Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad

302 Pages·2012·6.08 MB·English

by  Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries

Ensuring Safe Foods and Medical Products
Through Stronger Regulatory Systems
Abroad

THE NATIONAL ACADEMIES PRESS
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 Regulatory Systems in Developing
Countries

Board on Global Health

Board on Health Sciences 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
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NOTICE: The project that is the subject of this report was approved by the Governing Board of the
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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.

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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.

Copyright © National Academy of Sciences. All rights reserved.
Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad

Copyright © National Academy of Sciences. All rights reserved.
Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad

The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in
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The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent
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government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is
president of the Institute of Medicine.
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National Research Council.

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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, NC
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, 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, MD
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
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
ANNE CLAIBORNE, Senior Program Officer
PATRICIA CUFF, 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

v
Copyright © National Academy of Sciences. All rights reserved.
Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad

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
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.

vii
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 environmental
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 Administration (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 coordinated, will not be
sufficient for the task. The integrated global economy demands cooperation across borders—to
thwart terrorists, reduce environmental hazards, and ensure that our food and medical products
are safe and effective. This requires coordination across both industrialized trading partners 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 Regulatory
Systems in Developing Countries took up the vital task of helping the FDA to cope with the
reality that so much of the food, drugs, biologics, and medical products consumed in the United
States originate in countries with less-robust regulatory systems. This report describes ways the
United States can help strengthen regulatory systems in low- and middle-income countries and
promote cross-border partnerships—including government, industry, and academia—to foster
regulatory science and build a core of regulatory professionals. The committee’s report
emphasizes an array of practical approaches to ensure sound regulatory practices in today’s inter-
connected world.

I am very grateful to the committee and to the staff who developed this report and hope
that the insights, ideas, and recommendations offered here will enable residents in the United
States and in other countries to benefit from safer food and medicine.

Harvey V. Fineberg, M.D., Ph.D.
President, Institute of Medicine
viii

Copyright © National Academy of Sciences. All rights reserved.
Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad
Contents

Summary 1
1 Introduction 11
2 Core Elements of Regulatory Systems 29
3 Critical Issues 69
4 A Strategy to Building Food and Medical Product Regulatory Systems 126
5 International Action 142
6 Domestic Action 165
7 Conclusions and Priorities 199

Appendixes
A Glossary 205
B A Review of Tort Liability’s Role in Food and Medical Product Regulation 213
C Food and Medical Product Regulatory Systems of South Africa, Brazil, 228
India, and China

D Chinese Food Regulatory System 232

E Meeting Agendas 245

F Committee Member Biographies 264

G Analyzing Food Safety Alerts in European Union Rapid Alerts Systems for 271
Food and Feed

H Strengthening Core Elements of Regulatory Systems in Developing Countries: 285
Identifying Priorities and an Appropriate Role for the U.S. Food and Drug
Administration
ix

Copyright © National Academy of Sciences. All rights reserved.