|International Action||Recommendation 5-1: In the next 3 to 5 years, international and intergovernmental organizations should invest more in strengthening the capacity of regulatory systems in developing countries. The United States should work with interested countries to add it to the G20 agenda. Investments in international food and medical product safety should be a significant and explicitly tracked priority at development banks, regional economic communities, and public health institutions. International organizations should provide assistance to achieve meaningful participation of developing country representatives at international harmonization and standardization meetings.|
|Recommendation 5-2: In emerging economies, national regulatory authorities, regulated industry, and industry associations should engage in open and regular dialogue to exchange scientific and technical information before policies are written and after they are implemented. Starting in the next 3 to 5 years, these regulatory authorities should identify third parties, such as science academies, to convene the three pillars of a regulatory system—government, industry, and academia—in ongoing discussion to advance regulatory science, policy, and training.|
|Recommendation 5-3: Countries with stringent regulatory agencies should, within the next 18 months, convene a technical working group on sharing inspection reports with the longer-term goal of establishing a system for mutual recognition of inspection reports.|
|Recommendation 5-4: Industry associations should, over the next 3 years, define an acceptable protocol for sharing of internal inspection results among their members. After agreeing on the methods, they should regularly share their results among their members.|
|Recommendation 5-5: Starting in the next 5 years USAID, FDA, CDC, and USDA should provide (both directly and through WHO and FAO) technical support for strengthening surveillance systems in developing countries. This technical support could include development and sharing of surveillance tools, protocols for foodborne disease surveillance and post market surveillance of medical products, and training of national regulatory authority staff and national experts.|
|Domestic Action||Recommendation 6-1: The FDA should use enterprise risk management to inform its inspection, training, regulatory cooperation, and surveillance efforts. Enterprise risk management should apply to the agency’s entire operation, and it should incorporate a number of set criteria, such as country of manufacture or production, volume and type of product, facility inspection history, and trends or data shared from other regulatory authorities.|
|Recommendation 6-2: The FDA should develop an information and informatics strategy that will allow it to do risk-based analysis, monitor performance metrics, and move toward paperless systems. In the next 3 to 5 years, the FDA should propose, in all its international harmonization activities, a standardized vocabulary, a minimum data set to be collected, and the frequency of data collection.|
|Recommendation 6-3: The FDA should facilitate training for regulators in developing countries. The purpose is workforce training and professional development through an ongoing, standing regulatory science and policy curriculum. In the next 3 to 5 years, the FDA should broaden the scope of FDA University to educate FDA staffers on international compliance with its regulations. In the long term, the FDA should consider the options the committee puts forth in this chapter.|
|Recommendation 6-4: U.S. policy makers should integrate food and medical product safety objectives into their international economic development, trade, harmonization, and public health work. To this end, the FDA should lead in the development and adoption of international and harmonized standards for food and medical products.|
|Recommendation 6-5: The FDA, which currently requires one-up, one-back track-and-trace requirements for food, should, in the next year, hold a multi-sector, international, public workshop on applying them to medicines, biologics, and (when appropriate) to devices.|
|Recommendation 6-6: Starting in the next 2 years, the FDA and USDA should implement Cooperative Research and Development Agreements and other programs to encourage businesses and academia to research and develop innovations for low-cost, appropriate fraud prevention, intervention, tracking, and verification technologies along the supply chain.|
|Recommendation 6-7: The FDA should ensure an adequate mix of incentives to importers of food and medical products that are confirmed to meet U.S. regulatory standards. One such promising initiative is the 2-year FDA Secure Supply Chain pilot program. The FDA should evaluate this program immediately after its pilot phase (scheduled to end in 2014). The program should be expanded, if successful, to include a greater number of importers and food.|
|Recommendation 6-8: Over the next 10 years, U.S. government agencies should work to strengthen the ability of those harmed by unsafe food and medical products to hold foreign producers and importers liable in civil lawsuits.|
SOURCE: IOM, 2012.
|Problems||Food Systems||Medical Product Systems|
|Adherence to international standards||
|Controlling supply chains||
TABLE D-2 Continued
SOURCE: IOM, 2012.
IOM (Institute of Medicine). 2012. Ensuring safe foods and medical products through stronger regulatory systems abroad. Washington, DC: The National Academies Press.