Contains Nonbinding Recommendations 
 
 
 
 
Guidance for FDA Advisory Committee 
Members and FDA Staff : 
Voting Procedures for 
Advisory Committee Meetings  
 
 
 
 
 
For questions regarding this document, please contact the Advisory Committee Oversight 
and Management Staff at 301-827-1220 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
 
 August 2008 
  
  1    
Contains Nonbinding Recommendations 
 
 
 
Guidance for FDA Advisory Committee 
Members and FDA Staff:   
Voting Procedures for  
Advisory Committee Meetings
 
 
 
Additional copies are available from: 
 
Office of Consumer and Constituent Relations 
Office of the Commissioner 
Food and Drug Administration 
5600 Fishers Lane 
Rockville, MD  20857 
(Phone 301-827-4573) 
 
http://www/fda/gov/ohrms/dockets 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
 
 August 2008 
 
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Contains Nonbinding Recommendations 
 
 
 
GUIDANCE FOR FDA ADVISORY  
COMMITTEE MEMBERS AND FDA STAFF   
 
Voting Procedures for Advisory Committee Meetings 
 
 
 
This guidance represents the Food and Drug Administrations (FDAs) current thinking on this topic.  It 
 
does not create or confer any rights on any person and does not operate to bind FDA or the public.  You 
 
can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.  
 
If you want to discuss an alternative approach, contact the appropriate FDA staff. If you cannot identify 
 
the appropriate staff, call the appropriate number listed on the title page of this guidance. 
Introduction 
 
 
 
I.  Introduction 
 
This guidance provides guidance on advisory committee voting procedures and is 
intended for use by FDA advisory committee members and FDA staff involved with 
advisory committee matters.  This document  recommends  uniform  procedures that can 
be used for the voting process when votes are taken during advisory committee meetings.  
This document does not recommend when votes should be taken.    
 
FDAs guidance documents, including this guidance, do not establish legally 
enforceable responsibilities.  Instead, guidances describe the Agencys 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 
 
FDA's advisory committees provide  independent expert advice to the agency on a 
range of complex scientific,  technical, and policy issues, including questions related to 
the development and evaluation of products regulated by FDA.  Advisory committees are 
a valuable resource to FDA, and they make an important contribution to the agencys 
decision-making processes.  Although advisory committees provide recommendations to 
FDA, FDA makes the final decisions.  
 
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Advisory committees typically communicate advice or recommendations to the 
agency in two ways.  First, FDA learns from the discussion and exchange that occurs 
among advisory committee members, and from individual recommendations and 
suggestions made during the discussion of any advisory committee meeting.  Second, 
advisory committees often vote on a question or series of questions posed to the 
committee during a committee meeting.  As the agency makes its final decision, FDA 
seriously considers the recommendations made by advisory committees, including the 
advisory committee deliberations and voting. 
 
This document provides guidance on the procedures used for voting.  
 
There are some advisory committee meetings at which votes are not taken.  For 
example, votes are typically not taken at meetings to discuss the development of a 
clinical trial design or the development of a guidance document.   
 
At other  advisory committee meetings, members cast a formal vote on issues related 
to the approvability of a product submission.  In others, different questions may be posed 
to a committee for a formal vote.  Votes can be an effective means of communicating 
with FDA because they provide feedback on discrete questions.  These questions are 
generally scientific in nature and can involve a range of subjects, including evaluation of 
post-market safety data or pre-market assessment of a product's risk/benefit profile.  
Since all members vote on the same question, the results help FDA gauge a committees 
collective view on complex, multi-faceted issues.  FDA recognizes that many of the 
questions voted on by advisory committee members are complex and that the discussion 
that accompanies the voting is important.. The discussion, together with the votes, helps 
inform the agencys own deliberations on scientific and regulatory matters. 
 
Accordingly, FDA recommends adopting uniform voting procedures to help 
maximize the integrity and meaning of voting results.  In developing these 
recommendations, FDA is mindful of the legal requirements of the Federal Advisory 
Committee Act (FACA), other relevant statutes (e.g., the Federal Food, Drug, and 
Cosmetic Act), regulations (e.g., 21 CFR Part 14), guidance, policies, and the goals of 
FDAs advisory committee program.  
 
Transparency and public participation are critical features of the advisory committee 
process.  The use of secret ballots, long a hallmark of the American electoral experience, 
generally is not appropriate in the advisory committee context because the expert opinion 
of each member should be clearly understood and identified with that expert.  
Nevertheless, even with public balloting, the voting process can be managed to help 
maximize the integrity and utility of the outcome.   
 
There has been much discussion inside and outside FDA regarding sequential versus 
simultaneous voting.  Some have expressed concern that sequential voting, in which 
members cast public votes in turn, has the potential to compromise the integrity of the 
result.   
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For example, scholars and social scientists have studied the risk of momentum" in 
sequential voting, exploring whether some sequential voters may be influenced, perhaps 
even subconsciously, by the votes that precede theirs, especially if those votes are nearly 
identical or signal a clear trend1.  This potential risk may be aggravated in the advisory 
committee setting, where votes are often conducted in full view of a passionate public 
and participatory audience.  In the case of sequential voting, there is also a potential risk 
that comments made by a committee member or a designated federal officer (DFO) 
during the vote could inappropriately affect the deliberations of those who have not yet 
voted.  Another potential risk is that comments could alter the meaning (or interpretation) 
of the question at issue in such a way as to cast doubt on whether all the members voted 
on the identical question. 
 
III.  Policy 
 
Accordingly, to help maximize the integrity, consistency, and utility of advisory 
committee voting results, FDA recommends that the voting process include the following 
procedures:   
 
  The Chair and DFO of an advisory committee are encouraged to generate a robust 
discussion about the matter at issue before any voting takes place.  As part of this 
process, the Chair or DFO should encourage the non-voting members to 
participate in the discussion and should solicit the views of all members so that 
any comment, insight, or concern that could influence a voters conclusions on the 
matter at issue is heard and considered before a vote related to that matter occurs, 
not afterward.  The Chair or DFO should also consider in advance of the vote the 
need for the advisory committee members to have an opportunity following the 
vote to further explain any important qualifications related to their votes. 
 
  The question presented for a vote should have minimal qualifiers, not be leading, 
and should avoid the use of double or triple negatives.  When presenting a 
question for a vote, the Chair, DFO, or other senior agency officials should solicit 
and answer questions about its meaning before the vote begins.  The objective is 
to reduce any potential confusion and maximize the meaning of the voting results 
by ensuring that the votes are based on a consistent and collective understanding 
of the question at issue. 
 
  Voting should be done simultaneously.  The objective is to avoid any potential 
order bias associated with sequential voting and thereby enhance the integrity and 
meaning of the voting results.  The committee Chair or DFO has discretion to 
decide the precise method of voting on a meeting-by-meeting basis.  Examples 
                                                 
1   See, e.g., Callander, S. (2007):  Bandwagons and Momentum in Sequential Voting, Review of 
Economic Studies, 74, 653-684; Banerjee, A. (1992): A Simple Model of Herd Behavior, Quarterly 
Journal of Economics, 107, 797-817. 
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Contains Nonbinding Recommendations 
 
 
include a simultaneous show of hands, a simultaneous show of yes or no 
cards, or a balloting method in which members simultaneously cast written votes.  
The committee Chair or DFO should determine and announce the precise method  
at the beginning of the meeting.  Further, whatever method of voting is employed, 
the names of the committee members and their respective votes should be read 
aloud and otherwise made part of the public record shortly after the vote is taken.  
 
  The question put to the vote should not be the subject of further discussion or 
clarification while the voting is underway (i.e., whereas a discussion and 
clarification of the question is encouraged before the vote, there should be no 
discussion of the meaning of the question while members actually cast their 
simultaneous votes).  Once voting on a particular question has begun, that vote 
generally should not be terminated until the vote is complete.  Following 
completion of the vote, consistent with the first bullet above, advisory committee 
members may explain their vote.  Additional clarification of the question after a 
vote and a re-vote on a re-worded question may occur at the discretion of the 
DFO or committee chair. 
 
  In some instances, the Chair of an advisory committee may believe the committee 
should vote on a related or relevant question not posed by FDA.  If the Chair 
wants to put another question to a vote on his/her own initiative, the Chair should 
first check with the DFO or other senior FDA officials present to be sure that the 
question is appropriate for the meeting, that it is consistent with the topic 
identified in the meeting notices, and that it will not affect the conflict-of-interest 
screening that had been completed prior to the meeting. If a determination is made 
that the question should be posed, the Chair should discuss the matter with the 
committee members before the voting begins to ensure that the committee 
members collectively understand the question and feel adequately prepared (either 
through the background materials or their own expertise) to render a 
meaningful/informed vote on the new question.    
 
  Briefing materials provided to advisory committee members as background 
materials before an advisory committee meeting should be thorough and, to the 
extent possible, include the questions that will be voted upon by the committee.  
The objective is to maximize the meaning and utility of the voting results by 
ensuring that the voters have had ample opportunity to study background 
materials before the day of the meeting.   
 
For more information about FDA's advisory committee procedures, see 
http://www.fda.gov/oc/advisory/default.htm. 
 
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