The rapidly increasing flow of foreign drugs into the United States is illustrated by the fact that nearly 40% of the drugs Americans take are made overseas, and about 80% of active pharmaceutical ingredients are imported. Approximately half of medical devices used in the United States also come from abroad. These foreign goods often follow complex paths through multi-step supply chains to reach the United States.
This dynamic is very evident in the U.S. trade with China. From 2007 to 2011, the number of shipments of FDA-regulated products from China increased by 62 percent. This represented a fundamental change in both the economic and security landscape, and, as a result, FDA is requesting a budget authority increase of $10 million to strengthen the safety of foods, drug products, and ingredients exported from China to the United States.
The increased budget would allow FDA to improve its food and drug inspection and analytical capabilities by increasing its presence in China with 16 inspectors, and by adding three U.S.-based analysts. The Agency currently has eight staff members working in China. They serve at posts established in 2008 and 2009 in Beijing, Shanghai, and Guangzhou. In addition to inspecting Chinese facilities that manufacture food and medical products for export to the United States, FDA will inspect sites of clinical trials. FDA will also conduct follow-up inspections to ensure that firms continue to manufacture food and medical products under safe conditions.