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7
Conclusions and Priorities
This report is the product of the Institute of Medicine’s Committee on
Strengthening Core Elements of Regulatory Systems in Developing Countries’
deliberations. One task of this study was to identify the core elements of a
functional regulatory system. The committee described these elements, and
also what it sees as the minimal elements of a functional system, in Chapter 2.
The core elements of regulatory systems relate to specific responsibilities that
a regulatory authority takes to ensure product safety; the minimal elements
include processes that are necessary to allow government to function.
From March to December 2011 the committee visited key emerging
economies, spoke to representatives of the U.S. and various foreign govern-
ments, multinational and national food and medical product companies,
donor organizations, development banks, and universities. These meetings
informed the committee’s analysis of the main gaps in developing country
regulatory and product safety systems. A literature review complemented
this analysis. Table 4-1 describes how the committee used the problems
identified in Chapter 3 as its targets in forming its recommendations.
Chapters 5 and 6 describe the actions the committee believes would
protect the safety of the food and medical product supply and build the
capacity for reliable regulation in developing countries. As the study’s state-
ment of task (Box 1-1) points out, developing nations are a diverse group of
150 low- and middle-income countries. In its analysis the committee gave
more attention to those countries that trade substantially with the United
States, especially India, China, Thailand, South Africa, Mexico, and Brazil.
An interest in equity led it to give some attention to the problems of the
poorest countries as well.
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236 ENSURING SAFE FOODS AND MEDICAL PRODUCTS
The committee’s recommendations are informed by a perspective that
shares much with the Department of Health and Human Services’ Global
Health Strategy. The committee’s strategy had four main points: the pri-
macy of global public health, the importance of risk-based investments, the
usefulness of market incentives, and the necessity of international coordina-
tion. It recommended ways the Food and Drug Administration (FDA) can
use limited resources for maximum effect. The committee was not asked
to project the cost of these investments, nor did it have the proper data
or suitable expertise to do so, but it recommended a path for the FDA to
make the most of its limited resources and suggested other duties for other
government agencies, international organizations, industry, and universities.
ENTERPRISE RISK MANAGEMENT AS
A TOOL TO SET PRIORITIES
The value of enterprise risk management is central to the committee’s
recommendations and to its strategy for strengthening the capacity of
regulatory systems abroad. In order to set its priorities as an agency, the
FDA needs to undertake an agency-wide risk assessment, risk analysis, and
risk evaluation. This includes its capacity of building work. The committee
recommends that the FDA choose which foreign offices to scale up, what
topics to cover in trainings, and how to assign its staff using a scientific
risk analysis.
Some aspects of the FDA’s governing plan seem informed by modern
risk management. The agency has, for example, responded to globalization
by putting offices in India, China, Chile, and Mexico. Other agency deci-
sions, such as opening offices in Europe and the Middle East, seem on the
surface less grounded in scientific risk analysis. Ultimately, the committee
does not have access to the data that would inform the FDA’s risk assess-
ment, risk analysis, and risk evaluation framework. The FDA is in the best
position to undertake this project. The committee believes that the results
of a risk analysis could help Congress increase appropriations to the FDA
and give the agency latitude to shift its attention more to places outside of
the United States where much of the world’s food and medical products
are produced.
The committee is sensitive to the constraints the FDA’s limited budget
puts on its work. Given the current climate in Congress and the interna-
tional economic downturn it is unlikely that the FDA’s appropriations will
increase dramatically in the near future. Because of its limited budget the
FDA should consider working though existing networks, such as partner-
ing with universities on training programs, and should use enterprise risk
management to make the most of its modest budget.
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CONCLUSIONS AND PRIORITIES
A 3- TO 5-YEAR STRATEGY FOR THE FDA
The committee realizes that only the FDA has all the information nec-
essary to rank its priorities, and it can best do this through enterprise risk
management, dependent on quality data collected using modern information
systems. Recommendations 6-1 and 6-2 address these needs. A full over-
haul of the FDA informatics and information strategies will probably take
a decade; reorganizing the FDA would also take a long time. However, the
committee outlined steps toward these goals that can be met in the next 3
to 5 years. First among these is the use of enterprise risk management to al-
locate funding and staffing to the FDA’s foreign programs. Only over time,
after Congressional approval, could the agency make similar adjustments
to align its domestic actions with risk management principles. Similarly, the
paperless information system envisioned in Recommendation 6-2 is probably
at least 8 years away. But in the next 3 to 5 years, the FDA can identify a
standardized vocabulary and data collection method to use in its interna-
tional activities.
In general, building strong regulatory systems abroad will be a long
process, and success will be incremental. However some steps of the recom-
mendations put forth in Chapters 5 and 6 can be reached in the next 3 to
5 years. The committee sees these recommendations as practical steps the
FDA can take to improve product safety worldwide. Therefore, in the next
3 to 5 years the FDA should:
1. Join the regulatory authorities of the European Union, Canada,
Japan, Norway, Iceland, Switzerland, Australia, and New Zealand
in a working group on sharing inspections, making a plan for a sys-
tem of mutual recognition of inspections to eliminate the wasteful
duplication of work among similarly rigorous regulatory agencies
(Recommendation 5-3).
2. Work (as one of several U.S. government agencies charged in Rec-
ommendation 5-5) to strengthen pharmacovigilance and foodborne
diseases surveillance systems in developing countries. The agency
has technical depth in surveillance that it can channel to developing
countries both directly and thorough World Health Organization
(WHO) and Food and Agriculture Organization of the United Na-
tions (FAO).
3. Use enterprise risk management to focus its international pro-
grams, trainings, and offices (Recommendation 6-1).
4. Develop an informatics strategy that will eventually allow the FDA
to move to a paperless system and articulates a standard data for-
mat and vocabulary (Recommendation 6-2).
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238 ENSURING SAFE FOODS AND MEDICAL PRODUCTS
5. Revise the curriculum of the FDA staff college to better educate its
employees on the international ramifications of compliance with
U.S. regulations, while working through universities and existing
networks to train regulators abroad (Recommendation 6-3).
6. Lead in the development and adoption of international standards
for food and medical products. The committee acknowledges the
leadership the United States shows in developing international
standards, but it believes U.S. adoption of harmonized standards
leaves something to be desired (Recommendation 6-4).
7. Give serious, public consideration to expanding the one-up, one-
back, food traceability requirements to medical products (Recom-
mendation 6-5).
8. Issue Cooperative Research and Development Agreements and other
tools to encourage research into frugal technologies for fraud pre-
vention, supply chain management, tracking, and verification that
would be useful in developing counties (Recommendation 6-6).
9. Evaluate the Secure Supply Chain Pilot program in 2014 with a
plan to scale up the program (Recommendation 6-7).
POLITICAL WILL TO IMPLEMENT THE
COMMITTEE’S RECOMMENDATIONS
In their public statements over the past 2 years, the Department of
Health and Human Services (HHS) and its subordinate agencies, espe-
cially the FDA, have shown a commitment to responding to the challenges
brought on by globalization. The department’s Global Health Strategy
reflects political will for the changes the committee recommends. The strat-
egy’s first objective is to enhance global surveillance for disease and health
concerns (HHS, 2011). This is consistent with the committee’s recommen-
dation that the FDA, Centers for Disease Control and Prevention (CDC),
U.S. Department of Agriculture (USDA), and U.S. Agency for International
Development (USAID) should provide technical training in pharmacovigi-
lance and foodborne disease surveillance.
The Global Health Strategy also gives some attention to improving
the safety of the global supply chain for food and medical products (HHS,
2011). The committee believes that market incentives can strengthen the
global supply chain and that access to hard-currency markets such as the
United States can be that incentive. The Secure Supply Chain program, that
promises speedy entry into the U.S. market to foreign producers whose
products meet U.S. regulatory requirements, is an example of such a pro-
gram. The elegance of the one-up, one-back, traceability requirements is
also a compelling example of supply chain management. One-up, one-back
was initially met with low enthusiasm by food producers, and there is ev-
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CONCLUSIONS AND PRIORITIES
ery reason to expect that many medical product producers will resist the
committee’s recommendation 6-5. Nevertheless, this is a necessary step to
improve the global supply chain. Despite the FDA’s budget constraints, it
can advance a serious dialogue about the medical products supply chain by
immediately holding a public hearing on expanding the one-up, one-back
requirement. Its Secure Supply Chain pilot program is also promising and
should be evaluated, with the intent of large-scale expansion, in 2014.
The fifth objective of the HHS Global Health Strategy is to
strengthen and implement science-based international health and safety
standards and support multilateral efforts to improve them (HHS, 2011).
Recommendation 6-4 on FDA leadership in adopting standards contains
steps toward achieving this objective. Aside from being good health policy,
a harmonized set of standards would do much to facilitate trade and, in-
directly, to improve the economic development of low- and middle-income
countries that trade with the United States. Recommendation 6-3 also sup-
ports the strengthening of international health and safety standards. The
international, standing regulatory science training the committee recom-
mends would do much to empower regulators from the poorest countries to
better represent their nations at Codex and other standard setting meetings.
Standards developed with wider input would better reflect the needs of all
stakeholders.
Facilitating an international regulatory science college would also help
advance the Global Health Strategy objective of strengthening health sys-
tems (HHS, 2011). Training a stronger regulatory workforce to oversee
food and medical product regulatory systems is an international health
and development goal. Educating students from developing countries in the
new field of regulatory science would improve the technical knowledge of
the regulatory workforce. A more knowledgeable, credentialed workforce
would be expected to have better morale. This will take more than 10 years
to realize, but the investments in training that the FDA could contribute
both alone and through existing networks could improve product safety
and strengthen the health system in developing countries.
CONCLUSIONS
This report presents the work of the IOM Committee on Strengthening
Core Elements of Regulatory Systems in Developing Countries in answer
to the task given by the FDA and shown in Box 1-1. In response to this
task, the committee outlined in Chapter 2 the core elements of regulatory
systems. Chapter 3 responds to item B on the statement of task. Also in
that chapter the committee identifies the main needs in developing country
regulatory and product safety systems. Item C in the statement of task asks
for areas where progress might be made in the next 3-5 years; the commit-
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240 ENSURING SAFE FOODS AND MEDICAL PRODUCTS
tee outlines these in Table 4-1 and in this chapter, Chapter 7, as well as in
the explanation of its recommendations in Chapters 5 and 6. In response
to the statement of task items D the committee refers readers to Chapter
7. Statement of task item E, on contributions of universities, donors, and
international organizations, is answered briefly in Table 4-1 and in more
detail in Chapter 5. Parts of Chapter 6, particularly recommendations 6-3
and 6-6, also suggest contributions for industry and academia. Chapters 5
and 6 also address item F in the statement of task by describing how the
FDA can work in partnership with other stakeholders.
The committee relied on the specific questions outlined in the statement
of task to guide its deliberations. Table 7-1 lists the sections of the report
that respond to each question.
In accordance with the statement of task’s last paragraph, the commit-
tee gave the most attention to the problems of the emerging manufacturing
nations that do the most trade with the United States. The committee’s
TABLE 7-1
A Guide to the Statement of Task Questions and Their Answers in This Report
Question Addressed in Report
1. What critical issues do developing country regulatory
Chapter 3
authorities face, and how are they prioritized?
2. In what ways do they participate in standard-setting processes,
Chapter 3
organizations, and harmonization e orts?
3. What issues do they face in utilizing/implementing standards
Chapter 3
in a sustainable way?
4. What are the core elements of their regulatory systems, and
Chapter 2
are there others that should be considered?
5. What are the major gaps in systems, institutional structures,
Chapter 3
workforce, and competencies?
6. In what ways could those gaps be addressed? Chapters 4, 5, 6
7. In what ways could the U.S. FDA help address those gaps? Chapters 5, 6, 7
8. In what ways could others (as delineated above) help meet
Chapters 5, 6
those gaps?
9. In what ways could the FDA partner with others to help meet
Chapters 4, 5, 6
those gaps?
10. What recommendations have already been put forward to
Chapter 3
strengthen regulatory systems?
11. What obstacles exist to implement those recommendations? Chapter 3
12. What steps could be taken to remove those obstacles? Chapter 4
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CONCLUSIONS AND PRIORITIES
concern with equity also motivated it to consider the problems of the poor-
est countries as well.
This report identifies the main common problems in food and medical
product safety across a range of countries and product lines. The committee
concluded that developing countries have consistent problems with adher-
ence to international standards, controlling supply chains, infrastructure
deficits, laws, their workforce, institutional fragmentation, surveillance,
communication, and political will.
The 13 recommendations put forth in this report represent the com-
mittee’s consensus view of how to best bridge the gaps in food and medical
product regulatory systems in low- and middle-income countries. These are
multi-sectoral recommendations that have scope for implementation by a
variety of actors. The committee believes that the changes it suggests could
greatly improve the safety of food and medical products around the world.
REFERENCE
Department of Health and Human Services (HHS). 2011. The global health strategy of the
U.S. Department of Health and Human Services. Washington, DC.
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