Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad PDF
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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 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 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 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 978-0-309-22408-6 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2012 by the National Academy of Sciences. All rights reserved. Printed in the United States of America 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 serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin. Front cover photograph credit: © 2007 Natalia Moraru, Courtesy of Photoshare Back cover photograph credits, from top to bottom: © 2009 Joydeep Mukherjee, Courtesy of Photoshare; © 2006 Morgan Rog, Courtesy of Photoshare; © 2009 Wendy Leonard, Courtesy of Photoshare 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 scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal 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. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council. www.national-academies.org 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 1 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 19 Appendixes A Glosary 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 Fod Regulatory System 232 E Meting Agendas 245 F Commite 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.
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