The committee’s recommendations are informed by a perspective that shares much with the Department of Health and Human Services’ Global Health Strategy. The committee’s strategy had four main points: the primacy of global public health, the importance of risk-based investments, the usefulness of market incentives, and the necessity of international coordination. It recommended ways the Food and Drug Administration (FDA) can use limited resources for maximum effect. The committee was not asked to project the cost of these investments, nor did it have the proper data or suitable expertise to do so, but it recommended a path for the FDA to make the most of its limited resources and suggested other duties for other government agencies, international organizations, industry, and universities.

ENTERPRISE RISK MANAGEMENT AS A TOOL TO SET PRIORITIES

The value of enterprise risk management is central to the committee’s recommendations and to its strategy for strengthening the capacity of regulatory systems abroad. In order to set its priorities as an agency, the FDA needs to undertake an agency-wide risk assessment, risk analysis, and risk evaluation. This includes its capacity of building work. The committee recommends that the FDA choose which foreign offices to scale up, what topics to cover in trainings, and how to assign its staff using a scientific risk analysis.

Some aspects of the FDA’s governing plan seem informed by modern risk management. The agency has, for example, responded to globalization by putting offices in India, China, Chile, and Mexico. Other agency decisions, such as opening offices in Europe and the Middle East, seem on the surface less grounded in scientific risk analysis. Ultimately, the committee does not have access to the data that would inform the FDA’s risk assessment, risk analysis, and risk evaluation framework. The FDA is in the best position to undertake this project. The committee believes that the results of a risk analysis could help Congress increase appropriations to the FDA and give the agency latitude to shift its attention more to places outside of the United States where much of the world’s food and medical products are produced.

The committee is sensitive to the constraints the FDA’s limited budget puts on its work. Given the current climate in Congress and the international economic downturn it is unlikely that the FDA’s appropriations will increase dramatically in the near future. Because of its limited budget the FDA should consider working though existing networks, such as partnering with universities on training programs, and should use enterprise risk management to make the most of its modest budget.



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