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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
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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.
