Whether it’s suspect scallions from Mexico or contaminated ingredients from China used in the blood thinner heparin, the FDA is intimately familiar with the daunting task of policing the safety of food and medical products faced by regulators abroad. The FDA is responsible for protecting American consumers from unsafe food, medicines, biologics, and medical products that originate from many different countries and are transported through complex supply chains. Almost 40 percent of the fruits and nuts and 85 percent of the seafood that Americans purchase come from abroad. More than 80 percent of active pharmaceutical ingredients are imported, and 40 percent of medicines are imported as finished products.
U.S. law requires drug manufactures to prove safety before the FDA permits sale of their products, however many regulatory agencies abroad lack the legal framework, funding, training, and oversight that have helped to transform the FDA into one of the world’s top-notch regulatory agencies. At the request of the FDA, the IOM formed a committee to identify the core elements of food, medicine, medical product, and biologics regulatory systems in developing countries; to pin-point the main gaps in these systems; and to design a strategy to leverage the expertise of the FDA and other stakeholders to strengthen regulatory systems abroad.
Watch the IOM committee discuss its report