U.S. Food and Drug Administration
Performance Plan
2002
Increase the safety of imported products.
|
Increase the number of foreign inspections. Expand import coverage for all medical products. |
FDA is responsible for ensuring the safety of over 6 million import line entries (imported products) that cross our borders annually. The sources of these entries are diversifying and include more products from countries that are typically categorized as emerging economies, with emerging regulatory infrastructures. FDA conducts sampling and end point product testing as a means of determining that imported products have been properly produced.
Sampling and testing of imported products cannot be relied on as the only method of confirming that the products were manufactured in conformance with Good Manufacturing Practices (GMPs).
The Agency's foreign inspection program is an important part of attaining confidence that all imported products meet the same standards as domestic goods.
FDA will:
FDA continues efforts on the International Trade Data System (ITDS) initiative, intended to create an important electronic link to Customs, by which FDA can more effectively and efficiently decide which import entries can proceed and those for which we want to take samples or other administrative actions. When fully implemented, ITDS will establish a standard data set and a "single window" clearance mechanism for cargo, conveyance and crew. ITDS will increase public health by improving compliance with regulatory requirements, reduce the cost and burden of processing international trade transactions, and provide access to accurate and timely statistical international trade data and information."
Inspections and import surveillance are the primary means of assuring the safety of marketed products. Consumers rely on the FDA to prevent dangerous and unreliable products from entering into commerce. Public safety and confidence could be jeopardized by a failure to increase surveillance activities.
Products may enter the U.S. through one of approximately 300 Customs ports located throughout the country. While the FDA continues to undertake initiatives to improve import coverage, there is no substitute for physically examining products.
FDA's inspection force is attempting to monitor a regulated industry in an environment that has changed rapidly and become significantly more complex over the past several years. Contributing to this change have been the growth in international trade leading to a tripling of imports during the past 10 years; much more technologically complex and diverse products both domestically and inter- nationally; and increasing use of the Internet by industry to develop, produce, distribute and market their products.
Despite a decrease in the overall number of inspections, FDA's foreign inspection program continues to be one of the Agency's top priorities as more FDA regulated products originate from foreign sources. FDA conducted 880 foreign inspections in FY 2000, which represented a 12 percent increase over FY 1999. For FY 2001, approximately 1,100 foreign inspections are planned.
Imports of all FDA regulated products have been increasing over the last several years, however, FDA has only about 150 field investigators and inspectors assigned to import operations to review entry documents, determine product admissibility, collect samples, and conduct investigations. For FY 2000, FDA physically examined less than one percent of all entries offered for import into the United States.