FDA Advisory Committees: Process for Recruiting Members and Evaluating Potential Conflicts of Interest Page: 2 of 67
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GAO
Accountability. Integrity. Reliability
Highlights
Highlights of GAO-08-640, a report to
congressional requesters
Why GAO Did This Study
The Department of Health and
Human Services' (HHS) Food and
Drug Administration (FDA) has
been criticized about how it
recruits individuals to become
members of its advisory
committees and how it grants some
determinations that allow members
with conflicts of interest to
participate in committee meetings.
Advisory committee meetings can
include both standing and
temporary members. Temporary
members only serve for a particular
meeting. GAO was asked to
examine FDA's advisory committee
processes. GAO reported on
(1) how FDA recruited individuals
for membership and evaluated
candidates for potential conflicts of
interest, (2) barriers that were
reported to recruiting qualified
individuals to serve on committees,
and (3) the proportion of standing
and temporary members, and the
frequency with which members
with conflict of interest
determinations participated in
meetings.
GAO reviewed FDA advisory
committee policies and analyzed
meeting records for FDA's Center
for Biologics Evaluation and
Research (CBER), Center for Drug
Evaluation and Research (CDER),
and Center for Devices and
Radiological Health (CDRH). GAO
also interviewed individuals
familiar with FDA's committee
member recruiting process. GAO
did not examine the effects of
changes in FDA's advisory
committee processes resulting
from the FDA Amendments Act of
2007 and 2007 FDA policy revisions
as it was too soon to assess them.
To view the full product, including the scope
and methodology, click on GAO-08-640.
For more information, contact Marcia Crosse
at (202) 512-7114 or crossem @ gao.gov.FDA ADVISORY COMMITTEES
Process for Recruiting Members and Evaluating
Potential Conflicts of InterestWhat GAO Found
Prior to the FDA Amendments Act of 2007, FDA employed several methods to
recruit candidates for advisory committees and to evaluate candidates by
prescreening them for potential conflicts of interest. FDA recruited candidates
by announcing vacancies in the Federal Register, distributing recruitment
brochures at advisory committee meetings and national meetings, word-of-
mouth or asking current advisory committee members, and posting
recruitment and conflict of interest information on FDA's Web site. To
evaluate advisory committee candidates for conflicts of interest, FDA
reviewed the candidates' curricula vitae and usually conducted a prescreening
interview. FDA employed many of the same recruitment and evaluation
practices used by organizations previously identified by GAO as employing
methods that could ensure an independent and balanced advisory committee.
FDA faced barriers to recruiting qualified advisory committee candidates,
particularly those without potential conflicts of interest, according to FDA
officials and former FDA advisory committee members. However, GAO found
that the agency may have been able to mitigate these barriers by expanding its
outreach efforts. FDA staff and former FDA advisory committee members
GAO interviewed generally agreed that individuals with the expertise FDA
sought for its advisory committees were the same leading experts that
industry sought to conduct research. In addition, word-of-mouth-the
advisory committee member recruitment method FDA officials generally
agreed was most effective-was limited in the number of candidate
nominations it could generate. The FDA Amendments Act of 2007 modifies
FDA's process for prescreening candidates for committee membership.
Standing and temporary members were 58 and 42 percent, respectively, of the
1,218 participants in the 83 advisory committee meetings held by CBER,
CDER, and CDRH in 2004 and 2006 that GAO reviewed. FDA may permit an
advisory committee member who has a conflict of interest, or an appearance
of a conflict, and whose expertise is needed to participate in an advisory
committee meeting under certain circumstances by granting a conflict of
interest determination. More than half of the meetings had at least one
standing or temporary member with at least one conflict of interest
determination. The 200 members found to have at least one conflict of interest
determination represented about 16 percent of all 83 meetings' participants.
The FDA Amendments Act of 2007 limits the number of certain conflict of
interest determinations that FDA can grant and FDA's conflict of interest
policy revisions limit the amount of the disqualifying financial interests.
In its comments on a draft of this report, HHS noted that on August 4, 2008,
after GAO provided the draft report for its review, FDA issued four final
guidance documents concerning management of its advisory committees.
HHS also provided additional clarifications about aspects of FDA's advisory
committees. GAO revised the report to cite the final guidances and to
incorporate HHS's clarifications where appropriate.United States Government Accountability Office
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United States. Government Accountability Office. FDA Advisory Committees: Process for Recruiting Members and Evaluating Potential Conflicts of Interest, report, September 30, 2008; Washington D.C.. (https://digital.library.unt.edu/ark:/67531/metadc298139/m1/2/: accessed April 17, 2024), University of North Texas Libraries, UNT Digital Library, https://digital.library.unt.edu; crediting UNT Libraries Government Documents Department.