Working Group Releases Strategy to Ensure Import Safety

September 13, 2007
Pharmaceutical Technology Editors
ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration’s Interagency Working Group on Import Safety released a Strategic Framework based on a cost-effective, risk-based approach for ensuring the safety of products exported to the United States.

Washington, DC (Sept. 10)-The US Food and Drug Administration’s Interagency Working Group on Import Safety released a Strategic Framework based on a cost-effective, risk-based approach for ensuring the safety of products exported to the United States. Instead of assessing products at the border, the strategy recommends examining products’ entire life cycles. The strategy requires cooperation with foreign manufacturers to identify and mitigate risk during crucial parts of the production and distribution process.

The Strategic Framework follows several months of scandals involving contaminated products manufactured in China. The scandals prompted the US government to send a fact-finding team to China to address concerns about food and drug safety.

The Working Group aims to achieve continuous improvement in import safety by using the following six “building blocks”:

  • Advance a Common Vision

  • Increase Accountability, Enforcement, and Deterrence

  • Focus on Risk Over the Life Cycle of an Imported Product

  • Build Interoperable Systems

  • Foster a Culture of Collaboration

  • Promote Technological Innovation and New Science.

The building blocks recommend changes to the oversight process, including shared goals among federal agencies that promote import safety, better communication between parties in the global supply chain, and collaboration between government and industry.

The Framework says FDA has made 34 confidential arrangements with agencies in 17 countries to share approval, inspection, adverse-event, and emergency information about products manufactured in a partners’ territories. FDA currently has more than two such exchanges each day.

In a public statement, FDA Commissioner Andrew von Eschenbach strongly endorsed the Strategic Framework. He commended Health and Human Services Secretary Michael Leavitt for leading the Working Group and developing the Framework.

President Bush established the Working Group by executive order on July 18, 2007. The Working Group is charged with developing better ways to work with importers, manufacturers, and other governments to ensure the safety of imported products.

Related stories:

Senator Questions FDA’s Foreign Inspections (Aug. 16, 2007)

Asia Rises to Further Prominence in Global Pharmaceutical Market (Aug. 16, 2007)

China Takes Higher Initiative on Food and Drug Safety: Plans to Spend $1 Billion (Aug. 16, 2007)

FDA Suspends ORA Reforms and Field Laboratory Closures (Aug. 9, 2007)

US and China Plough through Food and Safety Dialogue

(Aug. 2, 2007)