July 1, 2011

FDA Seeks to Expand its Role in the Global Marketplace


Summer 2011

Today the U.S. Food and Drug Administration ("FDA") released a report that sets forth a "new strategy" it claims is required to "meet the challenges posed by rapidly rising imports of FDA-regulated products and a complex global supply chain."

"Global production of FDA-regulated goods has exploded over the past ten years," said Commissioner of Food and Drugs Margaret A. Hamburg, M.D., in a statement. "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."

In its report, "Pathway to Global Product Safety and Quality," the FDA proposes a dramatic change in strategy, seeking to expand its reach globally. Key elements of the strategy include:

  1. The FDA will partner with its counterparts worldwide to create global coalitions of regulators focused on ensuring and improving global product safety and quality.
  2. The coalitions of regulators will develop international data information systems and networks, and increase the regular and proactive sharing of data and regulatory resources across world markets.
  3. The FDA will build-in additional information gathering and analysis capabilities with an increased focus on risk analytics and information technology.
  4. The FDA increasingly will leverage the efforts of public and private third parties and industry, and allocate FDA resources based on risk.

The FDA's new strategy expands its current role in the global marketplace. Within the last few years the FDA has increased the number of foreign drug manufacturing inspections and collaborated with the European Union and Australia on drug inspections. The FDA continues to work with global leaders on regulation of medical devices and the inspection of thousands of foreign food facilities.

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