Report at a Glance
U.S. Agencies Should Take Steps to Boost Developing Nations' Regulatory Capacity to Ensure That Imported Foods and Drugs Are Safe
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.