GAO 

United States Government Accountability Office

Report to Congressional Requesters

OVERSIGHT OF 

CLINICAL 

INVESTIGATORS 

Action Needed to 

Improve Timeliness 

and Enhance Scope of 

FDA’s Debarment and 

Disqualification 

Processes for Medical 

Product Investigators 

September 2009 

GAO-09-807 
What GAO Found

United States Government Accountability Office

Why GAO Did This Study

Highlights

Accountability Integrity Reliability

September 2009

OVERSIGHT OF CLINICAL INVESTIGATORS

Action Needed to Improve Timeliness and Enhance 

Scope of FDA’s Debarment and Disqualification 

Highlights of GAO-09-807, a report to Processes for Medical Product Investigators

congressional requesters 

The Food and Drug Administration 

(FDA) oversees the clinical 

investigators who conduct research 

involving new drugs, biologics, and 

medical devices to ensure that their 

conduct does not compromise the 

safety of clinical trial participants 

or the integrity of clinical trial data. 

FDA can debar or disqualify 

investigators who have engaged in 

misconduct such as submitting 

fraudulent data. Debarred or 

disqualified investigators cannot 

engage in certain activities related 

to clinical research. GAO was 

asked to review FDA’s debarment 

and disqualification processes. 

GAO examined the length of time 

debarment and disqualification 

processes have taken and factors 

for those time frames, and the 

statutory and regulatory limitations 

of debarment and disqualification. 

GAO reviewed laws, regulations, 

and FDA files through November 5, 

2008, for (1) all investigators, study 

coordinators, and sub-investigators 

for whom FDA pursued debarment 

since receiving debarment 

authority in 1992; and (2) all 

clinical investigators for whom 

FDA pursued disqualification since 

FDA adopted its current process 

for initiating proceedings in 1998. 

What GAO Recommends

To improve its oversight, the 

Commissioner of FDA should 

pursue extending FDA’s debarment 

authority; extend disqualification to 

include drugs, biologics, and 

medical devices; and ensure the 

timely completion of debarment 

and disqualification proceedings. 

FDA agreed with GAO’s 

recommendations. 

More than half of the debarment proceedings in GAO’s review took 4 or more 

years, and factors contributing to these time frames included internal control 

weaknesses in the debarment process and competing priorities among 

responsible staff. FDA has statutory authority to debar individuals who have 

been convicted of felonies or certain misdemeanors related to the 

development, approval, or regulation of a drug or biologic. For the 18 

proceedings GAO reviewed, the length of time from an individual’s conviction 

through debarment (or as of November 5, 2008, for pending proceedings) 

ranged from about 1 year to nearly 11 years. Factors that contributed to delays 

included that FDA staff faced competing priorities and FDA had not 

established internal controls, such as time frames for the completion of steps 

in the debarment process. FDA has made or planned changes that could 

improve timeliness (e.g., by establishing time frames in March 2009), but the 

effects of such actions have yet to be seen. 

The time taken for disqualification proceedings varied and proceedings took 

longer when the investigator contested disqualification. FDA may disqualify 

investigators who repeatedly or deliberately failed to comply with FDA 

regulations or submitted false information to FDA or the sponsor of a clinical 

trial. For the 52 disqualification proceedings GAO reviewed, the length of time 

from initiation of a disqualification proceeding to its conclusion (or as of 

November 5, 2008, for pending proceedings) ranged from 26 days to more than 

a decade, with about one-third taking more than 2 years. In general, the more 

steps taken by the investigator to contest disqualification, the longer it took to 

complete the proceeding. Disqualification proceedings initiated in 1998 

through 2001 generally took longer than proceedings that were initiated more 

recently. FDA officials told us that a lack of time frames for these 

proceedings—an internal control weakness—may have contributed to longer 

proceedings. FDA made changes to its disqualification process (e.g., by 

establishing time frames in June 2008 and January 2009) that could further 

improve timeliness, but the full effect of these changes remains to be seen. 

FDA’s debarment authority does not fully extend to involvement with medical 

devices, and its regulations do not extend disqualification for drugs and 

biologics to medical devices and vice versa. As a result, an individual may be 

debarred from involvement with drugs and biologics, but not from 

involvement with medical devices, regardless of the kind of misconduct in 

which the individual engaged. FDA’s disqualification regulations allow an 

investigator who is disqualified for conduct related to drugs or biologics to 

serve as an investigator for medical devices; likewise, an individual who FDA 

disqualified for conduct related to medical devices remains able to serve as a 

clinical investigator for drugs and biologics. 

View GAO-09-807 or key components.

For more information, contact Marcia Crosse 

at (202) 512-7114 or crossem@gao.gov. 
Page i GAO-09-807 

Contents 

Letter 1

Background 6 

More than Half of Debarment Proceedings Took 4 or More Years, 

and Type of Debarment Pursued, Internal Control Weaknesses, 

and Competing Priorities Contributed to Longer Proceedings 17 

Times Taken for Disqualification Proceedings Varied and Factors 

Such as Clinical Investigators’ Contesting Disqualification and 

Internal Control Weaknesses May Have Contributed to Longer 

Proceedings 30 

FDA’s Debarment Authority Does Not Fully Extend to Involvement 

with Devices and Regulations Allow Disqualified Clinical 

Investigators to Conduct Trials for Other Investigational Medical 

Products 39 

Conclusions 42 

Recommendations for Executive Action 43 

Agency Comments 43 

Appendix I Scope and Methodology 45 

Appendix II Selected Features of Debarment and 

Disqualification 51 

Appendix III Debarment Proceedings Completed or Pending 

from May 13, 1992, through September 9, 2008 53 

Appendix IV Types of Misconduct Cited in Proposal to Debar 

Letters 55 

Appendix V Disqualification Proceedings Initiated from 

January 1, 1998, through September 9, 2008 57 

 FDA Oversight of Clinical Investigators
Appendix VI Types of Alleged Misconduct Cited in FDA’s 

Initiation of Disqualification Proceedings 61 

Appendix VII Comments from the Department of Health and 

Human Services 65 

Appendix VIII GAO Contact and Staff Acknowledgments 72 

Table 

Table 1: Examples of Misconduct Allegations Cited in NIDPOE 

Letters 62 

Figures 

Figure 1: FDA’s Debarment Process for Individuals 10 

Figure 2: FDA’s Disqualification Process for Clinical Investigators 13 

Figure 2 (cont.): FDA’s Disqualification Process for Clinical 

Investigators 14 

Figure 3: Time Taken for Completed and Pending Debarment 

Proceedings 19 

Figure 4: Lengths of Time for the 11 Completed Debarment 

Proceedings by Type of Debarment 21 

Figure 5: Time Taken for Completed and Pending Disqualification 

Proceedings 31 

Figure 6: Time Taken for Disqualification Proceedings Initiated in 

1998 through 2001, 2002 through 2005, and 2006 through 

2008 32 

Figure 7: Time Taken to Complete Disqualification Proceedings 34 

Page ii GAO-09-807 FDA Oversight of Clinical Investigators
Abbreviations 

CBER Center for Biologics Evaluation and Research 

CDER Center for Drug Evaluation and Research 

CDRH Center for Devices and Radiological Health 

FDA Food and Drug Administration 

NIDPOE Notice of Initiation of Disqualification Proceedings and 

 Opportunity to Explain 

NOOH Notice of Opportunity for Hearing 

This is a work of the U.S. government and is not subject to copyright protection in the 

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Page iii GAO-09-807 FDA Oversight of Clinical Investigators
Page 1 GAO-09-807 

 

United States Government Accountability Office

Washington, DC 20548 

 

September 25, 2009 

The Honorable Joe Barton 

Ranking Member 

Committee on Energy and Commerce 

House of Representatives 

The Honorable Greg Walden 

Ranking Member 

Subcommittee on Oversight and Investigations 

Committee on Energy and Commerce 

House of Representatives 

The Food and Drug Administration (FDA) has oversight responsibilities 

for clinical investigators who conduct research involving investigational 

medical products—including drugs, biologics, and devices1

—to ensure 

that their conduct does not compromise the quality or integrity of clinical 

trial data or the safety of clinical trial participants. The quality or integrity 

of the clinical trial data that FDA uses to determine whether an 

investigational medical product is safe and effective for the U.S. market 

can be compromised by misconduct, such as falsification of these results, 

and the safety of clinical trial participants can be jeopardized by 

misconduct, such as failing to obtain their informed consent. For example, 

if a clinical investigator falsifies data or fails to report trial participants’ 

adverse reactions to an investigational drug, flawed data could be used to 

assert the drug’s safety and the drug could potentially endanger the health 

of those who take it. Timely action against individuals who engage in such 

misconduct is a key component of effective oversight. 

As part of its oversight activities, FDA can take actions against clinical 

investigators who have engaged in certain types of misconduct; debarment 

and disqualification are two such actions. FDA has express statutory 

authority to debar individuals—including clinical investigators and the 

1

Investigational medical products include drugs, biologics, or devices that are the object of 

clinical investigations. For the purposes of this report, drugs refer to human drugs. 

Biologics include blood, vaccines, allergenic products, certain tissues, and cellular and 

gene therapies. Devices include medical devices used for the diagnosis, cure, mitigation, 

treatment, or prevention of a disease. In addition to drugs, biologics, and devices, FDA 

regulates other products, including animal drugs, food additives, and cosmetics, and was 

recently authorized to regulate tobacco products. 

 FDA Oversight of Clinical Investigators
sub-investigators and study coordinators who work for them2

—who have 

been convicted of certain crimes or who have engaged in certain 

misconduct related to the development or approval of any drug or 

biologic.3

 For example, FDA can debar an individual convicted of a felony 

in connection with submitting fraudulent data for nonexistent clinical trial 

participants or falsifying a report to conceal a failure to conduct a clinical 

trial as required. Debarred individuals cannot provide services to the drug 

or biologic industry as a clinical investigator, sub-investigator, study 

coordinator, or in any other capacity. Under FDA’s regulations, the agency 

may disqualify clinical investigators who repeatedly or deliberately failed 

to comply with FDA regulations or who repeatedly or deliberately 

submitted false information to FDA or the sponsor of the clinical trial in a 

required report. For example, FDA can disqualify a clinical investigator 

who failed to obtain informed consent from clinical trial participants. 

Disqualified clinical investigators are prohibited from receiving one or 

more types of investigational medical products, which include drugs, 

biologics, and devices, and as a result, they are prevented from serving as 

clinical investigators for clinical trials of these products. FDA posts on its 

Web site lists of those individuals whom the agency has debarred or 

disqualified. Sponsors of applications for new drugs and biologics must 

certify that debarred individuals did not provide services to them, and 

sponsors of investigational medical products may not provide these 

products to investigators who have been disqualified to receive them. 

Reports of some delays in debarring or disqualifying clinical investigators 

and questions about the scope of FDA’s debarment and disqualification 

activities have focused attention on FDA’s oversight of clinical 

investigators.4

 Previous reports have noted weaknesses in other aspects of 

FDA’s oversight of clinical investigators. We previously reported that 

FDA’s oversight efforts may allow violations of protections to clinical trial 

 

2

Clinical investigators have responsibility for the conduct of a particular clinical trial at one 

or more locations. Sub-investigators and study coordinators work under the supervision of 

clinical investigators and provide services such as recruiting and collecting data from 

clinical trial participants. 

3

21 U.S.C. § 335a. Debarment is also possible for certain criminal convictions unrelated to 

the development or approval of a drug or biologic. The drugs and biologics referred to in 

the statute are included in the definition of “drug product.” 21 U.S.C. § 321(dd). 

4

See, for example, U.S. House of Representatives, Committee on Energy and Commerce, 

Minority Staff, FDA’s Faulty Safeguards Against Corruption: Concerns Over Debarment 

Use and Authority. Prepared for Ranking Member Joe Barton (Washington, D.C.: Feb. 

2008). 

Page 2 GAO-09-807 FDA Oversight of Clinical Investigators
participants to go undetected because FDA inspected only a small 

percentage of the sites where clinical trials were conducted and FDA 

typically carried out these inspections after clinical trials were concluded.5

The Department of Health and Human Services’s Office of Inspector 

General previously reported on weaknesses in FDA’s oversight of clinical 

trials, including a lack of clear, specific guidance and inconsistency across 

FDA components in their responses to inspectional findings.6

 You asked 

us to review factors contributing to delays in FDA’s debarment an

disqualification proceedings. This report discusses (1) the length of time 

FDA’s debarment proceedings have taken and the factors contributing to 

the length of time they have taken, (2) the length of time FDA’s 

disqualification proceedings have taken and the factors contributing to the 

length of time they have taken, and (3) statutory and regulatory limitations 

to debarment and disqualification. 

d 

 

To determine how long FDA’s debarment proceedings have taken and to 

identify factors that contributed to the length of time they have taken, we 

reviewed FDA’s files regarding all clinical investigators, sub-investigators, 

and study coordinators whom FDA pursued or considered pursuing for 

debarment from the time that it was given authority to do so on May 13, 

1992, through September 9, 2008.7

 To identify these individuals, we 

reviewed information about FDA’s debarment proceedings from Federal 

Register notices (including proposal to debar letters, which FDA uses to 

initiate debarment actions, and debarment orders, which FDA uses to 

5

See, for example, GAO, Scientific Research: Continued Vigilance Critical to Protecting 

Human Subjects, GAO/HEHS-96-72 (Washington, D.C.: Mar. 8, 1996); GAO, Human 

Subjects Research: HHS Takes Steps to Strengthen Protections, But Concerns Remain, 

GAO-01-775T (Washington, D.C.: May 23, 2001); and GAO, Human Subjects Research: 

Undercover Tests Show the Institutional Review Board System Is Vulnerable to Unethical 

Manipulation, GAO-09-448T (Washington, DC.: Mar. 26, 2009). 

6

See, for example, two reports by the Department of Health and Human Services’s Office of 

Inspector General: FDA Oversight of Clinical Investigators, OEI-05-99-00350 (Washington, 

D.C.: Department of Health and Human Services, June 2000); and The Food and Drug 

Administration’s Oversight of Clinical Trials, OEI-01-06-00160 (Washington, D.C.: 

Department of Health and Human Services, Sept. 2007). 

7

We included sub-investigators and study coordinators because, like clinical investigators, 

they interacted directly with clinical trial participants. Clinical investigators, 

sub-investigators, and study coordinators are a subset of individuals who are subject to 

debarment. We excluded individuals who worked in other roles and who were debarred, 

for example, we excluded a senior vice president and a chemist whose misconduct could 

have affected the information available to FDA when evaluating applications to market 

new drugs or biologics, but who generally did not interact directly with clinical trial 

participants. 

Page 3 GAO-09-807 FDA Oversight of Clinical Investigators
complete debarment actions) and FDA’s Web site, and obtained additional 

information from FDA about individuals whom FDA pursued or 

considered pursuing for debarment. We identified 18 proceedings—13 

involving clinical investigators and 5 involving study coordinators.8

 For 

each proceeding, we reviewed relevant files in the FDA center that 

initiated the debarment action—either the Center for Drug Evaluation and 

Research (CDER) for misconduct related to drugs or the Center for 

Biologics Evaluation and Research (CBER) for misconduct related to 

biologics—and in FDA’s Division of Dockets Management, which 

maintains publicly available information about debarment proceedings. To 

determine the length of time each completed debarment proceeding took, 

we calculated the number of calendar days from the date of the 

individual’s conviction (or, if the individual’s conviction occurred before 

FDA received debarment authority, from the date when FDA received 

debarment authority—May 13, 1992) through publication of the debarment 

order in the Federal Register.

9

 For debarment proceedings that were 

pending at the time of our file review, we calculated the number of 

calendar days through the last day of our file review (Nov. 5, 2008).10 To 

identify factors that contributed to the length of time FDA’s debarment 

proceedings have taken, we analyzed the information we obtained from 

FDA’s files and obtained additional information from FDA officials (for 

example, by asking what occurred during long intervals for which we saw 

no documented activity). We examined laws, regulations, and guidance to 

determine whether there were criteria relevant to the times taken by 

debarment proceedings. We also examined internal control standards, 

which include the need to establish policies and procedures to help ensure 

 

8

One of the study coordinators was also a sub-investigator. 

9

For completed proceedings, we used the date that the debarment order was published in 

the Federal Register as the date of completion of the debarment proceeding. For the 

completed proceedings we reviewed, this date was also the effective date of the debarment 

order. 

10We defined a debarment proceeding as pending if, as of the last date of our file review 

(Nov. 5, 2008), FDA had issued a proposal to debar letter, but had not completed the 

debarment proceeding, or if FDA had identified an individual as one whose conviction 

could serve as a basis for debarment, but for whom FDA had not yet issued a proposal to 

debar letter. 

Page 4 GAO-09-807 FDA Oversight of Clinical Investigators
effective and efficient operations.11 We also interviewed FDA officials, 

including those involved with FDA’s Debarment Working Group, which 

was formed by FDA to review FDA’s debarment process, including the 

length of debarment proceedings. 

To determine how long FDA’s disqualification proceedings have taken and 

identify factors that contributed to the length of time they have taken, we 

reviewed FDA’s files regarding all clinical investigators for whom FDA 

pursued disqualification by issuing a Notice of Initiation of Disqualification 

Proceedings and Opportunity to Explain (NIDPOE) letter from January 1, 

1998, through September 9, 2008, for conduct related to drugs, biologics, 

or devices, whether these clinical investigators were ultimately 

disqualified or not.12 To identify these individuals, we reviewed 

information about FDA’s disqualification proceedings from FDA’s Web site 

and obtained additional information from FDA about individuals for whom 

FDA pursued disqualification. We identified 52 proceedings. For each 

proceeding, we reviewed relevant files in the FDA center that initiated the 

disqualification proceeding—CDER for drugs, CBER for biologics, or the 

Center for Devices and Radiological Health (CDRH) for devices—as well 

as in other FDA offices that maintained files relating to these 

disqualification proceedings. These other offices included the Office of 

Enforcement, the Office of the Ombudsman, and the Good Clinical 

Practice Program, an office within FDA responsible for coordinating 

policies for the conduct of clinical trials of FDA-regulated products that 

involve human participants.13 To determine the length of time each 

completed disqualification proceeding took, we calculated the number of 

calendar days from the date of issuance of the NIDPOE letter through the 

completion of the disqualification proceeding. For disqualification 

 

11These standards provide an overall framework for establishing and maintaining internal 

control and for identifying and addressing major performance and management challenges 

and areas at greatest risk of fraud, waste, abuse, and mismanagement. For example, under 

the standards for internal control, information should be recorded and communicated to 

management and others within an entity who need it and within a time frame that enables 

them to carry out their internal control and other responsibilities. See GAO, Standards for 

Internal Control in the Federal Government, GAO/AIMD-00-21.3.1 (Washington, D.C.: Nov. 

1999) and its supplemental guide, Internal Control Management and Evaluation Tool, 

GAO-01-1008G (Washington, D.C.: Aug. 2001). 

12According to FDA officials, prior to 1998, the agency typically initiated disqualification 

proceedings without issuing a NIDPOE letter. 

13In August 2009, the Good Clinical Practice Program was renamed the Office of Good 

Clinical Practice. 

Page 5 GAO-09-807 FDA Oversight of Clinical Investigators
proceedings that were pending at the time of our file review, we calculated 

the number of calendar days through the last day of our file review 

(Nov. 5, 2008). To identify factors that contributed to the length of time 

FDA’s disqualification proceedings have taken, we analyzed the 

information we obtained from FDA’s files and obtained additional 

information from FDA officials (for example, by asking what occurred 

during long intervals for which we saw no documented activity). To 

determine whether the length of time taken for disqualification 

proceedings changed during the years covered in our review, we divided 

disqualification proceedings into three groups based on the date that FDA 

issued the NIDPOE letter—those initiated before 2002, those initiated in 

2002 through 2005, and those initiated after 2005. We examined laws, 

regulations, guidance, and standards for internal control to determine 

whether there were criteria relevant to the times taken by disqualification 

proceedings. We also interviewed FDA officials, including those in each of 

the offices in which we reviewed disqualification files. 

To identify statutory and regulatory limitations to debarment and 

disqualification, we reviewed relevant laws, regulations, and guidance; 

reviewed files documenting FDA’s debarment and disqualification 

proceedings; and interviewed FDA officials involved with debarment and 

disqualification. We conducted this performance audit from June 2008 to 

September 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. For additional 

information about our scope and methodology, see appendix I. 

FDA has responsibilities for overseeing clinical investigators who conduct 

clinical trials of investigational medical products, including drugs, 

biologics, and devices. As part of its oversight activities, FDA can take 

actions such as debarment or disqualification against investigators and 

other individuals who have engaged in certain types of misconduct. 

Background 

FDA’s Oversight of Clinical 

Investigators 

FDA oversees clinical investigators to ensure that they comply with 

federal regulations governing the conduct of clinical trials. These 

regulations, which are intended to protect the quality and integrity of the 

clinical trial data and the safety of clinical trial participants, include 

requirements for the following: 

Page 6 GAO-09-807 FDA Oversight of Clinical Investigators
• Obtaining informed consent from clinical trial participants, 

• Obtaining approval for conducting a clinical trial from an institutional 

review board that has been tasked with reviewing that trial’s protections 

for participants,14

• Following the research plan for the clinical trial (including a protocol) that 

was approved by the institutional review board, 

• Reporting adverse events associated with the clinical trial, and 

• Submitting reports. 

FDA can disqualify clinical investigators who repeatedly or deliberately 

violate applicable regulations or who repeatedly or deliberately submit 

false information in a required report, and in some cases, an individual’s 

misconduct may result in a criminal conviction, providing a basis for 

debarment. FDA’s debarment and disqualification proceedings each 

consist of a series of steps involving actions taken by FDA and by the 

affected individual. These steps provide the individual with an opportunity 

to contest the charges against him or her. The number of steps involved 

for each proceeding can vary depending, for example, on whether the 

individual chooses to contest the charges by providing information or 

arguments against debarment or disqualification. 

Debarment Under the Generic Drug Enforcement Act of 1992,15 FDA has authority to 

debar individuals—including clinical investigators, sub-investigators, and 

study coordinators—who have been convicted of certain crimes, or 

engaged in other misconduct, related to the development, approval, or 

regulation of any drug or biologic from involvement with drugs and 

biologics.16 (FDA does not have comparable authority with regard to an 

individual involved in the medical device industry.) There are two types of 

 

14An institutional review board is an entity formally designated to review clinical trials and 

other research involving human subjects, with the purpose of protecting the rights and 

welfare of the clinical trial subjects. See 21 C.F.R. § 56.102(g) (2009). 

15Pub. L. No.102-282, § 2, 106 Stat. 149-158 (1992) (codified at 21 U.S.C. § 335a). 

16A debarred individual is prohibited from providing any service to—that is, from 

involvement with—any entity (an individual, partnership, association, or corporation) that 

has an approved or pending drug or biologic application. 21 U.S.C. §§ 321(e), 335a(c)(1)(B). 

Page 7 GAO-09-807 FDA Oversight of Clinical Investigators
debarment, and if based on a criminal conviction, debarment must be 

initiated within 5 years of the date of conviction: 

• Mandatory. Debarment is mandatory—and permanent—when FDA finds 

that an individual has been convicted of a felony under federal law for 

misconduct relating to the development or approval of any drug or 

biologic, or otherwise relating to the regulation of any drug or biologic.17

• Permissive. FDA may, but is not required to, seek permissive 

debarment—which is not permanent—under certain other conditions, for 

example, if the individual was convicted of a felony under state law for 

conduct related to the development or approval of any drug or biologic.18

For permissive debarment, FDA must determine that debarment is 

appropriate and determine the period of debarment by considering factors 

such as the nature and seriousness of the offense or offenses involved. An 

individual may be permissively debarred for up to 5 years for each offense. 

If the individual is permissively debarred for multiple offenses, the 

Commissioner of FDA may determine whether debarment periods will run 

concurrently or consecutively.19

As shown in figure 1, FDA’s debarment process involves multiple possible 

steps. The process starts when FDA learns of an individual’s conviction, 

determines that it provides a basis for debarment, and drafts a proposal to 

debar letter. For the debarment proceedings we reviewed, the relevant 

FDA center (CDER for drugs or CBER for biologics) was responsible for 

determining if there was a basis for debarment and drafting the proposal 

to debar letter, with input from the Office of the Chief Counsel.20 FDA 

provides the individual with a notice of its proposal to debar and provides 

 

1721 U.S.C. §§ 321(dd); 335a(a)(2), (c)(2)(A)(ii). 

1821 U.S.C. § 335a(b)(2)(B)(i)(I), (c)(2)(A)(iii). FDA may also permissively debar an 

individual who has not been convicted of a crime or convicted of a crime unrelated to the 

development or approval of a drug or biologic. For example, FDA may permissively debar 

an individual if the individual materially participated in acts that were the basis for another 

individual’s conviction for certain crimes, such as a felony conviction under state law for 

conduct related to the development or approval of a drug or biologic. In such cases, FDA 

must also find that the individual’s behavior demonstrates a pattern of conduct suggesting 

that the individual may violate other requirements under the Federal Food, Drug, and 

Cosmetic Act relating to drugs or biologics. 21 U.S.C. § 335a(b)(2)(B)(iii). 

1921 U.S.C. § 335a(c)(2)(A), (c)(3). 

20As of March 2009, the Office of Enforcement—not the center—is responsible for 

determining whether to pursue debarment and drafting the proposal to debar letter. 

Page 8 GAO-09-807 FDA Oversight of Clinical Investigators
an opportunity for a formal hearing to demonstrate why he or she should 

not be debarred.21 If the individual requests a hearing, he or she must 

provide information on disputed issues of material fact to justify a hearing, 

such as whether the individual was actually convicted as alleged in the 

notice and, if so, whether this conviction provides a basis for debarment. 

FDA evaluates this information and determines whether to grant a hearing. 

If the FDA Commissioner determines that there is no substantial issue of 

material fact, then he or she denies the hearing and debars the individual 

by issuing an order of debarment. FDA publishes a debarment order in the 

Federal Register. 

 

21Formal hearings conducted in the course of debarment proceedings are conducted under 

part 12, Title 21, Code of Federal Regulations, 2009. 

Page 9 GAO-09-807 FDA Oversight of Clinical Investigators
Figure 1: FDA’s Debarment Process for Individuals 

Notes: This figure presents the major steps that could be involved in the debarment proceedings we 

reviewed. These proceedings involved clinical investigators, sub-investigators, and study coordinators 

for whom FDA pursued or considered pursuing debarment from May 13, 1992, through September 9, 

2008. The number of steps involved for a proceeding can vary depending, for example, on whether 

the individual chooses to contest the charges by requesting a hearing. All clinical investigators, 

sub-investigators, and study coordinators whom FDA pursued or considered pursuing for debarment 

as of the last date of our file review (November 5, 2008) had been convicted of a crime. 

a

Proposal to debar letters specify that if the individual chooses to respond, he or she must submit a 

written notice of request for a formal hearing within 30 days of receiving the letter and must submit 

information on which the individual relies to justify a hearing within 60 days of receiving the letter. 

FDA staff learn that individual was convicted of a crime and determine 

whether to pursue debarment (mandatory or permissive)

FDA issues a proposal to debar letter, describing the conviction and 

misconduct and offering an opportunity for a formal hearinga

Individual does not submit a

timely request or declines the 

opportunity for a hearing

FDA Commissioner or 

delegate makes decision

Debarred Not debarred

Individual requests a formal hearing 

by the specified date

Request for hearing is:

Formal hearing 

conducted and 

presiding officer 

makes

recommendation

Not grantedb Granted

Source: GAO.

Page 10 GAO-09-807 FDA Oversight of Clinical Investigators
b

When a request for a hearing is denied, the FDA Commissioner (or delegate) generally issues a 

decision that includes both a denial of the hearing and a debarment order. 

Debarred individuals are prohibited from involvement with drugs and 

biologics. Debarment does not preclude such individuals from serving in 

any capacity to an entity that intends to market or is marketing a medical 

device or other FDA-regulated product, such as food additives or 

cosmetics. 

An individual’s debarment can end when the individual’s permissive 

debarment period has ended or if FDA terminates the individual’s 

debarment. FDA may terminate debarment if, for example, the conviction 

that served as the basis for the individual’s debarment is reversed.22

Disqualification Under federal regulations, FDA may disqualify clinical investigators from 

receiving investigational drugs, biologics, or devices if they repeatedly or 

deliberately failed to comply with pertinent FDA regulations or repeatedly 

or deliberately submitted false information to FDA or the sponsor of the 

clinical trial in a required report.23 Sub-investigators and study 

coordinators cannot be disqualified by FDA under current regulations. 

FDA initiates disqualification proceedings based on allegations of 

misconduct detected during an inspection of a clinical investigator.24

Before issuing a NIDPOE letter, FDA staff evaluate information gathered 

during the inspection, obtain additional clarifying information as 

necessary (including, in some cases, information obtained from other 

inspections), determine whether their observations provide a foundation 

for initiation of a disqualification proceeding, and, if so, draft the NIDPOE 

letter with input from FDA’s Office of the Chief Counsel. The misconduct 

alleged in the NIDPOE letter may have occurred years before the 

inspection. 

 

22As of June 18, 2009, FDA had not terminated debarment for any clinical investigators, 

sub-investigators, or study coordinators. 

2321 C.F.R. §§ 312.70, 812.119 (2008). 

24FDA conducts inspections of clinical investigators as part of its program to monitor the 

conduct of research involving investigational medical products. 

Page 11 GAO-09-807 FDA Oversight of Clinical Investigators
As shown in figure 2, FDA’s disqualification process involves multiple 

possible steps. FDA initiates a disqualification proceeding against a 

clinical investigator by providing the investigator with a NIDPOE letter.25

The NIDPOE letter details FDA’s allegations of misconduct and provides 

the investigator an opportunity to respond in writing or to meet informally 

with FDA officials to discuss the allegations. It also provides the 

investigator with the option of concluding the disqualification proceeding 

by entering into a consent agreement with FDA. The investigator and FDA 

may enter a consent agreement at any time before the Commissioner 

reaches a decision. 

 

25According to FDA officials, the agency typically initiated disqualification proceedings 

before 1998 without issuing a NIDPOE letter. If FDA determines that the investigator’s 

misconduct could pose an ongoing risk to the safety and welfare of clinical trial 

participants, it can take steps to suspend or restrict the study, thereby limiting that 

investigator’s research activities. FDA posts a list of investigators to whom it has issued a 

NIDPOE letter on its Web site, allowing sponsors and others to learn of the allegations of 

misconduct, and it notifies relevant sponsors and institutional review boards when a 

clinical investigator is disqualified. Other entities—such as sponsors of clinical trials or 

institutional review boards—may also take action to terminate a clinical trial or an 

investigator’s participation in it after misconduct has been identified. See 21 C.F.R. 

§§ 56.113; 312.42(a), (b)(i); 312.56(b) (2008). 

Page 12 GAO-09-807 FDA Oversight of Clinical Investigators
Figure 2: FDA’s Disqualification Process for Clinical Investigators 

FDA center issues a Notice of Initiation of Disqualification Proceedings

and Opportunity to Explain (NIDPOE) letter to a clinical investigatora

Investigator requests an 

informal conference by 

the specified date

Investigator does not 

submit a timely request 

or declines to respond in 

writing or in an informal 

conference

FDA issues a Notice of 

Opportunity for Hearing 

(NOOH) letter

Investigator submits

information in writing by 

the specified date

Disqualified

Investigator enters into a

consent agreement; 

disqualification process

endsb

FDA center evaluates information provided by investigator

(in writing and/or at the conference) and determines that the 

investigator’s explanation is

Satisfactory

Not disqualified

Disqualification process

ends; investigator is not 

disqualified

Not satisfactory

and/

or

Written materials Informal conference

A

Source: GAO.

See next page

Notes: This figure presents the major steps that could be involved in disqualification proceedings 

we reviewed that were initiated by FDA using a NIDPOE letter from January 1, 1998, through 

September 9, 2008. The number of steps involved for a proceeding can vary depending, for example, 

on whether the individual chooses to contest the charges by requesting a hearing. For the purposes 

of this report, we treat consent agreements that restrict clinical investigators’ activities as a form of 

disqualification. 

a

NIDPOE letters specify that if the clinical investigator chooses to respond, he or she must request an 

informal conference or indicate an intention to submit a written reply within 15 days and provide the 

written reply within 30 days of receiving the letter. 

b

The clinical investigator and FDA may enter into a consent agreement, terminating the 

disqualification process, at any time before the Commissioner reaches a decision. 

Page 13 GAO-09-807 FDA Oversight of Clinical Investigators
Figure 2 (cont.): FDA’s Disqualification Process for Clinical Investigators 

FDA issues NOOHa

Investigator does not 

submit a timely request 

or declines the 

opportunity for a hearing

FDA Commissioner or 

delegate makes decisiond

Disqualified

Investigator enters into a

consent agreement; 

disqualification process

endsb

Not 

grantedc Granted

A

Investigator requests a

regulatory hearing by the 

specified date.

Request for hearing is:

Disqualified

Disqualification process

ends; investigator is

disqualified

Not disqualified

Disqualification process

ends; investigator is not 

disqualified

Regulatory hearing 

conducted and presiding 

officer issues report

Disqualified

Investigator enters into a

consent agreement; 

disqualification process endsb

See previous page

Source: GAO.

a

Notice of Opportunity for Hearing (NOOH) letters specify that if the clinical investigator chooses to 

request a regulatory hearing, he or she must do so within 10 business days of receiving the letter. 

b

The clinical investigator and FDA may enter into a consent agreement, terminating the 

disqualification process, at any time before the Commissioner reaches a decision. 

c

When a request for a hearing is denied, the FDA Commissioner (or delegate) issues a decision that 

includes both a denial of the hearing and a notice of disqualification. 

d

Prior to rendering a decision, the Commissioner (or the Commissioner’s delegate) may, on his or her 

own initiative or at the request of the clinical investigator or center, review a decision by the presiding 

officer to deny a hearing, or to deny review of a particular issue during a hearing, because there is no 

genuine and substantial issue of fact to be resolved. 

Page 14 GAO-09-807 FDA Oversight of Clinical Investigators
If the clinical investigator provides a timely explanation in response to a 

NIDPOE letter in a written response or in an informal conference, the 

investigator’s explanation is evaluated by the FDA center (CDER for 

drugs, CBER for biologics, or CDRH for devices) that initiated the 

disqualification proceeding and the center’s legal counsel. To evaluate the 

information presented by the investigator, FDA staff may collect additional 

information (which could include conducting an additional inspection). If 

the center finds the investigator’s explanation for all of the allegations in 

the NIDPOE letter satisfactory, the disqualification proceeding is 

concluded and the investigator is not disqualified. Otherwise, FDA 

provides the investigator with an opportunity for a regulatory hearing to 

show why he or she should not be disqualified by issuing a Notice of 

Opportunity for Hearing (NOOH) letter, which details the allegations of 

misconduct that were included in the NIDPOE letter to which the 

investigator did not provide a satisfactory explanation.26 If the investigator 

requests a hearing, he or she must submit evidence of a genuine and 

substantial issue of fact that would warrant a regulatory hearing. FDA 

evaluates this information and determines whether to grant a hearing or 

not. If the Commissioner determines that there is no genuine and 

substantial issue of fact, then he or she denies the request for a hearing 

and decides whether to disqualify the investigator. If a regulatory hearing 

is held, a presiding officer issues a report with a recommendation to the 

Commissioner, who makes the final decision about whether to disqualify 

the investigator. The presiding officer and Commissioner are assisted by 

FDA attorneys who are not associated with the center that initiated the 

disqualification proceeding. 

Clinical investigators who are disqualified through a Commissioner’s 

decision (without entering into a consent agreement) are disqualified from 

receiving either investigational drugs and biologics or investigational 

devices, depending on the type of product with which the misconduct was 

associated. For those investigators who are disqualified through a consent 

agreement, because the investigator may negotiate the terms of 

disqualification with FDA, the terms of such consent agreements vary and 

 

26Regulatory hearings conducted in the course of disqualification proceedings are 

conducted under part 16, Title 21, Code of Federal Regulations (2009). 

Page 15 GAO-09-807 FDA Oversight of Clinical Investigators
may include restrictions on the investigator’s research activities.27 For 

example, the negotiated consent agreement might allow the individual to 

continue as a clinical investigator, but limit the number of clinical trials in 

which the investigator can participate at any one time. Disqualification 

does not preclude serving as a sub-investigator or study coordinator 

unless the terms of the consent agreement include such restrictions. 

Clinical investigators who have been disqualified may apply to be 

reinstated as eligible to again receive investigational medical products. If 

disqualification was through a Commissioner’s decision, disqualification is 

permanent unless the clinical investigator requests reinstatement, and the 

Commissioner determines that the investigator has presented adequate 

assurances that the investigator will use investigational medical products 

in compliance with pertinent FDA regulations.28 If the investigator’s 

disqualification was based on a consent agreement that restricted the 

investigator’s activities for a specified period of time, reinstatement 

requires FDA’s determination that the investigator met the terms of the 

consent agreement. 

For additional information about debarment and disqualification, see 

appendix II. 

 

27For the purposes of this report, we consider agreements that restrict clinical 

investigators’ activities as a form of disqualification and we treat attempts to negotiate the 

terms of a consent agreement as a form of contesting disqualification. In determining 

whether to agree to restrictions to a clinical investigator’s activities, FDA officials told us 

that they consider what will best ensure the protection of clinical trial participants and the 

integrity of the resulting data. 

2821 C.F.R. §§ 312.70(f), 812.119(f) (2008). 

Page 16 GAO-09-807 FDA Oversight of Clinical Investigators
More than half of the debarment proceedings we reviewed took 4 or more 

years, and permissive proceedings generally took longer than mandatory 

proceedings. Factors such as internal control weaknesses and competing 

priorities were associated with longer proceedings. The agency has made 

or plans to make changes to its debarment policies and procedures that 

may improve the timeliness of debarment proceedings, but the effect of 

these changes remains to be seen. 

More than Half of 

Debarment 

Proceedings Took 4 or 

More Years, and Type 

of Debarment 

Pursued, Internal 

Control Weaknesses, 

and Competing 

Priorities Contributed 

to Longer 

Proceedings 

More than Half of 

Debarment Proceedings 

Took 4 or More Years 

The 18 debarment proceedings we reviewed took from just over 1 year to 

more than a decade, with more than half taking 4 or more years.29 Of 

these 18 debarment proceedings—which were all of the proceedings 

FDA pursued or considered pursuing against clinical investigators, 

sub-investigators, and study coordinators since FDA obtained debarment 

authority in 1992—FDA completed 11 proceedings as of November 5, 2008. 

As shown in figure 3, the length of time to complete these 11 debarment 

proceedings—from an individual’s conviction through the publication of a 

debarment order in the Federal Register30—ranged from just over 1 year to 

 

29See app. III for additional information about the debarment proceedings we reviewed and 

app. IV for information about the misconduct cited in proposal to debar letters. 

30For two proceedings in which the individual’s conviction occurred before FDA received 

debarment authority, we calculated the length of time from the date when FDA received 

debarment authority—May 13, 1992. 

Page 17 GAO-09-807 FDA Oversight of Clinical Investigators
just over 6 years, with a median of 4.4 years.31 In addition to these 11 

completed proceedings, FDA was pursuing or considering pursuing 

debarment for 7 clinical investigators and study coordinators. The length 

of time taken for these seven pending debarment proceedings—from an 

individual’s conviction through the last day of our file review—ranged 

from just over 1 year to nearly 11 years, with a median of 3.3 years.32

 

31In one completed debarment proceeding that involved a study coordinator, FDA 

rescinded a debarment order after the agency learned that it had sent the proposal to debar 

letter to a different person with the same name as the study coordinator. By the time that 

FDA learned that the proposal to debar letter had been sent to the wrong person, the 

agency had already published a debarment order and just over 5 years had elapsed from the 

date of the study coordinator’s conviction. By law, FDA has 5 years from the date of an 

individual’s conviction to initiate a debarment action, and FDA initiates actions by notifying 

the individual of the proposed debarment. After considering the possibility of re-issuing a 

proposal to debar letter to the correct individual, FDA chose not to pursue debarment 

against the correct individual and rescinded the published debarment order. In our 

analysis, we treated this proceeding as completed and calculated that it took about 5 years 

from conviction to FDA’s publication of the debarment order. 

32After we completed our review of FDA’s debarment files, FDA debarred the individuals 

involved in five of the seven pending debarment proceedings. As of September 1, 2009, two 

of the debarment proceedings in our review remained pending. 

Page 18 GAO-09-807 FDA Oversight of Clinical Investigators
Figure 3: Time Taken for Completed and Pending Debarment Proceedings 

9%

18%

18%

55%

14%

29% 29%

29%

6+ years (1)

0-2 years (2)

2-4 years (2)

4-6 years (6)

6+ years (2)

0-2 years (2)

2-4 years (2)

4-6 years (1)

Source: GAO analysis.

Completed debarment proceedings (11 proceedings) Pending debarment proceedings (7 proceedings)

Notes: This figure presents, for clinical investigators, sub-investigators, and study coordinators, the 

length of time from conviction to completion for the 11 completed debarment proceedings and the 

length of time from conviction to November 5, 2008, for the 7 pending debarment proceedings. For 

two completed proceedings, the length of time was measured from the date when FDA received 

debarment authority (May 13, 1992) to completion because the clinical investigator was convicted 

before FDA received debarment authority. None of the debarment proceedings we reviewed took 

exactly 2 years or any exact multiple of 2 years to complete. Numbers of proceedings are shown in 

parentheses. Percentages for pending debarment proceedings do not add up to 100 percent due to 

rounding. 

Debarment Proceedings 

Generally Took Longer If 

They Involved Permissive 

Debarment or If the 

Individual Contested 

Debarment 

We found that permissive debarment proceedings generally took longer 

than mandatory proceedings. Of the 11 completed debarment proceedings, 

5 were permissive debarment proceedings that took 4 or more years from 

conviction to debarment, with a median of 5.0 years. In contrast, six 

completed mandatory debarment proceedings took from just over 1 year 

to just over 6 years from conviction to debarment, with a median of 

3.1 years. As shown in figure 4, the greatest difference between permissive 

and mandatory debarments was in the time it took to draft the proposal to 

Page 19 GAO-09-807 FDA Oversight of Clinical Investigators
debar letter. For each permissive proceeding, FDA took more than 2 years 

from when the agency began drafting the proposal to debar letter to 

issuance of the proposal; for each of the five mandatory proceedings for 

which FDA recorded the date on which it began drafting the proposal to 

debar letter, this step took less than 9 months.33

 

33FDA’s file for one proceeding involving mandatory debarment did not indicate when FDA 

began drafting the proposal to debar letter. 

Page 20 GAO-09-807 FDA Oversight of Clinical Investigators
Figure 4: Lengths of Time for the 11 Completed Debarment Proceedings by Type of 

Debarment 

0 1 2 3 4 5 6 7

E

D

C

B

A

Ka

J

I

H

G

Fa

Permissive proceedings

Mandatory proceedings

Years

Source: GAO analysis.

Conviction to initial draft of proposal to debar letter

Initial draft of proposal to debar letter to issuance of proposal to debar letter

Issuance of proposal to debar letter to debarment order

2.2

2.6

2.8

2.8

2.8

0.2

0.3

0.4

<1.2b

0.7

0.1

Page 21 GAO-09-807 FDA Oversight of Clinical Investigators
Notes: Proceedings A through E represent five completed permissive debarment proceedings and 

proceedings F through K represent six completed mandatory debarment proceedings for clinical 

investigators, study coordinators, and a sub-investigator. For each proceeding, the amount of time 

taken (in years) from FDA’s initial draft of the proposal to debar letter to issuance of the letter is 

presented. 

a

The date on which FDA received debarment authority, May 13, 1992, was used instead of the 

conviction date to calculate the length of time from conviction to the initial draft of the proposal to 

debar letter because the individual was convicted prior to May 13, 1992. 

b

FDA’s file for this proceeding did not indicate when FDA began drafting the proposal to debar letter. 

FDA took 1.2 years from conviction to FDA’s issuance of the proposal to debar letter, so the time that 

elapsed from FDA’s initial draft of the proposal to debar letter to issuance of the letter was less than 

1.2 years. 

According to FDA officials, the difference in the times taken between 

permissive and mandatory proceedings, including the difference in the 

times taken to draft proposal to debar letters, reflects the complexity of 

the statute and necessary analysis, including deciding the period of 

permissive debarment. FDA officials told us that the statutory standard for 

permissive debarment is more complex than the statutory standard for 

mandatory debarment, and that it may take more time to determine how a 

situation involving misconduct relates to the statutory standard for 

permissive debarment. They told us that the need to conduct an extensive 

analysis of a state felony conviction to determine which counts could 

provide a basis for permissive debarment was one factor that contributed 

to the time that elapsed between FDA’s initial drafting of the proposal to 

debar letter and the date on which the letter was issued in two permissive 

debarment proceedings. In one of the proceedings, just over 2.5 years 

elapsed between the initial draft of the proposal to debar letter and the 

date on which it was issued, and in the other proceeding, which was still 

pending as of the last date of our file review, nearly 3 years elapsed. 

We also found that debarment proceedings in which the individual 

contested debarment generally took longer to complete.34 Five of the 18 

proceedings we reviewed involved individuals who responded to FDA’s 

proposal to debar letter by requesting a formal hearing to contest 

debarment. These proceedings took from 6 months to about 6 years, with a 

median of 2.2 years, from FDA’s issuance of a proposal to debar letter to 

 

34Although 5 of the 18 proceedings we reviewed involved individuals who contested 

debarment by requesting a formal hearing, FDA officials informed us that the agency has 

never granted a formal hearing in a debarment proceeding because no one has provided 

evidence demonstrating that there were disputed issues of material fact. 

Page 22 GAO-09-807 FDA Oversight of Clinical Investigators
debarment.35 In contrast, there were nine debarment proceedings in which 

the individual received a proposal to debar letter, but did not contest 

debarment. These took from nearly 6 months to 1.5 years, with a median of 

9.6 months—about one-third of the time taken for the proceedings in 

which the individual requested a hearing—from FDA’s issuance of a 

proposal to debar letter to debarment.36 For example, in one proceeding 

that took just over 6 years from conviction to debarment, the clinical 

investigator contested debarment by submitting a hearing request in which 

the individual raised constitutional arguments about FDA’s proposal to 

debar. In that proceeding, it took more than 5 years and 4 months for FDA 

to complete the proceeding after the individual submitted the hearing 

request. According to FDA officials, the need to evaluate these legal 

arguments contributed to the delay. 

Internal Control 

Weaknesses and 

Competing Priorities 

Contributed to Longer 

Debarment Proceedings 

FDA identified several factors that contributed to the length of time taken 

to complete the debarment proceedings we reviewed. These factors 

included a lack of systematic procedures to help ensure timely 

communication of information relevant to debarment (such as conviction 

information) and a lack of policies and procedures that established time 

frames for debarment actions. These factors are related to weaknesses in 

FDA’s internal controls for debarment proceedings. In addition, for almost 

all of the proceedings, FDA cited limited resources due to competing 

priorities as a factor that contributed to the length of time taken to 

complete the proceedings. 

FDA did not have systematic procedures for ensuring timely 

communication of relevant information about individuals who were 

convicted of crimes that could serve as the basis for debarment. Internal 

control standards specify that information should be communicated to 

those who need it in a form and within a time frame that enables them to 

carry out their operational responsibilities. FDA, however, did not have 

systematic procedures for ensuring timely communication of information 

 

35One of the five proceedings in which the individual received a proposal to debar letter and 

requested a hearing was pending as of the last date of our file review. For this pending 

proceeding, the time that elapsed was calculated from the date on which FDA issued the 

proposal to debar letter to the last date of our file review. 

36Two of the nine proceedings in which the individual received a proposal to debar letter 

and did not request a hearing were pending as of the last date of our file review. For these 

pending proceedings, the time that elapsed was calculated from the date on which FDA 

issued the proposal to debar letter to the last date of our file review. 

Page 23 GAO-09-807 FDA Oversight of Clinical Investigators
that could be relevant to debarment and the informal procedures for 

communicating such information were not effective. FDA officials told us 

that communication between the center staff responsible for debarment 

and other FDA staff having information on convictions that might serve as 

a basis for debarment occurred on an informal basis (for example, by 

sending an e-mail a few times a year to other FDA staff) and that such 

communication may not have been sufficient for obtaining relevant 

information in a timely manner. For example, FDA officials told us that the 

CDER staff responsible for debarment did not learn of one clinical 

investigator’s December 2003 conviction (through a plea agreement) for 

submitting a fraudulent medical license to a sponsor (that subsequently 

submitted it to FDA) until August 2007, about 3 years and 9 months after 

the conviction. Other FDA staff, however, were aware of the investigator’s 

conviction in 2003. The Office of Criminal Investigations had been 

involved in the investigator’s conviction. In addition, as a part of the plea 

agreement, CDER entered into a consent agreement in which the 

investigator agreed to be disqualified from receiving investigational drugs 

and biologics (and other products).37 When asked to explain why the staff 

responsible for debarment learned of the conviction years after other FDA 

staff, FDA officials said that there may have been confusion about which 

CDER staff should obtain conviction information and that such confusion 

may have contributed to this delay. After we completed our file review, 

FDA issued a proposal to debar letter to the investigator on November 26, 

2008, about 1 year and 3 months after CDER staff responsible for 

debarment learned of the conviction, and published a debarment order in 

the Federal Register on June 12, 2009. Although the investigator, who was 

not incarcerated, was disqualified from serving as a clinical investigator 

for drugs, biologics, devices, and other FDA-regulated products, the 

investigator was not prohibited by FDA from being involved in research in 

any other capacity (for example, as a sub-investigator or study 

coordinator) until the investigator was debarred in June 2009. 

FDA officials involved with debarment told us that debarment proceedings 

were also delayed because FDA did not have established time frames for 

its completion of its actions in debarment proceedings. Implementation of 

appropriate policies and procedures to mitigate risks (such as the risk 

associated with failure to debar someone in a timely way) is one element 

of establishing appropriate internal controls. The only time frame related 

 

37The consent agreement was signed by the investigator in September 2003 and by a CDER 

official in May 2004. 

Page 24 GAO-09-807 FDA Oversight of Clinical Investigators
to FDA’s completion of any action involved in a debarment proceeding at 

the time of our file review was the statutory limit requiring that a 

debarment action be initiated within 5 years of a date of conviction.38 As a 

result, FDA officials lacked common expectations about how long 

completion of specific actions should take, expectations that would 

establish a basis for them to elevate concerns if actions were not 

completed in a timely manner. For example, if center staff became 

concerned about the length of time the Office of the Chief Counsel was 

taking to review a draft proposal to debar letter, they had no written time 

frames against which to compare the time taken, and no clearly 

established basis for elevating their concern about the time taken to 

facilitate completion of that review. 

In addition to factors related to internal control weaknesses, FDA officials 

told us that limited resources for debarment actions due to competing 

priorities contributed to the length of time taken for debarment 

proceedings. For 14 of the 18 proceedings we reviewed, FDA officials told 

us that the proceeding was delayed because of competing priorities. For 

example, they said that the officials responsible for drafting the proposal 

to debar letters had other responsibilities, including drafting regulations 

and responding to citizen petitions. They also said that the Office of the 

Chief Counsel’s review of key documents, such as debarment orders, was 

delayed because of competing responsibilities, such as participating in 

litigation. FDA officials told us that competing priorities in CDER or the 

Office of the Chief Counsel likely contributed to several gaps of time with 

no recorded activity in its longest debarment proceeding involving a 

clinical investigator. The investigator was convicted of 53 counts of 

criminal offenses under state law in December 1997 for misconduct that 

included bribing an employee to conceal information about the attempted 

suicide of a clinical trial participant and prescribing a controlled substance 

without a license. This proceeding included a period of more than 4 years 

and 8 months in which our review of FDA’s files revealed no documented 

activity. This proceeding was still pending in November 2008—nearly 

11 years after the investigator was convicted and nearly 6 years after he 

was released from prison in 2003.39 As a result, FDA had not debarred the 

investigator (which would have prohibited the investigator from 

 

3821 U.S.C. § 335a(l)(2). 

39We found that about 5 years elapsed between the individual’s conviction and FDA’s 

issuance of the proposal to debar letter and about 6 years had elapsed between FDA’s 

issuance of the proposal to debar letter and the last day of our file review. 

Page 25 GAO-09-807 FDA Oversight of Clinical Investigators
involvement with any entity that that has an approved or pending 

application for drugs or biologics) since his release from prison.40

FDA Has Recently Made or 

Planned Changes to Its 

Debarment Policies and 

Procedures That Could 

Improve Timeliness 

FDA has recently made changes to its debarment policies and procedures 

that could improve the timeliness of both permissive and mandatory 

debarment proceedings. In the spring of 2008, recognizing the need to 

improve FDA’s debarment process, including the timeliness of debarment 

proceedings, FDA established the Debarment Working Group to examine 

its debarment procedures and identify ways to improve them. As a result 

of that effort, FDA took steps to strengthen its internal controls by issuing 

a new staff manual guide in March 2009 and new standard operating 

procedures in April 2009.41 The staff manual guide establishes systematic 

procedures for timely communication of relevant information and time 

frames for completion of its actions in debarment proceedings. The 

changes in FDA’s debarment policies and procedures include the 

following: 

• FDA established systematic procedures to facilitate timely communication 

of information about potentially relevant convictions. Under the new staff 

manual guide, the Office of Enforcement is responsible for establishing 

procedures in cooperation with other relevant FDA components, including 

 

40FDA disqualified this clinical investigator through a consent agreement as required by the 

investigator’s plea agreement. Although the individual was disqualified in February 1999 

from receiving investigational drugs and biologics as a clinical investigator and from 

serving as a sub-investigator or an assistant in the clinical segment of a clinical study 

involving investigational drugs or biologics, this disqualification does not prevent him from 

participating in clinical research in some other capacity. 

41FDA has also taken other actions to improve its procedures related to debarment 

proceedings. After we found that FDA’s public debarment list—the list available on FDA’s 

Web site that is used by individuals or corporations that have an approved or pending drug 

application and others to identify individuals who have been debarred by FDA—contained 

a misspelling of the name of an individual who was debarred on July 26, 1993, the Office of 

Enforcement established new procedures to improve its process for approving and 

publishing debarment information on FDA’s Web site in October 2008. During the time that 

the debarred individual’s name was misspelled on the Web site, if an individual or 

corporation that had an approved or pending drug application searched the list for the 

debarred individual’s name, they would not have found a match and would not have 

learned of his debarment. After we notified FDA officials of the misspelling, FDA officials 

said that FDA corrected the spelling on the Web site on September 22, 2008. In January 

2009, FDA officials informed us that they had no indication that this debarred individual 

has worked in a position that would violate the terms of debarment and they had no plans 

to investigate his employment. FDA’s new procedures for approving and publishing FDA’s 

public debarment list on FDA’s Web site include procedures for periodically assessing the 

accuracy of published information. 

Page 26 GAO-09-807 FDA Oversight of Clinical Investigators
the Office of Criminal Investigations, and with the Department of Justice 

to facilitate the communication of information about convictions and 

misconduct relevant to debarment more systematically. The official in the 

Office of Enforcement who will oversee implementation of the new staff 

manual guide policies and procedures told us in April 2009 that the Office 

of Enforcement had put in place procedures to obtain conviction 

information from the Office of Criminal Investigations and the Department 

of Justice. Furthermore, according to the staff manual guide, the Office of 

Criminal Investigations is to provide quarterly reports to the Office of 

Enforcement that include all convictions occurring within the preceding 

3 months that may serve as a basis for debarment. The Office of 

Enforcement official told us that the quarterly reports from the Office of 

Criminal Investigations are to cover those convictions in which the Office 

of Criminal Investigations was involved and sentencing has occurred. In 

addition, the staff manual guide states that all FDA employees are 

responsible for informing the Office of Enforcement as soon as possible 

when they become aware of any individuals who may be subject to 

debarment. FDA officials said that after the staff manual guide was 

finalized and published, the Office of Enforcement announced this 

requirement to FDA employees. They also said that the Office of 

Enforcement may further formalize this requirement in FDA’s regulatory 

procedures manual. 

• FDA established time frames for completing debarment actions. The new 

staff manual guide for debarment establishes new policies and procedures 

that include time frames to help ensure faster completion of debarment 

proceedings.42 For example, the staff manual guide states that FDA is to 

complete a debarment proceeding in which an individual fails to respond 

to a proposal to debar letter within 350 calendar days of the individual’s 

 

42The staff manual guide specifies that the time frames will not become effective until FDA 

clears an initial backlog of potential debarment proceedings. FDA officials, including the 

official in the Office of Enforcement responsible for leading that office’s efforts to identify 

relevant convictions and initiate debarment proceedings, told us that as of June 2009 they 

had received information from the Office of Criminal Investigations and had identified 

more than 1,600 individuals with potentially relevant convictions. FDA officials said, 

however, that they had not yet identified the roles of the individuals or determined whether 

their convictions provide a basis for debarment. They said that pursuing debarment for 

individuals with convictions involving misconduct with a clear impact on the drug or 

biologic approval process or who are working for a company that has submitted a drug or 

biologic application to FDA will be the Office of Enforcement’s highest priority and that 

they estimate clearing the backlog of such individuals within 6 months using the time 

frames set forth in the staff manual guide. FDA officials said that the estimate is based on a 

number of factors, including the availability of a staff member to work exclusively on 

debarment proceedings. 

Page 27 GAO-09-807 FDA Oversight of Clinical Investigators
conviction. Although there are no consequences specified in the staff 

manual guide for failing to meet the new time frames, FDA officials said 

that they believe that drawing attention to time frames will help ensure 

more timely debarment proceedings and provide a basis for action to 

expedite them. In addition, the staff manual guide reassigns 

responsibilities for debarment proceedings that had belonged to CBER 

and CDER to the Office of Enforcement. Since March 2009, the Office of 

Enforcement’s responsibilities include (among other things) determining 

whether to initiate debarment actions, preparing and issuing proposal to 

debar letters, consulting with CDER and CBER to determine whether to 

pursue permissive debarment, working with officials from the Office of the 

Chief Counsel on legal matters, and preparing and issuing debarment 

orders (when a hearing request is not involved). The official in the Office 

of Enforcement who will oversee implementation of the new staff manual 

guide policies and procedures said that the establishment of time frames 

for debarment actions provides a basis for the Office of Enforcement to 

elevate any concerns that arise about the times taken and facilitate 

completion of those actions. This official said that this office will, for 

example, monitor the amount of time being taken by the Office of the 

Chief Counsel to review a draft proposal to debar letter to help ensure that 

the Office of the Chief Counsel is meeting the time frame (30 days) 

specified in the new staff manual guide for reviewing such documents. If 

the time frame is not met, the Office of Enforcement official plans to use 

the staff manual guide as a basis for raising the issue to other appropriate 

officials. 

FDA officials said that they are planning other changes to FDA’s 

debarment policies and procedures. They said that the Office of 

Enforcement is considering additional changes in standard operating 

procedures. In addition, to help implement the new policies and 

procedures, the official in the Office of Enforcement who will oversee 

their implementation said that the office plans to employ a full-time staff 

member whose primary responsibility will be to work on debarment 

proceedings. According to the new standard operating procedures, the 

staff member’s responsibilities will include obtaining conviction 

information, gathering information to help determine whether to pursue 

debarment, and coordinating the issuance of proposal to debar letters. 

FDA’s changes or planned changes in its debarment policies and 

procedures—including the steps taken to strengthen internal controls—

could reduce the length of time taken to complete debarment proceedings, 

but the effects of these changes remain to be seen. Meeting the time 

frames will require FDA to complete the debarment process in a 

Page 28 GAO-09-807 FDA Oversight of Clinical Investigators
significantly shorter length of time than it took to complete the process in 

the debarment proceedings we reviewed. For example, the new time frame 

to complete a debarment proceeding in which an individual fails to 

respond to a proposal to debar letter is 350 calendar days from an 

individual’s conviction. However, FDA took longer than 350 calendar days 

from conviction to debarment in all 7 completed proceedings in our review 

that did not include a hearing request, with 5 of the proceedings taking 

more than 4 years. In addition, it remains to be seen whether FDA will be 

able to focus or add to its limited resources on debarment proceedings. 

For example, although the official in the Office of Enforcement who will 

oversee implementation of the new staff manual guide policies and 

procedures told us that they plan to employ a full-time staff member 

whose primary responsibility will be to work on debarment proceedings, 

as of June 2009 the permanent position had not yet been filled.43 Finally, it 

is not yet clear whether the Office of the Chief Counsel will have sufficient 

resources available for assisting with debarment proceedings in a timely 

manner. An official in the Office of the Chief Counsel said that they did not 

expect any changes to the Office of the Chief Counsel’s resources, unless 

the number of debarment proceedings increases substantially. According 

to FDA, the Office of the Chief Counsel regularly evaluates its resource 

needs and any significant increases in the number of debarments will be 

factored into those evaluations. 

 

43According to the official in the Office of Enforcement who will oversee implementation of 

the new staff manual guide policies and procedures, the Office of Enforcement received 

clearance to fill this position in August 2009, but FDA had not filled the position as of 

September 1, 2009. While waiting for clearance of that announcement, FDA announced a 

temporary opening for an FDA employee to assume debarment-related responsibilities. 

This official told us that an FDA employee began acting in this temporary position in June 

2009. 

Page 29 GAO-09-807 FDA Oversight of Clinical Investigators
The times taken for the disqualification proceedings we reviewed varied 

widely and were longer when the clinical investigator contested 

disqualification. Factors such as a lack of established time frames (an 

internal control weakness) and competing priorities may have contributed 

to the length of time taken to complete disqualification proceedings. The 

agency has made changes to its disqualification procedures that may 

improve the timeliness of disqualification proceedings, but the full effect 

of these changes remains to be seen. 

Times Taken for 

Disqualification 

Proceedings Varied 

and Factors Such as 

Clinical Investigators’ 

Contesting 

Disqualification and 

Internal Control 

Weaknesses May 

Have Contributed to 

Longer Proceedings 

About One-Third of 

Disqualification 

Proceedings Took 2 or 

More Years and 

Proceedings Were 

Completed More Quickly 

Over Time 

The disqualification proceedings we reviewed varied widely in the time 

taken, with about one-third of the proceedings taking 2 or more years (see 

fig. 5).44 Of the 52 proceedings we reviewed—which included all of the 

disqualification proceedings FDA initiated with a NIDPOE letter from 

January 1, 1998, through September 9, 2008—FDA completed 47 

disqualification proceedings as of November 5, 2008. The length of time to 

complete these 47 disqualification proceedings—from issuance of a 

NIDPOE letter through disqualification or an FDA decision to terminate 

the proceeding—ranged from 26 days to more than 10 years, with a 

median of 1.1 years. In addition to these 47 completed proceedings, FDA 

initiated, but had not completed, 5 disqualification proceedings. The time 

taken for these 5 pending proceedings—from issuance of a NIDPOE letter 

through the last date of our file review—ranged from 70 days to more than 

7 years and 4 months, with a median of 2.5 years.45

 

44See app. V for additional information about the disqualification proceedings we reviewed 

and app. VI for information about the allegations of misconduct included in the NIDPOE 

letters used to initiate these disqualification proceedings. 

45We defined a disqualification proceeding as pending if, as of the last date of our file 

review (Nov. 5, 2008), FDA had issued a NIDPOE letter, but had not concluded the 

disqualification proceeding. After we completed our review of FDA’s disqualification files, 

FDA disqualified the clinical investigators involved in three of the five pending 

disqualification proceedings. As of September 1, 2009, two of the disqualification 

proceedings in our review remained pending. 

Page 30 GAO-09-807 FDA Oversight of Clinical Investigators
Figure 5: Time Taken for Completed and Pending Disqualification Proceedings 

20%

40%

Source: GAO analysis.

20%

6-8 years (1)

4-6 years (1)

2-4 years (1)

0-2 years (2)

11%

17% 66%

2%

10+ years (1)

2%

8-10 years (1)

2%

6-8 years (1)

4-6 years (5)

2-4 years (8)

0-2 years (31)

20%

Completed disqualification proceedings (47 proceedings) Pending disqualification proceedings (5 proceedings)

Notes: This figure presents the length of time from issuance of the NIDPOE letter to completion for 47 

completed disqualification proceedings (45 that ended in disqualification and 2 that did not) and the 

length of time from issuance of the NIDPOE letter to November 5, 2008, for 5 pending disqualification 

proceedings. All of these proceedings were initiated by a NIDPOE letter between January 1, 1998, 

and September 9, 2008. Numbers of proceedings are shown in parentheses. None of the 

disqualification proceedings we reviewed took exactly 2 years or any exact multiple of 2 years to 

complete. 

We also found that FDA’s disqualification proceedings initiated by a 

NIDPOE letter in 1998 through 2001 generally took longer to complete 

than proceedings that were initiated more recently (see fig. 6, which also 

shows pending proceedings). Completed proceedings initiated in 1998 

through 2001 took from just over 3 months to more than 10 years, with a 

median of 2.8 years. Completed proceedings initiated in 2002 through 2005 

took from just over 1 month to more than 4 years and 8 months, with a 

median of 0.9 years. Completed proceedings initiated in 2006 through 2008 

took from nearly 1 month to about 2 years, with a median of 0.5 years. 

Page 31 GAO-09-807 FDA Oversight of Clinical Investigators
Figure 6: Time Taken for Disqualification Proceedings Initiated in 1998 through 2001, 2002 through 2005, and 2006 through 

2008

6%

Pending (1)

17%

28%

Source: GAO analysis.

11%

6%

6-8 years (1)

4-6 years (3)

0-2 years (5)

2-4 years (6)

8+ years (2)

33%

81%

19%

Pending (3)

6%

Pending (1)

72%

11%

11%

0-2 years (13)

4-6 years (2)

2-4 years (2)

0-2 years

(13)

1998 through 2001 (18 proceedings) 2002 through 2005 (18 proceedings) 2006 through 2008 (16 proceedings)

Notes: This figure presents the length of time from issuance of the NIDPOE letter to completion of the 

proceeding (if completed as of Nov. 5, 2008) or pending status (if pending as of Nov. 5, 2008) for 18 

disqualification proceedings initiated by a NIDPOE letter in 1998 through 2001, 18 disqualification 

proceedings initiated by a NIDPOE letter in 2002 through 2005, and 16 disqualification proceedings 

initiated by a NIDPOE letter from January 1, 2006, through September 9, 2008. None of the 

disqualification proceedings we reviewed took exactly 2 years or any exact multiple of 2 years to 

complete. Numbers of proceedings are shown in parentheses. Percentages do not always add up to 

100 due to rounding. 

Factors Associated with 

Longer Disqualification 

Proceedings Included 

Whether the Clinical 

Investigator Contested 

Disqualification and 

Ongoing Criminal Cases 

Factors associated with longer disqualification proceedings included 

whether the clinical investigator contested disqualification and ongoing 

criminal cases. 

The more steps taken by the clinical investigator to contest 

disqualification, the longer it generally took to complete the proceeding 

(see fig. 7). As examples, disqualification proceedings generally took 

longer if the investigator contested disqualification by responding to the 

NIDPOE letter in a written response or informal conference, contested the 

terms of disqualification by attempting to negotiate the terms of a consent 

Page 32 GAO-09-807 FDA Oversight of Clinical Investigators
agreement, or contested disqualification by requesting a hearing.46 The two 

disqualification proceedings in our review in which FDA found the 

investigator’s explanation satisfactory and did not disqualify the individual 

were concluded relatively quickly. 

 

46In one proceeding for which the clinical investigator requested a hearing, the investigator 

was prohibited from receiving investigational drugs, biologics, devices, and other 

FDA-regulated products as part of a plea agreement in a criminal proceeding. This 

investigator entered the plea agreement after an FDA hearing had begun and FDA 

continued the disqualification proceeding. FDA officials told us that they concluded that 

the terms of the plea agreement would not be enforceable after about 3 years. The 

presiding officer recommended disqualification, and the investigator requested a 

Commissioner’s review. Just over 5 years after the investigator requested a Commissioner’s 

review—9.5 years after issuance of the NIDPOE letter—FDA completed this 

disqualification proceeding with a Commissioner’s decision to disqualify the investigator. 

We calculated the length of time this disqualification proceeding took from issuance of the 

NIDPOE letter to the date of the Commissioner’s disqualification decision. 

Page 33 GAO-09-807 FDA Oversight of Clinical Investigators
Figure 7: Time Taken to Complete Disqualification Proceedings 

Source: GAO.

Minimum

Median

Maximum

The clinical investigator

did not submit a written response 

or participate in an informal conference

did submit a written response 

or participate in an informal conference

and FDA found 

the investigator’s

explanation 

satisfactory

and entered a

consent agreement without 

attempting to 

negotiate its terms

and FDA did not find the 

investigator’s explanation 

satisfactory and issued a notice 

of opportunity for hearing.

The clinical investigator then:

and entered a

consent agreement after

attempting to 

negotiate its terms

and entered a

consent agreement without

attempting to 

negotiate its terms

and entered a

consent agreement after 

attempting to 

negotiate its terms

entered a

consent 

agreementa

did not 

request

a hearing 

and was

disqualifiedb

did

request

a hearing 

that was

granted or 

deniedc

(N=5) (N=6) (N=5)

(N=5) (N=3) (N=2) (N=3) (N=18)

Years

0

2

4

6

8

10

12

Notes: Data are for 47 disqualification proceedings initiated by a NIDPOE letter between January 1, 

1998, and September 9, 2008, and completed as of November 5, 2008. There was one 

disqualification proceeding in which FDA issued a Notice of Opportunity for Hearing to a clinical 

investigator who had not presented information in writing or participated in an informal conference; 

this proceeding is included among the five proceedings in which a hearing was requested and either 

granted or denied. 

Page 34 GAO-09-807 FDA Oversight of Clinical Investigators
a

These five proceedings involved two investigators who entered into a consent agreement with FDA 

without requesting a hearing and three investigators who entered into a consent agreement after 

requesting a hearing but before FDA either denied or granted the request for a hearing. 

b

These six proceedings involved investigators who did not request a hearing and were disqualified by 

a Commissioner’s decision. 

c

These five proceedings included one investigator whose request for a hearing was denied and who 

was disqualified by a Commissioner’s decision. Also included are four investigators whose requests 

for a hearing were granted. After one investigator’s hearing request was granted, the investigator 

agreed to restrictions on his research activities as part of a settlement agreement negotiated with the 

Department of Justice on behalf of FDA and other components of the Department of Health and 

Human Services. Another investigator entered into a consent agreement with FDA after the hearing 

was completed, but before the Commissioner reached a decision. The other two investigators whose 

requests for a hearing were granted were disqualified by a Commissioner’s decision after completion 

of the hearing; these two cases took 9.5 and 10.2 years, respectively. 

Another factor that contributed to longer proceedings was the suspension 

of disqualification actions during criminal cases related to the misconduct 

of the clinical investigators. For example, two of the five disqualification 

proceedings that were pending when we completed our file review were 

delayed for more than 2 years due to ongoing criminal cases. According to 

FDA officials, disqualification proceedings may be suspended during 

ongoing criminal cases for several reasons. Documents needed to support 

the disqualification proceedings (such as the medical records of clinical 

trial participants or forms prepared to document the conduct of the 

clinical trial) may be unavailable to FDA because they are in the custody 

of the United States Attorney as a result of the criminal investigation. In 

addition, FDA may be involved in negotiations to include, as part of a plea 

agreement, a consent agreement that would disqualify the investigator, 

and the disqualification proceeding may be delayed while conducting 

these negotiations. FDA may also agree to requests made by the clinical 

investigator or his or her legal counsel for additional time to respond to 

the disqualification proceeding so that he or she can focus on the criminal 

investigation. 

Internal Control 

Weaknesses and 

Competing Priorities May 

Have Contributed to 

Longer Disqualification 

Proceedings 

FDA officials told us that several factors contributed or may have 

contributed to the length of time taken to complete the disqualification 

proceedings that we reviewed. These factors included internal control 

weaknesses—specifically, a lack of appropriate policies and procedures to 

help ensure timely completion of disqualification actions by establishing 

time frames. In addition, FDA cited limited resources due to competing 

priorities and changes in personnel as factors associated with longer 

disqualification proceedings. 

Page 35 GAO-09-807 FDA Oversight of Clinical Investigators
FDA told us that a lack of time frames for FDA’s completion of 

disqualification proceedings might have contributed to longer 

proceedings. As with debarment proceedings, FDA officials lacked 

common expectations about how long completion of specific actions 

should take that would establish a basis for them to elevate concerns if 

actions were not completed in a timely manner. For example, if center 

staff became concerned about the length of time the Office of the Chief 

Counsel was taking to review a draft NOOH letter, they had no written 

time frames against which to compare the time taken and no clearly 

established basis for elevating their concern about the time taken to 

facilitate completion of that review. 

In addition to an internal control weakness, FDA told us that limited 

resources in the Office of the Chief Counsel for disqualification actions 

due to competing priorities contributed to the length of time taken to 

complete some disqualification proceedings. For example, FDA told us 

that limited resources and competing priorities contributed to delays in 

one disqualification proceeding, including a delay of about 3 years and 

9 months during which the clinical investigator’s request for a review of 

the presiding officer’s report was pending in FDA’s Offices of the Chief 

Counsel and Commissioner. FDA also told us that limited resources and 

competing demands contributed to a delay of about 1 year and 4 months in 

one proceeding in which the terms of a consent agreement were being 

negotiated and a delay of just over a year in another proceeding in which a 

presiding officer was reviewing arguments for and against holding a 

regulatory hearing. 

Changes in personnel also contributed to the length of time taken to 

complete certain disqualification proceedings. For example, in two 

proceedings we reviewed, regulatory hearings began with presiding 

officers who did not complete the hearings. As a result, new presiding 

officers had to be appointed and become familiar with the arguments of 

the cases, resulting in longer proceedings. In addition, FDA officials said 

that changes in center personnel, and the associated need to train new 

staff, contributed to some of the delays in completing disqualification 

proceedings that were initiated in the late 1990s and early 2000s. 

Page 36 GAO-09-807 FDA Oversight of Clinical Investigators
FDA has taken steps to enhance the timeliness of disqualification 

proceedings by establishing new policies and procedures that include time 

frames for its completion of disqualification actions. Until June 2008, FDA 

did not have time frames for its completion of any of its disqualification 

actions. Recognizing the need to improve the timeliness of its 

disqualification proceedings, FDA issued a new staff manual guide in June 

2008 that established time frames for disqualification actions that follow 

the issuance of a NOOH letter. In January 2009, FDA revised its regulatory 

procedures manual, establishing time frames for disqualification actions 

through and including issuance of a NOOH letter. Although no 

consequences are specified for failing to meet the new time frames, FDA 

officials said that they believe that drawing attention to time frames will 

help them ensure more timely disqualification proceedings and provide a 

basis for action to expedite them. In addition, FDA recently reassigned 

responsibility for monitoring the progress of all disqualification 

proceedings in which a NOOH letter has been issued to the Good Clinical 

Practice Program. The Good Clinical Practice Program began taking 

responsibility for these proceedings in spring of 2008, and hired a staff 

member to help oversee and monitor the disqualification process in June 

2008.47 Centers retain responsibility for initiating disqualification 

proceedings, evaluating responses from the clinical investigator, and 

determining whether to recommend issuance of a NOOH letter. The Good 

Clinical Practice Program is responsible for tracking the progress of all 

disqualification proceedings from issuance of the NIDPOE letter through 

completion and has created a database to do so. FDA officials told us that 

they believe that assigning monitoring responsibilities to the Good Clinical 

Practice Program should help ensure more timely completion of all 

disqualification proceedings. They told us that the establishment of time 

frames for disqualification actions provides a basis for elevating any 

concerns that arise about the time taken for actions and to facilitate 

completion of those actions. 

FDA Has Made Changes to 

Its Disqualification 

Policies and Procedures 

That Could Improve 

Timeliness 

FDA also told us that changes were made in recent years to provide 

additional resources for disqualification proceedings and that these 

changes have improved or will improve the timeliness of proceedings. For 

 

47Responsibility for disqualification proceedings that involved hearings had been assigned 

to the Office of Health Affairs until 1999 and to the Office of the Ombudsman from 1999 

until responsibility was re-assigned to the Good Clinical Practice Program starting in spring 

of 2008. FDA officials told us that they re-assigned these responsibilities to the Good 

Clinical Practice Program because of that office’s broader role within the agency as the 

focal point for issues arising in human research trials regulated by FDA. 

Page 37 GAO-09-807 FDA Oversight of Clinical Investigators
example, the agency told us that CDER has improved the timeliness of the 

center’s actions in disqualification proceedings because, since May 2006, 

additional CDER staff have been available to focus on initiating 

proceedings. In addition, the agency told us that over the past several 

years, the Office of the Chief Counsel increased its resources for drug 

matters, which resulted in an increase of resources for disqualification. 

According to FDA, the increase has enabled the office to handle more 

disqualification proceedings initiated by the centers and to handle more 

expeditiously the drafting and review of Commissioner’s decisions. 

FDA’s changes in its policies and procedures for disqualification—

including the steps taken to strengthen internal controls—could reduce 

the length of time taken to complete disqualification proceedings, but the 

full effect of these changes remain to be seen. Meeting the time frames 

would require FDA to complete some disqualification actions in a 

significantly shorter length of time than it took to complete these actions 

in some of the proceedings we reviewed. For example, the January 2009 

regulatory procedures manual specifies that a NOOH letter should be 

issued within 11 working days of the time the center forwards a 

recommendation to issue it, and we found that at least 13 of the 17 

proceedings we reviewed in which a NOOH letter was issued did not meet 

this time frame; instead, this step took more than 2 months in at least 5 

proceedings. The June 2008 staff manual guide specifies that a presiding 

officer should issue a report within 90 days of a regulatory hearing. None 

of the three proceedings with presiding officer reports that we reviewed 

were issued within 90 days. They were issued after about 14.5 months, 

23 months, and 42 months, respectively.48 In addition, the January 2009 

revisions to the regulatory procedures manual specify that a NIDPOE 

letter should be issued within about 9 and a half months of the inspection 

 

48These three presiding officer’s reports were issued before FDA issued the staff manual 

guide specifying the 90-day time frame for issuance of presiding officer’s reports. 

Page 38 GAO-09-807 FDA Oversight of Clinical Investigators
that revealed misconduct, and about two-thirds of the 52 proceedings we 

reviewed did not meet this time frame.49

FDA’s oversight of clinical investigators, sub-investigators, and study 

coordinators is limited by two aspects of its statutory debarment authority 

and because FDA’s regulations do not extend a clinical investigator’s 

disqualification for investigational drugs and biologics to investigational 

devices and vice versa. 

FDA’s Debarment 

Authority Does Not 

Fully Extend to 

Involvement with 

Devices and 

Regulations Allow 

Disqualified Clinical 

Investigators to 

Conduct Trials for 

Other Investigational 

Medical Products 

FDA’s Debarment 

Authority May Not Permit 

FDA to Address 

Misconduct Related to 

Medical Devices 

FDA’s debarment authority may not permit FDA to address misconduct in 

two significant ways. First, although an individual may have been debarred 

from involvement with drugs and biologics, a debarred individual is not 

necessarily precluded from involvement with FDA-regulated products 

other than drugs and biologics, such as medical devices. For example, in 

one completed debarment proceeding that we reviewed, a study 

coordinator who was involved in drug research was debarred as a result of 

being convicted of a federal felony. This study coordinator admitted 

destroying X-ray film reports and falsifying electrocardiogram results. 

Despite debarment, this individual could still provide services for an entity 

 

49For the disqualification proceedings we reviewed, the length of time from the last day of 

the inspection to issuance of the NIDPOE letter ranged from 23 days to more than 4 years, 

with a median of just over 1 year. In response to recommendations by the Department of 

Health and Human Services’s Office of Inspector General and to help improve the 

efficiency and consistency of its initiation of disqualification proceedings, FDA issued new 

guidance in December 2008 that clarifies the circumstances under which disqualification 

should be considered and specifies procedures for communication between the staff who 

conduct inspections and the staff who are responsible for initiating disqualification 

proceedings. 

Page 39 GAO-09-807 FDA Oversight of Clinical Investigators
that markets or intends to market FDA-regulated products other than 

drugs or biologics, including medical devices. 

Second, an individual may be debarred from involvement with drugs and 

biologics, but not from involvement with medical devices, regardless of 

the kind of misconduct in which the individual engaged. While the statute 

expressly authorizes FDA to debar an individual from involvement with 

drugs and biologics, there is no comparable authority with regard to an 

individual involved with medical devices. For example, one investigator 

who falsely advertised an unapproved investigational laser device for 

treating eye disorders as an FDA-approved device, and who falsified 

information in the medical records of patients treated with the device 

cannot be debarred by FDA from working in the medical device industry.50

A CDRH official told us that he would like FDA to have the authority to 

debar individuals like this investigator. When asked whether the agency 

had pursued obtaining this authority, the agency responded that the Office 

of the Chief Counsel was not aware of any efforts to expand FDA’s 

debarment authority, but did not provide a reason for not requesting this 

authority. 

FDA’s Regulations Allow 

Disqualified Clinical 

Investigators to Conduct 

Trials for Other Medical 

Products 

FDA’s disqualification regulations are included in two separate sets of 

regulations—one for drugs and biologics and another for devices—and 

both sets of regulations limit the types of products to which 

disqualification applies.51 As a result, FDA’s oversight of clinical 

investigators is limited. Under federal regulations, an investigator who is 

disqualified by a Commissioner’s decision for misconduct related to drugs 

or biologics is still able to serve as an investigator for devices, and an 

investigator who is disqualified by a Commissioner’s decision for 

misconduct related to devices is still able to serve as an investigator for 

drugs and biologics. Moreover, an investigator who is disqualified by a 

Commissioner’s decision for misconduct related to drugs, biologics, or 

devices is still able to serve as an investigator for other FDA-regulated 

investigational products, such as animal drugs and food additives. Of the 

nine completed proceedings we reviewed that resulted in disqualification 

by a Commissioner’s decision (instead of a consent agreement), eight 

 

50FDA disqualified this individual from receiving investigational devices as a clinical 

investigator and imposed a civil money penalty on the individual and his company of 

$1.1 million. This individual continued to function as a sponsor of an FDA-regulated device. 

5121 C.F.R. §§ 312.70 (drugs and biologics), 812.119 (devices) (2008). 

Page 40 GAO-09-807 FDA Oversight of Clinical Investigators
investigators were disqualified from receiving investigational drugs and 

biologics, but not devices, and one investigator was disqualified from 

receiving investigational devices, but not drugs or biologics. For example, 

one disqualified investigator (who, among other things, falsely reported 

that investigational vaccines had been administered to infants when they 

had not and failed to report that some clinical trial participants had 

been hospitalized) is prohibited from being a investigator for drugs or 

biologics, but is not disqualified from receiving medical devices or other 

FDA-regulated investigational products, and so can serve as a investigator 

for research on these products should this individual choose to do so.52

Compared to disqualifications that resulted from a Commissioner’s 

decision, FDA has more latitude in determining the consequences of 

disqualification when it results from a consent agreement between FDA 

and the investigator. Of the 35 completed proceedings we reviewed that 

resulted in disqualification through consent agreements,53

• Fifteen consent agreements contained more extensive restrictions by 

disqualifying the investigator from receiving any FDA-regulated 

investigational products (including drugs, biologics, devices, animal drugs, 

and food additives). For example, FDA concluded that one investigator 

failed to obtain required informed consent, failed to document that 

women were not pregnant before being given an investigational drug, and 

submitted false information. This investigator entered into a consent 

agreement with FDA that disqualified him from receiving any 

FDA-regulated investigational products, including drugs and biologics, as 

well as medical devices. If the investigator had been disqualified by a 

Commissioner’s decision, he could not have been disqualified from 

receiving medical devices or FDA-regulated investigational products other 

than drugs and biologics. 

• Nineteen consent agreements contained terms that restricted the 

investigator’s research activities in ways that differed from what would 

have resulted from a Commissioner’s decision. These consent agreements 

 

52See app. V for more information about the products that clinical investigators were 

disqualified from receiving. 

53In addition to disqualifications based on decisions by the Commissioner or consent 

agreements, one clinical investigator agreed to restrictions on his research activities as part 

of a settlement agreement negotiated with the Department of Justice on behalf of the FDA 

and other components of the Department of Health and Human Services. Also, FDA found 

the explanations offered by two clinical investigators satisfactory and concluded their 

disqualification proceedings without disqualification. 

Page 41 GAO-09-807 FDA Oversight of Clinical Investigators
generally allowed the investigator to continue to function as an 

investigator, but imposed certain restrictions on his or her research, for 

example, by restricting the number of studies he or she may engage in at 

any time or the number of participants he or she may enroll in studies. 

Some consent agreements also required the investigator to obtain training 

in the conduct of clinical trials. Unlike disqualification that results from a 

Commissioner’s decision, the consent agreements that specified 

restrictions generally applied to all FDA-regulated investigational products 

(not just drugs and biologics or devices) and were generally not 

permanent. In addition, some consent agreements specified restrictions on 

the individual’s activities as a sub-investigator—activities that are not 

restricted if disqualification results from a Commissioner’s decision. 

• One consent agreement disqualified an investigator from receiving drugs 

and biologics, but not other FDA-regulated investigational products. This 

consent agreement did not specify any other restrictions on the 

investigator’s activities. 

To strengthen FDA’s oversight of clinical investigators, FDA needs to 

ensure the timely completion of its debarments and disqualifications. 

Timely completion of these proceedings is critical to ensuring that 

individuals who have engaged in misconduct are prohibited from repeating 

the misconduct—that is, the actions that compromised the quality or 

integrity of clinical trial data or jeopardized the safety of clinical trial 

participants—and that individuals whose explanations FDA finds to be 

satisfactory can have their proceedings concluded quickly. While FDA’s 

recent changes in policies and organization of responsibilities could 

improve the timeliness of debarment and disqualification proceedings, it is 

too soon to tell whether these efforts will be effective. For example, 

implementing the new time frames that FDA has established for 

debarment and disqualification could be challenging because some of 

these time frames are substantially shorter than the times FDA actually 

took in the proceedings we reviewed. Given the agency’s competing 

priorities, it remains to be seen whether FDA will dedicate sufficient 

resources to debarment or disqualification proceedings to meet the time 

frames. 

Conclusions 

FDA’s authority to debar or disqualify clinical investigators is an important 

component of its oversight of clinical investigators, specifically its efforts 

to protect human subjects and ensure the integrity of the data upon which 

it relies when evaluating new drugs, biologics, or devices for the U.S. 

market. It is critical for FDA to take action—and to have the authority to 

Page 42 GAO-09-807 FDA Oversight of Clinical Investigators
take action—to prevent clinical investigators, sub-investigators, and study 

coordinators who engaged in serious misconduct from doing so again, 

whether in research that involves drugs, biologics, or devices. FDA’s 

current debarment authority does not fully extend to involvement with 

medical devices or prevent those who engaged in misconduct involving 

drugs or biologics from involvement with medical devices. In addition, 

FDA’s disqualification regulations limit a disqualification by a 

Commissioner’s decision to either investigational drugs and biologics or to 

investigational devices, thereby allowing an individual disqualified for 

misconduct related to drugs or biologics to receive investigational devices 

and vice versa. Moreover, a clinical investigator who is disqualified by a 

Commissioner’s decision is still able to serve as a clinical investigator for 

other FDA-regulated investigational products. As a result, FDA’s oversight 

of clinical investigators is limited. 

We recommend that the Commissioner of FDA take the necessary steps to 

complete the following three actions: Recommendations for 

Executive Action • Pursue debarment authority for medical devices that is consistent with the 

current debarment authority for drugs and biologics and prohibit any 

debarred individual from involvement with drugs, biologics, and medical 

devices. 

• Amend FDA regulations to ensure that those who have engaged in 

misconduct found sufficiently serious to warrant disqualification for one 

investigational medical product are not able to continue to serve as 

clinical investigators for any. 

• Monitor compliance with recently established time frames for debarment 

and disqualification proceedings and take appropriate action when those 

are not met. 

We provided a draft of this report to the Department of Health and Human 

Services for review. The department provided written comments from 

FDA. In its comments, FDA agreed with our recommendations. FDA’s 

comments are reprinted in appendix VII. FDA also provided technical 

comments and updated information, which we incorporated as 

appropriate. 

Agency Comments 

Page 43 GAO-09-807 FDA Oversight of Clinical Investigators
In its comments, FDA stated that the agency will endeavor to incorporate 

our recommendations into the agency’s procedures. FDA agreed that 

providing the agency with the debarment authority to prohibit those who 

were convicted of certain crimes or otherwise involved in criminal activity 

from being involved in the medical device industry would benefit the 

development and approval process for medical devices. FDA also agreed 

that if a clinical investigator is disqualified from participating in clinical 

trials involving one type of investigational medical product, it is generally 

appropriate that the investigator be prohibited from participating in 

investigations of any FDA-regulated product. FDA stated that the agency 

intends to pursue revision of its regulations concerning clinical 

investigator disqualification to address this issue. In addition, FDA agreed 

that monitoring its success in meeting the recently established time frames 

for debarment and disqualification will be important as the agency strives 

to improve the timeliness of the debarment and disqualification processes, 

and it summarized steps it has already taken to do so. 

As agreed with your offices, unless you publicly announce the contents of 

this report earlier, we plan no further distribution until 30 days from the 

report date. At that time, we will send copies to the Secretary of Health 

and Human Services, the Commissioner of FDA, relevant congressional 

committees, and interested parties. In addition, this report will be 

available at no charge on the GAO Web site at http://www.gao.gov. 

If you or your staff have any questions concerning 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 

Marcia Crosse 

report are listed in appendix VIII. 

Director, Health Care 

Page 44 GAO-09-807 FDA Oversight of Clinical Investigators
Appendix I: Scope and Methodology Appendix I: Scope and Methodology 

In this report, we examined the Food and Drug Administration’s (FDA) 

time frames for debarment and disqualification proceedings, as well as 

limitations to the agency’s statutory and regulatory authority related to 

these proceedings prior to November 2008. Until June 2008, other than the 

statutory requirement that debarment actions be initiated within 5 years of 

the date of the individual’s conviction, FDA did not have criteria 

establishing time frames for the various steps it must take in debarment or 

disqualification proceedings. During the course of our work, three actions 

occurred that changed FDA’s procedures for debarment and 

disqualification of clinical investigators. 

• In June 2008, FDA issued a staff manual guide that, among other 

provisions, established time frames for the steps it must take after offering 

the clinical investigator an opportunity for a regulatory hearing in a 

disqualification proceeding. 

• In January 2009, FDA issued a revised regulatory procedures manual that, 

among other provisions, established time frames for the steps it must take 

in disqualification proceedings prior to and through offering the clinical 

investigator an opportunity for a regulatory hearing. 

• In March 2009, FDA issued a staff manual guide that, among other 

provisions, established time frames for the steps it must take in debarment 

proceedings. 

At the time of our review, it was too soon to assess the effect of the 

changes in FDA’s procedures and guidance on debarment and 

disqualification proceedings. Consequently, this report focuses on FDA’s 

procedures as documented in proceedings that generally took place prior 

to issuance of the new time frames. We compare some of the times taken 

for the debarment and disqualification proceedings we reviewed with the 

new time frames. 

To address our objectives, we reviewed FDA’s debarment and 

disqualification files, interviewed FDA officials involved in debarment and 

disqualification proceedings, reviewed relevant laws, regulations, and FDA 

guidance, and reviewed standards for internal control. We conducted our 

file review from September 9, 2008, through November 5, 2008. 

To determine how long FDA’s debarment proceedings have taken and 

identify factors that contributed to the time frame for debarment, we 

reviewed FDA’s files regarding all clinical investigators, sub-investigators, 

and study coordinators involved in research on drugs or biologics 

Page 45 GAO-09-807 FDA Oversight of Clinical Investigators
Appendix I: Scope and Methodology 

intended for human use whom FDA pursued or considered pursuing for 

debarment from the time that it was given authority to do so on May 13, 

1992, through September 9, 2008.1

 To identify these individuals, we 

reviewed information about FDA’s debarment proceedings from Federal 

Register notices (including proposal to debar letters and final debarment 

orders) and FDA’s Web site, and we confirmed whether or not these 

individuals were clinical investigators, sub-investigators, or study 

coordinators with FDA officials. We compared the information about 

debarment proceedings from FDA’s Web site to the information in FDA’s 

files and sought clarification when there were discrepancies.2

 We 

identified 18 completed or pending debarment proceedings pursued by 

FDA from May 13, 1992, through September 9, 2008—13 involving clinical 

investigators and 5 involving study coordinators.3

For each of these 18 debarment proceedings, we reviewed relevant files in 

the FDA center that initiated the debarment action—either the Center for 

Drug Evaluation and Research (CDER) or the Center for Biologics 

Evaluation and Research (CBER)—and in FDA’s Division of Dockets 

Management, which maintains publicly available information about 

 

1

Clinical investigators agree with the sponsor of an investigational product to take 

responsibility for the conduct of a particular study at one or more locations. 

Sub-investigators work under the supervision of clinical investigators. Study coordinators 

work for the investigators and typically interact directly with clinical trial participants. We 

included sub-investigators and study coordinators because, like clinical investigators, they 

interact directly with clinical trial participants. Individuals in any of these roles may be 

debarred for certain misconduct related to the development, approval, or regulation of any 

drug or biologic. 

2

For example, we found that FDA’s Web site did not spell the name of one debarred 

individual as it was spelled in Federal Register notices. After we inquired about the 

discrepancy, FDA corrected the spelling on its Web site. 

3

We defined a debarment proceeding as pending if, as of the last date of our file review 

(Nov. 5, 2008), FDA had issued a proposal to debar letter, but had not completed the 

debarment proceeding, or if FDA had identified an individual as one whose conviction 

could serve as a basis for debarment, but for whom FDA had not issued a proposal to debar 

letter. Of the 18 completed or pending proceedings we identified, one of the study 

coordinators was also a sub-investigator. 

Page 46 GAO-09-807 FDA Oversight of Clinical Investigators
Appendix I: Scope and Methodology 

debarment proceedings.4 We reviewed the documentation in the files to 

identify the date of each action in the debarment proceeding, along with 

information about who was involved and what occurred. We determined 

that the information we collected during our file review was sufficiently 

reliable for our purposes. After reviewing these files, we obtained 

additional information from FDA officials about proceedings in which the 

documentation we reviewed was incomplete. We also asked FDA officials 

to explain what, if anything, had occurred during any time intervals for 

which our review of the files indicated that 270 calendar days or more had 

passed without documented activity. We also followed up on proceedings 

that were pending as of the last day of our file review and on proceedings 

for which FDA’s files on disqualification proceedings included information 

pertinent to a debarment proceeding. 

To determine the time each completed debarment proceeding took, we 

calculated the number of calendar days from the date of the individual’s 

conviction (or, for two proceedings in which the individual’s conviction 

occurred before FDA received debarment authority, from the date when 

FDA received debarment authority—May 13, 1992) through completion of 

the debarment proceeding (i.e., the date of publication of a debarment 

order in the Federal Register). If the proceeding was pending, we 

calculated the number of calendar days through the last day of our file 

review. We also calculated the number of days during certain intervals in 

debarment proceedings, for example, from conviction to the issuance of a 

proposal to debar letter. To identify factors that contributed to the length 

of time FDA’s debarment proceedings have taken, we analyzed the 

information we obtained from FDA’s files and the additional information 

we obtained from FDA officials. We examined laws, regulations, and 

guidance to determine whether there were criteria relevant to the times 

taken by debarment proceedings and we interviewed FDA officials, 

including officials in CDER, CBER, the Office of Enforcement, and those 

involved with FDA’s Debarment Working Group. 

 

4

In addition to the 18 debarment proceedings we identified, CDER also identified two 

individuals—a clinical investigator and a sub-investigator—who were convicted of relevant 

crimes, but who died while FDA was considering debarment. In addition, CDER officials 

told us that they did not debar one other clinical investigator who was convicted of a 

relevant crime because the staff responsible for debarments did not learn about the clinical 

investigator’s conviction until more than 5 years after the conviction and the law governing 

debarment specifies that FDA must initiate debarment proceedings within 5 years of the 

date of conviction. We did not include these three additional proceedings in our analyses. 

Page 47 GAO-09-807 FDA Oversight of Clinical Investigators
Appendix I: Scope and Methodology 

To determine how long FDA’s disqualification proceedings have taken and 

identify factors that contributed to the time frame for disqualification, we 

reviewed FDA’s files regarding all clinical investigators involved in 

research on drugs, biologics, or medical devices intended for human use 

for whom FDA pursued disqualification by issuing a Notice of Initiation of 

Disqualification Proceedings and Opportunity to Explain (NIDPOE) letter 

from January 1, 1998, through September 9, 2008, whether these clinical 

investigators were ultimately disqualified or not.5

 To identify these 

individuals, we reviewed information about FDA’s disqualification 

proceedings from FDA’s Web site and obtained additional information 

from FDA about individuals for whom FDA pursued disqualification. We 

compared the information about disqualification proceedings from FDA’s 

Web site to the information in FDA’s files and sought clarification when 

there were discrepancies.6

 We identified 52 completed and pending 

disqualification proceedings that FDA initiated by issuing a NIDPOE letter 

from January 1, 1998, through September 9, 2008.7

For each of these 52 disqualification proceedings, we reviewed relevant 

files in the FDA center that initiated the disqualification proceeding—

CDER, CBER, or the Center for Devices and Radiological Health 

(CDRH)—as well as in other FDA offices that maintained files relating to 

these disqualification proceedings. These other offices included the Office 

of Enforcement, which is involved in the issuance of, and coordination of 

responses to, notice of opportunity for hearing (NOOH) letters; the Office 

 

5

According to FDA officials, the agency typically initiated disqualification proceedings 

before 1998 without issuing a NIDPOE letter. 

6

For example, we found that FDA’s Web site did not accurately list the date on which 11 

clinical investigators were disqualified. After we inquired about the discrepancies, FDA 

corrected the dates on its Web site. 

7

In addition to disqualification proceedings initiated with a NIDPOE letter, clinical 

investigators may be disqualified or restricted through agreements negotiated with the 

Department of Justice or by entering a consent agreement with FDA after an inspection, 

but without issuance of a NIDPOE letter. In addition to the 52 disqualification proceedings 

initiated with a NIDPOE letter that we included in our review, we identified 10 proceedings 

in which clinical investigators were disqualified or restricted from January 1, 1998, through 

September 9, 2008, without issuance of a NIDPOE letter (four through consent agreements 

with FDA that were entered without issuance of a NIDPOE letter, four through plea 

agreements, and two through settlement agreements negotiated with the Department of 

Justice on behalf of the FDA and other components of the Department of Health and 

Human Services). In addition, we identified one NIDPOE letter, issued on February 24, 

2003, that was sent to an investigator who died after the inspection upon which the 

allegations in the NIDPOE letter were based, but before issuance of the NIDPOE letter. We 

did not include these additional proceedings in our analyses. 

Page 48 GAO-09-807 FDA Oversight of Clinical Investigators
Appendix I: Scope and Methodology 

of the Ombudsman, which was responsible for regulatory hearings held as 

part of disqualification proceedings prior to spring of 2008; and the Good 

Clinical Practice Program,8

 which began assuming responsibility for 

disqualification proceedings in spring of 2008 and hired a staff member to 

help oversee and monitor the disqualification process in June 2008. We 

reviewed the documentation in the files to identify the date of each action 

in the disqualification proceeding, along with information about who was 

involved and what occurred. We determined that the information we 

collected during our file review was sufficiently reliable for our purposes. 

After reviewing these files, we obtained additional information from FDA 

officials about proceedings in which the documentation we reviewed was 

incomplete. We also asked FDA officials to explain what, if anything, had 

occurred during any time intervals for which our review of the files 

indicated that 1 year or more had passed without documented activity. We 

also followed up on proceedings that were pending as of the last day of 

our file review. 

To determine the time each completed disqualification proceeding took, 

we calculated the number of calendar days from the date of issuance of 

the NIDPOE letter through the conclusion of the disqualification 

proceeding (i.e., the date of issuance of a notice of disqualification, the 

date a consent agreement was signed by FDA, the date that FDA 

concluded the disqualification proceeding without disqualifying the 

investigator, or the date of a settlement agreement that concluded the 

disqualification proceeding).9

 If the proceeding was pending, we 

calculated the number of calendar days through the last day of our file 

review. We also calculated the number of calendar days during certain 

 

8

In August 2009, the Good Clinical Practice Program was renamed the Office of Good 

Clinical Practice. 

9

For one proceeding in which FDA reissued the NIDPOE letter because the initial address 

was no longer correct, we used the initial issuance date for our calculations because that is 

the date FDA cited in the consent agreement that concluded the proceeding. For another 

proceeding, the investigator was prohibited from receiving investigational drugs, biologics, 

devices, and other FDA-regulated products as part of a plea agreement in a criminal 

proceeding. This investigator entered the plea agreement after an FDA hearing had begun 

and FDA continued the disqualification proceeding. FDA officials told us that they 

concluded that the terms of the plea agreement would not be enforceable after about 

3 years. The presiding officer recommended disqualification, and the investigator requested 

a Commissioner’s review. About 5 years after the investigator requested a Commissioner’s 

review—9.5 years after issuance of the NIDPOE letter—FDA completed this 

disqualification proceeding with a Commissioner’s decision to disqualify the investigator. 

We calculated the length of time this disqualification proceeding took from issuance of the 

NIDPOE letter to the date of the Commissioner’s disqualification decision. 

Page 49 GAO-09-807 FDA Oversight of Clinical Investigators
Appendix I: Scope and Methodology 

intervals in disqualification proceedings, for example, from

recommendation to issue a NOOH letter through issuance of that letter. To 

identify factors that contributed to the length of time FDA’s 

disqualification proceedings have taken, we analyzed the information we 

obtained from FDA’s files and the additional information we obtained 

from FDA officials. To determine whether the times taken for 

disqualification proceedings changed during the years covered in our 

review, we divided these proceedings into three groups based on the date 

when FDA issued the NIDPOE letter—those issued before 2002, those 

issued in 2002 through 2005, and those issued after 2005. We examined 

laws, regulations, and guidance to determine whether there were criteria 

relevant to the times taken by disqualification proceedings and we 

interviewed FDA officials. 

 a center’s 

To identify statutory and regulatory limitations of debarment and 

disqualification, we reviewed relevant laws, regulations, and guidance; 

reviewed files documenting FDA’s debarment and disqualification 

proceedings; and interviewed FDA officials involved with debarment and 

disqualification proceedings. 

We conducted this performance audit from June 2008 to September 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. 

Page 50 GAO-09-807 FDA Oversight of Clinical Investigators
Appendix II: Selected Features of Debarment 

and Disqualification 

Debarmenta

Disqualification 

Authority Pub. L. No.102-282, § 2 

(21 U.S.C. § 335a) 

21 C.F.R. §§ 312.2(a), 312.70 (2008) 

(drugs and biologics) 

21 C.F.R. § 812.119 (2008) (devices) 

Individuals to whom the 

action may be applied 

Individuals—including clinical investigators, 

sub-investigators, study coordinators, sponsors, and 

others—convicted of certain crimes or engaged in certain 

conduct. Debarment may be mandatory or permissive. 

Mandatory debarment: 

• For individuals convicted of a felony under federal law 

for conduct relating to the development, approval, or 

regulation of a drug product.b

Permissive debarment: 

• For individuals convicted of a misdemeanor under 

federal law or a felony under state law for conduct 

relating to the development, approval, or regulation of 

a drug or biologic, or convicted of a conspiracy to 

commit, aid, or abet such crimes or a felony for which 

debarment is mandatory, if the type of conduct 

undermines the regulatory process for drugs or 

biologics, 

• For individuals convicted of a felony for certain crimes 

or a conspiracy to commit, aid, or abet such a felony, 

if FDA finds that the individual has demonstrated a 

pattern of conduct sufficient to find there is reason to 

believe the individual may violate requirements related 

to drugs or biologics, or 

• For individuals who materially participated in acts that 

were the basis for a different individual’s conviction for 

certain crimes, if FDA finds that the individual has 

demonstrated a pattern of conduct sufficient to find 

there is reason to believe the individual may violate 

requirements related to drugs or biologics.c

Clinical investigators who have repeatedly or 

deliberately failed to comply with applicable 

FDA regulations or have repeatedly or 

deliberately submitted false information to 

FDA or the sponsor of the clinical trial in any 

required report. 

Examples of convictions 

or misconduct upon 

which the action could 

be based 

• Mail fraud (e.g., for submitting fraudulent data through 

the mail based on nonexistent clinical trial 

participants). 

• Making false statements (e.g., by providing a false 

and fraudulent medical license to qualify as a clinical 

investigator). 

• Repeatedly and deliberately failing to 

comply with FDA regulations requiring 

informed consent of clinical trial 

participants (e.g., by failing to advise 

them of the risks of participation). 

• Deliberately submitting false data to the 

sponsor of a clinical trial (e.g., submitting 

fraudulent data based on nonexistent 

clinical trial participants) in a required 

report. 

Appendix II: Selected Features of Debarment 

and Disqualification 

Page 51 GAO-09-807 FDA Oversight of Clinical Investigators
Appendix II: Selected Features of Debarment 

and Disqualification 

 Debarmenta Disqualification 

Consequences of the 

action for the individual 

No longer permitted to provide services in any capacity to 

an individual, corporation, partnership, or association that 

has an approved or pending drug or biologic application. If 

such services are provided, civil monetary penalties may 

be assessed.d

If disqualified by a Commissioner’s decision: 

• No longer entitled to receive 

FDA-regulated investigational drugs and 

biologics or FDA-regulated 

investigational devices and therefore 

unable to serve as a clinical investigator 

for the type of product (i.e., drugs and 

biologics or devices) for which the action 

was taken. 

If disqualified by consent agreement: 

• Terms of agreement may be subject to 

negotiation, which could result in 

disqualification from receiving some or 

all FDA-regulated investigational 

products, or restrictions such as limits on 

the number of clinical studies the 

investigator may conduct and requiring 

that the investigator be supervised by 

another clinical investigator. 

Duration Mandatory: Permanent. 

Permissive: Up to five years for each offense.e 

Disqualification is permanent unless 

otherwise specified in a consent agreement 

or the investigator is reinstated.f 

Time frame for initiation 

of action 

Must occur within 5 years of conviction or the date of the 

action on which debarment is based.g

No limit. 

Source: GAO. 

a

The selected features of debarment presented in this table relate to individuals (including clinical 

investigators, sub-investigators, and study coordinators) who may be debarred from involvement with 

drugs and biologics, and not to corporations, partnerships, or associations. 

b

The statutory definition of “drug product” includes drugs and biologics. 21 U.S.C. § 321(dd). 

c

Individuals may also be permissively debarred if they are high managerial agents who worked for, or 

who worked as a consultant for, an individual convicted of a felony resulting in debarment, and who 

had knowledge of such activity and knew it was a violation, but did not report it, and if FDA 

determines that the type of conduct which served as the basis for such other individual’s conviction 

undermines the process for the regulation of drugs or biologics. High managerial agents are officers 

or directors of a corporation or an association, partners of a partnership, or any employee or other 

agent of a corporation, association, or partnership having duties such that their conduct may fairly be 

assumed to represent the policy of the corporation, association, or partnership, and includes persons 

having management responsibility for submissions to the FDA regarding the development or approval 

of any drug product; production, quality assurance, or quality control of any drug product; or research 

and development of any drug product. 21 U.S.C. §§ 321(cc), 335a(b)(2)(B)(iv). 

d

21 U.S.C. § 335b(a)(7). 

e

If the individual is permissively debarred for multiple offenses, the Commissioner may determine 

whether debarment periods will run concurrently or consecutively. FDA is required to terminate an 

individual’s debarment if, for example, the conviction that served as the basis for the individual’s 

debarment is reversed. 21 U.S.C. §§ 335a(c)(2)(A), (d)(3)(B)(i). 

f

Clinical investigators who have been disqualified may apply to be reinstated as eligible to receive 

investigational products. Reinstatement requires a Commissioner’s determination that the investigator 

has presented adequate assurances that the investigator will employ investigational products in 

compliance with FDA regulations. 21 C.F.R. §§ 312.70(f), 812.119(f) (2008). 

g

21 U.S.C. § 335a(l)(2). 

Page 52 GAO-09-807 FDA Oversight of Clinical Investigators
Appendix III: Debarment Proceedings 

Completed or Pending from May 13, 1992, Appendix III: Debarment Proceedings through September 9, 2008 

Completed or Pending from May 13, 1992, 

through September 9, 2008 

Proceeding Individual’s role 

Center 

involved in 

proceedinga

 

Type of 

debarment 

proposedb

Date of 

conviction 

Date of 

issuance 

of proposal 

to debarc

Date of 

debarment 

orderd

Kostas, Constantine I. clinical investigator CDER mandatory 10/13/1988e 12/9/1992 6/25/1998

Fogari, Robert A. clinical investigator CDER mandatory 2/2/1989e1/4/1993 7/8/1993

Garfinkel, Barry D. clinical investigator CDER mandatory 11/19/1993 1/27/1995 4/2/1997

Fiddes, Robert A. clinical investigator CDER permissive 9/30/1997 5/31/2002 11/6/2002

Charpentier, Laverne M. study coordinator CDER permissive 10/21/1997 5/6/2002 12/2/2002

Rescindedf study coordinator CDER permissive 10/22/1997 5/6/2002 11/6/2002

Pending A clinical investigator CDER permissive 12/16/1997 11/26/2002 pendingg

Borison, Richard L. clinical investigator CDER permissive 10/8/1998 11/26/2002 9/30/2003

Peugeot, Renee sub-investigator and 

study coordinator 

CDER mandatory 3/23/2000 4/29/2002 1/13/2003

Caro Acevedo, Eduardo clinical investigator CDER permissive 2/16/2001 2/18/2004 3/24/2005

Pending B clinical investigator CDER permissive 10/28/2002 10/10/2007 pendingh

Pending C clinical investigator CDER debarment had not 

been proposedi

12/11/2003 pendingi

pendingi

Campbell, Maria Anne 

Kirkmanj

clinical investigator CDER mandatory 3/25/2004 2/28/2007 9/2/2008

Butkovitz, Anne L. study coordinator CBER mandatory 6/7/2005 2/21/2006 10/17/2006

Pending D clinical investigator CBER mandatory 8/4/2005 9/7/2007 pendingk

Pending E study coordinator CDER debarment had not 

been proposedl

12/6/2005 pendingl pendingl

Pending F clinical investigator CDER debarment had not 

been proposedm

4/24/2007 pendingm

pendingm

Pending G clinical investigator CDER debarment had not 

been proposedl

9/11/2007 pendingl

pendingl

Source: GAO analysis of data from FDA. 

Note: This table shows all completed or pending debarment proceedings initiated from May 13, 1992, 

through September 9, 2008, against clinical investigators, sub-investigators, and study coordinators 

involved in research on drugs or biologics intended for human use. The names of individuals who 

have been debarred are public information: Debarments are published in the Federal Register and 

FDA posts the names of debarred individuals on its Web site. We defined a debarment proceeding as 

initiated if FDA identified the individual as one whose conviction could serve as a basis for 

debarment. We defined a debarment proceeding as pending if, as of the last date of our file review 

(Nov. 5, 2008), FDA had issued a proposal to debar letter, but had not concluded the debarment 

proceeding, or if FDA had identified an individual as one whose conviction could serve as a basis for 

debarment, but for whom FDA had not issued a proposal to debar letter. In addition to the individuals 

in the proceedings above, CDER identified a clinical investigator and a sub-investigator who were 

convicted of relevant crimes, but who died while FDA was considering debarment. In addition, CDER 

identified a clinical investigator who was convicted of a relevant crime, but who was not debarred 

because CDER learned about the clinical investigator’s conviction more than 5 years after the 

conviction. The law governing debarment specifies that FDA must initiate debarment actions within 5 

years of the date of conviction. These proceedings are not included. 

Page 53 GAO-09-807 FDA Oversight of Clinical Investigators
Appendix III: Debarment Proceedings 

Completed or Pending from May 13, 1992, 

through September 9, 2008 

a

The FDA centers that pursued debarment of individuals in our review included CDER and CBER. 

b

There are two types of debarment: mandatory and permissive. Debarment is mandatory—and 

permanent—when FDA finds that an individual has been convicted of a felony under federal law for 

conduct relating to the development or approval of any drug or biologic, or otherwise relating to the 

regulation of any drug or biologic. FDA may seek permissive debarment—which is not permanent—

under certain other conditions, for example, if the individual was convicted of a felony under state law 

related to the development, approval, or regulation of drugs or biologics. To seek permissive 

debarment, FDA must determine that debarment is appropriate and determine the period of 

debarment by considering factors such as the nature and seriousness of the offense or offenses 

involved. An individual may be permissively debarred for up to 5 years for each offense. 

c

FDA issues a proposal to debar letter to initiate a debarment proceeding. This letter describes the 

conviction and actions of relevance to the proceeding, offers the investigator the opportunity for a 

formal hearing, and specifies the time period within which the investigator must provide a written 

request for a hearing. 

d

We defined a debarment proceeding as completed as of the date on which FDA published a 

debarment order in the Federal Register. 

e

The individual in this debarment proceeding was convicted prior to May 13, 1992, the date on which 

FDA obtained the authority to debar. The law governing debarment allows FDA to pursue debarment 

for individuals who were convicted prior to May 13, 1992. 

f

FDA rescinded the debarment order in January 2003 after the agency learned that it had sent the 

proposal to debar letter to another person with the same name as the individual involved in this 

proceeding. When FDA learned that the proposal to debar letter had been sent to the wrong person, 

just over 5 years had elapsed from the date of the study coordinator’s conviction. 

g

This debarment proceeding remained pending as of September 1, 2009. 

h

This debarment proceeding was pending as of November 5, 2008, which was the last date of our file 

review, but FDA issued a debarment order on June 12, 2009. 

i

FDA had not proposed debarment as of November 5, 2008, which was the last date of our file review, 

but FDA issued a proposal to debar letter for mandatory debarment on November 25, 2008, and a 

debarment order on June 12, 2009. 

j

This investigator is also known as Maria Anne Campbell. 

k

This debarment proceeding was pending as of November 5, 2008, which was the last date of our file 

review, but FDA issued a debarment order on November 24, 2008. 

l

FDA had not proposed debarment as of November 5, 2008, which was the last date of our file review, 

but FDA issued a proposal to debar letter for mandatory debarment on May 4, 2009, and a 

debarment order on August 4, 2009. 

m

FDA had not proposed debarment as of November 5, 2008, which was the last date of our file 

review, but FDA issued a proposal to debar letter for permissive debarment on June 2, 2009. This 

debarment proceeding remained pending as of September 1, 2009. 

Page 54 GAO-09-807 FDA Oversight of Clinical Investigators
Appendix IV: Types of Misconduct Cited in Appendix IV: Types of Misconduct Cited in Proposal to Debar Letters 

Proposal to Debar Letters 

Misconduct related to: 

Proceeding 

Falsifying 

study 

participant 

data 

Diverting 

funds for own 

financial gain

Bribing 

staff to 

conceal 

information

Illegally 

prescribing 

or allowing 

the illegal 

prescription 

of medication

Conspiring 

to defraud 

government Specific example of misconduct

Borison, Richard L. X X X Defrauded employer of more than 

$10 million in clinical research 

funds by diverting funds to entities 

owned or controlled by the clinical 

investigators. 

Butkovitz, Anne L. X Documented that study 

participants were contacted and 

that no serious adverse 

experiences had occurred when, 

in fact, such contacts were not 

made. 

Campbell, Maria 

Anne Kirkmana

X Submitted falsified data for a 

nonexistent study participant. 

Caro Acevedo, 

Eduardo 

X Received kickbacks in relation to 

the referral of Medicare 

beneficiaries to a durable medical 

equipment company, in violation 

of the Medicare anti-kickback law. 

Charpentier, 

Laverne M. 

X Substituted samples and data 

from qualifying subjects for 

nonqualifying subjects. 

Fiddes, Robert A. X Falsely reported that certain 

subjects participated in clinical 

studies when, in fact, they had 

not. 

Fogari, Robert A. X Falsified X-ray and physical exam 

results to show that the drug was 

effective. 

Garfinkel, Barry D. X Submitted data indicating that 

subject visits were conducted 

when, in fact, they were not. 

Kostas, 

Constantine I. 

X Submitted data for 70 fictitious 

study participants. 

Peugeot, Renee X Manipulated test results in clinical 

studies. 

Source: GAO analysis of data from FDA. 

Page 55 GAO-09-807 FDA Oversight of Clinical Investigators
Appendix IV: Types of Misconduct Cited in 

Proposal to Debar Letters 

Notes: A proposal to debar letter details the misconduct that led to an individual’s conviction. The 

proposal to debar letters covered in this table include those that FDA issued after receiving authority 

to debar on May 13, 1992, through September 9, 2008, for clinical investigators, sub-investigators, 

and study coordinators whose debarment proceedings were completed (and not rescinded) as of 

November 5, 2008 (the last date of our file review). The names of individuals who have been 

debarred are public information: Debarments are published in the Federal Register and FDA posts 

the names of debarred individuals on its Web site. 

a

This investigator is also known as Maria Anne Campbell. 

Page 56 GAO-09-807 FDA Oversight of Clinical Investigators
Appendix V: Disqualification Proceedings 

Initiated from January 1, 1998, through 

September 9, 2008 

Outcome Basis for outcome 

Proceeding 

FDA 

Centera

Dates of 

Inspections 

Date of 

issuance 

of 

NIDPOE 

letterb

Date of 

issuance 

of NOOH 

letterc

Date of 

outcome 

Disqualified 

to receive 

drugs and 

biologics 

Disqualified 

to receive 

devices Restrictedd

Neither 

disqualified 

nor 

restricted 

FDA 

decisione

Consent 

agreement

Settlement 

agreement

1 CDER 6/20-24/1996; 

5/19-23/1997 

3/23/1998 4/15/1999 6/18/2008 X X 

2 CDER 3/11-13/1998 7/1/1998 N/A 8/11/1999 X X 

3 CDER 3/9-10/1998 7/1/1998 N/A 9/10/1999 XfX 

4 CDER 6/10/1997- 

10/9/1997 

7/10/1998 6/28/1999 9/1/1999 XfX 

5 CDER 5/7/1997-

7/22/1997 

8/28/1998 8/18/1999 7/30/2002 X X 

6

g

CDER 4/12/1995-

5/16/1995 

11/6/1998 8/16/1999 5/20/2008 X X 

7 CDER 7/6-16/1998 12/23/1998 N/A 3/30/1999 X X 

8 CDER 2/5/1998- 

3/12/1998 

5/19/1999 2/19/2000 1/12/2004 Xf X 

9 CBER 12/7-9/1999 4/6/2000 1/8/2002 4/4/2003 X X X 

10 CDER 10/5/1999- 

11/11/1999 

4/7/2000 N/A 6/19/2002 XfX 

11 CBER 7/12/1999- 

9/15/1999 

6/30/2000h 11/1/2002 10/23/2006 X X 

12 CDER 11/22/1999- 

3/15/2000 

8/21/2000 N/A 8/23/2002 Xf X 

13 CDER 4/12/1999-

8/4/1999; 

2/27/2001- 

3/8/2001 

9/13/2000i

N/A 1/10/2005 X X X 

14 CBER 11/30/1999- 

1/19/2000 

11/30/2000 2/8/2002 2/9/2005 X X 

15 CDER 5/30/2000- 

6/27/2000 

4/13/2001 11/28/2003 2/5/2004 X X X 

16 CDRH 3/14/2001- 

4/18/2001 

5/11/2001 1/8/2002 6/18/2002 X X 

17 CBER 7/17/2000- 

8/4/2000 

6/21/2001 5/21/2002 pendingj

18 CDER 5/30/2000- 

6/27/2000 

6/27/2001 6/3/2002 9/24/2003 X X 

19 CDER 8/14-23/2001 6/27/2002 N/A 12/12/2002 X X X 

20 CDER 5/12/1998- 

7/21/1998 

10/23/2002 N/A 8/11/2003 XfX 

Appendix V: Disqualification Proceedings 

Initiated from January 1, 1998, through 

September 9, 2008 

Page 57 GAO-09-807 FDA Oversight of Clinical Investigators
Appendix V: Disqualification Proceedings 

Initiated from January 1, 1998, through 

September 9, 2008 

 Outcome Basis for outcome 

Proceeding 

FDA 

Centera

Dates of 

Inspections 

Date of 

issuance 

of 

NIDPOE 

letterb

Date of 

issuance 

of NOOH 

letterc

Date of 

outcome 

Disqualified 

to receive 

drugs and 

biologics 

Disqualified 

to receive 

devices Restrictedd

Neither 

disqualified 

nor 

restricted 

FDA 

decisione

Consent 

agreement

Settlement 

agreement

21 CBER 8/22/2001- 

11/16/2001 

11/6/2002 10/9/2003 1/9/2007 X X 

22 CBER 7/19/2002- 

9/6/2002 

6/23/2003 2/4/2004 3/14/2008 X X 

23 CDER 7/23/2001- 

8/28/2001 

12/3/2003 N/A pendingk

24 CDRH 5/2-21/2003 3/9/2004 N/A 2/8/2005 X X 

25 CDRH 6/2-6/2003 3/11/2004 N/A 2/8/2005 X X 

26 CBER 4/1-18/2003 4/22/2004 N/A 10/3/2004 X X X 

27 CDRH 4/11/2003- 

5/13/2003 

5/5/2004 N/A 4/10/2005 X X 

28 CDER 2/19/2002- 

4/3/2002 

6/10/2004 3/8/2006 5/11/2006 X X 

29 CDER 2/26/2002- 

3/29/2002; 

1/27/2003- 

2/14/2003 

6/8/2004l

N/A 11/28/2005 X X 

30 CDER 6/1-22/2000 8/17/2004 N/A 1/14/2005 Xf X 

31 CDER 11/14/2002- 

1/03/2003 

9/22/2004 8/14/2007 8/25/2008 X X 

32 CDRH 7/29/2002- 

8/9/2002; 

12/3-12/2002; 

1/27/2003- 

2/6/2003 

9/30/2004 N/A 4/15/2005 XfX 

33 CDER 10/21-25/2002 1/19/2005 N/A 6/23/2008 X X 

34 CDER 3/11-14/2002 3/1/2005 N/A 1/9/2006 X X 

35 CDER 7/24/2003- 

8/6/2003 

8/24/2005 N/A 9/29/2005 X X X 

36 CDRH 2/17/2004- 

3/23/2004; 

3/30/2004- 

4/1/2004 

10/21/2005 N/A 7/19/2006 X X 

37 CDER 3/10/2003- 

4/3/2003 

1/20/2006 N/A 10/11/2006 X X X 

38 CDER 3/4-10/2005 5/10/2006 N/A 2/21/2008 X X X 

39 CDER 7/29/2002- 

8/28/2002 

5/11/2006 pendingmpendingm

40 CDER 10/15-24/2002 5/18/2006 12/21/2007 5/8/2008 X X 

Page 58 GAO-09-807 FDA Oversight of Clinical Investigators
Appendix V: Disqualification Proceedings 

Initiated from January 1, 1998, through 

September 9, 2008 

 Outcome Basis for outcome 

Proceeding 

FDA 

Centera

Dates of 

Inspections 

Date of 

issuance 

of 

NIDPOE 

letterb

Date of 

issuance 

of NOOH 

letterc

Date of 

outcome 

Disqualified 

to receive 

drugs and 

biologics 

Disqualified 

to receive 

devices Restrictedd

Neither 

disqualified 

nor 

restricted 

FDA 

decisione

Consent 

agreement

Settlement 

agreement

41 CBER 2/8-28/2005; 

3/16/2005- 

8/2/2005 

1/24/2007 N/A 5/18/2007 X X X 

42 CDER 1/9-21/2004 5/9/2007 N/A 5/5/2008 X X 

43 CDRH 10/17-20/2006 7/31/2007 N/A 10/12/2007 X X 

44 CDER 2/16/2005- 

4/6/2005 

8/15/2007 N/A 9/10/2007 X X X 

45 CDER 8/25/2003- 

9/3/2003 

8/29/2007 N/A 4/24/2008 X X X 

46 CDER 10/25/2006- 

2/7/2007 

9/27/2007 N/A 2/12/2008 X X X 

47 CBER 6/16/2005- 

7/22/2005 

11/9/2007 N/A 4/28/2008 X X X 

48 CDER 8/2/2004- 

12/8/2004 

1/24/2008 N/A 7/25/2008 X X X 

49 CDER 5/17/2005- 

6/7/2005 

2/21/2008 N/A 8/25/2008 X X 

50 CDER 3/22/2007- 

4/18/2007 

3/31/2008 pendingn pendingn

51 CDER 1/22/2008- 

2/25/2008 

8/25/2008 N/A 9/22/2008 X X X 

52 CBER 5/8-12/2006; 

9/18-21/2006 

8/27/2008 pendingopendingo

Source: GAO analysis of data from FDA. 

N/A = not applicable 

Notes: This table shows all proceedings initiated by a NIDPOE letter from January 1, 1998, through 

September 9, 2008. We defined a disqualification proceeding as pending if, as of the last date of our 

file review (Nov. 5, 2008), FDA had issued a NIDPOE letter, but had not concluded the 

disqualification proceeding. One clinical investigator died after the inspection upon which the 

allegations in the NIDPOE letter were based, but before receiving the NIDPOE letter; this 

investigator’s case is not included. Clinical investigators who were disqualified from receiving drugs 

and biologics and from receiving devices were also disqualified from receiving any FDA-regulated 

investigational products, including food additives and animal drugs. 

a

The FDA centers that pursued disqualification of clinical investigators in our review were CDER, 

CBER, and CDRH. 

b

FDA issues a NIDPOE letter to initiate a disqualification proceeding. The NIDPOE letter details 

FDA’s allegations of misconduct based on its findings during one or more inspections and offers the 

clinical investigator an opportunity to respond to the allegations in writing or in an informal 

conference. 

c

FDA uses a NOOH letter to provide a clinical investigator an opportunity for a regulatory hearing as 

part of a disqualification proceeding. 

Page 59 GAO-09-807 FDA Oversight of Clinical Investigators
Appendix V: Disqualification Proceedings 

Initiated from January 1, 1998, through 

September 9, 2008 

d

When a clinical investigator was restricted, the clinical investigator agreed to certain restrictions on 

his or her research when entering a consent agreement with FDA or a settlement agreement 

negotiated with the Department of Justice. 

e

FDA decisions include decisions by the Commissioner (or delegate) to disqualify a clinical 

investigator and decisions by the responsible center to neither disqualify nor restrict the clinical 

investigator, based on the center’s finding that the investigator’s explanation for all of the allegations 

in the NIDPOE letter was satisfactory. 

f

This disqualification proceeding was concluded when the clinical investigator and FDA entered a 

consent agreement that specified restrictions to the investigator’s activities. The restrictions were 

subsequently removed because, under the terms of the consent agreement, they no longer applied. 

g

This investigator was prohibited from receiving investigational drugs, biologics, devices, and other 

FDA-regulated products as part of a plea agreement in a criminal proceeding. FDA continued the 

disqualification proceeding against this investigator after he entered the plea agreement. FDA officials 

told us that they concluded that the terms of the plea agreement would not be enforceable after about 

3 years and they continued the disqualification proceeding. 

h

FDA issued an amendment to the NIDPOE letter, which detailed additional allegations of 

misconduct, on August 17, 2001. 

i

FDA issued an amendment to the NIDPOE letter, which detailed additional allegations of misconduct, 

on June 23, 2003. 

j

This disqualification proceeding was pending as of November 5, 2008, when we completed our 

review of files, but has since been concluded. This clinical investigator was disqualified from receiving 

investigational drugs and biologics through a Commissioner’s decision on January 8, 2009. 

k

This disqualification proceeding remained pending as of September 1, 2009. 

l

FDA re-issued this NIDPOE letter on July 20, 2004, after learning that the original address was not 

correct. 

m

This disqualification proceeding was pending as of November 5, 2008, which was the last date of our 

file review. This clinical investigator was issued a NOOH letter on July 1, 2009. This disqualification 

proceeding remained pending as of September 1, 2009. 

n

This disqualification proceeding was pending as of November 5, 2008, which was the last date of our 

file review, but has since been concluded. This clinical investigator was issued a NOOH letter on 

March 4, 2009, and was disqualified from receiving investigational drugs, biologics, devices, and 

other FDA-regulated investigational products, including food additives and animal drugs, through a 

consent agreement on May 4, 2009. 

o

This disqualification proceeding was pending as of November 5, 2008, which was the last date of our 

file review, but has since been concluded. This clinical investigator was issued a NOOH letter on 

February 13, 2009; the NOOH letter was re-issued on March 9, 2009, after the agency learned that 

the investigator had not received the letter. This clinical investigator was disqualified from receiving 

investigational drugs and biologics through a Commissioner’s decision on August 6, 2009. 

Page 60 GAO-09-807 FDA Oversight of Clinical Investigators
Appendix VI: Types of Alleged Misconduct 

Cited in FDA’s Initiation of Disqualification Appendix VI: Types of Alleged Misconduct Proceedings 

Cited in FDA’s Initiation of Disqualification 

Proceedings 

Common types of alleged misconduct cited in NIDPOE letters issued by 

FDA from January 1, 1998, through September 9, 2008, included 

• Submitting false information to the sponsor or to FDA; 

• Failure to comply with requirements related to obtaining informed consent 

from clinical trial participants; 

• Failure to comply with requirements to obtain initial or continuing 

approval from an institutional review board; 

• Failure to follow the clinical trial’s research plan; 

• Failure to comply with requirements regarding the disposition of 

investigational drugs, biologics, or devices, such as maintaining records of 

their use; and 

• Failure to comply with requirements to prepare or maintain case histories 

or other records. 

Specific examples of the types of alleged misconduct detailed in the 

NIDPOE letters for the 45 completed proceedings that we reviewed that 

ended in disqualification (including restrictions) are shown in table 1. 

Page 61 GAO-09-807 FDA Oversight of Clinical Investigators
Appendix VI: Types of Alleged Misconduct 

Cited in FDA’s Initiation of Disqualification 

Proceedings 

Table 1: Examples of Misconduct Allegations Cited in NIDPOE Letters 

Letter Specific example of alleged misconduct 

1 Failed to maintain adequate and accurate case histories that recorded all observations and other data pertinent to a 

clinical trial of an investigational drug. 

2 Failed to obtain approval from the institutional review board for a verbal informed consent procedure that was used with 

the participants in a clinical trial of an investigational drug. 

3 Failed to maintain adequate and accurate records by inaccurately reporting that four clinical trial participants had been 

using a stable dose of a medication for a minimum of 7 days prior to their respective screening visit dates. 

4 Enrolled 390 high-risk participants in a clinical trial of an investigational test kit, even though the protocol and conditions of 

approval by the institutional review board limited the number of enrolled high-risk participants to 200. 

5 Failed to report to the institutional review board unanticipated adverse effects, including chronic and severe pain, 

experienced by several clinical trial participants after implantation of an investigational medical device. 

6 Failed to evaluate adverse events in a timely manner or to take appropriate action to protect participants in clinical trials of 

an investigational drug who experienced adverse events, including failing to take appropriate actions to evaluate the 

adverse reactions reported by one clinical trial participant for more than 6 months. 

7 Submitted false information in a required report to the sponsor of an investigational drug by submitting case report forms 

for over 200 clinical trial participants who had not, in fact, participated in the clinical trial. 

8 Failed to report to the sponsor adverse events, including headache, fever, and palpitations, that were experienced by 

participants in clinical trials of an investigational drug intended for the treatment of ear infection. 

9 Failed to maintain any records accounting for the use of investigational biologics in two clinical trials that involved 5 and

28 clinical trial participants, respectively. 

10 Failed to institute corrective actions in response to repeated letters sent over a period of 11 months by the sponsors of 

investigational drugs concerning violations of the protocols for clinical trials, discrepancies in required documentation, and 

missing medical records. 

11 Failed to document the occurrence and follow-up of serious adverse events (including hospitalizations) experienced by 

infant participants in a clinical trial of an investigational vaccine. 

12 Submitted false information to the sponsor of an investigational drug by submitting data from sputum samples that did not 

come from the actual clinical trial participants. 

13 Failed to recognize or evaluate adverse events in a timely manner and failed to take appropriate action to protect those 

who experienced adverse events, including continuing to provide an investigational drug to a clinical trial participant who 

experienced multiple signs and symptoms of myocardial injury and drug toxicity until one day before his death, about 3 

weeks after he began participating in the clinical trial. 

14 Failed to supervise the clinical trial of an investigational drug, allowing the study coordinator—who was not licensed as a 

physician in the state in which the trial occurred—to write medical orders that were not co-signed by a licensed physician. 

15 Enrolled an individual with a duodenal ulcer (but no gastric ulcer) in a clinical trial of an investigational drug intended for 

use with patients with gastric ulcer, even though the protocol stated that only patients with a gastric ulcer were eligible to 

participate. 

16 Failed to seek approval from the institutional review board for changing the protocol for a clinical trial of an investigational 

drug to allow enrollment of participants who, according to the approved protocol, should have been excluded from the 

clinical trial. 

17 Failed to provide FDA with required information identifying sub-investigators. 

18 Maintained two separate sets of medical records for clinical trial participants that covered the same time period, with one 

set of records (which were for his private practice) documenting that several participants had pre-existing conditions that 

should have precluded their enrollment in the study. 

Page 62 GAO-09-807 FDA Oversight of Clinical Investigators
Appendix VI: Types of Alleged Misconduct 

Cited in FDA’s Initiation of Disqualification 

Proceedings 

Letter Specific example of alleged misconduct 

19 Stored an investigational drug that was a controlled substance in an unlocked cabinet, thereby failing to take adequate 

precautions to prevent diversion of the controlled substance into illegal channels of distribution. 

20 Enrolled a clinical trial participant in a study for which he was ineligible because of impaired liver and renal function, gave 

the participant an investigational drug that likely contributed to his death, and altered laboratory results in the report to the 

sponsor to make it appear that the participant was eligible for enrollment. 

21 Failed to report to the institutional review board unanticipated problems that involved risks to humans in a timely manner, 

including failing to report for nearly 2 years that a participant in a clinical trial of an investigational drug experienced acute 

renal failure. 

22 Allowed participants enrolled in clinical trials of an investigational drug to continue taking medications that, according to 

the protocol, were prohibited during their participation. 

23 Submitted false information to the sponsor of an investigational drug by submitting reports based on medical records for 

clinical trial participants that had been written more than one year after the events they ostensibly described. 

24 Failed to meet a requirement of reporting the number of eyes treated by an investigational medical device to FDA. 

25 Exported an investigational new drug to unauthorized personnel in other countries and charged or received payment from 

overseas contacts in return for the use of the investigational drug without seeking FDA’s approval or authorization to 

export the investigational drug or to charge for it. 

26 Delegated certain tasks associated with a clinical trial of an investigational vaccine, including performing physical 

examinations and post-vaccination observations, to individuals who were not qualified to perform them. 

27 Failed to properly train and supervise sub-investigators and other staff involved in a clinical trial of an investigational 

biologic for infants, for example, by failing to inform an individual who administered the investigational biologic that he was

to obtain information about serious adverse experiences. 

28 Failed to submit blood samples taken from clinical trial participants to a laboratory for testing to evaluate the presence of 

clinically significant abnormal values as required by the protocols for two clinical trials of an investigational drug. 

29 Failed to obtain informed consent from 30 participants prior to enrolling them in a clinical trial of an investigational drug 

and instructed a staff member to backdate informed consent documents for 8 of them. 

30 Submitted false information to the sponsor of an investigational drug by fabricating all records associated with seven 

fictitious clinical trial participants, including forging consent forms, fabricating medical information, and knowingly and 

willingly submitting blood and urine samples, supposedly from these participants, but actually taken from surplus 

specimens from patients in his clinical practice. 

31 Failed to report serious adverse events, including deaths, to an institutional review board until months after their 

occurrence, even though the institutional review board had specifically required immediate reporting of any unanticipated 

problems, injuries, or deaths. 

32 Failed to obtain information about adverse events experienced by the participants in a clinical trial of an investigational 

drug, even though the protocol required collection of this information. 

33 Administered an investigational new vaccine that was obtained by an unapproved process to three clinical trial 

participants—one of whom later died—without authorization to administer that drug to human participants. 

34 Submitted false information to investigational drug sponsors and to the FDA by reporting that he had a Ph.D. degree or a 

family nurse practitioner degree when, in fact, he did not have valid degrees of either type. 

35 Continued to include participants in a clinical trial of an investigational drug after documenting that they had reactions 

such as pain that, according to the protocol, should have led to termination of their participation. 

36 Failed to ensure and document that all clinical trial participants were aware that a device was investigational prior to 

surgically implanting it. 

37 Failed to supervise clinical trials, causing submission of false information (electrocardiograms that had been altered to 

appear to have been recorded at a different time than they actually were) to the sponsor of an investigational drug. 

Page 63 GAO-09-807 FDA Oversight of Clinical Investigators
Appendix VI: Types of Alleged Misconduct 

Cited in FDA’s Initiation of Disqualification 

Proceedings 

Letter Specific example of alleged misconduct 

38 Failed to obtain written informed consent from three participants in a clinical trial of an investigational drug and falsified 

their signatures on informed consent documents some time after their enrollment in the trial. 

39 Gave participants in a clinical trial of an investigational drug amounts of the investigational drug that differed from those 

specified by the protocol. 

40 Did not have or provide to FDA a complete list of the clinical trial participants in whom an investigational medical device 

had been implanted. 

41 Delegated responsibilities that included screening and enrolling clinical trial participants to a study coordinator who lacked 

the medical training necessary to perform those functions and failed to supervise the study coordinator, resulting in 

enrollment of two participants who, for safety reasons, should have been excluded from the clinical trial of an 

investigational drug. 

42 Failed to document that informed consent was obtained from all clinical trial participants and that all participants met the

enrollment eligibility criteria for a clinical trial of an investigational device. 

43 Failed to obtain approval of the protocol for a clinical trial of an investigational drug from the institutional review board 

before initiating it. 

44 Submitted inaccurate and misleading reports to the institutional review board regarding the safety of a clinical trial of an

investigational biologic. 

45 Failed to maintain adequate and accurate case histories of participants in clinical trials of investigational drugs by making 

changes to records without documenting why or by whom these changes were made. 

Source: GAO analysis of data from FDA. 

Notes: A NIDPOE letter provides a clinical investigator with notice of initiation of a disqualification 

proceeding and details FDA’s allegations of misconduct based on its findings during one or more 

inspections of the clinical investigator’s conduct of one or more clinical trials. This letter offers the 

clinical investigator a chance to respond in writing or meet informally with FDA officials to discuss 

the alleged violations. FDA may determine not to pursue disqualification based on certain allegations 

cited in the NIDPOE letter after FDA’s evaluation of the clinical investigator’s response. The 

45 NIDPOE letters covered in this table were issued by FDA from January 1, 1998, through 

September 9, 2008, for disqualification proceedings that ended in disqualification (including 

restrictions). 

Page 64 GAO-09-807 FDA Oversight of Clinical Investigators
Appendix VII: Comments from the Appendix VII: Comments from the Department of Health and Human Services 

Department of Health and Human Services 

Page 65 GAO-09-807 FDA Oversight of Clinical Investigators
Appendix VII: Comments from the 

Department of Health and Human Services 

Page 66 GAO-09-807 FDA Oversight of Clinical Investigators
Appendix VII: Comments from the 

Department of Health and Human Services 

Page 67 GAO-09-807 FDA Oversight of Clinical Investigators
Appendix VII: Comments from the 

Department of Health and Human Services 

Page 68 GAO-09-807 FDA Oversight of Clinical Investigators
Appendix VII: Comments from the 

Department of Health and Human Services 

Page 69 GAO-09-807 FDA Oversight of Clinical Investigators
Appendix VII: Comments from the 

Department of Health and Human Services 

Page 70 GAO-09-807 FDA Oversight of Clinical Investigators
Appendix VII: Comments from the 

Department of Health and Human Services 

Page 71 GAO-09-807 FDA Oversight of Clinical Investigators
Appendix VIII: 

A

GAO Contact and Staff 

cknowledgments 

Page 72 GAO-09-807 

Appendix VIII: GAO Contact and Staff 

Acknowledgments 

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

In addition to the contact named above, Kim Yamane, Assistant Director; 

Kristen Joan Anderson; Hernán Bozzolo; Cathleen Hamann; Julian Klazkin; 

Ba Lin; and Jessica C. Smith made key contributions to this report. 

 FDA Oversight of Clinical Investigators

Staff 

Acknowledgments 

(290717) 
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