Food and Drug Administration
Improved Monitoring and Development of Performance Measures Needed to Strengthen Oversight of Criminal and Misconduct Investigations Gao ID: GAO-10-221 January 29, 2010The Food and Drug Administration (FDA) is responsible for protecting public health by regulating products such as prescription drugs and vaccines and has the authority to investigate alleged criminal activity related to FDA-regulated products, for example on the sale of counterfeit drugs. Within FDA, the Office of Criminal Investigations (OCI) investigates individuals and companies external to FDA. FDA also has the authority to investigate allegations of FDA employee misconduct and these internal investigations are conducted by the Office of Internal Affairs (OIA), a distinct office within OCI. GAO was asked to examine FDA's (1) oversight of OCI investigations, (2) oversight of OIA investigations, and (3) funding, staffing, and workload for OCI. GAO interviewed agency officials, reviewed FDA documents including those describing its investigative policies, and examined FDA data on OCI resources and workload, from fiscal years 1999 to 2008.
Although OCI maintains policies to guide its investigations, FDA's oversight of OCI's investigations of individuals and companies external to FDA is limited. As a key element of FDA's oversight of OCI, FDA's assessment of OCI's six field offices is intended to ensure compliance with investigative policies; however, the assessments are not being implemented in accordance with prescribed time frames. Of the 24 total office assessments that should have been completed by August 2009, only 7, or about 30 percent, were completed and one office had not been assessed in over 10 years. In addition, FDA lacks performance measures that could enhance the agency's oversight by allowing it to assess OCI's overall success. The OCI Director meets weekly with a senior official in the Office of Regulatory Affairs (ORA), the office in which OCI is located, but OCI is not required to report specific information to ORA or other FDA senior-level offices as part of its formal reporting relationship. As a result, FDA depends on OCI's Director to determine what aspects of OCI's investigations should be communicated to FDA senior managers. According to a senior ORA official, OCI operates more autonomously than other offices within ORA, in part, because of OCI's unique role and expertise within FDA. Similar to OCI, OIA has policies in place to guide its internal investigations, but FDA's oversight of OIA's investigations of FDA employees is limited. Although the OIA manager meets periodically with OCI's Director, FDA does not have a requirement for OIA to report specific information to OCI or other FDA senior-level offices on its investigative activities or a process in place to routinely monitor OIA's compliance with its investigative policies. The OIA manager told GAO that the number of investigations is such that he is generally involved in all of them, and can therefore review investigative documents before closing cases to assess compliance with investigative policies. The OIA manager told GAO that his review alleviates the need for a process to monitor compliance with OIA's investigative policies. The potential effectiveness of this review is limited because it relies on the OIA manager, who is also responsible for supervising investigations. FDA's funding and staffing for OCI generally increased annually between fiscal years 1999 and 2008, and OCI's investigative workload also increased over this 10-year period. OCI's funding and staffing include funding and staffing for OIA. OCI's funding, measured by the total funds expended, was about $19 million in fiscal year 1999 and was over $41 million in fiscal year 2008, representing an increase of about 73 percent, when adjusted for inflation. Staffing increased by about 40 percent during this period, from about 165 full-time equivalent employees to over 230. The largest increase in funding and staffing was between fiscal years 2002 and 2003. The OCI Director told GAO that this was the result of funding authorized by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 to address potential terrorist threats in connection with FDA-regulated products. Investigative workload also increased from fiscal year 1999 to 2008.
RecommendationsOur 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: Team: Phone:GAO-10-221, Food and Drug Administration: Improved Monitoring and Development of Performance Measures Needed to Strengthen Oversight of Criminal and Misconduct Investigations
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Report to the Ranking Member, Committee on Finance, U.S. Senate:
United States Government Accountability Office:
GAO:
January 2010:
Food and Drug Administration:
Improved Monitoring and Development of Performance Measures Needed to
Strengthen Oversight of Criminal and Misconduct Investigations:
GAO-10-221:
GAO Highlights:
Highlights of GAO-10-221, a report to the Ranking Member, Committee on
Finance, U.S. Senate.
Why GAO Did This Study:
The Food and Drug Administration (FDA) is responsible for protecting
public health by regulating products such as prescription drugs and
vaccines and has the authority to investigate alleged criminal
activity related to FDA-regulated products, for example on the sale of
counterfeit drugs. Within FDA, the Office of Criminal Investigations
(OCI) investigates individuals and companies external to FDA. FDA also
has the authority to investigate allegations of FDA employee
misconduct and these internal investigations are conducted by the
Office of Internal Affairs (OIA), a distinct office within OCI. GAO
was asked to examine FDA‘s (1) oversight of OCI investigations, (2)
oversight of OIA investigations, and (3) funding, staffing, and
workload for OCI. GAO interviewed agency officials, reviewed FDA
documents including those describing its investigative policies, and
examined FDA data on OCI resources and workload, from fiscal years
1999 to 2008.
What GAO Found:
Although OCI maintains policies to guide its investigations, FDA‘s
oversight of OCI‘s investigations of individuals and companies
external to FDA is limited. As a key element of FDA‘s oversight of
OCI, FDA‘s assessment of OCI‘s six field offices is intended to ensure
compliance with investigative policies; however, the assessments are
not being implemented in accordance with prescribed time frames. Of
the 24 total office assessments that should have been completed by
August 2009, only 7, or about 30 percent, were completed and one
office had not been assessed in over 10 years. In addition, FDA lacks
performance measures that could enhance the agency‘s oversight by
allowing it to assess OCI‘s overall success. The OCI Director meets
weekly with a senior official in the Office of Regulatory Affairs
(ORA), the office in which OCI is located, but OCI is not required to
report specific information to ORA or other FDA senior-level offices
as part of its formal reporting relationship. As a result, FDA depends
on OCI‘s Director to determine what aspects of OCI‘s investigations
should be communicated to FDA senior managers. According to a senior
ORA official, OCI operates more autonomously than other offices within
ORA, in part, because of OCI‘s unique role and expertise within FDA.
Similar to OCI, OIA has policies in place to guide its internal
investigations, but FDA‘s oversight of OIA‘s investigations of FDA
employees is limited. Although the OIA manager meets periodically with
OCI‘s Director, FDA does not have a requirement for OIA to report
specific information to OCI or other FDA senior-level offices on its
investigative activities or a process in place to routinely monitor OIA‘
s compliance with its investigative policies. The OIA manager told GAO
that the number of investigations is such that he is generally
involved in all of them, and can therefore review investigative
documents before closing cases to assess compliance with investigative
policies. The OIA manager told GAO that his review alleviates the need
for a process to monitor compliance with OIA‘s investigative policies.
The potential effectiveness of this review is limited because it
relies on the OIA manager, who is also responsible for supervising
investigations.
FDA‘s funding and staffing for OCI generally increased annually
between fiscal years 1999 and 2008, and OCI‘s investigative workload
also increased over this 10-year period. OCI‘s funding and staffing
include funding and staffing for OIA. OCI‘s funding, measured by the
total funds expended, was about $19 million in fiscal year 1999 and
was over $41 million in fiscal year 2008, representing an increase of
about 73 percent, when adjusted for inflation. Staffing increased by
about 40 percent during this period, from about 165 full-time
equivalent employees to over 230. The largest increase in funding and
staffing was between fiscal years 2002 and 2003. The OCI Director told
GAO that this was the result of funding authorized by the Public
Health Security and Bioterrorism Preparedness and Response Act of 2002
to address potential terrorist threats in connection with FDA-
regulated products. Investigative workload also increased from fiscal
year 1999 to 2008.
What GAO Recommends:
To improve oversight of its investigations, GAO recommends that FDA
regularly monitor OCI, and establish a process to monitor OIA for
compliance with its investigative policies. GAO also recommends that
FDA establish performance measures for OCI to assess whether OCI is
achieving its desired results. FDA agreed with GAO‘s recommendations.
View [hyperlink, http://www.gao.gov/products/GAO-10-221] or key
components. For more information, contact Marcia Crosse at (202) 512-
7114 or crossem@gao.gov.
[End of section]
Contents:
Letter:
Background:
OCI Maintains Policies to Guide Its Investigations but FDA's Oversight
of Those Investigations Is Limited:
FDA's Oversight of OIA Investigations Is Limited:
FDA's Funding and Staffing for OCI Investigations and OCI
Investigative Workload Have Increased:
Conclusions:
Recommendations for Executive Action:
Agency Comments and Our Evaluation:
Appendix I: Statistics from Investigations Involving the Office of
Criminal Investigations:
Appendix II: OCI Funding, Fiscal Years 1999 to 2008:
Appendix III: Comments from the Department of Health and Human
Services:
Appendix IV: GAO Contact and Staff Acknowledgments:
Tables:
Table 1: Description of the Office of Criminal Investigations'
Investigative Policies:
Table 2: Description of the Office of Internal Affairs' Investigative
Policies:
Table 3: Office of Criminal Investigations' Investigative Workload
Growth (Fiscal Years 1999 to 2008):
Table 4: Food and Drug Administration Funding for the Office of
Criminal Investigations, Actual and Inflation Adjusted to Fiscal Year
1999 Dollars (Fiscal Years 1999 to 2008):
Figures:
Figure 1: FDA's Organizational Structure for Conducting Investigations:
Figure 2: Office of Criminal Investigations' Funding and Staffing
Growth (Fiscal Years 1999 to 2008):
Figure 3: Number of Arrests and Convictions from Investigations
Involving the Office of Criminal Investigations (Fiscal Years 1999 to
2008):
Figure 4: Total Amount of Court-Ordered Fines and Restitution and
Assets Forfeited/Seized from Investigations Involving the Office of
Criminal Investigations (Fiscal Years 1999 to 2008):
Abbreviations:
ACRA: Associate Commissioner for Regulatory Affairs:
AIMS: Automated Investigative Management System:
CIR: Case Initiation Report:
CID: Criminal Investigation Division:
EPA: Environmental Protection Agency:
FDA: Food and Drug Administration:
FDCA: Federal Food, Drug, and Cosmetic Act:
FTE: full-time equivalent:
GDP: gross domestic product:
GPRA: Government Performance and Results Act of 1993:
HHS: Department of Health and Human Services:
OCC: Office of the Chief Counsel:
OCI: Office of Criminal Investigations:
OIA: Office of Internal Affairs:
OIG: Office of Inspector General:
ORA: Office of Regulatory Affairs:
ROI: Report of Investigation:
TIGTA: Treasury Inspector General for Tax Administration:
[End of section]
United States Government Accountability Office:
Washington, DC 20548:
January 29, 2010:
The Honorable Charles E. Grassley:
Ranking Member:
Committee on Finance:
United States Senate:
Dear Senator Grassley:
The Food and Drug Administration (FDA), an agency within the
Department of Health and Human Services (HHS), is responsible for
protecting public health by regulating products such as prescription
and over-the-counter drugs, human and pet food, medical devices,
cosmetics, and biological products such as vaccines. The products that
FDA regulates account for more than 20 percent of all consumer
spending in the United States annually--or approximately $1 trillion
worth of products. Its regulatory activities include taking
enforcement actions such as product recalls and investigating
allegations of criminal activity involving FDA-regulated products. In
response to a generic drug scandal that occurred in the 1980s and
increased criminal activity involving various FDA-regulated products,
FDA established the Office of Criminal Investigations (OCI) in 1991 to
conduct and coordinate criminal investigations for the
agency.[Footnote 1] OCI has investigated a wide variety of criminal
activities including the manufacture and sale of counterfeit drugs,
the illegal marketing of drugs, and the contamination of pet food.
While OCI focuses its investigative efforts on companies and
individuals external to FDA, another office within FDA--the Office of
Internal Affairs (OIA)--conducts internal investigations of
allegations of misconduct, criminal activity, or other violations of
applicable laws or regulations by FDA employees. FDA established OIA
in 1995 after a congressional subcommittee recommended that FDA
establish an internal affairs office.[Footnote 2] While OIA and OCI
have different purposes, OIA is organizationally part of OCI.[Footnote
3] You and others have raised concerns about OCI's and OIA's
procedures for conducting and coordinating investigations, that these
offices are operating without adequate oversight or accountability,
and that OCI's funding and staffing for criminal investigations have
grown significantly despite limited federal resources to fund other
FDA activities. At a congressional hearing in February 2008, on FDA's
investigation of a researcher employed outside of FDA accused of
fraudulently conducting a clinical study of the drug Ketek, you raised
concerns that OCI did not effectively coordinate its investigative
work with another FDA unit.[Footnote 4] In addition, based on an
internal investigation conducted by OIA of an FDA scientist with an
alleged conflict of interest, you concluded that certain investigative
findings were inaccurate and were not sufficiently reviewed within
FDA.[Footnote 5] Further, in 2008, concerns about accountability and
increases in funding and staffing at a time when resources were
limited for other parts of FDA prompted the House Committee on Energy
and Commerce to request information about OCI's recent operational and
staffing expenses.[Footnote 6] Because OIA is part of OCI, its funding
and staffing are provided and accounted for with funding and staffing
for the rest of OCI.
In light of these concerns, you asked us to conduct a review of FDA's
oversight of OCI and OIA investigations, including the investigative
policies and procedures each office has in place, and FDA's resources
for OCI and OIA investigations. In this report we examine (1) FDA's
oversight of OCI investigations, (2) FDA's oversight of OIA
investigations, and (3) FDA's funding, staffing, and workload for OCI.
To examine FDA's oversight of OCI investigations of individuals and
companies external to FDA, we reviewed FDA documents and interviewed
FDA managers and officials from other federal agencies. We reviewed
OCI documents describing its internal policies and procedures and
compared the policies with the broad components of the investigative
process which we identified by reviewing relevant investigative
standards and consulting with officials in several federal law
enforcement agencies and GAO's Forensic Audits and Special
Investigations Unit.[Footnote 7] We reviewed FDA organizational
charts, position descriptions for OCI managers, and FDA documents
describing office reporting requirements, as part of FDA's oversight
of OCI investigations. We also examined OCI's policy on conducting
office assessments (that is, its procedure for monitoring compliance
with investigative policies) and we reviewed reports that were based
on the completed office assessments for each of the six OCI field
offices as well as OCI's schedule of completed office assessments for
OCI's field offices.[Footnote 8] We interviewed OCI managers about
OCI's investigative process and the individual roles and
responsibilities for OCI staff and managers in conducting and
coordinating criminal investigations. We also interviewed an Assistant
U.S. Attorney from the U.S. Attorney's Office for the Western District
of Missouri, about the role of the U.S. Attorney in prosecuting cases
based on the investigative work of OCI.[Footnote 9] We interviewed an
associate commissioner in FDA's Office of Regulatory Affairs (ORA) and
OCI headquarters managers about OCI's reporting requirements, how ORA
and OCI monitor investigations, and how ORA and OCI assess OCI's
performance.[Footnote 10] To further understand the criminal
investigative process, including the management and oversight of
investigations, we conducted structured phone interviews with OCI's
field supervisors in each of OCI's six field offices. We interviewed
budget staff from ORA and OCI to understand the funding allocation
process and reporting requirements for OCI's funding. We also
interviewed officials who conduct investigations in HHS's Office of
Inspector General (OIG), the Environmental Protection Agency Criminal
Investigation Division (EPA CID), and the Treasury Inspector General
for Tax Administration (TIGTA) on how they measure the performance of
their investigative programs and monitor compliance with their
investigative policies and procedures.[Footnote 11] We reviewed
federal government internal control standards[Footnote 12] to identify
effective management practices for providing oversight, and compared
the standards with FDA's management practices for overseeing OCI
investigations. We focused on practices to monitor compliance with
policies and procedures, measure performance, and report pertinent
information to management. Finally, we reviewed OCI's investigative
statistics, such as arrests and convictions, from fiscal years 1999 to
2008.
To examine FDA's oversight of OIA's internal investigations of FDA
employees, we reviewed FDA documents and interviewed several FDA
managers and officials from the HHS OIG. Similar to our examination of
OCI, we reviewed documents describing OIA's policies and compared them
to the broad components of the investigative process which we
identified by reviewing investigative standards and consulting with
officials in relevant federal law enforcement agencies. We reviewed
FDA organizational charts and the position description for the OIA
manager. We interviewed OIA's manager about the roles and
responsibilities of the OIA staff and manager, and other FDA managers,
in conducting and coordinating its investigations of FDA employees. We
also interviewed the OCI Director and the OIA manager about what
information OIA reports to FDA management, how OIA monitors compliance
with its investigative policies and procedures, and what investigative
statistics are collected and maintained. We interviewed HHS OIG
officials from the Office of Investigations about the OIG's role in
conducting investigations of FDA employees. Similar to our OCI review,
we reviewed federal government internal control standards to identify
effective management practices for providing oversight, and we
compared the standards with FDA's management practices for overseeing
OIA investigations. We focused on practices to monitor compliance with
policies and procedures and report pertinent information to management.
To examine OCI funding,[Footnote 13] staffing, and workload, we
analyzed data provided by FDA and interviewed OCI officials.[Footnote
14] To examine OCI funding and staffing, we analyzed aggregate FDA
data from fiscal years 1999 to 2008 provided for OCI. We first
compared changes in funding in actual terms during this 10-year period
with changes in funding after adjusting for inflation. We used the
gross domestic product (GDP) price index for nondefense goods and
services to adjust for inflation.[Footnote 15] Second, we identified
changes in OCI's staffing during the same time period and we report on
staffing resources as the number of full-time equivalent (FTE) staff.
[Footnote 16] To examine changes in OCI's workload, we analyzed OCI
data on the number of opened and closed investigations each year from
fiscal years 1999 to 2008 as well as the number of ongoing
investigations, that is, those that remained open at the end of each
fiscal year. OCI investigative workload data came from OCI's Automated
Investigative Management System (AIMS), the data system that OCI uses
to track and maintain key information about each investigative case.
To assess the reliability of FDA data on investigative workload and
statistics, funding, and staffing, we reviewed existing information
about the data and we interviewed agency officials knowledgeable about
the data. We determined that the data were sufficiently reliable for
their use in this report.
We performed our performance audit from January 2009 to November 2009
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 has the authority to conduct investigations of alleged criminal
activity related to FDA-regulated products, such as the misbranding of
those products, and to investigate allegations of misconduct and
criminal activity by FDA employees. OCI, the office with
responsibility for conducting and coordinating criminal
investigations, is located within ORA and has field offices located
across the United States. OIA is a distinct office within OCI with
responsibility for investigating allegations involving FDA employees.
OCI's Director reports to the head of ORA and OIA's manager reports to
the OCI Director.
FDA's Authority to Conduct Investigations:
The Secretary of HHS has granted FDA the authority to conduct
investigations of alleged criminal activity related to FDA-regulated
products. Such criminal activity may involve violations of the Federal
Food, Drug, and Cosmetic Act (FDCA),[Footnote 17] the Federal Anti-
Tampering Act,[Footnote 18] and other statutes including provisions of
Title 18 of the United States Code.[Footnote 19] Under this authority,
FDA may investigate crimes such as the misbranding of FDA-regulated
products, product tampering, and the manufacture and sale of
unapproved FDA-regulated products. The Secretary of HHS has also
granted FDA the authority to investigate cases involving FDA
employees--that is, any allegations of misconduct, criminal activity,
or other violations of applicable laws or regulations.
Under the Inspector General Act of 1978, the HHS OIG also has the
authority to conduct investigations of FDA-regulated entities and to
investigate cases involving FDA employees.[Footnote 20] An HHS OIG
official stated that his agency focuses on investigating FDA-regulated
entities when HHS programs--such as Medicare and Medicaid--or funds
are involved.[Footnote 21] In addition, the HHS OIG has authority for
investigating cases involving HHS employees, which includes cases
involving FDA employees. This authority supersedes FDA's authority to
investigate its employees; HHS OIG can decide to investigate a case
independently, jointly with FDA, or decline to investigate a case,
which allows FDA to investigate the case independently.
Office of Criminal Investigations' and Office of Internal Affairs'
Structure, Staff, and Investigations:
In response to evidence of increased criminal activity in FDA-
regulated products, OCI was established in 1991 to conduct and
coordinate criminal investigations of violations of FDA-related
laws.[Footnote 22] OCI's mission includes working with and supporting
U.S. Attorneys, who initiate prosecution of OCI cases as well as
criminal cases for other investigative agencies.[Footnote 23] OCI is
composed of a headquarters office that has two divisions--
Administrative Operations and Investigative Operations--and six field
offices (see figure 1). Each field office covers a geographic region
of the United States, made up of several states, and within each field
office there are subordinate offices--referred to as resident and
domicile offices, also with responsibility for designated geographic
areas.[Footnote 24] OCI investigations are primarily conducted in the
field offices under the direction of field supervisors, and the
headquarters office provides policy, investigative, and administrative
support to the field offices.[Footnote 25] The field supervisors
report directly to the Special Agents in Charge of the Administrative
Operations and Investigative Operations Divisions, who in turn report
to the OCI Director.
Figure 1: FDA's Organizational Structure for Conducting Investigations:
[Refer to PDF for image: illustration]
Top level:
FDA Office of the Commissioner.
Second level, reporting to FDA Office of the Commissioner: FDA Office
of Regulatory Affairs (ORA).
Third level, reporting to FDA Office of Regulatory Affairs (ORA):
Office of Criminal Investigations (OCI).
Fourth level, reporting to Office of Criminal Investigations (OCI):
Office of Internal Affairs (OIA);
OCI Administrative Operations Division; OCI Investigative Operations
Division.
Fifth level, reporting to OCI Administrative Operations Division and
OCI Investigative Operations Division: 6 OCI Field Offices.
Sixth level, reporting to 6 OCI Field Offices: 6 OCI Resident Offices;
22 OCI Domicile Offices.
Source: GAO analysis of FDA organization charts.
[End of figure]
OCI's staff includes criminal investigators, forensic and information
technology personnel, and other support staff.[Footnote 26] Most of
OCI's staff is comprised of criminal investigators--in fiscal year
2008, 180 of the 223 OCI staff were criminal investigators.[Footnote
27] The role of the criminal investigator includes evaluating
allegations of criminal activity and determining whether an
investigation should be opened within OCI; if an investigation is
opened, investigators gather evidence using various investigative
techniques, such as electronic surveillance, and document the steps
taken in the course of the investigation.[Footnote 28] Criminal
investigators often complete their investigations by presenting their
cases to local U.S. Attorneys for prosecution.
OCI is located within ORA, the office with primary responsibility for
all FDA field activities such as conducting inspections of FDA-
regulated products and manufacturers (see figure 1).[Footnote 29]
OCI's Director reports to the head of ORA, the Associate Commissioner
for Regulatory Affairs (ACRA).[Footnote 30] OCI is funded as part of
ORA and ORA uses OCI's previous year's funding as a baseline for the
current year when allocating funding to OCI. In fiscal year 2008,
OCI's funding was $41.3 million.
OIA, which is a distinct office within OCI, was established in 1995 to
investigate cases involving FDA employees (see figure 1).[Footnote 31]
OIA's manager reports to the OCI Director.[Footnote 32] OIA's
investigations are intended to collect evidence to determine the
validity of allegations involving FDA employees so that FDA managers
can decide whether administrative actions against employees are
warranted. In cases where criminal sanctions are warranted, OIA refers
cases to U.S. Attorneys or local prosecutors for prosecution.[Footnote
33] OIA's staff in fiscal year 2008 included seven criminal
investigators and two support staff. Two of the seven criminal
investigators are supervisors. OIA investigators are usually assigned
from OCI although OIA sometimes recruits specifically for OIA
investigators.[Footnote 34] OCI's allocation of funding from ORA
includes funding for OIA, as well as OCI's other components. OCI then
further allocates funding from ORA among its components, including OIA.
According to the OCI Director, OCI prefers to hire experienced
criminal investigators from other federal law enforcement agencies
because they bring to OCI prior federal law enforcement training,
professional contacts, and expertise in several areas, including the
use of investigative techniques.[Footnote 35] Upon hire, OCI criminal
investigators must have completed basic and advanced federal law
enforcement training through their previous law enforcement agency and
all newly hired OCI criminal investigators attend an OCI-specific
training program.[Footnote 36] OCI criminal investigators also receive
continuing instruction in areas such as courses on the FDCA and the
Anti-Tampering Act, interviewing techniques, and internet
investigations. OIA investigators have the same training requirements
as OCI criminal investigators because they are generally assigned to
OIA from OCI; OIA provides additional training to OIA investigators on
internal affairs issues, such as employee rights.
OCI Maintains Policies to Guide Its Investigations but FDA's Oversight
of Those Investigations Is Limited:
Although OCI has policies to guide its investigations of individuals
and companies external to FDA, FDA's oversight of OCI's criminal
investigations is limited. As a key element of its oversight, FDA has
a process in place that is intended to ensure OCI's compliance with
investigative policies and procedures; however, FDA has not ensured
that this process is implemented by OCI in accordance with its
prescribed time frames. In addition, FDA lacks performance measures
that could enhance its oversight of OCI by allowing it to assess OCI's
overall success. Although the OCI Director regularly meets with the
ORA ACRA, there is no requirement for OCI to report regularly on
specific topics to FDA senior-level offices as part of the formal
reporting relationship. As a result, FDA relies on the OCI Director to
determine which aspects of OCI's operations and investigations are
made known to FDA's top management.
OCI Has Policies to Guide Its Investigations:
OCI has policies in place to guide its investigations of individuals
and companies external to FDA that address each of the five
investigative components that we identified by reviewing relevant
investigative standards and consulting with several federal law
enforcement agency officials (see table 1). OCI's policies generally
outline the role of the criminal investigator in the investigative
process as well as designate responsibilities for the field
supervisors and OCI headquarters management.[Footnote 37] The policies
also describe the necessary steps for documenting investigative
activities, including the review and approval of such activities by
field supervisors. For example, for the first component--documenting
and evaluating allegations/leads--OCI's policy on tampering states
that criminal investigators and their field supervisors must assess
the potential threat to the public health for all tampering
allegations, determine what investigative actions are warranted, and
report this information to headquarters management within 24 hours of
receipt. As an example of an OCI policy addressing collecting
information--the third component--when a criminal investigator plans
to conduct electronic surveillance of certain telephone
communications, the investigator must first obtain written approval
from the field supervisor, who in turn is required to forward the
approved request to headquarters management for final approval.
[Footnote 38]
Table 1: Description of the Office of Criminal Investigations'
Investigative Policies:
Component: Documenting and evaluating allegations/leads; Description
of the Office of Criminal Investigations' investigative policies:
* Upon receipt of an allegation or lead that requires additional
investigation, a Case Initiation Report (CIR) must be filled out by
the criminal investigator, approved by his/her field supervisor, and
sent to the Office of Criminal Investigations (OCI) headquarters
management for review. A CIR must also be completed for preliminary
cases, that is, those in which an allegation or lead does not
necessarily result in a criminal investigation.
Component: Opening an investigation; Description of the Office of
Criminal Investigations' investigative policies:
* Based upon the information in the CIR, OCI headquarters management
must decide if a case needs to be opened. If so, a case number is
assigned to the case.
Component: Collecting information;
Description of the Office of Criminal Investigations' investigative
policies:
* Certain interviews
must be documented, including suspect interviews, key victim/witness
interviews, and interviews that disclose complex information;
* Specific policies guide the use of specialized techniques such as
searching e-mail or internet usage, electronic surveillance,
confidential informants, and undercover operations. These techniques
generally require at least field supervisor approval and often
approval by headquarters management. The use of specialized techniques
may also require a warrant or court order;
* Evidence must be documented and catalogued using relevant standards
and under the supervision of the investigator's field supervisor and
also the field office official responsible for overseeing evidence.
Component: Documenting, managing, and tracking investigative data;
Description of the Office of Criminal Investigations' investigative
policies:
* To document and track allegations, OCI requires its criminal
investigators to submit a Report of Investigation (ROI) at least every
90 days to document their investigative activities, including
activities such as interviews, surveillance, and search warrants. The
ROI is required to be reviewed and approved by a field supervisor;
* Documents central to the investigation (i.e., CIRs, ROIs, Judicial
Action Forms, and Subject History Forms) must be entered into AIMS and
also sent as hard copies to OCI headquarters once they are approved by
a field supervisor.
Component: Resolution of the case;
Description of the Office of Criminal Investigations' investigative
policies:
* To resolve a case, OCI requires that its criminal investigators
document the outcome of each investigation in a closing ROI, including
any legal action taken against subjects that are charged with criminal
offenses. Indictments, arrests, and convictions which occur as a
result of a criminal investigation must be entered into AIMS;
* Field supervisors are responsible for making sure all appropriate
steps are taken prior to case closure. For example, the destruction of
evidence no longer needed must be documented.
Source: GAO analysis and summary of OCI policies.
Note: We identified the five investigative components by reviewing
relevant investigative standards and consulting with several federal
law enforcement agency officials.
[End of table]
A Key Element of FDA's Oversight of OCI to Ensure Its Compliance with
Investigative Policies Has Not Been Implemented within Established
Time Frames:
As a key element of its oversight, FDA has had an established process
in place to monitor OCI's compliance with investigative policies and
procedures since 1996, but FDA has not ensured that this process is
implemented by OCI in accordance with its prescribed time frames. As
stated in OCI policy, each field office's investigative and
administrative procedures are to be evaluated for compliance with OCI
policies through the office assessment process at least every 3 years,
depending on the availability of resources. The office assessment
process, according to OCI policy, is an oversight mechanism to ensure
that OCI is in compliance with its policies and procedures. The field
office assessment process has four steps that include a self
assessment and an onsite visit that is conducted by OIA
staff.[Footnote 39] For the self assessment, field office staff are
required to analyze compliance with OCI policies in 10 areas of
administrative and investigative operations, such as the supervision
of criminal investigator activities, and all identified findings of
noncompliance must be documented.[Footnote 40] For the onsite
inspection, OIA staff are to review certain administrative and
investigative files to assess compliance with OCI policies and
interview criminal investigators, for example about the adequacy of
the supervision that they receive. The field supervisor and OCI
Director are to be provided a final report, prepared by OIA staff,
summarizing the office assessment results. The field supervisor is to
work with OCI headquarters and OIA staff to correct any identified
areas of noncompliance and the corrective actions are required to be
documented. An example of a corrective action based on an office
assessment occurred in 2007 when OCI headquarters issued an interim
policy to clarify its existing policy on documenting the receipt of
evidence.
Of the 24 OCI field office assessments that should have been completed
by August 2009--4 for each of the six field offices--only 7, or about
30 percent, were completed.[Footnote 41] None of the six field offices
has been evaluated within the required 3-year time frame and only one
has been evaluated more than 1 time since 1996--the year the office
assessment policy was established. Moreover, the most recent
assessment for one field office was conducted over 10 years ago--in
1997.[Footnote 42] The field supervisor in this office told us in June
2009 that his office had recently begun another assessment.
According to the OCI Director, limited resources and logistical issues
have prevented FDA from assessing field office compliance with OCI's
investigative policies and procedures every 3 years. The OCI Director
stated that scheduling is a key concern given that the assessments
require multiple staff to be available to participate, including OCI
headquarters and field office staff and OIA staff. OCI's Director also
told us that once an assessment has begun, scheduling issues can
affect implementation of the assessment. For example, according to a
2007 final office assessment report, an ongoing trial and a mandatory
training program prevented OIA staff from interviewing certain field
office employees during the OIA-led onsite visit.
FDA Lacks Performance Measures that Could Enhance Its Oversight of OCI:
FDA lacks performance measures for OCI that could enhance its
oversight of OCI by allowing it to assess OCI's overall success. As
part of its performance plan, FDA has long-term goals, such as
improving patient and consumer safety, and associated performance
measures that the agency uses to assess whether it is meeting its
goals.[Footnote 43] However, FDA's current performance plan does not
include performance measures related to OCI under any of the agency's
long-term goals even though FDA considers OCI's role in enforcing FDA
laws and regulations to be essential to the agency's mission of
protecting public health. [Footnote 44] Congress passed the Government
Performance and Results Act of 1993 (GPRA) to encourage agencies to
focus on the performance and results of their programs, rather than
solely on program activities and resources.[Footnote 45] The
principles of the act include establishing measurable goals and
related measures, developing strategies for achieving results, and
identifying the resources that will be required to achieve the goals.
GPRA requires that federal agencies develop performance measures--
indicators that an agency will use to measure its performance against
its established goals--and prepare annual performance plans that
include a summary of the agency's performance measures.[Footnote 46]
The act does not require agencies to use these principles for
individual programs, but past GAO work[Footnote 47] and the experience
of leading organizations have demonstrated that the principles are the
basic underpinning for performance-based management--a means to
strengthen program performance.
OCI has also not established results-oriented goals and measures with
which to assess its own performance. OCI's Director said that
measuring the performance of FDA's criminal investigative program is a
challenge because of the difficulty in isolating the effects of OCI's
work from other factors that affect outcomes, but over which OCI has
limited control. For example, OCI could conduct a high-quality
investigation that does not lead to a prosecution. Criminal
prosecutions that result from investigations have been suggested by
some agencies to be a measure that reflects the work of criminal
investigative organizations. However, the OCI Director explained that
when an OCI case is presented to a U.S. Attorney's Office for a
prosecution decision, the U.S. Attorney's Office typically evaluates
the case based on a number of factors, including not only the strength
and quality of the evidence provided, but also the extent to which the
case falls under the office's current investigative and prosecutorial
priorities.[Footnote 48] Individual U.S. Attorney's Offices may
establish their own investigative and prosecutorial priorities based
on local crime problems and the needs of the local community. In
addition, there may be national prosecution priorities set by the
Department of Justice based on a national assessment of crime
problems. As an example, an Assistant U.S. Attorney told us that
mortgage fraud is a current investigative and prosecutorial priority.
He indicated that priorities often affect staffing and resources
within a U.S. Attorney's Office and may indirectly affect the ability
of the office to proceed on every matter presented for prosecution.
[Footnote 49]
Other federal agencies, however, have established performance measures
for their criminal investigative programs despite the challenge of
isolating the effects of their agency's investigative work from other
factors that might affect a given measure. For example, according to
its current strategic plan, the Department of Justice's Drug
Enforcement Administration has a performance measure targeting the
number of major organizations responsible for distributing drugs in
the United States that are dismantled annually.[Footnote 50] An EPA
official, while acknowledging the challenge in measuring performance
for criminal investigative programs, told us that her agency is
developing a performance measure addressing the reduction in repeat
environmental crimes among violators. This official added that
performance measures help inform and focus the management of EPA's
criminal enforcement program. Several agency officials we spoke with
acknowledged that the measures their agencies use are not perfect
because they do not have complete control over them. However, they
stated that their measures provide some indication of whether the
agencies are achieving results. Prior GAO work has noted similar
challenges in measuring performance in other federal agencies,
including those with criminal investigative programs.[Footnote 51]
However, according to a 2004 GAO report, federal managers do not
perceive issues such as "difficulty distinguishing between the results
produced by the program and results caused by other factors" to be a
substantial hindrance to measuring their agencies' performance.
[Footnote 52]
In the absence of standard performance measures, various FDA managers
described somewhat different views on how OCI's performance could best
be measured. For example, the OCI Director told us that OCI's
performance should be viewed based on FDA's overall mission to protect
the public health and how well OCI handles high-priority cases.
Furthermore, an FDA document states that OCI's impact on protecting
the public health cannot be measured solely by the number of arrests
and convictions. In contrast, one OCI field office supervisor told us
that he believed legal actions--including the number of annual
convictions and arrests that result from OCI investigations--are
indicators of how well OCI is performing. The acting ACRA told us that
OCI's performance should be assessed based, in part, on the court-
ordered fines and restitution that result from OCI investigations. OCI
maintains investigative statistics, which include court-ordered fines
and restitution, convictions, and arrests and reports certain
statistics on its Web site.[Footnote 53] For more information about
these statistics and other OCI investigative statistics, see appendix
I.
OCI Is Not Required to Report Specific Information to FDA Management:
OCI is not required to report specific information to ORA or other FDA
senior-level offices as part of its formal reporting relationship.
While the OCI Director meets regularly with the ORA ACRA, there is no
formal reporting requirement--that is, FDA does not have a protocol
establishing what information is to be reported, the time frame for
the information to be communicated, and the format in which the
information is reported--between OCI and FDA management[Footnote 54].
The OCI Director told us that he meets weekly with the ORA ACRA to
discuss any pertinent issues that arise, such as OCI's active
investigations, funding, or personnel. The OCI Director also advises
the ORA ACRA about results of the field office assessments. The OCI
Director told us that he meets on an as-needed basis with the Office
of the Commissioner, for example to brief the Commissioner on a case
involving an indictment. None of the meetings between the OCI Director
and the ORA ACRA or Office of the Commissioner are documented, for
example with meeting minutes or agendas. According to the acting ACRA,
OCI is not required to report any specific information to ORA, for
example, about OCI's investigative activities, performance, use of
funding, or monitoring activities. The lack of a requirement for OCI
to report regularly on specific topics to FDA senior-level offices
means that FDA has relied largely on the OCI Director to determine
which aspects of OCI's operations and investigations are made known to
FDA's top management. This management approach could place ORA, and
other FDA senior-level offices, in a reactive rather than leadership
position with respect to overseeing OCI and the criminal investigative
work OCI manages. Moreover, the ACRA noted that, compared to other
units within ORA, he has less of a 'chain-of-command' relationship
with OCI, and that OCI operates more autonomously than other offices
within ORA, in part, because of its unique role and expertise within
FDA. FDA and OCI officials said that they believe the existing
processes for the reporting of information are adequate for their
needs. We were unable to assess the adequacy of OCI's current reports
to ORA and the Office of the Commissioner due to the lack of meeting
documentation.
FDA's Oversight of OIA Investigations Is Limited:
Similar to OCI, OIA has policies in place to guide its internal
investigations of FDA employees but FDA's oversight of OIA
investigations is limited. FDA does not have formal arrangements in
place to oversee OIA investigations, such as a requirement for OIA to
report regularly on its investigative activities to FDA management
[Footnote 55] or a process to regularly monitor OIA's compliance with
its investigative policies.
OIA Has Policies to Guide Its Investigations:
OIA has policies in place to guide its internal investigations of FDA
employees and the policies address each of the five investigative
components we identified. As described earlier, we reviewed relevant
investigative standards and consulted with officials in several
federal law enforcement agencies to identify these components (see
table 2).[Footnote 56] The policies outline the responsibilities of
the OIA investigators and the OIA manager in the investigative process
including investigative activities where supervisory review and
approval must be documented. As an example of an OIA policy that
addresses the first component--documenting and evaluating allegations/
leads--an OIA investigator is required to complete a case initiation
form when a complaint about an FDA employee is received. The OIA
manager is then to review and approve the form, which includes
information about the type of alleged employee misconduct and the
source of the allegation. As another example, OIA's policies on
interviews address the third component--collecting information--by
outlining the rights of government employees during an
interview.[Footnote 57] For instance, for criminal allegations, an
employee has a right to have a lawyer present during a custodial
interview and to refuse to answer questions that could be self-
incriminating. For cases without criminal allegations, an employee may
have the right to have a union representative present during an
interview but may be compelled to answer questions or face
termination. OIA policy states that compelling an employee to answer
questions must be approved by the OIA manager prior to initiating the
interview.
Table 2: Description of the Office of Internal Affairs' Investigative
Policies:
Component: Documenting and evaluating allegations/leads;
Description of the Office of Internal Affairs' investigative policies:
* Investigators in the Office of Internal Affairs (OIA) who receive a
complaint must complete a Case Initiation Report (CIR) Form which must
be submitted to the OIA manager for evaluation and approval;
* OIA investigators must notify the HHS OIG upon receipt of
allegations with the reasonable potential for criminal charges or an
otherwise sensitive case. HHS OIG's decision to accept the case, work
the case jointly with OIA, or refer the case back to OIA must be
documented in the investigative file and also in a report of
investigation (ROI).
Component: Opening an investigation;
Description of the Office of Internal Affairs' investigative policies:
* Upon receipt of a CIR, the OIA manager must determine whether an
investigation should be initiated. If so, a case will be opened and
the case will be assigned to an OIA investigator.
Component: Collecting information;
Description of the Office of Internal Affairs' investigative policies:
* When collecting information for a case, OIA investigators must
follow relevant policies for initiating and conducting interviews;
* According to the OIA manager, OIA generally follows OCI's policies
when using relevant specialized techniques to collect information,
such as searching e-mail or internet usage, since it does not have
separate guidelines for these techniques.
Component: Documenting, managing, and tracking investigative data;
Description of the Office of Internal Affairs' investigative policies:
* OIA requires its investigators to document their investigative
activities in an ROI at least every 90 days, including activities such
as interviews, record of internet usage, or pending administrative
actions taken against an employee. However, an ROI must be submitted
within 10 days of any significant development in a case, such as an
employee termination or resignation. All ROIs must be reviewed and
approved by the OIA manager.
Component: Resolution of the case;
Description of the Office of Internal Affairs' investigative policies:
* To resolve a case, OIA must refer its investigative findings to the
FDA manager responsible for determining what, if any, administrative
action is necessary, ranging from a verbal reprimand to termination of
employment. Each OIA investigator will prepare the relevant documents
for referral to FDA management, in consultation with the OIA manager;
* OIA requests that the appropriate FDA manager inform the office
within 30 days about the details of any proposed administrative
actions taken, based upon OIA's investigation. Copies of the
investigative findings must also be sent to FDA's unit responsible for
employee relations;
* For cases that involve legal actions, OIA must document in the ROI
information such as alleged criminal violations, related evidence of
these violations, and a listing of witnesses and their testimony.
Source: GAO analysis and summary of OIA policies.
Note: We identified investigative components by reviewing relevant
investigative standards and consulting with several federal law
enforcement agency officials.
[End of table]
FDA Conducts No Formal Oversight of OIA:
Although the OIA manager said he meets periodically with the OCI
Director to discuss administrative issues such as hiring, FDA does not
conduct formal oversight of OIA with a requirement for it to report
regularly on its investigative activities or with a process to
routinely monitor OIA's compliance with its investigative policies.
[Footnote 58] According to OCI and OIA officials, OIA is not required
to formally report information to OCI or other senior-level FDA
offices, for example, about OIA's investigative activities or its use
of funding. The OIA manager said that he meets only when needed with
the OCI Director and that these meetings focus primarily on
administrative issues such as hiring or training; the OIA manager also
stated that he has minimal discussion with the OCI Director regarding
ongoing OIA investigations.[Footnote 59] However, the OIA manager told
us that he briefs the OCI Director about high-profile or otherwise
significant investigations. While there is no requirement for formal
reports, the OIA manager does share all case initiation reports for
OIA investigations with the OCI Director. OIA does not have a formal
oversight process in place for its management to monitor compliance
with its investigative policies. According to the OIA manager, the
office's small size and low number of investigations alleviate the
need for a formal monitoring process because he is involved to some
extent in all ongoing OIA investigations.[Footnote 60] That is, the
OIA manager told us that his involvement, which includes a review of
each OIA investigation's documentation prior to closure, helps to
ensure that OIA investigations are being conducted in accordance with
OIA policies. However, relevant internal control standards state that
the separation of duties and responsibilities is important for an
effective monitoring strategy.[Footnote 61] OIA does not maintain a
separation of duties as the OIA manager is directly involved in the
supervision of ongoing OIA investigations and is also responsible for
the review of OIA cases, which is the office's mechanism for ensuring
compliance with its investigative policies. The potential
effectiveness of OIA's monitoring process is limited by relying on the
OIA manager--rather than an external reviewer who is not involved in
ongoing investigations--to assess the office's compliance and to
correct any identified deficiencies.
FDA's Funding and Staffing for OCI Investigations and OCI
Investigative Workload Have Increased:
FDA's funding and staffing for OCI investigations and OCI's
investigative workload have increased between fiscal years 1999 and
2008. OCI's funding grew by about 73 percent when adjusted for
inflation and OCI's staffing also increased by about 40 percent.
Similarly, OCI's investigative workload--the number of opened, closed,
and active investigations--increased over this 10-year period.
[Footnote 62]
OCI Funding and Staffing Increased from Fiscal Years 1999 to 2008:
FDA's funding and staffing for OCI investigations increased from
fiscal years 1999 through 2008. OCI's funding and staffing include
funding and staffing for OIA.[Footnote 63] OCI funding covers staff
and operational expenses such as salaries, travel, and rent. Criminal
investigator salaries comprise the largest component. In fiscal year
1999, OCI funding was about $19 million. By fiscal year 2008, funding
had increased to over $41 million (see figure 2). When adjusted for
inflation, funding increased by about 73 percent over this 10-year
period and in actual terms, the funding increased by about 117 percent
(see appendix II for inflation adjustments). OCI staffing has also
grown--in fiscal year 1999 OCI had about 165 FTEs and staffing had
increased to over 230 FTEs by fiscal year 2008, representing about a
40 percent increase. The largest increase in OCI's funding and
staffing occurred between fiscal years 2002 and 2003; according to
OCI's Director, this increase was the result of funding authorized by
the Public Health Security and Bioterrorism Preparedness and Response
Act of 2002[Footnote 64], which provided OCI additional resources to
address potential terrorist threats in connection with FDA-regulated
products.
Figure 2: Office of Criminal Investigations' Funding and Staffing
Growth (Fiscal Years 1999 to 2008):
[Refer to PDF for image: two vertical bar graphs]
Fiscal year: 1999;
Funding (dollars in thousands): $19,073;
Staffing (full-time equivalents): 165.
Fiscal year: 2000;
Funding (dollars in thousands): $21,187;
Staffing (full-time equivalents): 176.
Fiscal year: 2001;
Funding (dollars in thousands): $23,105;
Staffing (full-time equivalents): 185.
Fiscal year: 2002;
Funding (dollars in thousands): $25,589;
Staffing (full-time equivalents): 186.
Fiscal year: 2003;
Funding (dollars in thousands): $31,041;
Staffing (full-time equivalents): 217.
Fiscal year: 2004;
Funding (dollars in thousands): $33,172;
Staffing (full-time equivalents): 218.
Fiscal year: 2005;
Funding (dollars in thousands): $35,328;
Staffing (full-time equivalents): 222.
Fiscal year: 2006;
Funding (dollars in thousands): $36,279;
Staffing (full-time equivalents): 221.
Fiscal year: 2007;
Funding (dollars in thousands): $37,803;
Staffing (full-time equivalents): 221.
Fiscal year: 2008;
Funding (dollars in thousands): $41,310;
Staffing (full-time equivalents): 230.
Funding from 1999 through 2008 represents an increase of about 117%.
Staffing from 1999 through 2008 represents an increase of about 40%.
Source: GAO analysis of FDA data.
Note: Outlays are used to approximate funding. Outlays during a fiscal
year may be for payment of obligations incurred in prior years (prior-
year obligations) or in the same year. Outlays made during a fiscal
year for prior-year obligations are generally made with prior-year
appropriations. OCI's funding and staffing include funding and
staffing for OIA.
[End of figure]
OCI's Investigative Workload Increased from Fiscal Years 1999 to 2008:
OCI's investigative workload--the number of opened, closed, and active
investigations each year--generally increased annually from fiscal
years 1999 to 2008.[Footnote 65] The number of investigations that OCI
opened each year generally increased. This number increased by 27
percent from fiscal year 1999 to 2008, from 370 to 471. OCI opened the
largest number of investigations in fiscal year 2005--513 cases (see
table 3). The number of closed investigations each year also generally
increased during this time. It increased by 108 percent, from 201 to
418, and the number of cases that OCI's criminal investigators
actively worked at the end of a fiscal year increased by 66 percent,
from 655 to 1087, from fiscal year 1999 to 2008. OCI's workload data
for cases opened in fiscal year 2008 show that most involved
investigations of misbranded products, unapproved products, and
product tampering.
Table 3: Office of Criminal Investigations' Investigative Workload
Growth (Fiscal Years 1999 to 2008):
Fiscal year: 1999;
Opened investigations: 370;
Closed investigations: 201;
Active/ongoing investigations: 655.
Fiscal year: 2000;
Opened investigations: 327;
Closed investigations: 270;
Active/ongoing investigations: 712.
Fiscal year: 2001;
Opened investigations: 334;
Closed investigations: 291;
Active/ongoing investigations: 755.
Fiscal year: 2002;
Opened investigations: 319;
Closed investigations: 309;
Active/ongoing investigations: 765.
Fiscal year: 2003;
Opened investigations: 394;
Closed investigations: 326;
Active/ongoing investigations: 833.
Fiscal year: 2004;
Opened investigations: 443;
Closed investigations: 351;
Active/ongoing investigations: 925.
Fiscal year: 2005;
Opened investigations: 513;
Closed investigations: 401;
Active/ongoing investigations: 1037.
Fiscal year: 2006;
Opened investigations: 390;
Closed investigations: 420;
Active/ongoing investigations: 1007.
Fiscal year: 2007;
Opened investigations: 425;
Closed investigations: 398;
Active/ongoing investigations: 1034.
Fiscal year: 2008;
Opened investigations: 471;
Closed investigations: 418;
Active/ongoing investigations: 1087.
Fiscal year: Change from 1999 to 2008;
Opened investigations: 27.3%;
Closed investigations: 108.0%;
Active/ongoing investigations: 66.0%.
Source: FDA data.
[End of table]
Conclusions:
Although OCI and OIA have policies that govern how they conduct
investigations, FDA's oversight of these investigations has been
limited. FDA has established a process to ensure compliance with OCI's
policies, but it does not routinely carry out this process as only
about 30 percent of the OCI field office assessments have been
completed. OIA's process to ensure compliance depends on its manager
rather than an external reviewer, that is, someone who is not directly
involved in ongoing investigations. Without a review process and
consistent implementation, FDA management cannot have reasonable
assurance that OCI and OIA investigative policies and procedures are
routinely followed and that deficiencies are promptly resolved when
identified. This is particularly important because OCI does work that
is different from much of the rest of FDA.
FDA management cannot determine whether OCI's criminal investigative
program is achieving its goals--a key element of accountability--
because OCI has not developed performance measures. Because FDA
managers have somewhat different perspectives on how best to assess
the performance of OCI's criminal investigative program, it is unclear
how OCI and other FDA managers with oversight responsibility can
strategically manage OCI's criminal investigative program to ensure
that it is operating successfully. Assessing program results is
especially important given that OCI appears to operate more
autonomously than other units within FDA's regulatory office.
Recommendations for Executive Action:
We recommend that the Secretary of HHS take the following three
actions:
* To ensure OCI's compliance with investigative policies, instruct the
Commissioner of FDA to have regular assessments of OCI's field offices
conducted in accordance with its existing policy.
* To ensure OIA's compliance with investigative policies, instruct the
Commissioner of FDA to establish a review procedure for the assessment
of OIA's compliance with its investigative policies.
* To assess whether OCI's criminal investigative program is achieving
its desired results, instruct the Commissioner of FDA to establish
performance measures and assess program results against them.
Agency Comments and Our Evaluation:
We provided a draft of this report to HHS for comment and received a
written response, which is included in this report as appendix III. In
its comments, HHS agreed with our three recommendations and described
its planned steps to implement them. HHS also provided technical
comments, which we incorporated as appropriate.
In its written comments, HHS described a new FDA internal committee to
address OCI, the interaction between the OCI Director and ORA ACRA,
and the interaction between the OCI Director and OIA manager. In
August, 2009, the FDA Commissioner established an internal review
committee--which includes representation from OCI and the Office of
the Commissioner--to develop recommendations to improve FDA's
enforcement efforts and enhance the coordination, communication, and
strategic alignment between OCI and other FDA components, such as ORA.
In its comments, HHS stated that the agency believes better
coordination and communication between OCI and others in ORA would
improve the effectiveness of FDA's overall regulatory and enforcement
efforts, which includes the criminal investigative work of OCI. While
the internal review committee has submitted its recommendations to the
FDA Commissioner for consideration, they have not been implemented.
HHS also described in its written comments the interaction between the
OCI Director and the ORA ACRA. HHS stated that the OCI Director
reports directly to the ACRA and that the OCI Director meets weekly
with the ACRA to discuss, among other things, OCI investigations. All
of this information was included in our draft report. HHS also stated
that the OCI Director and ACRA meet on an ad hoc basis as requested by
either party and frequently communicate to discuss emerging
activities. Further, HHS stated that the OCI Director attends regular
ORA meetings. In our review of FDA's oversight of OCI, we focused on
OCI's reporting of information within FDA. As we stated in the report,
although the OCI Director communicates regularly with the ACRA, OCI is
not required to report specific information to ORA or other FDA senior-
level offices as part of its formal reporting relationship. HHS
further stated that the types of regular interactions between the ACRA
and OCI Director are generally the same as those between the ACRA and
other ORA senior-level staff. Assessing the reporting relationships of
FDA offices other than OCI was beyond the scope of our work. HHS
commented that the ACRA conducts midyear and end-of-year performance
reviews of the OCI Director. We added this information to the report.
In its written comments, HHS also described the interaction between
the OCI Director and OIA manager. HHS stated that the OCI Director and
OIA manager communicate about certain investigations, such as those
that are high profile, and that the OIA manager reports directly to
the OCI Director. This information was already included in our draft
report. HHS stated that the OIA manager participates in all OCI
management meetings and that the OCI Director and OIA manager recently
initiated a regular monthly meeting to discuss OIA issues. HHS also
noted that the OCI Director evaluates the performance of the OIA
manager. We added information to the report on the recently initiated
monthly meetings and also noted in the report that the OIA manager's
performance is evaluated by the OCI Director.
HHS agreed with our three recommendations to strengthen its oversight
of criminal and other investigations and described the steps it would
take to implement them. Specifically, HHS stated that in order to
ensure OCI's compliance with its investigative policies, ORA and OCI
will allocate additional resources to comply with the time frames
established in OCI's existing policy for conducting regular
assessments of OCI's field offices. To ensure OIA's compliance with
its investigative policies, OCI is developing a new written policy for
conducting regularly scheduled assessments of OIA. Finally, HHS stated
that OCI is developing performance measures to determine the extent to
which OCI is achieving its desired results, as part of a new FDA-wide
initiative.
As we agreed with your office, 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
Commissioner of FDA and appropriate congressional committees. 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 me at (202) 512-7114 or crossem@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 major
contributions to this report are listed in appendix IV.
Sincerely yours,
Signed by:
Marcia Crosse:
Director, Health Care:
[End of section]
Appendix I: Statistics from Investigations Involving the Office of
Criminal Investigations:
Figures 3 and 4 provide information on the statistics that the Office
of Criminal Investigations (OCI) maintains about its investigations,
which include arrests, convictions, fines and restitution, and assets
forfeited/seized, since fiscal year 1999.
Figure 3: Number of Arrests and Convictions from Investigations
Involving the Office of Criminal Investigations (Fiscal Years 1999 to
2008):
[Refer to PDF for image: vertical bar graph]
Fiscal year: 1999;
Arrests: 395;
Convictions: 236.
Fiscal year: 2000;
Arrests: 426;
Convictions: 381.
Fiscal year: 2001;
Arrests: 430;
Convictions: 381.
Fiscal year: 2002;
Arrests: 364;
Convictions: 325.
Fiscal year: 2003;
Arrests: 361;
Convictions: 254.
Fiscal year: 2004;
Arrests: 405;
Convictions: 267.
Fiscal year: 2005;
Arrests: 418;
Convictions: 348.
Fiscal year: 2006;
Arrests: 362;
Convictions: 348.
Fiscal year: 2007;
Arrests: 509;
Convictions: 369.
Fiscal year: 2008;
Arrests: 408;
Convictions: 396.
Source: FDA data.
[End of figure]
OCI maintains statistics on the number of arrests and convictions
resulting from both investigations it conducts independently and with
other federal law enforcement agencies.[Footnote 66] As shown in
figure 3, the number of arrests and convictions has fluctuated
somewhat since fiscal year 1999. The number of arrests ranged from 361
in fiscal year 2003 to 509 in fiscal year 2007. Over the 10-year
period, the number of convictions has similarly fluctuated, from a low
of 236 convictions in fiscal year 1999 to a high of 396 in fiscal year
2008.
OCI also maintains statistics on the total amount of fines and
restitution and assets forfeited or seized resulting from both
investigations it conducts independently and with other federal law
enforcement agencies.[Footnote 67] Individuals convicted of a federal
crime can be ordered by the court at sentencing to pay a fine or
restitution and forfeited assets include seized and forfeited property
such as cash, businesses, and real estate.[Footnote 68] While the
total amount of court-ordered fines and restitution has fluctuated
widely from year to year, since fiscal year 2001 the amount has
exceeded the fiscal year 1999 level of $56.5 million and the highest
level--about $1.3 billion--was in fiscal year 2007 (see figure 4). The
total amount of assets forfeited has generally increased from a low of
$ 0.7 million in fiscal year 2000 to a high of $177.5 million in
fiscal year 2007.
Figure 4: Total Amount of Court-Ordered Fines and Restitution and
Assets Forfeited/Seized from Investigations Involving the Office of
Criminal Investigations (Fiscal Years 1999 to 2008):
[Refer to PDF for image: multiple line graph]
Fiscal year: 1999;
Fines/restitution: $56.5 million;
Assets forfeited/seized: $0.9 million.
Fiscal year: 2000;
Fines/restitution: $50.8 million;
Assets forfeited/seized: $0.7 million.
Fiscal year: 2001;
Fines/restitution: $99.8 million;
Assets forfeited/seized: $2.3 million.
Fiscal year: 2002;
Fines/restitution: $929.4 million;
Assets forfeited/seized: $13.5 million.
Fiscal year: 2003;
Fines/restitution: $821.1 million;
Assets forfeited/seized: $16.5 million.
Fiscal year: 2004;
Fines/restitution: $464.1 million;
Assets forfeited/seized: $18.9 million.
Fiscal year: 2005;
Fines/restitution: $169.1 million;
Assets forfeited/seized: $67 million.
Fiscal year: 2006;
Fines/restitution: $1,180 million;
Assets forfeited/seized: $35.8 million.
Fiscal year: 2007;
Fines/restitution: $1,280 million;
Assets forfeited/seized: $177.5 million.
Fiscal year: 2008;
Fines/restitution: $863.2 million;
Assets forfeited/seized: $149.3 million.
Source: FDA data.
[End of figure]
[End of section]
Appendix II: OCI Funding, Fiscal Years 1999 to 2008:
Table 4: Food and Drug Administration Funding for the Office of
Criminal Investigations, Actual and Inflation Adjusted to Fiscal Year
1999 Dollars (Fiscal Years 1999 to 2008):
Fiscal year: 1999;
Actual: $19,073,471;
Inflation adjusted: $19,073,471.
Fiscal year: 2000;
Actual: $21,187,301;
Inflation adjusted: $20,767,081.
Fiscal year: 2001;
Actual: $23,104,835;
Inflation adjusted: $22,124,445.
Fiscal year: 2002;
Actual: $25,589,446;
Inflation adjusted: $24,043,631.
Fiscal year: 2003;
Actual: $31,040,799;
Inflation adjusted: $28,587,184.
Fiscal year: 2004;
Actual: $33,172,169;
Inflation adjusted: $29,775,353.
Fiscal year: 2005;
Actual: $35,328,057;
Inflation adjusted: $30,725,678.
Fiscal year: 2006;
Actual: $36,279,224;
Inflation adjusted: $30,518,403.
Fiscal year: 2007;
Actual: $37,802,938;
Inflation adjusted: $30,952,200.
Fiscal year: 2008;
Actual: $41,309,714;
Inflation adjusted: $33,037,480.
Fiscal year: Change from 1999 to 2008;
Actual: 116.6%;
Inflation adjusted: 73.2%.
Source: GAO analysis of FDA data.
Note: Outlays are used to approximate funding. Outlays during a fiscal
year may be for payment of obligations incurred in prior years (prior-
year obligations) or in the same year. Outlays made during a fiscal
year for prior-year obligations are generally made with prior-year
appropriations. The Office of Criminal Investigations' funding and
staffing include funding and staffing for the Office of Internal
Affairs.
[End of table]
[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:
January 7, 2010:
Marcia Crosse:
Director, Health Care:
U.S. Government Accountability Office:
441 G Street N.W.
Washington, DC 20548:
Dear Ms. Crosse:
Enclosed are comments on the U.S. Government Accountability Office's
(GAO) report entitled: "Food and Drug Administration: Improved
Monitoring and Development of Performance Measures Needed to
Strengthen Oversight of Criminal and Misconduct Investigations" (GAO-
10-221).
The Department appreciates the opportunity to review this report
before its publication.
Sincerely,
Signed by:
Andrea Palm:
Acting Assistant Secretary for Legislation:
Enclosure:
[End of letter]
General Comments From The Department Of Health And Human Services
(HHS) On The Government Accountability Office's (GAO) Draft Report
Entitled: "Food And Drug Administration: Improved Monitoring And
Development Of Performance Measures Needed To Strengthen Oversight Of
Criminal And Misconduct Investigations" (GAO-10-221):
The Office of Criminal Investigations (OCI) was established in 1992 to
provide the Food and Drug Administration (FDA) with a specialized unit
to conduct and coordinate criminal investigations of the Federal Food,
Drug, and Cosmetic Act and other related laws. OCI is comprised
primarily of Special Agents, many of whom have extensive prior Federal
law enforcement experience and established professional contacts.
Among the crimes OCI agents investigate are counterfeit, unapproved or
illegally diverted drugs; product tampering and substitution;
fraudulent health treatments; illegal off-label promotion; and fraud
in product approval applications and clinical trials.
OCI has been successful in its declared mission "to conduct and
coordinate investigations of suspected criminal violations ... and to
collect evidence to support successful prosecutions." From 1992 until
the end of fiscal year 2009, OCI obtained 4,392 convictions that
resulted in the imposition of $9.89 billion in fines and restitution
and forfeited assets worth over $1 billion.
Commissioner's OCI/Center Coordination and Alignment Review Committee:
OCI has achieved a great deal of success during its relatively brief
history; however, FDA Commissioner Dr. Margaret A. Hamburg believes
that there are important opportunities for OCI and the Centers to
enhance information sharing and develop strategic priorities to
maximize public health impact and deterrence. In addition, Dr. Hamburg
believes that there are opportunities to increase communication and
coordination between the Office of Regulatory Affairs (ORA) district
offices and OCI field offices, as well as between the Centers and OCI,
which would improve enforcement efforts and enhance the effectiveness
of each of these organizations.
Consequently, as we discussed during the Exit Conference, Dr Hamburg
created an internal FDA Committee in August 2009, which includes
representation from interested FDA stakeholders, including the
Centers, OCI, Office of the Chief Counsel (OCC), and the Office of the
Commissioner. The Commissioner directed the Committee to examine
opportunities and develop recommendations to enhance coordination,
communication, and strategic alignment between OCI and other agency
components. Dr. Hamburg specifically identified the following
potential areas for enhanced coordination based, in part, on her
conversations with OCI leadership and FDA's Center Directors:
* Development of shared strategic priorities based on a public health
assessment of where patients and consumers are at greatest risk;
* Center and ORA Headquarters and field (district office) referral of
potential cases based on evidence of suspected fraud or other criminal
conduct;
* OCI identification of areas where regulatory action or public health
communication could prevent or minimize harm associated with products
or activities that are ongoing; and;
* OCI identification of critical information that could affect
regulatory decision making.
The Committee and its working groups have met regularly throughout the
fall, and have developed recommendations for the Commissioner's
consideration. In addition, the Committee and its working groups have
drafted Standard Operating Procedures and policy statements that will
help facilitate the implementation of the Committee's recommendations.
The Committee's findings and recommendations were presented to
the Commissioner, and once implemented, they will improve FDA's
enforcement efforts and enhance the coordination, communication, and
strategic alignment between ORA, OCI, and the Centers.
OCI Interaction with Associate Commissioner for Regulatory Affairs
(ACRA) and Office of Internal Affairs (OIA):
The OCI Director reports directly to the ACRA. The OCI Director has a
regularly scheduled in-person one-on-one with the ACRA each week to
exchange topical information related to OCIs/OIA's operational needs,
initiatives, activities and upcoming actions. During these sessions,
as with other senior ORA executives, there is an opportunity for a
free exchange of issues and concerns as well as a discussion about
ongoing initiatives and investigations within OCI/OIA. There are
routine discussions about major agency initiatives as they may relate
to OCI investigations or potential investigations. In addition to this
weekly meeting, ad hoc meetings are also held between the OCI Director
and the ACRA as requested by either party. Lastly the OCI Director and
ACRA frequently communicate through email and phone calls regarding
OCI emerging activities in which the ACRA or Commissioner may have an
interest. The Director also attends the ORA weekly conference call
with the ORA Headquarters and field staff as well as key ORA
management conferences throughout the year. This process has been
followed since the inception of OCI with each ACRA and has been
effective for the needs and expectations of both OCI and ORA
management. Generally, the interactions between the ACRA and the OCI
Director are the same as the regular interactions that the ACRA has
with other ORA senior executives.
There is also a face to face performance review at mid-year and end-of-
year between the OCI Director and the ACRA where the SES plan elements
are discussed and documented.
The OCI Director receives all OIA case initiation reports for review
and input. The OIA Special Agent in Charge (SAIC) confers with the
Director on certain cases and matters which may be high profile or
involve noteworthy issues. The Director and the OIA SAIC recently
initiated a regular monthly meeting to discuss OIA issues. The OIA
SAIC is a direct report to the Director of OCI and as such is rated
based on the SAIC's established performance plan. The 01A SAIC
participates in all OCI management meetings.
Responses to GAO Recommendations:
To ensure OCI's compliance with investigative policies, have regular
assessments of OCI's field offices conducted in accordance with its
existing policy.
FDA Response:
OCI acknowledges that limited resources and logistical issues have
prevented it from complying with its existing policy to conduct
regular assessments of its field offices. OCI will ensure compliance
with its investigative policies and conduct assessments of its field
offices in accordance with the schedule established in its current
office assessment procedures. ORA and OCI will allocate additional
resources to ensure that OCI has sufficient manpower to conduct
regular assessments that comply with the timeframes in OCI's internal
policy. The first round of assessments will begin in 2010.
To ensure OIA's compliance with investigative policies, establish a
review procedure for the assessment of OL4's compliance with its
investigative policies.
FDA Response:
OCI is developing a new written policy to conduct regularly scheduled
assessments of OIA's compliance with its investigative policies.
To assess whether OCI's criminal investigative program is achieving
its desired results, establish performance measures and assess program
results against them.
FDA Response:
We agree with GAO's recommendation and are working to develop
meaningful performance measures to determine the extent to which OCI
is achieving its desired results. OCI is developing program
performance measures as part of a new FDA-wide initiative called FDA-
TRACK. This initiative is focused on developing meaningful measures at
the program office level and tracking those measures on a monthly
basis. The measures and results will be reviewed with FDA's senior
leadership on a quarterly basis to assess how well each program office
is progressing towards achieving its desired goals. FDA-TRACK is
currently being piloted and is scheduled for a public roll-out in the
spring of 2010.
We believe that OCI's participation in FDA-TRACK, coupled with
strategic program reviews and targeted process improvements, will
significantly improve OCI's ability to measure its performance and
demonstrate achievement of its desired results.
[End of section]
Appendix IV: GAO Contact and Staff Acknowledgments:
GAO Contact:
Marcia Crosse, (202) 512-7114 or crossem@gao.gov:
Acknowledgments:
In addition to the contact named above, Thomas Conahan, Assistant
Director; Pamela Dooley; Cathy Hamann; Thomas Han; Jennel Harvey;
Eagan Kemp; and Lisa Motley made key contributions to this report.
[End of section]
Footnotes:
[1] The generic drug scandal in the late 1980s involved several drug
companies that falsified study data and bribed several FDA officials
to receive quick approval for their generic products. See Mylan Labs.
v. Akzo, N.V., 770 F. Supp. 1053, 1057-58 (D.Md. 1991).
[2] This recommendation was made by the Subcommittee on Oversight and
Investigations, House Committee on Energy and Commerce. See
Subcommittee on Oversight and Investigations of the Committee on
Energy and Commerce, U.S. House of Representatives, Less than the Sum
of its Parts: Reforms Needed in the Organization, Management, and
Resources of the Food and Drug Administration's Center for Devices and
Radiological Health (Washington, D.C.: May 1993).
[3] For the purposes of this report, when we refer to OCI we mean OCI
not including OIA, unless indicated otherwise.
[4] Statement of Senator Charles E. Grassley, hearing before the
Subcommittee on Oversight and Investigations of the Committee on
Energy and Commerce, House of Representatives, 110th Congress, 2nd
session, Ketek Clinical Study Fraud: What Did Aventis Know?, February
12, 2008, Serial No. 110-87.
[5] Letter to the Secretary of HHS and FDA Commissioner, February 6,
2008, from Senator Charles E. Grassley, Ranking Member, U.S. Senate,
Committee on Finance. See [hyperlink,
http://finance.senate.gov/press/Gpress/2008/prg020608.pdf].
[6] See [hyperlink,
http://republicans.energycommerce.house.gov/Media/File/News/05-14-
08_OCI_Letter.pdf], [hyperlink,
http://republicans.energycommerce.house.gov/Media/File/News/12.05.08_FDA
_OCI_Letter.pdf].
[7] We reviewed the President's Council on Integrity and Efficiency
Quality Standards for Investigations, and based on this review and
discussions with officials from relevant law enforcement agencies, we
identified five investigative components: (1) documenting and
evaluating allegations/leads; (2) opening an investigation; (3)
collecting information; (4) documenting, managing, and tracking
investigative data; and (5) case resolution. In 2008, this council
became part of the Council of the Inspectors General on Integrity and
Efficiency.
[8] The six OCI field offices are located in Chicago, IL; Kansas City,
MO; Los Angeles, CA; Miami, FL; New York, NY; and Washington, D.C.
[9] We interviewed this Assistant U.S. Attorney because of his
experience working with OCI.
[10] The OCI Director reports directly to the Associate Commissioner
for Regulatory Affairs in ORA, the office responsible for inspecting
all FDA-regulated products.
[11] We interviewed officials in EPA CID and TIGTA because these
agencies have separate criminal investigations offices that function
similarly to FDA's OCI. TIGTA also conducts internal affairs
investigations. We interviewed HHS OIG officials from the Office of
Investigations because the HHS OIG conducts criminal investigations
related to FDA-regulated products. These agencies are not the only
agencies with criminal investigations offices.
[12] See GAO, Standards for Internal Control in the Federal
Government, [hyperlink,
http://www.gao.gov/products/GAO-AIMD-00-21.3.1] (Washington, D.C.:
November 1999).
[13] For the purposes of this report, outlays are used to approximate
funding. Outlays during a fiscal year may be for payment of
obligations incurred in prior years (prior-year obligations) or in the
same year. Outlays made during a fiscal year for prior-year
obligations are generally made with prior-year appropriations.
[14] FDA's funding and staffing for OCI include funding and staffing
for OIA.
[15] The GDP price index for nondefense goods and services measures
the change in the value of nondefense-related goods and services
produced by the U.S. economy in a given period.
[16] One FTE represents 40 hours of work per week conducted by a
federal government employee over the course of 1 year. For the
purposes of this report, FTEs reflect filled positions.
[17] See 21 U.S.C. §§ 301-399a.
[18] See 18 U.S.C. § 1365.
[19] See 18 U.S.C. §§ 1341 (mail fraud), 2320 (trafficking in
counterfeit goods or services).
[20] See 5 U.S.C. app. 3. However, under the act, Inspectors General
may not carry out program operating responsibilities. See 5 U.S.C.
app. 3, § 9(a).
[21] For example, in 2007 and 2008, the HHS OIG and OCI worked jointly
on investigations involving violations of FDA-related laws that
resulted in the submission of false claims for reimbursement by HHS
programs.
[22] The FDA Commissioner delegated FDA's authority to conduct
criminal investigations to OCI. See 56 Fed. Reg. 67,076.
[23] U.S. Attorneys receive most of their criminal referrals from
federal investigative agencies. Once a referral is received, U.S.
Attorneys decide on the appropriateness of bringing criminal charges
and, if deemed appropriate, initiate prosecution.
[24] Field offices are the largest of the three types of OCI offices
and each of the 6 field offices has responsibility for several states.
Located within the field office jurisdictions, the 6 resident offices
each cover a smaller number of states than each field office. Domicile
offices are the smallest of the three types and they also cover
smaller jurisdictions than the field offices. For example, some
domicile offices cover jurisdictions that are smaller than a state.
There are 22 domicile offices and they are usually located within
private residences. Resident offices and domicile offices are not
evenly distributed across the field offices.
[25] According to an FDA official, OCI's current priorities include
conducting investigations of counterfeit medical products, imports,
and food safety.
[26] Some criminal investigators have polygraph training and also
serve as polygraph examiners.
[27] Criminal investigators are law enforcement officers as defined in
5 U.S.C. § 5541(3).
[28] Each OCI field office is assigned one or more attorneys from
FDA's Office of the Chief Counsel (OCC) to provide legal guidance and
prosecutorial support on OCI criminal investigations. OCC is located
in FDA's headquarters office.
[29] Other FDA field activities include conducting sample analysis of
regulated products and reviewing imported products offered for entry
into the United States.
[30] The ACRA is responsible for conducting midyear and end-of-year
performance reviews of the OCI Director. The ACRA reports directly to
FDA's Office of the Commissioner.
[31] The FDA Commissioner delegated FDA's authority to conduct
investigations involving FDA employees to OIA. See 60 Fed. Reg. 4417.
OIA also has responsibility for investigating, among other things,
threats against FDA facilities.
[32] The OCI Director is responsible for evaluating the performance of
the OIA manager.
[33] In addition to notifying HHS OIG about all cases involving
criminal allegations, OIA also notifies HHS OIG prior to referring
cases for prosecution.
[34] Throughout this report, we refer to criminal investigators that
work in OIA as OIA investigators.
[35] According to an OCI official, OCI's 17 criminal investigators
that were hired in fiscal year 2008 had an average of 10.2 years of
prior federal law enforcement experience, with a range of nearly 3.5
to 21 years of experience. These criminal investigators were hired
from several federal law enforcement agencies such as U.S. Secret
Service and HHS OIG.
[36] OCI criminal investigators attend the OCI-specific training
program at the Federal Law Enforcement Training Center, which is the
largest single provider of law enforcement training for the federal
government.
[37] Although the role of the U.S. Attorneys' Offices in the
investigative process is not formalized in OCI policy, OCI criminal
investigators generally document their interactions with attorneys
from the U.S. Attorneys' Offices during the course of an investigation.
[38] Criminal investigators must also comply with applicable laws
requiring that they obtain a court order.
[39] The four steps are (1) field office self assessment, (2) OCI
Headquarters-led onsite visit, (3) OIA-led onsite visit, and (4)
return visit by OIA. According to OCI policy, the second step includes
a review of the office self assessment and may be omitted, for
example, if significant issues of concern are not identified during
the field office self assessment. The fourth step--the return visit by
OIA--may also be omitted if the field office does not require
significant corrective actions.
[40] The 10 areas are (1) personnel and administration, (2) evidence,
(3) public affairs and liaison activities, (4) vehicles and safety,
(5) training, (6) management and supervision, (7) investigation
operations, (8) office space and security, (9) accountable/sensitive
property, and (10) financial management.
[41] A total of 24 completed assessments is expected because there are
six field offices and each should have had 4 assessments completed
between 1996--the year OCI's policy was established--and 2008.
[42] OCI finalized its policy in 1996 and the first office assessment
was completed in 1997.
[43] FDA's other long-term goals are to strengthen FDA for today and
tomorrow; increase access to new medical and food products; and
improve the quality and safety of manufactured products and the supply
chain. For more information about FDA's long-term goals and mission,
see Department of Health and Human Services, Food and Drug
Administration, FDA Strategic Action Plan: Charting Our Course for the
Future, Fall 2007. See [hyperlink,
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/%20Reports/Str
ategicActionPlan/UCM061415.pdf].
[44] FDA's fiscal year 2010 congressional budget justification for the
agency's field activities (i.e., ORA's program) describes OCI's role
to be essential to FDA's overall mission of protecting public health.
See Department of Health and Human Services, Fiscal Year 2010 Food and
Drug Administration Justification of Estimates for Appropriations
Committees. See [hyperlink,
http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/BudgetReports/uc
m153374.htm]. In addition, the FDA Commissioner stated in August 2009
that effective enforcement against violations of FDA laws is critical
to the agency's public health mission. See FDA Commissioner,
"Effective Enforcement and Benefits to Public Health," Food and Drug
Law Institute meeting, August 6, 2009. See [hyperlink,
http://www.fda.gov/NewsEvents/Speeches/ucm175983.htm].
[45] Pub. L. No. 103-62, 107 Stat. 285.
[46] Under GPRA, federal agencies are also required to report annually
on their progress in achieving their goals.
[47] For example, see GAO, Managing for Results: Enhancing Agency Use
of Performance Information for Management Decision Making, [hyperlink,
http://www.gao.gov/products/GAO-05-927] (Washington, D.C.: Sept. 9,
2005); GAO, Program Evaluation: Studies Helped Agencies Measure or
Explain Program Performance, [hyperlink,
http://www.gao.gov/products/GAO/GGD-00-204] (Washington, D.C.: Sept.
29, 2000); 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); and GAO, Managing for Results: Strengthening
Regulatory Agencies' Performance Management Practices, [hyperlink,
http://www.gao.gov/products/GAO/GGD-00-10] (Washington, D.C.: Oct. 28,
1999).
[48] The Assistant U.S. Attorney we interviewed told us that when a
criminal investigative agency is interested in pursuing an
investigation toward prosecution, the agency typically works with the
U.S. Attorney's Office to develop potential investigative strategies
which will tend to increase the likelihood of developing admissible
evidence necessary to facilitate prosecution.
[49] OCI's Director also told us that measuring the performance of OCI
is further complicated by the fact that, unlike other law enforcement
agencies, FDA's primary mission is to protect the public health.
Therefore, if OCI identifies an activity that could harm the public
during a criminal investigation, the agency must warn the public. The
OCI Director explained that while making such information public could
damage its criminal investigation, the agency's decision is based on
serving the agency's primary mission to protect the public health.
[50] This annual performance measure is included in DOJ's Strategic
Plan, Fiscal Years 2007-2012. See [hyperlink,
http://www.usdoj.gov/jmd/mps/strategic2007-2012/index.html].
[51] For example, see GAO, Combating Gangs: Better Coordination and
Performance Measurement Would Help Clarify Roles of Federal Agencies
and Strengthen Assessment of Efforts, [hyperlink,
http://www.gao.gov/products/GAO-09-708] (Washington, D.C.: July 24,
2009); and GAO, 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.: Mar. 10,
2004).
[52] See [hyperlink, http://www.gao.gov/products/GAO-04-38].
[53] See HHS, Food and Drug Administration, The Enforcement Story,
Fiscal Year 2008 (Rockville, MD: March 2009), chapter 6: Office of
Criminal Investigations. See [hyperlink,
http://www.fda.gov/ICECI/CriminalInvestigations/default.htm].
[54] GAO's Standards for Internal Control in the Federal Government do
not include specific guidelines for how information should be reported
to management. Instead, the standards state that information should be
recorded and communicated to management in a form and within a time
frame that enables them to carry out their oversight responsibilities.
See [hyperlink, http://www.gao.gov/products/GAO-AIMD-00-21.3.1].
[55] The OIA manager shares information about the initiation of OIA
investigations with the OCI Director.
[56] The investigative components are the same as those identified for
OCI's criminal investigations.
[57] These rights have been recognized by federal courts and are also
applicable at other federal agencies.
[58] GAO's Standards for Internal Control in the Federal Government do
not include specific guidelines for how information should be reported
to management. Instead, the standards state that information should be
recorded and communicated to management in a form and within a time
frame that enables them to carry out their oversight responsibilities.
See [hyperlink, http://www.gao.gov/products/GAO-AIMD-00-21.3.1].
[59] As of January 2010, the OCI Director and OIA manager had begun
holding regular monthly meetings to discuss OIA issues.
[60] OIA's staff in fiscal year 2008 included seven criminal
investigators. At the end of fiscal year 2008, OIA closed 85
investigations and had 18 ongoing cases. In comparison, OCI closed 418
investigations and had 1087 ongoing cases at the end of fiscal year
2008.
[61] According to GAO's internal control standards, the separation of
duties and responsibilities helps deter fraud and organizations should
examine their ongoing monitoring procedures by, among other things,
assessing the appropriateness of their organizational structure and
supervision. See GAO, Internal Control Standards: Internal Control
Management and Evaluation Tool, [hyperlink,
http://www.gao.gov/products/GAO-01-1008G] (Washington, D.C.: August
2001).
[62] The number of active investigations includes cases that are
ongoing at the end of a fiscal year regardless of when they were
opened.
[63] From fiscal years 1999 to 2002, OCI funding was used for OIA's
staffing expenses, such as salary and benefits, because OIA agents
were assigned from OCI. However, OCI funding was not used for OIA's
operational expenses during this time because OIA was located within
the Commissioner's Office. Funding for OIA's operational expenses
constituted a small portion of OCI's overall funding between fiscal
years 2003 and 2008; for instance, in fiscal year 2008, OIA's
operational expenses accounted for less than 1 percent of OCI's
overall funding.
[64] Pub. L. No. 107-188, 116 Stat. 594.
[65] These numbers do not include OIA's workload. We also examined
OIA's workload--the number of opened, closed, and active
investigations each year--between fiscal years 1999 and 2008. OIA's
workload remained fairly consistent over this 10-year period. On
average, OIA opened about 97 investigations and closed about 99
investigations each year. The average number of active investigations
between fiscal years 1999 and 2008 was about 27 each year.
[66] Statistics on arrests and convictions are maintained in OCI's
Automated Investigative Management System (AIMS). According to Food
and Drug Administration (FDA) officials, statistics on arrests and
convictions for investigations that OCI worked independently are not
easily or reliably retrievable in AIMS.
[67] Statistics on fines and restitution are included in AIMS.
According to FDA officials, statistics on fines and restitution for
investigations that OCI worked independently are not easily or
reliably retrievable in AIMS. OCI accesses statistics on assets
forfeited/seized from the Department of Justice Consolidated Asset
Tracking System.
[68] Most criminal fine payments go to the Crime Victims Fund, which
is used for grants to support victim assistance programs. See 42
U.S.C. § 10601. OCI participates in the Department of Justice Asset
Forfeiture Program, which is intended to deter criminal activity by
depriving criminals of property used or acquired through illegal
activities. Most forfeiture proceeds are used to fund law enforcement
activities. See 28 U.S.C. § 524 (c).
[End of section]
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