Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad

367 Pages·2016·8.01 MB·English

This PDF is available from The National Academies Press at http://www.nap.edu/catalog.php?record_id=13296
Ensuring Safe Foods and Medical Products Through Stronger
Regulatory Systems Abroad
Jim E. Riviere and Gillian J. Buckley, Editors; Committee on Strengthening
ISBN
Core Elements of Regulatory Systems in Developing Countries; Board on
978-0-309-22408-6
Global Health; Board on Health Sciences Policy; Institute of Medicine
360 pages
6 x 9
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Copyright © National Academy of Sciences. All rights reserved.
Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad
Ensuring Safe Foods
and Medical Products
Through Stronger
Regulatory Systems Abroad
Committee on Strengthening Core Elements of Food and Drug
Regulatory Systems in Developing Countries
Board on Global Health and the Board on Health Science Policy
Jim E. Riviere and Gillian J. Buckley, Editors
Copyright © National Academy of Sciences. All rights reserved.
Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad
THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001
NOTICE: The project that is the subject of this report was approved by the Governing
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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 competences and with regard for appropriate balance.
This study was supported by Contract No. HHSF22301015T, TO #18 between the National
Academy of Sciences and the U.S. Food and Drug Administration. Any opinions, findings,
conclusions, or recommendations expressed in this publication are those of the author(s) and
do not necessarily reflect the view of the organizations or agencies that provided support for
this project.
International Standard Book Number-13: 978-0-309-22408-6
International Standard Book Number-10: 0-309-22408-X
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Suggested citation: IOM (Institute of Medicine). 2012. Ensuring Safe Foods and Medical
Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National
Academies Press.
Photo credits:
Front cover
©2007 Natalie Moraru, Courtesy of Photoshare
Back cover, from top to bottom
© 2009 Joydeep Mukherjee, Courtesy of Photoshare
© 2006 Morgan Rog, Courtesy of Photoshare
© 2009 Wendy Leonard, Courtesy of Photoshare
Copyright © National Academy of Sciences. All rights reserved.
Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad
“Knowing is not enough; we must apply.
Willing is not enough; we must do.”
—Goethe
Advising the Nation. Improving Health.
Copyright © National Academy of Sciences. All rights reserved.
Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad
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Copyright © National Academy of Sciences. All rights reserved.
Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad
COMMITTEE ON STRENGTHENING CORE ELEMENTS OF
REGULATORY SYSTEMS IN DEVELOPING COUNTRIES
JIM E. RIVIERE (Chair), Burroughs Wellcome Fund Distinguished
Professor of Pharmacology; Director, Center for Chemical Toxicology
Research and Pharmacokinetics, College of Veterinary Medicine,
North Carolina State University, Raleigh
THOMAS BOLLYKY, Senior Fellow, Global Health, Economics, and
Development, Council on Foreign Relations, Washington, DC
CORRIE BROWN, Josiah Meigs Distinguished Teaching Professor,
Department of Veterinary Pathology, College of Veterinary Medicine,
University of Georgia, Athens
MARTHA BRUMFIELD, President, Martha A. Brumfield, LLC,
New York, NY
ROBERT BUCHANAN, Professor and Director, Center for Food Safety
and Security Systems, University of Maryland, College Park
JAKE YUE CHEN, Director, Indiana Center for Systems Biology
and Personalized Medicine; Associate Professor, IUPUI School of
Informatics, Indianapolis
JUNSHI CHEN, Senior Research Professor, Chinese Center for Disease
Control and Prevention, Beijing
JANE HENNEY, Professor of Medicine, University of Cincinnati, Ohio
CARLOS M. MOREL, Director, Center for Technological Development
in Health, Oswaldo Cruz Foundation (Fiocruz), Rio de Janeiro, Brazil
CLARE NARROD, Research Scientist and Risk Analysis Program
Manager, University of Maryland, Joint Institute for Food Safety and
Applied Nutrition, College Park
ANDY STERGACHIS, Professor, Departments of Epidemiology and
Global Health; Adjunct Professor, Departments of Pharmacy and
Health Sciences; Director, Global Medicines Program, School of
Public Health, University of Washington, Seattle
PRASHANT YADAV, Director, Healthcare Research, William Davidson
Institute, University of Michigan, Ann Arbor
Consultants
HOWARD A. ZUCKER, Pediatric Cardiac Anesthesiologist, Albert
Einstein College of Medicine; Senior Advisor, Division of Global
Health and Human Rights, Massachusetts General Hospital
v
Copyright © National Academy of Sciences. All rights reserved.
Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad
NOEL GREIS, Director, Center for Logistics and Digital Strategy;
Co-Director, UNC-Tsinghua Center for Logistics and Enterprise
Development, Kenan Institute of Private Enterprise, Kenan-Flagler
Business School, University of North Carolina at Chapel Hill
Staff
GILLIAN BUCKLEY, Program Officer, Study Director
PATRICIA CUFF, Senior Program Officer
ANNE CLAIBORNE, Senior Program Officer
KENISHA PETERS, Research Associate
RACHEL TAYLOR, Research Associate
MEGAN GINIVAN, Research Assistant
KATHLEEN BURNS, Intern (January-February 2012)
GAELAN RITTER, Intern (January-May 2011)
ELIZABETH WELLS, Intern (June-August 2011)
YING ZHANG, Intern (December 2010-December 2011)
JULIE WILTSHIRE, Financial Associate
PATRICK W. KELLEY, Director, Boards on Global Health and African
Science Academy Development
vi
Copyright © National Academy of Sciences. All rights reserved.
Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad
Reviewers
This report has been reviewed in draft form by individuals chosen
for their diverse perspectives and technical expertise, in accordance with
procedures approved by the National Research Council’s Report Review
Committee. The purpose of this independent review is to provide candid
and critical comments that will assist the institution in making its published
report as sound as possible and to ensure that the report meets institutional
standards for objectivity, evidence, and responsiveness to the study charge.
The review comments and draft manuscript remain confidential to protect
the integrity of the deliberative process. We wish to thank the following
individuals for their review of this report:
Bonnie Buntain, University of Calgary, Faculty of Veterinary Medicine
Stephen R. Byrn, Purdue University, Department of Industrial and
Physical Pharmacy
Chi-Wan Chen, Pfizer Inc., Global CMC
Cyprian Devine-Perez, New York University, Langone Medical Center
Linda Dimitropoulos, RTI International
David Fidler, Indiana University Maurer School of Law
Katherine A. High, University of Pennsylvania School of Medicine,
Howard Hughes Medical Institute; Center for Cellular and
Molecular Therapeutics, The Children’s Hospital of Philadelphia
Ann Marie Kimball, Bill & Melinda Gates Foundation
John E. Lamb, Abt Associates Inc., International Economic Growth
Division
Glenn Morris, University of Florida, Emerging Pathogens Institute
vii
Copyright © National Academy of Sciences. All rights reserved.
Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad
viii REVIEWERS
Donald W. Schaffner, Rutgers, the State University of New Jersey,
Department of Food Science
Christine L. Taylor, National Institutes of Health, Office of Dietary
Supplements
Liz Wagstrom, National Pork Producers Council
Richard Whiting, Exponent, Inc., Chemical Regulation and Food
Safety Center
Although the reviewers listed above have provided many constructive
comments and suggestions, they were not asked to endorse the conclusions
or recommendations, nor did they see the final draft of the report before its
release. The review of this report was overseen by Marla E. Salmon, Dean
and Professor, School of Nursing, University of Washington; and Johanna
T. Dwyer, Professor, School of Medicine and Friedman School of Nutrition
Science & Policy, Tufts University. Appointed by the National Research
Council and the Institute of Medicine, they were responsible for making
certain that an independent examination of this report was carried out in
accordance with institutional procedures and that all review comments
were carefully considered. Responsibility for the final content of this report
rests entirely with the authoring committee and the institution.
Copyright © National Academy of Sciences. All rights reserved.
Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad
Foreword
A very high proportion of the seafood we eat comes from abroad,
mainly from China and Southeast Asia. Most of the active ingredients in
medicines we take originate in other countries. A substantial share of the
produce we consume is grown in Latin America. Many low- and middle-
income countries have lower labor costs and fewer and less-stringent envi-
ronmental regulations than the United States, making them attractive places
to produce food and chemical ingredients for export. The diversity and
scale of imports makes it impractical for U.S. Food and Drug Administra-
tion (FDA) border inspections to be sufficient to ensure product purity and
safety, and incidents such as American deaths due to adulterated heparin
imported from China propelled the problem to public awareness. Beyond
manufacturing shortcuts, substitutes, and errors, the American food and
drug supply can be a potential means for intentional harm, and the risk of
terrorism intensifies the need for high levels of interagency collaboration
across the FDA, Centers for Disease Control and Prevention, Department
of Agriculture, and Department of Homeland Security.
Domestic programs, however, regardless of how well they are coordi-
nated, will not be sufficient for the task. The integrated global economy
demands cooperation across borders—to thwart terrorists, reduce environ-
mental hazards, and ensure that our food and medical products are safe and
effective. This requires coordination across both industrialized trading part-
ners and emerging economies that have not had the benefit of decades of legal
and technical development to ensure the safety of food and medical products.
The Institute of Medicine Committee on Strengthening Core Elements
of Food and Drug Regulatory Systems in Developing Countries took up
ix
Copyright © National Academy of Sciences. All rights reserved.