January 23, 2014

Strengthening Developing Nations’ Regulatory Capacity to Ensure That Imported Foods and Drugs Are Safe: Newly Released Report

IOM Committee meeting in Pretoria, South Africa

Andy Stergachis served on a committee of the Institute of Medicine on strengthening food and drug safety regulation in developing countries. The report of the committee, Ensuring Safe Foods and Medical Products through Stronger Regulatory Systems Abroad, was released on April 4, 2012. 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 the US.   The US FDA largely depends on inspections but as the volume of imports grows, the FDA cannot do this well without substantial improvement in the capacity of its counterpart agencies in emerging economies.  The committee found that many low- and middle-income nations do not have technologically advanced regulatory systems, which limits their oversight of food and drug safety.  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, including strengthening the surveillance systems in developing countries and assisting with capacity building and training.   The recommendations also urge the FDA and USDA to provide incentives for research and development of low-cost, appropriate fraud prevention, intervention, tracking, and verification technologies along the supply chain.