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6 Domestic Action In its Pathway to Product Safety the U.S. Food and Drug Adminis- tration (FDA) emphasizes the importance of operating as a “truly global agency fully prepared for a regulatory environment in which product safety and quality know no borders” (FDA, 2011b, p. 3). To this end, the agency must bridge the many gaps within regulatory systems abroad. In this chap- ter, the committee recommends actions the FDA and other U.S. government agencies can take to increase the efficiency of their own operations while improving the systems of their counterpart agencies abroad. USING RISK AS A GUIDING PRINCIPLE Chapter 4 describes the committee’s strategy in forming its recom- mendations and emphasizes that the FDA should let risk guide its efforts to build food and medical product regulatory systems abroad. In keeping with its focus on risk, the committee recommends that the FDA divide its limited resources according to risk. An understanding of risk will allow the FDA to choose what problems are its highest priorities. There are tradeoffs implicit in all decision making. Especially in capacity building, managers need to choose between different risks affecting differ- ent populations. When working across many countries, choosing to work with one population means less attention for others. Through the use of an enterprise risk management framework, the FDA can determine which risks are the most serious and have an objective way to rank its priorities. 193
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194 ENSURING SAFE FOODS AND MEDICAL PRODUCTS Recommendation 6-1: FDA should use enterprise risk management1 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 regula- tory authorities. The FDA’s implementation of an enterprise risk management system will be the best measure of this recommendation. The FDA’s allocation of resources in a way that reflects decisions grounded in enterprise risk man- agement will also be a measure of this recommendation. The FDA will also have to select which statistics best measure the impact of its inspections, trainings, and surveillance efforts. Choosing which metrics to monitor most closely will be part of the assessment. The timetable on which the FDA col- lects these data is up to the agency’s management, but it should be frequent, perhaps every quarter, but at least every 6 months. Should the results of an enterprise risk management analysis suggest full reorganization of the FDA, such a process would take time. In order to work toward this change promptly, the FDA needs to conduct enterprise- wide risk assessment, analysis, and evaluation. If its results suggest an inefficient or unscientific allocation of resources in the agency’s current operations, as one expects they will, then the FDA will need, at that time, to lobby Congress for permission to revise its operations. The agency has more freedom in running its capacity building pro- grams. Therefore, an enterprise risk management assessment, analysis, and evaluation can be used to reorganize international programs in the next 3 to 5 years. Enterprise-wide Risk Management Multinational food and medical product companies have been using enterprise risk management for some time (see Box 6-1). Even the most profitable business cannot afford to monitor every transaction on its supply chain with the same diligence. Instead, multinational companies develop a hierarchy of risk and devote resources to the highest risks in the hierarchy. These companies may have a broader data set to inform their estimates than the FDA would have. Nevertheless, the FDA has to work with the 1 Enterprise risk management is a discipline by which an organization “assesses, controls, exploits, finances, and monitors risks from all sources for the purpose of increasing the organization’s short- and long-term value to its stakeholders” (Casualty Actuarial Society- Enterprise Risk Management Committee, 2003, p.8).
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195 DOMESTIC ACTION BOX 6-1 E nterprise Risk Management Risk is the potential any action or inaction has to result in an undesir- able outcome. The concept of enterprise risk management comes from the financial services industry, but has been adapted for use in a variety of businesses, as well as in running governments and universities. The Committee of Sponsoring Organizations of the Treadway Commission defined enterprise risk management as “a process, effected by an entity’s board of directors, management and other personnel, applied in strategy setting and across the enterprise, designed to identify potential events that may affect the entity, and manage risk to be within its risk appetite, to provide reasonable assurance regarding the achievement of entity objectives” (COSO, 2004, p. 2). The principles of enterprise risk management allow any type of organization to assess areas where it has exposure to harm and evaluate the extent of the danger. Assessing mitigation strategies is an important part of enterprise risk management, as is financial and administrative planning against the organization’s risk profile. The advantage of an enterprise-wide risk management assessment (as opposed to a func- tional or discipline-based assessment) is that the organization’s man- agement gains a framework that presents the connected relationships between decisions and then allows it to integrate their responses to multiple threats (COSO, 2004). The use of enterprise risk management can guide staffing and training decisions. Over time, the use of enterprise risk management can help the organization transition from a culture of responding to crises when they happen to predicting and preventing them (Protiviti Inc., 2006). data available. Over time the agency may develop data sharing relationships with its counterpart agencies abroad. The FDA may also want to collabo- rate to develop its own risk assessment tool. A number of organizations have supported a risk-based approach to food and medical product regulatory strategy. The Pew Health Group encouraged using risk to guide inspections (Pew Health Group, 2011), as have industry spokespeople (Vijay, 2011). The committee’s recommenda- tion is also consistent with the 2010 Institute of Medicine report Enhancing Food Safety that argued for consistency in applying a risk-based food safety system (IOM, 2010). In understanding the committee’s emphasis on enterprise risk manage- ment it is important to consider that this is a way to manage the agency’s enterprise. That is to say, a way to manage everything the agency does. Enterprise risk management is a strategic perspective to set priorities for the
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196 ENSURING SAFE FOODS AND MEDICAL PRODUCTS agency, not a tactical perspective applied to any subfunction of the enter- prise, such as food safety or medical device safety. Many of the systematic steps in risk management at the enterprise level and at the subordinate levels can be described in similar terms. At the level of the organization’s leadership, concerns over specific product lines or countries need to be reconciled with the entire risk and opportunity profile the FDA needs to address. Food, drug, vaccine, and medical device safety must be reconciled with each other and with other FDA responsibilities. Enterprise risk man- agement can reconcile an array of risks at the agency level. The goal is for the FDA to optimally balance its limited resources with the full array of risks the agency needs to control. This committee recommends an enterprise-wide risk assessment be used to inform the FDA’s capacity building projects and all its routine work. An enterprise-wide assessment will help the FDA allocate its staffing, trainings, and operations to the highest risk, highest priority activities, not just the inspections. The FDA has, for some time, been working to base inspections on a risk assessment paradigm. In 2007 the FDA was already using a risk- based process to rank foreign manufactures according to the urgency of the need for inspection (GAO, 2007). In a speech to the Partnership for Safe Medicines, the FDA commissioner explained that the agency has systemati- cally ranked more than 1,000 active pharmaceutical ingredients according to respective risk of economically motivated adulteration (Hamburg, 2010). Clearly, the FDA has a strong foundation on which to build its enterprise risk management system. Its use of risk to guide foreign inspections is exemplary. The challenge to the agency now is to persuade others that it can better protect consumers if it allocates more of its resources, not just inspections, based on modern risk management. The use of enterprise risk management will be especially valuable to the FDA given the poor economy and fiscal austerity. The agency has been underfunded for years. The fiscal year 2010 budget was relatively generous to the FDA. This, combined with modest increases in fiscal years 2008 and 2009, brought the agency’s budget back to 1994 levels (see Figure 6-1) (McCain, 2011). At the same time, the agency’s responsibilities have increased dramatically. The increasing number of foreign food facility inspections demanded by the Food Safety Modernization Act (about 19,200 by 2016) cannot be reasonably managed by an agency that, according to a 2007 GAO report, operates on about one-seventh of its required budget (GAO, 2007; McCain, 2011). The committee believes that enterprise risk management will help the FDA triage its funding, which, especially during the 2012 election cycle, will likely be “hijacked and delayed by political maneuvering” (Semeniuk, 2011).
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197 DOMESTIC ACTION 9,000 8,000 Full-time equivalents 7,000 6,000 5,000 4,000 3,000 2,000 1,000 1994 1996 1998 2000 2002 2004 2006 2008 2010 Fiscal Year FIGURE 6-1 Full-time equivalents supported by congressional appropriations, from fiscal year 1994 to fiscal year 2010. SOURCE: McCain, 2011. Implementing Enterprise Risk Management at the FDA The committee recognizes that implementing an enterprise-wide risk management program is challenging for any large organization. Fortu- nately, the International Organization of Standardization and other enter- prise risk management experts publish guidance on implementing enterprise risk management strategies (COSO, 2004; ISO, 2009; Protiviti Inc., 2006). These sources all emphasize that the risk management framework is different for every organization. The committee agrees; this report does not dictate what the FDA’s strategy will be. Such a level of prescription would be inappropriate and impossible: it would require analysis of the agency’s internal data and consideration of internal contextual factors of which expert committees have no knowledge. Instead of dictating the agency’s plan, the committee recommends that the FDA undertake an enterprise- wide risk assessment in keeping with its objectives and the Department of Health and Human Services’ (HHS’) goals as explained in its Global Health Strategy (HHS, 2011). The Global Health Strategy provides a framework in which to evaluate all of the FDA’s activities and consider their risks. The department’s goals are protecting the health of Americans through global health action; advancing American interests in diplomacy, development,
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198 ENSURING SAFE FOODS AND MEDICAL PRODUCTS and security through global health action; and leading in science, policy, and programs that advance global health (HHS, 2011). The FDA’s enter- prise risk assessment will need to consider these goals and identify where the biggest risks are in relation to meeting them. The FDA’s risk management framework will define the processes, staff- ing, timelines, and budgeting needed to manage its risks. First, the FDA will undertake a thorough risk assessment. This will include identifying the risks it faces and evaluating its response options. In this phase the FDA will need to define how risks will be measured and when, and also how it will determine the level of the risks identified (ISO, 2009). Input from all stakeholders will be important to this process, especially as the FDA tries to determine if there are likely combinations of risk (ISO, 2009). The frame- work will mandate the schedule on which the FDA revisits its priorities to keep pace with changing risks. The next step will be a risk analysis that accounts for the sources and causes of risk as well as their consequences and likelihood of reoccurring. The risk analysis step may include analyzing internal data and running simulations of different crises. The last step is risk evaluation, which ana- lyzes the identified risks against pre-determined criteria to guide decisions. In risk evaluation, the FDA will consider the costs, effort, and benefits of all actions. A well-executed risk evaluation will provide the FDA’s leaders with the information they need to develop their capacity building priorities. Implementation in the Short-Term Should Focus on FDA Activities Outside the United States There are many restrictions on the FDA’s authority to allocate its resources domestically. Therefore, especially in the next 3 to 5 years, the committee sees promise in using enterprise-wide risk management to orga- nize the FDA’s foreign operations. Enterprise risk management depends on ongoing assessment of current and potential future risks. The FDA can use its data and, when confidential- ity agreements allow, reliable data from its counterpart agencies abroad to inform its understanding of product risks. These risks are always changing; the product lines and suppliers considered highest risk a decade ago are dif- ferent from those that are highest risk today. The FDA is best positioned to know which countries are increasing their exports to the United States. It should better define which countries are increasing their high-risk exports or which product lines are increasing in risk. Once it has identified these trends, it can allocate its resources accordingly. The FDA should also target its capacity building efforts to the countries and regions that export the highest risk products. The committee recommends that the FDA focus its resources on high-risk suppliers abroad for the next 3 to 5 years.
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199 DOMESTIC ACTION Enterprise risk management assessments should inform the FDA’s deci- sions on where to put its overseas staff, which overseas offices to scale up, and the best use of its overseas staff’s time. The FDA should devote the most energy to training people in countries that are exporting high-risk products. For example, holding workshops on food safety for regulators in the Middle East and North Africa, as the FDA did in 2010, does not appear to be a decision grounded in risk management (FDA, 2011a). Arab countries export little food to the United States or anywhere else; they are net food importers (World Bank, 2009). The implementation of a risk management system to all FDA work might better empower the staff of the Office of Technical Cooperation and Capacity Building to choose more useful topics and audiences for capacity building programs. Implementation in the Longer-Term Should Be FDA Activities in Both Domestic and International Markets The results of these assessments should also inform the FDA’s inspec- tions in the United States. There are some firms in the United States that have never failed inspection, yet Congress demands that the FDA revisit the sites every 2 years. The FDA is surely better aware than anyone that this is not an efficient use of its inspectors’ time, yet it is bound by dated laws. An enterprise risk management system would allow the FDA to reallocate its resources to give more attention to inspections abroad. The committee recognizes that the FDA will need to work with Con- gress to change the laws governing it if it is to fully revise its domestic work based on risk. It is important to remember that the existing laws were designed for a time when most foods and medical products were produced domestically. Nowadays, much of the food and pharmaceutical supply comes from abroad. This shift demands a complementary shift in the al- location of fixed resources to ensure product safety. The Food Safety Modernization Act requires the FDA to inspect at least 600 foreign facilities in 2011 and double those inspections every year until 2016.2 The FDA will struggle to meet these requirements, especially if Congress does not increase its funding (Stewart and Gostin, 2011). If the agency were able to reallocate its domestic staffing, then it could give more attention to needs overseas. This does not mean that the FDA should neglect inspection and product safety responsibilities in the United States. The Salmonella-tainted egg crisis of 2010 and persistent quality control problems at Johnson & Johnson are a reminder that American companies can also prove to be high risk (Kavilanz, 2010; Silverman, 2011; Un oeuf is enough, 2010). 2 21 USC 350(j)(a)(2)(D).
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200 ENSURING SAFE FOODS AND MEDICAL PRODUCTS USING INFORMATION TECHNOLOGY The committee’s recommendation of a modern systemic risk manage- ment system depends on upgrades to the FDA’s information technology system. A series of recent Government Accountability Office (GAO) re- ports have highlighted inaccuracies in the FDA’s foreign supplier database and problems with its data management system (GAO, 2008, 2010a, b, 2011). The FDA science review committee recommended in 2007 that the agency “enhance the program to monitor performance metrics and put the appropriate [information technology] infrastructure in place to track the evolution of those metrics” (FDA, 2007, p. 42). The committee sees efficient use of modern information technology as indispensible to a risk- based regulatory system. The proper use of such a system could improve cooperation and communication among regulatory agencies. Information technology holds great promise to enhance surveillance. The results drawn from reliable data management systems will give the public and legislators a better understanding of product safety threats. Recommendation 6-2: FDA should develop an information and infor- matics 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 harmoni- zation activities, a standardized vocabulary, a minimum data set to be collected, and the frequency of data collection. This recommendation can be measured when the FDA releases a stan- dardized vocabulary for data collection, a codebook of the minimum data required from all points on the supply chain, and a timetable explaining how often these data should be collected. As with the implementation of enterprise risk management, there are aspects of this recommendation that will take a decade to execute. A full overhaul of the FDA informatics and information strategy will take at least 10 years. However, in the next 3 to 5 years, the FDA can work out a standardized vocabulary and data collection protocols to propose for international use. Information and Informatics Strategies For the purposes of this report, information strategies are ways to ensure that all data about food and medical products are accurately col- lected, well annotated, recorded in permanent electronic media, and securely shared with authorized personnel for better information management. The
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201 DOMESTIC ACTION committee uses the term informatics strategies to describe how the data are cleaned of errors, transformed to proper formats, analyzed, and shared promptly with regulatory agents for better decision making. Modern information management uses networked computing infra- structure across national borders. Information management lays the foun- dation for computer-assisted automated information extraction. Without such data, risk modeling would be impossible. The strategy outlined in this report also emphasizes the need to share information across inter- national borders. The committee feels that the FDA should promote the development of secure and open protocols for electronic data capture, computerized data management, electronic data sharing, and decentral- ized data exchange. It is suitable that the FDA provide leadership in this international endeavor. A good architecture for storing, collecting, and exchanging information is key to reliable, modern food and medical product regulation, although the importance of such a system, especially in developing countries, is not always obvious. A regulatory agency has to access data and information about drug registration, facility inspections, and surveillance from dispa- rate data sources and in varying formats on an ongoing basis. In develop- ing countries much of these data is still stored as paper documents. This severely decreases the productivity of the already thinly staffed regulatory agencies. A functional informatics system thus has the ability to enhance the productivity of regulatory agencies in developing countries. Well-defined data architectures and topologies can allow the multiple agencies regulat- ing food and medical products to coordinate their work and reduce redun- dancy. In addition to sharing across different agencies within a country, common data architectures and good systems for information sharing can also facilitate better international harmonization. For example, the use of a reliable information system can allow the FDA to share inspection reports with its counterpart agencies in developing countries and vice versa. Collecting data in common formats can also lay the groundwork for developing tools that will make regulatory agencies more productive. Pharmacovigilance and postmarket surveillance are two areas that could greatly improve with informatics tools that allow for simpler data collection and analysis. The path to having modern informatics tools in developing country regulatory agencies depends on the FDA leading in defining com- mon standards, which will enable data collection, sharing, and (at some time in the more distant future) advanced decision support. The committee believes that moderate investments in informatics and information technol- ogy will yield significant long-term benefits in the quality of food and drug regulation.
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202 ENSURING SAFE FOODS AND MEDICAL PRODUCTS Used with the permission of Dwayne Powell and Creators Syndicate. All rights reserved. Challenges in Implementation The committee recognizes that implementing an information and in- formatics strategy will be difficult, especially in developing countries. First of all, the data sharing that it recommends requires collecting information from many sources at different agencies. For example, border rejection data, public safety breakout events, regulated product safety recall records, assessment reports of export and import companies, and product ingredi- ent tracking information all need to be collected and linked. There is also room for misunderstanding when many people are responsible for data collection. Field staff may have different interpretations of questions that can lead to inconsistencies in the data. Attempts to work with the European Union (EU) border rejection data, described in Appendix G, made it clear that worker inconsistency is a threat to data quality. Additionally, all large data analysis projects must deal with missing data and attempt to control for human error as much as possible. International survey and data collection experts in academia have ex- pertise in standardizing data collection across many different languages. Standardizing questions and response categories are challenging, but not impossible, especially for people who have worked on similar problems before. Programmers can easily adapt decision-making algorithms to tablet
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203 DOMESTIC ACTION computers and mobile phones, tools that would be accessible to field staff. Using such an algorithm, even minimally educated staff could be trained to collect and transmit standard data. The FDA’s informatics strategy should aim to produce reports that will be compatible with reports produced by its counterpart agencies abroad. As Chapter 2 explains, the committee sees collaboration with the FDA’s counterpart agencies abroad as fundamental to ensuring product safety. In a report on drug safety the GAO also encouraged such collaborations. The FDA should ensure that its information strategy uses the same measurement conventions or has an accurate way to adjust for different conventions. Most of all, the FDA’s information and informatics strategy will need to protect confidential information. The committee understands that willing- ness to share data may be minimal at first, especially in developing countries with a history of deficits in this area. De-identified or aggregated data can still be useful, however. Models for Implementation The biomedical research and financial services industries use modern information sharing, and the FDA might do well to study lessons learned from these sectors. All of them define a minimal set of XML-based files for information sharing. The data elements, semantics, and structure of such data sharing reports can be jointly determined in international standard setting committees. These committees would do well to draw on expertise at the World Wide Web Consortium and the Institute of Electrical and Elec- tronics Engineers. Participating countries should agree to minimal data re- porting elements. Experts need to identify the key minimal data set that will allow for the best communication among regulators and the best product safety assurances. Information management tools such as Protégé are based on ontologies, explicit definitions categories, and sub-categories of informa- tion and the relationships between them (Noy and Mcguinness, 2000). The use of Protégé and systems like it promotes a common understanding of the concepts and data being captured among different organizations. Over time, a shared ontology can facilitate adherence to basic standards and improve standards (Pisanelli et al., 1999). The committee proposes that the FDA encourage its counterparts in developed countries to develop similar information sharing and informatics strategies. Ideally, all agencies can agree on standardized data collection and information sharing practices from the start. Eventually, developed coun- try regulatory authorities can expand the system to include developing country regulatory authorities (GAO, 2011). The FDA should demonstrate how information and informatics strategies can improve its logistics and risk management in both domestic and export markets.
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224 ENSURING SAFE FOODS AND MEDICAL PRODUCTS This evaluation should be focused on scaling-up to include food producers and more drug firms. End-to-end supply chain visibility for food and medical products is the best insurance against safety lapses. The committee recommends that FDA evaluate the results from the Secure Supply Chain pilot for the technical and operational feasibility of scaling. A full-scale program should then be insti- tuted in which all interested manufacturers are enthusiastically encouraged to participate. In order to reduce the risk of non-compliance of these incen- tives programs with WTO law, FDA should develop these food and drug importer incentive programs in close consultation with U.S. trade officials and ensure participation is voluntary and pursuant to objective criteria that do not favor applicants of any one country over those of another. Promising Initiatives Globalization has dramatically altered where food and medical prod- ucts come from. The FDA cannot inspect all of the import lines to the United States or all foreign manufacturers exporting to the United States (GAO, 2008). Even if it could, the GAO pointed out that, “relying solely on inspections is insufficient to secure the drug supply chain” (GAO, 2010a, p. 29). The same is true of relying exclusively on end product testing and food safety inspections to ensure food safety (Young, 2011). There need to be other ways to ensure the safety of import lines. Market incentives drive food safety in the United States (Thomsen and McKenzie, 2001). The Food Safety Modernization Act requires the traceability of the food supply chain and holds suppliers accountable for ensuring HACCP compliance. The ability to assess the safety of ingredients produced overseas, in places where the FDA has no authority, is a challenge (FDA, 2009a). By expanding incentives programs, the FDA could help en- courage foreign producers to adhere to international standards and work to produce higher-quality products. The Food Safety Inspection Service has a program in place to ensure the quality of imported meat. This is not an incentives program, but it is a good example of bilateral coordination to facilitate trade (Box 6-3). The Secure Supply Chain program promotes drug safety. In this pro- gram, foreign firms voluntarily provide the same information FDA requires of American firms (FDA, 2009b). The pilot program includes 100 firms; each firm can include up to five drugs. To be eligible firms must be able to trace their products from manufacture through entry to the United States. They also need a plan for recalling the drug or active ingredient. Qualify- ing firms receive expedited entry of select products through customs (FDA, 2009b). The FDA and U.S. Customs and Border Protection agency are currently defining how to expedite entry. The solution will make use of the
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225 DOMESTIC ACTION BOX 6-3 The Food Safety Inspection Service The Food Safety and Inspection Service (FSIS) is the office within the USDA “responsible for ensuring that domestic and imported meat, poultry, and egg products are safe, wholesome, and accurately labeled” (FSIS, 2009). Meat imported into the United States must meet the same safety, quality, and labeling standards required of domestically produced meat. In order to assure this, the FSIS only allows importation of meat that has gone through its rigorous approval protocol that covers the entire import process (FSIS, 2009). Any country that wants to export meat to the United States must undergo an FSIS inspection and certification process called an equiva- lence determination process. This certification evaluates the meat inspec- tion processes of the exporting country. If the export inspection protocol in place is deemed equivalent to U.S. domestic inspection protocol, the country may be granted eligibility. By setting the standard at equiva- lence, the FSIS ensures products of equal quality without requiring that exporting countries conform to exact U.S. inspection procedures. Within a country, each producer wishing to export meat to the United States must undergo a similar certification. The evaluation process includes both offsite assessment of written protocols and procedures and an onsite inspection by an FSIS team. Both elements stress five primary categories of risk assessment as established by the FSIS: animal disease controls, sanitation controls, residue controls, slaughter and processing controls, and controls for enforcement. Countries and sites are periodi- cally reevaluated to ensure ongoing safety and equivalence. Countries and specific producers may lose eligibility, often temporarily, because of an outbreak of a disease affecting livestock or other adverse health conditions (FSIS, 2009, 2011). After the appropriate export country inspection paperwork has been filed, meat is re-inspected by an FSIS inspector before it is allowed past the port of entry. Products that are approved during this second inspec- tion are allowed into the United States for sale and are treated no dif- ferently than domestically produced products from that point forward (FSIS, 2009). Equivalent inspection practices, rather than identical ones, must be accepted by importing countries under the guidelines set forth by the WTO, specifically the Sanitary and Phytosanitary Measures (SPS) agreement. The SPS agreement concerns the international trade in food, animal, and plant products. As with all WTO agreements, the SPS agree- ment seeks to limit barriers to international trade, in part by ensuring that developing countries, often using less technologically advanced equip- ment, are not unfairly discriminated against. Regardless of the exact measures in place, if exports are of a suitable standard, then they must be treated as such (WTO, 2012).
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226 ENSURING SAFE FOODS AND MEDICAL PRODUCTS Customs-Trade Partnership Against Terrorism program, which offers prior- ity processing for products from companies with secure supply chains. The Secure Supply Chain pilot aims to enable FDA to determine the practicality of using a secure supply chain program to prevent importing sub-standard drugs (FDA, 2009b). The committee suggests that this program be evalu- ated immediately after its pilot phase and implemented and expanded, if successful, to include a greater number of importers and to food. INCREASING CIVIL LIABILITY Appendix B describes how the civil liability system, so essential to product safety in the United States, is flawed in low- and middle income countries, and so does not deter faulty manufacturing. Recommendation 6-8: Over the next 10 years, U.S. government agen- cies 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. The establishment of mechanisms that increase liability will measure this recommendation. This process will be slow, and it will require major revisions to the status quo that involves multiple government agencies. It is unlikely these changes could be made in less than 10 years. Product Liability in Developed Countries The U.S. legal system has two ways to ensure food and medical product safety. The first way is the regulatory framework built around the Federal Food, Drug, and Cosmetic Act; regulatory framework is the primary focus of the current report. Recent legislation has provided the FDA with a vari- ety of new tools with which to enforce this regulatory framework for both foods and medical products. If there is a sufficient likelihood that food is adulterated or misbranded, the FDA may administratively detain products or mandate a recall if there is reasonable probability that food will cause “serious adverse health consequences or death to humans or animals.”13 Food production facilities must register with the FDA in order to intro- duce their products into U.S. interstate commerce; the FDA can suspend that registration if there is reasonable probability that the food from that facility will harm humans or animals.14 The Food and Drug Administra- tion Amendments Act of 2007 also expanded the legal tools FDA uses to 13 21 USC 350(l). 14 21 U.S.C. 350(d)(a).
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227 DOMESTIC ACTION ensure drug and vaccine safety. The FDA may withdraw approval from a marketed drug or biologic,15 order labeling changes or the inclusion of package inserts about new safety information and recommendations,16 mandate postmarket observational studies or clinical trials to assess risks,17 and require sponsors to have strategies to ensure that the benefits of a drug will outweigh its risks.18 In general, most violations of the Federal Food, Drug, and Cosmetic Act are also subject to criminal enforcement, but few are subject to civil enforcement (Hutt et al., 2007). The second way that the U.S. legal system ensures food and medical product safety in the United States is product liability. Entities involved in the manufacture, distribution, and marketing of a food or drug product to the public are obligated under U.S. common law and, in some cases, U.S. federal and state statutes to ensure the safety of that product. Individuals that suffer harm from that food or drug product in the United States may bring a civil lawsuit against the manufacturers, importers, distributors, and marketers of that product. Any entity with significant contacts with the United States is potentially subject to the jurisdiction of U.S. courts. Redress is typically monetary compensation to cover the damages incurred by the injured party, but it may also involve punitive damages. Product liability plays an essential role in ensuring food and drug safety in the United States. The volume of commerce in FDA-regulated food and medical products far exceeds the resources and legal authority that FDA has to monitor and enforce the safety of those products. The threat of product liability suits, high litigation costs, and reputational damage help fill the gap by providing a significant economic incentive to companies to maintain and improve the safety of their products. Ultimately, it is retailers and manufacturers that are best able to ensure the safety of their products. There are limits to the role of product liability in imports. First of all, the FDA does not have jurisdiction in foreign markets, and even when its staff is permitted to inspect foreign establishments there are practical chal- lenges to working in a new country and in a different language. Further- more, U.S. plaintiffs have limited ability to litigate and enforce judgments against foreign firms with few U.S. contacts or assets. It is difficult for Americans to bring lawsuits against foreign firms in foreign country courts for injuries that occurred in the United States (Appendix B). U.S.-based importers and distributors may be able to avoid product liability when there is doubt that they knew or should have known about their suppliers’ actions (Bamberger and Guzman, 2008). It may be difficult for consumers 15 21 USC 355(e). 16 21 USC 355 (o) and 21 USC 355(r). 17 21 USC 355 (k)(3). 18 21 USC 355-1.
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228 ENSURING SAFE FOODS AND MEDICAL PRODUCTS to establish accountability for unsafe products when the supply chain is so complicated (Bamberger and Guzman, 2008). With the possibility of more limited liability, manufacturers and distributors of imported products may not have the same market incentives as their U.S. counterparts for continual improvement in consumer safety. Congress and U.S. government agencies (including, but not limited to, the Department of Justice, the Department of the Treasury, and the U.S. Trade Representative) should consider measures to strengthen the ability of those harmed by unsafe food and medical products to hold foreign pro- ducers, exporters to the United States, and U.S. importers of foreign prod- ucts liable. Congress could increase appropriations for criminal enforcement of the Federal Food, Drug, and Cosmetic Act or amend it to make violations subject to civil penalties. The FDA could issue more stringent guidance for high-risk drugs and foods, such as requiring importers to maintain a staff person at each foreign production facility for high-risk products (Bollyky, 2009). Scholars have made other thoughtful proposals to increase liability. The issuing of bonded warranties would oblige sellers to pay statutory dam- ages to people injured by unsafe products (Baker and Moss, 2009). Another option would be using discriminatory strict liability with damages based on the risk posed by the product and by the importer’s history (Bamberger and Guzman, 2008). Finally, developing country governments seeking to im- prove the safety of their food and drug production should consider measures to facilitate the ability of domestic consumers to hold firms accountable in civil suits for the harms caused by unsafe products (Appendix B). CONCLUSION During its meetings, the committee heard from FDA staff about the agency’s current work in capacity building and the challenges it faces in protecting the U.S. food and medical products supply. The committee com- mends FDA on its work, but sees some areas where it might improve its operations. First, it should use an enterprise risk management system to identify its most important priorities. That is, it should use risk to inform all its staffing and training decisions, not just its inspections. In the next 3 to 5 years, the FDA should use enterprise risk management to inform its work abroad, but eventually the committee recommends that it use this tool to plan its domestic work as well. The committee recognizes that Congress might need to revise the laws governing FDA for this to happen. The agency’s use of risk will depend on reliable data collection. A modern information and informatics strategy will allow the agency to col- lect and analyze data promptly. The FDA’s PREDICT system is a step in the right direction. The committee believes that in the next 10 years the agency should work toward a paperless system in its own operations and
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229 DOMESTIC ACTION in its dealings with its counterpart agencies abroad. The first step toward this system would be the development of a standard data format and vo- cabulary, which could be developed in 3 to 5 years. Regulators around the world need training on how to respond to the challenges of globalization. FDA has the technical depth and international presence to contribute to an ongoing, standing regulatory science and policy college, but developing this college will take a decade. In the meantime, the agency can work with universities and through existing training networks to make better training opportunities available. The FDA’s staff college is an exemplary training center that should be a model for an international regulatory science and policy college. In the next 3 to 5 years, FDA could require their staff to take courses on the international implementation of and compliance with American regulations. In the longer term, that is, in the next decade, FDA could work to develop a training program like the CDC’s Field Epidemiology Training Program. Involving industry and aca- demia in these efforts will also set a valuable example. The United States could also lead by example in its consistent use of international product standards. Harmonized standards make the market more predictable for foreign investors and exporters. USAID and other agencies can demonstrate U.S. commitment to harmonized standards by empowering scientists in low- and middle-income countries to participate actively in standard setting meetings. Over the next decade, product safety objectives should be fully integrated into U.S. foreign policy. The United States could also set a powerful example for industry and government around the world by expanding the one-up, one-back, track and trace requirements for food and medical products. The committee real - izes that this would be complicated, but believes that the FDA could make progress by holding a public workshop on expanding one-up, one-back in the next year. This workshop should include international stakeholders from government, industry, and academia. There is great potential for innovation in American universities. The government should, starting in the next 2 years, encourage research into simple and elegant technology that will help small-scale producers prevent fraud and control their supply chains. Similarly, the government can im- prove supply chain management by giving market incentives that reward supply chain management. The committee is especially impressed by the FDA’s Secure Supply Chain pilot program. The 2014 evaluation for this pilot should consider how to best expand this program to include a greater number of producers. Market incentives can do much to improve the safety of the food and medical products used around the world. The committee also sees value in increasing civil liabilities on foreign importers over the next 10 years.
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