The report outlining the strategy, called “Pathway to Global Product Safety and Quality,” says the FDA will partner with its counterparts worldwide to establish global coalitions of regulators focused on ensuring and improving global product safety and quality. In addition, the report notes the coalitions of regulators will establish international data information systems and networks and increase the regular and proactive sharing of data and regulatory resources across world markets.
As part of the strategy, the FDA will build in additional information gathering and analysis capabilities with an increased focus on risk analytics and information technology. Also, the FDA will increasingly leverage the efforts of public and private third-parties and industry and allocate FDA resources based on risk.
“Global production of FDA-regulated goods has exploded over the past ten years,” said Margaret A. Hamburg, commissioner of food and drugs. “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. There has been a perfect storm — more products, more manufacturers, more countries and more access. A dramatic change in strategy must be implemented.”
Overall, the change of strategy is designed to address global trends that are expected to be influential in coming years. These trends include western economies increasing productivity to compete with emerging markets, resulting in more imports and increased pressure to change manufacturing processes. Other trends include money, goods, data and people increasingly and more quickly crossing borders. Growing demand, constrained supply and increased regulatory and social scrutiny will determine what resources are used and how they are used. Finally, global governments will be expected to mitigate the negative impacts of globalization for citizens, thus making the operating environment for companies more complex.
“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. The FDA must further collaborate and leverage in order to close the gap between our import levels and our regulatory resources. This report is an important step in ensuring we are able to fulfill our critical public health mission.”