Date:  April 4, 2012



Agencies Should Take Steps to Boost Developing Nations'

Regulatory Capacity to Ensure That Imported Foods and Drugs Are Safe


WASHINGTON — Many low- and middle-income nations do not have technologically advanced regulatory systems, which limits their oversight of food and drug safety, says a new report from the Institute of Medicine.  The discovery of a counterfeit version of the cancer drug Avastin earlier this year underscores the challenges for U.S. regulators as imports increasingly dominate the American market.


The report recommends 13 steps that the U.S. Food and Drug Administration and other organizations can take over the next three to five years to bolster the safety systems in developing nations.  Partners in this effort include other federal agencies, international organizations, the regulated industries, and regulators in developing countries.   Recommended steps include encouraging the development of low-cost technologies to prevent fraud and assessing whether the pilot Secure Supply Chain program can be expanded.  The report also urges the regulatory agencies in developed nations and industry associations to devise ways to share inspection results and emphasizes the importance of donor investment in developing countries' regulatory systems.


More than 80 percent of active pharmaceutical ingredients and 40 percent of finished drugs come from abroad as does 85 percent of the seafood consumed in America, according to federal estimates.  Congress has charged FDA to inspect more foreign producers as the volume of imports grows, but given its modest budget, the agency cannot do its job well without substantial improvement in the capacity of its counterpart agencies in emerging economies, said the committee that wrote the report. 


The report urges FDA and its technologically advanced counterparts in the European Union, Canada, Japan, Norway, Iceland, Switzerland, Australia, and New Zealand to plan a system for mutual recognition of one another's inspections, which would eliminate the wasteful duplication of effort.  There is no need for American and European inspectors to examine the same facilities, especially when a vast number of facilities go uninspected, the committee said.  Industry associations also should work together to define a reliable way to share internal inspection results among their members within the next three years, the report adds.


FDA and other federal agencies, including the U.S. Department of Agriculture, U.S. Agency for International Development, and Centers for Disease Control and Prevention, should provide technical expertise, training, and tools to strengthen the surveillance systems in developing countries.  The agencies could provide this assistance directly or channel it through international organizations such as the World Health Organization, the report notes.  FDA and USDA also should provide incentives for businesses and academic groups to collaborate on developing inexpensive technologies that can be used in developing nations to prevent and detect fraud and provide tracking and verification of products along the supply chain. 


Noting the importance of international cooperation in building regulatory capacity in developing countries, the committee recommended that the U.S. government work with Mexico, the host of the next meeting of the G20 nations, to add food and medical product safety to the G20 agenda.  As an emerging manufacturing nation with a vigorous export economy, Mexico would be an ideal leader for a global initiative on food and medical product safety, the committee said.  


The FDA's pilot Secure Supply Chain program is a promising initiative that could help tighten control of the food and medical product supply chain, the report says.  The program rewards drug firms that can track their products from manufacture to market with expedited entry into the U.S. market.  FDA should evaluate the program after its pilot phase ends in 2014; if the program is successful, the agency should enlarge it to include more medical companies and expand it to food companies as well.


"The recommendations in this report represent the committee's consensus on how to best bridge the gaps in food and medical product regulatory systems in low- and middle-income countries," said committee chair Jim E. Riviere, Burroughs Wellcome Fund Distinguished Professor of Pharmacology and director, Center for Chemical Toxicology Research and Pharmacokinetics, College of Veterinary Medicine, North Carolina State University, Raleigh.  "These are multisectoral recommendations that involve action from a variety of stakeholders.  We believe that the changes we suggest could greatly improve the safety of food and medical products around the world." 


The report was sponsored by the Food and Drug Administration.  Established in 1970 under the charter of the National Academy of Sciences, the Institute of Medicine provides objective, evidence-based advice to policymakers, health professionals, the private sector, and the public.  The Institute of Medicine, National Academy of Sciences, National Academy of Engineering, and National Research Council together make up the independent, nonprofit National Academies.  For more information, visit or   A committee roster follows.




Christine Stencel, Senior Media Relations Officer

Shaquanna Shields, Media Relations Assistant

Office of News and Public Information

202-334-2138; e-mail


Copies of Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad are available from the National Academies Press; tel. 202-334-3313 or 1-800-624-6242 or on the Internet at  Additional information is available at Reporters may obtain a copy from the Office of News and Public Information (contacts listed above).

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Board on Global Health

Board on Health Sciences Policy

Food and Nutrition Board


Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries


Jim E. Riviere, D.V.M., Ph.D., D.Sc (chair)

Burroughs Wellcome Fund Distinguished Professor of Pharmacology, and


Center for Chemical Toxicology Research and Pharmacokinetics

College of Veterinary Medicine

North Carolina State University



Thomas Bollyky, J.D.

Senior Fellow

Global Health, Economics, and Development

Council on Foreign Relations

Washington, D.C.


Corrie Brown, D.V.M., Ph.D.

Joshia Meigs Distinguished Teaching Professor

Department of Veterinary Pathology
College of Veterinary Medicine
University of Georgia



Martha A. Brumfield, M.S., Ph.D.

Martha A. Brumfield LLC

New York City


Robert L. Buchanan, B.S., M.S., M.Phil., Ph.D.

Professor and Director
Center for Food Safety and Security Systems
University of Maryland

College Park


Jake Y. Chen, M.S., Ph.D.

Director and Associate Professor

Indiana Center for Systems Biology and Personalized Medicine

School of Informatics
Indiana University-Purdue University



Junshi Chen, M.D.

Senior Research Professor
Chinese Center for Disease Control and Prevention


Jane E. Henney, M.D.

Professor of Medicine
University of Cincinnati



Carlos M. Morel, M.D., Ph.D.

Center for Technological Development in Health
Oswaldo Cruz Foundation (Fiocruz)

Rio de Janeiro


Clare Narrod, M.S., Ph.D.

Research Scientist and Risk Analysis Program Manager

Joint Institute for Food Safety and Applied Nutrition

University of Maryland

College Park


Andy Stergachis, M.S., Ph.D.


Departments of Epidemiology and Global Health;

Adjunct Professor

Departments of Pharmacy and Health Sciences; and


Global Medicines Program
School of Public Health and Community Medicine

University of Washington



Prashant Yadav, M.B.A., Ph.D.


Healthcare Research

William Davidson Institute
University of Michigan

Ann Arbor





Gillian Buckley, Ph.D.

Study Director