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6
Domestic Action
In its Pathway to Product Safety the U.S. Food and Drug Adminis-
tration (FDA) emphasizes the importance of operating as a “truly global
agency fully prepared for a regulatory environment in which product safety
and quality know no borders” (FDA, 2011b, p. 3). To this end, the agency
must bridge the many gaps within regulatory systems abroad. In this chap-
ter, the committee recommends actions the FDA and other U.S. government
agencies can take to increase the efficiency of their own operations while
improving the systems of their counterpart agencies abroad.
USING RISK AS A GUIDING PRINCIPLE
Chapter 4 describes the committee’s strategy in forming its recom-
mendations and emphasizes that the FDA should let risk guide its efforts
to build food and medical product regulatory systems abroad. In keeping
with its focus on risk, the committee recommends that the FDA divide its
limited resources according to risk. An understanding of risk will allow the
FDA to choose what problems are its highest priorities.
There are tradeoffs implicit in all decision making. Especially in capacity
building, managers need to choose between different risks affecting differ-
ent populations. When working across many countries, choosing to work
with one population means less attention for others. Through the use of an
enterprise risk management framework, the FDA can determine which risks
are the most serious and have an objective way to rank its priorities.
193
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Recommendation 6-1: FDA should use enterprise risk management1 to
inform its inspection, training, regulatory cooperation, and surveillance
efforts. Enterprise risk management should apply to the agency’s 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 regula-
tory authorities.
The FDA’s implementation of an enterprise risk management system
will be the best measure of this recommendation. The FDA’s allocation of
resources in a way that reflects decisions grounded in enterprise risk man-
agement will also be a measure of this recommendation. The FDA will also
have to select which statistics best measure the impact of its inspections,
trainings, and surveillance efforts. Choosing which metrics to monitor most
closely will be part of the assessment. The timetable on which the FDA col-
lects these data is up to the agency’s management, but it should be frequent,
perhaps every quarter, but at least every 6 months.
Should the results of an enterprise risk management analysis suggest
full reorganization of the FDA, such a process would take time. In order to
work toward this change promptly, the FDA needs to conduct enterprise-
wide risk assessment, analysis, and evaluation. If its results suggest an
inefficient or unscientific allocation of resources in the agency’s current
operations, as one expects they will, then the FDA will need, at that time,
to lobby Congress for permission to revise its operations.
The agency has more freedom in running its capacity building pro-
grams. Therefore, an enterprise risk management assessment, analysis, and
evaluation can be used to reorganize international programs in the next 3
to 5 years.
Enterprise-wide Risk Management
Multinational food and medical product companies have been using
enterprise risk management for some time (see Box 6-1). Even the most
profitable business cannot afford to monitor every transaction on its supply
chain with the same diligence. Instead, multinational companies develop a
hierarchy of risk and devote resources to the highest risks in the hierarchy.
These companies may have a broader data set to inform their estimates
than the FDA would have. Nevertheless, the FDA has to work with the
1 Enterprise risk management is a discipline by which an organization “assesses, controls,
exploits, finances, and monitors risks from all sources for the purpose of increasing the
organization’s short- and long-term value to its stakeholders” (Casualty Actuarial Society-
Enterprise Risk Management Committee, 2003, p.8).
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BOX 6-1
E nterprise Risk Management
Risk is the potential any action or inaction has to result in an undesir-
able outcome. The concept of enterprise risk management comes from
the financial services industry, but has been adapted for use in a variety
of businesses, as well as in running governments and universities. The
Committee of Sponsoring Organizations of the Treadway Commission
defined enterprise risk management as “a process, effected by an entity’s
board of directors, management and other personnel, applied in strategy
setting and across the enterprise, designed to identify potential events
that may affect the entity, and manage risk to be within its risk appetite,
to provide reasonable assurance regarding the achievement of entity
objectives” (COSO, 2004, p. 2).
The principles of enterprise risk management allow any type of
organization to assess areas where it has exposure to harm and evaluate
the extent of the danger. Assessing mitigation strategies is an important
part of enterprise risk management, as is financial and administrative
planning against the organization’s risk profile. The advantage of an
enterprise-wide risk management assessment (as opposed to a func-
tional or discipline-based assessment) is that the organization’s man-
agement gains a framework that presents the connected relationships
between decisions and then allows it to integrate their responses to
multiple threats (COSO, 2004). The use of enterprise risk management
can guide staffing and training decisions. Over time, the use of enterprise
risk management can help the organization transition from a culture of
responding to crises when they happen to predicting and preventing
them (Protiviti Inc., 2006).
data available. Over time the agency may develop data sharing relationships
with its counterpart agencies abroad. The FDA may also want to collabo-
rate to develop its own risk assessment tool.
A number of organizations have supported a risk-based approach to
food and medical product regulatory strategy. The Pew Health Group
encouraged using risk to guide inspections (Pew Health Group, 2011), as
have industry spokespeople (Vijay, 2011). The committee’s recommenda-
tion is also consistent with the 2010 Institute of Medicine report Enhancing
Food Safety that argued for consistency in applying a risk-based food safety
system (IOM, 2010).
In understanding the committee’s emphasis on enterprise risk manage-
ment it is important to consider that this is a way to manage the agency’s
enterprise. That is to say, a way to manage everything the agency does.
Enterprise risk management is a strategic perspective to set priorities for the
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agency, not a tactical perspective applied to any subfunction of the enter-
prise, such as food safety or medical device safety. Many of the systematic
steps in risk management at the enterprise level and at the subordinate
levels can be described in similar terms. At the level of the organization’s
leadership, concerns over specific product lines or countries need to be
reconciled with the entire risk and opportunity profile the FDA needs to
address. Food, drug, vaccine, and medical device safety must be reconciled
with each other and with other FDA responsibilities. Enterprise risk man-
agement can reconcile an array of risks at the agency level. The goal is for
the FDA to optimally balance its limited resources with the full array of
risks the agency needs to control.
This committee recommends an enterprise-wide risk assessment be used
to inform the FDA’s capacity building projects and all its routine work. An
enterprise-wide assessment will help the FDA allocate its staffing, trainings,
and operations to the highest risk, highest priority activities, not just the
inspections. The FDA has, for some time, been working to base inspections
on a risk assessment paradigm. In 2007 the FDA was already using a risk-
based process to rank foreign manufactures according to the urgency of the
need for inspection (GAO, 2007). In a speech to the Partnership for Safe
Medicines, the FDA commissioner explained that the agency has systemati-
cally ranked more than 1,000 active pharmaceutical ingredients according
to respective risk of economically motivated adulteration (Hamburg, 2010).
Clearly, the FDA has a strong foundation on which to build its enterprise
risk management system. Its use of risk to guide foreign inspections is
exemplary. The challenge to the agency now is to persuade others that it
can better protect consumers if it allocates more of its resources, not just
inspections, based on modern risk management.
The use of enterprise risk management will be especially valuable
to the FDA given the poor economy and fiscal austerity. The agency has
been underfunded for years. The fiscal year 2010 budget was relatively
generous to the FDA. This, combined with modest increases in fiscal years
2008 and 2009, brought the agency’s budget back to 1994 levels (see
Figure 6-1) (McCain, 2011). At the same time, the agency’s responsibilities
have increased dramatically. The increasing number of foreign food facility
inspections demanded by the Food Safety Modernization Act (about 19,200
by 2016) cannot be reasonably managed by an agency that, according to
a 2007 GAO report, operates on about one-seventh of its required budget
(GAO, 2007; McCain, 2011). The committee believes that enterprise risk
management will help the FDA triage its funding, which, especially during
the 2012 election cycle, will likely be “hijacked and delayed by political
maneuvering” (Semeniuk, 2011).
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9,000
8,000
Full-time equivalents
7,000
6,000
5,000
4,000
3,000
2,000
1,000
1994 1996 1998 2000 2002 2004 2006 2008 2010
Fiscal Year
FIGURE 6-1
Full-time equivalents supported by congressional appropriations, from fiscal year 1994
to fiscal year 2010.
SOURCE: McCain, 2011.
Implementing Enterprise Risk Management at the FDA
The committee recognizes that implementing an enterprise-wide risk
management program is challenging for any large organization. Fortu-
nately, the International Organization of Standardization and other enter-
prise risk management experts publish guidance on implementing enterprise
risk management strategies (COSO, 2004; ISO, 2009; Protiviti Inc., 2006).
These sources all emphasize that the risk management framework is
different for every organization. The committee agrees; this report does not
dictate what the FDA’s strategy will be. Such a level of prescription would
be inappropriate and impossible: it would require analysis of the agency’s
internal data and consideration of internal contextual factors of which
expert committees have no knowledge. Instead of dictating the agency’s
plan, the committee recommends that the FDA undertake an enterprise-
wide risk assessment in keeping with its objectives and the Department of
Health and Human Services’ (HHS’) goals as explained in its Global Health
Strategy (HHS, 2011). The Global Health Strategy provides a framework
in which to evaluate all of the FDA’s activities and consider their risks. The
department’s goals are protecting the health of Americans through global
health action; advancing American interests in diplomacy, development,
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and security through global health action; and leading in science, policy,
and programs that advance global health (HHS, 2011). The FDA’s enter-
prise risk assessment will need to consider these goals and identify where
the biggest risks are in relation to meeting them.
The FDA’s risk management framework will define the processes, staff-
ing, timelines, and budgeting needed to manage its risks. First, the FDA
will undertake a thorough risk assessment. This will include identifying
the risks it faces and evaluating its response options. In this phase the FDA
will need to define how risks will be measured and when, and also how it
will determine the level of the risks identified (ISO, 2009). Input from all
stakeholders will be important to this process, especially as the FDA tries to
determine if there are likely combinations of risk (ISO, 2009). The frame-
work will mandate the schedule on which the FDA revisits its priorities to
keep pace with changing risks.
The next step will be a risk analysis that accounts for the sources and
causes of risk as well as their consequences and likelihood of reoccurring.
The risk analysis step may include analyzing internal data and running
simulations of different crises. The last step is risk evaluation, which ana-
lyzes the identified risks against pre-determined criteria to guide decisions.
In risk evaluation, the FDA will consider the costs, effort, and benefits of
all actions. A well-executed risk evaluation will provide the FDA’s leaders
with the information they need to develop their capacity building priorities.
Implementation in the Short-Term Should Focus on FDA Activities
Outside the United States
There are many restrictions on the FDA’s authority to allocate its
resources domestically. Therefore, especially in the next 3 to 5 years, the
committee sees promise in using enterprise-wide risk management to orga-
nize the FDA’s foreign operations.
Enterprise risk management depends on ongoing assessment of current
and potential future risks. The FDA can use its data and, when confidential-
ity agreements allow, reliable data from its counterpart agencies abroad to
inform its understanding of product risks. These risks are always changing;
the product lines and suppliers considered highest risk a decade ago are dif-
ferent from those that are highest risk today. The FDA is best positioned to
know which countries are increasing their exports to the United States. It
should better define which countries are increasing their high-risk exports
or which product lines are increasing in risk. Once it has identified these
trends, it can allocate its resources accordingly. The FDA should also target
its capacity building efforts to the countries and regions that export the
highest risk products. The committee recommends that the FDA focus its
resources on high-risk suppliers abroad for the next 3 to 5 years.
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Enterprise risk management assessments should inform the FDA’s deci-
sions on where to put its overseas staff, which overseas offices to scale up,
and the best use of its overseas staff’s time. The FDA should devote the
most energy to training people in countries that are exporting high-risk
products. For example, holding workshops on food safety for regulators
in the Middle East and North Africa, as the FDA did in 2010, does not
appear to be a decision grounded in risk management (FDA, 2011a). Arab
countries export little food to the United States or anywhere else; they
are net food importers (World Bank, 2009). The implementation of a risk
management system to all FDA work might better empower the staff of
the Office of Technical Cooperation and Capacity Building to choose more
useful topics and audiences for capacity building programs.
Implementation in the Longer-Term Should Be FDA Activities in
Both Domestic and International Markets
The results of these assessments should also inform the FDA’s inspec-
tions in the United States. There are some firms in the United States that
have never failed inspection, yet Congress demands that the FDA revisit the
sites every 2 years. The FDA is surely better aware than anyone that this
is not an efficient use of its inspectors’ time, yet it is bound by dated laws.
An enterprise risk management system would allow the FDA to reallocate
its resources to give more attention to inspections abroad.
The committee recognizes that the FDA will need to work with Con-
gress to change the laws governing it if it is to fully revise its domestic
work based on risk. It is important to remember that the existing laws were
designed for a time when most foods and medical products were produced
domestically. Nowadays, much of the food and pharmaceutical supply
comes from abroad. This shift demands a complementary shift in the al-
location of fixed resources to ensure product safety.
The Food Safety Modernization Act requires the FDA to inspect at
least 600 foreign facilities in 2011 and double those inspections every year
until 2016.2 The FDA will struggle to meet these requirements, especially
if Congress does not increase its funding (Stewart and Gostin, 2011). If
the agency were able to reallocate its domestic staffing, then it could give
more attention to needs overseas. This does not mean that the FDA should
neglect inspection and product safety responsibilities in the United States.
The Salmonella-tainted egg crisis of 2010 and persistent quality control
problems at Johnson & Johnson are a reminder that American companies
can also prove to be high risk (Kavilanz, 2010; Silverman, 2011; Un oeuf
is enough, 2010).
2 21 USC 350(j)(a)(2)(D).
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USING INFORMATION TECHNOLOGY
The committee’s recommendation of a modern systemic risk manage-
ment system depends on upgrades to the FDA’s information technology
system. A series of recent Government Accountability Office (GAO) re-
ports have highlighted inaccuracies in the FDA’s foreign supplier database
and problems with its data management system (GAO, 2008, 2010a, b,
2011). The FDA science review committee recommended in 2007 that the
agency “enhance the program to monitor performance metrics and put
the appropriate [information technology] infrastructure in place to track
the evolution of those metrics” (FDA, 2007, p. 42). The committee sees
efficient use of modern information technology as indispensible to a risk-
based regulatory system. The proper use of such a system could improve
cooperation and communication among regulatory agencies. Information
technology holds great promise to enhance surveillance. The results drawn
from reliable data management systems will give the public and legislators
a better understanding of product safety threats.
Recommendation 6-2: FDA should develop an information and infor-
matics 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 harmoni-
zation activities, a standardized vocabulary, a minimum data set to be
collected, and the frequency of data collection.
This recommendation can be measured when the FDA releases a stan-
dardized vocabulary for data collection, a codebook of the minimum data
required from all points on the supply chain, and a timetable explaining
how often these data should be collected.
As with the implementation of enterprise risk management, there are
aspects of this recommendation that will take a decade to execute. A full
overhaul of the FDA informatics and information strategy will take at
least 10 years. However, in the next 3 to 5 years, the FDA can work out
a standardized vocabulary and data collection protocols to propose for
international use.
Information and Informatics Strategies
For the purposes of this report, information strategies are ways to
ensure that all data about food and medical products are accurately col-
lected, well annotated, recorded in permanent electronic media, and securely
shared with authorized personnel for better information management. The
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committee uses the term informatics strategies to describe how the data
are cleaned of errors, transformed to proper formats, analyzed, and shared
promptly with regulatory agents for better decision making.
Modern information management uses networked computing infra-
structure across national borders. Information management lays the foun-
dation for computer-assisted automated information extraction. Without
such data, risk modeling would be impossible. The strategy outlined in
this report also emphasizes the need to share information across inter-
national borders. The committee feels that the FDA should promote the
development of secure and open protocols for electronic data capture,
computerized data management, electronic data sharing, and decentral-
ized data exchange. It is suitable that the FDA provide leadership in this
international endeavor.
A good architecture for storing, collecting, and exchanging information
is key to reliable, modern food and medical product regulation, although
the importance of such a system, especially in developing countries, is not
always obvious. A regulatory agency has to access data and information
about drug registration, facility inspections, and surveillance from dispa-
rate data sources and in varying formats on an ongoing basis. In develop-
ing countries much of these data is still stored as paper documents. This
severely decreases the productivity of the already thinly staffed regulatory
agencies. A functional informatics system thus has the ability to enhance the
productivity of regulatory agencies in developing countries. Well-defined
data architectures and topologies can allow the multiple agencies regulat-
ing food and medical products to coordinate their work and reduce redun-
dancy. In addition to sharing across different agencies within a country,
common data architectures and good systems for information sharing can
also facilitate better international harmonization. For example, the use of a
reliable information system can allow the FDA to share inspection reports
with its counterpart agencies in developing countries and vice versa.
Collecting data in common formats can also lay the groundwork for
developing tools that will make regulatory agencies more productive.
Pharmacovigilance and postmarket surveillance are two areas that could
greatly improve with informatics tools that allow for simpler data collection
and analysis. The path to having modern informatics tools in developing
country regulatory agencies depends on the FDA leading in defining com-
mon standards, which will enable data collection, sharing, and (at some
time in the more distant future) advanced decision support. The committee
believes that moderate investments in informatics and information technol-
ogy will yield significant long-term benefits in the quality of food and drug
regulation.
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Used with the permission of Dwayne Powell and Creators Syndicate. All rights reserved.
Challenges in Implementation
The committee recognizes that implementing an information and in-
formatics strategy will be difficult, especially in developing countries. First
of all, the data sharing that it recommends requires collecting information
from many sources at different agencies. For example, border rejection
data, public safety breakout events, regulated product safety recall records,
assessment reports of export and import companies, and product ingredi-
ent tracking information all need to be collected and linked. There is also
room for misunderstanding when many people are responsible for data
collection. Field staff may have different interpretations of questions that
can lead to inconsistencies in the data. Attempts to work with the European
Union (EU) border rejection data, described in Appendix G, made it clear
that worker inconsistency is a threat to data quality. Additionally, all large
data analysis projects must deal with missing data and attempt to control
for human error as much as possible.
International survey and data collection experts in academia have ex-
pertise in standardizing data collection across many different languages.
Standardizing questions and response categories are challenging, but not
impossible, especially for people who have worked on similar problems
before. Programmers can easily adapt decision-making algorithms to tablet
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computers and mobile phones, tools that would be accessible to field staff.
Using such an algorithm, even minimally educated staff could be trained to
collect and transmit standard data.
The FDA’s informatics strategy should aim to produce reports that will
be compatible with reports produced by its counterpart agencies abroad.
As Chapter 2 explains, the committee sees collaboration with the FDA’s
counterpart agencies abroad as fundamental to ensuring product safety. In
a report on drug safety the GAO also encouraged such collaborations. The
FDA should ensure that its information strategy uses the same measurement
conventions or has an accurate way to adjust for different conventions.
Most of all, the FDA’s information and informatics strategy will need to
protect confidential information. The committee understands that willing-
ness to share data may be minimal at first, especially in developing countries
with a history of deficits in this area. De-identified or aggregated data can
still be useful, however.
Models for Implementation
The biomedical research and financial services industries use modern
information sharing, and the FDA might do well to study lessons learned
from these sectors. All of them define a minimal set of XML-based files for
information sharing. The data elements, semantics, and structure of such
data sharing reports can be jointly determined in international standard
setting committees. These committees would do well to draw on expertise
at the World Wide Web Consortium and the Institute of Electrical and Elec-
tronics Engineers. Participating countries should agree to minimal data re-
porting elements. Experts need to identify the key minimal data set that will
allow for the best communication among regulators and the best product
safety assurances. Information management tools such as Protégé are based
on ontologies, explicit definitions categories, and sub-categories of informa-
tion and the relationships between them (Noy and Mcguinness, 2000). The
use of Protégé and systems like it promotes a common understanding of
the concepts and data being captured among different organizations. Over
time, a shared ontology can facilitate adherence to basic standards and
improve standards (Pisanelli et al., 1999).
The committee proposes that the FDA encourage its counterparts in
developed countries to develop similar information sharing and informatics
strategies. Ideally, all agencies can agree on standardized data collection and
information sharing practices from the start. Eventually, developed coun-
try regulatory authorities can expand the system to include developing
country regulatory authorities (GAO, 2011). The FDA should demonstrate
how information and informatics strategies can improve its logistics and
risk management in both domestic and export markets.
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This evaluation should be focused on scaling-up to include food producers
and more drug firms.
End-to-end supply chain visibility for food and medical products is the
best insurance against safety lapses. The committee recommends that FDA
evaluate the results from the Secure Supply Chain pilot for the technical and
operational feasibility of scaling. A full-scale program should then be insti-
tuted in which all interested manufacturers are enthusiastically encouraged
to participate. In order to reduce the risk of non-compliance of these incen-
tives programs with WTO law, FDA should develop these food and drug
importer incentive programs in close consultation with U.S. trade officials
and ensure participation is voluntary and pursuant to objective criteria that
do not favor applicants of any one country over those of another.
Promising Initiatives
Globalization has dramatically altered where food and medical prod-
ucts come from. The FDA cannot inspect all of the import lines to the
United States or all foreign manufacturers exporting to the United States
(GAO, 2008). Even if it could, the GAO pointed out that, “relying solely
on inspections is insufficient to secure the drug supply chain” (GAO, 2010a,
p. 29). The same is true of relying exclusively on end product testing and
food safety inspections to ensure food safety (Young, 2011). There need to
be other ways to ensure the safety of import lines.
Market incentives drive food safety in the United States (Thomsen
and McKenzie, 2001). The Food Safety Modernization Act requires the
traceability of the food supply chain and holds suppliers accountable for
ensuring HACCP compliance. The ability to assess the safety of ingredients
produced overseas, in places where the FDA has no authority, is a challenge
(FDA, 2009a). By expanding incentives programs, the FDA could help en-
courage foreign producers to adhere to international standards and work
to produce higher-quality products. The Food Safety Inspection Service has
a program in place to ensure the quality of imported meat. This is not an
incentives program, but it is a good example of bilateral coordination to
facilitate trade (Box 6-3).
The Secure Supply Chain program promotes drug safety. In this pro-
gram, foreign firms voluntarily provide the same information FDA requires
of American firms (FDA, 2009b). The pilot program includes 100 firms;
each firm can include up to five drugs. To be eligible firms must be able to
trace their products from manufacture through entry to the United States.
They also need a plan for recalling the drug or active ingredient. Qualify-
ing firms receive expedited entry of select products through customs (FDA,
2009b). The FDA and U.S. Customs and Border Protection agency are
currently defining how to expedite entry. The solution will make use of the
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BOX 6-3
The Food Safety Inspection Service
The Food Safety and Inspection Service (FSIS) is the office within
the USDA “responsible for ensuring that domestic and imported meat,
poultry, and egg products are safe, wholesome, and accurately labeled”
(FSIS, 2009). Meat imported into the United States must meet the same
safety, quality, and labeling standards required of domestically produced
meat. In order to assure this, the FSIS only allows importation of meat
that has gone through its rigorous approval protocol that covers the
entire import process (FSIS, 2009).
Any country that wants to export meat to the United States must
undergo an FSIS inspection and certification process called an equiva-
lence determination process. This certification evaluates the meat inspec-
tion processes of the exporting country. If the export inspection protocol
in place is deemed equivalent to U.S. domestic inspection protocol, the
country may be granted eligibility. By setting the standard at equiva-
lence, the FSIS ensures products of equal quality without requiring that
exporting countries conform to exact U.S. inspection procedures. Within
a country, each producer wishing to export meat to the United States
must undergo a similar certification. The evaluation process includes
both offsite assessment of written protocols and procedures and an
onsite inspection by an FSIS team. Both elements stress five primary
categories of risk assessment as established by the FSIS: animal disease
controls, sanitation controls, residue controls, slaughter and processing
controls, and controls for enforcement. Countries and sites are periodi-
cally reevaluated to ensure ongoing safety and equivalence. Countries
and specific producers may lose eligibility, often temporarily, because
of an outbreak of a disease affecting livestock or other adverse health
conditions (FSIS, 2009, 2011).
After the appropriate export country inspection paperwork has been
filed, meat is re-inspected by an FSIS inspector before it is allowed past
the port of entry. Products that are approved during this second inspec-
tion are allowed into the United States for sale and are treated no dif-
ferently than domestically produced products from that point forward
(FSIS, 2009).
Equivalent inspection practices, rather than identical ones, must
be accepted by importing countries under the guidelines set forth by
the WTO, specifically the Sanitary and Phytosanitary Measures (SPS)
agreement. The SPS agreement concerns the international trade in food,
animal, and plant products. As with all WTO agreements, the SPS agree-
ment seeks to limit barriers to international trade, in part by ensuring that
developing countries, often using less technologically advanced equip-
ment, are not unfairly discriminated against. Regardless of the exact
measures in place, if exports are of a suitable standard, then they must
be treated as such (WTO, 2012).
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Customs-Trade Partnership Against Terrorism program, which offers prior-
ity processing for products from companies with secure supply chains. The
Secure Supply Chain pilot aims to enable FDA to determine the practicality
of using a secure supply chain program to prevent importing sub-standard
drugs (FDA, 2009b). The committee suggests that this program be evalu-
ated immediately after its pilot phase and implemented and expanded, if
successful, to include a greater number of importers and to food.
INCREASING CIVIL LIABILITY
Appendix B describes how the civil liability system, so essential to
product safety in the United States, is flawed in low- and middle income
countries, and so does not deter faulty manufacturing.
Recommendation 6-8: Over the next 10 years, U.S. government agen-
cies 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.
The establishment of mechanisms that increase liability will measure
this recommendation. This process will be slow, and it will require major
revisions to the status quo that involves multiple government agencies. It is
unlikely these changes could be made in less than 10 years.
Product Liability in Developed Countries
The U.S. legal system has two ways to ensure food and medical product
safety. The first way is the regulatory framework built around the Federal
Food, Drug, and Cosmetic Act; regulatory framework is the primary focus
of the current report. Recent legislation has provided the FDA with a vari-
ety of new tools with which to enforce this regulatory framework for both
foods and medical products. If there is a sufficient likelihood that food is
adulterated or misbranded, the FDA may administratively detain products
or mandate a recall if there is reasonable probability that food will cause
“serious adverse health consequences or death to humans or animals.”13
Food production facilities must register with the FDA in order to intro-
duce their products into U.S. interstate commerce; the FDA can suspend
that registration if there is reasonable probability that the food from that
facility will harm humans or animals.14 The Food and Drug Administra-
tion Amendments Act of 2007 also expanded the legal tools FDA uses to
13 21 USC 350(l).
14 21 U.S.C. 350(d)(a).
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ensure drug and vaccine safety. The FDA may withdraw approval from
a marketed drug or biologic,15 order labeling changes or the inclusion of
package inserts about new safety information and recommendations,16
mandate postmarket observational studies or clinical trials to assess risks,17
and require sponsors to have strategies to ensure that the benefits of a drug
will outweigh its risks.18 In general, most violations of the Federal Food,
Drug, and Cosmetic Act are also subject to criminal enforcement, but few
are subject to civil enforcement (Hutt et al., 2007).
The second way that the U.S. legal system ensures food and medical
product safety in the United States is product liability. Entities involved in
the manufacture, distribution, and marketing of a food or drug product to
the public are obligated under U.S. common law and, in some cases, U.S.
federal and state statutes to ensure the safety of that product. Individuals
that suffer harm from that food or drug product in the United States may
bring a civil lawsuit against the manufacturers, importers, distributors, and
marketers of that product. Any entity with significant contacts with the
United States is potentially subject to the jurisdiction of U.S. courts. Redress
is typically monetary compensation to cover the damages incurred by the
injured party, but it may also involve punitive damages.
Product liability plays an essential role in ensuring food and drug safety
in the United States. The volume of commerce in FDA-regulated food and
medical products far exceeds the resources and legal authority that FDA
has to monitor and enforce the safety of those products. The threat of
product liability suits, high litigation costs, and reputational damage help
fill the gap by providing a significant economic incentive to companies to
maintain and improve the safety of their products. Ultimately, it is retailers
and manufacturers that are best able to ensure the safety of their products.
There are limits to the role of product liability in imports. First of all,
the FDA does not have jurisdiction in foreign markets, and even when its
staff is permitted to inspect foreign establishments there are practical chal-
lenges to working in a new country and in a different language. Further-
more, U.S. plaintiffs have limited ability to litigate and enforce judgments
against foreign firms with few U.S. contacts or assets. It is difficult for
Americans to bring lawsuits against foreign firms in foreign country courts
for injuries that occurred in the United States (Appendix B). U.S.-based
importers and distributors may be able to avoid product liability when
there is doubt that they knew or should have known about their suppliers’
actions (Bamberger and Guzman, 2008). It may be difficult for consumers
15 21 USC 355(e).
16 21 USC 355 (o) and 21 USC 355(r).
17 21 USC 355 (k)(3).
18 21 USC 355-1.
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228 ENSURING SAFE FOODS AND MEDICAL PRODUCTS
to establish accountability for unsafe products when the supply chain is so
complicated (Bamberger and Guzman, 2008). With the possibility of more
limited liability, manufacturers and distributors of imported products may
not have the same market incentives as their U.S. counterparts for continual
improvement in consumer safety.
Congress and U.S. government agencies (including, but not limited to,
the Department of Justice, the Department of the Treasury, and the U.S.
Trade Representative) should consider measures to strengthen the ability
of those harmed by unsafe food and medical products to hold foreign pro-
ducers, exporters to the United States, and U.S. importers of foreign prod-
ucts liable. Congress could increase appropriations for criminal enforcement
of the Federal Food, Drug, and Cosmetic Act or amend it to make violations
subject to civil penalties. The FDA could issue more stringent guidance for
high-risk drugs and foods, such as requiring importers to maintain a staff
person at each foreign production facility for high-risk products (Bollyky,
2009). Scholars have made other thoughtful proposals to increase liability.
The issuing of bonded warranties would oblige sellers to pay statutory dam-
ages to people injured by unsafe products (Baker and Moss, 2009). Another
option would be using discriminatory strict liability with damages based on
the risk posed by the product and by the importer’s history (Bamberger and
Guzman, 2008). Finally, developing country governments seeking to im-
prove the safety of their food and drug production should consider measures
to facilitate the ability of domestic consumers to hold firms accountable in
civil suits for the harms caused by unsafe products (Appendix B).
CONCLUSION
During its meetings, the committee heard from FDA staff about the
agency’s current work in capacity building and the challenges it faces in
protecting the U.S. food and medical products supply. The committee com-
mends FDA on its work, but sees some areas where it might improve its
operations. First, it should use an enterprise risk management system to
identify its most important priorities. That is, it should use risk to inform
all its staffing and training decisions, not just its inspections. In the next 3
to 5 years, the FDA should use enterprise risk management to inform its
work abroad, but eventually the committee recommends that it use this tool
to plan its domestic work as well. The committee recognizes that Congress
might need to revise the laws governing FDA for this to happen.
The agency’s use of risk will depend on reliable data collection. A
modern information and informatics strategy will allow the agency to col-
lect and analyze data promptly. The FDA’s PREDICT system is a step in
the right direction. The committee believes that in the next 10 years the
agency should work toward a paperless system in its own operations and
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229
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in its dealings with its counterpart agencies abroad. The first step toward
this system would be the development of a standard data format and vo-
cabulary, which could be developed in 3 to 5 years.
Regulators around the world need training on how to respond to the
challenges of globalization. FDA has the technical depth and international
presence to contribute to an ongoing, standing regulatory science and policy
college, but developing this college will take a decade. In the meantime, the
agency can work with universities and through existing training networks
to make better training opportunities available. The FDA’s staff college is
an exemplary training center that should be a model for an international
regulatory science and policy college. In the next 3 to 5 years, FDA could
require their staff to take courses on the international implementation of
and compliance with American regulations. In the longer term, that is, in
the next decade, FDA could work to develop a training program like the
CDC’s Field Epidemiology Training Program. Involving industry and aca-
demia in these efforts will also set a valuable example.
The United States could also lead by example in its consistent use of
international product standards. Harmonized standards make the market
more predictable for foreign investors and exporters. USAID and other
agencies can demonstrate U.S. commitment to harmonized standards by
empowering scientists in low- and middle-income countries to participate
actively in standard setting meetings. Over the next decade, product safety
objectives should be fully integrated into U.S. foreign policy.
The United States could also set a powerful example for industry and
government around the world by expanding the one-up, one-back, track
and trace requirements for food and medical products. The committee real -
izes that this would be complicated, but believes that the FDA could make
progress by holding a public workshop on expanding one-up, one-back
in the next year. This workshop should include international stakeholders
from government, industry, and academia.
There is great potential for innovation in American universities. The
government should, starting in the next 2 years, encourage research into
simple and elegant technology that will help small-scale producers prevent
fraud and control their supply chains. Similarly, the government can im-
prove supply chain management by giving market incentives that reward
supply chain management. The committee is especially impressed by the
FDA’s Secure Supply Chain pilot program. The 2014 evaluation for this
pilot should consider how to best expand this program to include a greater
number of producers.
Market incentives can do much to improve the safety of the food and
medical products used around the world. The committee also sees value in
increasing civil liabilities on foreign importers over the next 10 years.
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230 ENSURING SAFE FOODS AND MEDICAL PRODUCTS
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