professor of Surgery, Allegheny General Hospital, Pittsburgh, Pennsylvania
DEBORAH COTTON, Harvard University School of Public Health, Boston, Massachusetts
J. RICHARD CROUT, President, Boehringer Mannheim Pharmaceuticals, Rockville, Maryland
CAROLYNE K. DAVIS,* National and International Health Care Advisor, Ernst & Young, Washington, D.C.
JORDAN U. GUTTERMAN, Professor and Chairman, Department of Clinical Immunology and Biological Therapy, M.D. Anderson Cancer Center, Houston, Texas
SHEILA JASANOFF, Professor and Chair, Department of Science and Technology Studies, Cornell University, Ithaca, New York
PAUL MEIER,* Professor of Statistics, University of Chicago, Chicago, Illinois
THOMAS C. MERIGAN, JR.,* Becker Professor of Medicine and Head, Division of Infectious Disease, Stanford University School of Medicine, Stanford, California
RICHARD A. MERRILL,* Daniel Caplin Professor of Law, University of Virginia School of Law, Charlottesville, Virginia
HARRY M. MEYER, JR., President, Medical Research Division, American Cyanamid Company, Pearl River, New York
FRANK E. SAMUEL, JR., Government Strategy Associates, Washington, D.C.
LOUIS E. UNDERWOOD, Professor of Pediatrics, University of North Carolina, Chapel Hill, North Carolina
Page iv
ALBERT P. WILLIAMS, The RAND Corporation, Santa Monica, California
JAMES B. WYNGAARDEN,* Associate Vice Chancellor for Health Affairs, Duke University, and Foreign Secretary, National Academy of Sciences and Institute of Medicine, Washington, D.C.
Study Staff
RICHARD A. RETTIG, Study Director
STANLEY W. AMMONS, JR. Program Officer
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