June 07, 2011 Articles

A Global Outlook: FDA's Shifting Strategies to Address the Safety of Imported Goods

By Una Young Kang

This year, nearly 20 million shipments of imported drugs, medical devices, food, and cosmetics are expected to flow into this country. See Margaret A. Hamburg, M.D., Comm'r of Food and Drugs, Speech at the Center for Strategic and International Studies: FDA and the American Public: The Safety of Foods and Medical Products in the Global Age (Feb. 4, 2010). This figure represents, among other things, 15–20 percent of all food now consumed in the United States, up to 40 percent of all drugs that are taken by Americans, and up to 80 percent of the active pharmaceutical ingredients in those drugs. See id. Products regulated by the Food and Drug Administration (FDA) are currently imported from more than 150 countries, with more than 130,000 importers of record, and from more than 300,000 foreign facilities. See id. Adding to the complexity is the lack of uniformity of regulatory standards and capacities of these countries. In addition, many imported products cannot be traced to a single foreign source because they are composed of a number of components, each of which may be sourced from a variety of different suppliers in different countries. See FDA's Foreign Drug Inspection Program: Weaknesses Place Americans at Risk: Hearing Before the H. Subcomm. on Oversight and Investigations, H. Comm. on Energy and Commerce, 110th Cong. (Apr. 22, 2008) (statement of Andrew C. von Eschenbach, M.D., Comm'r of Food and Drugs: Safety of Medical Products with Foreign Components) (noting that "[t]he complexity of products and their components grows alongside an industry that is dispersed and decentralized").

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