GAO 

United States Government Accountability Office

Report to the Ranking Member, 

Committee on Finance, U.S. Senate 

FOOD AND DRUG 

ADMINISTRATION 

Improved Monitoring 

and Development of 

Performance 

Measures Needed to 

Strengthen Oversight 

of Criminal and 

Misconduct 

Investigations 

January 2010 

GAO-10-221 
What GAO Found

United States Government Accountability Office

Why GAO Did This Study

Highlights

Accountability Integrity Reliability

January 2010

FOOD AND DRUG ADMINISTRATION

Improved Monitoring and Development of 

Performance Measures Needed to Strengthen 

Highlights of GAO-10-221, a report to the Oversight of Criminal and Misconduct Investigations

Ranking Member, Committee on Finance, 

U.S. Senate 

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 FDAregulated products, for example on 

the sale of counterfeit drugs. 

Within FDA, the Office of Criminal 

Investigations (OCI) investigates 

individuals and companies external 

to FDA. FDA also has the authority 

to investigate allegations of FDA 

employee misconduct and these 

internal investigations are 

conducted by the Office of Internal 

Affairs (OIA), a distinct office 

within OCI. GAO was asked to 

examine FDA’s (1) oversight of OCI 

investigations, (2) oversight of OIA 

investigations, and (3) funding, 

staffing, and workload for OCI. 

GAO interviewed agency officials, 

reviewed FDA documents 

including those describing its 

investigative policies, and 

examined FDA data on OCI 

resources and workload, from 

fiscal years 1999 to 2008. 

What GAO Recommends

To improve oversight of its 

investigations, GAO recommends 

that FDA regularly monitor OCI, 

and establish a process to monitor 

OIA for compliance with its 

investigative policies. GAO also 

recommends that FDA establish 

performance measures for OCI to 

assess whether OCI is achieving its 

desired results. FDA agreed with 

GAO’s recommendations. 

Although OCI maintains policies to guide its investigations, FDA’s oversight of 

OCI’s investigations of individuals and companies external to FDA is limited. 

As a key element of FDA’s oversight of OCI, FDA’s assessment of OCI’s six 

field offices is intended to ensure compliance with investigative policies; 

however, the assessments are not being implemented in accordance with 

prescribed time frames. Of the 24 total office assessments that should have 

been completed by August 2009, only 7, or about 30 percent, were completed 

and one office had not been assessed in over 10 years. In addition, FDA lacks 

performance measures that could enhance the agency’s oversight by allowing 

it to assess OCI’s overall success. The OCI Director meets weekly with a 

senior official in the Office of Regulatory Affairs (ORA), the office in which 

OCI is located, but OCI is not required to report specific information to ORA 

or other FDA senior-level offices as part of its formal reporting relationship. 

As a result, FDA depends on OCI’s Director to determine what aspects of 

OCI’s investigations should be communicated to FDA senior managers. 

According to a senior ORA official, OCI operates more autonomously than 

other offices within ORA, in part, because of OCI’s unique role and expertise 

within FDA. 

Similar to OCI, OIA has policies in place to guide its internal investigations, 

but FDA’s oversight of OIA’s investigations of FDA employees is limited. 

Although the OIA manager meets periodically with OCI’s Director, FDA does 

not have a requirement for OIA to report specific information to OCI or other 

FDA senior-level offices on its investigative activities or a process in place to 

routinely monitor OIA’s compliance with its investigative policies. The OIA 

manager told GAO that the number of investigations is such that he is 

generally involved in all of them, and can therefore review investigative 

documents before closing cases to assess compliance with investigative 

policies. The OIA manager told GAO that his review alleviates the need for a 

process to monitor compliance with OIA’s investigative policies. The potential 

effectiveness of this review is limited because it relies on the OIA manager, 

who is also responsible for supervising investigations. 

FDA’s funding and staffing for OCI generally increased annually between 

fiscal years 1999 and 2008, and OCI’s investigative workload also increased 

over this 10-year period. OCI’s funding and staffing include funding and 

staffing for OIA. OCI’s funding, measured by the total funds expended, was 

about $19 million in fiscal year 1999 and was over $41 million in fiscal year 

2008, representing an increase of about 73 percent, when adjusted for 

inflation. Staffing increased by about 40 percent during this period, from 

about 165 full-time equivalent employees to over 230. The largest increase in 

funding and staffing was between fiscal years 2002 and 2003. The OCI Director 

told GAO that this was the result of funding authorized by the Public Health 

Security and Bioterrorism Preparedness and Response Act of 2002 to address 

potential terrorist threats in connection with FDA-regulated products. 

Investigative workload also increased from fiscal year 1999 to 2008. 

View GAO-10-221 or key components.

For more information, contact Marcia Crosse 

at (202) 512-7114 or crossem@gao.gov. 
Page i GAO-10-221 

Contents 

Letter 1

Background 6 

OCI Maintains Policies to Guide Its Investigations but FDA’s 

Oversight of Those Investigations Is Limited 10 

FDA’s Oversight of OIA Investigations Is Limited 19 

FDA’s Funding and Staffing for OCI Investigations and OCI 

Investigative Workload Have Increased 22 

Conclusions 25 

Recommendations for Executive Action 25 

Agency Comments and Our Evaluation 26 

Appendix I Statistics from Investigations Involving the Office 

of Criminal Investigations 29 

Appendix II OCI Funding, Fiscal Years 1999 to 2008 32 

Appendix III Comments from the Department of Health and 

Human Services 33 

Appendix IV GAO Contact and Staff Acknowledgments 38 

Tables 

Table 1: Description of the Office of Criminal Investigations’ 

Investigative Policies 12 

Table 2: Description of the Office of Internal Affairs’ Investigative 

Policies 20 

Table 3: Office of Criminal Investigations’ Investigative Workload 

Growth (Fiscal Years 1999 to 2008) 24 

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) 32 

 Criminal and Misconduct Investigations 
Figures 

Figure 1: FDA’s Organizational Structure for Conducting 

Investigations 8 

Figure 2: Office of Criminal Investigations’ Funding and Staffing 

Growth (Fiscal Years 1999 to 2008) 23 

Figure 3: Number of Arrests and Convictions from Investigations 

Involving the Office of Criminal Investigations (Fiscal 

Years 1999 to 2008) 29 

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) 31 

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 

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Page ii GAO-10-221 Criminal and Misconduct Investigations
Page 1 GAO-10-221 

 

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 FDAregulated 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.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.2

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). 

 Criminal and Misconduct Investigations 
 

While OIA and OCI have different purposes, OIA is organizationally part of 

OCI.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.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.5

 Further, in 2008, concerns about accountability and 

increases in funding and staffing at a time when resources were limited 

other parts of FDA prompted the House Committee on Energy and 

Commerce to request information about OCI’s recent operational and 

staffing expenses.

for 

 are 

 rest of OCI. 

 

6

 Because OIA is part of OCI, its funding and staffing

provided and accounted for with funding and staffing for the

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. 

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 

http://finance.senate.gov/press/Gpress/2008/prg020608.pdf. 

6

See http://republicans.energycommerce.house.gov/Media/File/News/05-14-

08_OCI_Letter.pdf, 

http://republicans.energycommerce.house.gov/Media/File/News/12.05.08_FDA_OCI_Letter.

pdf. 

Page 2 GAO-10-221 Criminal and Misconduct Investigations
 

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.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.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.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.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 

 

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. 

10The OCI Director reports directly to the Associate Commissioner for Regulatory Affairs in 

ORA, the office responsible for inspecting all FDA-regulated products. 

Page 3 GAO-10-221 Criminal and Misconduct Investigations
 

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.11 We reviewed federal government internal control standards12

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 

 

11We 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 FDAregulated products. These agencies are not the only agencies with criminal investigations 

offices. 

12See GAO, Standards for Internal Control in the Federal Government, 

GAO-AIMD-00-21.3.1 (Washington, D.C.: November 1999). 

Page 4 GAO-10-221 Criminal and Misconduct Investigations
 

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,13 staffing, and workload, we analyzed data 

provided by FDA and interviewed OCI officials.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.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.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 

 

13For 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. 

14FDA’s funding and staffing for OCI include funding and staffing for OIA. 

15The 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. 

16One 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. 

Page 5 GAO-10-221 Criminal and Misconduct Investigations
 

that the evidence obtained provides a reasonable basis for our findings 

and conclusions based on our audit objectives. 

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. 

Background 

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),17 the Federal Anti-Tampering Act,18

and other statutes including provisions of Title 18 of the United States 

Code.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.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.21 In 

 

17See 21 U.S.C. §§ 301-399a. 

18See 18 U.S.C. § 1365. 

19See 18 U.S.C. §§ 1341 (mail fraud), 2320 (trafficking in counterfeit goods or services). 

20See 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). 

21For 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. 

Page 6 GAO-10-221 Criminal and Misconduct Investigations
 

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.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.23 OCI 

is composed of a headquarters office that has two divisions—

Administrative Operations and Investigative Operations—and six field 

offices (see fig. 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.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.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. 

 

22The FDA Commissioner delegated FDA’s authority to conduct criminal investigations to 

OCI. See 56 Fed. Reg. 67,076. 

23U.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. 

24Field 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. 

25According to an FDA official, OCI’s current priorities include conducting investigations of 

counterfeit medical products, imports, and food safety. 

Page 7 GAO-10-221 Criminal and Misconduct Investigations
 

Figure 1: FDA’s Organizational Structure for Conducting Investigations 

6 OCI

Resident Offices

22 OCI 

Domicile Offices

Office of Criminal 

Investigations (OCI)

FDA Office of 

Regulatory Affairs (ORA)

FDA Office of 

the Commissioner

OCI Administrative

Operations Division

OCI Investigative

Operations Division

Office of Internal 

Affairs (OIA) 

6 OCI

Field Offices

Source: GAO analysis of FDA organization charts.

OCI’s staff includes criminal investigators, forensic and information 

technology personnel, and other support staff.26 Most of OCI’s staff is 

comprised of criminal investigators—in fiscal year 2008, 180 of the 223 

OCI staff were criminal investigators.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.28 Criminal investigators 

often complete their investigations by presenting their cases to local U.S. 

Attorneys for prosecution. 

 

26Some criminal investigators have polygraph training and also serve as polygraph 

examiners. 

27Criminal investigators are law enforcement officers as defined in 5 U.S.C. § 5541(3). 

28Each 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. 

Page 8 GAO-10-221 Criminal and Misconduct Investigations
 

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 fig. 1).29 OCI’s Director reports to the 

head of ORA, the Associate Commissioner for Regulatory Affairs 

(ACRA).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 fig. 1).31 OIA’s manager 

reports to the OCI Director.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.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.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 

29Other FDA field activities include conducting sample analysis of regulated products and 

reviewing imported products offered for entry into the United States. 

30The 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. 

31The 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. 

32The OCI Director is responsible for evaluating the performance of the OIA manager. 

33In addition to notifying HHS OIG about all cases involving criminal allegations, OIA also 

notifies HHS OIG prior to referring cases for prosecution. 

34Throughout this report, we refer to criminal investigators that work in OIA as OIA 

investigators. 

Page 9 GAO-10-221 Criminal and Misconduct Investigations
 

techniques.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.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. 

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 seniorlevel 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 Maintains 

Policies to Guide Its 

Investigations but 

FDA’s Oversight of 

Those Investigations 

Is Limited 

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 

 

35According 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. 

36OCI 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. 

Page 10 GAO-10-221 Criminal and Misconduct Investigations
 

management.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.38

 

37Although 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. 

38Criminal investigators must also comply with applicable laws requiring that they obtain a 

court order. 

Page 11 GAO-10-221 Criminal and Misconduct Investigations
 

Table 1: Description of the Office of Criminal Investigations’ Investigative Policies 

Component 

Description of the Office of Criminal Investigations’ investigative 

policies 

Documenting and evaluating allegations/leads • 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. 

Opening an investigation • 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. 

Collecting information • 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. 

Documenting, managing, and tracking investigative data • 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. 

Resolution of the case • 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. 

Page 12 GAO-10-221 Criminal and Misconduct Investigations
 

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.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.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. 

A Key Element of FDA’s 

Oversight of OCI to Ensure 

Its Compliance with 

Investigative Policies Has 

Not Been Implemented 

within Established Time 

Frames 

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 

 

39The 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. 

40The 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. 

Page 13 GAO-10-221 Criminal and Misconduct Investigations
 

30 percent, were completed.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 1997.42 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.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 

 

41A 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. 

42OCI finalized its policy in 1996 and the first office assessment was completed in 1997. 

43FDA’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 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/ 

%20Reports/StrategicActionPlan/UCM061415.pdf. 

Page 14 GAO-10-221 Criminal and Misconduct Investigations
 

agency’s mission of protecting public health.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.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.46 The act does not require agencies to use these principles for 

individual programs, but past GAO work47 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 

 

44FDA’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 http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ 

BudgetReports/ucm153374.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 http://www.fda.gov/ 

NewsEvents/Speeches/ucm175983.htm. 

45Pub. L. No. 103-62, 107 Stat. 285. 

46Under GPRA, federal agencies are also required to report annually on their progress in 

achieving their goals. 

47For example, see GAO, Managing for Results: Enhancing Agency Use of Performance 

Information for Management Decision Making, GAO-05-927 (Washington, D.C.: Sept. 9, 

2005); GAO, Program Evaluation: Studies Helped Agencies Measure or Explain Program 

Performance, GAO/GGD-00-204 (Washington, D.C.: Sept. 29, 2000); GAO, Agency 

Performance Plans: Examples of Practices That Can Improve Usefulness to 

Decisionmakers, GAO/GGD/AIMD-99-69 (Washington, D.C.: Feb. 26, 1999); and GAO, 

Managing for Results: Strengthening Regulatory Agencies’ Performance Management 

Practices, GAO/GGD-00-10 (Washington, D.C.: Oct. 28, 1999). 

Page 15 GAO-10-221 Criminal and Misconduct Investigations
 

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.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.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.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 

 

48The 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. 

49OCI’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. 

50This annual performance measure is included in DOJ’s Strategic Plan, Fiscal Years 2007-

2012. See http://www.usdoj.gov/jmd/mps/strategic2007-2012/index.html. 

Page 16 GAO-10-221 Criminal and Misconduct Investigations
 

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.51 However, 

according to a 2004 GAO report, federal managers do not perceive issue

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’ pe

s 

rformance.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.53 For more information about 

these statistics and other OCI investigative statistics, see appendix I. 

51For example, see GAO, Combating Gangs: Better Coordination and Performance 

Measurement Would Help Clarify Roles of Federal Agencies and Strengthen Assessment 

of Efforts, GAO-09-708 (Washington, D.C.: July 24, 2009); and GAO, Results-Oriented 

Government: GPRA Has Established a Solid Foundation for Achieving Greater Results, 

GAO-04-38 (Washington, D.C.: Mar. 10, 2004). 

52See GAO-04-38. 

53See HHS, Food and Drug Administration, The Enforcement Story, Fiscal Year 2008 

(Rockville, MD: March 2009), chapter 6: Office of Criminal Investigations. See 

http://www.fda.gov/ICECI/CriminalInvestigations/default.htm. 

Page 17 GAO-10-221 Criminal and Misconduct Investigations
 

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.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. 

OCI Is Not Required to 

Report Specific 

Information to FDA 

Management 

 

54GAO’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 

GAO-AIMD-00-21.3.1. 

Page 18 GAO-10-221 Criminal and Misconduct Investigations
 

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 management55 or a process to regularly 

monitor OIA’s compliance with its investigative policies. 

FDA’s Oversight of 

OIA Investigations Is 

Limited 

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).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.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. 

 

55The OIA manager shares information about the initiation of OIA investigations with the 

OCI Director. 

56The investigative components are the same as those identified for OCI’s criminal 

investigations. 

57These rights have been recognized by federal courts and are also applicable at other 

federal agencies. 

Page 19 GAO-10-221 Criminal and Misconduct Investigations
 

Table 2: Description of the Office of Internal Affairs’ Investigative Policies 

Component Description of the Office of Internal Affairs’ investigative policies 

Documenting and evaluating allegations/leads • 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). 

Opening an investigation • 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. 

Collecting information • 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. 

Documenting, managing, and tracking investigative data • 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. 

Resolution of the case • 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. 

Page 20 GAO-10-221 Criminal and Misconduct Investigations
 

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.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.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.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.61 OIA does not maintain a separation of duties as the 

FDA Conducts No Formal 

Oversight of OIA 

 

58GAO’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 

GAO-AIMD-00-21.3.1. 

59As of January 2010, the OCI Director and OIA manager had begun holding regular monthly 

meetings to discuss OIA issues. 

60OIA’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. 

61According 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, GAO-01-1008G (Washington, D.C.: August 

2001). 

Page 21 GAO-10-221 Criminal and Misconduct Investigations
 

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’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.62

FDA’s Funding and 

Staffing for OCI 

Investigations and 

OCI Investigative 

Workload Have 

Increased 

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.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 fig. 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 app. 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, 

 

62The number of active investigations includes cases that are ongoing at the end of a fiscal 

year regardless of when they were opened. 

63From 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. 

Page 22 GAO-10-221 Criminal and Misconduct Investigations
 

this increase was the result of funding authorized by the Public Health 

Security and Bioterrorism Preparedness and Response Act of 2002,64

which provided OCI additional resources to address potential terrorist 

threats in connection with FDA-regulated products. roducts. 

Figure 2: Office of Criminal Investigations’ Funding and Staffing Growth (Fiscal Years 1999 to 2008) 

0

50

100

150

200

250

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008

Fiscal year

0

5,000

10,000

15,000

20,000

25,000

30,000

35,000

40,000

45,000

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008

Fiscal year

Funding (Dollars in thousands) Staffing (Full-time equivalents)

An increase of about 117% 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. 

 

64Pub. L. No. 107-188, 116 Stat. 594. 

Page 23 GAO-10-221 Criminal and Misconduct Investigations
 

OCI’s investigative workload—the number of opened, closed, and active 

investigations each year—generally increased annually from fiscal years 

1999 to 2008.65 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. 

OCI’s Investigative 

Workload Increased from 

Fiscal Years 1999 to 2008 

Table 3: Office of Criminal Investigations’ Investigative Workload Growth 

(Fiscal Years 1999 to 2008) 

Fiscal year 

Opened 

investigations

Closed 

investigations

Active/ongoing 

investigations

1999 370 201 655

2000 327 270 712

2001 334 291 755

2002 319 309 765

2003 394 326 833

2004 443 351 925

2005 513 401 1037

2006 390 420 1007

2007 425 398 1034

2008 471 418 1087

Change from 1999 to 2008 27.3% 108.0% 66.0%

Source: FDA data. 

 

65These 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. 

Page 24 GAO-10-221 Criminal and Misconduct Investigations
 

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. 

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. 

Conclusions 

Recommendations for 

Executive Action 

• 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. 

Page 25 GAO-10-221 Criminal and Misconduct Investigations
 

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. 

Agency Comments 

and Our Evaluation 

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. 

Page 26 GAO-10-221 Criminal and Misconduct Investigations
 

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 http://www.gao.gov. 

Page 27 GAO-10-221 Criminal and Misconduct Investigations
 

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, 

Marcia Crosse 

Director, Health Care 

Page 28 GAO-10-221 Criminal and Misconduct Investigations
A

In

Inv

ppendix I: Statistics from Investigations 

volving the Office of Criminal

estigations 

Page 29 GAO-10-221 

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) 

Source: FDA data.

Fiscal year

Number of arrests and convictions

Arrests

Convictions

0

100

200

300

400

500

600

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008

395

236

426

381

430

381

254

361

325

364

267

348

418 405 396 408

369

509

348 362

OCI maintains statistics on the number of arrests and convictions resulting 

from both investigations it conducts independently and with other federal 

law enforcement agencies.1

 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 

 

1

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. 

 Criminal and Misconduct Investigations 
Appendix I: Statistics from Investigations 

Involving the Office of Criminal 

Investigations 

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.2

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.3

 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 fig. 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. 

 

2

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. 

3

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). 

Page 30 GAO-10-221 Criminal and Misconduct Investigations
Appendix I: Statistics from Investigations 

Involving the Office of Criminal 

Investigations 

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) 

Fines/restitution

Assets

forfeited/seized

0

200

400

600

800

1,000

1,200

1,400

1999 2000 2001 2002 2003 2004 2005 2006 2007 2008

Fiscal year

56.5

0.9

50.8

0.7

99.8

2.3

929.4

13.5

821.1

16.5

464.1

18.9

169.1

67.0

1,180.0

35.8

1,280.0

177.5

863.2

149.3

Dollars in millions

Source: FDA data.

Page 31 GAO-10-221 Criminal and Misconduct Investigations
Appendix II: OCI Funding, Fiscal Years 1999 

to 2008 

Page 32 GAO-10-221 

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 Actual Inflation adjusted

1999 $19,073,471 $19,073,471 

2000 21,187,301 20,767,081 

2001 23,104,835 22,124,445 

2002 25,589,446 24,043,631 

2003 31,040,799 28,587,184 

2004 33,172,169 29,775,353 

2005 35,328,057 30,725,678 

2006 36,279,224 30,518,403 

2007 37,802,938 30,952,200 

2008 41,309,714 33,037,480 

Change from 1999 to 2008 116.6% 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. 

 Criminal and Misconduct Investigations 
Appendix III: Comments from the Department Appendix III: Comments from the of Health and Human Services 

Department of Health and Human Services 

Page 33 GAO-10-221 Criminal and Misconduct Investigations
Appendix III: Comments from the Department 

of Health and Human Services 

Page 34 GAO-10-221 Criminal and Misconduct Investigations
Appendix III: Comments from the Department 

of Health and Human Services 

Page 35 GAO-10-221 Criminal and Misconduct Investigations
Appendix III: Comments from the Department 

of Health and Human Services 

Page 36 GAO-10-221 Criminal and Misconduct Investigations
Appendix III: Comments from the Department 

of Health and Human Services 

Page 37 GAO-10-221 Criminal and Misconduct Investigations
Appendix IV: 

A

GAO Contact and Staff 

cknowledgments 

Page 38 GAO-10-221 

Appendix IV: GAO Contact and Staff 

Acknowledgments 

Marcia Crosse, (202) 512-7114 or crossem@gao.gov 

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. 

 Criminal and Misconduct Investigations 

GAO Contact 

Acknowledgments 

(290746) 
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