4

A Strategy to Building Food and Medical Product Regulatory Systems

As Chapter 1 explains, this report is the product of the Food and Drug Administration’s (FDA’s), and the entire Department of Health and Human Services’ (HHS’), expanding interest in health beyond U.S. borders. In keeping with its task to speak to the common elements of food and medical product regulation and the common problems across low- and middle-income countries, the committee made recommendations that could improve food and medical product safety for a range of stakeholders. After identifying the common gaps in food and medical product regulatory systems in emerging economies, the committee developed a strategic plan for how the FDA and other stakeholders could best work to bridge these gaps. The committee’s strategy builds on the nexus of global health, trade, and development. In making its recommendations, the committee kept in mind that international trade and modern supply chains mean that every country has a stake in the safety standards of its least developed trading partner.

The committee’s strategy also emphasizes that food and medical product regulatory systems are an essential piece of the health system in any country. The deficits in the systems of the poorest countries are, because of global trade, vulnerabilities in the richest. HHS Secretary Kathleen Sebelius commented on this vulnerability when introducing the HHS Global Health Strategy on January 5, 2012, explaining, “we can no longer separate global health from America’s health” (Sebelius, 2012), mentioning in particular the globalization of the food and medical product supply. The department’s new health strategy emphasizes the importance of improving global disease surveillance, increasing the integrity of the food and medical product supply chain, implementing scientifically rigorous international health and safety



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4 A Strategy to Building Food and Medical Product Regulatory Systems As Chapter 1 explains, this report is the product of the Food and Drug Administration’s (FDA’s), and the entire Department of Health and Hu- man Services’ (HHS’), expanding interest in health beyond U.S. borders. In keeping with its task to speak to the common elements of food and medical product regulation and the common problems across low- and middle-income countries, the committee made recommendations that could improve food and medical product safety for a range of stakeholders. After identifying the common gaps in food and medical product regulatory sys- tems in emerging economies, the committee developed a strategic plan for how the FDA and other stakeholders could best work to bridge these gaps. The committee’s strategy builds on the nexus of global health, trade, and development. In making its recommendations, the committee kept in mind that international trade and modern supply chains mean that every country has a stake in the safety standards of its least developed trading partner. The committee’s strategy also emphasizes that food and medical prod- uct regulatory systems are an essential piece of the health system in any country. The deficits in the systems of the poorest countries are, because of global trade, vulnerabilities in the richest. HHS Secretary Kathleen Sebelius commented on this vulnerability when introducing the HHS Global Health Strategy on January 5, 2012, explaining, “we can no longer separate global health from America’s health” (Sebelius, 2012), mentioning in particular the globalization of the food and medical product supply. The department’s new health strategy emphasizes the importance of improving global disease surveillance, increasing the integrity of the food and medical product supply chain, implementing scientifically rigorous international health and safety 147

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148 ENSURING SAFE FOODS AND MEDICAL PRODUCTS standards, and advancing health diplomacy (HHS, 2011). The committee recognizes that there are times when the goals of commerce and health will conflict. Some of the gaps Chapter 3 describes, especially the deficits in communication and political will, are a function of this tension. Never- theless, it would be a mistake to ignore the broad common ground where nations can work together on health programs, development, and trade. The committee believes that food and medical product safety are in this common ground. Investments in food and drug regulation are to the mutual benefit of the investor and the recipient. GLOBAL HEALTH, TRADE, AND DEVELOPMENT Adequate regulation aims to assure food and drug safety. Regulatory authorities have a first responsibility to look after the health of their own countries’ citizens. But in a larger sense, food and medical product safety is a cornerstone for global health, trade, and economic development (Bollyky, 2009; Fidler, 2001; Unnevehr, 2007). Food and Medical Product Safety and Global Health Rich and poor countries alike feel the costs of unsafe food and medical products. Foodborne disease outbreaks have occurred on every continent over the last decade (WHO, 2002). The Centers for Disease Control and Prevention (CDC) estimates that, in the United States alone, every year roughly 1 out of 6 (48 million people) are sickened, 128,000 are hospital- ized, and 3,000 die from foodborne diseases (CDC, 2011). In developing countries, the burden is even greater. More than 2 million people die each year from diarrhea, much of which is caused by foodborne contaminants (WHO, 2012). At worst, toxically adulterated drugs kill patients; at best they hold back recovery, confuse clinicians, and impede disease control. Though precise estimate are hard to come by, millions of counterfeit pre- scriptions are probably filled every year in the United States alone (Pew Health Group, 2011). The incidence of counterfeiting is greater when regulatory and enforcement systems are weak: in Africa, parts of Asia and Latin America, and the former Soviet Union (WHO, 2009). No national regulatory authority, including the FDA, can totally ensure the safety of food and medical products in its markets. Unsafe foods and drugs cross national boundaries with trade and travel; technology makes international commerce easier. The volume of the global trade in food and drugs and the complexity of its supply chains overwhelm border control and inspection efforts. There are legal and practical limits on the ability

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149 BUILDING FOOD AND MEDICAL PRODUCT REGULATORY SYSTEMS of an importing country’s regulatory authority to inspect foreign food and medical product producers and suppliers (Bollyky, 2009). As a result, the adequacy of the food and drug safety in any one country is dependent on the adequacy of regulation in others. Food and Medical Product Safety and Trade Over the past 50 years, barriers to international trade have declined substantially with lower tariffs, reduced quotas, and preferential trade agreements (Bhagwati, 2002). International manufacturing and modern distribution systems have made food and medical products truly global industries. Increased competition, thinning profit margins, and a relentless drive for productivity have pushed multinational food and drug compa- nies to source their production in low- and middle-income countries and through complex, fragmented supply chains (FDA, 2011). The resulting growth in international food and drug trade volume has been spectacular. Agricultural exports from developing countries nearly doubled between 1990 and 2000 and continue to increase rapidly (Aksoy and Ng, 2010). In the United States alone, imports of FDA-regulated food and drug products have increased by more than 13 percent annually since 2002, with imports from Mexico, India, China, and Thailand increasing the fastest (FDA, 2011). U.S. imports of medical devices quadrupled over the past 10 years (FDA, 2011). The international food and drug trade is not unilateral. American companies, for example, sell an increasing amount of drugs and medical devices in low- and middle-income countries (Johnson, 2009). Bilateral food and drug trade between developing countries has likewise expanded (Miller, 2009). The past decade has seen many food and drug safety crises, some because of contamination in developing countries. As supply chains have grown more complex and food is no longer produced solely in any one country, regulators find their laws, written decades ago, insufficient to protect the modern supply chain. The private sector responded initially by implementing private standards such as Global-gap, Hazard Analysis and Critical Control Points, good manufacturing practices, etc. to ensure product safety, and many of the private standards were stricter than the public standards (Willems et al., 2005). Subsequently, many countries such as the United States, European Union (EU) members, Canada, and Japan have found it necessary to modernize their product safety requirements. Suppliers to these countries, and to companies that sell in these countries, need to ensure they are meeting the changing monitoring and traceability requirements. If they do not, they will lose a lucrative market.

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150 ENSURING SAFE FOODS AND MEDICAL PRODUCTS Food and Medical Product Safety and International Development The global food and drug trade has been an engine of international economic development. Many people in low- and middle-income countries earn their livings in farming and manufacturing. Drug manufacturing is an important growth sector in developing countries like India and China (FDA, 2011). Continued trade and investment in the food and drug sector will depend on local governments and producers ensuring that the safety and quality requirements of importing governments and corporations are met. Unsafe food and drugs hold back economic development in many ways. Foodborne illnesses caused $35 billion in medical costs and lost productiv- ity in the United States in 1997 and likely causes much more today (WHO, 2007). International efforts to improve nutrition in low- and middle-income countries depend on safe, nutritious food and a plentiful, clean water sup- ply (Lupien, 2008). Foodborne illnesses and substandard drugs are most harmful to the most vulnerable: children, pregnant women, the sick, and the elderly. Deliberately and fraudulently misidentified shipments and products undermine the customs, regulations, and rule of law in low- and middle- income countries (Bollyky, 2009). A functioning regulatory system is a key piece of the public health system and one that is missing in many countries. International develop- ment organizations have the funding, staffing, and institutional strength to improve functioning of regulatory systems, but to do this they need techni- cal input from expert regulators. Regulators would benefit from working though the established development networks that aid organizations have implemented. Unfortunately, the two groups often work in relative isolation from each other. STRATEGY FOR BRIDGING THE GAPS IN FOOD AND MEDICAL PRODUCT REGULATION A four-part strategy that includes an emphasis on public health, risk- based investments, suitable incentives, and international coordination could help bridge the gaps in food and medical product safety regulation around the world. An explanation of the four pieces of this strategy follows. Emphasis on Global Public Health The cornerstone of this strategy is its recognition that adequate regula- tion of food and medical products is essential for public health, improved well-being, and long lifespan. Public health is itself a predictor of economic development; healthy, strong people can work better and earn more (Strauss and Thomas, 1998). Growth during early childhood predicts adult health

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151 BUILDING FOOD AND MEDICAL PRODUCT REGULATORY SYSTEMS and cognitive ability (Case and Paxson, 2008; Richards et al., 2002). Malnutrition and disease rob poor countries of the intellectual capital that could fuel their growth. Unsafe food and water cause the problem; unreliable and poor qual- ity drug supplies compound it. Childhood disease causes malabsorption of nutrients and poor growth; malnutrition, in turn, aggravates infections (Guerrant et al., 2008). There is an emerging body of evidence that chronic early exposure to aflatoxin, a dangerous mycotoxin produced from fungus that infects grain, also causes childhood stunting (Gong et al., 2002; Wild, 2007). Malaria, bacterial infections, parasites, and vaccine-preventable dis- eases are all commonplace in developing countries. Their prevention and treatment depend on national regulatory authorities as much as they depend on the primary health care system, but donor investments in health favor disease-specific programming and improving primary health care to the exclusion of developing the food and medical products regulatory system. This is ultimately a short-sighted donor strategy. This report maintains that regulatory systems are an important piece of the public health system, a posi- tion taken by the FDA in its Pathway to Global Product Safety and Quality. Risk-based Investments The committee recognizes that it is neither practical nor sensible for any stakeholder to divide limited resources equally among all regulated products. Modern regulatory science demands an understanding of risk, “the probability of an adverse event . . . caused under specified circum- stances by exposure to an agent” (IPCS, 2004, p. 13). In 2010 the Institute of Medicine’s (IOM’s) report Enhancing Food Safety expanded on this concept, describing a risk-based system as one that “facilitates decision making to reduce public health risk in light of limited resources and addi- tional factors” (IOM, 2010, p. 79). Data drives a risk-based system; only through surveillance and epidemiological analysis can the risks of a food or medical product lapse be understood. Risk analysis sets out rules that allow for comparison of seemingly disparate problems. The risks with the greatest threat to public health are ranked highest and those with little risk to public health are ranked lower (IOM, 2010). The best risk-based systems involve all the stakeholders in their process and encourage open dialogue (IOM, 2010). A system properly grounded in risk analysis has the ability to respond to a product safety emergency in a way that will not disrupt the background functioning of the system (IOM, 2010). To this end, the committee’s strategy emphasizes risk. National regula- tory authorities should give the most attention to the highest-risk products. Risk can guide the investments international organizations make in prod- ucts, industries, countries, and regions. Stringent regulatory authorities

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152 ENSURING SAFE FOODS AND MEDICAL PRODUCTS have surveillance data that others can share to inform their understanding of risk. Over time, as surveillance systems and risk analysis capacity im- proves in emerging economies, a wider scope of data will be available and a better understanding of risk in different parts of the world will emerge. Suitable Market Incentives The committee’s strategy includes building incentives that encourage strong national regulatory authorities and higher compliance with interna- tional standards. The United States and the EU are examples of markets with much stricter controls than in low- and middle-income countries (Euro Consultants, 2010). Access to lucrative, highly regulated export markets is a powerful incentive for emerging economies to raise their own food and drug standards (Maertens and Swinnen, 2009; Vogel, 1997). Once a pro- ducer meets the safety standards required by the export market, spillover effects may occur to local production (Unnevehr et al., 2003; Vogel and Kagan, 2002). The committee’s emphasis on incentives aims to make international standards more attractive for exporters in developing countries. If large, stringently regulated economies, such as the United States, ensure an ade- quate mix of incentives that offer competitive advantage in their markets, this would benefit trading partners confirmed to meet their higher regula- tory standards (Bollyky, 2009). In accordance with World Trade Orga- nization (WTO) law, such incentives should not favor the applicants of one country over another. Some of the committee’s recommendations will address policymakers in importing economies. The committee considered consistent use of international standards as an important guiding principle in its recommendations. Retailers and manufacturers need to better control their supply chains, including the supply chains of all their suppliers. Retailers and manufac- turers are also the ones in the best position to do this in the short term. Already, supermarkets enforce standards and regulate their supply chains; multinational pharmaceutical companies do the same (Havinga, 2006; O’Marah, 2007). To manage its supply chains, industry needs to consider which suppliers are most credible and which ones are compliant with regular inspections. Manufacturers and retailers also have a wealth of ex- pertise that they can share with their suppliers on how to run production efficiently, keep waste low, and other safe ways to maximize profits. U.S. retailers and manufacturers are in the best position to ensure the safety of their products. They can do this by adopting stronger prevention measures and control of their supply chains. There are already good incen- tives for U.S. companies to control their suppliers. It is relatively simple and inexpensive to bring a lawsuit to court in the United States, and there are no disincentives to sue, encouraging a litigious culture. For the defendant

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153 BUILDING FOOD AND MEDICAL PRODUCT REGULATORY SYSTEMS companies, litigation is expensive, and even if the plaintiff settles, a lawsuit can damage the firm’s reputation. There are legal and practical limits to the ability of U.S. consumers to hold foreign producers responsible for the harm their products cause in the United States, however. In some cases, U.S. firms can avoid product liability when there is no evidence that they knew or should have known about vulnerabilities in their suppliers’ products (Bamberger and Guzman, 2008). The committee sees value in encouraging retailers and manufactur- ers to improve oversight of their suppliers by increasing liability for the importation of unsafe food and medical products. In its strategy the com- mittee recognizes that there are different ways to enforce product liability, discussed further in Chapter 6. Some agricultural economists fear that smallholders will not be able to access high-value agricultural markets given the strict standards (Graffham and MacGregor, 2009; Okello et al., 2011). New economic incentives could help small producers stay competitive in the global marketplace. Narrod et al. (2009) describe how public–private partnerships can encourage farm- to-table connections that can meet demands for food safety and still retain smallholders in the supply chain. Unfortunately, such market incentives often do not exist in many developing countries where there is limited qual- ity testing in the marketplace. In the agri-food sector in particular, much of the food produced by smallholders in poor countries is consumed locally. Successful multinational corporations understand how to use market incentives with their suppliers. But there are still many retailers and manu- facturers that need to better control their supply chains, including the sup- ply chains of all their partners. International Coordination Product safety crises know no national borders. The past decade of product safety scares has driven this point home. The committee sees in- ternational cooperation as a foundation for effective product safety regula- tion. The committee also values international collaboration in the capacity building programs that it recommends. Cooperation among all nations and international organizations is one of the main principals the committee considered when making its recommendations. Although food and medi- cal product regulation is a national and even local process, success requires international coordination. The committee believes that international cooperation will support the building of a cadre of regulators in developing countries. Critics of an inter- national approach might maintain that the national regulatory authority of each nation is solely responsible for its country’s product safety. This was true 20 years ago, but this report explains why the rapid increase in global trade has created a worldwide interdependence of regulators. Much as the

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154 ENSURING SAFE FOODS AND MEDICAL PRODUCTS World Health Organization (WHO) is the backbone of the public health system in developing countries, international product safety cooperation should be the backbone of regulatory systems. Cooperation among nations does not mean that each country has to do things the same way. What one country considers an emergency may be a routine incident in another (WHO and FAO, 2010). However, inter- national cooperation becomes more important during a serious product safety lapse. During the heparin incident of 2008, for example, U.S. and Chinese regulators and industry representatives had to work together to identify the contaminated drug and its source. A stronger framework for international collaboration might have improved this process. Figure 4-1 shows conceptually how more serious events require higher levels of inter- national coordination. Intergovernmental institutions are the experts in the sensitive area of international coordination. The WTO is the leader on coordinating international trade; the WHO has a similar voice in international health. Universities often have collaborative research centers in other countries. International nongovernmental organizations (NGOs) have expertise in coordinating operations on the same project in different countries. The development banks have long worked on projects at the intersection of health and economic development. The World Bank funded a project on building capacity for food and drug safety in India that contributed to the development of the 2006 Indian Integrated Food Law (World Bank, 2009). Requires central coordination Crisis Scaling down the response Scaling up the response Emergency Incident Business as usual FIGURE 4-1 Product safety events. SOURCE: Adapted from WHO and FAO, 2010. Reprinted with permission from the Food and Agricultural Organization of the United Nations.

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155 BUILDING FOOD AND MEDICAL PRODUCT REGULATORY SYSTEMS The same project also built 13 new food safety labs and 6 new drug test- ing labs in India and renovated dozens more (World Bank, 2009). Rational pharmaceutical use and medicines registration have long been one of the Inter-American Development Bank’s main program areas (Guiffrida, 2001); the bank has implemented a drug inventory and distribution plan in Nica- raguan hospitals (IADB, 2006). The Asian Development Bank is working to build the drug regulatory authority in Mongolia (ADB, 2010). This program established a drug regulatory authority in Mongolia, upgraded the Mongolian drug-control laboratories, modernized its laboratory accredita- tion process, and strengthened postmarketing surveillance (ADB, 2008). The African Development Bank funded a successful project to improve sanitary and phytosanitary (SPS) measures, improve food safety standards, and strengthen SPS institutions (Magalhães, 2010). In making its recommendations, the committee encourages cooperation among regulatory authorities from industrial and emerging economies. The Group of Twenty (G20) international forum is a venue that brings leaders of these countries together to advance an agenda of a strong, sustainable, and balanced global economy; it would be a useful venue to elevate the prior- ity of food and medical product safety for global health, development, and trade. International and intergovernmental institutions such as the WHO, the Food and Agriculture Organization (FAO) of the United Nations (UN), development banks, and other UN organizations, many of which are already promoting good regulatory practices, can be international leaders in facili- tating and supporting regulatory cooperation and strengthening. National and local governments, industry, and consumers are also all stakeholders that the committee considers central to its strategy. Its recommendations will have a global focus, in an effort to reduce accusations of double standards for imported and domestic products. This strategy sees the key overlaps among public health, economic development, and trade, and it values the safety of all foods and medical products produced around the world. The committee also sees regional collaborations, both regional eco- nomic partnerships and regional public health networks, as important to international coordination. In its Resource Guide on Drug Regulation in Developing Countries, the British government’s aid agency observed that “regional cooperation may allow scarce expertise to be more efficiently applied” (Gray, 2004, p. 3). The committee agrees with this sentiment. All countries should work toward a long-term goal of having a reliable health system, and this includes a system for food and medical product safety. But in the short term, regional collaboration will allow smaller and less technologically advanced countries to benefit from their neighbors’ systems. Box 4-1 describes a successful international collaboration in South Amer- ica; the South American countries that worked together on medfly eradica- tion were able to improve their agricultural exports and their food security.

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156 ENSURING SAFE FOODS AND MEDICAL PRODUCTS BOX 4-1 Mediterranean Fruit Fly Eradication in Chile The Mediterranean fruit fly, also known as medfly, is a destructive fruit pest that destroys crops when it deposits its eggs on host fruits and veg- etables. The larvae damage the fruit as they feed on the pulp and tunnel through it, which encourages the entrance of secondary pathogens (Bergsten et al., 1999). Although the medfly originated in Africa, it arrived in Latin America in 1901 and rapidly spread throughout the continent. The medfly’s destruc- tion of fruit and vegetable crops posed a threat to the region’s export industry because it not only lowered the market value of the crop, but also rendered many crops unfit for human consumption (Vail et al., 1976). The need to minimize economic losses and ensure consumer safety encouraged the development of eradication programs such as Chile’s Agriculture and Livestock Service’s “Fruit Flies in Chile” project (Labos and Machuca, 1998). Suppression programs such as this one called for collaboration among surrounding countries and international organizations. One exemplary partnership was between Chile and the International Atomic Energy Agency (IAEA). It began in 1987 during the first phase of the usage of the sterile insect technique (SIT) to repress medflies (Labos and Machuca, 1998). Field research demonstrated that bringing sterile males into Chile from Guatemala, Hawaii, and Mexico had been highly effective, so the IAEA assisted Chile in building a factory to produce sterile medflies and provided the necessary technical support (IAEA and UNDP, 1998). Another successful negotiation was the binational agreement between Chile and Peru. The Chilean province of Arica borders Peru and had the highest risk of infestation because medflies could enter northern Chile through the southern Peruvian border. It was imperative that Chile and Peru cooperate to eliminate the pest. With Chile’s guidance, the Peruvian government effectively introduced sterile males to these regions. This resulted in a dramatic reduction in medfly population densities and reduced the invasion pressure into Chile (Gonzalez and Troncoso, 2005). Chile finally achieved a medfly free status in November 1995. This allowed it to expand its exports to markets where it had previously been banned such as China and Japan. In 1996, Chile’s total agriculture exports were worth $1 billion (Sims, 1996). By 2011, agriculture exports had increased nearly sevenfold (This is Chile, 2011). Chile’s medfly-free status allowed it to become the largest fruit exporter in South America (IAEA, 2007). Chile’s success led it to help neighboring countries in eradicating the medfly. The SIT program has been applied in other Latin American countries such as Argentina, Bolivia, Colombia, Uruguay, and Ecuador. The goal of these methods is to ensure the complete eradication of the medfly pest from the major fruit-growing regions of Latin America (IAEA and UNDP, 1998).

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157 BUILDING FOOD AND MEDICAL PRODUCT REGULATORY SYSTEMS THE ORGANIZATION OF THE COMMITTEE’S RECOMMENDATIONS After identifying the nine main problems in developing country product safety systems and agreeing on a common strategy to solve these problems, the committee formed 13 recommendations. These recommendations sug- gest actions for the FDA, international organizations, the G20, developing country regulatory authorities, developed country regulatory authorities, industry associations, and other branches of the U.S. government includ- ing USAID, the CDC, and USDA. Meaningful change in product safety systems will take time, and success will be measured in increments. With this in mind, the committee suggested actions for the short and long term. See Table 4-1.

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TABLE 4-1 158 Recommended Actions to Address the Nine Main Problems in Developing Country Product Safety Systems Critical Issue Recommendations Timeframe Action Adherence to 5-1: Increasing international investments 1 year Bring regulatory capacity building to the 2012 G20 meeting agenda international 3-5 years Track investments in regulatory systems and training standards 5-3: Working toward shared inspections 18 months Share inspection reports among stringent regulatory agencies ≈10 years Establish a system for mutual recognition of inspection reports 5-4: Sharing inspection results voluntarily 3 years Share industry inspection results among members 6-5: Expanding one-up, one-back track 1 year Convene a public workshop on expanding one-up, one-back and trace 6-7: Giving market incentives for supply 2 years Evaluate the Secure Supply Chain program in 2014 chain management 3-5 years Scale up the Secure Supply Chain program based on evaluation Controlling 5-4: Sharing inspection results voluntarily 3 years Share industry inspection results among members supply chains 6-2: Using information technology 3-5 years Articulate a standard data format and vocabulary ≈10 years Develop an informatics strategy that moves to paperless systems 6-5: Expanding one-up, one-back track 1 year Convene a public workshop on expanding one-up, one-back and trace 6-6: Researching inexpensive technology 2 years Issue CRADAs that benefit producers and regulators abroad 3-5 years Stimulate industry and academic research on behalf of small producers 6-7: Giving market incentives for supply 2 years Evaluate the Secure Supply Chain program in 2014 chain management 3-5 years Scale up the Secure Supply Chain program based on evaluation

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Critical Issue Recommendations Timeframe Action Infrastructure 5-2: Encouraging open dialogue among 3-5 years Identify neutral venues to bring together government, industry, and deficits government, industry, and academia in academia emerging economies Ongoing Regular, open dialogue on regulatory science and policy 6-2: Using information technology 3-5 years Articulate a standard data format and vocabulary ≈10 years Develop an informatics strategy that moves to paperless systems 6-4: Leadership in adopting standards 3-5 years Adopt international standards in the U.S. ≈10 years Fully integrate product safety into U.S. foreign policy Strong legal 6-4: Leadership in adopting standards 3-5 years Adopt international standards in the U.S. foundation ≈10 years Fully integrate product safety into U.S. foreign policy 6-8: Increasing civil liability ≈10 years Hold producers and importers liable for unsafe products Workforce 5-2: Encouraging open dialogue among 3-5 years Identify neutral venues to bring together government, industry, government, industry, and academia in and academia emerging economies Ongoing Regular, open dialogue on regulatory science and policy 5-3: Working toward shared inspections 18 months Share inspection reports among stringent regulatory agencies ≈10 years Establish a system for mutual recognition of inspection reports 5-5: Strengthening surveillance systems 3 years Develop pharmacovigilance plans 5 years Improve the foodborne disease surveillance systems ≈10 years Build a cadre of trained epidemiologists 159 continued

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TABLE 4-1 Continued 160 Critical Issue Recommendations Timeframe Action Workforce, 6-3: Bridging training gaps at home 3-5 years Revise the curriculum at the FDA sta college continued and abroad Work through existing networks to train trainers abroad Support academic exchanges ≈10 years Facilitate the development of a standing regulatory science college Implement an apprenticeship program like the FETP 6-4: Leadership in adopting standards 3-5 years Adopt international standards in the United States ≈10 years Fully integrate product safety into U.S. foreign policy Fragmentation 5-2: Encouraging open dialogue among 3-5 years Identify neutral venues to bring together government, industry, government, industry, and academia in and academia emerging economies Ongoing Regular, open dialogue on regulatory science and policy Surveillance 5-5: Strengthening surveillance systems 3 years Develop pharmacovigilance plans 5 years Improve the foodborne disease surveillance systems ≈10 years Build a cadre of trained epidemiologists 6-2: Using information technology 3-5 years Articulate a standard data format and vocabulary ≈10 years Develop an informatics strategy that moves to paperless systems 6-4: Leadership in adopting standards 3-5 years Adopt international standards in the United States ≈10 years Fully integrate product safety into U.S. foreign policy 6-6: Researching inexpensive technology 2 years Issue CRADAs that benefit producers and regulators abroad 3-5 years Stimulate industry and academic research on behalf of small producers

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Critical Issue Recommendations Timeframe Action Communication 5-2: Encouraging open dialogue among 3-5 years Identify neutral venues to bring together government, industry, government, industry, and academia in and academia emerging economies Ongoing Regular, open dialogue on regulatory science and policy 5-3: Working toward shared inspections 18 months Share inspection reports among stringent regulatory agencies ≈10 years Establish a system for mutual recognition of inspection reports 5-4: Sharing inspection results voluntarily 3 years Establish a protocol for sharing anonymous internal inspection results Ongoing Publish these results in association newsletters and other publications 6-2: Using information technology 3-5 years Articulate a standard data format and vocabulary ≈10 years Develop an informatics strategy that moves to paperless systems 6-6: Researching inexpensive technology 2 years Issue CRADAs that benefit producers and regulators abroad 3-5 years Stimulate industry and academic research on behalf of small producers Political will 5-1: Increasing international investments 1 year Bring regulatory capacity building to the 2012 G20 meeting agenda 3-5 years Track investments in regulatory systems and training 5-2: Encouraging open dialogue among 3-5 years Identify neutral venues to bring together government, industry, government, industry, and academia in and academia emerging economies Ongoing Regular, open dialogue on regulatory science and policy 6-4: Leadership in adopting standards 3-5 years Adopt international standards in the United States ≈10 years Fully integrate product safety into U.S. foreign policy 6-7: Market incentives for supply 2 years Evaluate the Secure Supply Chain program in 2014 chain management 3-5 years Scale up the Secure Supply Chain program based on evaluation 6-1: Using enterprise risk management to rank priorities 3-5 years Choose priorities for FDA foreign operations 161 ≈10 years Lobby Congress to reorganize FDA operations based on risk

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