The committee realizes that only the FDA has all the information necessary to rank its priorities, and it can best do this through enterprise risk management, dependent on quality data collected using modern information systems. Recommendations 6-1 and 6-2 address these needs. A full overhaul of the FDA informatics and information strategies will probably take a decade; reorganizing the FDA would also take a long time. However, the committee outlined steps toward these goals that can be met in the next 3 to 5 years. First among these is the use of enterprise risk management to allocate funding and staffing to the FDA’s foreign programs. Only over time, after Congressional approval, could the agency make similar adjustments to align its domestic actions with risk management principles. Similarly, the paperless information system envisioned in Recommendation 6-2 is probably at least 8 years away. But in the next 3 to 5 years, the FDA can identify a standardized vocabulary and data collection method to use in its international activities.

In general, building strong regulatory systems abroad will be a long process, and success will be incremental. However some steps of the recommendations put forth in Chapters 5 and 6 can be reached in the next 3 to 5 years. The committee sees these recommendations as practical steps the FDA can take to improve product safety worldwide. Therefore, in the next 3 to 5 years the FDA should:


1.   Join the regulatory authorities of the European Union, Canada, Japan, Norway, Iceland, Switzerland, Australia, and New Zealand in a working group on sharing inspections, making a plan for a system of mutual recognition of inspections to eliminate the wasteful duplication of work among similarly rigorous regulatory agencies (Recommendation 5-3).

2.   Work (as one of several U.S. government agencies charged in Recommendation 5-5) to strengthen pharmacovigilance and foodborne diseases surveillance systems in developing countries. The agency has technical depth in surveillance that it can channel to developing countries both directly and thorough World Health Organization (WHO) and Food and Agriculture Organization of the United Nations (FAO).

3.   Use enterprise risk management to focus its international programs, trainings, and offices (Recommendation 6-1).

4.   Develop an informatics strategy that will eventually allow the FDA to move to a paperless system and articulates a standard data format and vocabulary (Recommendation 6-2).

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