Dr. Riviere is the CVM Distinguished Professor of Pharmacology and the Director of the Center for Chemical Toxicology Research and Pharmacokinetics. He chairs the Institute on Medicine of the National Academies Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries.
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 http://nationalacademies.org.