Industry News

FDA Announces Transformative New Global Strategy

June 22, 2011


On June 20, 2011, in response to surging imports of FDA-regulated goods and a rapidly evolving global trade environment, the U.S. Food and Drug Administration (FDA) released a report entitled,
Pathway to Global Product Safety and Quality,” revealing the FDA’s new global strategy. The report calls for the FDA to transform its business practices and to act globally to carry out its mission of promoting and protecting the health of U.S. consumers. According to the report, shipments of FDA-regulated goods, which stood at 6 million shipments a decade ago, are expected to quadruple to 24 million shipments this year. The FDA also expects imports of FDA-regulated products to triple between 2007 and 2015. Imports comprise nearly two-thirds of the fruits and vegetables consumed in the U.S. and 80 percent of the active pharmaceutical ingredients in medications sold in the U.S. The report further states that the FDA does not have the resources to adequately keep pace with the pressures of globalization.

The FDA tailored its transformation plan to address four major trends, including Western economies increasing their productivity to compete with emerging markets and economies, leading to more imports and increased pressure; money, goods, data and people increasingly and more quickly crossing borders; growing demand, constrained supply, and increased regulatory and social scrutiny that will determine resource uses and costs; and increasing calls on Governments worldwide to mitigate the negative impacts of globalization. The FDA hopes to address these trends by transforming its business practices to include greater use of global partnerships and coalitions, developing international data information systems and networks, building information gathering and analysis capabilities that focus on risk analytics and information technology, and leveraging the efforts of third parties and industry. In particular, the FDA report proposes four key changes to address the fundamental alterations to the economic and security landscape that have accompanied globalization:

  • The FDA will partner with its counterparts worldwide to create global coalitions of regulators focused on ensuring and improving global product safety and quality
  • 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
  • The FDA will build in additional information gathering and analysis capabilities with an increased focus on risk analytics and information technology
  • The FDA increasingly will leverage the efforts of public and private third parties and industry and allocate FDA resources based on risk