Global production of food and other goods regulated by the US Food and Drug Administration has skyrocketed over the past decade so much so that the distinction between domestic and imported products is now obsolete, according to Commissioner of Food and Drugs Margaret A. Hamburg, M.D.
"There has been a perfect storm - more products, more manufacturers, more countries and more access. A dramatic change in strategy must be implemented," she said last week, as the FDA unveiled a new strategy to meet the challenges posed by rapidly rising imports of FDA-regulated products and a complex global supply chain.
The strategy, outlined in a report called the Pathway to Global Product Safety and Quality, calls for the agency to transform the way it conducts business and to act globally in order to promote and protect the health of the nation's consumers. For example, the FDA says it will:
partner with its counterparts worldwide to create global coalitions of regulators focused on ensuring and improving global product safety and quality. These 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.
build in additional information gathering and analysis capabilities with an increased focus on risk analytics and information technology.
leverage the efforts of public and private third parties and industry and allocate FDA resources based on risk.
augment changes already set in motion. For instance, between 2007 and 2009, the FDA increased the number of foreign drug manufacturing inspections by 27 percent and has opened a series of international offices in key locations. FDA has also collaborated with its counterparts in the European Union and Australia on drug inspections, worked to integrate certain aspects of drug regulation via the International Conference on Harmonization and joined the Pharmaceutical Inspection Cooperation/Scheme (PIC/S) which is an organization of the drug manufacturing inspectorates from 39 countries. The FDA and other global leaders are also creating an expanded global regulators forum for medical devices.
broaden its food safety efforts under the FDA Food Safety Modernization Act (FSMA). This new law creates a new foods safety system, in which FDA has a legislative mandate to require comprehensive preventive controls across the food supply chain and has new tools to hold players in the supply chain responsible. There are also new inspection mandates, including a mandate leading to the inspection of more than 19,000 foreign food facilities in the year 2016.
These new initiatives will enable the FDA to better address fundamental global shifts that are on the horizon. In particular, the agency says it is preparing for these worldwide trends:
Western economies will increase their productivity to compete with emerging markets and economies, leading to more imports and increased pressure to reinvent manufacturing processes.
Money, goods, data and people will increasingly and more quickly cross borders. Today, a typical U.S. manufacturing company relies on more than 35 different contract manufacturers around the world.
Growing demand, constrained supply, and increased regulatory and social scrutiny will determine what resources are used, how they are used, and the cost. Manufacturers will adopt new manufacturing processes and emerging technologies in response.
Governments worldwide will increasingly be called upon to mitigate the sometimes negative impacts of globalization on their citizens, making the operating environment for companies more complex.
"FDA regulated imports have quadrupled since 2000," Commissioner 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."
