FDA ANNOUNCES NEW GLOBAL STRATEGY

FDA Announces New Global Strategy to Ensure Safety of Imported Products

The Food and Drug Administration issued June 20 a report entitled Pathway to Global Product Safety and Quality that sets forth a new global strategy designed to meet the challenges posed by rapidly growing imports of FDA-regulated products and a complex global supply chain. The report calls for the agency to transform the way it conducts business and act globally in order to promote and protect the health of U.S. consumers. This transformation will be achieved by partnering with other government agencies around the world to create global coalitions of regulators focused on ensuring and improving global product safety and quality. The coalitions will in turn develop international data information systems and networks and increase the regular and proactive sharing of data and regulatory resources across world markets.

The FDA also intends to build in additional information gathering and analysis capabilities with an increased focus on risk analytics and information technology and will increasingly leverage the efforts of public and private third parties and industry and allocate FDA resources based on risk.

The FDA notes in a press release that this new strategic outlook addresses emerging trends and builds on changes already set in motion by the agency. The emerging trends include an increase in the productivity of Western economies to compete with emerging markets and economies, leading to more imports and increased pressure to reinvent manufacturing processes; an increase in the volume and speed of cross-border flows of money, goods, data and people; growing demand, constrained supply and increased regulatory and social scrutiny that will determine the usage patterns and cost of resources; and a call on governments to mitigate the sometimes negative impacts of globalization on their citizens, which will in turn make the operating environment for companies more complex. The FDA will also continue to partner with other federal agencies, U.S. states and nations across the world, and will look to Congress to provide additional tools for the agency to keep pace with globalization. The FDA notes that this process “will not be easy” and will require the agency to “engage all stakeholders in a process that will unfold over several years.”

The FDA has sought to expand its global outlook in recent years. For example, it increased by 27 percent the number of foreign drug manufacturing inspections performed between 2007 and 2009. The agency has also opened several international offices, has collaborated with regulators in the European Union and Australia on drug inspections, has worked to harmonize certain aspects of drug regulation via the International Conference on Harmonization, and joined the Pharmaceutica Inspection Cooperation/Scheme. The FDA also highlights in the press release its mission to broaden food safety efforts under the FDA Food Safety Modernization Act, which among other things requires the inspection of more than 19,000 foreign food facilities in 2016.

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