Procedures for Evaluating Appearance 
 
Issues and Granting Authorizations for 
Participation in FDA Advisory 
Committees
 
 
Guidance for the Public, FDA Advisory Committee 
Members, and FDA Staff 
 
DRAFT GUIDANCE 
 
This guidance document is being distributed for comment purposes only. 
 
Submit comments on this draft document by the date provided in the Federal Register 
notice announcing the availability of the draft guidance.  Submit written comments to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852.  Submit electronic comments to 
http://www.regulations.gov.  You should identify all comments with the docket number 
listed in the notice of availability that publishes in the Federal Register. 
 
Additional copies are available from the Advisory Committee Oversight and 
Management Staff, Office of Special Medical Programs, Office Medical Products and 
Tobacco, Food and Drug Administration, 10903 New Hampshire Ave., WO32-5103, 
Silver Spring, MD 20993, or by calling 301-796-8220, or by email to 
Michael.Ortwerth@fda.hhs.gov.  Persons interested in obtaining a copy of the draft 
guidance may do so by downloading an electronic copy from the Internet at either 
http://www.fda.gov/RegulatoryInformation/Guidances/ucm122044.htm or 
http://www.regulations.gov.    
U.S. Department of Health and Human Services 
Food and Drug Administration 
Office of Medical Products and Tobacco 
Office of Special Medical Programs 
 Center for Biologics Evaluation and Research (CBER)  
Center for Drug Evaluation and Research (CDER)  
Center for Devices and Radiological Health (CDRH)  
Center for Food Safety and Applied Nutrition (CFSAN)  
Center for Tobacco Products (CTP) 
National Center for Toxicological Research (NCTR) 
June 2016   
Table of Contents 
I.  INTRODUCTION .......................................................................................................................... 3 
II.  BACKGROUND ............................................................................................................................ 4 
III.  WHAT IS THE SCOPE OF THIS GUIDANCE? ....................................................................... 5 
IV.  DETERMINING WHETHER AN APPEARANCE ISSUE EXISTS ........................................ 6 
A.  WHAT IS THE SCREENING PROCESS TO IDENTIFY POSSIBLE APPEARANCE ISSUES? .......................... 6 
B.  WHAT CIRCUMSTANCES MAY CREATE AN APPEARANCE ISSUE?...................................................... 7 
1.  Direct and Predictable Effect on the Current Financial Interest of a Member of the Advisory 
Committee Members Household ................................................................................................ 7 
2.  A Person or Entity with Whom the Member has a Covered Relationship is or Represents a 
Party to the Matter .................................................................................................................. 8 
3.  Other Circumstances that May Raise a Question about the Members Impartiality ................. 11 
V.  DETERMINING WHETHER TO GRANT A SECTION 502 AUTHORIZATION ............. 13 
A.  WHETHER A REASONABLE PERSON WOULD QUESTION THE MEMBERS IMPARTIALITY ................. 13 
B.  WHETHER THE GOVERNMENTS INTEREST IN THE MEMBERS PARTICIPATION OUTWEIGHS THE 
CONCERN THAT A REASONABLE PERSON MAY QUESTION THE INTEGRITY OF THE AGENCYS 
PROGRAMS AND OPERATIONS ......................................................................................................... 13 
VI.  APPENDIX: EXAMPLES OF APPEARANCE ISSUES AND FACTORS FDA WOULD 
CONSIDER IN DETERMINING WHETHER TO GRANT A SECTION 502 
AUTHORIZATION ..................................................................................................................... 18 
VII.  ATTACHMENT: FDA FORM 3410.....................................................................21 
 
  2   
 
Procedures for Evaluating Appearance 
Issues and Granting Authorizations for 
Participation in FDA Advisory 
Committees 
Guidance for the Public, FDA Advisory Committee 
Members, and FDA Staff 
This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
Administration (FDA or Agency) on this topic.  It does not establish any rights for any person 
and is not binding on FDA or the public.  You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.  To discuss an alternative approach, 
contact the FDA staff responsible for this guidance as listed on the title page.   
 
I.  INTRODUCTION 
 
Advisory committees provide independent, expert advice to FDA on a range of 
issues affecting the public health.1  To protect the credibility and integrity of advisory 
committee advice, FDA screens advisory committee members2 carefully for two 
categories of potentially disqualifying interests or relationships:   
 
(1)  current financial interests that may create a recusal obligation under Federal 
conflict of interest laws; and  
(2)  other interests and relationships that do not create a recusal obligation under 
Federal conflict of interest laws but that may create the appearance that a 
member lacks impartiality, known as appearance issues.   
 
In August 2008, FDA issued a guidance describing the process it uses to decide 
whether an advisory committee member has potentially disqualifying interests in the first 
category, i.e., current financial conflicts of interest that may create a recusal obligation 
                                                 
1 Advisory committees provide advice and recommendations to FDA; their recommendations are not 
binding on the agency. Final decisions are made by FDA.  5 USC App. 2  9(b); 21 CFR  14.5.    
2 This guidance applies to special Government employees (SGEs) and regular Government employees 
(RGEs) invited to participate in FDA advisory committees subject to the Federal Advisory Committee Act 
(FACA) (5 USC  App. 2).  For purposes of the guidance, we refer to these SGEs and RGEs as advisory 
committee members. 
  3   
under Federal conflict of interest laws.3  The 2008 guidance also describes FDAs 
process for determining whether to grant a waiver for an advisory committee member 
with a financial conflict of interest to participate in an advisory committee meeting.  
 
This draft guidance addresses FDAs process for evaluating whether an advisory 
committee member has potentially disqualifying interests or relationships that fall into 
the second category of interests: appearance issues.  It also describes FDAs process for 
determining whether to authorize a member with an appearance issue to participate in the 
advisory committee meeting. 
     
FDAs guidance documents, including this guidance, do not establish legally 
enforceable rights or responsibilities.  Instead, guidances describe the Agency's current 
thinking on a topic and should be viewed only as recommendations, unless specific 
regulatory or statutory requirements are cited.  The use of the word should in Agency 
guidances means that something is suggested or recommended, but not required. 
 
II.  BACKGROUND 
 
Members of FDAs advisory committees are subject to Government-wide 
standards of ethical conduct regulations in addition to Federal conflict of interest laws.  
Even where a member has no financial interests that would require her to refrain from 
participating in an advisory committee meeting (recuse herself) under Federal conflict 
of interest laws, the member may be disqualified from participation under the 
Government-wide Federal regulation at 5 CFR  2635.502 (section 502) if she has 
interests or relationships that may create the appearance that she lacks impartiality on the 
issue before the advisory committee.4  Section 502 implements the ethical principle that a 
Government employee should be impartial in performing her official duties, meaning that 
she must not give preferential treatment to any private organization or individual or use 
public office for private gain.  To the extent that a members performance of official 
duties might appear to benefit her or certain other individuals close to her, she must take 
appropriate steps to avoid even an appearance of violating these ethical principles.5   
 
Section 502 gives FDA and other agencies significant flexibility and discretion in 
deciding whether a member with an appearance issue should participate in a particular 
                                                 
3 FDA Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for 
Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees, available 
at http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM125646.pdf .  See also FDA 
Guidance for the Public, FDA Advisory Committee Members, and FDA Staff:  Public Availability of 
Advisory Committee Members Financial Interest Information and Waivers, available at 
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM295372.pdf.  
4 5 CFR  2635.502(a)-(e). 
5 Section 502 proposed rule, 56 Fed. Reg. at 33785. 
  4   
matter.6  Under section 502, when a member has an appearance issue, FDA may 
authorize the member to participate in the advisory committee meeting based on a 
determination, made in light of all relevant circumstances, that the interest of the 
Government in the members participation outweighs the concern that a reasonable 
person may question the integrity of the agencys programs and operations.7  If FDA 
does not issue an authorization, the individual may not participate in the meeting or the 
portion of the meeting involving the particular matter relevant to the appearance issue.8  
In determining whether to grant an authorization under section 502 to a member with an 
appearance issue, FDA balances the agencys interest in access to the advice of qualified 
experts to make important public health decisions with the need to avoid serious 
questions about the members impartiality.   
 
Section 502 places the initial burden of identifying potential appearance issues on 
the member.9  It also gives the member the initial responsibility to recuse herself where 
she determines that the circumstances would cause a reasonable person with knowledge 
of the relevant facts to question her impartiality in the matter, unless she informs FDA of 
the issue and receives authorization from FDA to participate.10  FDA provides assistance 
to members in fulfilling these duties.  FDA has the discretion to make independent 
determinations about whether a member has an appearance issue and to decide whether to 
grant her an authorization to participate once an appearance issue is identified.11  
 
Sections IV and V of this guidance explain how FDA reviews potential 
appearance issues and grants authorizations for advisory committee members under 
section 502.     
 
III.  WHAT IS THE SCOPE OF THIS GUIDANCE? 
 
 This guidance applies to advisory committee meetings.  Section 502 specifically 
describes appearance issues that arise from meetings that relate to particular matters 
involving specific parties12.  However, section 502(a)(2) also provides that an 
employee who is concerned that circumstances other than those specifically described in 
this section would raise a question regarding her impartiality to use the process described 
                                                 
6 56 Fed. Reg. at 33778, 33786 (July 23, 1991) (Section 502 proposed rule).   
7 5 CFR  2635.502(d). 
8 5 CFR  2635.502(e). 
9 5 CFR  2635.502(a). 
10 Id. 
11 5 CFR  2635.502(c). 
12 Office of Government Ethics (OGE) regulations define a particular matter involving specific parties to 
include any judicial or other proceeding, application, request for a ruling or other determination, contract, 
claim, controversy, investigation, charge, accusation, arrest or other particular matter involving a specific 
party or parties. The term typically involves a specific proceeding affecting the legal rights of the parties, or 
an isolatable transaction or related set of transactions between identified parties.  5 CFR  2640.102(1) 
and 2635.502.   
  5   
in this section to determine whether she should or should not participate in a particular 
matter.  This guidance will address those circumstances specifically described as well as 
other circumstances that could raise appearance issues, as contemplated by section 502.   
 
The principal focus of section 502 is on particular matters involving specific 
parties.  These are proceedings that affect the legal rights of specific companies, 
organizations, or individuals.  Advisory committee meetings involving review of a 
product approval application or the safety of, or labeling changes for, a specific product 
are particular matters involving specific parties.  If a committee reviews two or more 
specific products in a single meeting, each constitutes a separate particular matter 
involving a specific party. 
 
This guidance applies only to special government employees (SGEs) and regular 
government employees (RGEs), referred to collectively in this guidance as members13 
invited to participate in FDA advisory committees subject to the Federal Advisory 
Committee Act (FACA)(5 USC  App.2) engaged in activities involving  a particular 
matter.  It does not apply to members serving on a FDA advisory committee who are not 
SGEs or RGEs.14   
 
This guidance addresses only appearance issues under section 502.  This guidance 
does not address financial conflicts of interest that disqualify members from participation 
under 18 USC  208.15   
 
IV.  DETERMINING WHETHER AN APPEARANCE ISSUE 
EXISTS 
A.  What is the Screening Process to Identify Possible 
Appearance Issues? 
 
  In preparation for an advisory committee meeting involving a particular 
matter, members report to FDA any interests related to the subject matter of the 
meeting.16  These interests are reported on the Confidential Financial Disclosure 
Report (also known as the Form FDA 3410, an alternate form approved by OGE 
to be used in lieu of the OGE confidential financial disclosure report, Form OGE-
                                                 
13 Most FDA advisory committee members are appointed as SGEs.  However, advisory committee 
members may also be RGEs.  For example, FDA may request participation by employees of the United 
States Department of Agriculture, the Centers for Disease Control and Prevention, or other Federal 
agencies where these employees expertise is needed. 
14 Some participants at advisory committee meetings are neither SGEs nor RGEs.  Industry representatives, 
for example, are not SGEs and are appointed to advisory committees to provide the point of view of the 
industry they represent.  Industry representatives are not subject to federal conflict of interest laws or 
standards of ethical conduct regulations. 
15 As noted, FDA has issued guidance on these financial conflicts of interest, supra note 4.  
16  http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM125646.pdf 
  6   
450).  The Form FDA 3410 is specifically tailored to meet the needs of FDAs 
advisory committees.17, 18  Although the Confidential Financial Disclosure Report 
Form FDA 3410 primarily focuses on current financial interests, it also asks for 
information about past financial interests that directly relate to the products or 
issues to be considered at the meeting, and any other interests or relationships that 
might give rise to an appearance issue.19  A member may seek assistance from 
FDA in completing this form.  In completing this form, a member is required to 
report anything that would create an appearance issue not otherwise disclosed on 
the Form.  The member may make a threshold judgment as to whether the 
information would cause a reasonable person to question her participation, and so 
inform the agency.   
   
  FDA reviews the completed Confidential Financial Disclosure Report for 
each member in advance of every committee meeting to determine whether an 
appearance issue exists.  As part of this review, FDA may ask for clarification 
about reported interests or about interests not reported but of which FDA may 
otherwise be aware.     
B.  What Circumstances May Create an Appearance Issue? 
   
  Section 502 specifically lists certain interests and relationships that could 
create an appearance issue, described below in subsections 1 and 2.  It also 
includes a catch-all provision, described in subsection 3, which covers any 
other circumstances that may cause a reasonable person to question the members 
impartiality.  Once these circumstances described in this section raise a concern 
regarding the impartiality of the member, FDA considers the totality of the 
circumstances when determining to grant an authorization, as described in section 
V. 
1.  Direct and Predictable Effect on the Current 
Financial Interest of a Member of the Advisory 
Committee Members Household 
 
Under section 502, the following scenario would raise a potential 
appearance issue: where the particular matter coming before the advisory 
committee is likely to have a direct and predictable effect on the 
current financial interest of a member of the advisory committee 
members household.  
                                                 
17 In some rare instances where the particular matter before the committee is broad and far-reaching and 
will affect a class of non-federal entities without reference to a specific product or type of product, the 
agency may decide to use the Form OGE-450 for members to report their financial interests.   
18 Form FDA 3410 asks members to identify anything that would give an appearance of a conflict where 
Form OGE-450 does not specify appearance issues.   
19 See 5 CFR  2635.502(a). 
  7   
 
 The phrase direct and predictable effect, as used in section 502, 
has the same meaning as under the Federal financial conflict of interest 
statutes.20  Specifically, a particular matter will have a direct effect on a 
financial interest if there is a close causal link between any decision or 
action to be taken in the matter and any expected effect of the matter on 
the financial interest.21  A particular matter will have a predictable effect 
if there is a real, as opposed to a speculative, possibility that the matter 
will affect the financial interest.22  
 
In applying this direct and predictable effect standard for 
purposes of section 502, FDA considers the interests of member[s] of 
[the individuals] household.23  In this respect, section 502 is broader 
than the Federal financial conflict of interest statutes, which direct FDA to 
consider the financial interests of a member or the members spouse and 
minor children only, not other potential household members.24  As used in 
section 502, the phrase member of [the individuals] household is 
construed broadly to include, for example, adult children and parents 
living with the member, as well as others sharing the members house, 
whether or not related to her (although it would not include a houseguest 
who lives in the house for a month or less). 25  FDA evaluates each set of 
the circumstances in determining whether a reasonable person would 
consider an individual to be part of the members household for purposes 
of section 502.26  
2.  A Person or Entity with Whom the Member has a 
Covered Relationship is or Represents a Party to 
the Matter 
 
Under section 502, the following scenario would also raise a 
potential appearance issue: where a person (or entity) with whom the 
advisory committee member has a covered relationship is or 
                                                 
20 See 5 CFR  2635.402(b)(1), 18 USC  208. 
21 5 CFR  2640.103(a)(3)(i). 
225 CFR  2640.103(a)(3)(ii). For more information on how FDA evaluates whether a meeting will have a 
direct and predictable effect on an members current financial interest, please refer to FDAs guidance on 
financial conflicts of interest, FDA Guidance for the Public, FDA Advisory Committee Members, and FDA 
Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory 
Committee Meetings, available at 
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM125646.pdf.    
235 CFR  2635.502(a). 
24Compare 18 USC  208(a) with 5 CFR  2635.502(a). 
25 57 Fed. Reg. at 35006, 35026 (Aug. 7, 1992) (Section 502 final rule).     
26 Id. 
  8   
represents a party to the matter coming before the advisory committee.  
Both covered relationship and party to the matter are described below.   
 
Covered Relationship:  Section 502(b)(1) provides that a 
member has a covered relationship with the following people and 
entities:  
(i) A person with whom the member has or is seeking a business, 
contractual, or other financial relationship other than a routine 
consumer transaction;27  
(ii) A person who is a member of her household or a relative with 
whom she has a close personal relationship; 
(iii) A person or entity for which the member has, within the last 
year,28 served as an employee, officer, director, consultant, agent, 
attorney, trustee, contractor, or general partner;  
(iv) A person or entity for which the members spouse, parent, or 
dependent child currently serves or is seeking to serve as an 
employee, officer, director, consultant, contractor, agent, attorney, 
trustee, or general partner; and  
(v) An organization, other than a political party, in which the 
member is an active participant.  Mere membership in an 
organization, payment of dues, or the donation or solicitation of 
financial support does not, by itself, constitute active participation.   
 
Section 502s covered relationship prong requires consideration 
of a broader set of relationships and interests than under the Federal 
financial conflict of interest statutes.  For example: 
 
  Household Members and Relatives:  Section 502 provides for 
consideration of situations where: the members household 
(discussed above in Section IV.B.1); or (b) relatives with 
whom the member has a close personal relationship (e.g., adult 
children, parents, in-laws), whether or not they reside in the 
members household, are a party or party representative to the 
particular matter before the committee.  (As noted, Federal 
conflict of interest laws cover the financial interests of the 
member, her spouse, and minor children, not adult children or 
other household members.)   
 
                                                 
27 This paragraph specifically excludes situations in which the relationship is with a prospective employer 
as defined in 5 CFR  2635.603(c).  The latter type of relationship is governed by the financial conflict of 
interest analysis under 18 USC  208.  
28 Within the last year means within the 12 months preceding the date of the advisory committee meeting. 
  9   
  Certain Past Financial Interests:  Section 502 covers certain 
past financial relationships.  For example, if the member, in the 
previous year, has served as a consultant to a sponsor of a 
product before the committee, she has a covered relationship 
with a party to the particular matter before the committee.  
(The financial conflict of interest analysis applies only to the 
members current financial interests and those under 
negotiation or for which she has an agreement.) 
 
  Certain Current Financial Interests:  Even where a members 
current financial relationship has been determined not to create 
a recusal obligation under Federal financial conflict of interest 
laws, it could present an appearance issue under section 502.  
For example, if a member has a current consulting contract 
with a sponsor of a product being reviewed by the advisory 
committee, but the members contract is not related to the 
product or issue being considered by the committee, FDA may 
conclude that the particular matter before the committee is 
unlikely to have a direct and predictable effect on the 
members financial interest under Federal financial conflict of 
interest statutes (depending on the particular circumstances).  
However, the members contractual relationship with the 
sponsor would constitute a covered relationship under 
section 502 and could present an appearance issue. 
 
  Certain Relationships that Exist through the Members Role 
with an Employer or Organization:  Even where there is no 
recusal obligation under Federal financial conflict of interest 
laws, FDAs practice is to consider that the member could still 
have an appearance issue under section 502 if: (1) she holds a 
leadership position with her employer, or is an active 
participant in an organization, and; (2) that employer or 
organization has a financial relationship with the sponsor 
whose product is coming before the advisory committee. This 
appearance issue may exist even if the employers or 
organizations relationship is unrelated to the products or issues 
before the committee and the member was not personally 
involved in the funded activity.  Leadership responsibilities 
could include managerial or supervisory duties or any fiduciary 
duties.  Active participation could include service as an 
official of the organization or otherwise directing the activities 
  10   
of the organization.29  Because of this broad coverage of 
section 502, FDAs practice is that a member that holds a 
leadership position with her employer, or is an active 
participant in an organization, should report any financial 
relationships that are known to the member between her 
employer and the party or parties to the particular matter before 
the committee.  This reporting applies even when the financial 
relationship is unrelated to the products or issues before the 
committee, the member has not been personally involved in the 
funded activity, and the financial interest has ended within the 
past 12 months.30 
 
Party to the Matter:  The determination of who is a party to the 
matter depends on the specific facts of each case, in particular whose legal 
rights or obligations will be affected by the particular matter before the 
committee.  Generally, FDA considers a party to include any sponsor of 
the product(s) coming before the advisory committee.  Other entities with 
certain types of financial relationships related to the product(s), such as 
licensees, may also be parties to the matter.   
 
3.  Other Circumstances that May Raise a Question about 
the Members Impartiality  
 
Section 502 provides a catch-all for other circumstances that 
may create an appearance issue:  where circumstances other than those 
specifically described may raise a question about the members 
impartiality.31  In FDAs experience section 502, such circumstances 
could include: 
 
  Particular Matters of General Applicability: Generally, 
section 2635.502 focuses on particular matters involving 
specific parties.  However, section 2635.502(a)(2) provides a 
mechanism for SGEs to determine whether they should recuse 
                                                 
29 For example, a member may have an appearance issue if she is an officer in a nonprofit organization that 
has received funding from the sponsor within the past year, whether or not that funding relates to the 
product or issues before the committee and even if all monies have been paid and all services rendered.  A 
member also may have an appearance issue if she has a leadership role at a university (e.g., dean) that has 
funding from the sponsor to carry out clinical trials on products that are unrelated to the products before the 
committee, even if the member has no personal involvement with the clinical trials.  
30 For example, the Chair of a clinical division at a hospital should report any grants or contracts that have 
been awarded to her division by the sponsor even if the grant has been completed in the past year and all 
monies have been paid and all services rendered.  Likewise, a president or director of an organization is 
expected to report any funds the sponsor has given to the organization in the past year. 
31 5 CFR  2635.502(a)(2). 
  11   
themselves from other particular matters that are not 
described elsewhere in the rule.  Particular matters of general 
applicability involve potential changes to regulations or 
agency guidance, or other broad topics such as policy-making 
and decisions that affect an entire class of products, such as 
reviewing labeling changes for an entire class of products32.  
Particular matters of general applicability tend to raise fewer 
appearance issues than particular matters involving specific 
parties33.  However, the agency may require members to recuse 
from particular matters that do not involve specific parties, 
based on the concern that the members impartiality reasonably 
may be questioned under the circumstances.   
 
  Relationships that are Not Technically Covered 
Relationships:  Professional, social, or other relationships that 
are not technically a covered relationship under section 502 
could still raise concerns about the members impartiality.  For 
example, an appearance issue may arise if the member has a 
close personal relationship (but not technically a covered 
relationship) with someone who is a party or party 
representative, such as if the member is a close friend with the 
patent holder on the product at issue.  Additionally, if the 
member has a close personal relationship with an officer of the 
sponsor, these scenarios may raise appearance concerns.34  
 
  Past Financial Interests Ending More Than One Year Before 
the Meeting that Suggest a Close Relationship with the 
Sponsor or Involvement with the Product(s) before the 
Committee:  Although interests or relationships more than a 
year old do not generally give rise to appearance issues, there 
may be exceptions when these involvements suggest close ties 
to the sponsor or product(s).  These include: 
  Past relationships with the sponsor that were long-term and 
o
of substantial value.  
  Past involvement with the product(s) at issue. 
o
 
  Other Relationships or Interests, Whether Current or Past, 
that May Raise Questions about the Members Impartiality:  
                                                 
32 A particular matter of general applicability means a particular matter that is focused on the interests of a 
discrete and identifiable class of persons, but does not involve specific parties.  5 CFR  2640.102(m). 
33 Section 502 proposed rule, 56 Fed. Reg. at 33786. 
34 Section 502, final rule, 57 Fed. Reg. at 35026. 
  12   
These relationships or interests involving the member (or a 
member of her household) may include:   
  Past involvement in a lawsuit related to the product(s) or 
o
issues before the committee or otherwise involving the 
sponsor. 
  Involvement as a subject in a clinical trial of one of the 
o
products at issue. 
        
V.  DETERMINING WHETHER TO GRANT A SECTION 
502 AUTHORIZATION 
A.  Whether a Reasonable Person Would Question the 
Members Impartiality 
 
Determining whether to grant a section 502 authorization requires 
evaluating the circumstances described above and then assessing whether these 
interests, relationships, or circumstances would cause a reasonable person with 
knowledge of the relevant facts to question the members impartiality in the 
particular matter.35  This question assumes the perspective of reasonable person 
who knows the circumstances, not the perspective of the unreasonable, 
uninformed, or overly zealous.36  As discussed in Section IV.A, a member, under 
section 502, may make a threshold judgment on whether a reasonable person 
would question her impartiality and may disqualify herself from participation.   
 
If FDA concludes that a reasonable person would not question the 
members impartiality, there is no appearance issue and the member may 
participate in the meeting.37  If FDA concludes that an appearance issue exists and 
is still interested in having that member participate, FDA then asks whether the 
Governments interest in the members participation outweighs the concern that a 
reasonable person may question the integrity of the agencys programs and 
operations.  If so, FDA may grant an authorization before the meeting to allow the 
member to participate.  If FDA does not grant an authorization, the member may 
not participate in the meeting.   
 
B.  Whether the Governments Interest in the Members 
Participation Outweighs the Concern that a Reasonable 
                                                 
35 5 CFR  2635.502(a).   
36 Section 502, final rule, 57 Fed Reg. at 35008.  This test does not depend on whether the public has actual 
knowledge of the appearance issue.   
37 5 CFR  2635.502(c)(2). 
  13   
Person May Question the Integrity of the Agencys 
Programs and Operations 
 
  According to OGE, section 502 is intended to give an agency broad 
discretion to determine whether a members possible appearance issue is so 
significant that it should disqualify them from participation.38  As OGE has 
explained, section 502 authorizations call for the agency [decision makers] 
exercise of judgment and not the application of [a] precise [formula] from which 
only one correct conclusion can be reached.39   
 
Even so, the regulation provides a non-exclusive list of factors that an 
agency may take into consideration in deciding whether to grant a section 502 
authorization.  In general, these factors are intended to provide greater flexibility 
and discretion to the agency than those that apply to granting waivers from 
disqualifying conflicts of interest under 18 USC  208.40  The factors that may be 
taken into consideration are: 
 
(1) The nature of the relationship involved; 
(2)  The effect that resolution of the matter would have upon the financial 
interests of the person involved in the relationship; 
(3) The nature and importance of the members role in the matter, 
including the extent to which the member is called upon to exercise 
discretion in the matter; 
(4) The sensitivity of the matter; 
(5) The difficulty of reassigning the matter to another expert; and 
(6) Adjustments that may be made in the members duties that would 
reduce or eliminate the likelihood that a reasonable person would question 
her impartiality.41 
 
(1)  The Nature of the Relationship Involved:  As noted, appearance 
issues may arise from: (1) a personal relationship between the member and 
another individual, e.g., a household member whose financial interests may be 
affected or close relative, who may be a party to the particular matter that is the 
subject of the advisory committee meeting; or (2) a past or present professional or 
other relationship between the member and a company, person, or organization 
that is a party or party representative to the matter before the advisory committee.  
Relationships with the party to the matter that have been determined to be 
unrelated to the particular matter before the committee might, depending on the 
circumstances, present lesser appearance concerns than relationships more 
                                                 
38 Section 502 proposed rule, 56 Fed Reg at 33786. 
39 Section 502 final rule, 57 Fed. Reg. at 35027. 
40 Section 502 proposed rule, 56 Fed Reg at 33786. 
41 5 CFR  2635.502(d)(1)-(6). 
  14   
directly related to the particular matter.  For other types of relationships, in 
analyzing the nature of a particular relationship to determine whether a section 
502 authorization may be warranted, FDA considers the totality of the 
circumstances, such as:  
 
  Whether the relationship is current or past (past relationships weigh 
more in favor of participation); 
  If a past relationship existed within the prior 12 months (relationships 
that have not existed within the prior 12 months weigh more in favor 
of participation); 
  Whether the relationship is, or was, related to the product before the 
committee (relationships not related to the product, e.g., a contractual 
relationship not related  to the product, weigh more in favor of 
participation than related relationships);  
  The magnitude of the financial interest created by the relationship 
(small interests weigh more in favor to participation); and 
  If the member conducted or was otherwise involved with past research 
on the product, whether that research will be reviewed by the 
committee (the general principle is that a member should not review 
her own work). 
 
(2)  The Effect that Resolution of the Matter Would Have Upon the 
Financial Interests of the Person Involved in the Relationship:  FDA considers 
whether the outcome of the particular matter before the advisory committee may 
have an effect on the current financial interests of a household member or relative 
with whom the member has a close personal relationship because the household 
member or relative is employed by or otherwise has a financial relationship with 
the company (or other party) whose product is before the advisory committee.  In 
these rare cases, FDA may take into account: 
 
  Whether the company is small or large (interests in a company with a 
wide range of products weigh more in favor of granting a section 502 
authorization because of the greater likelihood that the outcome of the 
meeting will not affect the financial stability of the company and, 
therefore, the continuing viability of the household member or 
relatives employment or other relationship with the sponsor). 
  Whether the financial interest is related to a product before the 
committee (interests not related to the product weigh more in favor of 
participation);  
  Whether a household members or relatives employment with a party 
is related to the product or is in a division of the company that is 
  15   
responsible for the product (employment in the company that is not 
related to the product can weigh more in favor of participation; and 
  The magnitude of the interest (small interests weigh more in favor of 
participation). 
 
(3)  The Nature and Importance of the Members Role in the Matter, 
Including the Extent to which the Member is Called upon to Exercise 
Discretion in the Matter:  Advisory committees provide only recommendations 
to FDA; final decisions are made by FDA.42  The fact that the members 
recommendations are solely advisory in nature, and are not made individually but 
as only one member of a committee of experts, might weigh in favor of granting a 
section 502 authorization, depending on the circumstances.     
   
(4)  The Sensitivity of the Matter:  At the time that FDA screens members 
for appearance issues, it may be difficult to predict whether the matter to be 
addressed by the committee will be considered sensitive or controversial.  FDA 
nonetheless considers whether the issue coming before the committee is likely to 
generate significant public interest or the potential for litigation.  In highly 
sensitive cases, FDA may be less likely to grant a section 502 authorization, 
depending on the analysis of the other factors.   
 
(5)  The Difficulty of Reassigning the Matter to Another Expert:   
Members of FDA advisory committees are scientific experts who are leaders in 
their respective disciplines.  Depending on the nature of the matter before the 
committee, and the needs of the agency for experts with a background in a highly 
specialized area or sub-specialty, the pool of individuals with the required 
expertise may be very limited.  Scheduling conflicts may further limit the 
available pool of experts who are able to participate in a committee meeting.  
FDA evaluates each situation to determine what is best to uphold public 
confidence in the scientific integrity of the advisory committee process while 
ensuring that the committee has the necessary expertise.  Where a member has 
particular expertise or experience that is very important to the committees work, 
or where others with comparable expertise  have conflicts or appearance issues 
more extensive than the members, FDA is more likely to grant a section 502 
authorization.  Where there are alternate experts who possess comparable 
expertise and have fewer conflicts and appearance issues, FDA is less likely to 
grant a section 502 authorization.  In situations where there is a need for a 
diversity of expert opinion and there is a limited pool of experts on a particular 
matter, FDA is more likely to grant a section 502 authorization. 
 
                                                 
42 5 USC App. 2  9(b); 21 CFR  14.5.    
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(6)  Adjustments that May be Made in the Members Duties that Would 
Reduce or Eliminate the Likelihood that a Reasonable Person Would Question 
the Members Impartiality:  In situations where the appearance concern is 
significant, the agency may consider adjusting the scope of the members 
participation to minimize the concern while allowing the agency to obtain 
relevant expertise.  If adjustments can be made to a members role to reduce or 
eliminate the likelihood that a reasonable person would question the integrity of 
the agencys programs or operations, FDA is more likely to grant a section 502 
authorization.  Such adjustments may include limiting the members participation 
to engaging in committee discussions but not voting, or allowing the member only 
to give a presentation on a select topic and respond to questions directly related to 
that presentation but not to participate in committee discussions or voting.   
 
* * * 
 
  In deciding whether to grant an authorization, FDA may take into account all of 
these six factors.  To help explain this decision-making process, the Appendix contains 
examples of appearance issues and factors FDA would consider in deciding whether to 
grant a section 502 authorization for the member to participate in the advisory committee 
meeting. 
 
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VI.  APPENDIX: EXAMPLES OF APPEARANCE ISSUES 
AND FACTORS FDA WOULD CONSIDER IN 
DETERMINING WHETHER TO GRANT A SECTION 502 
AUTHORIZATION  
 
Where a member has an appearance issue under section 502 with respect to the 
particular matter that is the subject of an advisory committee meeting, FDA evaluates 
whether, in light of all the relevant circumstances, the agencys interest in the members 
participation in the meeting outweighs the concern that a reasonable person may question 
the integrity of the agencys programs and operations.  This evaluation is fact-specific 
and is conducted on a case-by-case basis.  This Appendix describes three examples in 
which a member would be considered to have an appearance issue under section 502.  
There are several factors FDA considers relevant in determining whether to grant a 
section 502 authorization for the member to participate in the meeting.  These factors can 
exhibit various degrees of weight in the authorization decision depending upon the 
specific conditions and scenario regarding the member.  The examples below are 
intended only to illustrate how some of these factors could be applied.  Each situation is 
evaluated on its own merits and facts considering multiple factors. 
 
Scenario:  The advisory committee is reviewing the safety and efficacy of a product.  
The meeting is a particular matter involving specific parties with one party to the 
matter (the sponsor).     
 
Example #1: The members primary employment is as a dean of the medical school at a 
large university.  The member reported that her employer has a multi-year grant from the 
product sponsor (i.e., the sponsor of the product that will be reviewed and evaluated at 
the advisory committee meeting) and the grant is not related to the product before the 
committee.  This is an interest or relationship that could cause a reasonable person to 
question the members impartiality. 
 
Factors FDA Would Consider in Determining Whether or Not to Grant a Section 502 
Authorization For the Member to Participate in the Meeting: 
  Whether the member receives any personal funding or remuneration from the 
grant (if not, this would weigh in favor of  a section 502 authorization); 
  Size and diversity of the range of products made or under development by the 
sponsor providing the grant funding to the employer (the larger and more diverse 
the range of products the more this would weigh in favor of a section 502 
authorization); 
  Whether the members employer relies solely, or principally, on this grant from 
the sponsor (if not, this would weigh in favor of  a section 502 authorization); 
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  Whether the matter before the committee is considered sensitive or controversial 
(matters that are typical and routine without controversy would weigh in favor of 
a section 502 authorization); 
  Whether the member has expertise that is important to the committees work and 
others with comparable expertise have conflicts or appearance issues more 
extensive than the members (if so, this would weigh in favor of a section 502 
authorization);  
  If there is a need for multiple experts in a field (if so, this would weigh in favor of 
a section 502 authorization). 
 
Example #2: The member serves on the board of directors of a nonprofit organization 
that receives donations from the sponsor.  This is an interest or relationship that could 
cause a reasonable person to question the members impartiality. 
 
Factors FDA Would Consider in Determining Whether or Not to Grant a Section 502 
Authorization For the Member to Participate in the Meeting: 
 
  Whether the nonprofit organization has taken a position on the product or the 
meeting topic (if not, this would weigh in favor of a section 502 authorization); 
  Whether the member receives any personal funding or remuneration from the 
donations given to the nonprofit by the sponsor (if not, this would weigh in favor 
of a section 502 authorization); 
  Size and diversity of the range of products made or under development by the 
sponsor providing donations to the nonprofit organization (the larger and more 
diverse the range of products the more this would weigh in favor of a section 502 
authorization ); 
  Whether the matter before the committee is considered sensitive or controversial 
(if not, this would weigh in favor of a section 502 authorization);  
  Whether the member has expertise that is very important to the committees work 
and others with comparable expertise have conflicts or appearance issues more 
extensive than the members (if so, this would weigh in favor of a section 502 
authorization); 
  If there is a need for multiple experts in the field (if so, this would weigh in favor 
of a section 502 authorization). 
 
Example #3: The member had a consulting contract43 with the sponsor that ended four 
months ago.44  The consulting contract and relationship with the sponsor has ended and 
all monies received.  This is an interest or relationship that could cause a reasonable 
person to question the members impartiality. 
 
                                                 
43 Consulting contracts do not ordinarily constitute employment and therefore do not usually implicate 18 
U.S.C. 208.  However, in this example the member still has a covered relationship with the sponsor and 
therefore the agency analyzes the interest under 5 CFR 2635.502. 
44 In instances where the contract is completed and all monies paid, the member will still have a covered 
relationship under section 502 with the entity for a period of 12 months.   
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Factors FDA Would Consider in Determining Whether or Not to Grant a Section 502 
Authorization For the Member to Participate in the Meeting: 
 
  Whether the members contract with the sponsor was related to the product before 
the committee (if not, this would weigh in favor of a section 502 authorization); 
  The magnitude of the financial payments to the member under the contract (a 
small amount would weigh in favor of a section 502 authorization); 
  Size and diversity of the range of products made or under development by the 
sponsor (the larger and more diverse the range of products the more this would 
weigh in favor of a section 502 authorization ); 
  Whether the work done under the contract will be a focus of the discussions of the 
meeting (if not, this would weigh in favor of a section 502 authorization); 
  Whether the matter before the committee is considered sensitive or controversial 
(if not, this would weigh in favor of a section 502 authorization);  
  Whether the member has expertise that is very important to the committees work 
and others with comparable expertise have conflicts or appearance issues more 
extensive than the members (if so, this would weigh in favor of a section 502 
authorization); 
  If there is a need for multiple experts in a given field (if so, this would weigh in 
favor of a section 502 authorization). 
 
    
   
 
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ATTACHMENT: FORM FDA 3410 
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