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IOM Report Lays Out a Blueprint for Improving Regulatory Systems Worldwide

IOM Report Lays Out a Blueprint for Improving Regulatory Systems Worldwide The emergence of the global economy is affecting the supply chains of food and medical products, raising public health and safety concerns throughout the world. To combat the situation, governments are looking at improving regulatory systems to ensure that medical products and foods are safe regardless of where they are produced or consumed. In the United States, the supply chain issue has drawn the attention of Congress and the Food and Drug Administration (FDA) because an estimated 80% of active pharmaceutical ingredients and 40% of finished drugs come from abroad. Food is also a concern, as it is also increasingly imported; for example, about 85% of seafood consumed in the United States is from abroad. The US Food and Drug Administration is hoping for international cooperation among governments and industry to help ensure the safety of the increasingly worldwide food and medical products supply chains. Problems are also being imported. Contaminated heparin made in China caused 150 deaths in the United States in 2007. In 2011, counterfeit Avastin (bevacizumab), suspected to have been made somewhere in the Middle East, was discovered being shipped through the United Kingdom to US medical facilities. In 2007, some pet foods containing vegetable proteins imported into the United States from China were recalled after the FDA learned they were sickening and killing cats and dogs. Members of Congress have told the FDA they want the agency to be more active in overseeing imported medical products and food. However, a lack of funding and mandated priorities that focus on domestic production prevent the agency from providing robust oversight of products made abroad. In turn, the FDA is asking Congress to provide the necessary funding and legislation that could make the agency more effective at ensuring the safety of imports. FDA leaders have pointed out that a key element to more effective oversight would be to allow for more cooperation among regulatory agencies domestically and around the world. To aid in its arguments, the FDA commissioned a report by the Institute of Medicine (IOM), “Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad,” which was released April 4 (http://tinyurl.com/74pegz6). In the foreword to the report, IOM President Harvey V. Fineberg, MD, PhD, wrote about the supply chain issue: “Domestic programs, however, regardless of how well they are coordinated, will not be sufficient for the task. The integrated global economy demands cooperation across borders—to thwart terrorists, reduce environmental hazards, and ensure that our food and medical products are safe and effective. This requires coordination across both industrialized trading partners and emerging economies that have not had the benefit of decades of legal and technical development to ensure the safety of food and medical products.” The IOM report suggested that the FDA take the lead in assisting other countries in developing their own effective regulatory systems. In turn, these countries could then provide safety and quality data for their own medical products and food that would assure the FDA that those products will not harm users in the United States. But the FDA does not want this leadership role to be perceived as a top-down relationship with other countries, said Mary Lou Valdez, MSM, associate commissioner of the agency's Office of International Programs. “We commissioned the IOM study to initiate a dialogue within the global community about the essentialness of strengthening regulatory systems in developing countries,” said Valdez, who noted that the IOM's 12-person writing committee included members from China and Brazil. “What folks do not appreciate is that it is essential for countries to have strong regulatory processes to improve their own public health outcomes and to lead to better, more robust, economies.” Jim E. Riviere, DVM, PhD, chair of the IOM writing committee, agreed that international cooperation is crucial. “The regulatory system seems reactive, and this is an underlying problem; FDA has 20 million product lines to worry about. There need to be changes, and the agency realizes it cannot do it alone,” said Riviere, who is also director, Center for Chemical Toxicology Research and Pharmacokinetics, College of Veterinary Medicine, North Carolina State University in Raleigh. Another hurdle facing the FDA is how it is structured. The agency was formed when the production of foods and drugs was primarily handled by domestic operations. As such, the FDA split its oversight between domestic and foreign production, emphasizing regulating foods and drugs produced in the United States, with the trade-off being less emphasis on overseas regulation. Riviere said that structure is no longer viable today. “There needs to be a complete shift between domestic and foreign oversight and a realization that we are in an international economy,” he said. Critical issues A program of partnerships with regulatory systems in other countries faces some sizable hurdles. The IOM report identified the following critical issues in creating food and medical product safety systems in developing countries: Adherence to international standards. The least developed countries often lack the scientific expertise to send advocates to international meetings for setting standards, meaning these countries become standard takers and not participants in standard setting. Controlling supply chains. Inventory planning and managing demand are difficult in places that have neither reliable transportation infrastructure nor sufficient managerial expertise in the health workforce. Infrastructure. Deficits in infrastructure, such as the lack of pest control or refrigeration, are a key factor in supply chain control. Also, quality control laboratories are few, and the ones that do exist often suffer from outdated equipment or an unreliable power supply. Laws. Some countries have no laws governing product safety while others have laws that are confusing or contradictory. Workforce. Regulatory agencies in some countries suffer from too few staff, inadequately trained workers, trouble retaining staff, and problems with morale. Corruption is both a cause and an effect of many of the workforce problems. Fragmentation. Regulatory responsibilities in low- and middle-income countries are often scattered among many different agencies, so the inability to coordinate among the agencies becomes a problem. Surveillance. Systems to evaluate emerging safety signals are poor, making it difficult to effectively monitor medical product safety, track epidemics, or perform risk analyses. Communication. This can be a problem not only among multiple regulatory agencies within a country, but also within the agencies themselves, between the agencies and industry and consumer groups, and among different nations' regulatory agencies. Political will. Product safety is not a high priority in countries with skeletal health systems, poor sanitation, and high mortality. And ironically, the vast increase in foreign aid for health over the last 10 years has had an unintended consequence of decreasing national governments' allocations to health, to the detriment of food and medical product safety. Recommendations The writing committee made 13 specific recommendations it believes will improve product safety and public health around the world, including the following: International and intergovernmental organizations should invest more in strengthening regulatory systems in developing countries. Investments in international food and medical product safety should be a significant and explicitly tracked priority for development banks, regional economic communities, and public health institutions. In emerging economies, national regulatory authorities, regulated industry, and industry associations should engage in open and regular dialogue to exchange expert scientific and technical information before policies are written and after they are implemented. Countries with stringent regulatory agencies, such as the United States, European Union member states, and Japan, should, within the next 18 months, convene technical working groups on sharing inspection reports with the longer-term goal of establishing a system for mutual recognition of inspection reports. “This is a simple step that could reduce a great deal of waste,” the committee members wrote. “There is no need for American and European inspectors to duplicate each other's work, especially when a vast number of facilities go uninspected.” Industry associations should, over the next 3 years, define an acceptable protocol for sharing internal inspection results among their members. Currently, companies are hesitant to share what they consider proprietary information. Regulatory offices in the United States, such as the FDA and the Department of Agriculture, should provide technical support for strengthening surveillance systems in developing countries. This technical support should include development of surveillance tools, protocols for foodborne disease surveillance and postmarket surveillance of medical products, and training of national regulatory authority staff and national experts. Industry help wanted The Pew Health Group, which has testified before congressional committees advocating for improving the FDA's surveillance of medical product and food supply chains, is in general agreement with the findings and recommendations of the IOM report. Pew's own report, “After Heparin, Protecting Consumers From the Risks of Substandard and Counterfeit Drugs,” published last year, includes many of the same recommendations (http://tinyurl.com/6lplt8c). But all improvement in regulatory systems can be futile if businesses do not want to be monitored and simply move their operations to countries with less rigorous regulatory oversight, said Allan Coukell, director of medical programs at the Pew Health Group. “It's not like quality problems and disasters like heparin are in the best interests of the industry as a whole, and there are many companies working diligently to address this regulatory problem,” Coukell said. “But not all work as diligently.” Industry does appear interested in improving the supply chain. Pharmaceutical manufacturers and suppliers came together in 2009 to form Rx-360, an international pharmaceutical supply chain consortium of drug manufacturers, suppliers, auditors, and associations, to enhance quality and authenticity throughout the supply chain. Last year, Rx-360 established a supply chain security workgroup to develop and share best practices and information on security processes and to enhance collaboration among stakeholders. “No company wants safety problems that hurt patients and lower the confidence in their products,” said Martin Van Trieste, Rx-360 treasurer and the senior vice president of quality at Amgen. “If the American consumer loses confidence, many tragic consequences can occur.” Meanwhile, the FDA is working with Congress to address the supply chain safety issue. The agency wants additional legal authority; currently, it is barred from sharing certain nonpublic information with other regulatory agencies that might lead to timely identification, prevention, and resolution of emerging threats, and it cannot use foreign audit data collected by regulators in countries with strong oversight systems. The FDA also wants Congress to give it the ability to refuse admission of an import if inspection of the manufacturing facility is delayed, limited, or denied and to allow it to destroy unsafe drugs coming into the country through international mail. The agency also wants industry to assume its appropriate responsibility for imported products. Some of the FDA's requests could be fulfilled later this year when Congress takes up reauthorization of the Prescription Drug User Fee Act and considers creating a generic drug user fee program. These user fee programs allow the FDA to collect monies from drug makers to fund the drug approval process and certain drug safety programs. Coukell, who has testified at congressional hearings on the user fee programs, said he believes there is bipartisan agreement to increase FDA inspections of overseas drug plants (the FDA is mandated to inspect US facilities every 2 years, but there is no requirement for inspections outside the country); to inspect highest-risk facilities first; and to increase information sharing and collaboration among US regulatory agencies and with those in other countries. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

IOM Report Lays Out a Blueprint for Improving Regulatory Systems Worldwide

JAMA , Volume 307 (19) – May 16, 2012

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Publisher
American Medical Association
Copyright
Copyright © 2012 American Medical Association. All Rights Reserved.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.2012.4485
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Abstract

The emergence of the global economy is affecting the supply chains of food and medical products, raising public health and safety concerns throughout the world. To combat the situation, governments are looking at improving regulatory systems to ensure that medical products and foods are safe regardless of where they are produced or consumed. In the United States, the supply chain issue has drawn the attention of Congress and the Food and Drug Administration (FDA) because an estimated 80% of active pharmaceutical ingredients and 40% of finished drugs come from abroad. Food is also a concern, as it is also increasingly imported; for example, about 85% of seafood consumed in the United States is from abroad. The US Food and Drug Administration is hoping for international cooperation among governments and industry to help ensure the safety of the increasingly worldwide food and medical products supply chains. Problems are also being imported. Contaminated heparin made in China caused 150 deaths in the United States in 2007. In 2011, counterfeit Avastin (bevacizumab), suspected to have been made somewhere in the Middle East, was discovered being shipped through the United Kingdom to US medical facilities. In 2007, some pet foods containing vegetable proteins imported into the United States from China were recalled after the FDA learned they were sickening and killing cats and dogs. Members of Congress have told the FDA they want the agency to be more active in overseeing imported medical products and food. However, a lack of funding and mandated priorities that focus on domestic production prevent the agency from providing robust oversight of products made abroad. In turn, the FDA is asking Congress to provide the necessary funding and legislation that could make the agency more effective at ensuring the safety of imports. FDA leaders have pointed out that a key element to more effective oversight would be to allow for more cooperation among regulatory agencies domestically and around the world. To aid in its arguments, the FDA commissioned a report by the Institute of Medicine (IOM), “Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad,” which was released April 4 (http://tinyurl.com/74pegz6). In the foreword to the report, IOM President Harvey V. Fineberg, MD, PhD, wrote about the supply chain issue: “Domestic programs, however, regardless of how well they are coordinated, will not be sufficient for the task. The integrated global economy demands cooperation across borders—to thwart terrorists, reduce environmental hazards, and ensure that our food and medical products are safe and effective. This requires coordination across both industrialized trading partners and emerging economies that have not had the benefit of decades of legal and technical development to ensure the safety of food and medical products.” The IOM report suggested that the FDA take the lead in assisting other countries in developing their own effective regulatory systems. In turn, these countries could then provide safety and quality data for their own medical products and food that would assure the FDA that those products will not harm users in the United States. But the FDA does not want this leadership role to be perceived as a top-down relationship with other countries, said Mary Lou Valdez, MSM, associate commissioner of the agency's Office of International Programs. “We commissioned the IOM study to initiate a dialogue within the global community about the essentialness of strengthening regulatory systems in developing countries,” said Valdez, who noted that the IOM's 12-person writing committee included members from China and Brazil. “What folks do not appreciate is that it is essential for countries to have strong regulatory processes to improve their own public health outcomes and to lead to better, more robust, economies.” Jim E. Riviere, DVM, PhD, chair of the IOM writing committee, agreed that international cooperation is crucial. “The regulatory system seems reactive, and this is an underlying problem; FDA has 20 million product lines to worry about. There need to be changes, and the agency realizes it cannot do it alone,” said Riviere, who is also director, Center for Chemical Toxicology Research and Pharmacokinetics, College of Veterinary Medicine, North Carolina State University in Raleigh. Another hurdle facing the FDA is how it is structured. The agency was formed when the production of foods and drugs was primarily handled by domestic operations. As such, the FDA split its oversight between domestic and foreign production, emphasizing regulating foods and drugs produced in the United States, with the trade-off being less emphasis on overseas regulation. Riviere said that structure is no longer viable today. “There needs to be a complete shift between domestic and foreign oversight and a realization that we are in an international economy,” he said. Critical issues A program of partnerships with regulatory systems in other countries faces some sizable hurdles. The IOM report identified the following critical issues in creating food and medical product safety systems in developing countries: Adherence to international standards. The least developed countries often lack the scientific expertise to send advocates to international meetings for setting standards, meaning these countries become standard takers and not participants in standard setting. Controlling supply chains. Inventory planning and managing demand are difficult in places that have neither reliable transportation infrastructure nor sufficient managerial expertise in the health workforce. Infrastructure. Deficits in infrastructure, such as the lack of pest control or refrigeration, are a key factor in supply chain control. Also, quality control laboratories are few, and the ones that do exist often suffer from outdated equipment or an unreliable power supply. Laws. Some countries have no laws governing product safety while others have laws that are confusing or contradictory. Workforce. Regulatory agencies in some countries suffer from too few staff, inadequately trained workers, trouble retaining staff, and problems with morale. Corruption is both a cause and an effect of many of the workforce problems. Fragmentation. Regulatory responsibilities in low- and middle-income countries are often scattered among many different agencies, so the inability to coordinate among the agencies becomes a problem. Surveillance. Systems to evaluate emerging safety signals are poor, making it difficult to effectively monitor medical product safety, track epidemics, or perform risk analyses. Communication. This can be a problem not only among multiple regulatory agencies within a country, but also within the agencies themselves, between the agencies and industry and consumer groups, and among different nations' regulatory agencies. Political will. Product safety is not a high priority in countries with skeletal health systems, poor sanitation, and high mortality. And ironically, the vast increase in foreign aid for health over the last 10 years has had an unintended consequence of decreasing national governments' allocations to health, to the detriment of food and medical product safety. Recommendations The writing committee made 13 specific recommendations it believes will improve product safety and public health around the world, including the following: International and intergovernmental organizations should invest more in strengthening regulatory systems in developing countries. Investments in international food and medical product safety should be a significant and explicitly tracked priority for development banks, regional economic communities, and public health institutions. In emerging economies, national regulatory authorities, regulated industry, and industry associations should engage in open and regular dialogue to exchange expert scientific and technical information before policies are written and after they are implemented. Countries with stringent regulatory agencies, such as the United States, European Union member states, and Japan, should, within the next 18 months, convene technical working groups on sharing inspection reports with the longer-term goal of establishing a system for mutual recognition of inspection reports. “This is a simple step that could reduce a great deal of waste,” the committee members wrote. “There is no need for American and European inspectors to duplicate each other's work, especially when a vast number of facilities go uninspected.” Industry associations should, over the next 3 years, define an acceptable protocol for sharing internal inspection results among their members. Currently, companies are hesitant to share what they consider proprietary information. Regulatory offices in the United States, such as the FDA and the Department of Agriculture, should provide technical support for strengthening surveillance systems in developing countries. This technical support should include development of surveillance tools, protocols for foodborne disease surveillance and postmarket surveillance of medical products, and training of national regulatory authority staff and national experts. Industry help wanted The Pew Health Group, which has testified before congressional committees advocating for improving the FDA's surveillance of medical product and food supply chains, is in general agreement with the findings and recommendations of the IOM report. Pew's own report, “After Heparin, Protecting Consumers From the Risks of Substandard and Counterfeit Drugs,” published last year, includes many of the same recommendations (http://tinyurl.com/6lplt8c). But all improvement in regulatory systems can be futile if businesses do not want to be monitored and simply move their operations to countries with less rigorous regulatory oversight, said Allan Coukell, director of medical programs at the Pew Health Group. “It's not like quality problems and disasters like heparin are in the best interests of the industry as a whole, and there are many companies working diligently to address this regulatory problem,” Coukell said. “But not all work as diligently.” Industry does appear interested in improving the supply chain. Pharmaceutical manufacturers and suppliers came together in 2009 to form Rx-360, an international pharmaceutical supply chain consortium of drug manufacturers, suppliers, auditors, and associations, to enhance quality and authenticity throughout the supply chain. Last year, Rx-360 established a supply chain security workgroup to develop and share best practices and information on security processes and to enhance collaboration among stakeholders. “No company wants safety problems that hurt patients and lower the confidence in their products,” said Martin Van Trieste, Rx-360 treasurer and the senior vice president of quality at Amgen. “If the American consumer loses confidence, many tragic consequences can occur.” Meanwhile, the FDA is working with Congress to address the supply chain safety issue. The agency wants additional legal authority; currently, it is barred from sharing certain nonpublic information with other regulatory agencies that might lead to timely identification, prevention, and resolution of emerging threats, and it cannot use foreign audit data collected by regulators in countries with strong oversight systems. The FDA also wants Congress to give it the ability to refuse admission of an import if inspection of the manufacturing facility is delayed, limited, or denied and to allow it to destroy unsafe drugs coming into the country through international mail. The agency also wants industry to assume its appropriate responsibility for imported products. Some of the FDA's requests could be fulfilled later this year when Congress takes up reauthorization of the Prescription Drug User Fee Act and considers creating a generic drug user fee program. These user fee programs allow the FDA to collect monies from drug makers to fund the drug approval process and certain drug safety programs. Coukell, who has testified at congressional hearings on the user fee programs, said he believes there is bipartisan agreement to increase FDA inspections of overseas drug plants (the FDA is mandated to inspect US facilities every 2 years, but there is no requirement for inspections outside the country); to inspect highest-risk facilities first; and to increase information sharing and collaboration among US regulatory agencies and with those in other countries.

Journal

JAMAAmerican Medical Association

Published: May 16, 2012

Keywords: institute of medicine (u.s.)

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