Food and Drug Administration
Overseas Offices Have Taken Steps to Help Ensure Import Safety, but More Long-Term Planning Is Needed
Gao ID: GAO-10-960 September 30, 2010
An increasing volume of food and medical products marketed in the United States are produced in foreign countries. This globalization has challenged the Food and Drug Administration (FDA), which is responsible for ensuring the safety of these products. In late 2008 and early 2009, FDA established overseas offices comprised of 42 total staff covering particular countries or regions--China, Europe, India, Latin America, and the Middle East. The offices are to engage with foreign stakeholders to develop information that FDA officials can use to make better decisions about products manufactured in foreign countries, among other activities. GAO examined (1) the steps overseas offices have taken to help ensure the safety of imported products and (2) the extent to which FDA has engaged in long-term strategic and workforce planning for the overseas offices. GAO reviewed documentation of overseas office activities and planning. GAO also visited offices in China, India, and Latin America to interview FDA officials, officials from other U.S. agencies overseas, and foreign regulators and other stakeholders.
FDA's overseas offices have engaged in a variety of activities to help ensure the safety of imported products, but officials report challenges that could limit their effectiveness, due to an increasing workload and other factors. A primary activity for the offices has been establishing relationships with foreign stakeholders (such as foreign regulators and industry) and U.S. agencies overseas. FDA officials and foreign stakeholders said they had limited contact prior to the opening of the offices, and each noted that the overseas offices are beneficial for relationship building, although relationship building can be time consuming. FDA overseas officials have also gathered information about regulated products and shared it with U.S. officials to assist with decision making. Although FDA has used some of this information to take regulatory actions, some FDA overseas officials told us that they lack feedback regarding the utility of much of the information that they submit to the agency. FDA's offices in China and India include investigators who inspect foreign establishments. In these two countries, as of June 2010, the overseas investigators conducted 48 inspections since they were posted overseas. The FDA overseas officials have also started to provide training, responses to queries, and other assistance to foreign stakeholders to help them improve their regulatory systems and better understand FDA regulations. These officials said, however, that an increasing interest in this type of assistance from foreign stakeholders, while important, could lead to an unmanageable workload. Although FDA staff and others have pointed to several immediate benefits of the offices, it is early and their impact on the safety of imported products is not yet clear. FDA is in the process of long-term strategic planning for the overseas offices and has not developed a long-term workforce plan. FDA expects to complete a 5-year strategic plan to manage office activities by October 2010. Officials said that they intend to include performance goals and measures for the offices in the strategic plan, but that it will be difficult to quantify office contributions toward long-term outcomes. Also, coordination of the overseas offices with other parts of FDA has been a challenge, and strategic planning efforts can help ensure this coordination. FDA has not yet developed a long-term workforce plan to help ensure that it is prepared to address potential overseas office staffing challenges. Overseas staff agree to 2-year rotations, and workforce planning has focused on preparing to fill any 2011 vacancies. FDA has experienced challenges staffing some office locations and officials from FDA and other agencies with overseas staff have identified potential recruitment and retention challenges that could affect FDA's mission. They said that recruiting staff with language skills and reintegrating returning staff into domestic operations may be difficult. Certain FDA staff experienced a reduction in their pay when they went overseas. Workforce planning could help FDA prepare for potential staffing challenges. GAO recommends that the Commissioner of FDA take steps to enhance strategic planning to ensure coordination between overseas and domestic activities and develop a workforce plan to help recruit and retain overseas staff. FDA agreed with GAO's recommendations.
Recommendations
Our recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.
Director:
Marcia G. Crosse
Team:
Government Accountability Office: Health Care
Phone:
(202) 512-3407
GAO-10-960, Food and Drug Administration: Overseas Offices Have Taken Steps to Help Ensure Import Safety, but More Long-Term Planning Is Needed
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Report to the Committee on Oversight and Government Reform, House of
Representatives:
United States Government Accountability Office:
GAO:
September 2010:
Food and Drug Administration:
Overseas Offices Have Taken Steps to Help Ensure Import Safety, but
More Long-Term Planning Is Needed:
GAO-10-960:
GAO Highlights:
Highlights of GAO-10-960, a report to the Committee on Oversight and
Government Reform, House of Representatives.
Why GAO Did This Study:
An increasing volume of food and medical products marketed in the
United States are produced in foreign countries. This globalization
has challenged the Food and Drug Administration (FDA), which is
responsible for ensuring the safety of these products. In late 2008
and early 2009, FDA established overseas offices comprised of 42 total
staff covering particular countries or regions”China, Europe, India,
Latin America, and the Middle East. The offices are to engage with
foreign stakeholders to develop information that FDA officials can use
to make better decisions about products manufactured in foreign
countries, among other activities. GAO examined (1) the steps overseas
offices have taken to help ensure the safety of imported products and
(2) the extent to which FDA has engaged in long-term strategic and
workforce planning for the overseas offices. GAO reviewed
documentation of overseas office activities and planning. GAO also
visited offices in China, India, and Latin America to interview FDA
officials, officials from other U.S. agencies overseas, and foreign
regulators and other stakeholders.
What GAO Found:
FDA‘s overseas offices have engaged in a variety of activities to help
ensure the safety of imported products, but officials report
challenges that could limit their effectiveness, due to an increasing
workload and other factors. A primary activity for the offices has
been establishing relationships with foreign stakeholders (such as
foreign regulators and industry) and U.S. agencies overseas. FDA
officials and foreign stakeholders said they had limited contact prior
to the opening of the offices, and each noted that the overseas
offices are beneficial for relationship building, although
relationship building can be time consuming. FDA overseas officials
have also gathered information about regulated products and shared it
with U.S. officials to assist with decision making. Although FDA has
used some of this information to take regulatory actions, some FDA
overseas officials told us that they lack feedback regarding the
utility of much of the information that they submit to the agency. FDA‘
s offices in China and India include investigators who inspect foreign
establishments. In these two countries, as of June 2010, the overseas
investigators conducted 48 inspections since they were posted
overseas. The FDA overseas officials have also started to provide
training, responses to queries, and other assistance to foreign
stakeholders to help them improve their regulatory systems and better
understand FDA regulations. These officials said, however, that an
increasing interest in this type of assistance from foreign
stakeholders, while important, could lead to an unmanageable workload.
Although FDA staff and others have pointed to several immediate
benefits of the offices, it is early and their impact on the safety of
imported products is not yet clear.
FDA is in the process of long-term strategic planning for the overseas
offices and has not developed a long-term workforce plan. FDA expects
to complete a 5-year strategic plan to manage office activities by
October 2010. Officials said that they intend to include performance
goals and measures for the offices in the strategic plan, but that it
will be difficult to quantify office contributions toward long-term
outcomes. Also, coordination of the overseas offices with other parts
of FDA has been a challenge, and strategic planning efforts can help
ensure this coordination. FDA has not yet developed a long-term
workforce plan to help ensure that it is prepared to address potential
overseas office staffing challenges. Overseas staff agree to 2-year
rotations, and workforce planning has focused on preparing to fill any
2011 vacancies. FDA has experienced challenges staffing some office
locations and officials from FDA and other agencies with overseas
staff have identified potential recruitment and retention challenges
that could affect FDA‘s mission. They said that recruiting staff with
language skills and reintegrating returning staff into domestic
operations may be difficult. Certain FDA staff experienced a reduction
in their pay when they went overseas. Workforce planning could help
FDA prepare for potential staffing challenges.
What GAO Recommends:
GAO recommends that the Commissioner of FDA take steps to enhance
strategic planning to ensure coordination between overseas and
domestic activities and develop a workforce plan to help recruit and
retain overseas staff. FDA agreed with GAO‘s recommendations.
View [hyperlink, http://www.gao.gov/products/GAO-10-960] or key
components. For more information, contact Marcia Crosse at (202) 512-
7114 or crossem@gao.gov or Lisa Shames at (202) 512-3841 or
shamesl@gao.gov.
[End of section]
Contents:
Letter:
Background:
FDA's Overseas Offices Have Taken Steps to Assist Regulatory
Oversight, but Challenges Could Limit Their Effectiveness:
FDA Is in the Early Stages of Long-Term Strategic Planning and Has Not
Developed a Long-Term Workforce Plan for the Overseas Offices:
Conclusions:
Recommendations for Executive Action:
Agency Comments and Our Evaluation:
Appendix I: U.S. Agencies and Other Stakeholders Interviewed during
Site Visits:
Appendix II: Overview of FDA's Overseas Offices:
Appendix III: Comments from the Department of Health and Human
Services:
Appendix IV: GAO Contacts and Staff Acknowledgments:
Related GAO Products:
Tables:
Table 1: Number of Inspections Conducted by FDA and Its Overseas
Offices in China and India, through June 10, 2010:
Table 2: U.S. Agencies and Other Stakeholders Interviewed during Site
Visits:
Table 3: Number of FDA Staff Currently Working in Overseas Locations,
as of July 2010:
Table 4: Dates That Overseas Staff Arrived on Site:
Figures:
Figure 1: FDA's Main Organizational Structure, as of June 2010:
Figure 2: Geographic Responsibilities of FDA's Overseas Offices,
Including Their Locations and Opening Dates:
Abbreviations:
CDC: Centers for Disease Control and Prevention:
CDSCO: Central Drugs and Standard Control Organization:
DHS: Department of Homeland Security:
DOJ: Department of Justice:
FDA: Food and Drug Administration:
HHS: Department of Health and Human Services:
OIP: Office of International Programs:
ORA: Office of Regulatory Affairs:
USDA: U.S. Department of Agriculture:
[End of section]
United States Government Accountability Office:
Washington, DC 20548:
September 30, 2010:
The Honorable Edolphus Towns:
Chairman:
The Honorable Darrell Issa:
Ranking Member:
Committee on Oversight and Government Reform:
House of Representatives:
The globalization of food production and medical product manufacture
has presented the Food and Drug Administration (FDA) with challenges.
FDA is charged with ensuring the safety of imported products,
including food[Footnote 1] and medical products (drugs, biologics, and
medical devices). FDA's oversight of imported products includes
inspecting foreign manufacturing establishments and examining imported
products at the U.S. border. Demands on the agency have soared, due in
part to the globalization of the industries that FDA regulates,
according to an FDA advisory board.[Footnote 2] FDA-regulated imported
products arrive from more than 200 countries and territories, and the
volume of these imports more than tripled from 1998 to 2008.
A series of recent incidents of illness and death caused by
contaminated food and medical products highlight FDA's challenges in
ensuring the safety of these imported goods. In 2007, FDA learned that
certain pet foods were sickening and killing cats and dogs and
contained ingredients imported from China that were contaminated with
melamine, an industrial chemical that has no approved use as an
ingredient in animal or human food in the United States. In 2008, more
than 50 people became ill with Salmonella from Honduran cantaloupes,
and more than 1,400 people became ill with Salmonella from Mexican
peppers. Also in 2008, FDA began an investigation after receiving
reports of serious adverse events in people receiving heparin sodium,
a commonly used blood thinner. The agency later learned that an active
pharmaceutical ingredient found in this drug contained a contaminant
and had been manufactured at a Chinese establishment never inspected
by FDA.
In recent reports, we highlighted weaknesses in FDA's oversight of
these imported products. For example, in 2008, we identified
weaknesses involving both FDA's inspection of foreign establishments
and its oversight of products at the U.S. border.[Footnote 3] In
addition, we included federal oversight of both food and medical
products in our High-Risk Series in 2009 due, in part, to increased
globalization of the production of regulated products.[Footnote 4] In
November 2007, the President's Interagency Working Group on Import
Safety made several recommendations to improve federal oversight of
imported products, including that FDA establish a field presence in
key foreign locations.[Footnote 5] FDA subsequently launched an
initiative to establish five overseas offices covering particular
countries or regions--China, Europe, India, Latin America, and the
Middle East.
You expressed interest in FDA's new overseas offices and whether the
agency is taking the steps necessary to ensure the safety of imported
products. In particular, you asked us to gather information on the
plans, goals, and activities of the overseas offices and the
challenges they face. We examined:
1. the steps the overseas offices have taken to help ensure the safety
of imported products, and:
2. the extent to which FDA has engaged in long-term strategic and
workforce planning for the overseas offices.
To examine steps the overseas offices have taken to help ensure the
safety of imported products, we reviewed the offices' fiscal year 2009
accomplishment reports and other documentation of their activities. We
also interviewed FDA officials from each of FDA's five overseas
offices to learn about their activities, challenges, and
accomplishments. For three of the overseas offices--China, India, and
Latin America--we interviewed office staff during on-site visits in
February and March 2010. During these visits, we also interviewed
officials from U.S. agencies with overseas offices and foreign
stakeholders, such as officials from FDA's foreign regulatory
counterparts, trade associations, and operators of food and medical
product establishments. (See app. I for a list of U.S. agencies and
other stakeholders we interviewed during the site visits.) We also
interviewed domestically based FDA officials responsible for
regulating products, conducting foreign inspections, and overseeing
the importation of foreign products to learn about their interactions
with the overseas offices. To determine the number of inspections that
were conducted by FDA officials overseas, we obtained information from
FDA's Field Accomplishments and Compliance Tracking System.[Footnote
6] To assess the reliability of these data we reviewed related
documentation, interviewed knowledgeable agency officials, performed
electronic data testing, and compared inspection counts to published
data. We found counts of inspections sufficiently reliable for the
purposes of our report.
To examine the extent to which FDA engaged in long-term strategic
planning for the overseas offices, we reviewed FDA's strategic
planning documents. These included draft strategic plans developed by
each overseas office and documents related to FDA's plans for
evaluating the performance of the offices. Through the review of these
documents and interviews with overseas and domestic officials, we
examined the integration of strategic planning for the overseas
offices with planning by other agency components. To examine the
extent to which FDA engaged in long-term workforce planning, we
reviewed FDA staffing requirements for the overseas offices and
interviewed current overseas staff to learn about their experiences
and challenges. We examined the status of FDA's workforce planning for
the overseas offices, including planning for staff reintegration into
FDA's domestic operations. To learn about how other agencies have
approached the staffing of their overseas offices, we also interviewed
officials from other federal agencies that have had overseas staff for
several years, including the Centers for Disease Control and
Prevention (CDC) and the Foreign Agricultural Service. We also
considered information in our previous reports on strategic planning,
workforce planning, and the creation of overseas offices by other
federal agencies to examine issues for FDA to consider in future
planning.[Footnote 7]
We conducted this performance audit from January 2010 to September
2010, in accordance with generally accepted government auditing
standards. Those standards require that we plan and perform the audit
to obtain sufficient, appropriate evidence to provide a reasonable
basis for our findings and conclusions based on our audit objectives.
We believe that the evidence obtained provides a reasonable basis for
our findings and conclusions based on our audit objectives.
Background:
FDA is responsible for ensuring the safety of food and medical
products marketed in the United States. FDA has opened overseas
offices to assist it in the oversight of products manufactured
overseas. While FDA's overseas offices have only recently opened,
other federal agencies have long-standing overseas offices and, in
previous work, we have identified strategic and workforce planning as
important in managing these offices.
FDA Oversight of Imported Products:
FDA is responsible for ensuring that products marketed in the United
States meet the same statutory and regulatory requirements, whether
they are produced in the United States or a foreign country. FDA also
works with representatives of other countries to reduce the burden of
regulation, harmonize regulatory requirements, and achieve appropriate
reciprocal arrangements.[Footnote 8]
FDA's responsibilities for overseeing the safety of imported products
are divided among its centers and offices. FDA's six regulatory
centers are each responsible for the regulation of specific types of
products.[Footnote 9] In addition, the Office of Regulatory Affairs
(ORA) performs fieldwork, such as inspecting foreign establishments
and examining products at the U.S. border, on behalf of all the
product centers to promote compliance with FDA requirements and the
applicable laws. To enhance FDA's activities in this regard, the
centers and ORA also engage with foreign regulators and industry
through a variety of activities, such as conducting and attending
training workshops. In addition, each center and ORA has staff
dedicated to managing these international activities.
Responsibility for leading, managing, and coordinating all of FDA's
international activities and its overseas offices lies with the Office
of International Programs (OIP), within the Office of the
Commissioner. (See fig. 1) FDA, including OIP, has historically had
staff based only in the United States. OIP engages with international
health and regulatory partners on a variety of issues, including
holding bilateral meetings, establishing confidentiality agreements
with regulatory counterparts for sharing information on regulated
products, and holding meetings to harmonize FDA and international
regulatory requirements.
Figure 1: FDA's Main Organizational Structure, as of June 2010:
[Refer to PDF for image: organizational chart]
Top level:
Office of the Commissioner:
* Office of International Programs (including the overseas offices).
Second level, reporting to the Office of the Commissioner: Responsible
for the regulation of specific types of products:
* Center for Biologics Evaluation and Research;
* Center for Devices and Radiological Health;
* Center for Drug Evaluation and Research;
* Center for Tobacco Products;
* Office of Foods:
- Center for Food Safety and Applied Nutrition;
- Center for Veterinary Medicine;
* Office of Regulatory Affairs; Performs field work on behalf of the
centers to promote compliance;
* National Center for Toxicological Research; No regulatory mandate,
conducts research.
Source: FDA.
[End of figure]
Development and Structure of FDA's Overseas Offices:
FDA developed a proposal to establish the overseas offices in May
2008. The stated mission of the offices is to engage with foreign
stakeholders to develop information that FDA officials can use to make
better decisions about products manufactured in foreign countries for
the U.S. market. FDA stated that establishing relationships with
foreign stakeholders and gathering information are important responses
to globalization, in part because the agency is not able to inspect
all of the foreign establishments that manufacture products for the
U.S. market. During this planning, FDA identified several broad
categories of activities that would serve as the initial focus for the
offices, with the expectation that they would evolve as OIP and the
offices gained experience. These activities included (1) establishing
relationships with U.S. agencies located overseas and foreign
stakeholders, including regulatory counterparts and industry; (2)
gathering better information locally on product manufacturing and
transport to U.S. ports; (3) improving FDA's capacity to conduct
foreign inspections; and (4) providing assistance to build the
capacity of counterpart agencies to better assure the safety of the
products manufactured and exported from their countries.[Footnote 10]
As of July 2010, most of the offices had opened overseas, and each of
these had posts in multiple locations.[Footnote 11] (See fig. 2.)
However, the Middle East Office staff continued to work in the United
States while FDA was in the process of finalizing plans to locate the
office overseas. Also, as of July 2010, the Europe Office was planning
to open its post in Parma, Italy, by late fall 2010. The first FDA
staff member was deployed overseas in November 2008, to the China
Office, and most staff arrived overseas in the middle of 2009. FDA
budgeted $29.9 million for the overseas offices in fiscal year 2009.
For fiscal year 2010, the agency increased its budget for the overseas
offices by $1 million, bringing the year's total to $30.9 million. All
staffing and administrative costs associated with the offices are
included in these budgeted amounts. In addition to the regions covered
by the overseas offices, OIP has domestic offices that cover other
regions of the world, such as its Africa and Asia Office.
Figure 2: Geographic Responsibilities of FDA's Overseas Offices,
Including Their Locations and Opening Dates:
[Refer to PDF for image: illustrated world map]
China Office:
Beijing, China (Nov. 2008);
Shanghai, China (May 2009);
Guangzhou, China (July 2009).
India Office:
New Delhi, India (Dec. 2008);
Mumbai, India (June 2009).
Middle East Office:
As of July 2010, FDA had not opened the Middle East Office overseas.
Europe Office:
London, United Kingdom (June 2009);
Brussels, Belgium (May 2009);
Parma, Italy (Fall 2010 expected).
Latin America Office:
San Jose, Costa Rica (Apr. 2009);
Santiago, Chile (Aug. 2009);
Mexico City, Mexico (Feb. 2010).
Sources: GAO analysis of FDA information; Map Resources (map).
Notes: OIP also has domestic offices that cover other regions of the
world. For example, it has an Africa and Asia Office and a
Quadrilateral and Trilateral Office, which is responsible for agency
interactions with Canada, Australia, and New Zealand.
[End of figure]
FDA officials said it was important to staff the overseas offices with
experienced personnel who could represent the agency and speak on its
behalf in foreign countries. As of July 2010, FDA had a total of 42
staff assigned to the overseas offices. Of these, FDA had posted 24
staff overseas; planned to assign 1 person to Parma, Italy by fall
2010; had 3 staff for the Middle East Office, who were still working
in the United States; and had 14 locally employed staff in India,
China, and Latin America, some of whom have technical expertise, while
others focus on administrative issues.[Footnote 12] Each office has a
director in that country or region to whom all staff members report.
The offices also all have technical experts responsible for engaging
with foreign stakeholders and gathering information on food or medical
products. In China and India, FDA also placed investigators, who
conduct inspections. Like other overseas staff, the investigators are
part of OIP for administrative purposes, but decisions regarding which
establishments to inspect are made by ORA, which receives input on
this from the centers. FDA officials stated that they did not assign
investigators to Latin America because U.S.-based investigators can
gain access to establishments in that region more quickly than in
China or India. OIP staff in the United States also assist the
overseas offices.
FDA staff agreed to be posted overseas for an initial 2-year rotation.
The Department of Health and Human Services (HHS) requires that its
overseas staff commit to rotations of no more than 2 years per tour.
However, they have the option to renew up to two times, for a total of
6 years in one country. In addition, HHS requires that staff spend a
total of no more than 8 years overseas before returning to the United
States for at least 1 year.
(See appendix II for more information on the development and structure
of FDA's overseas offices.)
Federal Strategic and Workforce Planning:
Strategic planning is utilized by agencies to manage their programs
more effectively by clearly establishing goals and objectives and
describing how program activities can serve those goals. Strategic
planning can help agencies develop strategies to address current and
future management challenges. In our prior work, we have identified a
variety of leading practices for successful strategic planning.
[Footnote 13] One of these practices is the development of a set of
results-oriented performance measures. Agencies use performance
measures to help evaluate program performance, demonstrate progress in
achieving results, balance competing priorities, and inform decision
making. Such results-oriented performance measures should, whenever
possible, demonstrate a program's contributions toward the long-term
outcomes, or the results the agency expects a program to achieve.
Given FDA's mission to ensure the safety of food and medical products,
we have previously noted that the agency's long-term outcomes should
focus on public health.[Footnote 14] Agencies can show their interim
progress and contributions toward long-term outcomes using short-term
and intermediate goals and measures. When long-term outcomes may be
influenced by multiple agency programs and external factors, short-
term and intermediate measures can also demonstrate a program's
specific contribution to a long-term outcome.[Footnote 15]
In addition, workforce planning is utilized by agencies to align their
workforce with current and future program needs and develop long-term
strategies for recruiting, training, and retaining staff.[Footnote 16]
Approaches to such planning can vary with each agency's particular
needs and mission, but should share certain principles, such as the
identification of skills and competencies to fill critical workforce
gaps and the strategies needed to recruit them. Workforce planning, in
essence, helps agencies think strategically about how to put the right
people in the right jobs at the right time.
In a February 2010 report, we noted that FDA was not fully utilizing
practices for effective strategic and workforce planning.[Footnote 17]
We stated that most of FDA's established performance measures were not
results-oriented as they did not focus on the actual public health
outcomes of FDA's work. We also stated that FDA's internal
coordination between its centers and offices was one of the major
management challenges facing the agency. We recommended, and FDA
agreed, that the agency issue an up-to-date strategic workforce plan,
make its performance measures more results-oriented, and more clearly
align center and office program activities to FDA's strategic goals.
We have also previously reported on the importance of strategic and
workforce planning for other federal agencies managing offices
overseas. For example, in 2002, the U.S. Customs Service posted
officials at foreign ports to screen cargo containers. We noted that
long-term program success would require strategic plans that clearly
establish the program's goals and objectives, results-oriented
performance measures, and a workforce plan.[Footnote 18] We have also
noted challenges faced by other federal agencies with long-standing
offices overseas. In our review of workforce planning by CDC, an
agency within HHS that has 270 U.S. and 1,400 locally employed staff
overseas, we noted that the agency has faced difficulties hiring and
retaining staff posted overseas due, in part, to a lengthy hiring
process and limited opportunities for promotion.[Footnote 19] In
addition, we have previously reported on the Department of State's
challenges staffing qualified personnel to hardship locations
overseas, which the agency defines as locations where differential pay
incentives are provided to compensate staff for the severity or
difficulty of the local conditions.[Footnote 20]
FDA's Overseas Offices Have Taken Steps to Assist Regulatory
Oversight, but Challenges Could Limit Their Effectiveness:
FDA's overseas offices are establishing relationships with foreign
stakeholders and U.S. federal agencies located overseas, gathering
information to assist regulatory decision making, conducting
establishment inspections, and providing capacity building to foreign
stakeholders in an effort to help ensure the safety of imported
products. Though FDA officials cite specific benefits associated with
the overseas offices, overseas officials report facing a variety of
challenges that may limit their ability to enhance agency oversight.
Overseas Offices Have Begun to Establish Relationships with Foreign
Stakeholders and U.S. Federal Agencies Located Overseas, but the
Process Takes Time:
One of the primary activities for the newly established offices, after
their initial set-up,[Footnote 21] has been to develop relationships
with foreign stakeholders and other U.S. federal agencies located
overseas. FDA has identified building relationships as a key step
towards better understanding foreign regulatory processes, identifying
possible collaborative activities, sharing information, and building
capacity. FDA officials said that prior to the opening of the overseas
offices, the agency had little knowledge of the regulatory structures
in some countries with which the overseas offices interact or lacked
points of contact with some of their regulatory counterparts. For
example, FDA's overseas officials said that prior to the opening of
the overseas offices it took the agency a month to identify their
Chinese regulatory counterparts during the melamine crisis.[Footnote
22] Similarly, prior to the opening of the India Office, FDA had a
limited understanding of its regulatory counterparts. For example, it
was unclear which Indian regulatory agency is responsible for
overseeing food products exported to the United States.[Footnote 23]
FDA's overseas officials in that office are still working to clarify
their regulatory counterparts in certain areas.
Both foreign stakeholders and other federal agency officials located
overseas report that FDA's presence overseas is beneficial for
relationship building. Some of the foreign stakeholders that we spoke
with said that they either had not interacted with FDA prior to the
opening of the overseas offices or had only limited contact. Officials
from both FDA and its foreign regulatory counterparts told us that
having a local FDA presence has enabled them to start building a
personal connection and trust that would be hard to develop otherwise.
FDA officials said, for example, that being located overseas allows
them to attend local conferences and better reach out to industry
stakeholders. In comparison, officials from FDA's Middle East Office
and Africa and Asia Office--both FDA offices without overseas
locations--said that it is challenging to develop relationships with
foreign stakeholders from the United States and on-going, real-time
communication is difficult. Some of these officials also told us that
they have not been able to develop relationships with foreign
stakeholders to the same extent as their colleagues in the overseas
offices. FDA overseas officials have also begun collaborating with
other federal agencies collocated at overseas embassies, through both
formal and informal interactions, such as embassy workgroups on
health. Federal agency officials we spoke with said that having FDA
located overseas will be important for FDA and helpful for the other
federal agencies located overseas. For example, some of these
officials said that FDA's overseas presence allows their agencies to
spend less time on issues related to FDA-regulated products.
Although FDA's relationship with foreign stakeholders has grown, FDA's
overseas officials have identified continued challenges to forming
these relationships. Officials in some of FDA's overseas offices told
us that relationships with foreign regulators are taking longer to
develop than FDA originally anticipated. For example, FDA officials in
India said that it has been both difficult and time consuming to
schedule meetings with their counterparts because Indian regulators
must obtain permission from senior levels of their government before
participating in meetings with FDA. In comparison, FDA officials said
that memorandums of agreement with Chinese regulatory agencies have
greatly facilitated relationship building.[Footnote 24] Though some
foreign stakeholders suggested that such agreements could benefit
FDA's relationship with Indian regulators, FDA officials said that
these agreements are time consuming to create and they did not yet
know if this type of agreement was needed in India. Additionally,
officials located in overseas offices that focus on a geographic
region, such as Latin America or the Middle East, said they are
challenged by the number of different regulators with whom they must
establish relationships. In contrast to the single-country focus of
the China and India Offices, the Latin America and Middle East Offices
cover 37 and 21 countries, respectively. Also, the regulatory
structure of some countries can make relationship building difficult.
In China and India, regulations are developed at the national level,
but are generally enforced at the local level to varying degrees,
according to officials from foreign regulatory agencies. Because of
this, officials from other U.S. agencies located in these countries
said that FDA will probably have to establish relationships with
multiple layers of government officials.
FDA's overseas officials also face pressure to spend time contributing
to trade discussions involving U.S. industries and other U.S. federal
agencies located abroad. Industry officials said that it would be
helpful for the overseas offices to intervene in situations where they
believe a misunderstanding of FDA's regulations by foreign regulators
inhibits trade. For example, an industry official cited one instance
where a U.S. product was allowed entry into China only after FDA's
China Office provided documentation to the Chinese government showing
equivalency between Chinese and U.S. standards. Industry officials
with concerns may also contact federal agencies that promote U.S.
products, such as the Department of Commerce, which may then solicit
FDA to provide technical assistance to their trade discussions.
Federal agency officials said that it is beneficial to have FDA's
overseas staff participate in such discussions because FDA is highly
regarded by foreign stakeholders due to its scientific and regulatory
expertise. FDA's overseas officials said that they provide technical
expertise, rather than advocate for specific companies, during these
discussions. Although the overseas officials said they participate as
technical advisors in these discussions to a limited extent--as trade
promotion is not directly related to FDA's mission and it may take
time away from the offices' other activities--they generally
acknowledge that participating in such activities is a necessary part
of collaborating with other federal agencies located in the embassies
overseas.
Overseas Offices Gathered Information to Assist Regulatory Decision
Making, but Lacked Feedback on Its Effectiveness:
FDA's overseas officials are also gathering firsthand information
about regulated products and sharing it with domestic FDA components
with the intention that it will help the agency make better decisions
about the regulation of imported products. FDA officials report that
being located overseas provides the agency with better access to
firsthand information about regulated products from local media, other
federal agencies, and other sources. For example, an official from the
Department of State said that the department routinely provides
information on food and medical products to other federal agency
officials located in the Beijing embassy, including FDA's China
Office. In contrast, officials in the Middle East Office said that
their information-gathering efforts suffer because they are not
located overseas. They are limited to reading media available in the
United States and do not have easy access to industry or other
government agencies located overseas. FDA officials report that the
information collected by the overseas offices is something the agency
would not have had timely access to prior to the opening of the
overseas offices. For example, FDA officials said that the use of
melamine in products had been widely known in certain sectors of the
Chinese dairy industry prior to the melamine crisis. However, FDA did
not learn about its use until after it learned of pets sickened by the
ingredient. ORA officials speculate that if the agency had staff
stationed locally at the time, they would have known about the
information in a timelier manner.
FDA officials identified specific cases in which the agency took
actions based on information gathered by the overseas offices,
although some overseas officials also reported a lack of feedback on
the usefulness of this information from the centers and ORA. FDA
officials said that much of the information collected by the overseas
offices does not necessitate action by the agency, although they said
that four import bulletins have been issued based on information
gathered from the overseas offices.[Footnote 25] Specifically, between
October 2009 and May 2010, FDA issued import bulletins on garlic
powder suspected of heavy metal contamination from any country, food
products from China suspected of toxic pesticide contamination, food
products from India suspected of using water contaminated with
pesticides, and flour products from China suspected of being bleached
with limestone. In these cases, FDA officials in the United States
reported that they would not have known about this information in such
a timely manner without being informed by the overseas offices.
However, overseas officials submit information to OIP on a weekly
basis, but said they often have not received feedback on whether
center and ORA officials find the information they gather to be useful
or generally did not know who this information was shared with within
the agency.
FDA's overseas officials have also been collecting information on
foreign regulatory agencies. Officials in some of the overseas
offices--such as the India, Latin America, and Middle East Offices--
have begun to develop summaries of foreign regulatory agencies and
other documents that analyze key regulatory issues. For example, the
India Office is comparing regulations from the United States and
India, and also developing summaries and points of contact for Indian
regulatory agencies. Officials in this office said that they want to
use this type of information to better understand the responsibilities
and limitations of their local counterparts. However, OIP officials
acknowledged a general lack of coordination with the centers and ORA
regarding the development of these types of documents. The overseas
officials said that they are conducting work that they consider to be
valuable to the centers and ORA but do not yet know if this is the
case. FDA officials said that they plan to obtain feedback on these
documents from centers and offices once they are complete.
Overseas Investigators Have Conducted Inspections, Although Most
Foreign Inspections Were Conducted by Domestic-Based Investigators:
FDA's overseas investigators have conducted inspections of
establishments producing products for the U.S. market since arriving
in the overseas offices, although most inspections are still conducted
by domestic investigators. The overseas investigators we spoke with
estimate that they spend between 30 and 80 percent of their time on
inspections. From June 16, 2009, the first date on which investigators
in the China or India Office conducted an inspection,[Footnote 26]
through June 10, 2010, FDA's overseas officials--including seven
investigators and a technical expert who can perform inspections--
conducted a total of 48 inspections in China and India.[Footnote 27]
In comparison, during that same time period, FDA's domestic
investigators conducted a total of 132 inspections in these two
countries. There is variation across product areas in the portion of
inspections conducted by overseas officials. For example, the overseas
investigators conducted all 13 of the inspections of food
establishments in these countries, while domestic investigators
conducted 120 of the 144 inspections of drug establishments. (See
table 1.) FDA officials said the agency does not have a goal for how
many inspections it would like the overseas investigators to conduct,
but it would like to see overall increases in the number of
inspections conducted in both China and India. However, we found that
FDA conducted about 8 percent fewer inspections (a decrease from 196
inspections) in China and India during this time period than during
the previous 12-month period--June 16, 2008, through June 15, 2009.
Table 1: Number of Inspections Conducted by FDA and Its Overseas
Offices in China and India, through June 10, 2010:
Type of inspection: Food; Overseas staff;
China: 13;
India: 0;
Total: 13.
Type of inspection: Food; Domestic staff;
China: 0;
India: 0;
Total: 0.
Type of inspection: Food; Total;
China: 13;
India: 0;
Total: 13.
Type of inspection: Drugs (human and animal); Overseas staff;
China: 9;
India: 15;
Total: 24.
Type of inspection: Drugs (human and animal); Domestic staff;
China: 38;
India: 82;
Total: 120.
Type of inspection: Drugs (human and animal); Total;
China: 47;
India: 97;
Total: 144.
Type of inspection: Medical devices and radiological health; Overseas
staff;
China: 10;
India: 1;
Total: 11.
Type of inspection: Type of inspection: Medical devices and
radiological health;
China: 10;
India: 2;
Total: 12.
Type of inspection: Medical devices and radiological health; Total;
China: 20;
India: 3;
Total: 23.
Type of inspection: Total; Overseas staff;
China: 32;
India: 16;
Total: 48.
Type of inspection: Total; Domestic staff;
China: 48;
India: 84;
Total: 132.
Type of inspection: Total; Total;
China: 80;
India: 100;
Total: 180.
Source: GAO analysis of FDA data.
[End of table]
FDA officials report that having investigators located overseas allows
the agency to conduct more timely inspections with greater
flexibility. For example, some of these officials indicated that for
domestic-based investigators, visa and other delays can result in an
inspection being conducted several months after an establishment is
notified of FDA's intent to conduct an inspection. For the
investigators located overseas, however, inspections may be conducted
within weeks of notifying an establishment. In one instance, FDA
officials said an investigator in India conducted an inspection of a
drug establishment on short notice that was needed as part of the drug
approval process.[Footnote 28] FDA officials said that establishing
relationships with foreign regulatory authorities is also intended to
help the agency to schedule inspections more quickly in times of
crisis and to more quickly identify information about problematic
products. The overseas investigators noted that being local gives them
the ability to extend the length of an inspection or reschedule an
inspection, which they say is difficult for ORA investigators
traveling from the United States to do. Overseas investigators also
told us that greater flexibility in scheduling and conducting foreign
inspections may improve the quality of inspections conducted overseas.
In addition to conducting inspections, FDA's overseas investigators
and other staff have been involved in preliminary investigations that
may precede establishment inspections. For example, officials from one
center said that the China, India, and Latin America Offices have been
utilized to contact establishments that were selected by that center
for inspection in order to verify certain information, such as their
location. Center officials report that the overseas offices staff have
been able to more readily obtain responses from the foreign
establishments than domestic-based staff and that this activity has
helped them improve the quality of the information they have prior to
conducting inspections. Overseas officials have suggested that they
could also assist other centers in a similar manner by conducting more
of these investigations. Furthermore, some FDA officials, including
staff stationed overseas, stated that the overseas offices could be
better utilized in inspection planning. Specifically, these officials
stated that the overseas offices could contribute to the process of
assisting the centers in selecting establishments for inspection and
provide assistance to domestic-based investigators traveling abroad.
Overseas Offices Have Provided Assistance to Build the Capacity of
Foreign Stakeholders, but Some Officials Raised Concerns about
Potential Future Workload:
FDA officials said that the agency's foreign capacity building efforts
are in their early stages and the agency is planning to increase these
efforts in the future. Overseas officials stated that their local
presence makes it easier to arrange training on FDA regulations for
foreign stakeholders and respond to their follow-up questions. Other
federal agencies, such as the Foreign Agricultural Service, have
partnered with the overseas offices to conduct training and invited
FDA overseas officials to present at their events. FDA has indicated
that many of the regulatory agencies with which the overseas offices
interact are in various levels of development. For example, India
recently created a new food regulatory agency and is in the process of
developing regulations for the oversight of medical devices, according
to India Office officials. FDA officials said that being overseas
allows the agency to assist the countries in building their regulatory
infrastructures. Officials from the India, China, Latin America, and
Middle East Offices have engaged in activities related to helping
countries develop their regulatory systems. For example, FDA's
overseas officials said they have been able to provide comments to
foreign regulatory counterparts on draft regulations and provide
information on the U.S. regulatory system that could inform the
development of these foreign systems.
The overseas offices have also helped to identify and translate FDA's
policies and regulations into foreign languages, such as Spanish and
Chinese. Because FDA did not have an inventory of translated
materials, the China, Latin America, and Middle East Offices have been
working to identify what documents have already been translated and
what needs to be completed. FDA officials report that translating
agency policies and regulations is valuable and integral to its
overseas efforts, but also an expensive and time-consuming process.
Some stakeholders also reported that they have begun to translate such
documents because they could not wait for FDA to do so. Due to the
resources needed to translate documents and the fact that many people--
both internal and external to FDA--are eager to translate the agency's
documents, overseas officials suggest that the agency needs to make
strategic decisions about which documents it chooses to translate.
Foreign stakeholders report that FDA's efforts related to the
translation of FDA's policies and regulations have been beneficial,
though it would also be useful for the agency to conduct training in
conjunction with the translated documents.
FDA's overseas officials have been involved in answering queries from
foreign stakeholders about FDA's regulations, and some of these
officials anticipate future workload challenges as a result. For
example, officials from many of the agency's overseas offices said
they have fielded queries from foreign regulators and industry
regarding FDA's policies and regulations. These queries are then
coordinated with the centers to obtain technical expertise, if needed.
Foreign stakeholders told us that FDA's overseas staff are more
accessible and approachable than staff located in the United States.
Though currently manageable, officials from the Latin America Office
said they spend a significant portion of their time responding to such
queries and believe that it is likely to become unmanageable as more
local stakeholders learn about the office and the office's duties
expand. FDA officials also said that, if pending food safety
legislation is enacted,[Footnote 29] they expect the overseas offices
to receive an overwhelming number of requests for information and
training on how the food safety law would impact products imported to
the United States. Additionally, some center staff have expressed
concerns regarding the workload generated by the overseas offices as
queries received by the overseas offices are often forwarded to
experts within the centers.
FDA Is in the Early Stages of Long-Term Strategic Planning and Has Not
Developed a Long-Term Workforce Plan for the Overseas Offices:
FDA planning for the overseas offices initially focused on guiding
early activities and the agency is now developing a 5-year strategic
plan, which it expects to complete by October 2010. FDA has not yet
developed a long-term workforce plan to help ensure that it is
prepared to address potential recruitment and retention challenges.
FDA Has Initiated Long-Term Strategic Planning for the Overseas
Offices but Acknowledges Challenges Identifying Outcome-Oriented Goals
and Measures and Coordinating across Offices and Centers:
FDA engaged in strategic planning to guide the initial activities and
priorities of the overseas offices. Prior to opening the offices, FDA
developed the broad categories of activities for the overseas offices
that it considered important for furthering FDA's mission to ensure
the safety of imported products. In the summer and fall of 2009, after
the offices opened and at the direction of OIP, each office utilized
those categories of activities to develop a plan for fiscal year 2010
to describe its initial activities and short-term goals. The offices
tailored the plans to reflect circumstances of the country or region
in which they are located. For example, the China Office's plan
included activities related to implementing FDA's memorandums of
agreement with Chinese regulatory agencies. These plans remained in
draft form and were not finalized. OIP officials said that these draft
plans were primarily intended to help guide the initial activities of
each overseas office and that they will lay the groundwork for long-
term planning.
With the overseas offices now open, FDA has begun to develop a 5-year
strategic plan to manage the activities of the offices. Officials said
that the draft fiscal year 2010 plans and the initial experiences of
the offices are helping to guide the development of a 5-year plan.
Officials said that it was necessary for FDA to gain experience
overseas before OIP could begin long-term planning. Rather than have
each overseas office continue to complete its own strategic plan,
activities and goals specific to each office will be incorporated into
a single OIP-wide strategic plan. Officials stated that, as of July
2010, they were in the process of developing the 5-year plan and
anticipated completing the plan by October 2010.
As part of its strategic planning, FDA is in the process of
identifying a set of short-term and intermediate performance goals and
measures that demonstrate overseas office contributions to long-term
outcomes, though agency officials said that doing so will be a
challenge. To identify goals and measures, officials said that the
agency first needs to gather performance information on overseas
office activities and to develop an understanding of how overseas
office activities can contribute to intended agency outcomes. As part
of an agencywide FDA initiative,[Footnote 30] OIP is currently
tracking information on selected overseas office activities, such as
the number of inspections conducted by overseas staff. It is also
tracking each office's progress toward completing a specific project.
For example, it is tracking the Middle East Office's progress planning
a conference on food safety in the region. Officials stated that
tracking this type of performance information will help the agency
identify performance goals and measures that demonstrate how overseas
office activities contribute to agency strategic goals. However,
officials said that developing performance goals and measures for the
overseas offices will be a challenge due to the difficulty in directly
attributing contributions to long-term outcomes specifically to the
activities of the offices, as they feed into the work of the centers
and ORA. In addition, they said that many benefits of the offices,
such as improved relationships with regulatory counterparts, will be
difficult to quantify. Agency officials said that this challenge is
not confined to the overseas offices, as FDA as a whole has
encountered challenges identifying goals and measures that capture its
performance. According to officials, while OIP intends to include a
set of short-term and intermediate goals and measures in the 5-year
plan, they said that these will be considered developmental and may
change. Officials indicated that the establishment of baselines and
targets for those measures will take additional time, and the time
line for achieving meaningful targets may extend well beyond 5 years.
OIP officials have identified the coordination of overseas office
activities with the centers and ORA as a management challenge and OIP
is taking steps during strategic planning to align the overseas
offices with the rest of the agency. The lack of coordination
regarding the oversea offices' development of documents on foreign
product regulation and involvement in inspection planning highlights
this challenge. To help coordinate overseas office and domestic FDA
activities, OIP hosted a retreat with senior staff from the centers,
ORA, and Office of the Commissioner to discuss OIP's planning for the
overseas offices in December 2009. After the retreat, OIP officials
held follow-up meetings with center and ORA officials to obtain more
information on how the offices can meet the needs of the centers and
ORA. OIP officials told us that another retreat to discuss long-term
planning is scheduled for October 2010. Furthermore, there are also
agencywide international workgroups that provide forums to discuss
FDA's international activities. OIP hosts one such group, in which OIP
officials and officials who represent internationally focused programs
within the centers and ORA meet monthly to discuss FDA's international
activities, including the activities of overseas offices.[Footnote 31]
Monthly meetings have also been initiated between certain centers and
overseas offices. For example, because of the volume of
pharmaceuticals manufactured in India, the India Office holds monthly
teleconferences with officials from the Center for Drug Evaluation and
Research to help coordinate their activities. Given the diversity of
agency components involved in overseeing imported products, it is
important that the activities of the overseas offices are effectively
coordinated with those of the rest of the agency.
FDA Has Not Developed a Strategic Workforce Plan to Prepare for
Potential Staffing Challenges for Its Overseas Offices:
FDA has not yet developed a long-term workforce plan to ensure that
future overseas office staffing needs are met. As of June 2010, FDA
workforce planning for the overseas offices had focused on addressing
short-term staffing issues to prepare for upcoming vacancies. Given
the 2-year rotations required by HHS, the first group of staff who
went overseas in 2009 will have the option of returning to the United
States in 2011. FDA has established procedures for overseas staff to
renew their rotations and a preliminary time line for staffing
possible upcoming vacancies. According to FDA's time line, staff will
make their renewal decisions 9 months before the end of their 2-year
rotation. The majority of staff arrived overseas in the middle of 2009
and they will therefore make their decisions around fall 2010. While
FDA officials told us they expect most staff will renew their
rotations, they expect some staff will return home and FDA will need
to fill those positions. FDA officials acknowledge the value of a
workforce plan, but do not expect to develop one until the offices
have been open longer. They said a workforce plan will be more
important after the agency assesses turnover from the first 2-year
rotation.
FDA has already experienced challenges staffing some locations, and
recruitment and retention issues associated with FDA's overseas
offices necessitate advance workforce planning. Although FDA officials
state that the agency was generally able to recruit staff with the
desired level of experience for most overseas office locations, the
agency has already encountered staffing difficulties. As of July 2010,
it had one such vacancy in Mexico and four in India. Domestic FDA
staff have been sent to Mexico on temporary assignments to address a
staffing gap in that office and FDA plans to fill staffing gaps in the
India Office through temporary assignments of less than 60 days.
[Footnote 32] Staffing the FDA offices in China, India, and Mexico may
be particularly challenging as the posts are located in cities
classified by the Department of State as hardship posts. Furthermore,
FDA officials have expressed interest in expanding the number of
overseas offices, such as the addition of new locations in Africa,
Brazil, and Canada. While FDA has no finalized plans for this
expansion, additional locations would necessitate recruiting
additional overseas staff. Advance planning is needed as the staffing
process for overseas positions is lengthy due to several factors, such
as obtaining necessary security and medical clearances to work
overseas. FDA officials estimate that the process for recruiting and
posting future overseas staff members will take 9 months.
FDA staff and staff from other federal agencies with overseas staff
have identified potential challenges associated with staffing overseas
offices that could impact recruitment and retention. One potential
challenge for FDA is to ensure the effective reintegration of
returning staff into domestic positions. Although all returning staff
are guaranteed a position at FDA, they are not guaranteed their former
position.[Footnote 33] Some overseas FDA staff with whom we spoke
questioned whether their posting overseas will serve as a career
enhancing opportunity and expressed uncertainty regarding their
ability to obtain a desired position within FDA upon their return.
Similarly, CDC staff we talked with stated that CDC has also faced
these types of reintegration challenges for its overseas staff and
told us that uncertainty about career implications can negatively
affect recruitment for overseas positions. FDA officials indicated
that they are in the process of establishing a mechanism for returning
staff to be selected for appropriate positions.
Recruiting overseas office staff with language skills, which has been
cited as an advantage to forming relationships, may be a challenge in
the future. Although not a requirement for FDA's overseas staff, all
staff members in the Latin America Office and some members of the
China, India, and Middle East Offices have local language skills. In
the case of the Latin America Office, fluency in Spanish was
identified by OIP as desirable, deeming language proficiency important
for establishing relationships with government and industry officials
in the region. Some China Office staff, along with other federal
agency officials located in China, similarly stated that the ability
to hold basic conversations in Mandarin is important for establishing
diplomatic relationships with Chinese government officials. Although
officials told us that government and industry officials in India
generally speak English, FDA investigators in India stated that their
being able to speak Hindi, or other local languages, can help in
conducting inspections. In addition to its professional advantages,
FDA and other officials said that language skills can benefit staff
morale by improving their overseas living experience. However,
maintaining or expanding the portion of staff with language skills
would limit the pool of available candidates to staff positions
overseas.
FDA also faces challenges that could affect recruitment and retention
that result from certain HHS policies. For example, FDA and other HHS
staff posted overseas do not receive locality pay,[Footnote 34] though
staff at certain locations may receive hardship pay, a cost of living
adjustment, and other benefits.[Footnote 35] Some staff experience an
overall decrease in pay when they move overseas.[Footnote 36] For
example, four staff in the Latin America Office experienced an average
decrease of about $8,000 due to the loss of locality pay.[Footnote 37]
In addition, FDA staff near retirement age may be especially averse to
accept or renew overseas positions because the lack of locality pay
can affect retirement compensation and other overseas salary
adjustments are not included in retirement calculations.[Footnote 38]
This could particularly pose recruitment problems given FDA's intent
to staff the offices with experienced FDA personnel.
In addition, the HHS policy of 2-year staff rotations places a premium
on staff retention and staff being trained and prepared when they
arrive overseas. FDA and other officials generally estimated that it
takes from 6 months to a year for incoming overseas office staff to
adapt to, and become effective in, their new positions. Moreover,
staff may need time to establish functional working relationships with
regulatory counterparts and industry officials. Other federal
agencies, such as the Foreign Agricultural Service, have cited
benefits from maintaining minimum overseas posting commitments of 3
and 4 years, such as increased staff effectiveness and reduced
relocation costs. FDA and CDC officials have each noted that minimum
posting commitments in excess of 2 years could negatively affect
recruitment for overseas positions and that a 2-year commitment
provides the agency with flexibility if an employee has performance
problems. However, the effectiveness of the overseas offices could be
adversely affected if too many staff leave after their first 2-year
rotation.
In addition to U.S. nationals, FDA also has to ensure it is able to
recruit and retain locally employed staff in its overseas offices. As
of July 2010, FDA had two overseas office vacancies for locally
employed staff. FDA overseas staff told us that such staff provide
valuable contributions toward the activities of the offices. For
example, they have helped overseas staff better understand local
regulations, connected staff to in-country stakeholders, and, in the
China Office, provided translation services. In addition, locally
employed staff are not limited in their length of service and can
remain in their positions for an extended period of time. Therefore,
officials from other federal agencies we talked with cited the
important role that such staff play in providing continuity to
overseas offices as U.S. national staff return home. However, federal
officials also told us that locally employed staff are difficult to
retain, often because staff have skills and expertise that are in
demand.
CDC, which is also an agency within HHS, has long-standing overseas
offices and has engaged in workforce planning to address these types
of staffing challenges. In 2007, CDC established a strategic workforce
plan to help recruit staff for international positions, developed a
program that trains staff for international work and temporarily
assigns them overseas, and instituted an initiative to help returning
staff receive consideration for domestic positions upon their return.
CDC reports that the training program has helped with staff interest
and preparation for overseas postings. FDA does not have as many staff
overseas as agencies such as CDC, nor does it have a history of
overseas placements. The small number of staff at each FDA overseas
office means that staffing gaps can leave specific mission areas
unaddressed. For example, an office may have one staff member
dedicated to pharmaceutical products, so a vacancy in that position
could create a gap in that specific product area.
Conclusions:
The opening of FDA's overseas offices represents a significant change
for the agency as it attempts to respond to the needs of
globalization. Although it is still early and the impact of the
overseas offices on the safety of imported products is not yet clear,
overseas FDA staff, domestic FDA staff, and foreign stakeholders have
pointed to several immediate benefits. The offices have initially
focused their efforts on cultivating relationships with foreign
stakeholders, and they plan to continue working to strengthen FDA's
efforts in building foreign capacity and gathering information about
regulated products. The offices have also been used to inspect
facilities that are exporting food and medical products to the United
States, although their impact on the agency's overall number of
foreign inspections may be minimal as most inspections are still
conducted by domestic staff.
As we previously recommended for the agency overall, strategic
planning will be important to ensure the overseas offices are able to
effectively execute their mission. The agency's efforts to begin long-
term strategic planning and identify initial goals and measures are a
positive first step. The variety of potential activities that the
overseas offices could perform and an already mounting workload make
it necessary that FDA continue to engage in strategic planning to
identify those activities most important to ensuring the safety of
imported products. While identifying goals and measures that
demonstrate overseas office contributions to long-term outcomes will
be a challenge, continuing such planning will be critical for FDA to
assess the extent to which the overseas offices are helping to ensure
the safety of imported products. Given the variety of other FDA
centers and offices that have responsibilities related to imported
products, it will also be important that planning efforts ensure the
activities of the overseas offices are effectively integrated with the
centers and offices.
FDA reported that it has generally been successful in hiring qualified
staff for the overseas offices, but without a comprehensive workforce
plan, the agency has little assurance that it will be equipped to
address future staffing challenges. Overseas assignments are new to
the agency and staffing gaps overseas could leave specific mission
areas, such as food or medical devices, unaddressed. As current staff
rotate out of their positions and return to the United States, such a
plan could ensure that a well-qualified pool of applicants, who
possess diplomatic and, in some cases, language skills, are on hand to
replace them. This planning could also make sure that FDA is able to
attract and retain a talented pool of locally employed staff who can
provide continuity to the operation of the offices. A strategic
approach to workforce planning could also help FDA develop a strategy
to reintegrate returning overseas staff into the agency's domestic
operations. Such efforts could encourage overseas staff to extend
their 2-year commitment and alleviate concerns about what will happen
to their careers once they complete their tour of duty at overseas
posts. Without a comprehensive, strategic approach to workforce
planning, there is little assurance that FDA will be able to place the
right people in the right positions at the right time.
Recommendations for Executive Action:
To help ensure that FDA's overseas offices are able to fully meet
their mission of helping to ensure the safety of imported products, we
recommend that the Commissioner of FDA take the following two actions:
* Ensure, as it completes its strategic planning process for the
overseas offices, that it develops a set of performance goals and
measures that can be used to demonstrate overseas office contributions
to long-term outcomes related to the regulation of imported products
and that overseas office activities are coordinated with the centers
and ORA.
* Develop a strategic workforce plan for the overseas offices to help
ensure that the agency is able to recruit and retain staff with the
experience and skills necessary for the overseas offices and to
reintegrate returning overseas staff into FDA's domestic operations.
Agency Comments and Our Evaluation:
We provided a draft of this report to HHS for review, and HHS provided
written comments, which are reprinted in appendix III. In its
comments, HHS noted that FDA concurred with our recommendations and
stated that they would help strengthen the agency's efforts. HHS said
that FDA has already begun a long-term strategic planning process. HHS
also indicated that, now that FDA's overseas offices are staffed and
functioning, the agency will begin a workforce planning process. In
addition, HHS emphasized that FDA's collaboration with its foreign
regulatory counterparts and other stakeholders has become critical to
the agency's ability to fulfill its mission of overseeing the safety
of food and medical products. HHS stressed that strong, well-
developed, and well-maintained in-country relationships are required
to accomplish this mission and pointed out that the establishment of
the overseas offices is one major way in which FDA can strengthen its
relationships and better coordinate with foreign stakeholders. HHS's
comments also cited FDA's accomplishments since the overseas offices
have opened and highlighted several challenges that the agency faces
as it moves forward, including how to best focus overseas office
interactions with regulatory counterparts, share information gathered
by the overseas offices with the rest of the agency, and manage its
overseas investigators. HHS also provided us with technical comments,
which we incorporated as appropriate.
As agreed with your offices, unless you publicly announce the contents
of this report earlier, we plan no further distribution until 30 days
from the report date. At that time, we will send copies to the
appropriate congressional committees, the Commissioner of the Food and
Drug Administration, and other interested parties. The report also
will be available at no charge on the GAO Web site at [hyperlink,
http://www.gao.gov].
If you or your staff have any questions about this report, please
contact Marcia Crosse at (202) 512-7114 or crossem@gao.gov or Lisa
Shames at (202) 512-3841 or shamesl@gao.gov. Contact points for our
Offices of Congressional Relations and Public Affairs may be found on
the last page of this report. GAO staff who made key contributions to
this report are listed in appendix IV.
Signed by:
Marcia Crosse:
Director, Health Care:
Signed by:
Lisa Shames:
Director, Natural Resources and Environment:
[End of section]
Appendix I: U.S. Agencies and Other Stakeholders Interviewed during
Site Visits:
[End of section]
Table 2 lists the federal agencies and other stakeholders we met with
during site visits to Beijing, Guangzhou, and Shanghai, China; San
Jose, Costa Rica; and New Delhi and Mumbai, India.
Table 2: U.S. Agencies and Other Stakeholders Interviewed during Site
Visits:
Location: China: Beijing;
U.S. government agency:
* Centers for Disease Control and Prevention, Department of Health and
Human Services (HHS);
* Economic Section, Department of State;
* Environment, Science, Technology, and Health Section, Department of
State;
* Foreign Agricultural Service, U.S. Department of Agriculture (USDA);
* Foreign Commercial Service, Department of Commerce;
* Immigration and Customs Enforcement, Department of Homeland Security
(DHS);
* National Institutes of Health, HHS;
* Office of the U.S. Trade Representative;
* Public Affairs Section, Department of State;
Other stakeholders:
* American Chamber of Commerce China;
* China Quality Association for Pharmaceuticals;
* Covington & Burling, LLP;
* GE Healthcare;
* General Administration of Quality Supervision, Inspection and
Quarantine of the People's Republic of China;
* Natural Products Association;
* Peking University;
* R&D Based Pharmaceutical Association Committee;
* State Food and Drug Administration;
* World Health Organization.
Location: China: Guangzhou;
U.S. government agency:
* Agricultural Trade Office, USDA;
* Economic/Political Section, Department of State;
* Foreign Commercial Service, Department of Commerce;
* Immigration and Customs Enforcement, DHS;
* U.S. Patent and Trademark Office, Department of Commerce;
Other stakeholders:
* American Chamber of Commerce in South China;
* Guangzhou Luxe Seafood Enterprises, LTD;
* Guangdong Food and Drug Administration.
Location: China: Shanghai;
U.S. government agency:
* Agricultural Trade Office, USDA;
* Foreign Commercial Service, Department of Commerce;
Other stakeholders:
* American Chamber of Commerce Shanghai;
* AstraZeneca;
* BD Diagnostics;
* Boehringer Ingelheim;
* Ecolab;
* Eurofins Technology Service;
* General Mills;
* Keller and Heckman, LLP;
* Shanghai Pudong Medical Device Trade Association;
* Shanghai Food and Drug Administration;
* United States Pharmacopeia;
* WuXi AppTec Co., Ltd.;
* Yum! Brands.
Location: Costa Rica: San Jose;
U.S. government agency:
* Animal and Plant Health Inspection Service, USDA;
* Drug Enforcement Agency, Department of Justice (DOJ);
* Foreign Agricultural Service, USDA;
* Foreign Commercial Service, Department of Commerce;
Other stakeholders:
* Camara Costarricense de la Industria Alimentaria;
* Instituto Interamericano de Cooperación para la Agricultura;
* La Federación Centroamericana de Laboratorios;
* Ministerio de Comercio Exterior;
* Ministerio de Salud;
* Servicio Nacional de Salud Animal.
Location: India: New Delhi;
U.S. government agency:
* Centers for Disease Control and Prevention, HHS;
* Drug Enforcement Agency, DOJ;
* Foreign Agricultural Service, USDA;
* U.S. Agency for International Development;
Other stakeholders:
* Agricultural and Processed Food Products Export Development
Authority;
* Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha and
Homoepathy, Ministry of Health and Family Welfare;
* Central Drugs Standard Control Organization (CDSCO);
* Confederation of Indian Industry;
* Federation of Indian Chambers of Commerce and Industry;
* Food Safety and Standards Authority of India.
Location: India: Mumbai;
U.S. government agency: [Empty];
Other stakeholders:
* CDSCO West Zone;
* Cipla Limited;
* Drug Information Association;
* Food and Drug Administration Maharashtra State;
* Laxmi Enterprises;
* Spices Board, Ministry of Commerce and Industry.
Source: GAO.
[End of table]
[End of section]
Appendix II: Overview of FDA's Overseas Offices:
This appendix describes the purpose, planning and development, and
locations and staffing of the Food and Drug Administration's (FDA)
overseas offices.
Purpose of FDA's Overseas Offices:
The posting of staff in FDA's overseas locations is a key part of the
agency's strategy for expanding its oversight of imported food and
medical products. Products regulated by FDA are manufactured in
countries throughout the world, although there is significant
variation in the types of products coming from different regions. From
fiscal year 1998 to fiscal year 2008, the volume of FDA-regulated
imported products more than tripled from less than 5 million import
entry lines to more than 17 million import entry lines.[Footnote 39]
These imported products arrive from about 200 countries. According to
the U.S. Department of Agriculture's (USDA) Economic Research Service,
the growing presence of imported foods reflects various trends:
seasonal demands for produce from warm-weather regions; rising
consumer demand for ethnic food, beverages, and spices; integration of
nontraditional regions into global supply chains; and falling
agricultural trade barriers. Based on USDA data, imported food
comprises 15 percent of the U.S. food supply, including 60 percent of
fresh fruits and vegetables and 80 percent of seafood. Likewise, the
pharmaceutical industry has increasingly relied on global supply
chains in which each manufacturing step may be outsourced to foreign
establishments. According to FDA, the number of drug products
manufactured at foreign establishments has more than doubled since
2002, with China and India accounting for the greatest shares of this
growth.
FDA has acknowledged that globalization has fundamentally changed the
environment for regulating food and medical products and created
unique regulatory challenges for the agency. The increasing number of
foreign establishments precludes FDA from being in a position to
inspect them all to ensure the safety of all imported products. We
have previously recommended that FDA conduct more inspections of
foreign drug establishments and FDA has agreed that it should do so.
[Footnote 40] However, agency officials have emphasized that a variety
of strategies are necessary to ensure the safety of imported products
and that conducting inspections is one of multiple approaches it is
taking.[Footnote 41] In establishing the overseas offices, FDA
recognized that gathering information to make decisions and building
the technical capacity of foreign counterparts, with the goal of
improving their regulatory systems, was especially important for
ensuring the safety of imported products.
Planning and Development:
Initial planning and development of the overseas offices was led by
the Office of the Commissioner, in consultation with internal and
external federal stakeholders. An FDA official involved in early
planning said that the Office of International Programs (OIP)
collaborated with center and ORA officials in various ways, such as
through senior leadership meetings and one-on-one meetings. In
addition, OIP held regular FDA-wide teleconferences to update staff on
the progress and activities of the overseas offices. FDA officials
said their planning was aided by advice they sought from certain
federal departments and agencies with staff located overseas. For
example, FDA obtained advice on budgeting from the Centers for Disease
Control and Prevention (CDC) and USDA's Foreign Agricultural Service.
In addition, CDC and the Department of State were both helpful in
walking FDA through the process of establishing the overseas offices.
FDA initially identified several broad categories of activities in
which the overseas offices would engage. FDA officials indicated that
these activities would serve as the initial focus for the offices and
could be refined as the agency gains experience overseas, although
they have not yet changed substantially. These activities included (1)
establishing relationships with U.S. agencies located overseas and
foreign stakeholders, including regulatory counterparts and industry;
(2) gathering better information locally on product manufacturing and
transport to U.S. ports; (3) improving FDA's capacity to conduct
foreign inspections; and (4) providing assistance to help build the
capacity of counterpart agencies to better assure the safety of the
products manufactured and exported from their countries. FDA described
how these activities are intended to enhance the decisions the agency
makes about imported products:
* Establishing relationships with foreign stakeholders, including
regulatory counterparts and industry, is intended to help them better
understand U.S. regulatory requirements and help FDA better understand
the regulatory and business practices of other countries, with the
ultimate goal of improving the quality of imported products
manufactured in these countries. Collaborating with other federal
agencies, such as CDC, that are located overseas and have
complementary missions allows the agencies to coordinate activities
and share information on product quality and safety issues.
* Routinely gathering information on a wide variety of potential
factors, such as weather events and key changes among foreign
regulatory counterpart agencies, is intended to help FDA identify
potential problems and respond more quickly to developing problems.
* Improving its capacity to conduct foreign inspections will enable
FDA to more rapidly obtain information regarding whether foreign
establishments comply with FDA requirements.
* Providing capacity building to foreign stakeholders and leveraging
the resources of other international organizations, is intended to
build the technical capacity of foreign counterparts, with the goal of
improving the regulatory systems in these countries to ensure the
safety of products exported to the United States.
Locations and Staffing:
FDA's selection of locations for the overseas offices was influenced
by characteristics relevant to product regulation. Most overseas
offices are in regions or countries that export a significant
percentage of the total volume of products to the United States. The
Middle East Office was identified as an area from which the volume of
imported products is expected to rise. The goals of the Middle East
Office are to increase knowledge about the region by working with
FDA's counterpart agencies and to identify opportunities for capacity
building. The offices are also generally located in regions that FDA
described as having regulatory systems less mature than FDA's. The
agency indicated that it intended to work with regulators in these
regions to help strengthen their capacity. For example, FDA officials
indicated that the Indian government is in the process of making
significant changes to its food and drug regulatory systems and has
specifically requested FDA's help with the implementation of its new
system. FDA also sought to work with local industry in these locations
to ensure that products that are manufactured or processed from this
region and exported to the United States meet U.S. standards of
quality and safety. In contrast, FDA selected Europe to provide an
opportunity for the agency to further partner with a mature regulatory
system. Therefore, the Europe Office has staff in the U.S. mission to
the European Union, in Brussels, Belgium, to engage with the European
Commission and staff members embedded within the European Medicines
Agency and the European Food Safety Authority so that FDA can further
leverage its preexisting relationships with those regulators.[Footnote
42] Other issues also factored into FDA's selection of certain
locations. For example, FDA also selected China and Latin America
because they were the source of recent problematic products, such as
contaminated heparin and produce.
FDA officials stressed the importance of staffing the overseas offices
with experienced personnel who would be equipped to represent the
agency and speak on its behalf in the foreign country. The number and
type of staff assigned to each office varies, depending on the office
priorities and the kinds of products, such as food, drugs, or medical
devices, most commonly imported from the country or region. Each
office has a director to whom all staff members in that country or
region report, and technical experts, who are responsible for engaging
with foreign stakeholders and gathering information in the area of
food, medical products, or both. FDA placed investigators in Mumbai,
India and Guangzhou and Shanghai, China, in part to ensure that
investigators could reach establishments more quickly when necessary.
According to FDA, having investigators in these countries will also
allow the agency to more rapidly inspect manufacturing and processing
facilities that are producing goods destined for the United States.
FDA elected not to position investigators in Latin America because it
determined that U.S.-based investigators are able to more easily
travel and gain access to establishments in that region. Overseas
office investigators perform inspections and also engage in
information gathering and capacity building. The India, China, and
Latin America Offices have hired locally employed staff with technical
expertise regarding regulated products as well as locally employed
staff to perform administrative functions.[Footnote 43] Table 3 shows
the number of FDA staff currently working in overseas locations as of
July 2010.
Table 3: Number of FDA Staff Currently Working in Overseas Locations,
as of July 2010:
Location: China: Beijing;
Country or regional director: 1;
Technical experts: 3;
Food investigators: 0;
Medical product investigators: 0;
Locally employed staff: 2;
Total: 6.
Location: China: Guangzhou;
Country or regional director: 0;
Technical experts: 0;
Food investigators: 2;
Medical product investigators: 0;
Locally employed staff: 1;
Total: 3.
Location: China: Shanghai;
Country or regional director: 0;
Technical experts: 0;
Food investigators: 0;
Medical product investigators: 2;
Locally employed staff: 2;
Total: 4.
Location: Europe: Brussels, Belgium;
Country or regional director: 1;
Technical experts: 0;
Food investigators: 0;
Medical product investigators: 0;
Locally employed staff: 0;
Total: 1.
Location: Europe: London, England;
Country or regional director: 0;
Technical experts: 1;
Food investigators: 0;
Medical product investigators: 0;
Locally employed staff: 0;
Total: 1.
Location: Europe: Parma, Italy[A];
Country or regional director: 0;
Technical experts: 0;
Food investigators: 0;
Medical product investigators: 0;
Locally employed staff: 0;
Total: 0.
Location: India: New Delhi;
Country or regional director: 1;
Technical experts: 4;
Food investigators: 0;
Medical product investigators: 0;
Locally employed staff: 2;
Total: 7.
Location: India: Mumbai;
Country or regional director: 0;
Technical experts: 0;
Food investigators: 0;
Medical product investigators: 3;
Locally employed staff: 1;
Total: 4.
Location: Latin America: San Jose, Costa Rica;
Country or regional director: 1;
Technical experts: 3;
Food investigators: 0;
Medical product investigators: 0;
Locally employed staff: 2;
Total: 6.
Location: Latin America: Mexico City, Mexico;
Country or regional director: 0;
Technical experts: 1;
Food investigators: 0;
Medical product investigators: 0;
Locally employed staff: 2;
Total: 3.
Location: Latin America: Santiago, Chile;
Country or regional director: 0;
Technical experts: 1;
Food investigators: 0;
Medical product investigators: 0;
Locally employed staff: 2;
Total: 3.
Location: Total[B];
Country or regional director: 4;
Technical experts: 13;
Food investigators: 2;
Medical product investigators: 5;
Locally employed staff: 14;
Total: 38.
Source: GAO analysis of FDA data.
[A] FDA has hired a technical expert who has not yet posted to the
agency's office located in Parma, Italy.
[B] The Middle East Office has not yet opened overseas, but a Regional
Director and two technical experts have been hired and are located in
the United States.
[End of table]
Some of the overseas offices were not fully staffed at the time that
they opened. Table 4 shows the dates that the FDA staff arrived at
each of the overseas locations.
Table 4: Dates That Overseas Staff Arrived on Site:
Office: China: Beijing;
Arrival of first staff: November 2008;
Arrival of additional staff: May 2009 to July 2009.
Office: China: Guangzhou;
Arrival of first staff: July 2009;
Arrival of additional staff: N/A.
Office: China: Shanghai;
Arrival of first staff: May 2009;
Arrival of additional staff: June 2009.
Office: Europe: Brussels, Belgium;
Arrival of first staff: May 2009;
Arrival of additional staff: N/A.
Office: Europe: London, England;
Arrival of first staff: June 2009;
Arrival of additional staff: N/A.
Office: Europe: Parma, Italy[A];
Arrival of first staff: N/A;
Arrival of additional staff: N/A.
Office: India: New Delhi;
Arrival of first staff: November 2008;
Arrival of additional staff: June 2009 to August 2009.
Office: India: Mumbai;
Arrival of first staff: June 2009;
Arrival of additional staff: July 2009 to January 2010.
Office: Latin America: San Jose, Costa Rica;
Arrival of first staff: April 2009;
Arrival of additional staff: August 2009.
Office: Latin America: Mexico City, Mexico;
Arrival of first staff: February 2010;
Arrival of additional staff: N/A.
Office: Latin America: Santiago, Chile;
Arrival of first staff: August 2009;
Arrival of additional staff: N/A.
Office: Middle East: Office location(s) not yet determined.
Source: GAO analysis of FDA data.
[A] FDA has hired a technical expert who has not yet posted to the
agency's office located in Parma, Italy.
[End of table]
As of July 2010, the Latin America Office and the India Office had two
vacancies each for technical experts, and the India Office also had
two food investigator vacancies. Two of the offices also had vacancies
for locally employed staff. In addition, the Middle East Office had
one vacancy for a medical product investigator and three vacancies for
locally employed staff that the agency plans to fill once the office
is located overseas.
[End of section]
Appendix III: Comments from the Department of Health and Human
Services:
Department Of Health & Human Services:
Office Of The Secretary:
Assistant Secretary for Legislation:
Washington, DC 20201:
September 9, 2010:
Marcia Crosse:
Director, Health Care:
U.S. Government Accountability Office:
441 G Street N.W.
Washington, DC 20548:
Dear Ms. Crosse:
Attached are comments on the U.S. Government Accountability Office's
(GAO) report entitled: "Food and Drug Administration Overseas Offices
have Taken Steps To Help Ensure Import Safety, But Long-Term Planning
Is Needed" (GA0-10-960).
The Department appreciates the opportunity to review this report
before its publication.
Sincerely,
Signed by:
Jim Esquea:
Assistant Secretary for Legislation:
Attachment:
[End of letter]
General Comments Of The Department Of Health And Human Services (HHS)
On The Government Accountability Office's (GAO) Draft Report Entitled,
"Food And Drug Administration: Overseas Offices Have Taken Steps To
Help Ensure Import Safety, But Long-Term Planning Is Needed" (GA0-10-
960):
The Department appreciates the opportunity to comment on the GAO's
findings in this draft report. HHS and FDA appreciate GAO's
recognition of the progress FDA has made standing up its overseas
offices, and look forward to using the report to further strengthen
these efforts.
Annually, the United States imports more than $2 billion worth of FDA-
regulated products from roughly 200 countries or territories, using
almost 100,000 importers, through over 300 U.S. ports”of-entry.
According to the Operational and Administrative System for Import
Support (OASIS), last year, there were 20 million line entries of FDA-
regulated product that crossed our borders; ten years ago, there were
just 6 million. That's around 100,000 shipments each working day that
cross our borders. These shipments included 40 percent of our finished
drugs, 80 percent of our active pharmaceutical ingredients, the
majority of our seafood, and large quantities of the fresh fruits and
vegetables in our supermarkets.
The globalization of the production and manufacture of these products
presents consumers, practitioners, regulators, and companies with many
challenges. These challenges are consuming an ever larger amount of
FDA's time and effort, and they have fundamentally changed the
environment for regulating food and medical products.
Some of these unique regulatory challenges for FDA include:
* More "non-traditional" foreign facilities and clinical trials sites
supplying pivotal data;
* An ever-increasing volume of imported products and data, even with
the recent turndown in the global economy;
* Greater complexity in supply chains and clinical trials;
* Imports of products and data coming from countries with less well
resourced and less well developed regulatory systems;
* Less clarity on accountability by both regulators and industry
during various segments of a product's movement through its global
supply chain; and;
* Greater opportunities for economic fraud.
Within the context of its domestic mission, FDA is increasingly
assuming the role of a global public health agency and is a
significant leader in the larger global regulatory and scientific
enterprises that affect the products for which we are responsible in
the United States. Today, FDA is responsible for the oversight of tens
of millions of foreign shipments every year, and ensuring public
health at home now mandates that we continue to engage ever more
strategically abroad. As FDA expands its engagements within the
international community and as it works to implement standards and
oversight that help protect the safety of food and medical products at
home and abroad, collaboration with counterparts and other
stakeholders within the global regulatory and scientific enterprises
has become critical to fulfilling our public health mission.
International engagement is no longer a discretionary component of
FDA's activities; it is a fundamental component of how the Agency
fulfills its mission.
One major way in which FDA is strengthening and better coordinating
its international engagements is by establishing permanent FDA posts
abroad in strategic locations. These initial posts are now staffed
with experienced senior FDA technical experts and inspectors. The
process of "standing up" these posts began approximately 22 months
ago. It was a new undertaking for FDA, as the Agency had never
previously had its staff permanently assigned overseas.
The report documents the many accomplishments that the Agency has made
since that decision to establish FDA overseas posts.
These accomplishments include:
* Selecting sites and identifying goals for the overseas offices;
* Hiring of staff;
* Deploying 42 staff members (and their families) to the various
foreign posts;
* Establishing secure IT communications between deployed staff and
headquarters;
* Obtaining and communicating information that is contributing to the
Agency's decision-making to improve the safety and quality of imported
products;
* Providing technical cooperation to help further build the capacity
of certain foreign regulatory authorities to undergird efforts to help
their countries produce safe products for export to the United States
and produce safer products for their own citizens;
* Developing first year strategic plans for each office; and;
* Developing SOPs for administrative handling of the first cycle of
renewals of overseas appointments.
We want to highlight, and concur strongly with, the report's
discussion of the importance of and the challenges associated with
building personal and organizational relationships in foreign
locations. For many years, the Agency has had very good knowledge of
regulatory structures and contacts in the countries with which we had
regular interaction, including many of those in which we now have
offices. We believe the new foreign posts have provided a much richer
context for a more dynamic relationship with our counterpart agencies
in those countries, and the report highlights the benefits that such
day-to-day interaction provides to the Agency.
For FDA, these strong personal and organizational relationships lead
to the trust that is necessary to enable the discussions and promote
the information exchanges that are pivotal in preventing and, when
necessary, responding to product safety problems. Through these
engagements, FDA personnel located in foreign posts can obtain and
transmit more robust and timely information to FDA's Centers and
border personnel so that they can make better decisions about the
safety and quality of the products they allow to be imported into the
United States. Being able to accomplish that mission requires having
strong, well-developed, and well-maintained in-country relationships
at multiple levels.
FDA's Response to GAO Recommendations:
GAO recommends that the U.S. Commissioner of Food and Drugs take steps
to enhance long-term strategic planning to ensure coordination between
overseas and domestic activities and develop a workforce plan to help
recruit and retain overseas staff.
FDA concurs with these recommendations and, as the report notes,
already has begun a long-term strategic planning process as part of a
broader FDA initiative. Now that the overseas posts are staffed and
functioning, OIP will initiate a workforce planning process. As noted
in the report, FDA recognizes that this process will be iterative and
will benefit from the experience of several cycles of overseas staff
appointments (deployment and return). Although FDA has a very small
number of overseas staff compared to the Centers for Disease Control
(CDC), FDA looks forward to benefiting from the experience of CDC's
established efforts in workforce planning for its international
assignments as we proceed with this undertaking.
FDA also notes that we are supporting our strategic planning efforts
by employing the FDA-TRACK performance management initiative to
identify and track performance indicators and milestones for key
program activities. The transparency of this management process
contributes to the coordination of our overseas and domestic activities.
There are additional challenges that OIP and FDA face, and
opportunities we must pursue:
In China, we had a challenge identifying our responsible Chinese
regulatory counterpart when the first melamine contamination issue
arose. The overriding problem was that, early in the crisis, the
Chinese authorities themselves did not know readily whether the issue
would fall under their regulatory, criminal, or other state function.
Until the Chinese clarified who would be leading their government's
response, FDA interacted with its routine counterparts and, through
them, was informed how the Chinese government planned to manage the
situation.
Similarly, the India Office staff has now come to understand the
complexities of the Indian regulatory system, and it has enabled FDA
to stay abreast of and, when requested, to engage with Indian
regulators regarding their system and the reform currently underway.
In short, the establishment of the foreign posts has significantly
enhanced our knowledge of other countries' regulatory structures and
has allowed for the development of the kinds of relationships that now
benefit FDA, especially when public health crises with FDA-regulated
products arise, and as those countries develop and enhance their
regulatory programs.
Another challenge that presents opportunity is how to focus our
interactions with our counterpart agencies through international
arrangements we have with them. These arrangements can take various
forms, depending on the need and the issues to be addressed. For
example, the HHS 2007 agreements with Chinese regulators were signed
at the Departmental level. More typically, the Agency itself
negotiates and signs our arrangements with counterparts on an agency-
to-agency basis. They include confidentiality commitments and product
specific arrangements and are used on a daily basis to help facilitate
FDA's public health work with other countries. In addition, FDA has
developed "implementation plans" and other documents to help better
define and focus FDA's engagements with our regulatory counterparts.
FDA is currently exploring with its Indian and other counterparts
whether such documents would help facilitate and focus interactions.
Additionally, our foreign offices face how best to provide information
to the rest of FDA and assure 02 efforts add value to the Agency. As
one approach to meeting this challenge, we are currently developing
prototypes of "analytical papers" on specific in-country topics for
use by the Agency's centers and ORA. Once the Centers and ORA comment
on these prototypes, we can better assess their usefulness and
determine how best to implement this approach. OW can then produce
analytical papers on the topics that the Centers and ORA have already
identified as potentially useful.
The foreign offices also produce environmental scanning reports (i.e.,
weekly reports from foreign posts regarding in-country events that
might affect the safety, quality, or availability of FDA-regulated
products from their respective regions). These reports have been the
geneses of FDA public health actions, and, in order to enhance their
use by the Agency, OIP has developed a searchable electronic database
in which this information is now housed, and, in the near future,
Agency officials will have access to this database and will be able to
use the information both in acute situations and for longer term
programmatic and operational planning. At present, we provide
information from the database through weekly electronic OIP reports.
02 expects a continuing need to refine these reports and continually
enhance the other ways we engage with and communicate the information
we gather to ORA and the Centers.
Another challenge is how our in-country inspectors will use their
time. Inspectors can, for example, conduct establishment and facility
inspections, participate in training workshops for and interact with
local inspectors, learn more about the abilities and practices of the
local inspectorates to help determine how much FDA could leverage the
information they provide, and participate in conferences to help
educate various stakeholders in-country about FDA requirements and
expectations regarding the safety and quality of products destined for
U.S. consumers. The mix for an inspector in any given country at any
given time will vary and be driven by the conditions in that country
at that time. Our challenge will be to choose the mix that maximally
enhances the safety of products destined for the United States.
GAO's observations and recommendations will help us meet these
challenges as we move forward in implementing this new, and now
fundamental, part of FDA's organization and work program.
[End of section]
Appendix IV: GAO Contacts and Staff Acknowledgments:
GAO Contacts:
Marcia Crosse at (202) 512-7114 or crossem@gao.gov Lisa Shames at
(202) 512-3841 or shamesl@gao.gov:
Staff Acknowledgments:
In addition to the contact name above, Jose Alfredo Gómez, Assistant
Director; Geraldine Redican-Bigott, Assistant Director; Kevin Bray;
Michael Erhardt; William Hadley; Cathleen Hamann; Rebecca Hendrickson;
Julian Klazkin; Deborah Ortega; and Michael Rose made key
contributions to this report.
[End of section]
Related GAO Products:
FDA--High Risk Reports:
High-Risk Series: An Update. [hyperlink,
http://www.gao.gov/products/GAO-09-271]. Washington, D.C.: January 22,
2009.
High-Risk Series: An Update. [hyperlink,
http://www.gao.gov/products/GAO-07-310]. Washington, D.C.: January 31,
2007.
FDA--Food Production and Medical Product Oversight:
Drug Safety: FDA Has Conducted More Foreign Inspections and Begun to
Improve its Information on Foreign Establishments, but More Progress
is Needed. [hyperlink, http://www.gao.gov/products/GAO-10-961].
Washington, D.C.: September 30, 2010.
Food Safety: FDA Could Strengthen Oversight of Imported Food by
Improving Enforcement and Seeking Additional Authorities. [hyperlink,
http://www.gao.gov/products/GAO-10-699T]. Washington, D.C.: May 6,
2010.
Food and Drug Administration: Opportunities Exist to Better Address
Management Challenges. [hyperlink,
http://www.gao.gov/products/GAO-10-279]. Washington, D.C.: February
19, 2010.
Food Safety: Agencies Need to Address Gaps in Enforcement and
Collaboration to Enhance Safety of Imported Food. [hyperlink,
http://www.gao.gov/products/GAO-09-873]. Washington, D.C.: September
15, 2009.
Food and Drug Administration: FDA Faces Challenges Meeting Its Growing
Medical Product Responsibilities and Should Develop Complete Estimates
of Its Resource Needs. [hyperlink,
http://www.gao.gov/products/GAO-09-581]. Washington, D.C.: June 19,
2009.
Seafood Fraud: FDA Program Changes and Better Collaboration among Key
Federal Agencies Could Improve Detection and Prevention. [hyperlink,
http://www.gao.gov/products/GAO-09-258]. Washington, D.C.: February
19, 2009.
Drug Safety: Better Data Management and More Inspections Are Needed to
Strengthen FDA's Foreign Drug Inspection Program. [hyperlink,
http://www.gao.gov/products/GAO-08-970]. Washington, D.C.: September
22, 2008.
Food Safety: Selected Countries' Systems Can Offer Insights into
Ensuring Import Safety and Responding to Foodborne Illness.
[hyperlink, http://www.gao.gov/products/GAO-08-794]. Washington, D.C.:
June 10, 2008.
Centers for Disease Control and Prevention: Human Capital Planning Has
Improved, but Strategic View of Contractor Workforce Is Needed.
[hyperlink, http://www.gao.gov/products/GAO-08-582]. Washington, D.C.:
May 28, 2008.
Medical Devices: Challenges for FDA in Conducting Manufacturer
Inspections. [hyperlink, http://www.gao.gov/products/GAO-08-428T].
Washington, D.C.: January 29, 2008.
Federal Oversight of Food Safety: FDA's Food Protection Plan Proposes
Positive First Steps, but Capacity to Carry Them Out Is Critical.
[hyperlink, http://www.gao.gov/products/GAO-08-435T]. Washington,
D.C.: January 29, 2008.
Oversight of Food Safety Activities: Federal Agencies Should Pursue
Opportunities to Reduce Overlap and Better Leverage Resources.
[hyperlink, http://www.gao.gov/products/GAO-05-213]. Washington, D.C.:
March 30, 2005.
Food Safety: FDA's Imported Seafood Safety Program Shows Some
Progress, but Further Improvements Are Needed. [hyperlink,
http://www.gao.gov/products/GAO-04-246]. Washington, D.C.: January 30,
2004.
Container Security: Expansion of Key Customs Programs Will Require
Greater Attention to Critical Success Factors. [hyperlink,
http://www.gao.gov/products/GAO-03-770]. Washington, D.C.: July 25,
2003.
Strategic Planning and Management:
Intellectual Property: Enhanced Planning by U.S. Personnel Overseas
Could Strengthen Efforts. [hyperlink,
http://www.gao.gov/products/GAO-09-863]. Washington, D.C.: September
30, 2009.
Department of State: Additional Steps Needed to Address Continuing
Staffing and Experience Gaps at Hardship Posts. [hyperlink,
http://www.gao.gov/products/GAO-09-874]. Washington, D.C.: September
17, 2009.
Human Capital: Sustained Attention to Strategic Human Capital
Management Needed. [hyperlink,
http://www.gao.gov/products/GAO-09-632T]. Washington, D.C.: April 22,
2009.
Centers for Disease Control and Prevention: Human Capital Planning Has
Improved, but Strategic View of Contractor Workforce Is Needed.
[hyperlink, http://www.gao.gov/products/GAO-08-582]. Washington, D.C.:
May 28, 2008.
Results-Oriented Government: GPRA Has Established a Solid Foundation
for Achieving Greater Results. [hyperlink,
http://www.gao.gov/products/GAO-04-38]. Washington, D.C.: March 10,
2004.
Human Capital: Key Principles for Effective Strategic Workforce
Planning. [hyperlink, http://www.gao.gov/products/GAO-04-39].
Washington, D.C.: December 11, 2003:
A Model of Strategic Human Capital Management. [hyperlink,
http://www.gao.gov/products/GAO-02-373SP]. Washington, D.C.: March 15,
2002.
Agency Performance Plans: Examples of Practices That Can Improve
Usefulness to Decisionmakers. [hyperlink,
http://www.gao.gov/products/GAO/GGD/AIMD-99-69]. Washington, D.C.:
February 26, 1999.
Managing for Results: Critical Issues for Improving Federal Agencies'
Strategic Plans. [hyperlink,
http://www.gao.gov/products/GAO/GGD-97-180]. Washington, D.C.:
September 16, 1997.
Executive Guide: Effectively Implementing the Government Performance
and Results Act. [hyperlink,
http://www.gao.gov/products/GAO/GGD-96-118]. Washington, D.C.: June 1,
1996.
[End of section]
Footnotes:
[1] FDA, an agency within the Department of Health and Human Services
(HHS), shares responsibility for the oversight of food with the U.S.
Department of Agriculture's Food Safety and Inspection Service, which
oversees the safety of meat, poultry, and processed egg products, both
domestic and imported, and verifies that shipments of these products
meet its requirements. FDA is responsible for the safety of virtually
all other foods, including milk, seafood, fruits, and vegetables.
[2] FDA Science Board, Subcommittee on Science and Technology, FDA
Science and Mission at Risk (November 2007), [hyperlink,
http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-
4329b_02_01_FDA%20Report%20on%20Science%20and%20Technology.pdf]
(accessed May 18, 2010). The Science Board, which is an advisory board
to the commissioner of FDA, provides advice on, among other things,
specific complex and technical issues as well as emerging issues
within the scientific community.
[3] GAO, Food Safety: Agencies Need to Address Gaps in Enforcement and
Collaboration to Enhance Safety of Imported Food, [hyperlink,
http://www.gao.gov/products/GAO-09-873] (Washington, D.C.: Sept. 15,
2009) and GAO, Drug Safety: Better Data Management and More
Inspections Are Needed to Strengthen FDA's Foreign Drug Inspection
Program, [hyperlink, http://www.gao.gov/products/GAO-08-970]
(Washington, D.C.: Sept. 22, 2008).
[4] GAO, High-Risk Series: An Update, [hyperlink,
http://www.gao.gov/products/GAO-09-271] (Washington, D.C.: January
2009).
[5] Action Plan for Import Safety: A roadmap for continual improvement
(November 2007), [hyperlink,
http://www.importsafety.gov/report/actionplan.pdf] (accessed Dec. 30,
2009). The President's Interagency Working Group on Import Safety was
created by President Bush in 2007, is chaired by the Secretary of HHS,
and is composed of officials from several different federal agencies.
[6] FDA later indicated that it inadvertently excluded a few
inspections from the Field Accomplishments and Compliance Tracking
System data that the agency originally provided. We subsequently
included these inspections in our analysis.
[7] For a list of these and other related reports, see Related GAO
Products later in this publication.
[8] See 21 U.S.C. § 393(b)(3).
[9] FDA's seventh center, the National Center for Toxicological
Research, does not have a regulatory mandate. Instead, it conducts
research that supports FDA's regulatory and public health mission by
focusing, for example, on the detection and prevention of toxicity and
adverse events associated with FDA-regulated products.
[10] FDA's capacity building, also known as technical assistance or
technical cooperation, includes the provision of scientific,
technical, regulatory, or inspection assistance, and education and
training to help strengthen public health regulatory infrastructures
abroad, especially for countries where exports to the United States
are significant or increasing. FDA also engages with foreign industry
to help assure their understanding of U.S. standards.
[11] The offices in China, India, and Latin America are located in
either U.S. embassies or consulates managed by the Department of
State. The office in Europe has an official at the U.S. mission to the
European Union, in Brussels, an official in London embedded within the
European Medicines Agency, and plans to assign an official in Parma,
Italy to be embedded within the European Food Safety Authority.
[12] Locally employed staff, also known as Foreign Service Nationals,
are non-U.S. citizens who are generally employed at U.S. missions.
[13] See, for example, GAO, Managing for Results: Critical Issues for
Improving Federal Agencies' Strategic Plans, [hyperlink,
http://www.gao.gov/products/GAO/GGD-97-180] (Washington, D.C.: Sept.
16, 1997).
[14] GAO, Food and Drug Administration: Opportunities Exist to Better
Address Management Challenges, [hyperlink,
http://www.gao.gov/products/GAO-10-279] (Washington, D.C.: Feb. 19,
2010).
[15] GAO, Agency Performance Plans: Examples of Practices That Can
Improve Usefulness to Decisionmakers, [hyperlink,
http://www.gao.gov/products/GAO/GGD/AIMD-99-69] (Washington, D.C.:
Feb. 26, 1999).
[16] GAO, Human Capital: Key Principles for Effective Strategic
Workforce Planning, [hyperlink, http://www.gao.gov/products/GAO-04-39]
(Washington, D.C.: Dec. 11, 2003).
[17] [hyperlink, http://www.gao.gov/products/GAO-10-279].
[18] GAO, Container Security: Expansion of Key Customs Programs Will
Require Greater Attention to Critical Success Factors, [hyperlink,
http://www.gao.gov/products/GAO-03-770] (Washington, D.C.: July 25,
2003).
[19] GAO, Centers for Disease Control and Prevention: Human Capital
Planning Has Improved, but Strategic View of Contractor Workforce Is
Needed, [hyperlink, http://www.gao.gov/products/GAO-08-582]
(Washington, D.C.: May 28, 2008).
[20] GAO, Department of State: Additional Steps Needed to Address
Continuing Staffing and Experience Gaps at Hardship Posts, [hyperlink,
http://www.gao.gov/products/GAO-09-874] (Washington, D.C.: Sept. 17,
2009).
[21] FDA officials stated that the first priority of the overseas
offices was to locate staff overseas and conduct activities to set up
the offices, which took a substantial effort.
[22] Several regulatory agencies in China share responsibility for
overseeing food and FDA officials said there was confusion about which
agency oversaw the contaminated products. These agencies include the
Ministry of Agriculture, the State Food and Drug Administration, and
the General Administration of Quality Supervision, Inspection and
Quarantine, which regulates products bound for export.
[23] Indian regulation of food products is also split between several
agencies. The Food Safety and Standards Authority of India oversees
the regulation of food manufactured for consumption in India, while
food exported to other countries, including the United States, is
overseen by various bodies, including the Export Inspection Council
and the Agricultural and Processed Food Products Export Development
Authority.
[24] In 2007, FDA, through HHS, signed memorandums of agreement with
Chinese agencies--specifically, the State Food and Drug Administration
and the General Administration of Quality Supervision, Inspection and
Quarantine--that regulate food and medical products for export to the
United States. As part of these agreements, the agencies agreed to
collaborate on activities intended to ensure the safety of imported
products, such as providing technical assistance, and meet annually to
discuss the progress of the agreement.
[25] FDA may issue an import bulletin, which may advise FDA staff to
sample products when they are offered for import, in an effort to
collect information about possible contamination. Import bulletins are
generally valid for 90 days after issuance, and FDA will review the
information developed from the import bulletin to see if there is a
need for further action.
[26] Investigators are located in the China and India Offices, but not
the other overseas offices. FDA officials said the agency did not post
investigators in the Latin America Office, for example, because it
determined that it would make more economic and logistical sense for
inspections in Latin America to be conducted by domestic-based
investigators.
[27] FDA officials said that there may be a delay in entering
inspection information in the Field Accomplishments and Compliance
Tracking System. We analyzed data that were up-to-date as of June 10,
2010, and these data may not include all inspections conducted by the
agency during this time period.
[28] FDA must approve a new drug application before the drug listed in
the application can be marketed in the United States, which may
include an inspection of the manufacturing establishment. The agency
may also conduct periodic surveillance inspections of products already
approved for marketing. In other work, we noted that the majority of
foreign establishments manufacturing human drugs that were inspected
in fiscal year 2009 were inspected as part of the drug approval
process, rather than for ongoing surveillance. See GAO, Drug Safety:
FDA Has Conducted More Foreign Inspections and Begun to Improve Its
Information on Foreign Establishments, but More Progress is Needed,
GAO-10-961 (Washington, D.C.: Sept. 30, 2010). Similarly, we found
that 94 percent of drug manufacturing inspections conducted by
overseas investigators in China and India from June 16, 2009, through
June 10, 2010, were conducted as part of the drug approval process.
[29] See, for example, Food Safety Enhancement Act of 2009, H.R. 2749,
111th Cong. (2009) and FDA Food Safety Modernization Act, S. 510,
111th Cong. (2009).
[30] OIP identified measures to track and each of the overseas office
selected a key office project as a part of FDA-TRACK, an FDA-wide
performance management initiative that was initiated in January 2010.
[31] This workgroup is known as the International Working Group. In
addition, FDA has the Globalization Steering Committee, an agencywide
workgroup examining FDA's regulation of foreign products.
[32] FDA has limited the temporary assignments to less than 60 days
overseas because the Department of State requires medical clearance
for longer assignments.
[33] Returning ORA investigators are an exception and can assume their
former positions with ORA upon their return.
[34] Locality pay is a supplement to the rate of basic pay that is
provided to federal employees within given localities in the
continental United States to offset any gap between federal and
nonfederal salaries. According to FDA officials, HHS has the authority
to provide locality pay to overseas staff and is currently in the
process of examining whether to do so.
[35] A cost of living adjustment is provided to federal employees
posted at overseas locations where the cost of goods and services is
more expensive, relative to Washington, D.C. In addition, FDA staff
posted at overseas locations receive benefits that are not provided to
domestic staff, such as subsidized housing and reimbursed private
education for staff members' school age children.
[36] Some staff experience an increase in pay when they go overseas.
[37] The decrease in salary for the four Latin America Office staff
ranged from about $600 to $18,900. For one of these staff, FDA helped
offset the loss of locality pay by approving the staff member for a
student loan repayment program that provided $10,000 to pay back
student loans.
[38] The retirement compensation for federal employees is calculated,
in part, upon the highest average pay--inclusive of locality pay--
earned during any 3 consecutive years of service, which is typically
the last 3 years of employment.
[39] An entry line is each portion of an import shipment that is
listed as a separate item on an entry document. Items in an import
entry having different tariff descriptions or FDA product codes must
be listed separately.
[40] See [hyperlink, http://www.gao.gov/products/GAO-08-970], p. 43.
[41] The cost of these approaches varies. For example, in fiscal year
2009, FDA budgeted $29.9 million for the overseas offices. FDA also
indicated that the Office of Regulatory Affairs (ORA), which conducts
inspections, had average inspections costs of $22,100 for food
establishments, $30,300 for medical device and radiological health
establishments, $41,700 for animal drug establishments, $53,000 for
human drug establishments, and $63,600 for biologic establishments.
Based on these average costs, we calculated that, in that year, if ORA
had dedicated $29.9 million to conducting overseas inspections, it may
have been able to inspect an additional 470 to 1353 establishments,
depending on the type of establishments inspected. The estimates do
not include some costs--including those for translation and security
services, the FDA centers' costs for reviewing foreign inspection
reports and related compliance activities, the Office of International
Programs overseas office related costs, and the Office of Commissioner
overhead.
[42] As part of the agreement between FDA and European officials, the
European Medicines Agency and the European Food Safety Authority also
have staff embedded within FDA in the United States.
[43] Locally employed staff are foreign nationals and other locally
employed residents (including U.S. citizens) who are legally eligible
to work at U.S. missions abroad.
[End of section]
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