Department of Health and Human Services

OFFICE OF 

INSPECTOR GENERAL 

O A
UTSIDE  CTIVITIES

FDA E
OF  MPLOYEES

Daniel R. Levinson

Inspector General 

February 2006

OEI-01-04-00400
 Office of Inspector General 

http://oig.hhs.gov 
The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, 
as amended, is to protect the integrity of the Department of Health and Human Services 
(HHS) programs, as well as the health and welfare of beneficiaries served by those 
programs.  This statutory mission is carried out through a nationwide network of audits, 
investigations, and inspections conducted by the following operating components: 
Office of Audit Services 
The Office of Audit Services (OAS) provides all auditing services for HHS, either by 
conducting audits with its own audit resources or by overseeing audit work done by others. 
Audits examine the performance of HHS programs and/or its grantees and contractors 
in carrying out their respective responsibilities and are intended to provide independent 
assessments of HHS programs and operations in order to reduce waste, abuse, and 
mismanagement and to promote economy and efficiency throughout HHS. 
Office of Evaluation and Inspections 
The Office of Evaluation and Inspections (OEI) conducts management and program 
evaluations (called inspections) that focus on issues of concern to HHS, Congress, and 
the public.  The findings and recommendations contained in the inspections generate 
rapid, accurate, and up-to-date information on the efficiency, vulnerability, and 
effectiveness of departmental programs.  OEI also oversees State Medicaid Fraud 
Control units which investigate and prosecute fraud and patient abuse in the Medicaid 
program. 
Office of Investigations 
The Office of Investigations (OI) conducts criminal, civil, and administrative 
investigations of allegations of wrongdoing in HHS programs or to HHS beneficiaries 
and of unjust enrichment by providers.  The investigative efforts of OI lead to criminal 
convictions, administrative sanctions, or civil monetary penalties. 
Office of Counsel to the Inspector General 
The Office of Counsel to the Inspector General (OCIG) provides general legal services to 
OIG, rendering advice and opinions on HHS programs and operations and providing all 
legal support in OIG's internal operations. OCIG imposes program exclusions and civil 
monetary penalties on health care providers and litigates those actions within HHS. 
OCIG also represents OIG in the global settlement of cases arising under the Civil False 
Claims Act, develops and monitors corporate integrity agreements, develops compliance 
program guidances, renders advisory opinions on OIG sanctions to the health care 
community, and issues fraud alerts and other industry guidance.    E X E C U T I V E   S U M M A R Y  

OBJECTIVES 
1. 	 To describe the nature of outside activities for which Food and Drug 
Administration (FDA) employees received approval between 
2000 and 2003. 
2. 	 To determine the extent to which FDA senior-level employees 
provided required information on their outside activity request 
forms and financial disclosure statements between 2000 and 2003. 
3. 	 To assess FDAs process for reviewing outside activity requests 
between 2000 and 2003. 
BACKGROUND 
In general, employees of the Department of Health and Human Services 
(HHS) are allowed to work privately with non-Federal entities on their 
personal time through outside activities, which in some cases require 
prior approval.  Examples of outside activities include consulting, 
teaching, speaking, and writing related to official duties.  These 
activities must not conflict with employees official duties.  Employees 
may be financially compensated for these activities.  Outside activities 
must be approved in accordance with regulations issued by the Office of 
Government Ethics and supplemental rules issued by HHS. 
The media and Congress have recently paid increased attention to the 
oversight of outside activities within HHS. A December 2003 
investigative report in The Los Angeles Times raised concerns regarding 
the ethics program at the National Institutes of Health (NIH).  In a 
hearing conducted by the U.S. House of Representatives Committee on 
Energy and Commerce that focused on the NIH, an FDA employee was 
called to testify regarding his approved participation in an outside 
activity with a significantly regulated organization.  Certain FDA 
employees are prohibited from working with significantly regulated 
organizations, which are entities whose products are regulated by FDA. 
In June 2004, FDA completed an internal review of all ongoing outside 
activities to determine whether they complied with applicable laws and 
regulations.  To further ensure the integrity of the FDA review process 
for outside activities, the Committee on Energy and Commerce 
requested that the Office of Inspector General conduct an independent 
review of FDAs oversight of outside activities. 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  i  EE XX EE CC UU TT II VV EE    SS UU MM MM AA RR YY
The Ethics and Integrity Staff within FDAs Office of the Commissioner, 
Office of Management, implements and oversees the ethics program at 
FDA, which includes providing oversight of outside activities and the 
filing of financial disclosure statements that collect details on 
employees assets, income, liabilities, and outside activities. FDA, 
through the Ethics and Integrity Staff, takes a decentralized approach 
to the review and approval of outside activities, delegating the review 
and approval authority to the eight offices and centers within FDA, 
hereafter referred to as centers. 
When an employee seeks to participate in an outside activity, he or she 
submits an outside activity request (the HHS-520 form) to his or her 
supervisor. The supervisor makes a recommendation regarding 
whether the activity should be approved and then forwards the form to 
staff reviewers who provide additional review before forwarding it to the 
final approving official, who determines whether the activity will be 
approved. 
We reviewed FDAs database of all outside activity requests employees 
submitted between 2000 and 2003. We also conducted a retrospective 
review of all outside activity requests and supporting documentation 
that senior-level employees submitted to FDA between January 1, 2000, 
and December 31, 2003. We defined senior-level employees to be those 
who, as of January 2004, were required to file Standard Form 278 
public disclosure financial forms. We only reviewed requests that were 
received by FDA; we did not assess whether employees conducted any 
additional outside activities that were not reported in requests to FDA. 
We also interviewed the staff in each center identified by FDA as the 
most knowledgeable about the outside activity review process between 
2000 and 2003. Finally, we reviewed written procedures related to 
outside activities from the eight centers. 
NATURE OF OUTSIDEACTIVITIES 
Eleven percent of all FDA employees received approval for a total of 
2,592 outside activities between calendar years 2000 and 2003. Of 
the 13,973 employees at FDA as of the end of fiscal year 2003, 
1,571 employees received approval to participate in outside activities 
between 2000 and 2003. Most employees participated in only one 
activity. Eighty percent of the activities were conducted by employees 
who file confidential financial disclosure forms. The most common types 
OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  ii  E X E C U T I V E   S U M M A R Y  
of outside activities involved teaching, lecturing, speechwriting, and 
presenting. 
Twenty-six percent of FDA senior-level employees received approval 
for a total of 55 outside activities between calendar years 2000 and 
2003.  Of the 90 senior-level employees at FDA as of January 2004,     
23 received approval to participate in outside activities between 2000 
and 2003.  Most senior-level employees participated in one or two 
outside activities, and most of the activities were not compensated.  
The most common types of outside activities for senior-level employees 
involved serving on boards or writing and editing.  Forty percent of 
senior-level employees approved activities were performed during time 
off from work. 
VULNERABILITIES 
Limited information inhibits FDAs ability to effectively review 
outside activity requests. 
o 	 Complete information allows FDA reviewers to effectively assess 
the appropriateness of proposed outside activities and to identify 
potential conflicts of interest.  Of the 55 approved outside 
activities for senior-level employees, all but 3 were missing at 
least 1 piece of information required on the HHS-520 form. 
o 	 Although nearly all of the forms had deficiencies, most of these 
omissions, considered independently, appeared to be minor. 
However, the extent and frequency of these deficiencies in the 
forms we reviewed raise systemic concerns about how FDA 
collects and reviews information regarding employees outside 
activities. 
o 	 Even when required information was provided, it was often 
limited.  The information contained in the senior-level employees 
outside activity requests reviewed often contained vague or 
minimal information, or lacked position descriptions or 
documentation regarding the details of the outside activities. 
o 	 Outside activities of senior-level employees were not disclosed as 
required on annual financial disclosure forms 46 percent of the 
time. 
o 	 Limited information made it difficult for our reviewers to identify 
potential conflicts of interest and to determine the 
appropriateness of several activities of senior-level employees. 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  iii  EE XX EE CC UU TT II VV EE    SS UU MM MM AA RR YY
Inadequacies in the review process limit FDAs ability to effectively 
review outside activity requests. 
o 	 FDA policies and procedures do not fully address many key 
aspects of the process. 
o 	 Twenty-three of the fifty-five outside activity requests we 
reviewed for senior-level employees were approved after the start 
date. Seven activities were approved for longer than the 5-year 
maximum period allowed at the time of our review. In three 
instances, forms with multiple activities were approved. 
o 	 We did not find written recusals for any of the senior-level 
employees outside activities. However, we were not able to 
determine whether written recusals were required. No center 
routinely notified supervisors of approved outside activity 
requests. 
o 	 Staff in the eight centers do not receive specialized training 
regarding the review of outside activity requests. At five of the 
eight centers, the function of review of outside activities was a 
collateral duty for staff responsible for determining the 
completeness of information on the request forms. 
RECOMMENDATIONS 
We identified numerous problems regarding inadequate documentation 
and insufficient processes and procedures that may hinder the ability of 
reviewers to assess the appropriateness of the outside activities. 
Considered together, these vulnerabilities indicate the importance of 
continued vigilance to ensure the integrity of the review process. We 
recognize that both HHS and FDA have several initiatives planned or 
underway. The effectiveness of FDAs new system for reviewing outside 
activities will continue to be dependent on the quality of information 
submitted and the adequacy of the review process. We make the 
following recommendations to FDA on ways to improve and ensure the 
integrity of its review process for outside activities: 
Improve the quality and extent of information for outside activities. 
o 	 Require all employees to submit additional details on the nature 
of their proposed outside activities and their current official 
duties. 
OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  iv  EE XX EE CC UU TT II VV EE    SS UU MM MM AA RR YY
o 	 Ensure that all employees fill out their outside activity requests 
completely. 
o 	 Cross-check financial disclosure forms with those employees 
outside activities for the previous year. 
Address the inadequacies in the review process for outside 
activities. 
o 	 Develop complete policies and procedures on outside activities for 
all centers and employees. 
o 	 Ensure that outside activity requests are approved before their 
scheduled start dates. 
o 	 Ensure that activities are approved for periods not exceeding the 
maximum amount of time allowed by HHS or FDA. 
o 	 Ensure that each outside activity receives its own separate 
review. 
o 	 Require recusals, if needed, to be made in writing and 
disseminated to immediate supervisors and other key personnel 
for all outside activities that are related to employees official 
duties. 
o 	 Ensure that supervisors are notified of all approvals and 
disapprovals. 
o 	 Enhance training related to outside activities. 
o 	 Consider centralizing some or all aspects of the review process for 
outside activities. 
SUMMARY OFAGENCY COMMENTS 
In its comments, FDA notes a variety of HHS and agency initiatives 
that address the recommendations we made, including the revised 
HHS-520 and new written policies and procedures. 
One area with which FDA clearly takes issue is our discussion of 
recusals. FDA points out that the HHS-520 form itself provides 
information on recusal obligations to employees, and that by 
recommending approval of an outside activity, a supervisor 
acknowledges that an employee will recuse himself or herself 
whenever appropriate. FDA also suggests that our recommendation 
regarding recusals implies that when a written recusal is made, an 
OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  v  E X E C U T I V E   S U M M A R Y  
activity that otherwise would not be approved because of a conflict of 
interest becomes approvable. 
OFFICE OF INSPECTOR GENERAL RESPONSE 
While this review was underway, both HHS and FDA announced or 
implemented initiatives aimed at strengthening the review process for 
outside activities.  We recognize that the revised supplemental 
regulations and FDAs forthcoming policies and procedures address 
some of the recommendations we make in this report.  We encourage 
HHS and FDA to continue their efforts to improve the outside activities 
review process. 
In response to FDAs concerns about recusals, we reiterate that written 
recusals, when necessary, are protective of employees who are 
participating in outside activities.  The process of an employee writing a 
separate recusal statement and the supervisor reviewing that statement 
provides an opportunity for important, deliberate discussion and 
planning that may not arise in the absence of a written statement. 
Under no circumstances should FDA approve outside activities that 
pose conflicts of interest, and in fact, we found no evidence that it has. 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  vi    T A B L E   O F   C O N T E N T S  

EXECUTIVE SUMMARY ........................................  i

INTRODUCTION ................................................ 1 

NATURE OF OUTSIDE ACTIVITIES .......................... 9 

VULNERABILITIES ............................................ 12 

Limitedinformation on outsideactivities  . . . . . . . . . . . . . . . . . . .  12

Inadequacies in the review process  . . . . . . . . . . . . . . . . . . . . . . . .  16

RECOMMENDATIONS ......................................... 20 

SUMMARY OF AGENCY COMMENTS ........................ 26 

OFFICE OF IN SPECTOR GENERAL RESPONSE ........... 26 

ENDNOTES ..................................................... 28 

APPENDIXES .................................................. 32 

A:  Methodology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  32

B:  Natureof Outside Activities . . . . . . . . . . . . . . . . . . . . . . . . . . .  38

C:  ErrorsFound on Outside Activity Requests. . . . . . . . . . . . . . .  50

D:  HHS and FDA Initiatives.  . . . . . . . . . . . . . . . . . . . . . . . . . . . .  52

E:  AgencyComments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  54

ACKNOWLEDGMENTS ......................................... 60
   I N T R O D U C T I O N  

OBJECTIVES 
1. 	 To describe the nature of outside activities for which Food and Drug 
Administration (FDA) employees received approval between 
2000 and 2003. 
2. 	 To determine the extent to which FDA senior-level employees 
provided required information on their outside activity request 
forms and financial disclosure statements between 2000 and 2003. 
3. 	 To assess FDAs process for reviewing outside activity requests 
between 2000 and 2003. 
BACKGROUND 
Federal employees hold positions of public trust and are accountable for 
the responsible use of public funds.  As such, the public expects Federal 
employees actions and decisions to demonstrate integrity and 
objectivity. Therefore, pursuant to congressional mandate, the Office of 
Government Ethics (OGE) has put into place an ethics program that 
addresses a broad array of topics, including employees outside 
activities. Each department in the executive branch is responsible for 
implementing its ethics program. 
In general, employees of the Department of Health and Human Services 
(HHS) are allowed to work and interact privately with non-Federal 
entities on their personal time through outside activities, which in some 
cases require prior approval.  Examples of outside activities include 
consulting, teaching, speaking, and writing related to employees official 
duties. These activities must not conflict with employees official duties, 
and may or may not involve financial compensation. 
Outside activities are not necessarily related to employees professions, 
but some outside activities provide employees of FDA with opportunities 
to work with industry, academia, hospitals, and nonprofit organizations 
to help enhance knowledge and foster scientific discoveries.  Some 
outside activities can allow FDA employees to build and maintain their 
professional expertise. Outside activities can also provide opportunities 
for FDA employees to maintain licensures or certifications.   
Certain outside activities may create actual or apparent conflicts of 
interest for employees.  Pursuant to 18 U.S.C.  208(a), an actual 
conflict of interest arises when an employee personally and 
substantially participates, in an official capacity, in a particular matter 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  1  I N T R O D U C T I O N  
in which he or she has a personal or imputed financial interest, if the 
matter will have a direct and predictable effect on that interest.  
Additionally, pursuant to 5 CFR  2635.502, the appearance of a loss of 
impartiality arises when an employee participates, in an official 
capacity, in a matter in which he has certain defined associations or 
interests that would cause a reasonable person . . . to question his 
impartiality in the matter. 
Recent Concerns Regarding Outside Activities Within HHS 
The media and Congress have recently paid increased attention to the 
oversight of outside activities within HHS. A December 2003 
investigative report in The Los Angeles Times raised concerns regarding 
the ethics program at the National Institutes of Health (NIH).1  The Los 
Angeles Times article alleged that the approval of consulting 
arrangements for several senior-level scientists at NIH had created 
serious conflicts of interest that may have biased agency decisions. 
These allegations resulted in a number of internal and external 
inquiries, including several congressional hearings, into potential 
conflicts of interest arising from outside activities at NIH. 
In a hearing conducted by the U.S. House of Representatives Committee 
on Energy and Commerce that focused on NIH, an FDA employee was 
called to testify regarding his approved participation in an outside 
activity with a significantly regulated organization.  Certain FDA 
employees are prohibited from working with significantly regulated 
organizations, which are organizations whose products are regulated by 
FDA (see pages 45 for more information).  FDA indicated, in a 
prepared statement submitted to the committee, that at the time of 
approval the organization was not significantly regulated, but that the 
organizations status had changed during the course of the activity.  
After learning of this case, FDA conducted an internal review of all 
ongoing outside activities to determine whether they complied with 
applicable laws and regulations.  To further ensure the integrity of the 
FDA review process for outside activities, the Committee on Energy and 
Commerce requested that the Office of Inspector General (OIG) conduct 
an independent review of FDAs oversight of outside activities. 
Requirements for Outside Activities at FDA 
Office of Government Ethics. OGE was established by the Ethics in 
Government Act of 1978, 5 U.S.C. App.  OGE oversees ethics programs 
at all executive branch agencies.  In October 1992, OGE promulgated 
Governmentwide Standards of Ethical Conduct for Employees of the 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  2  I N T R O D U C T I O N  
Executive Branch, which became effective on February 3, 1993, and 
include Subpart H on outside activities.2 OGE regulations require 
employees to comply with 18 U.S.C.  209, which bars employees from 
accepting outside compensation for work conducted in an official 
capacity.3  OGE regulations also prohibit employees from engaging in 
outside activities, both compensated and uncompensated, that would 
conflict with those employees official duties to such a degree that they 
would have to be disqualified from performing essential parts of their 
jobs.4  Further, employees are required to endeavor to avoid actions that 
would create any appearance of violating the standards of ethical 
conduct.5 
Although OGE promulgates the rules that provide a general framework 
for ethical conduct, it delegates to individual departments the authority 
to permit particular kinds of outside activities and/or to require prior 
approval for outside activities.  However, OGE does conduct routine 
audits of agencies ethics programs to ensure compliance with applicable 
regulations. OGE conducted such a review of FDAs ethics program in 
2004. 
OGE also oversees Government financial disclosure requirements.   
Certain executive branch employees, including some FDA employees, 
must disclose their compensated outside activities on annual financial 
disclosure forms.  Financial disclosure may be public or confidential, 
depending on an employees pay schedule and grade. 
Employees for whom the minimum base pay in their pay band is equal 
to or greater than 120 percent of the minimum rate of base pay for the 
GS-15, and certain other designated officials such as Presidential 
appointees and members of the uniformed services above a certain pay 
grade, must annually file the public financial disclosure form, the 
Standard Form (SF)-278.6  An agency may also propose that OGE 
require filing of the SF-278 for additional positions, through a process 
known as equal classification.  An agency would propose equal 
classification if it could demonstrate that the responsibilities and 
influence of certain positions were equivalent to those of employees in 
other agencies or components who, by virtue of their salary structures, 
were required to file the SF-278. When equal classification is granted, 
employees in those positions must file the SF-278. 
The SF-278 form captures all outside sources of assets worth at least 
$1,000, as well as outside income and liabilities, along with the financial 
value for each item.  Also, the SF-278 captures all compensated outside 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  3  I N T R O D U C T I O N  
activities for which the income is greater than $200 and certain 
compensated and uncompensated positions. 
Other employees who do not file the SF-278 but who hold positions of 
significant decisionmaking authority, as determined by FDA, are 
required to annually file the confidential financial disclosure form, the 
OGE-450.  Recently, FDA expanded the number of employees who are 
required to annually file the OGE-450.7  This form captures certain 
assets worth at least $1,000; income, liabilities, and outside activities 
for which compensation exceeds $200; and certain compensated and 
uncompensated positions. However, the OGE-450 form does not require 
employees to disclose the precise financial values of these items. 
In fiscal year 2003, 54 percent of FDA employees were required to file 
one of these financial disclosure forms.  Employees who do not meet the 
criteria for either the SF-278 or the OGE-450 do not file any annual 
financial disclosure forms. 
Department of Health and Human Services.  Agencies may impose, with 
OGE concurrence, additional limitations on outside activities.  In 1996, 
HHS promulgated the HHS Supplemental Standards of Ethical Conduct 
for employees.8  The HHS supplemental regulations prohibit HHS 
employees from engaging in any compensated employment related to 
HHS-funded activities; they also prohibit employees from providing 
consultative or professional services for compensation in preparing 
grant applications, contract proposals, and certain other documents for 
submission to HHS.  In addition, the regulations require employees to 
request and receive written approval for certain outside activities prior 
to engaging in those outside activities.  The types of activities that 
trigger the prior approval requirement include, but are not limited to:  
(1) providing consultative or professional services; (2) teaching, 
speaking, writing, or editing that relates to official duties or results 
from contact with certain prohibited sources; and (3) serving on certain 
boards or advisory bodies.9 
The HHS supplemental regulations provide additional restrictions on 
relationships between FDA employees and significantly regulated 
organizations.10  The regulations define significantly regulated 
organizations as organization[s] for which the sales of products 
regulated by the Food and Drug Administration (FDA) constitute ten 
percent or more of annual gross sales in the organizations previous 
fiscal year; where an organization does not have a record of sales of 
FDA-regulated products, it will be deemed to be significantly regulated 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  4  I N T R O D U C T I O N  
if its operations are solely in fields regulated by FDA.11  With limited 
exceptions, FDA employees and their spouses and children are 
prohibited from having financial interests in significantly regulated 
organizations. In addition, FDA employees who are required to file 
annual financial disclosure forms are also generally prohibited from 
participating in outside activities with significantly regulated 
organizations. Finally, all FDA employees are required to obtain prior 
approval before engaging in any outside employment or self-employed 
business activity.12 
In February 2005, HHS issued, with OGE concurrence, an interim final 
rule that revised portions of the HHS supplemental regulations.13 
Previously, the HHS supplemental regulations stipulated that outside 
activities shall be approved unless they violated a statutory or 
regulatory requirement.  Under the interim final rule, however, the 
standard for approval is higher. Previously, the regulations stated that, 
Approval shall be granted unless it is determined that the outside 
employment or other outside activity is expected to involve conduct 
prohibited by statute or Federal regulation . . . .14  However, the 
interim final rule established a higher standard for approval:  Approval 
shall be granted only upon a determination that the outside 
employment or other outside activity is not expected to involve conduct 
prohibited by statute or Federal regulation . . . .15  Our review was 
conducted prior to the interim final rule; therefore, our findings are 
based on the previous version of the supplemental regulations. 
Outside Activity Approval Process at FDA 
The Ethics and Integrity Staff within FDAs Office of the Commissioner, 
Office of Management, implements and oversees the ethics program at 
FDA, which includes providing oversight of outside activities and the 
filing of financial disclosure statements.  During the period of our 
review, FDAs Deputy Ethics Counselor delegated the authority to 
approve outside activity request forms to the Ethics and Integrity Staff. 
The Ethics and Integrity Staff took a decentralized approach to the 
review of outside activities, delegating the review authority to the eight 
offices and centers within FDA, hereafter referred to as centers.16 
Outside activity requests. Generally, the review process for outside 
activity requests begins when an employee completes and submits a 
Request for Approval of Outside Activity form, the HHS-520. All full-
time and part-time HHS employees who wish to engage in certain 
outside activities must complete this document. The HHS-520 collects 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  5  I N T R O D U C T I O N  
information on an employees position, the nature of the proposed 
outside activity, the period of time over which the outside activity will 
be performed, and the method of compensation; it thereby helps 
reviewers determine whether a proposed outside activity may pose a 
real or apparent conflict of interest.  As of January 2004, the amount of 
compensation must also be provided, pursuant to a HHS-wide directive 
from the Designated Agency Ethics Official.17  This official has authority 
delegated from the Secretary of HHS to oversee the HHS ethics 
program. Further, in April 2005, HHS released a new version of the 
HHS-520, which requires employees to provide additional information 
regarding their requests for outside activities.  Our review covered 
requests submitted prior to these changes. 
The review process for outside activities has also changed since the 
period of our review, calendar years (CY) 2000 through 2003.  In this 
report, we capture the review process that was in place during the 
period of our review.  Although this process varied across the eight 
centers, generally an employee submitted the HHS-520 form to his or 
her supervisor, who performed an initial review and recommended 
whether the request should be approved.  Staff reviewers in the centers, 
typically program or management analysts, then saw and reviewed the 
request before forwarding it to the final approving official, who made 
the final determination regarding approval.18  The final approving 
official was typically the center director but, during the period of our 
review, final approving officials often delegated the final approving 
authority to members of their staffs, often the staff reviewers in the 
centers.  However, as of June 2004, FDA required center directors to 
provide the final review of all requests, and no longer permitted them to 
delegate this authority.19 Throughout this report, we use the general 
term reviewers to refer to all of the individuals who have roles in the 
outside activity review process, which includes supervisors, staff 
reviewers, and final approving officials. 
As stated previously, regulations generally prevent FDA employees who 
are required to file annual financial disclosure reports from engaging in 
outside activities that involve significantly regulated organizations.  
The list of these organizations, referred to as the yellow book, is updated 
annually by the Ethics and Integrity Staff.   
After requests have been approved or disapproved, centers forward 
HHS-520 forms to FDAs Ethics and Integrity Staff, who maintain a 
database of all outside activity requests.   
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  6  I N T R O D U C T I O N

METHODOLOGY 
Our review is based on four data sources:  (1) FDAs database of outside 
activities, (2) a file review of outside activity requests and related 
documentation, (3) interviews, and (4) a procedure review.  (For a 
complete description of our methodology, see Appendix A.)   
We analyzed FDAs database of all outside activity requests submitted 
between CYs 2000 and 2003 to make summary statements about the 
number and nature of outside activities at FDA as a whole. 
We chose the timeframe between CYs 2000 and 2003 because it allowed 
us to examine trends by year.  We did not include CY 2004 because 
complete data were not available and some outside activities policies 
and procedures changed during CY 2004.   
For our file review, we conducted a retrospective review of all outside 
activity requests that senior-level employees submitted for approval 
between CYs 2000 and 2003.  We defined senior-level employees to be 
those who were required to file SF-278 public disclosure forms as of 
January 2004. FDA provided us with a list of 90 employees who met 
that criterion.  This group of senior-level employees included, but was 
not limited to, center and office directors and deputy directors. 
Our file review included three methodologies:  (1) a descriptive review, 
(2) a completeness review, and (3) a compliance review. For the 
descriptive review, we tallied the number and nature of the outside 
activity requests overall and conducted trend analyses of the approved 
activities. One limitation of this review is that it may have been subject 
to underreporting, as we did not assess whether employees conducted 
any additional outside activities between CYs 2000 and 2003 that were 
not reported to FDA in outside activity requests. For the completeness 
review, we calculated the extent to which the required documentation 
was filled out completely and correctly. 
For the compliance review, two OIG analysts, and when necessary a 
third, independently assessed each approved outside activity using a set 
protocol and documented whether the activity appeared to be allowable 
under existing requirements.  A limitation of this review is that we 
made our assessments based solely on the documentation provided by 
FDA and did not follow up with employees or reviewers for further 
details on the outside activities. 
We also interviewed the employees in each center who were identified 
by FDA as being those most knowledgeable about the review process in 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  7  I N T R O D U C T I O N  
the centers between CYs 2000 and 2003.  These employees are typically 
program and management analysts in the centers (we refer to them 
throughout this report as staff reviewers).  We used a structured 
questionnaire to conduct the interviews.  Questions addressed topics 
such as centers procedures for reviewing outside activity requests and 
challenges staff reviewers face in reviewing outside activity requests. 
Finally, we requested operating procedures related to outside activities 
from all centers.  We assessed and compared these documents.   
We conducted this inspection in accordance with the Quality Standards 
for Inspections issued by the Presidents Council on Integrity and 
Efficiency and the Executive Council on Integrity and Efficiency. 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  8    N A T U R E   O F   O U T S I D E   A C T I V I T I E S

In this section we provide a summary of the number and types of 
outside activities in which FDA employees participated between 
CYs 2000 and 2003.  We start with a summary of all employees, then 
address senior-level employees.  For more information on the nature of 
FDA employees outside activities, see Appendix B. 
Eleven percent of all FDA employees received 
approval for a total of 2,592 outside activities 
between CYs 2000 and 2003 
FDA approved all but 14 outside activity requests 
o 	 Of the 13,973 employees at FDA as of the end of fiscal year 2003,    
1,576 employees requested approval for 2,606 outside activities 
between CYs 2000 and 2003.  FDA approved 2,592 outside activity 
requests for 1,571 employees.  It is not surprising that most 
activities were approved; departmental supplemental regulations 
at the time the requests were submitted stipulated that outside 
activity requests are to be approved unless they violated statute 
or regulation.20 
Most employees received approval for one outside activity, but a few 
received approval for more than five 
o 	 Of the 1,571 employees who received approval for outside 
activities between CYs 2000 and 2003, 68 percent received 
approval for just 1 activity, and another 20 percent received 
approval for 2 activities. 
o 	 Three percent of employees participated in more than five 
activities between CYs 2000 and 2003. The maximum was 
38 approved outside activities for 1 employee. 
Employees who filed the confidential financial disclosure statement 
accounted for 80 percent of the approved outside activities 
o 	 Employees who did not file financial disclosure statements 
accounted for 18 percent of the approved outside activities, and 
employees who filed public financial disclosure statements 
accounted for the remaining 2 percent. 
Employees at the two largest centers accounted for 60 percent of the 
approved outside activities 
o 	 Employees at the Center for Drug Evaluation and Research 
received approval for 812 outside activities, and employees at the 
OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES	 9  N A T U R E   O F   O U T S I D E   A C T I V I T I E S  
Office of Regulatory Affairs received approval for 750 approved 
outside activities, between CYs 2000 and 2003. 
The most common types of approved outside activities involved teaching, 
lecturing, speechwriting, and presenting 
o 	 FDA characterized 19 percent of approved outside activities as 
involving teaching, lecturing, speechwriting, and presenting.  
Seventeen percent involved activities characterized by FDA as 
miscellaneous activities, including self-employment.  Fourteen 
percent involved providing consultative or professional services.21 
Twenty-six percent of FDA senior-level 
employees received approval for a total of   
55 outside activities between CYs 2000 and 2003 
FDA approved all 55 outside activity requests made by senior-level 
employees 
o 	 Of the 90 senior-level employees at FDA as of January 2004,  
23 submitted 55 outside activity requests.  FDA approved all of 
them. 
Most of the 23 senior-level employees with approved outside activities 
received approval for 1 or 2 outside activities 
o 	 Of the 23 senior-level employees who received approval for outside 
activities, 14 received approval for only 1 or 2 outside activities 
between CYs 2000 and 2003.  The maximum was five approved 
outside activities for one employee. 
Senior-level employees at three centers accounted for 64 percent of the 
approved outside activities for senior-level employees 
o 	 Senior-level employees at the Center for Food Safety and Applied 
Nutrition received approval for 15 outside activities; senior-level 
employees at the Center for Drug Evaluation and Research and 
the Center for Veterinary Medicine each received approval for   
10 outside activities. 
The most common types of approved outside activities for senior-level 
employees involved serving on a board or writing and editing 
o 	 Thirty-six percent of the approved outside activities for senior-
level employees involved serving on a board.  Another 20 percent 
involved writing and editing. 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  10  N A T U R E   O F   O U T S I D E   A C T I V I T I E S  
The most common venues for senior-level employees outside activities 
were journals and other publications, professional societies, and 
universities 
o 	 Journals and other publications, professional societies, and 
universities each accounted for 20 percent of the approved outside 
activities for senior-level employees. 
o 	 None of the activities involved the biotechnology or 
pharmaceutical industries or any significantly regulated 
organizations. 
Fifty-eight percent of approved outside activities for senior-level employees 
involved no compensation 
o 	 For the 20 activities that did involve compensation, the most 
common form was reimbursement for travel and expenses. 
Forty percent of approved outside activities for senior-level employees 
involved time off, and 29 percent of these activities involved a week or more 
of time off 
o 	 Senior-level employees indicated that they would take time off to 
perform 22 outside activities.  For those 22 activities, employees 
indicated that they would take between 1 and 36 business days 
off. The median amount of time off was 7 business days per 
activity. 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  11  V U L N E R A B I L I T I E S  
  V U L N E R A B I L I T I E S  
Limited information inhibits FDAs ability to 

effectively review outside activity requests 

Of the 55 approved outside activities for senior-level employees, all but     
3 were missing at least 1 piece of information required on the HHS-520 form 
Although nearly all of the forms had deficiencies, most of these 
omissions, considered independently, appeared to be minor. However, 
the extent and frequency of these deficiencies raise systemic concerns 
about how FDA collects and reviews information regarding employee 
outside activities.  The areas highlighted in this section represent some 
of the more serious omissions or errors.  Appendix C contains a complete 
listing of deficiencies on the outside activity requests.  
When the information provided on outside activity request forms is 
incomplete, it becomes more difficult for supervisors, staff reviewers, 
and final approving officials to identify and address potential concerns.  
The information contained on the HHS-520 is, at FDA, the only 
information that employees are required to provide when they request 
approval for outside activities.  Complete information allows FDA 
reviewers to consider potential conflicts of interest and make informed 
recommendations with regard to approval. 
Several items on the HHS-520 solicit information that is used to provide 
assurance that potential conflicts of interest, prohibited by regulations, 
are not present in proposed activities.  Forms were often missing 
responses to these items.  Seven requests were missing statements 
about whether compensation would be derived from HHS grants or 
contracts.  Five requests were missing statements about whether would-
be associates would be seeking grants from Federal agencies. One 
request was missing a statement that the outside activity did not 
conflict with official duties. 
Though all centers use the same HHS-520 form, internal processing 
policies and procedures vary from center to center.  Three of eight 
centers explicitly state in their procedures that forms submitted for 
approval should always be complete, and as we have noted, complete 
information is crucial for making informed decisions on outside activity 
requests. FDA staff reviewers at six of eight centers described forms 
not being filled out completely or adequately as a moderate or minor 
challenge.22 
We also found a number of examples of supervisors failing to provide 
required information on the forms. Four requests were missing the 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  12  V U L N E R A B I L I T I E S  
supervisors signatures. Seven requests were missing supervisors 
recommendations regarding approval.  The supervisor is responsible for 
verifying that proposed outside activities do not overlap with employees 
official duties.  The result of this substantive review is a 
recommendation to the final approving official on whether requests 
should be approved. 
Nine requests were missing the signature of the final approving official, 
and 14 were missing the final approving officials decision regarding 
approval.  All five centers that have written procedures on outside 
activities detail the appropriate signature and approval processes for 
outside activity requests in those procedures. 
Nine requests were missing the second page of the HHS-520.  This page 
contains space for reviewers to comment on the requests.  This page also 
generally contains a signed statement that the employee received the 
Notice to Applicants for Prior Approval of Outside Activities and the 
Excerpts from the Standards of Ethical Conduct for Employees of the 
Executive Branch and the Department of Health and Human Services 
Supplemental Agency Ethics Regulations, which summarize the 
responsibilities of employees who are engaged in outside activities. 
When request forms are incomplete, the staff reviewers must follow up 
to obtain complete information on proposed outside activities.  At two of 
the eight centers, the FDA staff reviewers we interviewed indicated that 
they always or often follow up with employees for additional 
information during the review process; staff reviewers at another two 
centers indicated that they sometimes follow up with employees for 
more information. 
Even when required information was provided, it was often limited 
In our review of senior-level employees outside activity requests, we 
often encountered information that was vague or otherwise limited.  
Based on the limited nature of information provided on the HHS-520 
forms, it was often not possible for our reviewers to determine what 
tasks were involved in the proposed outside activities or how those tasks 
related to employees official duties; therefore, it was difficult to 
determine whether the activities were appropriately approved for these 
senior-level employees. At least 1 of our reviewers needed more 
information on employees job duties for 53 of the cases reviewed, and at 
least 1 reviewer needed more information on the nature of employees 
proposed outside activities for 50 of the cases reviewed.  For all 
requests, at least one reviewer needed more information on the 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  13  VV UU LL NN EE RR AA BB II LL II TT II EE SS  
difference between employees official duties and the proposed outside 
activities. For 49 of the cases reviewed, at least 1 reviewer wanted 
additional information on the outside organizations with which the 
employees would be working. 
Beyond the HHS-520 form, FDA does not require additional 
documentation that could be useful for the supervisors, staff reviewers, 
and final approving officials. Only eight of the senior-level employees 
requests had additional information attached. Of these eight, four 
requests included letters of invitation, three included correspondence 
related to the outside engagements, and one included additional 
information on the outside organization. No position descriptions or job 
billets were attached to any requests. Information contained in these 
types of attached documents can provide important context to FDA 
reviewers. 
To address concerns about inadequately detailed requests, the HHS 
Designated Agency Ethics Official recently reminded officials 
throughout HHS of the importance of performing due diligence when 
reviewing ethics forms. In a memo, this official stated that: 
Performing due diligence that is appropriate to the circumstances 
should be a standard operating procedure. Conduct internet searches, 
make phone calls to the entities involved, talk to the employees, elicit 
responses from them . . . .23 
Outside activities of senior-level employees were not disclosed as required 
on annual financial disclosure forms 46 percent of the time 
Regulations require employees who file annual financial disclosure 
reports to disclose any outside activities in each year they are engaged 
in the outside activities.24 
However, supervisors, staff reviewers, and final approving officials in 
the centers do not oversee the employees annual financial disclosure 
statements and therefore cannot reconcile outside activity requests with 
financial disclosure forms. Recently, FDA announced that it will be 
reconciling employees outside activity requests and financial disclosure 
statements annually.25 
Limited information made it difficult for our reviewers to determine the 
appropriateness of several activities of senior-level employees 
Determining whether an outside activity comported with pertinent 
ethics regulations required a judgment based on limited information. 
To increase the consistency of this judgment, two OIG reviewers 
independently reviewed each outside activity request to assess its 
OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  14  VV UU LL NN EE RR AA BB II LL II TT II EE SS  
appropriateness. A third and final reviewer resolved cases in which the 
two initial reviewers disagreed. 
Our review included all available documentation associated with these 
activities for senior-level employees, as provided by FDA. However, it is 
important to point out that these documents do not necessarily include 
all facts known to or considered by the FDA reviewers at the time of 
their reviews. FDA staff reviewers indicated that they sometimes 
conduct additional research to get information about proposed activities. 
Reviewers may also have additional information and knowledge 
regarding particular center employees official duties. 
In no instance was the documentation we reviewed adequate for us to 
make a definitive determination regarding whether an activity was 
appropriate. As demonstrated in this section, the information contained 
in the documentation for outside activity requests was often minimal, 
which made it difficult to determine whether activities were 
appropriate. Therefore, based upon the information contained on the 
forms alone, we could not state with certainty that any activity was or 
was not allowable. Instead, we made one of three determinations for 
each activity: (1) appears to be allowable, (2) appears not to be 
allowable, or (3) cannot determine. 
For cases in which the documentation did not suggest any violation of 
the regulations, our reviewers identified activities as appears to be 
allowable, even if more information would be necessary to definitively 
determine that they were in fact allowable. Our reviewers would only 
have identified activities as appears not to be allowable if the 
documentation suggested any violations of the regulations. Finally, our 
reviewers identified activities as cannot be determined when the 
information available was so incomplete that they were unable to make 
a determination, or when the information available raised concerns that 
the activity may have violated the regulations. 
None of the outside activity requests we reviewed involved significantly 
regulated organizations. Ultimately, our reviewers determined that 
44 activities appeared to be allowable and none appeared not to be 
allowable; however, our reviewers could not determine the 
appropriateness of the remaining 11 activities because the information 
provided was so incomplete or the forms were filled out incorrectly. 
Inadequate documentation for outside activities can, intentionally or 
unintentionally, obscure potential violations. If reviewers conduct 
additional research on requests, they may uncover and resolve those 
OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  15  V U L N E R A B I L I T I E S  
potential problems before violations occur, but this may not happen in 
every case. We forwarded the 11 activities for which we could not make 
determinations on appropriateness to FDA for further review.  FDA 
determined through additional review that all of these 11 activities 
were allowable. 
Inadequacies in the review process limit FDAs ability  In this section, we describe several 
to effectively review outside activity requests  inadequacies in the review process 
for outside activities. In many 
cases, neither FDA policies nor center procedures address these issues. 
Approvals after the start date 
FDA approved 23 of the 55 outside activity requests we reviewed for 
senior-level employees after the start dates listed on those requests. 
HHS regulations mandate that outside activities must be approved in 
advance.26 
In our review, many approvals after the start dates were due to late 
submissions.  For 12 of the 23 late approvals, employees submitted the 
outside activity requests after the activities had already begun.  Late 
requests were filed anywhere between 4 and 279 calendar days after 
those activities were supposed to begin, with a median of 65 calendar 
days after the start dates provided on the HHS-520 forms. Additionally, 
late approvals may occur if any of the reviewers need to follow up with 
employees for additional information on their requests.27 
Between 2000 and 2003, none of the eight centers provided deadlines for 
the submission of outside activity requests in their written procedures.  
However, one center recently changed its procedures to specify that 
requests should be submitted at least 3 weeks in advance of the start 
dates to allow sufficient time for review. 
Approvals exceeding the maximum time period allowed by FDA 
Between CYs 2000 and 2003, FDA allowed employees to request 
approval for activities for periods up to 5 years.28  We found seven 
instances of activities of senior-level employees being approved for 
periods exceeding 5 years.  Not only does this violate FDA policy, but it 
also makes it difficult to ensure that activities continue to be 
appropriate as employees may change official job duties over time. 
Recently, both HHS and FDA have limited the timeframe for approvals 
of outside activities to 1-year periods.29 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  16  V U L N E R A B I L I T I E S  
Approvals of multiple activities on one request form 
In three instances, outside activity requests of senior-level employees 
were approved despite the fact that multiple outside entities were listed 
on the forms.  In one case, an employee requested permission to review 
articles for multiple publications.  In another case, an employee 
requested permission to work with multiple clinical and research 
centers.  In a third case, an employee requested permission to work with 
five separate organizations, including a foreign government entity.  
Neither FDA policies nor center procedures address the issue of 
multiple activities on a single request.  It is important that a unique 
HHS-520 form be submitted for each distinct outside activity, because 
this form is designed to provide details on only one particular activity.  
Activities with different entities may pose different types of concerns, 
and so requests to engage in separate outside activities should be 
submitted and reviewed independently. 
Inadequate use of written recusals 
We did not find written recusals present for any of the senior-level 
employees outside activities that we reviewed.  However, we were not 
able to determine whether written recusals were required.  Staff 
reviewers we interviewed indicated that they had limited experience 
with recusals, and it is uncertain to what extent recusals are addressed 
at the time activities are approved.  Also, FDAs expectations with 
regard to written recusals are unclear; neither FDA policies nor center 
procedures mention the use of written or unwritten recusals. 
Pursuant to the prohibition in the Federal conflict of interest statute,  
18 U.S.C. 208, and OGE regulations, all employees who participate in 
outside activities are obligated either to recuse themselvesin other 
words disqualify themselvesfrom any official duty matters that may 
create an actual conflict of interest or an appearance of loss of 
impartiality in the performance of official duties, or to request a waiver 
or authorization.30  To make employees aware of this obligation, all 
employees participating in outside activities are supposed to receive two 
forms, the Notice to Applicants for Prior Approval of Outside Activities 
and Excerpts from the Standards of Ethical Conduct, which mention 
the requirement that employees recuse themselves, but do not include 
further details.  OGE guidance suggests that written recusals can help 
to prevent conflicts of interest from arising.31 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  17  V U L N E R A B I L I T I E S  
Inadequate notification of supervisors 
Staff reviewers at none of the eight centers reported that they routinely 
notify employees supervisors of final decisions on outside activity 
requests, although staff reviewers at some centers did indicate that 
employees administrative staffs may be notified of final decisions. 
Therefore, even though supervisors review and sign off on outside 
activity requests before sending them for final approval, they are 
frequently not made aware of final decisions. When supervisors are 
unaware of ongoing outside activities, they may not be able to monitor 
employees assignments to avoid conflicts of interest.  Neither FDA 
policies nor center procedures address notification of supervisors. 
Inadequate followup on ongoing outside activities 
Staff reviewers at only two centers reported that they follow up on 
ongoing outside activities, and they reported that they only follow up to 
determine whether activities are continuing or whether they will be 
renewed at the end of their approval periods.  Staff reviewers at none of 
the centers reported that they follow up to determine whether the 
nature or time commitment of approved activities are in line with the 
specifications of the requests, whether employees official job duties 
have changed, or whether ethics rules are being observed. 
Neither FDA policies nor center procedures address the frequency or 
amount of followup for ongoing outside activities; however, in 2004, 
FDA announced that it will only approve activities for 1-year periods.32 
In addition, the interim final rule limits approvals to 1-year periods, 
and further calls for employees who participate in outside activities to 
submit reports on their outside activities annually.33  This shortened 
period of approval will result in followup for all outside activities at 
least once per year.  
Inadequate training 
Staff reviewers at only one of the eight centers reported providing 
training on outside activities to its employees during the past several 
years.  There is currently no requirement for annual ethics training for 
all employees at FDA, although new FDA employees receive ethics 
training, and annual ethics training is required for employees who file 
financial disclosure reports.34  Still, staff reviewers at only one center 
identified inadequate training of employees as a moderate challenge, 
staff reviewers at four centers identified it as a minor challenge, and 
staff reviewers at the remaining three centers indicated that it was not 
a challenge. 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  18  VV UU LL NN EE RR AA BB II LL II TT II EE SS  
Neither FDA nor any of the centers have provided training specifically 
geared toward supervisors, and none of the staff reviewers we 
interviewed indicated that this posed a major or moderate challenge, 
although staff reviewers at four centers identified inadequate 
supervisor training as a minor challenge. Yet, it is crucial to have well-
trained supervisors who understand their roles in the outside activity 
review process and vet outside activity requests adequately. 
Finally, neither FDA nor any of the centers have provided training 
specifically geared toward reviewers. It is important that these 
reviewers are trained to effectively review outside activity requests. 
FDA staff reviewers we spoke with at one center indicated that 
insufficient training of reviewers posed a moderate challenge, and staff 
reviewers at two other centers indicated that this was a minor 
challenge. It is crucial that reviewers are trained regarding how to 
properly screen requests for potential conflicts of interest. 
Varying levels of staffing 
At five of the eight centers, the review of outside activities was a 
collateral duty for staff reviewers. This includes the two centers with 
the most outside activity requests between CYs 2000 and 2003. The 
other centers had at least one full-time person dedicated to outside 
activities and, in some cases, other ethics matters. In centers where 
outside activity review is a collateral duty, it may be difficult for staff 
reviewers to develop expertise in the review of requests. Perhaps this is 
one reason that staff reviewers did not recognize as challenges many of 
the inadequacies we have identified. Staff reviewers at one center 
identified inadequate staffing as a moderate challenge, and staff 
reviewers at three centers indicated that it was a minor challenge. 
Staff reviewers at the remaining four centers indicated that inadequate 
staffing was not a challenge. 
OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  19    R E C O M M E N D A T I O N S  

Although we did not identify any outside activities that appeared to 
violate applicable statutes or regulations, we did identify numerous 
problems regarding inadequate documentation and insufficient 
processes and procedures that may hinder the ability of reviewers to 
assess the appropriateness of the outside activities.  Considered 
together, these vulnerabilities indicate the importance of continued 
vigilance in ensuring the integrity of FDAs review process and in 
preventing employees from participating in inappropriate outside 
activities in the future.  
We recognize that both HHS and FDA have several initiatives planned 
or underway that aim to improve the review process for outside 
activities. (See Appendix D for a list of these initiatives.)  Most notably, 
in February 2005, HHS issued an interim final rule to revise the 
supplemental regulations; this interim final rule addresses some of the 
vulnerabilities identified in this report.  Over the past year, FDA also 
issued to employees new guidance documents on outside activities 
processes. We encourage HHS and FDA to continue their efforts to 
improve the outside activities review process. 
The effectiveness of FDAs new system for reviewing outside activities 
will continue to depend on the quality of information submitted and the 
adequacy of the review process.  Below, we make recommendations to 
FDA on ways to improve information and ensure the integrity of its 
review process for outside activities. 
Improve the Quality and Extent of Information for Outside Activities 
Require all employees to submit additional details on the nature of their 
proposed outside activities and their current official duties.  Having sufficient 
information on the nature of an activity is crucial to determining 
whether the activity should be approved. Equally important is having 
sufficient information on the nature of an employees current job duties. 
Together, this information allows reviewers to identify any overlap 
between a proposed outside activity and an employees official duties.  
HHS has revised the HHS-520 form to capture additional information 
on outside activities.  However, FDA must ensure that employees 
provide adequate, substantive information. 
We recommend that FDA require employees to submit the following 
with all outside activity requests: 
o 	 Statements, written by employees, that describe precisely and 
accurately in substantive ways the work that will be performed 
for outside entities. 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  20  R	 E C O M M E N D A T I O N S  
o 	 Detailed descriptions of employees current job-related activities, 
in addition to copies of their position descriptions.  The interim 
final rule requires employees to submit additional information 
about their official duties and any relationships between their 
official duties and their outside activities.35 
o 	 Written letters of invitation and agendas, whenever they are 
available. These items can provide important information on 
what is involved in proposed outside activities. 
o 	 All consulting contracts and other agreements, whenever they are 
available. These agreements can provide important information 
on the nature of proposed activities. 
Ensure that all employees fill out their outside activity requests completely. 
We found that not only were required forms incomplete, but also that 
answers were sometimes too vague to be meaningful.  It is important 
for reviewers to have complete information because it allows them to 
consider potential conflicts of interest and make informed 
recommendations as to whether requests should be approved.  To 
assist employees in filling out these forms properly, FDA could 
develop standardized checklists that would provide employees with 
guidance to ensure that all proper documentation is submitted and 
complete.  In no instance should FDA approve an outside activity 
when documentation is incomplete. 
Cross-check financial disclosure forms with employees outside activities for 
the previous year.  We found that outside activities were not always 
properly disclosed on the applicable financial statements as required 
by OGE regulations.36  Ensuring disclosure on these forms promotes 
transparency in employees outside affiliations and earnings.  It also 
serves as another check on whether employees are free of conflicts of 
interest.  FDA has already indicated that it will begin performing this 
annual cross-check; we encourage FDA to develop a policy that 
explicitly requires this annual review, which will help ensure that 
employees are accurately reporting required information. 
Address the Inadequacies in the Review Process for Outside Activities 
Develop complete policies and procedures on outside activities for all centers 
and employees.  The FDA Ethics and Integrity Staff maintains a Web 
site with information on outside activities, including the supplemental 
regulations, recent advisories, and directions for completing the HHS
520 form.  However, these policies and procedures do not address many 
key aspects of the process that we found to be problematic. Despite the 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  21  R E C O M M E N D A T I O N S  
problems we found, staff reviewers at only one of eight centers indicated 
that a lack of clear policies posed a major challenge. 
Although FDA provides some guidance for outside activities on its ethics 
Web site, it lacks agency-wide policies and procedures.  Furthermore, 
not all centers maintain their own written procedures. To ensure that 
employees are aware of the ethics rules for outside activities and to 
ensure consistency, it is important that FDA develop standard agency-
wide policies and procedures that address how to submit requests, as 
well as how to review requests.  These policies and procedures should 
encompass the recommendations we offer in this report.  FDA is 
currently developing policies and procedures for reviewing outside 
activities and intends to distribute them to staff upon completion. 
Ensure that outside activity requests are approved before their scheduled start 
dates. HHS regulations require that all approvals occur prior to start 
dates.37  However, we found that many outside activity requests are still 
being approved after the start date.  FDA should reemphasize the 
expectation that centers comply with these regulations and should 
ensure that centers are in compliance. 
Further, it is important for centers to collect information when 
employees come forward after the fact to disclose activities, as this 
provides a record of employees noncompliance and the nature of the 
activities conducted. However, this does not mean that activities should 
be approved when they are disclosed after the start date.  In fact, if 
centers discover that ongoing or completed outside activities are not 
allowable, appropriate disciplinary action should be taken 
(e.g., counseling, written or oral reprimands, requiring the employee to 
return any compensation, prohibiting participation in future outside 
activities, and, in the most extreme circumstances, removing the 
employee). Even for cases in which outside activities are allowable, 
FDA should consider taking appropriate disciplinary action, especially if 
employees demonstrate patterns of submitting late requests. 
To help ensure that there is adequate time for a careful, thorough 
review of each request, FDA should establish an appropriate timeframe 
for employees to submit their requests.  This should allow time for 
reviewers to conduct their reviews and follow up with the employees, if 
necessary, for clarification.  We recognize that such a deadline may not 
always be feasible, but we encourage FDA to use the deadline whenever 
possible. 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  22  R E C O M M E N D A T I O N S  
Ensure that activities are approved for periods not exceeding the maximum 
amount of time allowed by HHS or FDA. We found seven activities that 
FDA approved for more than 5 years, in violation of its policy at the 
time of approving outside activities for a maximum of 5 years.  Recently, 
FDA changed its policy so that outside activities can only be approved 
for 1-year periods.38  FDA must ensure that its employees and reviewers 
comply with this policy. 
Ensure that each outside activity receives it own separate review. We found 
three instances in which employees requested approval for multiple 
outside activities on the same forms, and one additional instance in 
which an employee said only that he would review articles for journals, 
but did not provide the names of the journals or publishers.  FDA must 
ensure that each outside activity request receives its own complete and 
independent review.  Each request should be submitted individually, 
with its own supporting documentation. This will help ensure that 
reviewers are able to thoroughly review each individual proposed 
activity for potential conflicts of interest. 
Require recusals, if needed, to be made in writing and disseminated to 
immediate supervisors and other key personnel for all outside activities that are 
related to employees official duties. Pursuant to the prohibition of  
18 U.S.C.  208 and OGE regulations, all employees who participate in 
outside activities are obligated to recuse themselvesin other words 
disqualify themselvesfrom any official duty matters that may create 
actual or apparent conflicts of interest unless they request and receive a 
waiver or authorization.39  OGE guidance suggests that written recusals 
can help to prevent conflicts of interest from arising.40 
All employees participating in outside activities are supposed to receive 
two forms, the Notice to Applicants for Prior Approval of Outside 
Activities and Excerpts from the Standards of Ethical Conduct, which 
mention the requirement that employees recuse themselves, but do not 
include further details. These materials are included in the revised 
HHS-520 form.  Recusals protect employees who are participating in 
outside activities by allowing for the establishment of screening and 
gatekeeping practices that help to ensure that employees do not 
encounter conflicts between their official duties and outside activities.41 
Having a recusal in writing is important because it provides a way to 
inform supervisors and subordinates of a disqualification and its scope.  
It also serves as a point of accountability.  Supervisors and other key 
personnel who are informed of recusals can serve as important checks 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  23  R E C O M M E N D A T I O N S  
on employees to ensure that they are meeting their recusal obligations.  
We recognize that simply by recommending approval of an outside 
activity a supervisor is acknowledging that an employee is obligated to 
recuse himself or herself whenever necessary.  However, the process of 
an employee writing a separate recusal statement and the supervisor 
reviewing that statement provides an opportunity for important, 
deliberate discussion and planning that may not arise in the absence of 
a written statement.  
Further, we recognize that if recusals are very widely disseminated, 
there are implications for employee privacy.  However, at the very least, 
an employees immediate supervisors should be aware of any recusal.  
Supervisors serve as gatekeepers who can ensure that information 
implicated in employees recusals does not reach those employees. 
Ensure that supervisors are notified of all approvals and disapprovals.  We 
found that supervisors were not systematically notified of final decisions 
on outside activity requests. In addition to being aware of any recusals, 
it is important for the integrity of the process that all relevant parties 
are informed of final decisions regardless of outcome.  Supervisors can 
play an important role in ensuring that their employees work remains 
free of conflicts even after activities are approved as job duties and 
assignments change over time. 
Enhance training related to outside activities.  Existing OGE regulations 
require annual ethics training for only those employees who file 
financial disclosure forms.42  The regulations do not require annual 
ethics training for all employees.  We recommend that FDA require all 
employees, regardless of whether they file financial disclosure forms, to 
participate in annual ethics training that addresses outside activities.  
The fact that so many of the HHS-520 forms we reviewed contained 
deficiencies signaled to us that employees may need additional training 
on how to adequately complete these forms. 
In addition to training all employees, FDA should also require all 
supervisors to receive regular training on how to review requests for 
outside activities.  Supervisors play a critical role in the review process, 
and therefore they should know how to conduct these reviews 
effectively. Further, all staff reviewers and final approving officials 
should receive training on how to review requests. 
Consider centralizing some or all aspects of the review process for outside 
activities.  FDA already has a centralized ethics office, the Ethics and 
Integrity Staff, that reviews all financial disclosure forms.  This office 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  24  R	 E C O M M E N D A T I O N S  
currently maintains copies of all outside activity requests.  Further, it 
has begun to perform an additional check of outside activity requests 
submitted by FDA employees after final determinations have been made 
within requesting employees respective centers.  Staff reviewers 
indicated that they frequently contact the Ethics and Integrity Staff 
with questions on proposed outside activities. 
FDA may have much to gain in terms of consistency and complete 
documentation by centralizing all or some facets of the outside activities 
review process, including: 
o 	 Centralized training for all employees, supervisors, staff 
reviewers, and final approving officials; 
o 	 Centralized routine internal audits of the outside activity review 
process conducted by the centers; and 
o 	 Centralized decisionmaking regarding outside activity requests. 
We recognize that centers vary in size and mission and that taking 
steps toward centralization may be challenging.  Further, the presence 
of reviewers in the centers may serve as a reminder of the important 
role of ethics in the day-to-day business of FDA.  Entirely removing the 
current role of reviewers from the centers may have the effect of losing 
specialized knowledge regarding (1) the activities common to individual 
centers, and (2) the evolving duties and activities of center employees 
who are engaged in outside activities. 
Yet, consolidating the oversight of these functions into one area with 
full-time experts may have significant benefits. First and foremost, it 
would allow FDA to further develop the knowledge and experience of its 
cadre of full-time ethics officials, whose expertise in the review of 
outside activities would continue to evolve.  Currently, the review of 
outside activities is a collateral duty for some staff. 
Centralization could help ensure the independence of the 
decisionmaking process, since the Ethics and Integrity Staff is more 
removed than current reviewers from the employees in the centers. 
Reviewers would not be making decisions regarding their immediate 
colleagues.  Further, a central ethics staff would be in a better position 
than individual center staff to ensure that financial disclosure forms 
and outside activity requests correspond, as the review of financial 
forms is already a centralized duty of the Ethics and Integrity Staff. 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  25  R E C O M M E N D A T I O N S  
Finally, centralization would provide FDA with the ability to conduct 
analysis to identify potentially problematic trends within and across 
centers over time. 
SUMMARY OF AGENCY COMMENTS 
In its comments, FDA notes a variety of HHS and agency initiatives 
that address the recommendations we made.  For example, FDA 
describes how the recently revised HHS-520 form will capture 
additional information on all proposed outside activities.  Further, 
FDA is creating written policies and procedures regarding outside 
activities and has enhanced aspects of its outside activities training.  
FDA also identifies some of the potential benefits of outside activities. 
One area with which FDA takes issue is our discussion of recusals.  
FDA points out that the HHS-520 form itself provides information on 
recusal obligations to employees, and that by recommending approval 
of an outside activity, a supervisor acknowledges that an employee 
will recuse himself or herself whenever appropriate.  FDA also 
suggests that our recommendation regarding recusals implies that 
when a written recusal is made, an activity that otherwise would not 
be approved because of a conflict of interest becomes approvable. 
For FDAs complete comments, see Agency Comments, page 54. 
OFFICE OF INSPECTOR GENERAL RESPONSE 
While this review was underway, both HHS and FDA announced or 
implemented initiatives aimed at strengthening the review process for 
outside activities.  We recognize that the revised supplemental 
regulations and FDAs forthcoming policies and procedures address 
some of the recommendations we make in this report.  We encourage 
HHS and FDA to continue their efforts to improve the outside activities 
review process. 
In response to FDAs comments about recusals, we reiterate that 
written recusals, when necessary, are protective of employees who 
participate in outside activities.  As OGE has observed, 
Documentation, whether or not required, provides greater protection 
both for the individual employee and the agency with regard to the 
scope and terms of the commitment to recuse.43  The process of an 
employee writing a recusal statement and the supervisor reviewing that 
statement provides an opportunity for important, deliberate discussion 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA E MPLOYEES  26  R E C O M M E N D A T I O N S  
and planning that may not arise in the absence of a written statement. 
That written recusal statement may be made somewhere on the HHS
520 form itself, or in a separate e-mail or memorandum. 
Further, we reiterate that written recusals allow for the establishment 
of screening and gatekeeping practices that help to ensure that 
employees do not encounter conflicts between their official duties and 
outside activities.  As OGE has stated, . . . a screening arrangement 
creates a viable process for preventing covered matters from coming 
before an employee.  This, in turn, could prevent a violation of an 
employees recusal obligations.44  We do not mean to imply that 
otherwise-problematic activities are approvable where recusals are 
present; rather, recusals inform supervisors and coworkers of potential 
conflicts that could arise during the course of an outside activity.  Under 
no circumstances should FDA approve outside activities that pose 
conflicts of interest, and in fact, we found no evidence that it has. 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  27    E N D N O T E S  

1 Wilman, D.  December 7, 2003.  Stealth Merger:  Drug Companies and 
Government Medical Research.  The Los Angeles Times:  A1, A32-33. 
2 5 CFR Part 2635. 
3 5 CFR  2635.801(d)(5). 

4 5 CFR  2635.802(b). 

5 5 CFR  2635.801(c). 

6 5 CFR  2634.202. 

7 Food and Drug Administration memorandum to all FDA employees,  

June 4, 2004. 
8 5 CFR  5501. 
9 5 CFR  5501.106(d). 
10 5 CFR  5501.106(c)(3).  This section of the supplemental regulations 
remained essentially unchanged under the interim final rule.      
70 Fed. Reg. 5543, 5559 (Feb. 3, 2005). 
11 5 CFR  5501.101. 
12 5 CFR  5501.106(d)(2). 
13 70 Fed. Reg. 5543 (Feb. 3, 2005).  The final rule was issued in        
70 Fed. Reg 51559 (Aug. 31, 2005).  
14 5 CFR  5501.106(d)(4). 
15 70 Fed. Reg. 5543,5559 (Feb. 3, 2005). 
16 The FDA Deputy Ethics Counselor is now the final approving official 
for all outside activity requests.  
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  28  17 Department of Health and Human Services memorandum to Deputy 
Ethics Counselors and Ethics Contacts, January 27, 2004. 
18 Further, staff reviewers indicated that additional individuals may 
review requests or comment before the final decision is made. 
19 Food and Drug Administration memorandum to all FDA employees, 
June 4, 2004. 
20 5 CFR  5501.106(d)(4).  At the time this review was conducted, the 
regulation stipulated that Approval shall be granted unless it is 
determined that the outside employment or other outside activity is 
expected to involve conduct prohibited by statute or Federal      
regulation . . . .  In the interim final rule of February 2005, the standard of 
approval is higher:  Approval shall be granted only upon a determination 
that the outside employment or other outside activity is not expected to 
involve conduct prohibited by statute or Federal regulation . . . . 
[emphasis added]. 
21 We aggregated two of FDAs classifications of outside activities: 
Professional and Consultative Services (295), and Consulting (65). 
22 Staff reviewers at two centers described it as not being a challenge at 
all. 
23 Department of Health and Human Services memorandum to Deputy 
Ethics Counselors and Ethics Contacts, August 13, 2004, p. 1.  
24 5 CFR  2634.307 for public filers; 5 CFR  2634.907(a)(6) for 
confidential filers. 
25 Food and Drug Administration memorandum to all FDA employees, 
June 4, 2004. 
26 5 CFR  5501.106(d)(1).  This expectation remains the same in the 
February 2005 interim final rule.  70 Fed. Reg. 5543, 5559 (Feb. 3, 2005). 
27 For initial outside activity requests that were submitted prior to the 
start dates listed on those requests, the median amount of time between 
employees signatures and final approving officials signatures was     
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  29  12.5 calendar days.  Of the 16 initial outside activity requests for which we 
could perform this calculation, 8 were submitted less than 12.5 calendar 
days in advance. 
28 Food and Drug Administration memorandum to all FDA employees, 
October 4, 2004. 
29 Food and Drug Administration memorandum to all FDA employees, 
October 4, 2004.  Also, the February 2005 interim final rule calls for 
approvals not to exceed 1 year. 
30 5 CFR  2635, Subpart D (for conflicting financial interests) and    
5 CFR  2635, Subpart E (for appearance of loss of impartiality). 
31 U.S. Office of Government Ethics memorandum to Designated Agency 
Ethics Officials (Recusal Obligation and Screening Arrangements),    
April 26, 1999. OGE referenced and elaborated on this 1999 memorandum 
in a subsequent memorandum to Designated Agency Ethics Officials, 
General Counsels, and Inspectors General (Effective Screening 
Arrangements for Recusal Obligations), June 1, 2004. 
32 Food and Drug Administration memorandum to all FDA employees, 
October 28, 2004. 
33 70 Fed. Reg. 5543, 5559 (Feb. 3, 2005). 
34 5 CFR  2638.704(a) for public filers; 5 CFR  2638.705(a)(3) for 
confidential filers. 
35 Additionally, the interim final rule calls for supervisors to prepare 
statements . . . addressing the extent to which the employees duties are 
related to the proposed outside activity . . . .  70 Fed. Reg. 5543, 5559  
(Feb. 3, 2005). 
36 5 CFR  2634.307 for public reports; 5 CFR  2634.907(a)(6) for 
confidential reports.  
37 5 CFR  5501.106(d)(1).  The requirement for prior approval remains 
the same in the February 2005 interim final rule. 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  30  38 Food and Drug Administration memorandum to all FDA employees, 
October 4, 2004.  Also, the February 2005 interim final rule calls for 
approvals not to exceed 1 year. 
39 5 CFR  2635, Subpart D (for conflicting financial interests) and    
5 CFR  2635, Subpart E (for appearance of loss of impartiality). 
40 U.S. Office of Government Ethics memorandum to Designated Agency 
Ethics Officials (Recusal Obligation and Screening Arrangements),    
April 26, 1999. OGE referenced and elaborated on this 1999 memorandum 
in a subsequent memorandum to Designated Agency Ethics Officials, 
General Counsels, and Inspectors General (Effective Screening 
Arrangements for Recusal Obligations), June 1, 2004. 
41 Ibid. 
42 5 CFR  2638.704(a) for public filers; 5 CFR  2638.705(a)(3) for 
confidential filers.   
43 U.S. Office of Government Ethics memorandum to Designated Agency 
Ethics Officials, April 26, 1999, p. 2. 
44 U.S. Office of Government Ethics memorandum to Designated Agency 
Ethics Officials, General Counsels, and Inspectors General, June 1, 2004,  
p. 2. 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  31    A P P E N D I X   ~   A  

METHODOLOGY 
FDA Database 
FDA provided us with a copy of a database maintained by the Ethics 
and Integrity Staff that contained information on all outside activity 
requests submitted by all FDA employees between CYs 2000 and 2003.  
We used this database to make summary statements about the number 
and nature of outside activities at FDA as a whole. 
Throughout this report, we analyze data from the timeframe between 
CYs 2000 and 2003.  We chose this period because it allowed us to 
examine trends by year. Further, complete data for CY 2004 were not 
available, and some outside activities policies and procedures changed 
during CY 2004. 
File Reviews 
We conducted a retrospective review of all outside activity requests that 
senior-level employees submitted to FDA between CYs 2000 and 2003.  
We defined senior-level employees to be those who were required to file 
SF-278 public disclosure forms as of January 1, 2004.  FDA provided us 
with a list of 90 employees who met that criterion.  This group included, 
but was not limited to, center and office directors and deputy directors. 
We focused our review on senior-level employees because these 
employees may be most likely to engage in outside activities that 
involve substantial influence and compensation, and therefore may be 
most likely to pose the greatest risk for FDA in terms of potential 
conflicts of interest.  However, restricting our review to employees in 
this group presents some limitations.  For example, it may be the case 
that employees who do not hold senior-level positions are more likely to 
engage in high-risk, high-compensation outside activities. 
We requested outside activity request forms (HHS-520 forms) and 
supporting documentation for all outside activities requested by these 
senior-level employees within the timeframe of our review.  Supporting 
documentation that we received included, as appropriate:  
o  Public Financial Disclosure (SF-278) Reports, 
o  Confidential Financial Disclosure (OGE-450) Reports, 
o  Correspondence, 
o  Reviewer notes, and 
o  Letters of invitation. 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  32  A P P E N D I X   ~   A  
We considered a request to be within the timeframe of our review if the 
date the employee signed the request fell between January 1, 2000, and 
December 31, 2003. We received 55 outside activity requests from FDA 
that met this criterion.  We did not assess whether employees conducted 
any additional outside activities between 2000 and 2003 that were not 
reported in outside activity requests, which represents a potential 
limitation of our review.  However, the responsibility for submitting 
request forms rests with employees. 
Our review included initial requests, revised requests, and renewal 
requests. An initial request is made when an employee submits an 
HHS-520 for the first time for a particular activity.  A revised request 
would be submitted if an employee had to change information provided 
on an initial request.  A renewed request is submitted if an activity 
continues beyond the end date originally stated in the initial request. 
Our population of approved outside activities included initial requests, 
renewals, revised requests, and outside activity requests that did not 
specify the request type.  Because we intended to analyze all outside 
activity requests submitted in the timeframe of our study, we included 
all types of requests regardless of whether the supervisor or final 
approving official provided complete information. 
Our file review included three methodologies:  (1) a descriptive review, 
(2) a completeness review, and (3) a compliance review. 
Descriptive review. For each outside activity request in our timeframe, 
we extracted the details of the outside activity from the HHS-520 and 
supporting documents into a Microsoft Access database.  If the amount 
of compensation for the activity was listed on the HHS-520, the 
applicable financial disclosure form, or any other documentation in the 
file, we recorded that.  Finally, we noted any additional documentation 
that the employee submitted as part of the outside activity request.  We 
tallied the number and nature of outside activities overall, as well as by 
year, activity type, compensation type, institute, employee type, and 
time commitment.  When an employee provided an estimated range for 
the time commitment, we used the midpoint in our analysis. 
Completeness review.  We calculated the extent to which forms were 
filled out completely and correctly. For each outside activity request in 
our timeframe, we documented in our database the dates on which the 
employee, the supervisor, and the final approving official signed off on 
the outside activity request.  We also recorded, whenever applicable, 
whether or not the employee had listed the outside activity on his or her 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  33  A P P E N D I X   ~   A  
financial disclosure form (SF-278 or OGE-450) for that year.1 We 
documented the number of missing signatures, and also noted other 
missing items of information on the HHS-520 form. 
Compliance review.  We reviewed all approved outside activity requests 
that senior-level employees submitted between January 1, 2000, and 
December 31, 2003, to determine whether the activities complied with 
the pertinent requirements for avoiding conflicts of interest. 
We used the following statutes, regulations, and policies as our criteria: 
o 	 Federal ethics laws regarding conflict of interest 
(18 U.S.C.  205, 18 U.S.C.  208, and 18 U.S.C.  209); 
o 	 Governmentwide Standards of Ethical Conduct for Employees of 
the Executive Branch (codified in 5 CFR  2635); 
o 	 HHS Supplemental Standards of Ethical Conduct 
(codified in 5 CFR  5501); and 
o 	 FDA policy. 
We compared the organizations listed on outside activity request forms 
to the FDA yellow book listings of significantly regulated organizations 
for each year in the period of our review to determine whether proposed 
activities involved organizations listed as significantly regulated at the 
time the requests were made.  (An exception to the prohibition on 
outside activities with significantly regulated organizations applies 
where the employment is limited to clerical or similar services (such as 
cashier or janitorial services) in retail stores, such as supermarkets, 
drug stores, or department stores.)2 
Aside from employment with significantly regulated entities, it is 
important to note that the criteria used for our compliance review do not 
explicitly prohibit certain types of outside activities (e.g., consulting 
arrangements).  Therefore, determining whether an outside activity 
1	 We used this information to calculate the frequency with which outside activity requests 
were recorded as required by regulation.  For each year between CYs 2000 and 2003, we 
determined whether an activity was ongoing by checking the start and end dates 
provided on the HHS-520 form.  If an activity was ongoing during a particular year, we 
cross-checked the employees appropriate financial disclosure (if available) to determine 
whether that activity was listed anywhere on the form.  We then divided the number of 
times that activities were disclosed in the years during which they were ongoing            
(56 times) by the number of times activities should have been disclosed (104 times).  
Overall, activities were only disclosed as required 54 percent of the time. 
2	 5 CFR  5501.106. 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  34  A P P E N D I X   ~   A  
adhered to the regulations necessarily involved a judgment call on our 
part.  To increase consistency, two OIG reviewers used a standardized 
protocol to independently review each outside activity request and any 
available supporting documentation.  A final OIG reviewer was 
consulted to resolve cases in which the two initial reviewers disagreed.  
For the cases in which the two initial reviewers agreed, no third 
reviewer was used. 
Our review included all available FDA documentation regarding these 
activities. However, it is important to point out that these documents 
do not necessarily include all facts known to or considered by FDA 
reviewers at the time of their reviews.  The staff reviewers we 
interviewed indicated to us that they often do additional research to get 
information about proposed activities. 
In no instance was the documentation we reviewed adequate for our 
reviewers to make a definitive determination regarding whether an 
activity was appropriate. As demonstrated in the Vulnerabilities 
section of this report, the information contained in the documentation 
for outside activity requests was often inadequate; inadequate 
information limits reviewers ability to make decisions on 
appropriateness.  Therefore, we cannot state with absolute certainty 
that any activity was or was not allowable.  Instead, we made one of 
three determinations for each activity: (1) appears to be allowable, 
(2) appears not to be allowable, and (3) cannot determine. 
For the cases in which the documentation contained enough information 
and did not appear to violate any regulations, our reviewers identified 
the activity as appears to be allowable, even if more information would 
be necessary to definitively determine that the activity was in fact 
allowable. Our reviewers would only have identified an activity as 
appears not to be allowable if the documentation indicated a violation 
of the regulations.  Finally, our reviewers identified activities as cannot 
be determined when the information available was so incomplete that 
they were unable to make a determination, or when the information 
raised concerns that the activity may have violated the regulations.  
Ultimately, our reviewers could not determine the appropriateness of  
11 activities, but did determine that none of the activities violated 
statute or regulations.  However, it is quite possible that we have 
underestimated the number of activities that should not have been 
approved.  Inadequate documentation for outside activities can, 
intentionally or unintentionally, hide potential violations.  If reviewers 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  35  A P P E N D I X   ~   A  
conduct additional research on requests, they may uncover and resolve 
those potential problems before they become violations, but this may not 
happen in every case. 
In general, we did not seek additional information beyond what was 
provided in the files.  For example, we did not speak with any employees 
or reviewers at FDA or research outside organizations with which 
employees requested permission to work.  As a result, an important 
limitation of this methodology is that we cannot comment on whether 
FDA reviewers considered additional facts during their reviews of these 
outside activity requests. 
We recorded, as part of our assessment, whether specific pieces of 
additional information would have been helpful in making 
determinations.  This information included greater detail on the 
following items:  the nature of the outside activity, the nature of the 
employees job duties, the difference between the outside activity and 
the employees job duties, and the outside organization. 
Interviews With FDA Staff Reviewers 
We interviewed the employees in each of the eight centers whom FDA 
designated as responsible for and/or most knowledgeable about the 
review process for outside activities between CYs 2000 and 2003.  We 
refer to these employees as staff reviewers. We used a structured 
questionnaire to conduct these interviews.  The questionnaire addressed 
centers procedures for reviewing outside activity requests; the training 
that centers provide to employees, supervisors, staff reviewers, and final 
approving officials on outside activities; staff reviewers approaches to 
identifying ethics violations regarding outside activities; challenges staff 
reviewers face in the outside activities review process; and staff 
reviewers recommendations for improving processes for outside 
activities. We conducted all interviews by telephone. We also spoke 
with FDA Ethics and Integrity Staff to learn of initiatives FDA has 
planned or underway to improve its system for addressing outside 
activities. FDA Ethics and Integrity Staff served as a resource for 
clarifying our questions on FDA ethics policy throughout our review. 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  36  A P P E N D I X   ~   A  
Procedure Review 
We requested operating procedures related to outside activities from all 
eight centers.  FDA allows, but does not require, its centers to develop 
written operating procedures for implementing FDA policies on outside 
activities. Staff reviewers at five centers indicated that their centers 
have written procedures and provided those procedures to us.  These 
included standard operating procedures, Web site printouts, and 
memoranda. We counted the number of centers that maintained these 
documents and compared the documents to one another. 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  37    A P P E N D I X   ~   B  

NATURE OF OUTSIDE ACTIVITIES 
Eleven percent of all FDA employees received approval to 
participate in a total of 2,592 outside activities between   
CYs 2000 and 2003. 
FDA approved all but 14 outside activity requests.  Of the 13,973 employees 
at FDA, 1,576 employees submitted 2,606 outside activity requests 
between CYs 2000 and 2003.  FDA approved 2,592 requests for  
1,571 employees and disapproved 14 requests.  (See Table 1 below.)  It is 
not surprising that the overwhelming majority of requests were 
approved. For the period covered by this review, HHS supplemental 
regulations called for outside activity requests to be approved unless 
they clearly violated statute.3  The interim final rule calls for a higher 
standard of approval: activities are only to be approved upon a 
determination that [activities are not] expected to involve conduct 
prohibited by statute or Federal regulation . . . .  Further, FDA 
employees may confer with supervisors, staff reviewers, or Ethics and 
Integrity Staff before formally submitting requests to ensure that their 
proposals are approvable. 
The number of requests for outside activities increased between  
CYs 2001 and 2002.  One possible explanation for this increase may be 
the overall growth of the FDA workforce between CYs 2001 and 2002. 
 Table 1.  Number of FDA Employees and
 Outside Activity Requests by Year, CY 20002003
Number of  Number of 
Number 
Calendar Year  Outside Activity  Approved Outside 
of Employees * 
Requests  Activity Requests 
2000  13,047  515  515 
2001  13,104  515 512 
2002  14,038  784 779 
2003  13,973  792 786 
Totals  - 2,606  2,592
 * Reported as the number of employees at the end of the fiscal year.
 Source:  Office of Inspector General analysis of FDA data, 2005. 
3  5 CFR  5501.106. 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  38  A P P E N D I X   ~   B  
Most employees received approval for one outside activity, but a few received 
approval for more than five. Of the 1,571 employees who received approval 
to participate in outside activities between CYs 2000 and 2003,   
68 percent received approval for only 1 activity, and another 20 percent 
received approval for 2 outside activities.  Three percent of employees 
received approval for more than 5 activities over the 4-year period.  The 
maximum was 38 approved outside activities for 1 employee between 
CYs 2000 and 2003.  (See Table 2 below.) 
 Table 2.  Number of Approved Outside Activities
 for FDA Employees, CY 20002003
Number of  Number of  Percent of 
Approved Activities  Employees Participating  Employees Participating 
1  1,066  68 
2  311 20 
3      92 6 
4      49 3 
5      16 1 
6      17 1 
7 or more  20 1 
Totals  1,571  100
 Source:  Office of Inspector General analysis of FDA data, 2005. 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  39  A P P E N D I X   ~   B  
Employees who file the confidential financial disclosure form accounted for 80 
percent of the approved outside activities.  Employees who are required to 
annually file the confidential financial disclosure form (OGE-450) 
accounted for 80 percent of approved outside activities between  
CYs 2000 and 2003.  Employees who do not file any financial disclosure 
accounted for 18 percent of approved outside activities, and employees 
who file the public financial disclosure form accounted for only 2 percent 
of approved outside activities, between CYs 2000 and 2003.      
(See Table 3 below.) 
 Table 3.  Number of Approved Outside Activities
 for FDA Employees by Filer Status, CY 20002003
Number of  Percent of 
Approved  Approved  Number of  Percent of 
Filer Status 
Outside  Outside  Employees *  Employees
Activities  Activities 
 Confidential Filer  2,084  80   7,374  53
 Nonfiler  457  18   6,463  46
 Public Filer      51  2      136  1
      Totals  2,592  100  13,973  100
 * Reported as the number of employees at the end of fiscal year 2003.

 Source:  Office of Inspector General analysis of FDA data, 2005.

Certain FDA employees must disclose their compensated outside 
activities on an annual financial disclosure form, which may be public or 
confidential, depending on an employees pay.  By statute, some 
employees who meet income or appointment requirements must file the 
public financial disclosure form, the SF-278.  FDA requires additional 
employees in positions of significant decisionmaking authority to 
annually file the confidential financial disclosure form, the OGE-450.  
This form requires employees to list certain compensated and 
uncompensated positions.  Most employees, however, are not required to 
file any sort of financial disclosure. 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  40  A P P E N D I X   ~   B  
Employees at the two largest centers accounted for 60 percent of the approved 
outside activities.  Employees at the Center for Drug Evaluation and 
Research received approval for 812 outside activities, and employees at 
the Office of Regulatory Affairs received approval for 750 approved 
outside activities, between CYs 2000 and 2003.  The percentage of 
employees participating in outside activities, by center, ranged from 
7 percent at the Office of the Commissioner to 14 percent at the Center 
for Veterinary Medicine.  (See Table 4 below.) 
 Table 4.  Approved Outside Activities for FDA Employees,
 by Center, CY 20002003
Number of  Percent of 
Number of  Percent of 
Approved  Approved 
Participating  Participating 
Center  Outside  Outside 
Center  Center 
Activity  Activity 
Employees  Employees **
Requests  Requests 
 Center for Drug Evaluation and Research  812  31  423  13
 Office of Regulatory Affairs 750  29 536  13
 Center for Food Safety and Applied Nutrition 259  10 131  10
 Center for Biologics Evaluation and Research 244  9 116  10
 Center for Devices and Radiological Health  205  8 142  9
 Office of the Commissioner  142  5  113  7
 Center for Veterinary Medicine  130  5  78  14
 National Center for Toxicological Research  50  2 32  9
      Totals  2,592  *  1,571  -
 * Column does not sum to 100 due to rounding.

 ** Reported as the number of employees at the end of fiscal year 2003.

 Source:  Office of Inspector General analysis of FDA data, 2005.

  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  41  A P P E  N  D   I X    ~   B  
. 
The most common types of approved outside activities involved teaching, 
lecturing, speechwriting, and presenting. Nineteen percent of the approved 
outside activities involved teaching, lecturing, speechwriting, and 
presenting. Seventeen percent involved what FDA designated as 
miscellaneous activities, and another 14 percent involved consulting 
or providing professional or consultative services.  (See Table 5 below.) 
 Table 5.  Nature of Approved Outside Activities
 for FDA Employees, CY 20002003
Number of  Percent of 
1  Approved  Approved 
Type of Outside Activity 
Outside  Outside 
Activities  Activities
 Teaching, Lecturing, Speechwriting, and Presenting 490  19
2 
 Miscellaneous  436  17
3 
 Consulting, Professional, and Consultative Services  360  14
 Trade, Industrial, and Service Occupations  294  11
4 
 Writing, Editing, and Serving on Editorial Boards  227  9
 Clinical Professional Practice  221  9
 Holding Office in a Professional Organization or Society  218  8
 Sales and Clerical Positions  189  7
 Serving on a Board or Committee  65  3
5 
 Private Professional Practice and Other Professional Activities  55  2
 Self-Employed Positions  37  1
      Totals  2,592  100
  1   We report the types of activities by the classifications FDA made in its database of outside

 activities.

  2   This category included, for example, a variety of self-employed positions that were categorized

 as miscellaneous before FDA created a separate self-employed activity category in the database.

  3   We aggregated two of FDA's classifications of outside activities:  Professional and Consultative

 Services (295) and Consulting (65).

  4   We aggregated two of FDA's classifications of outside activities:  Writing and Editing (162) and

 Writing/Editing/Member of Editorial Board (65).

  5   We aggregated two of FDA's classifications of outside activities:  Other Professional Activity with

 Remuneration (35) and Private Professional Practice (20).

 Source:  Office of Inspector General analysis of FDA data, 2005.

  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  42  A P P E N D I X   ~   B  
Twenty-six percent of FDA senior-level employees received 
approval to participate in a total of 55 outside activities 
between CYs 2000 and 2003. 
We defined senior-level employees as those who were required to file the 
SF-278 public financial disclosure form as of January 2004.  This group 
includes, for example, center directors and deputy directors. 
FDA approved all 55 outside activity requests made by senior-level employees. 
Of the 90 senior-level employees at FDA as of January 2004,  
23 submitted 55 outside activity requests.  FDA approved all of these 
requests. (See Table 6 below.)  As described earlier in this Appendix, 
there are several possible explanations for a high approval rate. 
The number of senior-level employees requesting approval, and the 
number of approvals, remained relatively constant from CYs 2000 to 
2003. 
 Table 6.  Number of FDA Senior- Level Employees and
 Approved Outside Activity Requests by Year, CY 20002003
Number of Employees  Number of Approved 
Calendar Year 
Requesting Approval  Outside Activity Requests 
2000 9  13 
2001 9  11 
2002  12  15 
2003  11  16 
Totals  - 55
 Source:  Office of Inspector General analysis of FDA data, 2005. 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  43  A P P E N D I X   ~   B  
Most senior-level employees received approval for one or two outside activities. 
Over half of the senior-level employees at FDA received approval for 
only one or two outside activities between CYs 2000 and 2003.  The 
median number of outside activities approved per employee was two.  
The maximum was five approved outside activities for one employee 
between CYs 2000 and 2003.  (See Table 7 below.) 
 Table 7.  Number of Approved Outside Activities
 for FDA Senior- Level Employees, CY 20002003
Number  Number of  Percent of 
of Activities  Participating Employees  Participating Employees 
1    6 2 6  
2    8 3 5  
3    4 1 7  
4    4 1 7  
5    1 4  
Totals  23  *
 * Column does not sum to 100 due to rounding.

 Source:  Office of Inspector General analysis of FDA data, 2005.

  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  44  A P P E N D I X   ~   B  
Senior-level employees at three centers accounted for 64 percent of the 
approved outside activities.  Senior-level employees at the Center for Food 
Safety and Applied Nutrition received approval for 15 outside activities 
between CYs 2000 and 2003.  At both the Center for Drug Evaluation 
and Research and the Center for Veterinary Medicine, senior-level 
employees received approval for 10 outside activities between CYs 2000 
and 2003.  (See Table 8 below.) 
 Table 8.  Approved Outside Activities for FDA Senior- Level Employees,
 by Center, CY 20002003
Number of  Percent of 
Approved  All Approved  Number of 
Number of 
Outside  Outside  Senior-Level 
Senior-Level 
Center  Activity  Activity  Employees 
Employees 
Requests for  Requests for  at Center 
at Center **
Senior-Level  Senior-Level  Participating 
Employees  Employees 
 Center for Food Safety and Applied Nutrition  15  27  7  18
 Center for Drug Evaluation and Research  10  18  6  13
 Center for Veterinary Medicine  10  18  3  7
 Office of the Commissioner 9  16  3  25
 Center for Biologics Evaluation and Research 6  11  2  9
 Office of Regulatory Affairs 4 7  1  9
 National Center for Toxicological Research  1 2  1  1
 Center for Devices and Radiological Health  - - 0  8
      Totals  55  **  23  90
 * Column does not sum to 100 due to rounding.

 ** Reported as the number of senior-level employees as of January 1, 2004.

 Source:  Office of Inspector General analysis of FDA data, 2005.

  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  45  A P P E N D I X   ~   B  
The most common types of approved outside activities of senior-level 
employees involved serving on a board or writing and editing. 
Thirty-six percent of the approved outside activities for senior-level 
employees involved serving on boards.  Another 20 percent of approved 
outside activities for senior-level employees involved writing and 
editing. (See Table 9 below.) 
 Table 9.  Nature of Approved Outside Activities
 for FDA Senior- Level Employees, CY 20002003
Number of Approved  Percent of Approved 
Type of Outside Activity * 
Outside Activities  Outside Activities
 Serving on a Board  20  36
 Writing and Editing  11  20
 Clinical Professional Practice 4  7
 Serving on a Committee  4  7
 Lecturing  4  7
 Serving as a Professor  4  7
 Legal Consulting  3  5
 Other  2  4
 Performing Research  2  4
 Consulting  1  2
      Totals  55  **
 * We report the types of activities by the classifications our reviewers made.

 ** Column does not sum to 100 due to rounding.

 Source:  Office of Inspector General analysis of FDA data, 2005.

  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  46  A P P E N D I X   ~   B  
The most common venues for senior-level employees outside activities were 
journals and other publications, professional societies, and universities. 
Journals and other publications, professional societies, and universities 
each accounted for 20 percent of the approved outside activities for 
senior-level employees. None of the activities involved the 
biotechnology or pharmaceutical industries or any other significantly 
regulated organizations. (See Table 10 below.) 
 Table 10.  Types of Organizations With Which FDA Senior-Level
 Employees Received Approval for Outside Activities, CY 20002003
Number of Approved  Percent of Approved 
Type of Outside Organization * 
Outside Activities  Outside Activities
 Professional Societies  11  20
 Journals and Publishers  11  20
 Universities  11  20
 Hospitals and Clinics  6  11
 Personal and Social Organizations  5  9
 Financial Institutions  3  5
 Law Firms  3  5
 Cannot Determine  2  4
 Charities  2  4
 Museums  1  2
      Totals  55  100
 * We report the types of organizations by the classifications our reviewers made.
 Source:  Office of Inspector General analysis of FDA data, 2005. 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  47  A P P E N D I X   ~   B  
Fifty-eight percent of approved outside activities for senior-level employees 
involved no compensation.  Employees must report on their HHS-520s the 
type(s) of compensation they are to receive for performing outside 
activities. An outside activity may involve more than one type of 
compensation; employees may also perform outside activities without 
compensation.  There are no limits on the types or amounts of 
compensation that employees may receive for outside activities. 
Of the 20 activities for which employees reported that they would 
receive compensation, the most common form was reimbursement for 
travel and expenses. Of these 20 activities, we were able to obtain the 
actual amount of compensation for only 5.  Four of these five activities 
involved reimbursement for travel and expenses ranging from $1,800 to 
almost $32,000 per activity. The other activity involved an honorarium 
valued between $1,000 and $15,000.4  (See Table 11 below.) 
 Table 11.  Types of Compensation That FDA Senior- Level
 Employees Received for Approved Outside Activities, CY 20002003
Number of Approved  Percent of Approved 
Type of Compensation *  Activities Involving  Activities Involving 
This Type  This Type **
 None  32  58
 Expense and Travel Reimbursement  12  22
Fees 5  9
 Royalties  2  4
 Honoraria  1  2
 Salaries  1  2
 Per Diem Payments  1  2
 * Three outside activity requests did not indicate whether or what types of compensation would be

 received.

 ** Column sums to more than 100 percent because some outside activities involved more than

 one type of compensation.

 Source:  Office of Inspector General analysis of FDA data, 2005.

4	 Prior to January 2004, employees were not required to report the amount of 
compensation to be received for outside activities on the HHS-520 forms.  Therefore, 
when possible, we obtained this information from annual financial disclosure forms and 
from employees who voluntarily disclosed the amount of compensation on their HHS-520 
forms. 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  48  A P P E N D I X   ~   B  
This portion of our analysis regarding compensation is limited by the 
fact that compensation amounts were self-reported by the employees.  
We did not independently verify the types or amounts of compensation 
that employees actually received. 
Forty percent of approved outside activities for senior-level employees involved 
time off, and 29 percent of these activities involved a week or more of time off. 
To participate in outside activities, employees often have to take time 
off from work.  For the 22 outside activities for which senior-level 
employees indicated that time off would be required, these employees 
reported that they would take off between 1 and 36 business days from 
work. The median amount of time employees anticipated taking off to 
perform outside activities was 7 business days per activity. 
As noted earlier in this report, 13 senior-level employees received 
approval for multiple outside activities between CYs 2000 and 2003.  To 
do so, three of these senior-level employees reported taking more than a 
month off from work over this 4-year period.  Further, one senior-level 
employee reported taking more than 7 months off from work to perform 
outside activities between 2000 and 2003. 
Employees may also use personal time, or hours outside of the normal 
workday, to engage in outside activities.  For 46 of the 55 senior-level 
outside activity requests we reviewed, employees documented the 
amount of time that would be spent on the activities.  Total time spent 
on activities, including both time off and time outside of the workday, 
ranged from 1 to 143 calendar days per activity.  The median amount of 
time spent on outside activities, per activity, was 12.5 calendar days.  
There are no explicit limits on the amount of time that employees may 
use to perform outside activities. 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  49    A P P E N D I X   ~   C  

ERRORS FOUND ON OUTSIDE ACTIVITY REQUESTS FOR 
FDA SENIOR-LEVEL EMPLOYEES 
The following tables illustrate:  (1) the frequency of errors on FDA 
senior-level employees outside activity request forms, and (2) the 
problems we uncovered in our review of FDA senior-level employees 
outside activity request forms. 
 Number of Errors Found on Approved Outside Activity Requests
 of FDA Senior- Level Employees, CY 20002003
Number of  Number of Request Forms  Percent of Request Forms 
Errors  With Errors  With Errors 
0    3  5  
1    0 0  
2 1 4   25  
3 1 2   22  
4 1 2   22  
5    8   15  
6    4 7  
7    2 4  
Totals  55  100
 Source:  Office of Inspector General analysis of FDA data, 2005. 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA E MPLOYEES  50  A P P E N D I X   ~   C  

 Errors Found on Approved Outside Activity Requests
 of FDA Senior- Level Employees, CY 20002003
Number of  Percent of 
Missing Item on the HHS-520 
Requests  Requests
 Missing at least one of the following items  52  95
 HHS-520, Item 4:  Grade and salary (one or both missing)  40  73
 HHS-520, Item 18:  Action taken (any part of Item 18)  22  40
     Item 18a:  Final action  14  25
     Item 18b:  Final approving official signature  9  16
     Item 18c:  Final approving official title  14  25
     Item 18d:  Signature date  12  22
 HHS-520, Item 16:  Additional information attached?  16  29
 HHS-520:  Request type  15  27
 HHS-520, Item 17:  Action recommended by reviewing
9  16
 official (any part of Item 17)
     Item 17a:  Recommended action 7  13
     Item 17b:  Reviewing official signature 4  7
     Item 17c:  Reviewing official title  7  13
     Item 17d:  Signature date 5  9
 Second page of the HHS-520  9  16
 HHS-520, Item 12:  Will compensation be derived from an
7  13
 HHS grant or contract?
 HHS-520, Item 8:  Estimated time involved 6  11
 HHS-520, Item 10:  If providing consultative or professional
 services, are your would-be associates receiving or will they 5  9
 seek, a grant or contract from a federal agency?
 HHS-520, Item 11:  Method of basis of compensation   3  5
 HHS-520, Item 5:  Name, address and business of person
 2  4
 or organization for whom outside services will be performed
 HHS-520, Item 6:  Location where services will be performed  2  4
 HHS-520, Item 3:  Title of position  1  2
 HHS-520, Item 9:  Do your official duties relate in any way
 1  2
 to the proposed activity?
 HHS-520, Item 1:  Name  - -
 HHS-520, Item 2:  Organizational location  - -
 HHS-520, Item 7:  Nature of activity  - -
 HHS-520, Item 13:  Statement that form contains true,
- -
 complete, and correct information 
 HHS-520, Item 14:  Signature of employee  - -
 HHS-520, Item 15:  Signature date  - -
 Source:  Office of Inspector General analysis of FDA data, 2005. 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  51  AAA PPP PPP EEE NNN DDD III XXX     ~~~     CCC    
  A P P E N D I X   ~   D  

HHS AND FDAINITIATIVES 
To strengthen the process for reviewing outside activity requests, HHS 
and FDA have the following initiatives recently completed, planned, or 
underway. 
HHS Interim Final Rule 
HHS issued an interim final rule in February 2005 that imposes new 
responsibilities on FDA and other HHS employees who engage in 
outside activities.5  The following are some of the provisions of the 
interim final rule that relate to outside activities: 
o 	 Employees must provide additional detailed information in their 
outside activities requests. The revised HHS-520 form, released 
in April 2005, captures significantly more information than the 
previous version. 
o 	 Employees must file annual reports on their outside activities. 
o 	 Outside activities may only be approved for 1-year periods. 
Other HHS Initiatives 
o 	 As of January 2004, HHS employees who request approval for 
outside activities must list the amount of compensation to be 
received on their request forms. 
o 	 In August 2004, the HHS Designate Agency Ethics Official sent a 
memorandum to officials throughout HHS to remind them of the 
importance of performing due diligence when reviewing ethics 
forms. 
o 	 In April 2005, HHS released a revised version of the HHS-520 
form that captures more information than the previous version. 
FDA Internal Review 
o 	 In June 2004, the Acting FDA Commissioner ordered a review of 
approximately 1,800 outside activities to assess compliance with 
relevant ethics rules. This review found no outside activities that 
raised concerns, except for one problematic activity of which FDA 
was already aware. 
5  70 Fed. Reg. 5,543, Feb. 3, 2005. 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  52  A P P E N D I X   ~   D  
FDA Enhanced Oversight 
In light of the June 2004 internal review of outside activities, the 
Acting FDA Commissioner announced several new requirements for 
outside activities, including the following: 
o 	 Prior to the interim final rule, FDA limited approvals for outside 
activities to 1-year periods. 
o 	 FDA first required center directors to be the final approving 
officials for all outside activity requests, and later required the 
FDA Deputy Ethics Counselor to be the final approving authority 
for all outside activity requests.  This duty cannot be delegated, as 
it often was in the past. 
o 	 FDA has expanded the number of employees who are required to 
annually file the confidential financial disclosure form, the  
OGE-450. 
o 	 FDA will begin conducting annual reviews of outside activities in 
which they will cross-check financial disclosure forms to 
determine compliance with filing regulations.   
o 	 FDA is working on a comprehensive Agency-Wide Staff Manual 
Guide on Outside Activities, which will be released to all 
employees upon completion. 
FDA Enhanced Information Management 
o 	 Prior to the release of the revised HHS-520 form in April 2005, 
FDA employees were required to use the HHS-520-1 outside 
activities request form, which was unique to FDA and, in part, 
completed electronically. 
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  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  59    A C K N O W L E D G M E N T S  

This report was prepared under the direction of Joyce M. Greenleaf, 
Regional Inspector General for Evaluation and Inspections in the 
Boston regional office.  Other principal Office of Evaluation and 
Inspections staff who contributed include: 
Aimee Golbitz, Team Leader 
Steven Keenan, Project Leader 
Michael Flood, Program Analyst 
Ayana Everett, Program Specialist 
Elise Stein, Director, Public Health and Human Services 
Technical Assistance  
Barbara Tedesco, Mathematical Statistician 
Kevin Farber, Mathematical Statistician 
Office of Counsel to the Inspector General 
Melinda Golub, Senior Counsel 
  OEI-01-04-00400  OUTSIDE ACTIVITIES OF FDA EMPLOYEES  60