FDA to Step Up Inspections of Imported Products

Agency cites big increase in drugs, foods produced abroad

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MONDAY, June 20 (HealthDay News) -- The U.S. Food and Drug Administration announced Monday a new strategy to help ensure the safety and quality of imported drugs and food products.

The plan, which calls for coalitions of international regulators and increased data sharing, was created in response to rapidly rising imports of FDA-regulated products and a complex global supply chain. The strategy is outlined in a special report called the Pathway to Global Product Safety and Quality, the agency said in a news release.

"Global production of FDA-regulated goods has exploded over the past 10 years. In addition to an increase in imported finished products, manufacturers increasingly use imported materials and ingredients in their U.S. production facilities, making the distinction between domestic and imported products obsolete," FDA Commissioner Dr. Margaret A. Hamburg said in the news release. "There has been a perfect storm -- more products, more manufacturers, more countries and more access. A dramatic change in strategy must be implemented."

To protect the health of U.S. consumers, the FDA needs to modify the way it conducts business and to act globally, according to the report. This new approach includes four main elements:

• The FDA needs to team with counterparts worldwide to create international coalitions of regulators charged with improving and guaranteeing product quality and safety.
• These coalitions need to develop international information systems and networks and boost their sharing of data and regulatory resources.
• The FDA must improve its information gathering and analysis capabilities, with an increased emphasis on risk analysis.
• There will be increased FDA cooperation with industry, public and private groups, and the agency will allocate its resources based on risk.

The FDA said it's also expanding its food-safety efforts under the FDA Food Safety Modernization Act (FSMA). There will be new inspection mandates, including one to inspect more than 19,000 foreign-food facilities by the year 2016.

"FDA-regulated imports have quadrupled since 2000," Hamburg said. "The FDA and our global regulatory partners recognize this new reality and realize we must work proactively and collaboratively to address the challenges we face."

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SOURCE: U.S. Food and Drug Adminstration, news release, June 20, 2011

Last Updated: June 20, 2011

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