focus on accountability of those involved in the food enterprise from farm to table, and accompanying national authorities’ regulatory capacity and systems to set standards and to help assure that accountability. This global shift suggests that the FDA’s leadership in developing risk-based approaches and preventive controls in support of food safety could contribute to new, normative global standards to be adopted through a multitude of networks, partnerships, and information-sharing venues.

In the case of medical products, drug falsification is growing in complexity, scale, geographic scope, and negative public health impact. Data limitations prevent public health policy makers from addressing adequately the issues surrounding falsified medicines in a comprehensive, systematic, and sustainable way. Increasing international trade of pharmaceuticals and sales via the Internet has further facilitated the entry of falsified products into the normal supply chain. Combating falsified medicines requires collaboration at national, regional, and international levels, involving a diverse range of stakeholders.

Equally important, strengthening regulatory capacity in the developing world will reap tremendous benefits for the health and quality of life of individuals and communities in those countries. Stronger regulatory systems in other countries can help to bolster current U.S. government (USG) investments being made in public health and development, e.g., through the President’s Global Health Initiative and USG agencies, as well as U.S. contributions through multilateral organizations, and the broader global health and development community. These efforts increasingly embrace the principles of health systems strengthening, government ownership, and universal coverage. Regulatory frameworks, authorities, and institutions need to be seen as central to these efforts in assuring the safety and quality of food and medical products, and in securing the full benefits of those investments; and networks of regulators need to be linked to the broader global health community. Good regulation that assures the quality and safety of food and medical products is as fundamental to the success of a health system as is the quality of any other components of a health system.

There is also much opportunity and need for greater efficiency and sustainable impact in complementing what has traditionally been a commodity-based approach with a systems approach to the FDA’s global engagement and what has been a traditionally ad hoc approach with what should be a sustainable, strategic approach. We need to explore the benefits and challenges of strengthening regulatory systems through dialogue and carefully delineated strategies that align well with the FDA’s mission and that allow us to partner with others, both in the regulatory arena and in the broader global health arena.



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