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Project Information

Project Information


Stronger Food and Drug Regulatory Systems Abroad


Project Scope:

The 2012 IOM report Ensuring Safe Food and Medical Products through Stronger Regulatory Systems Abroad put considerable emphasis on capacity building in developing countries as a means to improve the safety of food and drugs around the world. Recommendations called for building regulatory agencies in low- and middle-income countries; strengthening the scientific and technical underpinning for regulatory policy and action; increasing technical support for post-market surveillance; and placing regulatory systems in the global economic, development, and trade agenda. While progress has been made on these goals, the global regulatory landscape has changed significantly since 2012. It is therefore timely to assess progress made towards these goals and the current regulatory landscape. With this in mind, an ad hoc committee convened by the National Academies of Sciences, Engineering, and Medicine should: 

 

·       Assess how the challenges and opportunities facing regulators have changed since 2012 and  how technology and innovation effects their work;

 

·       Discuss the transition off donor aid and the capacity of regulatory systems to ensure the safety and quality of regulated products; the lack of post-market surveillance in many countries; and the challenges of regulating the informal medicines market;

 

·       Recommend ways to increase scientific robustness at food and drug regulatory agencies in low- and middle-income countries;

 

·       Identify concrete steps to raise visibility and increase investment in global food and drug safety as part of global health, development, and trade programming of the United States government and internationally, and;

 

·       Examine the priority given to food and drug regulatory systems in low- and middle-income countries and suggest ways to increase will for developing such systems at the national or regional levels.



Status: Current

PIN: HMD-BGH-18-06

Project Duration (months): 18 month(s)

RSO: Buckley, Gillian

Board(s)/Committee(s):

Board on Global Health

Topic(s):

Health and Medicine



Geographic Focus:

Committee Membership

Committee Post Date: 12/03/2018

Catherine E. Woteki - (Chair)
Catherine Woteki, Ph.D., R.D., is a professor in the Department of Food Science and Human Nutrition at Iowa State University. From 2010-2016, she served as chief scientist and Under Secretary for U.S. Department of Agriculture’s (USDA) Research, Education, and Economics mission area. In that role, she developed the Office of the Chief Scientist, established the USDA Science Council, and instituted the Department’s first scientific integrity and open data policies. She was called upon to lead scientific delegations to China and the first Meeting of Agricultural Chief Scientists held under the auspices of the G-20. Dr. Woteki is an advocate for building the platforms needed to enhance domestic and international food and agricultural research. Prior to joining USDA, Dr. Woteki served as Global Director of Scientific and Regulatory Affairs for Mars, Incorporated, where she managed the company's scientific policy on matters of health, nutrition, and food safety. From 2002-2005, she was Dean of Agriculture and Professor of Human Nutrition at Iowa State University, and also head of the Agricultural Experiment Station. Dr. Woteki served as the first Under Secretary for Food Safety at the USDA from 1997-2001, where she oversaw the safety of meat, poultry and egg products.
Lystra Antoine
Lystra Antoine, J.D., M.B.A., is dedicated to results-driven strategies to improve the human condition through safe, reliable and sustainable food systems, and joined the Global Food Safety Partnership (GFSP) as its chief executive officer in August 2016. Her top three priorities are to: (1) focus the GFSP to achieve its strategic objectives; (2) expand the awareness and involvement of key stakeholders; and (3) elevate the importance of food safety to achieve the Sustainable Development Goals. For four years prior to joining the GFSP, Lystra was the global director for DuPont Pioneer's sustainable agriculture development efforts and was responsible for designing and leading the implementation of agriculture development initiatives that helped smallholder farmers improve their livelihoods and increase their contribution to the value chain. Lystra spent sixteen years at the World Bank prior to joining DuPont. She holds an M.B.A. from SUNY Buffalo and a J.D. from Georgetown University Law Center.
Mikel Arriola
Mikel Arriola, J.D. M.P.P., LL.M., has a degree in law from the Universidad Anáhuac del Norte, Master in Public Policy and Public Administration from the London School of Economics and Political Science in London, England, as well as a Master of Laws from the University of Chicago, United States. His career has been developed mainly in the public sector. In 2002, he was Banrural's Contentious Coordinator.From 2003 to 2005 he worked at Financiera Rural where he held the positions of regulatory compliance manager and corporate deputy director of the General Directorate. In 2007 he joined the Ministry of Finance and Public Credit, institution in which he was advisor to the Secretary, General Director of Income Planning of the undersecretary of Revenue and, as of 2009 Head of the Tax Legislation Unit of the Undersecretary of Revenue. In March 2011 he was appointed Federal Commissioner for Protection against Health Risks of the Ministry of Health and in December 2012 his ratification was announced to continue to head the Cofepris. In February 2016, Mr. Arriola was appointed general director of the Mexican Institute of Social Security. Mr. Arriola also participated in the modification of the regulation of the General Health Law in the matter of advertising to take out of the air dozens of "miracle" products that promised to lose weight, giving guidelines to the Health Prevention Model against chronic-degenerative diseases.
Maria E. Bottazi
Maria Elena Bottazzi, Ph.D., is the associate dean of the National School of Tropical Medicine and co-section head and professor of Pediatrics (Tropical Medicine) and professor of Molecular Virology & Microbiology at Baylor College of Medicine in Houston, Texas. She is also a distinguished professor in the Department of Biology at Baylor University in Waco, Texas. Dr. Bottazzi is the co-director for Texas Children's Hospital Center for Vaccine Development a Product Development Partnership (PDP) at Baylor College of Medicine. Dr. Bottazzi is an internationally-recognized scientist with more than 18 years of experience in translational research and vaccine development for neglected tropical diseases. In addition, her major interest is in the role of vaccines as control tools integrated into international public health programs and initiatives. Dr. Bottazzi’s philosophy focuses on motivating and empowering peers and young generations of scientists building strong inter- and intra-relationships and positively contributing to scientific and global health effectiveness. Dr. Bottazzi is Editor in Chief of Current Tropical Medicine Reports, Springer, US and Associate Editor for Public Library of Science (PLoS) Neglected Tropical Disease Journal. Dr Bottazzi, has a bachelor degree in Microbiology and Clinical Chemistry from the National Autonomous University in Honduras, and a doctorate in Molecular Immunology and Experimental Pathology from the University of Florida. Her post-doctoral training in Cellular Biology was completed at University of Miami and Pennsylvania. Her academic tenure initiated at the George Washington University where she served for 11 years as associate professor and vice chair for administration in the Department of Microbiology, Immunology and Tropical Medicine.
Julie A. Caswell
Julie Caswell, M.S., Ph.D.,is a distinguished professor in the Department of Resource Economics at the University of Massachusetts Amherst. Her research focuses on understanding the operation of domestic and international food systems, with particular interest in the economics of food quality and labeling, especially for safety and nutrition, and international trade. Dr. Caswell is a fellow of the Agricultural and Applied Economics Association (AAEA) and she is a past-president of AAEA. She held a Fulbright Distinguished Lectureship at the University of Tuscia in Viterbo, Italy for April-June 2009. Dr. Caswell has served on the several National Academies committees in the United States, including chairing the committee that published Supplemental Nutrition Assistance Program: Examining the Evidence to Define Benefit Adequacy in 2013 and is currently serving on the Food and Nutrition Board. Dr. Caswell is senior associate dean for Education and Student Development in the College of Social and Behavioral Sciences at UMass Amherst. Dr. Caswell received her PhD jointly in Agricultural Economics and Economics from the University of Wisconsin–Madison.
Hudu Mogtari
Hudu Mogtari, M.B.A., is the former chief executive officer (CEO) of the Food and Drugs Authority (FDA) of Ghana. He holds an Executive MBA degree from the Ghana Institute of Management and Public Administration and a BSc Pharm from the University of Hacettepe in Ankara, Turkey. He was awarded a certificate in Strategic Management in Regulatory and Enforcement Agencies at the Harvard Kennedy School of Government. He also has training in Clinical Investigation by the Centre for Drug Evaluation and Research of the U.S. FDA, advanced training in Diabetes and Endocrinology at the Centre for Diabetes and Endocrinology in South Africa as well as training at the United States Pharmacopoeia. Mr. Mogtari has over 20 years’ experience as a pharmacist and he was the country manager for Eli Lilly prior to his appointment as the CEO of the FDA. Under his leadership the FDA has achieved ISO 17025 accreditation for its Drugs Physico-Chemical Laboratory. The FDA has also been designated as a Regional Centre of Regulatory Excellence in the area of Medicines Evaluation and Registration as well as Clinical Trials Oversight.
Clare Narrod
Clare Narrod, Ph.D., M.S., is the director of the Risk Analysis program at Joint Institute For Food Safety And Applied Nutrition (JIFSAN) and leads the monitoring and impact effort associated with the evaluation of JIFSAN's capacity building efforts. She received her Ph.D. in Energy Management and Environmental Policy in 1997 and a Master's Degree in International Development and Appropriate Technology both from the University of Pennsylvania. From 1998-2000 she served as an American Association for the Advancement of Science Risk Analysis fellow at USDA. Prior to coming to JIFSAN she worked at the International Food Policy Research Institute, the United States Department of Agriculture, and at the Food and Agriculture Organization. She has consulted for the World Bank and the Inter-American Institute for Cooperation on Agriculture. She has field experience in Brazil, China, Costa Rica, Ethiopia, Ghana, India, Indonesia, Kenya, Nigeria, Thailand, Mali, Mexico, Vietnam, and Zambia. She has taught in Colombia, China, India, Malaysia, Russia, and the US. She started her career in the government where she conducted and reviewed risk assessments and cost-benefit analyses of proposed and final rules for Agency clearance associated with reducing the risk of animal and plant diseases and improving food safety. In addition to her work at JIFSAN she is also a scientific advisory board member of the Institute for Food and Agricultural Literacy at UC Davis, World Food Center and on the board of directors for the Center for Foodborne Illness, Research & Prevention. In the past she has been a working group member on a Global Food Ethics Project at John Hopkins Berman Institute for Bioethics, a member of the expert panel for a Global Regulatory Competency and Curricula, and a consensus committee member on the Institute of Medicine’s study on "Strengthening Core Elements of Food Safety Regulatory Systems in Developing Countries."
Jonathan Quick
Jonathan Quick, M.D., M.P.H., is senior fellow emeritus at MSH, where he previously served as president and chief executive officer from 2004-2017. In January of 2017 he transitioned to the role of Senior Fellow. A family physician and health management specialist, Dr. Quick focuses on global health security. He is the author of The End of Epidemics: The Looming Threat to Humanity and How to Stop It. Dr. Quick was director of essential drugs and medicines policy at the World Health Organization from 1996 to 2003. Prior to that, he served with MSH as founding director of the drug management program/center for pharmaceutical management, then as a long-term advisor for the Afghanistan Health Sector Support Project and the Kenya Health Care Financing Project. He has worked in international health since 1978 and has carried out assignments in over 70 countries in Africa, Asia, Latin America, and the Middle East. He is the senior editor of Managing Drug Supply, co-author of the Financial Times Guide to Executive Health; and has written over 100 other books, articles, and chapters. He is on the faculty of Harvard Medical School Department of Global Health and Social Medicine and Boston University School of Public Health, and is a fellow of the Royal Society of Medicine. He has a first degree from Harvard University and an M.D., with distinction in research, and M.P.H. from the University of Rochester.
Joshua M. Sharfstein
Joshua Sharfstein, M.D., is vice dean for Public Health Practice and Community Engagement and professor of the Practice in Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health. He is also the director of the Bloomberg American Health Initiative. Previously, Dr. Sharfstein served as secretary of the Maryland Department of Health and Mental Hygiene, as principal deputy commissioner of the U.S. Food and Drug Administration, and as health commissioner of Baltimore City. In these positions, he pursued creative solutions to longstanding challenges, including drug overdose deaths, infant mortality, unsafe consumer products, and school failure. He is an elected member of the National Academy of Medicine and the National Academy of Public Administration.
Markus Taussig
Markus Taussig, D.B.A., is an associate professor in the Management and Global Business Department at Rutgers Business School. Previous to his doctoral studies in strategy at Harvard Business School, Markus lived in Vietnam for 11 years, where he researched development of that country’s nascent private sector for the World Bank, The Asia Foundation, and various bilateral aid organizations. His academic work on business strategy in developing countries has been published in the Strategic Management Journal, Journal of Law, Economics and Organization, Journal of International Business Studies, Journal of East Asian Studies and Business Horizons. His more recent work on strategies for increasing regulatory compliance in developing countries in the Academy of Management Journal and the American Political Science Review was funded by the Jameel Poverty Action Lab, World Bank, and National University of Singapore, and has received best paper awards from the Academy of Management’s Public and Non-Profit Division and the International Association for Chinese Management Research. He is currently working on follow up studies on regulatory compliance in Myanmar and Malaysia.
Raymond Wigenge
Raymond Wigenge, M.Sc., M.B.A., is a food technologist with over 25 years experience in food safety and regulation. He attained his M.Sc. in Food Science and Technology at Ghent University Belgium in 1997. He is also a holder of B.Sc. Food Science and Technology obtained at Sokoine University of Agriculture, Tanzania in 1989. Other academic qualifications include M.B.A. obtained in year 2013 at Eastern and Southern African Management Institute, Arusha, Tanzania and a diploma in animal production in 1980 in Mbeya Tanzania. Since 1982, he has been employed as a public servant and served in different capacities such as Livestock Extension Officer and agricultural tutor for three and half years. He has served in different roles, including: food control officer, chief food inspector, Zone Offices and Local Government Authority coordinator, and as director of Food Safety for the Tanzanian Food and Drug Authority (FDA). During his career, he developed food regulations and guidelines, conducted food inspections, and was engaged in developing and implementing the food safety control system in Tanzania. He led development of the draft national food safety policy. He also designed a system for surveillance and investigation of food borne diseases and acted as a key liaison between the Tanzania FDA and UN agencies such as FAO, WHO, the Codex Alimentarius Commission.
Veronika Wirtz
Veronika Wirtz, M.Sc., Ph.D., is an associate professor in the Department of Global Health at the Boston University School of Public Health, where she is also director of the World Health Organization Collaborating Center in Pharmaceutical Policy. Her research focuses on health system strengthening and policy and program evaluations of medicines access and utilization. She is a visiting professor of the National Institute of Public Health (INSP) in Mexico and coordinator of a student exchange program between the institutions of her affiliation. Her interest and expertise include medicines price analysis, generic medicines policies, quality use of medicines, access to medicines for non-communicable diseases and the role of the private sector to promote equitable access and efficient use of medicines in low and middle income countries. Between 2014 and 2016 she was the co-chair of The Lancet Commission on Essential Medicine Policies. From 2004 to 2012 she was researcher and lecturer at the National INSP in Mexico and a founding member and Head of the Medicines in Public Health Research Group which is a multi-disciplinary team of 15 experts in health economics, epidemiology, social science carrying out pharmaceutical policy analysis in Mexico and Latin America. Over the last years she has regularly taught short courses in Pharmacoepidemiology and Medicines Utilization Research at INSP in Mexico. She has worked as a technical adviser for various international organizations, among them the World Health Organization, the Pan American Health Organization, the Global Fund to fight AIDS, Tuberculosis and Malaria, the Bill and Melinda Gates Foundation, Alliance for Health Systems and Policy Research, Health Action International and the Ford Foundation. She has also worked with the Ministry of Health in Mexico on various program evaluations and capacity building initiatives. She published widely in international peer review journals such as The Lancet, British Medical Journal, World Health Organization Bulletin, Health Policy and Planning, Health Policy, Value in Health, Social Science and Medicine, Tropical Medicine and International Health. Since Fall 2016 she is associate editor of Health Systems & Reform, a leading journal publishing health system and policy research. She received her training as a pharmacist from Albert-Ludwigs-University in Freiburg, Germany and her Master in Clinical Pharmacy and Ph.D. from the University of London in the UK.
Prashant Yadav
Prashant Yadav, M.B.A., Ph.D., is a globally recognized scholar in the area of healthcare supply chains. He is the author of many peer-reviewed scientific publications and his work has also been featured in prominent print and broadcast media including The Economist, The Financial Times, Nature, and BBC. Outside academia, Dr. Yadav works closely with governments and global organizations in the area of policy and investment strategy design for healthcare supply chains. He currently works as Strategy Leader-Supply Chain at the Bill & Melinda Gates Foundation. Dr. Yadav serves on the advisory boards of many global organizations and social enterprises. He has been invited for expert testimony on the issue of medicine supply chains in the US Congress and legislative bodies in other countries. He was a Commissioner on the Lancet Commission on Essential Medicines and has been a member of multiple national Academy of Medicine Expert Committees. He was Chair of the Market Dynamics Advisory Group of the Global Fund to fight AIDS, TB and Malaria, Geneva and Co-chair of Procurement and Supply Chain Management at the Roll Back Malaria Partnership. Prashant’s research papers have been the recipient of the best paper awards from the Production and Operations Management Society, INFORMS, and other professional societies. He was inducted as a Chartered Fellow of the CILT in 2011. Before his current role, Dr. Yadav was vice president of healthcare at the William Davidson Institute at the University of Michigan and a faculty member at the Ross School of Business at the University of Michigan. Before that he was professor of Supply Chain Management at the MIT-Zaragoza International Logistics Program and a research affiliate at the MIT Center for Transportation and Logistics.

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Events



Location:

Keck Center
500 5th St NW, Washington, DC 20001
Event Type :  
Meeting

Description :   

The first meeting of the Committee Stronger Food and Drug Regulatory Systems Abroad will be held on January 8-9, 2019, at the National Academies' Keck Center, located at 500 5th Street NW, Washington, DC. At this meeting the committee will discuss the study and begin gathering data.

During the closed portions of the meeting, the committee will complete the bias and conflict of interest discussion, review the HMD study process, discuss the Statement of Task, and plan the next steps of the study.





If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Sarah Ann New
Contact Email:  snew@nas.edu
Contact Phone:  (202) 334-3956

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