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Criminal and Misconduct Investigations' which was released on March 4, 
2010. 

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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 FDAs (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, FDAs 
oversight of OCIs investigations of individuals and companies 
external to FDA is limited. As a key element of FDAs oversight of 
OCI, FDAs assessment of OCIs 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 agencys oversight by 
allowing it to assess OCIs 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 OCIs Director to determine what aspects of OCIs 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 OCIs unique role and expertise within FDA. 

Similar to OCI, OIA has policies in place to guide its internal 
investigations, but FDAs oversight of OIAs investigations of FDA 
employees is limited. Although the OIA manager meets periodically with 
OCIs 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 OIAs investigative policies. 
The potential effectiveness of this review is limited because it 
relies on the OIA manager, who is also responsible for supervising 
investigations. 

FDAs funding and staffing for OCI generally increased annually 
between fiscal years 1999 and 2008, and OCIs investigative workload 
also increased over this 10-year period. OCIs funding and staffing 
include funding and staffing for OIA. OCIs 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 GAOs 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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