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Appendix D Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad BOX D-1 Statement of Task from the 2012 Report The FDA has requested that the Institute of Medicine convene a consensus study to assist the FDA in: (A) Identifying the core elements of needed pharmaceutical, biologics, medical device, and food safety regulatory systems development in developing countries; and in (B) Prioritizing these needs and recommending a strategic approach to the FDAâs moving forward to address regulatory capacity needs in the context of globalization. In addition to identifying and prioritizing the core elements of regulatory systems development, the consensus study would also identify: (C) Potential areas in which progress could be made in a 3- to 5-year e frame; (D) e frame; (E) Priorities for FDA engagement; (F) Areas to which others (bilateral donors, development banks, foundations, academia, industry, and non-governmental organizations) are best suited to contribute; and (G) How the FDA might best âpartnerâ with these other institutions to bring to their efforts the expertise that the FDA has in an effort to leave a more sustainable âfootprintâ from both their and the FDA resource commitments. Specific questions to be explored by the Consensus Study Committee shall at least include: 1. What critical issues do developing country regulatory authorities face, and how are they prioritized? 2. In what ways do they participate in standard-setting processes, organizations, and harmonization efforts? 3. What issues do they face in utilizing/implementing standards in a sustainable way? 4. What are the core elements of their regulatory systems, and are there others that should be considered? 5. What are the major gaps in systems, institutional structures, workforce, and competencies? 6. In what ways could those gaps be addressed? 7. In what ways could the U.S. FDA help address those gaps? 8. In what ways could others (as delineated above) help meet those gaps? 9. In what ways could the FDA partner with others to help meet those gaps? PREPUBLICATION COPY: UNCORRECTED PROOFS D-1
D-2 STRONGER REGULATORY SYSTEMS ABROAD BOX D-1 Continued 10. What recommendations have already been put forward to strengthen regulatory systems? 11. What obstacles exist to implement those recommendations? 12. What steps could be taken to remove those obstacles? 13. What incentives and controls would be needed to support efforts? Given that âdeveloping countriesâ include a heterogeneous group of about 150 low- and middle-income countries, for the purposes of this study emphasis will be given to understanding in some depth the issues for a limited number of countries that currently are or are expected to soon become major pharmaceutical and agricultural trading partners with the United States (e.g., Mexico, Brazil, South Africa, India, Thailand, and China). SOURCE: (Institute of Medicine, 2012) TABLE D-1 Recommendations from the 2012 report Type Recommendation International Recommendation 5-1: In the next 3 to 5 years, international and Action intergovernmental organizations should invest more in strengthening the capacity of regulatory systems in developing countries. The United States should work with interested countries to add it to the G20 agenda. Investments in international food and medical product safety should be a significant and explicitly tracked priority at development banks, regional economic communities, and public health institutions. International organizations should provide assistance to achieve meaningful participation of developing country representatives at international harmonization and standardization meetings. Recommendation 5-2: In emerging economies, national regulatory authorities, regulated industry, and industry associations should engage in open and regular dialogue to exchange scientific and technical information before policies are written and after they are implemented. Starting in the next 3 to 5 years, these regulatory authorities should identify third parties, such as science academies, to convene the three pillars of a regulatory systemâgovernment, industry, and academiaâin ongoing discussion to advance regulatory science, policy, and training. Recommendation 5-3: Countries with stringent regulatory agencies should, within the next 18 months, convene a technical working group on sharing inspection reports with the longer-term goal of establishing a system for mutual recognition of inspection reports. Recommendation 5-4: Industry associations should, over the next 3 years, define an acceptable protocol for sharing of internal inspection results among their members. After agreeing on the methods, they should regularly share their results among their members. Recommendation 5-5: Starting in the next 5 years USAID, FDA, CDC, and USDA should provide (both directly and through WHO and FAO) PREPUBLICATION COPY: UNCORRECTED PROOFS
APPENDIX D D-3 technical support for strengthening surveillance systems in developing countries. This technical support could include development and sharing of surveillance tools, protocols for foodborne disease surveillance and post market surveillance of medical products, and training of national regulatory authority staff and national experts. Domestic Action Recommendation 6-1: FDA should use enterprise risk management to inform its inspection, training, regulatory cooperation, and surveillance efforts. Enterprise risk management should apply to the agencyâs entire operation, and it should incorporate a number of set criteria such as country of manufacture or production, volume and type of product, facility inspection history, and trends or data shared from other regulatory authorities. Recommendation 6-2: FDA should develop an information and informatics strategy that will allow it to do risk-based analysis, monitor performance metrics, and move toward paperless systems. In the next 3 to 5 years, the FDA should propose, in all its international harmonization activities, a standardized vocabulary, a minimum data set to be collected, and the frequency of data collection. Recommendation 6-3: The FDA should facilitate training for regulators in developing countries. The purpose is workforce training and professional development through an ongoing, standing regulatory science and policy curriculum. In the next 3 to 5 years, the FDA should broaden the scope of FDA University to educate FDA staffers on international compliance with its regulations. In the long term, the FDA should consider the options the committee puts forth in this chapter. Recommendation 6-4: U.S. policy makers should integrate food and medical product safety objectives into their international economic development, trade, harmonization, and public health work. To this end, the FDA should lead in the development and adoption of international and harmonized standards for food and medical products. Recommendation 6-5: FDA, which currently requires one-up, one-back track-and-trace requirements for food, should, in the next year, hold a multi- sector, international, public workshop on applying them to medicines, biologics, and (when appropriate) to devices. Recommendation 6-6: Starting in the next 2 years, the FDA and USDA should implement Cooperative Research and Development Agreements and other programs to encourage businesses and academia to research and develop innovations for low-cost, appropriate fraud prevention, intervention, tracking, and verification technologies along the supply chain. Recommendation 6-7: FDA should ensure an adequate mix of incentives to importers of food and medical products that are confirmed to meet U.S. regulatory standards. One such promising initiative is the 2-year FDA Secure Supply Chain pilot program. The FDA should evaluate this program immediately after its pilot phase (scheduled to end in 2014). The program should be expanded, if successful, to include a greater number of importers and food. PREPUBLICATION COPY: UNCORRECTED PROOFS
D-4 STRONGER REGULATORY SYSTEMS ABROAD Recommendation 6-8: Over the next 10 years, U.S. government agencies should work to strengthen the ability of those harmed by unsafe food and medical products to hold foreign producers and importers liable in civil lawsuits. SOURCE: (Institute of Medicine, 2012) TABLE D-2 Gaps in Regulatory Systems in Developing Countries Gaps Problems Food Systems Medical Product Systems Adherence to international â¢ Lack of awareness of public â¢ Problems adhering to quality standards health risks standards â¢ Lack of funding and â¢ Lack of funding for quality- expertise control laboratories â¢ Lack of adherence to â¢ Challenges implementing manufacturing and good manufacturing practices agricultural standards â¢ Inconsistent adherence to international research standards Controlling supply chains â¢ Lack of good transportation â¢ Inefficient post-market and storage surveillance â¢ Inadequate equipment â¢ Lack of optimal storage â¢ Lack of modern information technology and supply chain management Infrastructure â¢ Lack of laboratories, manufacturing, and market infrastructure â¢ Lack of information technology and communication â¢ Lack of reliable electricity, water sanitation, and pest control â¢ Lack of adequate roads Laws â¢ Outdated or poorly coordinated laws governing food or drug safety â¢ Lack of enforcement of existing regulations Workforce â¢ Too few regulatory staff â¢ Insufficient technical training for staff â¢ Problems retaining staff Institutional fragmentation â¢ No clear assignment of responsibilities or established protocol for enforcement, unclear chain of command â¢ Lack of established communication channels between and within agencies PREPUBLICATION COPY: UNCORRECTED PROOFS
APPENDIX D D-5 Surveillance â¢ Passive foodborne disease â¢ Lack of pharmacovigilance surveillance systems â¢ Lack of food chain security â¢ Passive or spontaneous and information sharing adverse event reporting â¢ Lack of active and postmarket surveillance Communication â¢ Lack of communication within a regulatory authority and across government agencies that share regulatory responsibility â¢ Lack of communication between regulatory authorities and regulated industry â¢ Lack of communication between the regulatory authority and the public â¢ Lack of communication with counterpart regulatory agencies abroad Political will â¢ Competing priorities and limited budgets â¢ Corruption and lack of accountability SOURCE: (IOM, 2012) BOX D-2 Essential Elements of Food and Medical Product Regulatory Systems Government is the foundation for a strong regulatory system. As the national standard-setting body, governments: â¢ use science and risk as a basis for developing policy; â¢ participate in international cooperation and harmonization of standards; â¢ make ethical decisions; and â¢ recognize, collect, and transmit evidence when breaches of law occur. A food and medical product regulatory system integrates: â¢ product safety through good manufacturing, clinical, laboratory, and agricultural practices; â¢ staff development and training for employees; â¢ monitoring and evaluation of product quality using laboratories; â¢ inspection and surveillance of products throughout the supply chain; â¢ risk assessment, analysis, and management; and â¢ emergency response. Protecting the publicâs health is crucial in a food and medical product regulatory system. The system needs to quickly communicate information to the public in emergencies to ensure the publicâs safety. SOURCE: (IOM, 2012) PREPUBLICATION COPY: UNCORRECTED PROOFS
D-6 STRONGER REGULATORY SYSTEMS ABROAD REFERENCE IOM (Institute of Medicine). 2012. Ensuring safe foods and medical products through stronger regulatory systems abroad. Washington, DC: The National Academies Press. PREPUBLICATION COPY: UNCORRECTED PROOFS