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Appendix H Strengthening Core Elements of Regulatory Systems in Developing Countries: Identifying Priorities and an Appropriate Role for the U.S. Food and Drug Administration SECTION B: BACKGROUND AND OBJECTIVE There is increasing recognition within the U.S. Food and Drug Admin- istration (FDA) of the need to engage more strategically in the arena of global regulatory technical assistance and to harness more effectively the potential for multiple, cascading benefits of FDA’s and others’ investments in this domain. Strengthening regulatory capacity is immensely important to the FDA’s ability to better monitor and ensure the safety of the supply chain for food, feed, medical products, and cosmetics that enter the United States and is part of the FDA’s regulatory remit to assure the quality and safety of these products at home. The FDA is responsible for tens of millions of shipments of such com- modities every year, as exemplified by the 40 percent of fresh fruit and produce in the United States that comes from other countries and the approx- imately 80 percent of active pharmaceutical ingredients in drugs consumed in the United States. A very large percentage of source countries represent developing economies with varying levels of regulatory oversight. Thus, we have a strong national interest in making sure that the countries of origin of these products have regulatory systems that apply, utilize, and enforce stan- dards that support product safety comparable to that in the United States. The FDA is in a position to help lead efforts with its well-recognized strength as one of the global regulatory “gold standards,” and FDA’s advice and col- laboration is generally welcomed. In the case of food safety, around the globe, the 20th-century paradigm of a focus on food safety intervention at ports-of-entry is shifting to a 345
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346 ENSURING SAFE FOODS AND MEDICAL PRODUCTS focus on accountability of those involved in the food enterprise from farm to table, and accompanying national authorities’ regulatory capacity and systems to set standards and to help assure that accountability. This global shift suggests that the FDA’s leadership in developing risk-based approaches and preventive controls in support of food safety could contribute to new, normative global standards to be adopted through a multitude of networks, partnerships, and information-sharing venues. In the case of medical products, drug falsification is growing in com- plexity, scale, geographic scope, and negative public health impact. Data limitations prevent public health policy makers from addressing adequately the issues surrounding falsified medicines in a comprehensive, systematic, and sustainable way. Increasing international trade of pharmaceuticals and sales via the Internet has further facilitated the entry of falsified products into the normal supply chain. Combating falsified medicines requires col- laboration at national, regional, and international levels, involving a diverse range of stakeholders. Equally important, strengthening regulatory capacity in the developing world will reap tremendous benefits for the health and quality of life of individuals and communities in those countries. Stronger regulatory sys- tems in other countries can help to bolster current U.S. government (USG) investments being made in public health and development, e.g., through the President’s Global Health Initiative and USG agencies, as well as U.S. contributions through multilateral organizations, and the broader global health and development community. These efforts increasingly embrace the principles of health systems strengthening, government ownership, and universal coverage. Regulatory frameworks, authorities, and institutions need to be seen as central to these efforts in assuring the safety and qual- ity of food and medical products, and in securing the full benefits of those investments; and networks of regulators need to be linked to the broader global health community. Good regulation that assures the quality and safety of food and medical products is as fundamental to the success of a health system as is the quality of any other components of a health system. There is also much opportunity and need for greater efficiency and sus- tainable impact in complementing what has traditionally been a commodity- based approach with a systems approach to the FDA’s global engagement and what has been a traditionally ad hoc approach with what should be a sustainable, strategic approach. We need to explore the benefits and chal- lenges of strengthening regulatory systems through dialogue and carefully delineated strategies that align well with the FDA’s mission and that allow us to partner with others, both in the regulatory arena and in the broader global health arena.
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347 APPENDIX H SECTION C: DESCRIPTION/SPECIFICATION/WORK STATEMENT FDA has requested that the Institute of Medicine convene a consensus study to assist FDA in (1) identifying the core elements of needed regula- tory systems development in developing countries; and (2) prioritizing these needs and recommending a strategic approach to FDA’s moving forward to address regulatory capacity needs in the context of globalization. In addi- tion to identifying the core elements of regulatory systems development, the consensus study would also identify potential areas in which progress could be made in a 3- to 5-year timeframe; priorities for FDA engagement; and areas to which others (bilateral donors, development banks, founda- tions, academia, industry and non-governmental organizations) are best suited to contribute and how FDA might best “partner” with these other institutions to bring to their efforts that expertise that FDA has in an effort to leave a more sustainable “footprint” from both their and our resource commitments. Questions to be explored by the consensus study committee shall at least include 1. What critical issues do developing country regulatory authorities face? 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, work- force 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 FDA partner with others to help meet those gaps? 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?
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348 ENSURING SAFE FOODS AND MEDICAL PRODUCTS WORK PLAN Committee on Regulatory Systems Capacity in Developing Countries A multi-disciplinary committee of members comprised of global health thought leaders with expertise in regulatory affairs and health systems and representing developed and developing country regulatory authorities shall be assembled. The committee shall meet a number of times to conduct its work. The Committee shall meet once for presentation of the charge and discussion with the sponsors (in open session) and to develop a work plan (in closed, deliberative session). Preliminary input into critical issues, gaps and priorities for developing country regulatory authorities will be given. (Questions 1-3) The second meeting shall focus on Questions 4-6, defining the core ele- ments of regulatory systems and gaps in systems, institutional structures, workforce, and competencies. The third meeting shall include a public session with invited speakers to initiate discussions related to Questions 7, 8, and 9 (ways the FDA could address those gaps and the roles of others in meeting needs). The Committee shall then meet two additional times in closed session to develop a consensus report with recommendations on strengthening regulatory systems, identifying barriers and obstacles, ways to address those obstacles, and incentives and controls (Questions 10-13). Product and Dissemination Plan One consensus report shall be produced, with the potential for deriva- tive publications in peer-reviewed journals. Staffing The core staff for the project shall include a senior program officer who will be the lead study director for the committee (100%); an associate pro- gram officer who will assist in all committee activities (100%); and a senior program assistant who will provide project administrative support (100%). The core team will be supplemented by a financial associate (5%) and board administrative assistant (5%). The director of the Board on Global Health will provide general guidance and oversight and technical support at 15%. Timeframe The timeframe for the Consensus Study would be 15 months, from September 2010 to December 2011.