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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

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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-13: 978-0-309-22408-6 International Standard Book Number-10: 0-309-22408-X 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. 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

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“Knowing is not enough; we must apply. Willing is not enough; we must do.” — Goethe Advising the Nation. Improving Health.

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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 Acad- emy 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 engi- neers. 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 engineer- ing programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is presi- dent 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 Insti- tute 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 Sci- ences 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

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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

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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

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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

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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.

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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

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x FOREWORD 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 empha- sizes 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

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Acknowledgments This report is a product of the cooperation and contributions of many people. The committee and staff are especially grateful to Anton Bandy, Jim Banihashemi, Laura DeStefano, Sarah Ziegenhorn, Vilija Teel, and Joel Wu of the Institute of Medicine (IOM). We also thank Linda Meyers and Maria Oria of the IOM Food and Nutrition Board for their advice. We also appreciate the contributions Bill McLeod of the National Academies and Elisabeth Reese of the National Research Council made to this report. The committee’s overseas workshops went smoothly thanks to the warm hospitality of the Chinese Academy of Engineering, especially Yuan Min; the University of São Paulo School of Public Health, especially Viviane Jaremcrusk, Helena Ribeiro, and Carolina Cavanha de Azeredo Santos; the Academy of Science of South Africa, especially Roseanne Diab, Lebo Makgae, Phakamile Truth Mngadi, and Nthabiseng Toale; and the Public Health Foundation of India, especially Ramanan Laxminarayan, Srinath Reddy, Geetha Ramesh, Sunita Ramesh, and Susmita Roy. Hongtao Ren of the Chinese Embassy and Debapriya Dutta of the Indian Embassy helped the committee and staff plan their travel in China and India respectively. The following Food and Drug Administation (FDA) foreign staff also worked tirelessly to help the committee and IOM staff prepare for their overseas workshops: Beverly Corey, Dennis Doupnik, Zimei (Mandy) Fu, Christopher Hickey, WeiHua (Evid) Liu, Ana Maria Osorio, Bruce Ross, Brenda Uratani, and Lixia Wang. Many people kindly introduced the IOM staff to key speakers. They are particularly grateful to Bob Baker, Dai Ellis, Michael Gropp, Mat Heyman, Paul Young, and Chen Zu. xi

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xii ACKNOWLEDGMENTS The committee thanks all the speakers and moderators who participated in committee meetings, as well as others who provided information, input, and assistance. They include: Elaine Alexander, Claudio Poblete Amaro, Deborah Autor, Vani Bhambri Arora, Sunil Bahl, K.A. Balaji, Shabir Banoo, Sarah Barber, Sameer Barde, Arthur Bird, Carl-Maria Bohny, Kate Bond, James Browder, Regina Brown, Irene Chan, Wen Chang, Philip Chen, Gary Cheng, Jiayi Cheng, Qian Cheng, Nicholas Crisp, Robert Crookes, Sanjay Dave, Raymonde De Vries, Jose Luis Di Fabio, Ke Ding, Jagdish Dore, Albinus D’Sa, Raymond Dugas, Peter Karim Ben Embarek, Ernesto Enriquez, Gao Fang, Gerd Fleischer, Bernadette Franco, Xiao Geng, Débora Germano, Marc Gilkey, Carlos Alberto Goulart, Zhai Peng Gui, Rosane Cuber Guimarães, Qingwu Guo, Margaret Hamburg, Moazzem Hossain, Yinglian Hu, Rong Xiao Hua, Dennis Hudson, Ekopimo Okon Ibia, Anil Jauhri, Ghazala Javed, Arun Jha, Ding Jianhua, Zhang Jinghua, Loveleen Johri, Abhay Kadam, Greg Kalbaugh, Jincheng Kang, Sangeeta Kaul, Bi Kexin, C.B. Kotak, Don Kraemer, Michael Kravchuk, Pramod Kumar, Celestine Kumire, Hector Lazaneo, Li Lei, Sun Lei, David Leishman, Henry Leng, Yu Li, Derick Litthauer, Benny Liu, Patrick Lukulay, Mac Lumpkin, Maeve Magner, Onika Vig Mahajan, Lebo Makgae, Daniel Matlala Malose, R.M. Mandlik, Karen Midthun, Yuan Min, Henri A. Minnaar, Bejon Misra, M. Mitra, Neeraj Mohan, Lauro Moretto, Sana Mostaghim, Guo Nan, Kirti Narsai, Margareth Ndomondo-Sigonda, Skhumbuzo Ngozwana, Thanh Nguyen, Sergio Nishioka, Sarah Olembo, Adriana Valenzuela Palma, Janardan Panday, Ana Marisa Cordero Peña, Michael S. Pepper, Sylvia Pereira, Xu Yan Ping, Teizhinha de Jeusus Andreolli Pinto, Manuel Neto Pinto, Ajay Pitre, Amanda Poldi, Devendra Prasad, Rajeev Raizada, Raquel Ramilo, Ailton José Rebelo, Mike Robach, Chen Rui, S.K. Saxena, Nirupa Sen, D.G. Shah, Zuo Shuyan, Sarah Simons, G.N. Singh, Jasvir Singh, Ritambhara Singh, Rajinder Sood, Renato Spindel, John T. Sproul, Nick Starke, Gavin Steel, Marco Antonio Stephano, Silvia Storpirtis, Wei Sun, Pramod Swaich, Marta Taniwaki, Asit Tripathy, Pieter Truter, Mary Lou Valdez, Tarun Vij, Amelia Villar, Tanya Vogt, Liz Wagstrom, Sun Wei, Raymond Wigenge, Haiyan Xu, Lily Xu, Guo Xueping, Alice Yang, Steve Yang, Zhang Yi, Ji Yingping, Ma Yong, Worasuda Yoongthong, Li Yu, Penggui Zai, Jainkang (Jack) Zhang, Libin Zhao, Qiang Zheng, and Janette Zhou. The committee and staff thank the U.S. Food and Drug Administration for generously funding this study.

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Acronyms and Abbreviations ADR adverse drug reaction AFDO Association of Food and Drug Officials AMRH African Medicines Regulatory Harmonization Anvisa National Health Surveillance Agency (Brazil) AOAC Association of Official Analytic Communities APEC Asia Pacific Economic Cooperation APEDA Agricultural and Processed Food Products Export Authority API active pharmaceutical ingredient ASEAN Association of Southeast Asian Nations AUIBAR African Union Interafrican Bureau for Animal Resources BIO Biotechnology Industry Organization CDC Centers for Disease Control and Prevention CDSCO Central Drugs Standard Control Organization (India) CFSAN Center for Food Safety and Applied Nutrition COE Centers of Excellence CPSI Center for Science in the Public Interest CRADA Cooperative Research and Development Agreement DHS Department of Homeland Security DNA deoxyribonucleic acid DOE Department of Energy DOJ Department of Justice xiii

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xiv ACRONYMS AND ABBREVIATIONS EDQM European Directorate for the Quality of Medicines and Healthcare EFSA European Food Safety Authority EIC Export Inspection Council of India EMA European Medicines Agency EPA Environmental Protection Agency EU European Union EURASFF European Union’s Rapid Alert Systems for Food and Feed FAO Food and Agriculture Organization of the United Nations FBI Federal Bureau of Investigation FDA Food and Drug Administration FIAE Food Industry Association Executives FICCI Federation of Indian Chambers of Commerce and Industry FSMA FDA Food Safety Modernization Act FSSAI Food Safety and Standards Authority of India G20 The Group of 20 GAO Government Accountability Office GAP Good Agricultural Practices GHTF Global Harmonization Task Force GIZ Gesellschaft für Internationale Zusammenarbeit (Society for International Cooperation) GMP Good Manufacturing Practices GPhA Generic Pharmaceutical Association HACCP Hazard Analysis and Critical Control Points HIV human immunodeficiency virus HPV human papillomavirus HS Harmonized System Codes IAEA International Atomic Energy Agency IANPHI International Association of National Public Health Institutes IBA International Biopharmaceutical Association ICDRA International Conference of Drug Regulatory Authorities ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICMSF International Commission on Microbiological Specifications for Food IICA Inter-American Institute for Cooperation on Agriculture IPPC International Plant Protection Convention ISO International Organisation for Standardization

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xv ACRONYMS AND ABBREVIATIONS MCC Medicines Control Council of South Africa MDMA Medical Device Manufacturers Association MRA Medicines Regulatory Authority NEPAD New Partnership for Africa’s Development NMRA National Medicines Regulatory Authority OECD Organisation for Economic Co-operation and Development OIE World Organisation for Animal Health PAHO Pan American Health Organization PhRMA Pharmaceutical Research and Manufacturers of America PREDICT Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting SEAICRN Southeast Asia Infectious Disease Clinical Research Network SFDA State Food and Drug Administration (China) SIT sterile insect technique SPPA Strategic Partnership Program Agroterrorism SPS Sanitary and Phytosanitary Measures SPS Strengthening Pharmaceutical Systems SRA stringent regulatory authority TBT Technical Barriers to Trade TRIPS trade-related aspects of intellectual property rights UN United Nations UNICEF United Nations Children’s Fund UNIDO United Nations Industrial Development Organization USAID United States Agency for International Development USDA United States Department of Agriculture USP United States Pharmacopeia USTR United States Trade Representative WHO World Health Organization WTO World Trade Organization

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Contents Summary 1 1 Introduction 13 2 Core Elements of Regulatory Systems 33 3 Critical Issues 79 4 A Strategy to Building Food and Medical Product Regulatory Systems 147 5 International Action 165 6 Domestic Action 193 7 Conclusions and Priorities 235 Appendixes A Glossary 243 B A Review of Tort Liability’s Role in Food and Medical Product Regulation 253 C Food and Medical Product Regulatory Systems of South Africa, Brazil, India, and China 273 D Chinese Food Regulatory System 283 E Meeting Agendas 297 F Committee Member Biographies 319 G Analyzing Food Safety Alerts in European Union Rapid Alerts Systems for Food and Feed 329 H Strengthening Core Elements of Regulatory Systems in Developing Countries: Identifying Priorities and an Appropriate Role for the U.S. Food and Drug Administration 345 xvii

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