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Report to Congressional Requesters: 

United States Government Accountability Office: 
GAO: 

September 2008: 

FDA Advisory Committees: 

Process for Recruiting Members and Evaluating Potential Conflicts of 
Interest: 

GAO-08-640: 

GAO 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. 

What 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. 

To view the full product, including the scope and methodology, click on 
[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-08-640]. For more 
information, contact Marcia Crosse at (202) 512-7114 or 
crossem@gao.gov. 

[End of section] 

Contents: 

Letter: 

Results in Brief: 

Background: 

FDA Used Several Methods to Recruit Candidates for Advisory Committee 
Membership and Prescreened Candidates for Potential Conflicts of 
Interest: 

Barriers Existed to Recruiting Qualified FDA Advisory Committee 
Candidates, Particularly Those without Potential Conflicts of Interest, 
but FDA May Have Been Able to Mitigate Barriers by Expanding Outreach 
Efforts: 

Most Advisory Committee Meeting Participants Were Standing Members, and 
Many Members Had Conflict of Interest Determinations: 

Agency Comments and Our Evaluation: 

Appendix I: Major 2007 Actions Affecting FDA Recruiting and Conflict of 
Interest Determination Processes: 

Appendix II: Scope and Methodology: 

Appendix III: Factors That May Affect FDA Advisory Committee Meeting 
Recommendations: 

Appendix IV: FDA Advisory Committees for the Three Centers Analyzed: 

Appendix V: Comments from the Department of Health and Human Services: 

Appendix VI: GAO Contact and Staff Acknowledgments: 

Related GAO Products: 

Tables: 

Table 1: Four Possible Member Conflict of Interest Determinations for 
FDA Advisory Committee Meetings Prior to October 1, 2007, Changes: 

Table 2: Selected Advisory Committee Recruitment Methods of FDA, EPA, 
and National Academies Prior to October 1, 2007: 

Table 3: Selected Advisory Committee Prescreening Methods of FDA, EPA, 
and National Academies Prior to October 1, 2007: 

Table 4: Standing and Temporary Member Totals for 83 FDA Advisory 
Committee Meetings by Center: 2004 and 2006: 

Table 5: Type and Number of Conflict of Interest Determinations for 200 
Standing and Temporary Members for 49 Selected CBER, CDER, and CDRH 
Advisory Committee Meetings, 2004 and 2006: 

Figures: 

Figure 1: FDA Organizational Structure for CBER, CDER, and CDRH 
Advisory Committee Administration Prior to August 30, 2007: 

Figure 2: Conflict of Interest Determination Process for FDA Advisory 
Committee Members: CBER, CDER, and CDRH: 

Abbreviations: 

AAMC: Association of American Medical Colleges: 

ACOMS: Advisory Committee Oversight and Management Staff: 

ACS: Advisors and Consultants Staff: 

CBER: Center for Biologics Evaluation and Research: 

CDC: Centers for Disease Control and Prevention: 

CDER: Center for Drug Evaluation and Research: 

CDRH: Center for Devices and Radiological Health: 

EIS: Ethics and Integrity Staff: 

EPA: U.S. Environmental Protection Agency: 

FACA: Federal Advisory Committee Act: 

FDA: Food and Drug Administration: 

HHS: Department of Health and Human Services: 

MDAC: Medical Devices Advisory Committee: 

NIH: National Institutes of Health: 

OGE: Office of Government Ethics: 

PhRMA: Pharmaceutical Research and Manufacturers of America: 

SGE: special government employee: 

[End of section] 

United States Government Accountability Office:
Washington, DC 20548: 

September 30, 2008: 

The Honorable Edward Kennedy: 
Chairman: 
The Honorable Michael B. Enzi: 
Ranking Member: 
Committee on Health, Education, Labor, and Pensions: 
United States Senate: 

The Honorable Richard J. Durbin: 
United States Senate: 

The Food and Drug Administration (FDA) is responsible for ensuring the 
safety and efficacy of drugs, biological products, and medical devices 
the American public uses every day. FDA convenes scientific advisory 
committees to provide independent expertise and technical assistance to 
help the agency make decisions about the development and evaluation of 
products regulated by FDA. Advisory committees include standing 
members, who are appointed by FDA to serve a specified term on an 
advisory committee, and may include temporary members, who are selected 
by FDA to serve at only one specific meeting.[Footnote 1] Other 
individuals that may contribute to the advisory committee meeting 
discussion include guest speakers, such as researchers who are invited 
to present scientific papers and individuals who speak on behalf of the 
companies whose products are at issue. Members of the public are also 
allowed to speak during an open public hearing portion of the advisory 
committee meeting. The advisory committees' recommendations are not 
binding on the agency, but the agency usually follows the advisory 
committees' advice. 

Some advisory committee members might have financial conflicts of 
interest for all or part of a committee meeting depending on the issues 
or products to be discussed. Conflicts of interest, for example, might 
include a member having financial investments in a drug manufacturer 
whose product is under review. While some conflicts of interest could 
require that a member be prohibited from participating in a meeting, 
FDA may permit a member to participate in advisory committee meeting 
discussions under certain circumstances by granting waivers of the 
statutory prohibition on participation. FDA can also authorize a member 
to participate when the statutory conflict of interest prohibition 
would not have been violated, but there is the appearance of a conflict 
of interest, such that the member's impartiality involving the 
committee meeting's discussions could be questioned. For purposes of 
this report, both types of decisions are called conflict of interest 
determinations.[Footnote 2] FDA has been criticized about how it 
recruits qualified individuals for its advisory committees and how it 
grants some conflict of interest determinations allowing members with 
conflicts of interest to participate in committee meetings. FDA 
maintains that its advisory committee members are preeminent scientists 
in their field, and that it is inevitable that some of these experts 
will have grants from, and contracts with, the regulated industries, 
which could constitute a potential conflict of interest or present the 
appearance of partiality. FDA asserts that its ability to make conflict 
of interest determinations is essential to its effort to access the 
most expert medical and scientific advice available. Others contend, 
however, that the objectivity of the advice and recommendations given 
by FDA advisory committees can be affected by the involvement of 
conflicted members. 

You have expressed interest in information about how FDA identified, 
recruited, and prescreened qualified candidates and about FDA's use of 
standing and temporary members and the extent these members received 
conflict of interest determinations. In this report we describe (1) how 
FDA recruited individuals for advisory committee membership and 
evaluated candidates by prescreening them for potential conflicts of 
interest,[Footnote 3] (2) barriers that were reported to recruiting 
qualified individuals to serve on FDA advisory committees, particularly 
candidates without potential conflicts of interest, and (3) the 
proportion of standing and temporary members in advisory committee 
meetings, and the frequency with which members with one or more 
conflict of interest determinations participated in advisory committee 
meetings. 

To report on these issues, we reviewed the Department of Health and 
Human Services' (HHS)[Footnote 4] and FDA's advisory committee 
regulations, policies, and guidances. We also reviewed the federal 
conflict of interest statutes and the Office of Government Ethics (OGE) 
regulations. We interviewed FDA's Advisory Committee Oversight and 
Management Staff (ACOMS) and Ethics and Integrity Staff (EIS). We also 
interviewed staff such as executive secretaries, who manage advisory 
committees; review division directors; and advisory committee 
management staff from the three FDA centers that we analyzed: the 
Center for Biologics Evaluation and Research (CBER), which regulates 
biological products such as blood and vaccines; the Center for Drug 
Evaluation and Research (CDER), which regulates drugs; and the Center 
for Devices and Radiological Health (CDRH), which regulates medical 
devices and radiological products. We chose to analyze these three 
centers because most of FDA's advisory committees were affiliated with 
them--and these centers' advisory committee meetings represented more 
than 80 percent of the total FDA advisory committee meetings held in 
2004 and 2006. 

To examine how FDA recruited individuals for advisory committee 
membership and prescreened candidates for potential conflicts of 
interest, in addition to interviews with FDA officials, we interviewed 
representatives from selected advocacy organizations that participate 
in nominating candidates for advisory committee membership, such as the 
Pharmaceutical Research and Manufacturers of America (PhRMA) and Public 
Citizen's Health Research Group. We compared FDA's recruitment and 
prescreening methods to the methods used by the U.S. Environmental 
Protection Agency (EPA) and the National Academies,[Footnote 5] 
organizations we identified in 2004 as employing specific recruitment 
and prescreening methods that could ensure independent and balanced 
advisory committees.[Footnote 6] We updated our information on EPA's 
and the National Academies' recruitment and prescreening methods 
through interviews with agency officials. 

To examine barriers that were reported to recruiting qualified 
individuals to serve on FDA advisory committees, particularly 
candidates without potential conflicts of interest, we interviewed 
individuals and groups familiar with FDA's advisory committee 
recruitment processes and officials from organizations we identified in 
2004 as employing specific recruitment methods that could ensure 
independent and balanced advisory committees. Individuals interviewed 
included current and former FDA staff; former CBER, CDER, and CDRH 
advisory committee members; staff involved with the advisory committee 
process at EPA, the National Institutes of Health (NIH), and the 
National Academies; and staff from the Association of American Medical 
Colleges (AAMC), PhRMA, and consumer advocacy groups that have taken a 
position on FDA's nomination and selection processes for advisory 
committee members. 

To determine the proportion of participants in advisory committee 
meetings who were standing members or temporary members and the 
proportion of those members who received conflict of interest 
determinations, we analyzed advisory committee meetings held by CBER, 
CDER, and CDRH--the three FDA centers with both the most advisory 
committees and the most committee meetings. We did not examine FDA's 
other centers' advisory committee meetings. Beginning in November 2005, 
FDA was required to post information on its Web site about the conflict 
of interest waivers it granted that allowed certain members to 
participate in meetings.[Footnote 7] We chose to review the committee 
meetings held in 2004 and 2006--2 years with the most recent data when 
we began our work--because (1) 2004 was the last full year before FDA 
began to post waiver information in 2005, and (2) 2006 was the first 
full year in which the waiver information had to be posted. We excluded 
2005 from the analysis because it was the year the Web site posting 
requirement began. We reviewed FDA's advisory committee meeting records 
and conflict of interest determination records and assessed the 
reliability of these data by (1) reviewing existing information about 
the data and (2) interviewing agency officials knowledgeable about the 
data. We found that the data were sufficiently reliable for our 
analysis. 

During the course of our work, two major actions occurred that changed 
FDA's recruitment and conflict of interest policies. In March 2007, FDA 
issued a draft advisory committee guidance that revises FDA's policy on 
how it screens individuals to determine if they have conflicts of 
interest for a specific advisory committee meeting.[Footnote 8] In 
addition, Congress amended the Federal Food, Drug, and Cosmetic Act to 
include, among other provisions, a section addressing recruitment, 
prescreening, and conflicts of interest, which took effect on October 
1, 2007.[Footnote 9] At the time of our review, it was too soon to 
assess the effect of the changes on FDA's processes. Consequently, this 
report focuses on FDA's organization, processes, and conflict of 
interest determinations as documented prior to the 2007 actions. 
Appendix I describes these policy actions in greater detail and we note 
FDA procedures that have been affected by them throughout the report. 
Appendix II provides a more detailed explanation of the scope and 
methodology for this report. We conducted our work from October 2006 
through September 2008 in accordance with generally accepted government 
auditing standards. 

Results in Brief: 

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 for nominations; and posting information 
about the recruitment process on FDA's Web site. To prescreen advisory 
committee candidates, FDA officials reviewed the candidates' curricula 
vitae and usually conducted an interview to determine whether there was 
any financial interest or activity that might present a potential 
conflict of interest. FDA employed many, but not all, of the 
recruitment and prescreening methods used by EPA and the National 
Academies, 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, we 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 generally agreed that individuals with the 
expertise FDA sought for its advisory committees were the same leading 
experts industry sought to conduct research. In addition, the advisory 
committee member recruitment method generally agreed to be most 
effective was limited in the number of candidate nominations it could 
generate. Some former advisory committee members told us that other 
barriers to membership related to aspects of FDA advisory committee 
service, including the time commitment involved in preparing for and 
attending advisory committee meetings, the financial disclosure 
information reporting requirements, and the negative publicity 
surrounding some advisory committee meetings. FDA employed several 
recruitment methods to identify qualified FDA advisory committee 
candidates. However, we found that the agency may have been able to 
mitigate barriers by expanding outreach efforts to retired experts, 
experts from colleges and universities, and individuals with 
epidemiological and statistical expertise. The FDA Amendments Act of 
2007 modifies FDA's process for prescreening candidates for advisory 
committee membership. 

Most FDA advisory committee meeting participants from the 2 recent 
years we analyzed were standing members who served a specified term on 
an advisory committee, but a large minority of participants were 
temporary members who served at one specific meeting. In the 83 
advisory committee meetings held by CBER, CDER, and CDRH in 2004 and 
2006, 58 percent of the 1,218 meeting participants were standing 
members and 42 percent were temporary members. FDA may permit an 
advisory committee member who has a conflict of interest and whose 
expertise is needed to participate in an advisory committee meeting 
under certain circumstances by granting a conflict of interest 
determination. About 16 percent of the members received conflict of 
interest determinations that allowed them to participate. Forty-nine of 
the 83 meetings had at least one standing or temporary member with a 
conflict of interest determination. Members can receive more than one 
type of determination and some received both a financial conflict of 
interest waiver and an appearance authorization. Two hundred 
participants in these 49 meetings had 234 conflict of interest 
determinations. The FDA Amendments Act of 2007 limits the number of 
certain conflict of interest determinations--the statutory waivers-- 
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 guidances concerning management of its advisory committees 
including how it determines the eligibility of advisory committee 
members with conflicts of interest to participate in meetings.[Footnote 
10] The guidance documents were available to us in draft form during 
the course of our work and the portions of the draft guidances that we 
discussed in the report did not change in the final guidances. 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. 

Background: 

FDA uses advisory committees to provide expert advice and make 
recommendations to help the agency reach regulatory decisions, 
particularly concerning controversial issues or new products. FDA 
advisory committees are subject to the Federal Advisory Committee Act 
(FACA), which requires that committee memberships be fairly balanced in 
terms of views presented and the functions to be performed by the 
advisory committee.[Footnote 11] FDA advisory committees have charters 
that explain the purpose of the committee and specify the number of 
standing committee members and the expertise needed by the members. 
[Footnote 12] FDA advisory committee members can be medical 
professionals, scientists, researchers, industry leaders, consumers, 
and patients. At an advisory committee meeting, committee members 
generally meet publicly to discuss and evaluate information about a 
specific issue.[Footnote 13] Depending on the issues or products to be 
discussed at a committee meeting, a committee member may have a 
potential financial conflict of interest.[Footnote 14] In that event, 
FDA decides whether the member's expertise is needed for discussing 
those issues or products, and if so, whether the member should be 
granted a conflict of interest determination--a waiver or an appearance 
authorization--to participate in the meeting. The members who do 
participate in the committee meeting may make recommendations to FDA-- 
by voting or by consensus through discussions--that are nonbinding on 
the agency.[Footnote 15] (See app. III.) 

FDA Advisory Committees: 

FDA has 31 advisory committees that are administratively attached to 
FDA centers or to the Office of the Commissioner. Most of the advisory 
committees--25--are attached to three FDA centers:[Footnote 16] CDER 
has 16 committees, CBER has 5, and CDRH has 4.[Footnote 17] (See app. 
IV.) Advisory committees usually meet as individual committees but may 
meet jointly to consider issues involving shared interests. Joint 
committee meetings may involve two advisory committees from the same 
center or from two different centers depending on the issue to be 
discussed. Advisory committees may also have subcommittees that meet to 
review specific information that may be presented later to the full 
advisory committee.[Footnote 18] 

Advisory Committee Management: 

FDA's overall management and coordination of its advisory committees is 
the responsibility of ACOMS. Each of the three centers we analyzed also 
has its own advisory committee management entity--CBER's Division of 
Scientific Advisors and Consultants, CDER's Advisors and Consultants 
Staff (ACS), and CDRH's Integrity, Committee and Conference Management 
Branch--responsible for administrative support, such as the preparation 
of nomination packages for potential committee members and the review 
of members' conflicts of interest. (See fig. 1.) Each FDA advisory 
committee has an executive secretary who manages the committee 
activities, including recruiting for advisory committee membership and 
prescreening candidates for potential conflicts of interest.[Footnote 
19] 

Figure 1: FDA Organizational Structure for CBER, CDER, and CDRH 
Advisory Committee Administration Prior to August 30, 2007: 

[See PDF for image] 

FDA Office of the Commissioner: 

* Center for Biologics Evaluation and Research (CBER); 
- Office of Management; Division of Scientific Advisors and Consultants 
(DSAC)[A]; 
- Other CBER offices; 5 CBER advisory; committees; 

* Center for Drug Evaluation and Research (CDER); 
- Office of Executive Programs; Advisors and Consultants Staff 
(ACS)[A]; 
- Other CDER offices; Other CDER divisions; 16 CDER advisory 
committees; 

* Center for Devices and Radiological Health (CDRH); 
- Office of Management Operations; Division of Ethics and Management 
Operations; Integrity, Committee and Conference Management Branch 
(ICCMB)[A]; 
- Other CDRH offices; Other CDRH divisions; 4 CDRH advisory committees 
(CDRH’s Medical Devices Advisory Committee has 18 panels)[B]; 

* Office of External Relations; 
- Advisory Committee Oversight and Management Staff (ACOMS); 

* Office of Management; Office of Management Programs; Ethics and 
Integrity Staff (EIS); 

* 12 other FDA offices and centers. 

Sources: Based on FDA organizational charts and GAO interviews with FDA 
officials. 

Notes: The chart reflects the FDA organizational structure for CBER, 
CDER, and CDRH advisory committee administration prior to August 30, 
2007. FDA amended its organizational structure on August 30, 2007. FDA 
advisory committees can be attached to offices or divisions. A center's 
advisory committees are attached to the center division or office with 
subject matter responsibility for the committee's issue areas. CDER and 
CDRH advisory committees are usually attached to a division--also 
referred to as a review division--and CBER's committees are more 
closely linked to its center's offices. For example, CDER's Anti- 
Infective Drugs Advisory Committee is attached to CDER's Division of 
Anti-Infective and Ophthalmologic Products and CBER's Blood Products 
Advisory Committee is attached to its Office of Blood Research and 
Review. ACS, ACOMS, and EIS are a part of the office they are connected 
to rather than a separate group under it. 

[A] Center's advisory committee management staff. 

[B] For purposes of this report, the 18 panels' meetings were 
considered to be individual advisory committee meetings. 

[End of figure] 

Advisory Committee Members: 

There are two general types of FDA advisory committee members—standing 
and temporary. Standing members are appointed by FDA to a specific 
advisory committee, serve a specific term, and are expected to attend 
all committee meetings. Temporary members are appointed by FDA to serve 
for one specific advisory committee meeting. 

Standing Members: 

Individuals appointed to serve on an FDA advisory committee as standing 
committee members generally are appointed as special government 
employees (SGE),[Footnote 20] and they are subject to federal conflict 
of interest statutes and regulations. Standing members are chosen for 
their expertise and skills and are expected to provide advice on the 
basis of their own best judgment. Federal government employees who are 
not employed by FDA, such as federal employees with NIH, may also be 
appointed as standing members and are also subject to these conflict of 
interest statutes and regulations.[Footnote 21] FDA advisory committee 
standing members serve staggered membership terms of no more than 4 
years and are expected to attend all committee meetings.[Footnote 22] 
CBER and CDER advisory committees’ maximum standing committee 
membership ranges from 9 to 26 members per committee, but most 
committees have 11 or 13 member maximums. CDRH’s 18 Medical Devices 
Advisory Committee (MDAC) panels can have a combined maximum of 159 
standing members. 

Advisory committee charters may allow a committee to have members who 
serve as representatives of specific interests—consumer, industry, or 
patient representatives. Consumer representatives are appointed by FDA 
as SGEs, are subject to federal conflict of interest statutes and 
regulations, and are standing members on an advisory committee. These 
individuals present the perspective of interested individual consumers 
and consumer organizations, and may, for example, be consumer advocates 
or consumer lawyers.[Footnote 23] Industry representatives are standing 
members; however, they are not SGEs and, therefore, not subject to the 
same conflict of interest laws and regulations applicable to federal 
employees.[Footnote 24] Industry representatives may participate in 
committee discussions to ensure that the industries affected by the 
committee’s issue jurisdiction are heard, but they are not permitted to 
vote on committee recommendations. Patient representatives are 
appointed as SGEs and are usually selected on a meeting-by-meeting 
basis for advisory committee meetings that focus on topics specific to 
a disease.[Footnote 25] For example, an advisory committee meeting 
involving approval of a lung cancer drug might have as its patient 
representative a caregiver or an individual with the disease who can 
discuss patient concerns. 

Temporary Members: 

FDA may also select temporary advisory committee members to serve for a 
specific advisory committee meeting given the issues or products to be 
discussed to provide additional expertise or to ensure that a quorum of 
members is present to conduct a meeting.[Footnote 26] Advisory 
committee charters for the three centers indicate a maximum number of 
temporary members who can serve for a specific meeting, usually no more 
than 10 members. Temporary members are usually appointed as SGEs and 
are subject to conflict of interest statutes and regulations.[Footnote 
27] They may be members of the center’s consultant pool[Footnote 28] or 
members of other FDA advisory committees from the same or a different 
FDA center. Federal employees from the Centers for Disease Control and 
Prevention (CDC) or NIH, for example, who provide specialized expertise 
for a meeting, may also serve as temporary members and are subject to 
conflict of interest statutes and regulations. 

Federal Conflict of Interest Provisions May Permit Member 
Participation: 

FDA may permit an advisory committee member—standing or temporary—who 
has a conflict of interest and whose expertise is needed, to 
participate in a meeting under certain circumstances. There are four 
conflict of interest determinations—three statutory waivers and an 
appearance authorization as provided for in OGE regulations—that FDA 
can use to permit members with a conflict of interest or the appearance 
of a conflict of interest to participate. 

Federal law prohibits federal employees, including SGEs, from 
personally and substantially participating in an advisory committee 
meeting involving a particular matter[Footnote 29] that would have a 
direct and predictable effect on the employee’s financial interest or 
the interests of others specified by law.[Footnote 30] In determining 
whether an FDA advisory committee meeting involves a particular matter, 
FDA officials told us that they first consider each topic to be 
discussed at the meeting and determine whether it involves specific 
parties, a class of persons, or the interests of a large and diverse 
group of people.[Footnote 31] If one of the meeting topics involves 
specific parties or a class of persons, FDA officials then determine 
whether the advisory committee members who will attend the meeting have 
any conflicts of interest or the appearance of conflicts of interest 
involving that meeting topic. Officials told us if they are uncertain 
whether a meeting topic is a particular matter, the issue is referred 
to FDA’s ACOMS and EIS. EIS may refer the issue to HHS’s general 
counsel which may also seek advice from the OGE. The law has two waiver 
provisions that allow standing and temporary members to participate in 
an advisory committee meeting if certain criteria are met. One 
waiver—known as a § 208(b)(3) waiver—applies only to SGEs serving on an 
advisory committee subject to FACA. When granting this waiver, FDA 
certifies in writing in advance that the need for the SGE’s services 
outweighs the potential for a conflict of interest at a specific 
upcoming meeting.[Footnote 32] Another type of waiver—known as a § 
208(b)(1) waiver—applies to federal employees generally, including SGEs 
and those not employed by FDA but who are members of FDA committees. 
When granting these waivers, FDA must determine that the interest 
involved is not so substantial as to be deemed likely to affect the 
integrity of the services which the government may expect from that 
individual.[Footnote 33] FDA may grant a member a full or a limited 
waiver—a written certification—to allow participation in the meeting. A 
full waiver may allow a member to participate in the discussions and to 
vote on recommendations. FDA may also grant a limited waiver to allow a 
member to discuss but not to vote on the recommendations.[Footnote 34] 
In addition, there are certain situations in which the member’s 
financial interest qualifies for an exemption from the application of 
the conflict of interest statutes and regulations applicable to federal 
employees, as provided by OGE regulations, and participation will be 
permitted despite the outside interest.[Footnote 35] 

In addition to 18 U.S.C. § 208, there was a provision in the Food and 
Drug Administration Modernization Act, in effect prior to October 2007, 
which effectively prohibited CBER and CDER advisory committee members 
from voting on committee meeting topics involving clinical 
investigations or approvals of drugs or biologics in which the member 
or his or her immediate family could gain financially from the 
committee’s advice.[Footnote 36] However, FDA could grant a waiver of 
this voting restriction—known as the § 355(n)(4) waiver—to a member if 
FDA determined that his or her participation was necessary to provide 
the committee with essential expertise. No waiver could be granted if 
the meeting involved the member’s own scientific work, such as work 
done by the member to develop a new drug being considered for approval 
by CDER.[Footnote 37] 

Finally, federal regulations require the consideration of the 
appearance of a conflict of interest for advisory committee members who 
will be participating in a specific-parties meeting when there are 
circumstances in which the member’s impartiality could be questioned. 
[Footnote 38] The appearance of a conflict may be created when someone 
in the advisory committee member’s household has a financial interest 
that will likely be affected by the committee’s actions or when one of 
the parties involved in the meeting has a close personal or 
professional relationship to the committee member.[Footnote 39] To 
grant an appearance authorization, FDA determines that the interest of 
the agency in the member’s participation in an advisory committee 
meeting’s topic outweighs the concern that a reasonable person with 
knowledge of the relevant facts would question the member’s 
impartiality in the matter before the advisory committee,[Footnote 40] 
which may call into question the integrity of FDA’s programs and 
operations.[Footnote 41] (See table 1 for a summary of the four 
conflict of interest determinations.) 

Table 1: Four Possible Member Conflict of Interest Determinations for 
FDA Advisory Committee Meetings Prior to October 1, 2007, Changes: 

Type of conflict of interest determination: Statutory waivers: 
18 U.S.C. § 208(b)(3) waiver of the criminal financial conflict of 
interest specific to SGEs serving on an advisory committee subject to 
the Federal Advisory Committee Act; 
Criteria for granting conflict of interest determinations to allow 
attendance at a meeting or part of a meeting: A committee member’s 
service is needed and outweighs the potential conflict of interest 
created by his or her personal or imputed financial interest; 
Standing and temporary member types that can receive conflict of 
interest determinations, SGEs: [Check]; 
Standing and temporary member types that can receive conflict of 
interest determinations, Other federal employees: [Empty]. 

Type of conflict of interest determination: Statutory waivers: 
18 U.S.C. § 208(b)(1) waiver of the criminal financial conflict of 
interest[A]; 
Criteria for granting conflict of interest determinations to allow 
attendance at a meeting or part of a meeting: A committee member’s 
personal or imputed financial interest is not so substantial as to be 
deemed likely to affect the integrity of the services which the 
government may expect from that member; 
Standing and temporary member types that can receive conflict of 
interest determinations, SGEs: [Empty]; 
Standing and temporary member types that can receive conflict of 
interest determinations, Other federal employees: [Check][B]. 

Type of conflict of interest determination: Statutory waivers: 
21 U.S.C. § 355(n)(4) waiver of financial conflict of interest 
involving drugs and biologics matters[C]; 
Criteria for granting conflict of interest determinations to allow 
attendance at a meeting or part of a meeting: A committee member—or his 
or her immediate family—could gain financially from the advice given 
but the member’s voting participation is necessary to provide the 
committee with essential expertise; 
Standing and temporary member types that can receive conflict of 
interest determinations, SGEs: [Check]; 
Standing and temporary member types that can receive conflict of 
interest determinations, Other federal employees: [Check]. 

Type of conflict of interest determination: Regulatory authorization: 
5 C.F.R. § 2635.502 appearance authorization to allow a committee 
member to participate when his or her impartiality could be questioned; 
Criteria for granting conflict of interest determinations to allow 
attendance at a meeting or part of a meeting: A committee member’s 
impartiality involving specific parties meeting could be questioned by 
a reasonable person with knowledge of the relevant facts, but the 
interests of the government in the member’s participation outweigh the 
concern that a reasonable person may question the integrity of the 
agency’s programs and operations; 
Standing and temporary member types that can receive conflict of 
interest determinations, SGEs: [Check]; 
Standing and temporary member types that can receive conflict of 
interest determinations, Other federal employees: [Check]. 

Sources: GAO analysis of applicable conflict of interest statutes and 
regulations and FDA information. 

Notes: 18 U.S.C. § 208(b)(2) provides for the OGE to exempt certain 
financial interests from application of the criminal financial conflict 
of interest law. When a committee member's financial interest that 
gives rise to the conflict is covered by one of the Office of 
Government Ethics' regulatory exemptions, the member can participate 
without FDA needing to grant an individual waiver. 

[A] Although 18 U.S.C. § 208(b)(1) applies to federal employees 
generally, including SGEs and those not employed by FDA who are members 
of FDA advisory committees because 18 U.S.C. § 208(b)(3) specifically 
authorizes waivers for SGEs serving on FACA committees, FDA applied 18 
U.S.C. § 208(b)(3) to SGEs in this context. 

[B] The FDA's 18 U.S.C. § 208(b)(1) waivers we analyzed were granted 
only to federal employees not employed by FDA. 

[C] Prior to October 1, 2007, the 21 U.S.C. § 355(n)(4) waiver applied 
only to allowing a committee member to vote on matters related to 
clinical investigations and approvals of drugs and biologics, which 
generally involved only CBER and CDER advisory committee meetings. On 
October 1, 2007, the FDA Amendments Act of 2007 repealed 21 U.S.C § 
355(n)(4), but at the same time also created a new provision applying a 
similar waiver to all FDA advisory committee members. See Pub. L. No. 
110-85, § 701, 121 Stat. 823, 900-04 (pertinent provision codified at 
21 U.S.C. § 379d-1(c)(2)(B)). 

FDA Conflict of Interest Determination Process: 

The appropriate FDA center review division and committee management 
staff for the advisory committee meeting decide whether a member meets 
the requirements for an applicable conflict of interest determination 
to allow him or her to participate. To assist in making conflict of 
interest determinations, FDA uses its Waiver Criteria 2000 guidance, 
which provides policies and procedures for handling conflicts of 
interest.[Footnote 42] On the basis of the advisory committee meeting's 
topic and its designation, the center review division involved in the 
advisory committee meeting typically compiles a list of companies and 
products affected by the meeting's topic. The advisory committee 
management staff then sends a memorandum with the final list of 
companies and products and the FDA Form 3410--the FDA financial 
disclosure form--to the advisory committee members. Members review the 
memorandum, complete the Form 3410, and report back to FDA on whether 
they believe they have any personal or imputed financial interests and 
past involvements with the affected companies and products listed for 
the upcoming advisory committee meeting's topic.[Footnote 43] 

The FDA center advisory committee management staff for the particular 
advisory committee review members' FDA financial disclosure forms and 
determine whether a member has a potential conflict of interest for the 
meeting or a part of the meeting.[Footnote 44] If a member has a 
conflict, FDA can: 

* accept a member's decision to not participate because of the member's 
own decision that he or she has a conflict of interest,[Footnote 45] 

* exclude or disqualify a member from participating, 

* seek another individual with the appropriate expertise needed to 
participate who has a less significant or no conflict of interest, or: 

* decide the member's expertise is needed, and that the member meets 
the criteria for a conflict of interest determination to allow him or 
her to participate in the meeting discussion and vote.[Footnote 46] 

If there is a question about whether a member should be granted a 
determination, the center's advisory committee management entity may 
seek advice from the review division. If there are further questions 
about whether the determination should be granted, advice may be sought 
from FDA's ACOMS and EIS.[Footnote 47] ACOMS and EIS review all 
conflict of interest determinations before their final approval. The 
final decision to grant or deny a determination is made by the FDA 
Associate Commissioner for Policy and Planning.[Footnote 48] (See fig. 
2.) 

Figure 2: Conflict of Interest Determination Process for FDA Advisory 
Committee Members: CBER, CDER, and CDRH: 

[See PDF for image] 

Center finds a member has a conflict of interest and determines the 
member’s expertise is needed. 

Center’s advisory committee management staff prepares a conflict of 
interest determination.[A] 

Ethics and Integrity Staff (EIS) reviews and concurs or not with the 
conflict of interest determination. 

Advisory Committee Oversight and Management Staff (ACOMS) reviews the 
determination. 

FDA Associate Commissioner for Policy and Planning approves or denies 
the determination.[B] 

Source: GAO interviews with FDA officials. 

[A] For our report, FDA conflict of interest determinations are 
statutory § 208 and § 355(n) financial interest waivers, and appearance 
authorizations as provided for in OGE regulations. 

[B] The FDA Associate Commissioner title was changed in August 2007 to 
the Deputy Commissioner for Policy. 

[End of figure] 

Since November 2005, FDA has been subject to requirements related to 
public disclosure of its conflict of interest waivers on its Web site. 
From November 2005 until October 2007, FDA had been required by law to 
publicly post the nature and basis of conflict of interest waivers on 
its Web site.[Footnote 49] As of October 2007, the FDA Amendments Act 
of 2007 require FDA to publicly disclose on the agency's Web site, 
prior to every advisory committee meeting, the reasons for all waivers 
granted as well as the type, nature, and magnitude of the financial 
interests being waived.[Footnote 50] In October 2007, FDA announced 
draft guidance[Footnote 51] to implement agencywide procedures for the 
public disclosure of (1) the type, nature, and magnitude of any 
financial conflict of interest for which an advisory committee member 
has been granted a waiver for a committee meeting on its Web site, 
[Footnote 52] and (2) conflict of interest waivers that would be 
written so that information protected from public disclosure would not 
appear in the waivers and thus would not need to be redacted. Public 
disclosure at an FDA advisory committee meeting can also, for example, 
include an announcement naming the attending members who have conflict 
of interest determinations. 

FDA Used Several Methods to Recruit Candidates for Advisory Committee 
Membership and Prescreened Candidates for Potential Conflicts of 
Interest: 

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 advisory committee membership. 
[Footnote 53] Common recruitment methods used by FDA include announcing 
vacancies in the Federal Register, distributing recruitment brochures 
at advisory committee meetings and national meetings, receiving 
nominations by word-of-mouth or asking current advisory committee 
members for nominations, and posting information about recruitment on 
FDA's Web site. Candidates who are selected to serve on an FDA advisory 
committee either as a consumer representative, industry representative, 
or patient representative are recruited and nominated using a different 
process than candidates identified for standing advisory committee 
membership. To prescreen candidates, FDA reviewed candidates' curricula 
vitae and usually conducted prescreening interviews. FDA officials 
within the three FDA centers we studied, CBER, CDER, and CDRH, 
prescreened each candidate to determine whether there was any financial 
interest or activity that might present a potential conflict of 
interest if the individual were to become an advisory committee member. 
FDA employed many of the same recruiting and prescreening methods as 
those employed by EPA and the National Academies, organizations we 
previously identified as employing certain recruitment and prescreening 
methods that could ensure independent and balanced advisory committees. 

FDA Employed Several Methods to Recruit Candidates for Advisory 
Committee Membership: 

FDA employed several recruitment methods to identify candidates for 
standing advisory committee membership, prior to the FDA Amendments Act 
of 2007. FDA officials in CBER, CDER, and CDRH told us that the methods 
commonly used to recruit candidates include announcing advisory 
committee vacancies in the Federal Register, distributing recruitment 
brochures at advisory committee meetings and national meetings, and 
receiving nominations by word-of-mouth or asking current advisory 
committee members for nominations. The FDA officials we interviewed 
stated that asking current advisory committee members for nominations 
was the most effective recruitment method because the members 
understand the advisory committee process and the commitment level 
required to serve as an FDA advisory committee member, and can 
communicate this information to the potential candidate. FDA staff in 
CBER and CDRH told us that posting vacancy announcements in the Federal 
Register was the least effective method of identifying qualified 
candidates because the centers received unsolicited curricula vitae 
from individuals seeking full-time jobs with FDA. 

Other recruitment methods reported include identifying possible 
candidates from the center’s consultant pool, which is a list of 
individuals whom FDA has determined have expertise that may be needed 
for future advisory committee meetings, and posting recruitment 
information on FDA’s Web site. CDRH staff reported that searching the 
consultant pool for a potential candidate is preferred because the 
executive secretary and the review division are usually familiar with 
the individual’s performance on an advisory committee and the 
individual is familiar with the advisory committee process. In February 
2007, FDA posted on its Web site a link to information about advisory 
committees and available vacancies for individuals interested in 
advisory committee membership. From the Web site, the public can access 
information about current advisory committee vacancies, required 
qualifications to become an advisory committee member, and instructions 
on how to apply for advisory committee membership.[Footnote 54] 

Candidates who are selected to serve on an FDA advisory committee 
either as a consumer representative, industry representative, or 
patient representative are recruited and nominated using a different 
process than candidates identified for standing advisory committee 
membership. FDA officials work with consumer and industry organizations 
to identify qualified candidates to serve as representatives. Consumer 
and industry groups nominate the candidates and FDA indicated that it 
generally accepts the organizations’ recommendations for nomination. 
[Footnote 55] For patient representatives, FDA’s Office of Special 
Health Issues’ Patient Representative Program is responsible for 
recruiting and nominating candidates. When an advisory committee 
meeting topic is of particular importance to the patient population 
(e.g., cancer or HIV/AIDS-related topics), the advisory committee’s 
executive secretary will ask Patient Representative Program staff to 
recommend a patient representative to attend the advisory committee 
meeting. 

FDA Prescreened Advisory Committee Member Candidates for Potential 
Conflicts of Interest: 

FDA officials in the three centers told us they prescreened advisory 
committee member candidates to determine whether they had any financial 
interests or if they were involved in any activity that might pose a 
potential conflict of interest, even though prior to October 1, 2007, 
HHS did not require its agencies to prescreen candidates at the time of 
their nomination to an advisory committee.[Footnote 56] To prescreen 
candidates, FDA reviewed the candidates’ curricula vitae and usually 
conducted a prescreening interview. The FDA officials told us that the 
interview is usually conducted by telephone using a prescreening form. 
[Footnote 57] The prescreening form asks candidates to provide 
information about their current investments, employment and consulting 
relationships held in the past 12 months, and current and past 
contracts and grants. 

FDA Used Many of the Same Recruiting and Prescreening Methods as Those 
Employed by Organizations Identified as Having Some Promising 
Recruitment and Prescreening Methods: 

FDA employed many of the same recruiting and prescreening methods as 
EPA and the National Academies, organizations found to have some 
promising methods that could ensure that advisory committee members are 
independent and advisory committees are balanced.[Footnote 58] Prior to 
October 1, 2007, FDA generally used the same recruitment methods as EPA 
and the National Academies (see table 2). One exception was FDA’s 
method for obtaining nominations for potential members from the public. 
FDA provides an e-mail address on its Web site for nominations, a 
method that relies on individuals submitting to the agency, via e-mail, 
a curriculum vitae and contact information. In contrast, EPA’s Science 
Advisory Board’s Web site allows the public to self-nominate or 
nominate an individual to be an advisory committee member by submitting 
information via a form on its Web site. 

Table 2: Selected Advisory Committee Recruitment Methods of FDA, EPA, 
and National Academies Prior to October 1, 2007: 

Recruitment methods: Request nominations from professional or specialty 
practice societies and organizations related to the advisory 
committee’s general topic; 
FDA: [Check]; 
EPA: [Check]; 
National Academies: [Check]. 

Recruitment methods: Ask current advisory committee members for 
nominations; 
FDA: [Check]; 
EPA: [Check]; 
National Academies: [Check]. 

Recruitment methods: Ask staff within the organization for nominations; 
FDA: [Check]; 
EPA: [Check]; 
National Academies: [Check]. 

Recruitment methods: Publish advisory committee vacancies in the 
Federal Register; 
FDA: [Check]; 
EPA: [Check]; 
National Academies: [Empty]. 

Recruitment methods: Has brochure explaining advisory committee 
membership; 
FDA: [Check]; 
EPA: [Check]; 
National Academies: [Check]. 

Recruitment methods: Post recruitment information on organization’s Web 
site; 
FDA: [Check]; 
EPA: [Check]; 
National Academies: [Check]. 

Recruitment methods: Enable people to nominate candidates and to self-
nominate directly through an electronic form on the organization’s Web 
site; 
FDA: [Empty]; 
EPA: [Check]; 
National Academies: [Empty]. 

Note: Represents the recruitment methods FDA employed prior to the 
implementation of the FDA Amendments Act of 2007. FDA still uses these 
recruitment methods; however, the FDA Amendments Act of 2007 provides 
additional recruitment methods that FDA may employ. 

Sources: GAO analysis of FDA, EPA, and National Academies staff 
interviews, and GAO-04-328. 

[End of table] 

Prior to October 1, 2007, FDA also employed many but not all of the 
same prescreening methods as EPA and the National Academies (see table 
3). EPA and the National Academies asked candidates to complete an 
official financial disclosure and background form prior to being 
selected as a committee member.[Footnote 59] An EPA official we 
interviewed stated that asking candidates for detailed financial 
information prior to selection to an advisory committee enables EPA to 
identify individuals without conflicts of interest early in the 
advisory committee recruitment process. An FDA official told us that 
FDA did not ask candidates to complete a financial disclosure and 
background form because the form would require responses about specific 
products or companies or both, which may not be known at the time of 
the prescreening interview.[Footnote 60] 

Table 3: Selected Advisory Committee Prescreening Methods of FDA, EPA, 
and National Academies Prior to October 1, 2007: 

Prescreening methods: Review curriculum vitae or summaries of related 
professional experience; 
FDA: [Check]; 
EPA: [Check]; 
National Academies: [Check]. 

Prescreening methods: Interview candidates about financial interests 
and activities; 
FDA: [Check]; 
EPA: [Check]; 
National Academies: [Empty]. 

Prescreening methods: Post a sample financial disclosure information 
form on the organization’s Web site; 
FDA: [Check]; 
EPA: [Check]; 
National Academies: [Check]. 

Prescreening methods: Ask candidates to complete the organization’s 
official financial disclosure form prior to being selected as a 
committee member; 
FDA: [Empty]; 
EPA: [Check]; 
National Academies: [Check]. 

Prescreening methods: Post a provisional advisory committee member list 
on the organization’s Web site for public comment on possible conflicts 
of interest; 
FDA: [Empty]; 
EPA: [Check][A]; 
National Academies: [Check]; 

Sources: GAO analysis of FDA, EPA, and National Academies staff 
interviews, and [hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-04-
328]. 

Notes: As of October 1, 2007, candidates for FDA advisory committees 
were required to complete an official financial disclosure form that 
provides information about the individual's financial interest prior to 
being appointed as an advisory committee member. These methods 
represent the prescreening methods FDA employed prior to the issuance 
of the implementation of the FDA Amendments Act of 2007; FDA still uses 
these prescreening methods. 

[A] EPA's Science Advisory Board publishes the names and biographical 
sketches of candidates on its Web site to obtain public comments on 
proposed candidates. 

[End of table] 

EPA's and the National Academies' prescreening methods included 
obtaining input from the general public whereas FDA's methods generally 
did not. For example, EPA's Science Advisory Board used a public notice 
process to obtain public comments on proposed candidates. The names and 
biographical sketches of candidates are posted on its Web site, and EPA 
requests the public to provide information, analysis, or documentation 
that the agency should consider in evaluating the candidates. 
Similarly, the National Academies publicly announces the slate of 
provisional study committee members by posting their biographies on its 
Web site, and requests public comment. FDA did not post a list of 
potential nominees on its Web site and did not seek public comment 
about potential candidates. 

Barriers Existed to Recruiting Qualified FDA Advisory Committee 
Candidates, Particularly Those without Potential Conflicts of Interest, 
but FDA May Have Been Able to Mitigate Barriers by Expanding Outreach 
Efforts: 

According to FDA officials, former FDA advisory committee members, and 
a PhRMA representative, FDA faced barriers to recruiting qualified 
individuals to serve on its advisory committees, particularly 
candidates without potential conflicts of interest, although FDA may 
have been able to mitigate these barriers by expanding its outreach 
efforts. FDA officials, former FDA advisory committee members, and a 
PhRMA representative identified the following barriers: FDA sought the 
same leading experts as industry; FDA's most effective recruitment 
method--word-of-mouth--was limited in the number of potential 
candidates it could generate; and aspects of FDA advisory committee 
service deterred some potential advisory committee members. FDA already 
employed several recruitment methods to identify qualified FDA advisory 
committee candidates. However, FDA may have been able to mitigate 
barriers by focusing additional outreach efforts on recruiting retired 
experts, experts from colleges and universities, and individuals with 
epidemiological and statistical expertise. Under the FDA Amendments Act 
of 2007, FDA's process for prescreening candidates for advisory 
committee membership has been modified. (See app. I.) 

Barriers Existed to Recruiting Qualified Individuals to Serve on FDA 
Advisory Committees: 

FDA officials, former FDA advisory committee members, and a PhRMA 
representative identified barriers that existed to recruiting qualified 
FDA advisory committee candidates, particularly those without potential 
conflicts of interest. These barriers were that FDA sought the same 
experts as industry, FDA's most effective advisory committee 
recruitment method was limited in the number of potential candidates it 
could generate, and aspects of FDA advisory committee service may have 
deterred some potential advisory committee members. 

The Experts FDA Sought to Serve on Its Advisory Committees Frequently 
Had Industry Ties: 

FDA contended that it sought the same leading experts to serve on its 
advisory committees as industry sought to conduct its research and 
product trials. As a result, the experts FDA deemed most qualified to 
serve on its advisory committees often had industry ties, according to 
the agency. 

FDA officials, former FDA advisory committee members, and a PhRMA 
representative generally agreed that many individuals who have the 
experience necessary to participate on an advisory committee have 
industry ties. FDA officials told us that private industry sponsors 
most medical development in the United States. As a result, people in 
fields relevant to FDA advisory committees gain experience from working 
with industry. A representative from PhRMA told us if an individual has 
no or minimal potential conflicts of interest, he would question 
whether the person has the expertise needed to serve on an FDA advisory 
committee. 

FDA's Most Effective Recruitment Method Had Limitations: 

Although FDA employed several methods to recruit advisory committee 
candidates, FDA staff generally agreed that word-of-mouth, such as 
informal discussions among FDA advisory committee members, agency 
staff, and interested parties, was most effective in generating 
nominations for qualified advisory committee candidates. FDA officials 
and former FDA advisory committee members told us that this recruitment 
method was effective because people familiar with the advisory 
committee process--FDA review division staff and FDA advisory committee 
members--can identify individuals who would be qualified to serve on 
advisory committees because they understand what advisory committee 
membership entails. Former members also noted that advisory committee 
members, who are experts in their field, know other qualified experts 
who could serve as advisory committee members. Similarly, former 
advisory committee members explained that asking FDA review division 
staff for recommendations was effective because these individuals are 
active in the scientific community and can also identify individuals 
qualified to serve on FDA's advisory committees. 

Despite being effective in generating nominations, word-of-mouth 
recruitment is limited because only the colleagues of FDA advisory 
committee members or FDA staff learn about the opportunity to serve on 
committees rather than a broader pool of candidates. Two former FDA 
advisory committee members cautioned that, while they believe word-of- 
mouth is an effective recruitment method, it may lead to self- 
perpetuating committee membership, in which a limited group of peers 
continually comprise an advisory committee. An official from EPA echoed 
these concerns, stating that, although this is an effective method to 
recruit candidates for some EPA advisory committees, it also is 
problematic because he believes advisory committee members only 
nominate their colleagues. Similarly, former advisory committee members 
noted that FDA staff nominations may also be problematic. For example, 
one former member explained that it gives the appearance that FDA may 
pad its advisory committees, which could compromise the committees' 
perceived independence. 

Some Aspects of FDA Advisory Committee Service May Have Deterred 
Potential Members: 

Some aspects of FDA advisory committee service may have also deterred 
qualified advisory committee candidates. More than half of the 12 
former FDA advisory committee members we spoke with agreed that the 
time commitment involved in preparing for and attending FDA advisory 
committee meetings acted as a deterrent for some potential advisory 
committee members. Standing members of an FDA advisory committee are 
expected to participate in all meetings held by that advisory committee 
unless they are excluded from a meeting due to a conflict of interest. 
For example, CDER's Anti-Infective Drugs Advisory Committee held three 
meetings in 2006. Unless excluded, a standing member of this committee 
would have been expected to attend all three advisory committee 
meetings. 

In addition, more than half of the 12 former advisory committee members 
we interviewed also agreed that FDA's work-related activities and 
financial information disclosure reporting requirements dissuaded some 
people from becoming an advisory committee member, although some said 
that the public disclosure of an individual's conflict of interest 
waivers was not a deterrent[Footnote 61]. As mentioned earlier, 
advisory committee members complete financial disclosure forms before 
each advisory committee meeting, and since November 2005 FDA has posted 
information disclosing the nature and basis of advisory committee 
member conflict of interest waivers on its Web site.[Footnote 62] 

The negative publicity surrounding certain advisory committee meetings, 
especially media attention to some members' ties to industry, may have 
also deterred some people from serving on FDA advisory committees. An 
FDA advisory committee management official in CDER, the center with the 
most advisory committee meetings held in years 2004 and 2006 combined, 
explained that public scrutiny concerning advisory committee members' 
conflicts of interest is the most difficult challenge FDA staff face in 
generating member nominations. The FDA official said people serving on 
FDA advisory committees "feel like they are in fishbowls" and are 
concerned that they are considered tainted if they receive a conflict 
of interest waiver. A representative from PhRMA echoed these concerns, 
stating that many FDA advisory committees receive public scrutiny, 
which may act as a disincentive for individuals to serve on committees. 
Some former advisory committee members we spoke with also agreed that 
the media attention surrounding certain advisory committee meetings can 
deter people from serving on FDA advisory committees, although some 
former members either disagreed or said that qualified candidates 
should be prepared to withstand media pressure. 

FDA May Have Been Able to Mitigate Barriers by Expanding Outreach 
Efforts: 

FDA may have mitigated barriers to recruiting qualified advisory 
committee candidates, particularly those without potential conflicts of 
interest, if it had expanded outreach efforts to retired experts, 
experts from universities and colleges, and individuals with 
statistical and epidemiological expertise. Former advisory committee 
members and representatives from entities knowledgeable about FDA 
advisory committee recruitment agreed that expanding outreach efforts 
to retired experts, experts from universities and colleges, and 
individuals with statistical and epidemiological expertise would be 
effective in recruiting qualified FDA advisory committee members, 
particularly those without conflicts of interest. In addition, although 
FDA stated that it employed several methods to recruit advisory 
committee members, representatives from consumer groups said that FDA 
should make a greater effort to recruit qualified advisory committee 
candidates, particularly those without conflicts of interest. 

Most former advisory committee members we spoke with generally agreed 
that FDA could have expanded outreach efforts to retired experts in 
fields relevant to its advisory committees in order to mitigate 
barriers to recruiting qualified advisory committee candidates, 
particularly those without potential conflicts of interest. Retired 
experts are no longer employed and, therefore, may be less likely to 
have current ties to industry. For example, a National Academies 
official we spoke with explained that when the type of expertise needed 
for a committee lends itself to inherently conflicted professionals-- 
for example, if a committee focuses on the operations of drug 
manufacturers--the organization could seek an individual who is 
retired. However, some FDA officials noted that retired experts may not 
be familiar with new science and technologies or interested in 
committing the time necessary to serve on an advisory committee, or 
they may have conflicts of interest because they consult privately. 

One FDA official said that the center in which she is employed may 
recruit individuals who retired in the past 2 years to participate on 
an advisory committee or panel, but individuals retired longer than 
that are usually not familiar with current technologies and are, 
therefore, not qualified for the center's advisory committee or panel 
participation. Although the majority of former advisory committee 
members we spoke with agreed that expanding outreach efforts to retired 
experts would improve FDA's advisory committee process, many former 
members noted that FDA advisory committees require members who are 
active in their field. 

Most former FDA advisory committee members and the consumer groups we 
spoke with agreed that expanding outreach efforts to experts from 
universities and colleges would be effective in recruiting qualified 
advisory committee candidates.[Footnote 63] FDA noted that most of its 
advisory committee members are already academicians. An AAMC official 
suggested that FDA ask medical colleges to solicit their own staff to 
serve on FDA advisory committees. He also told us that AAMC does not 
currently assist FDA with advisory committee recruitment, but it would 
if asked. For example, he said AAMC would be willing to post FDA 
advisory committee member vacancies on its Web site at no cost. 
However, two former members noted that academicians may receive 
industry funding for research or consulting and, therefore, may have 
conflicts of interest. The FDA Amendments Act of 2007 modifies FDA's 
process for prescreening candidates for advisory committee membership. 
For example, the act directs FDA to develop outreach strategies for 
potential members of advisory committees at universities, colleges, and 
other academic research centers. 

Most former FDA advisory committee members and consumer groups we 
interviewed said that expanding outreach efforts to epidemiologists and 
statisticians would be effective in recruiting qualified advisory 
committee candidates, particularly those without potential conflicts of 
interest. According to some former advisory committee members, 
epidemiologists and statisticians add expertise in data analysis to FDA 
advisory committees. For example, biostatisticians could provide 
expertise in interpreting clinical trial data. Representatives from two 
consumer advocacy groups told us these individuals may be less likely 
than clinicians to have conflicts of interest and may bring a different 
focus to committee deliberations.[Footnote 64] According to these 
consumer interest group representatives, the agency’s advisory 
committees are overly weighted towards clinicians and clinical 
trialists.[Footnote 65] One representative told us that clinicians are 
more likely to have potential conflicts of interest because they are 
more likely to have received industry funding, and another 
representative said that they generally have a bias towards product 
approval because they seek more options—that is, drugs and medical 
devices—to help with diagnosis and treatment of their patients. 
[Footnote 66] The majority of the former FDA advisory committee members 
we interviewed agreed that focusing outreach efforts on recruiting 
statisticians and epidemiologists would be an effective way for FDA to 
recruit qualified advisory committee candidates, particularly those 
without potential conflicts of interest. In The Future of Drug Safety – 
Promoting and Protecting the Health of the Public: FDA’s Response to 
the Institute of Medicine’s 2006 Report, FDA stated in 2007 that it 
will increase the epidemiology expertise on its drug-related advisory 
committees.[Footnote 67] The FDA Amendments Act of 2007 modifies FDA’s 
process for prescreening candidates for advisory committee membership. 
(See app. I.) 

Most Advisory Committee Meeting Participants Were Standing Members, and 
Many Members Had Conflict of Interest Determinations: 

Our analysis of the composition of FDA advisory committee meeting 
participants from 2 recent years indicates that most participants were 
standing members, but a large minority of participants were temporary 
members. In the 83 advisory committee meetings held by CBER, CDER, and 
CDRH in 2004 and 2006, standing and temporary members were 58 and 42 
percent, respectively, of the 1,218 total meeting participants. 
[Footnote 68] An advisory committee member who has a conflict of 
interest and whose expertise is needed may be permitted by FDA to 
participate in an advisory committee meeting under certain 
circumstances by granting a conflict of interest determination. About 
16 percent of the participants received a conflict of interest 
determination that allowed them to participate.[Footnote 69] In 49 of 
the 83 meetings, at least one participating standing or temporary 
member had at least one conflict of interest determination that allowed 
the member to participate. The 200 participants with conflict of 
interest determinations in those 49 meetings had a total of 234 
determinations. The FDA Amendments Act of 2007 limits the number of 
conflict of interest determinations—statutory waivers—that FDA can 
grant and FDA’s conflict of interest policy revisions change the amount 
of the disqualifying financial interests. 

Most Advisory Committee Meeting Participants Were Standing Members: 

Standing members were the predominant participants in the 83 advisory 
committee meetings held by CBER, CDER, and CDRH in 2004 and 2006 that 
we analyzed. These 83 meetings were held before the 2007 FDA advisory 
committee process and statutory changes. Temporary members participated 
in 79 of the 83 meetings. Of the 1,218 participants in the 83 meetings, 
58 percent were standing members and 42 percent were temporary. (See 
table 4.) The participants in CDER’s 17 meetings held in 2006 were 
nearly evenly split between standing and temporary members at 52 
percent and 48 percent respectively. 

Table 4: Standing and Temporary Member Totals for 83 FDA Advisory 
Committee Meetings by Center, 2004 and 2006: 

FDA center: CBER; There were 22 advisory committee meetings; 11 in 2004 
and 11 in 2006; 
2004, Standing members: 58% (96); 
2004, Temporary members: 42% (70); 
2004, Total members[A]: 100% (166); 
2006, Standing members: 70% (122); 
2006, Temporary members: 30% (52); 
2006, Total members[A]: 100% (174). 

FDA center: CDER; There were 31 advisory committee meetings; 14 in 2004 
and 17 in 2006; 
2004, Standing members: 61% (137); 
2004, Temporary members: 39% (86); 
2004, Total members[A]: 100% (223); 
2006, Standing members: 52% (137); 
2006, Temporary members: 48% (125); 
2006, Total members[A]: 100% (262). 

FDA center: CDRH; There were 30 advisory committee meetings; 17 in 2004 
and 13 in 2006; 
2004, Standing members: 55% (127); 
2004, Temporary members: 45% (103); 
2004, Total members[A]: 100% (230); 
2006, Standing members: 56% (92); 
2006, Temporary members: 44% (71); 
2006, Total members[A]: 100% (163). 

FDA center: Total (percentage averages); There were a total of 83 
advisory committee meetings; 42 in 2004 and 41 in 2006, with 1,218 
members; 
2004, Standing members: 58%; 
2004, Temporary members: 42%; 
2004, Total members[A]: 100% (619); 
2006, Standing members: 59%; 
2006, Temporary members: 41%; 
2006, Total members[A]: 100% (599). 

Source: GAO analysis of FDA's CBER, CDER, and CDRH advisory committee 
meeting records for 2004 and 2006. 

Note: All CBER, CDER, and CDRH advisory committee meetings held in 2004 
and 2006 are included except joint advisory committee meetings and 
advisory committee subcommittee meetings. CDER and CDRH held 10 joint 
meetings in 2004 and 2006 and temporary members made up less than one- 
third of the combined standing and temporary member total for those 
meetings in both years. 

[A] Represents the total number of standing and temporary members who 
attended each advisory committee meeting, so individual members may be 
counted more than once. 

[End of table] 

At Least One Standing or Temporary Member Had a Conflict of Interest 
Determination in over Half of the Advisory Committee Meetings: 

Forty-nine of the 83 advisory committee meetings we analyzed—over half 
of all the meetings—had at least 1 standing or temporary member with a 
conflict of interest determination.[Footnote 70] FDA may permit an 
advisory committee member who has a conflict of interest and whose 
expertise is needed to participate in an advisory committee meeting 
under certain circumstances by granting a conflict of interest 
determination. Two hundred standing and temporary members—about 16 
percent of the 83 meetings’ 1,218 participants—had at least one 
conflict of interest determination. Forty-two of the 49 meetings—86 
percent—had 2 or more members who received at least one conflict of 
interest determination. Ninety-five percent of CDER’s 2004 and 2006 
meetings had 2 or more members with determinations followed by CBER (85 
percent) and CDRH (73 percent). 

The 200 members had 234 conflict of interest determinations. (See table 
5). Most members—167—had only 1 conflict of interest determination; 33 
members each had 2 or more determinations. Standing members had 62 
percent (nearly two-thirds) of the 234 determinations and temporary 
members had 38 percent (over one-third). 

Table 5: Type and Number of Conflict of Interest Determinations for 200 
Standing and Temporary Members for 49 Selected CBER, CDER, and CDRH 
Advisory Committee Meetings, 2004 and 2006: 

Type of conflict of interest determination: Statutory waivers: 
Financial interest waiver—special government employee (§ 208(b)(3)); 
2004 and 2006, Standing member: 104; 
2004 and 2006, Temporary member: 51; 
Total determinations: 155. 

Type of conflict of interest determination: Statutory waivers: 
Financial interest waiver—involving drugs and biologics topics (§ 
355(n)(4))[A]; 
2004 and 2006, Standing member: 15; 
2004 and 2006, Temporary member: 12; 
Total determinations: 27. 

Type of conflict of interest determination: Statutory waivers: 
Financial interest waiver—federal government employee (§ 208(b)(1))[B]; 
2004 and 2006, Standing member: 4; 
2004 and 2006, Temporary member: 5; 
Total determinations: 9. 

Type of conflict of interest determination: Statutory waivers: 
2004 and 2006, Standing member: 
2004 and 2006, Temporary member: 
Total determinations: 

Type of conflict of interest determination: Regulatory authorization: 
Appearance authorization (§ 2635.502); 
2004 and 2006, Standing member: 23; 
2004 and 2006, Temporary member: 20; 
Total determinations: 43. 

Type of conflict of interest determination: Total; 
2004 and 2006, Standing member: 146; 
2004 and 2006, Temporary member: 88; 
Total determinations: 234. 

Source: GAO analysis of FDA CBER, CDER, CDRH advisory committee meeting 
records for 2004 and 2006. 

Notes: For all three centers, the advisory committee meetings chosen 
were those with (1) the advisory committee meeting designation most 
often used by the center's advisory committees--for CDER and CDRH, 
specific-parties meetings and for CBER, non-specific party meetings, 
and (2) at least one standing or temporary member who received a 
conflict of interest determination. For all three centers, if a meeting 
had both a specific-parties and a non-specific party meeting topic, the 
meeting was included if any standing or temporary member attending the 
meeting received a conflict of interest determination. A participant 
may have been granted more than one conflict of interest determination, 
for example, an individual may have had both a § 208(b)(1) waiver and 
an appearance authorization. 

[A] Prior to October 1, 2007, the 21 U.S.C. § 355(n)(4) waiver applied 
only to voting on topics related to clinical investigations and 
approvals of drugs and biologics, which generally involved only CBER 
and CDER advisory committee meetings. 

[B] The FDA 18 U.S.C. § 208(b)(1) waivers we analyzed were granted only 
to federal employees not employed by FDA. Although 18 U.S.C. § 
208(b)(1) applies to federal employees generally including SGEs and 
those not employed by FDA who are members of FDA advisory committees, 
because 18 U.S.C. § 208(b)(3) specifically authorizes waivers for SGEs 
serving on FACA committees, FDA applied 18 U.S.C. § 208(b)(3) to SGEs 
in this context. 

[End of table] 

Among the 234 conflict of interest determinations, the most often 
granted determination--155--was the § 208(b)(3) financial interest 
waiver. Standing members had 104 and temporary members had 51 of these 
waivers. This waiver can be granted for either specific-parties or non- 
specific party advisory committee meeting topics and to standing and 
temporary SGE members, so it should have been the conflict of interest 
determination most often granted to members.[Footnote 71] Nearly one- 
half of the 155 § 208(b)(3) waivers--72--were granted to CDER meeting 
members, 50 to standing, and 22 to temporary members. The remaining 79 
of the 234 determinations were 36 statutory waivers--§ 355(n)(4) 
waivers (27) and § 208(b)(1) financial interest waivers (9)[Footnote 
72]--and 43 regulatory § 2635.502 appearance authorizations. The FDA 
Amendments Act of 2007 limits the number of certain conflict of 
interest determinations--the statutory waivers--that FDA can grant and 
FDA's conflict of interest policy revisions change the amount of the 
disqualifying financial interests. 

Agency Comments and Our Evaluation: 

HHS reviewed a draft of this report and provided comments, which are 
reprinted in appendix V. HHS also provided technical comments, which we 
incorporated as appropriate. 

In its comments, HHS noted that on August 4, 2008, after we had 
provided the draft report for its review on July 29, 2008, FDA issued 
four final guidance documents concerning management of its advisory 
committees. The guidances include stricter limits on financial 
conflicts of interest for committee members, improved committee meeting 
voting procedures, and process improvements for disclosing information 
about advisory committee members' financial interests and waivers, and 
for preparing and making publicly available information given to 
advisory committee members for specific matters considered at advisory 
committee meetings. These final guidance documents were available to us 
in draft form during the course of our work and the portions of the 
draft guidances that we discussed in the report did not change in the 
final 2008 guidances. 

HHS commented on several other aspects of the draft report. First, HHS 
asked us to note that our findings are applicable only to CBER, CDER, 
and CDRH advisory committee meetings, and we revised our report to 
clarify that we did not include all of the FDA centers. Our work 
focused on those three FDA centers because most of FDA's advisory 
committees were affiliated with them; these centers' advisory committee 
meetings represented more than 80 percent of the total FDA advisory 
committee meetings held in 2004 and 2006. 

Second, HHS commented that three groups of experts we included in the 
report as possible sources for expanding the agency's recruitment 
outreach for advisory committee members--academic experts, 
epidemiologists and statisticians, and retired experts--may not be more 
likely to be free of conflicts of interest. These expert groups were 
identified by individuals we interviewed as sources they believed could 
be less likely to have conflicts of interest, and we attributed the 
statements to those individuals in the report. In addition, the FDA 
Amendments Act of 2007 discusses FDA's advisory committee recruitment 
methods and directs FDA to develop and implement strategies on 
effective outreach to the academic community. 

Third, HHS commented that the comparison of the recruitment methods 
used by EPA and the National Academies to FDA's recruitment methods did 
not consider additional restraints FDA may have in selecting qualified, 
minimally conflicted individuals to serve on an advisory committee. 
However, the report focuses on EPA's and the National Academies' 
methods to identify potential advisory committee members and uncover 
conflicts of interest that are not employed by FDA. The approaches 
employed by these other organizations may provide additional options 
that FDA could use to expand the pool of potential advisory committee 
members. 

Finally, HHS commented on our use of the term conflict of interest 
determinations. Throughout our report, we used the term to include both 
conflict of interest waivers and appearance authorizations granted to 
advisory committee members to allow them to participate in advisory 
committee meetings. Although the standards for these determinations are 
different, they are all made to allow members to participate in 
advisory committee meetings notwithstanding ethical concerns over their 
participation. We revised the report to clarify that the FDA Amendments 
Act of 2007 provisions involving the agency's advisory committees only 
apply to conflict of interest waivers. 

As we agreed with your offices, unless you publicly announce the 
contents of this report earlier, we plan no further distribution of it 
until 30 days from its date. We will then send copies to others who are 
interested and make copies available to others who request them. In 
addition, the report will also be available at no charge on our Web 
site at [hyperlink, http://www.gao.gov]. 

If you or your staffs have any questions about this report, please 
contact me at (202) 512-7114 or crossem@gao.gov. Contact points for our 
Offices of Congressional Relations and Public Affairs may be found on 
the last page of this report. GAO staff who made major contributions to 
this report are listed in appendix VI. 

Signed by: 

Marcia Crosse: 
Director, Health Care: 

[End of section] 

Appendix I: Major 2007 Actions Affecting FDA Recruiting and Conflict of 
Interest Determination Processes: 

In 2007, two major actions occurred that affect the Food and Drug 
Administration's (FDA) processes for recruiting and prescreening 
individuals for advisory committee membership and for granting 
financial conflict of interest waivers to allow members to participate 
in advisory committee meetings. Those two actions were the passage of 
the FDA Amendments Act of 2007--an amendment of the Federal Food, Drug, 
and Cosmetic Act[Footnote 73]--and FDA's draft March 2007 conflict of 
interest guidance.[Footnote 74] 

The FDA Amendments Act of 2007 modifies the agency process for 
prescreening candidates for advisory committee membership. The act 
requires FDA to develop and implement strategies to conduct outreach to 
potential advisory committee candidates at universities and colleges, 
other academic research centers, professional and medical societies, 
and patient and consumer groups. FDA may also develop a new committee 
member recruitment method, which would allow entities, such as 
universities and other academic research centers, receiving funding 
from the National Institutes of Health, the Agency for Healthcare 
Research and Quality, the Centers for Disease Control and Prevention, 
or the Veterans Health Administration, to identify a person whom FDA 
could contact about the nomination of individuals to serve on advisory 
committees. Under the prescreening modification, a candidate for FDA 
advisory committee membership, as of October 1, 2007, completes the 
Office of Government Ethics Form 450 or FDA Form 3410--financial 
disclosure reports that provide information about the individual's 
financial interests--prior to being appointed as an FDA advisory 
committee member. According to the FDA Amendments Act of 2007, this pre-
appointment financial review is intended to reduce the likelihood that 
a candidate, if appointed as a member, would later require a statutory 
conflict of interest determination to participate in advisory committee 
meetings. 

Conflict of interest determinations to allow a member with a conflict 
to participate in an advisory committee meeting are affected by both 
FDA's draft March 2007 guidance and the FDA Amendments Act of 2007. The 
draft guidance provides that an advisory committee member with personal 
financial conflicts of interest--referred to as disqualifying financial 
interests in the guidance--generally would not be allowed to 
participate in an advisory committee meeting if the combined value of 
those interests exceeds $50,000. FDA would not grant a waiver in those 
circumstances unless the FDA Commissioner determined a waiver was 
appropriate. Two provisions of the FDA Amendments Act of 2007 affect 
conflict of interest determinations. First, the law repealed 21 U.S.C. 
§ 355(n)(4)--the § 355 (n)(4) waiver--that applied only to members 
voting on FDA advisory committee meeting matters related to the 
clinical investigations and approvals of drugs and biologics--usually 
Center for Biologics Evaluation and Research (CBER) and Center for Drug 
Evaluation and Research (CDER) advisory committee meetings. The law 
also created a new waiver provision--the § 712(c)(2)(B) waiver--to all 
FDA advisory committee members. Under the new provision, an individual 
or a member of his or her immediate family who has a financial conflict 
of interest cannot participate unless FDA determines that a waiver is 
necessary to afford the advisory committee essential expertise. The law 
also limits the number of waivers that FDA can grant advisory committee 
members, reducing the number of waivers (per total meetings) granted 
annually by 5 percent for a total reduction of 25 percent over 5 
years.[Footnote 75] 

[End of section] 

Appendix II: Scope and Methodology: 

In this report, we examined FDA's advisory committee member 
recruitment, selection, and conflicts of interest prescreening and 
screening processes, as well as the agency's use of temporary and 
standing advisory committee members.[Footnote 76] We chose to analyze 
three FDA centers--CBER, CDER, and CDRH--because most of FDA's advisory 
committees were affiliated with them--and these three centers' advisory 
committee meetings represented more than 80 percent of the total FDA 
advisory committee meetings held in the two years we included. We did 
not examine FDA's other centers' advisory committee meetings. 
Specifically, we describe (1) how FDA recruited individuals for 
advisory committee membership and evaluated candidates by prescreening 
them for potential conflicts of interest, (2) barriers that were 
reported to recruiting qualified individuals to serve on FDA advisory 
committees, particularly candidates without potential conflicts of 
interest, and (3) the proportion of standing and temporary members who 
participated in advisory committee meetings, and the frequency with 
which members with one or more conflict of interest determinations 
participated in advisory committee meetings. 

During the course of our work, two major actions occurred that changed 
FDA's recruitment and conflict of interest policies. (See app. I.) In 
March 2007, FDA issued a draft advisory committee guidance that revises 
how FDA screens individuals to determine if they have conflicts of 
interest for a specific advisory committee meeting.[Footnote 77] In 
addition, Congress amended the Federal Food, Drug, and Cosmetic Act to 
include, among other provisions, a section addressing recruitment, 
prescreening, and conflicts of interest, which took effect on October 
1, 2007.[Footnote 78] At the time of our review, it was too soon to 
assess the effect of the changes on FDA's processes, consequently, this 
report focuses on FDA's organization, processes, and conflict of 
interest determinations as documented prior to the 2007 actions. 

To address our objectives, we performed a literature review of studies 
related to FDA advisory committee member recruitment, selection, and 
conflict of interest prescreening and screening processes. We reviewed 
Office of Government Ethics and federal conflict of interest laws, and 
Department of Health and Human Services' (HHS) and FDA's written 
policies, guidance, reports, and forms related to advisory committee 
management. We interviewed individuals and groups familiar with FDA's 
advisory committee member recruitment, selection, and conflict of 
interest screening processes including FDA staff, selected former 
advisory committee members,[Footnote 79] and representatives from the 
Association of American Medical Colleges (AAMC), Center for Science in 
the Public Interest, Pharmaceutical Research and Manufacturers of 
America (PhRMA), and Public Citizen's Health Research Group. In 
addition, we reviewed FDA's advisory committee meeting records and 
conflict of interest determination records for advisory committee 
meetings held by three FDA centers--CBER, CDER, and CDRH--in 2004 and 
2006. We chose to analyze these three centers because most of FDA's 
advisory committees were affiliated with them--and these centers' 
advisory committee meetings represented more than 80 percent of the 
total FDA advisory committee meetings held in 2004 and 2006. Details on 
the scope of our work and methods to address each objective follow. 

To examine how FDA recruited individuals for advisory committee 
membership and prescreened candidates for potential conflicts of 
interest, we reviewed HHS and FDA written policies, guidances, reports, 
and forms related to advisory committee management. These documents 
include HHS's Federal Advisory Committee Management Handbook, FDA's 
Policy and Guidance Handbook for FDA Advisory Committees, and FDA's 
quarterly reports to Congress on its efforts to identify and screen 
qualified people for appointment to FDA advisory committees. We also 
reviewed advisory committee information on FDA's Web site and examined 
FDA forms used to prescreen candidates for advisory committee 
membership. 

In addition, we interviewed staff from FDA's Advisory Committee 
Oversight and Management Staff; FDA's Ethics and Integrity Staff; staff 
from CBER, CDER, and CDRH; and advocacy organizations that nominate 
individuals to serve on FDA's advisory committees, including PhRMA and 
Public Citizen's Health Research Group. We also interviewed officials 
from organizations we previously identified as employing specific 
recruitment and prescreening methods that could ensure independent and 
balanced advisory committees. These organizations are the U.S. 
Environmental Protection Agency (EPA) and the National Academies. 

To examine barriers that were reported to recruiting qualified 
individuals to serve on FDA advisory committees, particularly 
candidates with no potential conflicts of interest, we interviewed 
individuals and groups familiar with FDA's advisory committee 
recruitment process and officials from organizations we identified in 
2004 as employing specific recruitment methods that could ensure 
independent and balanced advisory committees. Individuals interviewed 
include staff from CBER, CDER, and CDRH office, review division, and 
advisory committee management; 12 former CBER, CDER, and CDRH advisory 
committee members; staff from EPA, the National Institutes of Health, 
and the National Academies who were involved with the advisory 
committee process at their organizations; and staff from AAMC, PhRMA, 
and consumer advocacy groups that have taken a position on FDA's 
nomination and selection processes for advisory committee members. 

To determine the proportion of participants in FDA's CBER, CDER, and 
CDRH advisory committee meetings who were standing members or temporary 
members, we reviewed FDA's advisory committee meeting records for 83 
meetings held by the 3 centers in 2004 and 2006. The 83 meetings did 
not include (1) the 10 joint advisory committee meetings--meetings 
involving 2 advisory committees--held in 2004 and 2006, which were 
analyzed separately, or (2) advisory committee subcommittee meetings, 
which are not covered by the Federal Advisory Committee Act. Beginning 
in November 2005, FDA was required to post information on its Web site 
about the conflict of interest waivers it granted that allowed certain 
members to participate in meetings.[Footnote 80] We chose to review the 
committee meetings held in 2004 and 2006--2 years with the most recent 
data when we began our work--because (1) 2004 was the last full year 
before FDA began to post waiver information in 2005, and (2) 2006 was 
the first full year in which the waiver information had to be posted. 
We excluded 2005 from the analysis because it was the year the Web site 
posting requirement began. To verify the number of standing and 
temporary members who attended the 83 meetings, we reviewed the 2004 
and 2006 FDA advisory committee meeting records, which included meeting 
minutes, meeting summaries, meeting transcripts, lists of meeting 
attendees, and annual committee member rosters--the list of standing 
members--for the years 2004 and 2006. If an advisory committee meeting 
was conducted for more than 1 day, a standing or temporary member was 
included in the analysis, if the member attended at least 1 day of the 
meeting. 

To analyze the number and type of conflict of interest determinations 
received by standing and temporary members, we analyzed 49 of the 83 
CBER, CDER, and CDRH advisory committee meetings held in 2004 and 2006. 
The following criteria were used to select the 49 meetings: (1) the 
advisory committee meetings with the designation most often used by the 
centers--for CDER and CDRH, specific-parties meetings and, for CBER, 
non-specific party meetings, and (2) advisory committee meetings that 
had at least one standing or temporary member who received at least one 
conflict of interest determination. If an advisory committee meeting 
involved both a specific-parties and a non-specific party meeting 
topic, the meeting was included if any standing or temporary member 
attending the meeting received a conflict of interest 
determination.[Footnote 81] 

To determine the number and type of conflict of interest determinations 
among the 49 advisory committee meetings' standing and temporary 
members, we created a participant-level data collection instrument to 
retrieve information from FDA's advisory committee meeting records and 
conflict of interest waiver records for each advisory committee meeting 
included in the project analysis. We reviewed the following records to 
collect the needed data: conflict of interest waivers and their 
conflict of interest checklists,[Footnote 82] acknowledgement and 
consent for disclosure of potential conflicts of interest forms, 
[Footnote 83] and appearance authorization memorandums.[Footnote 84] 
Information we collected included the advisory committee meeting 
participant's status (for example, standing or temporary member) and 
the conflict of interest determination (for example, § 208(b)(3) 
waiver). When FDA issued its March 2007 Draft 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, we narrowed the scope of our work and excluded 
an assessment of whether FDA adhered to its FDA Waiver Criteria 
Document (2000) when it made its conflict of interest determinations 
for the meetings we analyzed. To assess the reliability of the conflict 
of interest determination information we summarized, we reviewed 
questions from 5 percent of the data collection instruments completed 
for the 49 advisory committee meetings for accuracy in transferring 
conflict of interest determination information from the FDA records, 
and determined the information collected was sufficiently reliable for 
our report. 

We conducted our work from October 2006 through September 2008 in 
accordance with generally accepted government auditing standards. 

[End of section] 

Appendix III: Factors That May Affect FDA Advisory Committee Meeting 
Recommendations: 

FDA may, like other federal agencies, determine its advisory 
committees' meeting topics to suit its own purposes. There are many 
factors involved in conducting an FDA advisory committee meeting that 
may affect a committee's recommendations to the agency, in addition to 
any possible effects from a committee member's conflicts of interest. 
Also, like other federal agencies, FDA generally has the freedom to 
accept, reject, or modify its advisory committees' recommendations. 
[Footnote 85] The following discussion of various meeting factors is 
limited to FDA's CBER, CDER, and CDRH advisory committees. For each 
advisory committee meeting, the FDA staff involved may include 
individuals from the review division[Footnote 86] with subject matter 
expertise on the advisory committee's meeting topics and the division 
director; the review team--the FDA staff working on a particular 
product being considered by the advisory committee; the advisory 
committee's executive secretary; and the center's advisory committee 
meeting management entity. 

Pre-Advisory Committee Meeting Decisions: 

* Who should be selected as standing advisory committee members? The 
FDA advisory committee charters--the committee's organizational 
document--list the expertise a committee's standing members should 
have. The review division is involved in the selection of nominees for 
a committee's standing members and the expertise they represent. It has 
been suggested that a member's type of expertise may affect how the 
member analyzes the information provided at an advisory committee 
meeting and what recommendation decision the member makes. 

* Who should be selected as the advisory committee chair? Review 
divisions determine who is selected to serve as an advisory committee's 
chair rather than committee members choosing a chair from among 
themselves.[Footnote 87] In consultation with the review division, the 
chair's responsibilities may include helping develop the meeting's 
agenda and topic questions, deciding the meeting's voting procedure, 
monitoring the length of meeting presentations, and approving meeting 
minutes. 

Advisory Committee Meeting Decisions: 

* Why is an advisory committee meeting needed? Although an advisory 
committee may have a regular meeting schedule, the advisory committee's 
review division decides when an advisory committee meeting is 
needed.[Footnote 88] Meetings may be held when there are controversial 
issues that committee advice could help the agency resolve. For 
example, in July 2007, two of CDER's advisory committees met jointly to 
consider whether Avandia, a diabetes drug, should remain on the market 
given concerns that its use increased heart risks for those with 
diabetes.[Footnote 89] 

* What is the advisory committee meeting's topic and what questions are 
to be answered? The review division selects the topic, develops the 
issues FDA seeks advice on into topic questions for the advisory 
committee to address at the meeting, and compiles the background 
information for the committee to review.[Footnote 90] 

Other options for developing possible meeting topics: 

* Subcommittee meetings: The review division may select a limited 
number of advisory committee members--including at least two standing 
members--and other consultants to serve as a subcommittee to discuss 
and develop an issue of FDA's choosing. The subcommittee then provides 
this information to an advisory committee for its consideration. 
[Footnote 91] 

* Homework assignments: FDA may also select advisory committee members 
and other experts to conduct homework assignments,[Footnote 92] again 
on issues of FDA's choosing. A homework assignment may involve, for 
example, an in-depth review of an issue that may be considered as a 
potential topic at an upcoming advisory committee meeting or review of 
a product early in its development. 

* Are temporary members needed, and if yes, who should be selected? The 
review division will determine whether the standing committee members 
able to attend the meeting have the needed expertise to address the 
topics to be discussed at the advisory committee meeting. If additional 
expertise is determined to be necessary, temporary members can be 
selected to serve on the committee for the meeting.[Footnote 93] The 
review division decides which individuals--usually from the center's 
consultant pool--are selected to serve as temporary members. Each 
center maintains a consultant pool and selects the pool's individual 
experts. 

* Are guest speaker presentations needed, and if yes, who should be 
selected? The review division may determine that additional information 
needs to be presented at an advisory committee meeting. The division 
can select and invite guest speakers to make presentations and answer 
questions before the committee.[Footnote 94] Guest speakers may, for 
example, be members of other FDA advisory committees, individuals from 
a center's consultant pool, federal employees from other agencies, or 
national or international experts from outside FDA. Guest speakers do 
not vote, and they do not participate in the committee's discussions. 

* Are patient representatives needed, and if yes, who should be 
selected? CBER, CDER, and CDRH cancer-related advisory committees are 
required to have patient representatives participate in all advisory 
committee meetings. For other advisory committees, the review division 
considers the topic to be discussed at a particular meeting when 
determining whether it is necessary for a patient representative to 
serve at an advisory committee meeting. Patient representatives usually 
serve on advisory committees that focus on disease-specific topics such 
as reviews of products and therapies for HIV/AIDS and cancer diagnosis 
and treatment.[Footnote 95] When participating in CBER and CDER 
advisory committees' meetings, patient representatives usually vote, 
but when participating in CDRH's committee meetings, they do not vote. 

* Who should be selected to make FDA's presentations at meetings? A 
review division's role at an advisory committee meeting is to present 
the issues and data concerns the advisory committee will consider, and 
to pose questions to the committee throughout the meeting. For example, 
a review division director may introduce the committee meeting topic-- 
for example, a new drug approval application, provide the regulatory 
history concerning how similar drugs were developed, describe any 
issues that have arisen with similar drugs, and discuss the types of 
clinical trials used to evaluate the previously approved drugs. The 
review division determines which FDA staff attend the meeting and 
whether they make presentations. 

Advisory Committee Meeting Conflict of Interest Determinations: 

* What companies and products are determined to be affected by the 
meeting topic? After an advisory committee meeting's topic is selected, 
the review division compiles a list of the companies and products it 
determines are affected by the topic. The list is then reviewed by the 
advisory committee's management entity, for example, CDER's Advisors 
and Consultants Staff. The more affected companies or products 
involved, the greater the possibility that committee members may have 
financial interests in an affected company or product, and the greater 
the possibility that members may have conflicts of interests. 

* To which advisory committee members with conflicts of interest does 
FDA decide to grant conflict of interest determinations? For each 
advisory committee meeting, the center's advisory committee meeting 
management entity reviews each member's possible conflicts of interest 
based on the information the member self reports on his or her FDA 
financial disclosure form--3410--and determines whether they will 
affect the individual's ability to participate in the meeting. If there 
are members that are determined to have conflicts of interest, the 
review division may seek individuals with similar expertise, who do not 
have conflicts of interest, to participate in the meeting as temporary 
members.[Footnote 96] Advisory committee members who have conflicts of 
interest, but who have expertise the review division determines is 
needed for the committee's meeting topic, can be given a conflict of 
interest determination if the standards of the applicable statutes and 
regulations are met. 

Recommendations from the Advisory Committee Meeting: 

* How does the advisory committee reach its meeting's recommendation-- 
by voting or reaching a consensus? The review division, which 
determines the meeting topic and questions, can indicate whether the 
committee should vote or reach a consensus on the recommendations made 
at the committee meeting. A committee chair may also decide that an 
issue should be addressed by a vote of the members. Generally, 
committee members vote when a meeting has a specific topic, such as a 
new drug approval application. There may be instances when the members 
reach a consensus opinion without voting. 

* What options does FDA have concerning the advisory committee 
meeting's recommendation? Following an advisory committee meeting, the 
center's review division evaluates the advisory committee's 
recommendation to determine whether FDA should accept or reject it, 
have the committee discuss the meeting topic again, or hold workshops 
on the meeting topic subject. FDA, like other federal agencies, 
generally does not have to accept its advisory committees' 
recommendations. 

Recent Studies on FDA Advisory Committee Meeting Recommendations: 

Recent studies have focused on whether FDA advisory committee members 
with conflict of interest determinations that allow them to participate 
in the committee meetings may influence the committee's 
recommendations. 

* Public Citizen's 2006 study:[Footnote 97] The Public Citizen study on 
FDA conflicts of interest found a "weak relationship" between an FDA 
advisory committee member who had a conflict of interest and who also 
voted in favor of the drug at issue. The study also found that 
excluding advisory committee members (standing members) and voting 
consultants (temporary members) who had conflict of interest 
determinations would not have altered the overall vote result--whether 
favorable or unfavorable toward a drug--of any advisory committee 
meeting studied. 

* National Research Center for Women & Families 2006 report:[Footnote 
98] The National Research Center's report, which included information 
from other studies of FDA advisory committees and their members with 
conflicts of interest, concluded that "it is possible to understand how 
a few committee members with conflicts of interest can have a 
disproportionate impact on approval recommendations."[Footnote 99] The 
report stated that because FDA has its advisory committees meet to 
discuss controversial or innovative products, "the public might 
therefore expect that many of the drugs and devices reviewed by 
advisory committees would not be recommended for approval."[Footnote 
100] Using 11 randomly selected CDER and CDRH advisory committees, the 
report found that 79 percent of the 89 products reviewed between 1998 
and 2005 were recommended for approval, and that the recommendations 
were usually unanimous.[Footnote 101] 

* FDA's 2007 study:[Footnote 102] A research firm under contract with 
FDA assessed the relationship of FDA advisory committee members' 
expertise and their financial conflicts of interest. The study 
concluded that (1) standing advisory committee members with higher 
expertise were more likely than other standing members to have been 
granted conflict of interest waivers, (2) alternative members-- 
temporary members--could be found for a specific advisory committee 
meeting, but many of them would likely require conflict of interest 
waivers, and (3) the ability to create a conflict-of-interest-free 
advisory committee was speculative. 

[End of section] 

Appendix IV: FDA Advisory Committees for the Three Centers Analyzed: 

Center for Biologics Evaluation and Research: 

* Allergenic Products Advisory Committee:
* Blood Products Advisory Committee:
* Cellular, Tissue and Gene Therapies Advisory Committee:
* Transmissible Spongiform Encephalopathies Advisory Committee:
* Vaccines and Related Biological Products Advisory Committee: 

Center for Drug Evaluation and Research: 

* Anesthetic and Life Support Drugs Advisory Committee:
* Anti-Infective Drugs Advisory Committee:
* Antiviral Drugs Advisory Committee:
* Arthritis Advisory Committee:
* Cardiovascular and Renal Drugs Advisory Committee:
* Dermatologic and Ophthalmic Drugs Advisory Committee:
* Drug Safety and Risk Management Advisory Committee:
* Endocrinologic and Metabolic Drugs Advisory Committee:
* Gastrointestinal Drugs Advisory Committee:
* Nonprescription Drugs Advisory Committee:
* Oncologic Drugs Advisory Committee:
* Peripheral and Central Nervous System Drugs Advisory Committee:
* Pharmaceutical Science and Clinical Pharmacology Advisory Committee:
* Psychopharmacologic Drugs Advisory Committee:
* Pulmonary-Allergy Drugs Advisory Committee:
* Reproductive Health Drugs Advisory Committee: 

Center for Devices and Radiological Health: 

* Device Good Manufacturing Practice Advisory Committee:
* Medical Devices Advisory Committee[Footnote 103]
- Anesthesiology and Respiratory Therapy Devices Panel:
- Circulatory System Devices Panel:
- Clinical Chemistry and Clinical Toxicology Devices Panel:
- Dental Products Panel:
- Ear, Nose, and Throat Devices Panel:
- Gastroenterology-Urology Devices Panel:
- General and Plastic Surgery Devices Panel:
- General Hospital and Personal Use Devices Panel:
- Hematology and Pathology Devices Panel:
- Immunology Devices Panel:
- Medical Devices Dispute Resolution Panel:
- Microbiology Devices Panel:
- Molecular and Clinical Genetics Panel:
- Neurological Devices Panel:
- Obstetrics-Gynecology Devices Panel:
- Ophthalmic Devices Panel:
- Orthopaedic and Rehabilitation Devices Panel:
- Radiological Devices Panel:
* National Mammography Quality Assurance Advisory Committee:
* Technical Electronic Product Radiation Safety Standards Committee: 
[Footnote 104] 

[End of section] 

Appendix V: Comments from the Department of Health and Human Services: 

Department Of Health and Human Services:	
Office Of The Secretary: 
Assistant Secretary for Legislation: 
Washington, DC 20201 

August 28, 2008: 

Marcia Crosse: 
Director, Health Care: 
U.S. Government Accountability Office: 
441 G Street NW: 
Washington, D.C. 20548: 

Dear Ms. Crosse: 

Enclosed are the Department's comments on the U.S. Government 
Accountability Office's (GAO) draft report entitled, "FDA Advisory 
Committees: Process for Recruiting Members and Evaluating Potential 
Conflicts of Interest" (GAO-08-640). 

The Department appreciates the opportunity to comment on this draft 
before its publication. 

Sincerely, 

Signed by: 

Jennifer R. Luong: 

for: Vincent J.	Ventimiglia, Jr. 
Assistant Secretary for Legislation: 

Attachment: 

Comments Of The Department Of Health And Human Services (HHS) On The 
U.S. Government Accountability Office's (GAO) Draft Report Entitled, 
"FDA Advisory Committees: Process For Recruiting Members And Evaluating 
Potential Conflicts Of Interest" (GAO-08-640): 

The Food and Drug Administration (FDA) appreciates the opportunity to 
review and comment on the Government Accountability Office's (GAO) 
draft report. As the report acknowledges, during the time period 
covered by the report, FDA has issued new guidance to determine 
eligibility for participation of advisory committee members with 
potential conflicts of interest. The new guidance establishes a more 
stringent policy to limit waivers of conflict of interest beyond the 
requirements in the applicable law. We have made a number of additional 
improvements to our advisory committee process that are not described 
in the report -- including final guidance on public disclosure of 
advisory committee members' financial information and waivers, final 
guidance on voting procedures, final guidance on availability of 
briefing materials, draft guidance on criteria for when to hold an 
advisory committee meeting, and website improvements. These actions 
occurred during the period of the report. We expect these new policies 
to further strengthen public confidence in the integrity of FDA's 
advisory committees. 

We have a number of general comments on the report, as described below. 

Scope: 

The GAO report is based on data from CBER, CDER, and CDRH advisory 
committee meetings held in 2004 and 2006. We suggest that the findings 
in the report be clearly identified as limited in applicability to 
CBER, CDER, and CDRH committees. 

Recruitment efforts: 

The GAO report suggests that FDA may have been able to mitigate 
acknowledged bathers to recruiting qualified advisory committee 
candidates without potential conflicts of interest. 

1. An additional variable that is not discussed in the report is FDA's 
efforts, consistent with FACA, to achieve gender, ethnic, and 
geographic balance. FDA strives for members from across the United 
States and for individuals who are as diverse as the United States. In 
addition, we strive for diversity in points of view to facilitate 
thorough discussions of all sides of the issues. These efforts may 
limit the pool of experts for recruiting. 

2. The GAO report suggests that FDA could have expanded its recruitment 
efforts to "experts from college and universities." We note that 
individuals from academia make up the bulk of the standing members and 
temporary voting members that serve on our committees. These sources 
are clearly not without potential conflicts of interest, as the 
financial interests of the academic institution employing such experts 
are imputed to the member under the laws that we must apply. 

3. The GAO report suggests that FDA expand outreach to "individuals 
with epidemiological and statistical expertise". We have not found that 
any one particular biomedical specialty reliably yields lower conflict 
of interest issues. We have found that our statisticians and 
epidemiologists are as likely to have significant conflicts of 
interests as other special government employees (SGEs) because they are 
as likely to be involved in medical/pharmaceutical research as other 
specialists. 

4. The GAO report also identifies retired experts as a possible source 
of conflict-free members. FDA has concerns, as noted on page 37 of the 
report, that many retired individuals may not have remained current 
with rapidly evolving technologies. In addition, it has been our 
experience that retired experts often have large pharmaceutical stock 
portfolios and, if still active in their field, may be actively 
involved in pharmaceutical consulting - both of which are potential 
conflicts of interest. 

5. In the report, GAO compared methods used by EPA and the National 
Academies to FDA methods. We believe that extrapolating findings from 
experts in one industry to another should be done cautiously. Companies 
that develop new drugs and devices naturally seek the best scientific 
expertise to help develop such products and the experts experienced 
with such product development consequently have unique insights that 
can greatly benefit the FDA. As a result, many scientists with 
expertise and knowledge of FDA-regulated products have financial ties 
to the pharmaceutical industry. The FDA has an additional burden that 
neither the EPA nor the National Academies deal with - the timelines 
within the Prescription Drug User Fee Act (PDUFA) and within the 
Medical Device User Fee Modernization Act. For example, PDUFA sets time 
limits within which FDA must decide the fate of a particular New Drug 
Application or supplement. This means that the FDA must strive to 
locate not only a qualified minimally conflicted SGE within a certain 
period of time, but also one that is available to serve on the 
committee at the time it must meet. 

Use of term "conflict of interest determinations:" 

The GAO report defines the term "conflict of interest determinations" 
to include both (1) waivers of the statutory conflict of interest 
prohibitions and (2) determinations that the agency may make under 5 
CFR 2645.502 concluding that a reasonable person with knowledge of the 
relevant facts would not question the impartiality of the individual. 
We believe that combining these two very different determinations in 
one term is confusing and misleading. A waiver or exception is
granted only after determining that a potential conflict of interest 
exists but that the statutory standard for a waiver can be met. If 
there is a potential conflict of interest, FDA may not authorize the 
individual's participation under the provisions of 5 CFR 2645.502 but 
must instead apply the statutory criteria for waivers. 

In contrast, an impartiality determination may be made when the 
statutory prohibition on participation does not apply but the 
individual or FDA has asked for a review of whether his participation 
would create an appearance of a conflict. In those cases where FDA has 
issued an impartiality determination, the agency has concluded that a 
reasonable person with knowledge of the relevant facts would not 
question the impartiality of the individual or has authorized the 
employee to participate because the interest of the Government in the 
employee's participation outweighs the concern that a reasonable person 
may question the integrity of the agency's programs and operations.
We note that the report in several instances inaccurately uses the term 
"conflict of interest determination" when "waiver or exception" should 
be used. We have identified these instances in FDA's technical comments 
that accompany these general comments. 

[End of section] 

Appendix VI: GAO Contact and Staff Acknowledgments: 

GAO Contact: 

Marcia Crosse, (202) 512-7114 or crossem@gao.gov: 

Acknowledgments: 

In addition to the contact above, Martin Gahart, Assistant Director; 
George Bogart; Helen Desaulniers; Adrienne Griffin; Cathleen Hamann; 
Martha Kelly; Deitra Lee; Amanda Pusey; Daniel Ries; Opal Winebrenner; 
and Suzanne Worth made key contributions to this report. 

[End of section] 

Related GAO Products: 

Federal Advisory Committee Act: Issues Related to the Independence and 
Balance of Advisory Committees. [hyperlink, http://www.gao.gov/cgi-
bin/getrpt?GAO-08-611T]. Washington, D.C.: April 2, 2008. 

Drug Safety: Further Actions Needed to Improve FDA's Postmarket 
Decision-making Process. [hyperlink, http://www.gao.gov/cgi-
bin/getrpt?GAO-07-856T]. Washington, D.C.: May 9, 2007. 

NIH Conflict of Interest: Recusal Policies for Senior Employees Need 
Clarification. [hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-07-
319]. Washington, D.C.: April 30, 2007. 

Drug Safety: FDA Needs to Further Address Shortcomings in Its 
Postmarket Decision-making Process. [hyperlink, http://www.gao.gov/cgi-
bin/getrpt?GAO-07-599T]. Washington, D.C.: March 22, 2007. 

Food and Drug Administration: Decision Process to Deny Initial 
Application for Over-the-Counter Marketing of the Emergency 
Contraceptive Drug Plan B Was Unusual. [hyperlink, 
http://www.gao.gov/cgi-bin/getrpt?GAO-06-109]. Washington, D.C.: 
November 14, 2005. 

Federal Research: NIH and EPA Need to Improve Conflict of Interest 
Reviews for Research Arrangements with Private Sector Entities. 
[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-05-191]. Washington, 
D.C.: February 25, 2005. 

Federal Advisory Committees: Additional Guidance Could Help Agencies 
Better Ensure Independence and Balance. [hyperlink, 
http://www.gao.gov/cgi-bin/getrpt?GAO-04-328]. Washington, D.C.: April 
16, 2004. 

University Research: Most Federal Agencies Need to Better Protect 
against Financial Conflicts of Interest. [hyperlink, 
http://www.gao.gov/cgi-bin/getrpt?GAO-04-31]. Washington, D.C.: 
November 14, 2003. 

[End of section] 

Footnotes: 

[1] Standing members are individuals appointed to serve on an FDA 
advisory committee and are part of the official advisory committee 
roster of authorized membership. Temporary members are individuals that 
FDA selects to serve for a specific advisory committee meeting to 
provide additional expertise or to ensure that a quorum of members is 
present to conduct a meeting. 

[2] In this report, we use the term conflict of interest waivers to 
refer to FDA's decision to allow an individual with a financial 
conflict of interest to participate in an advisory committee meeting as 
provided by statute. We use the term appearance authorization to refer 
to FDA's decision to authorize an individual to participate in an 
advisory committee meeting, as provided for in regulations issued by 
the Office of Government Ethics (OGE), when the individual's 
impartiality could be questioned. 

[3] FDA uses the term prescreen to define the initial process of 
evaluating an individual's financial interests to determine whether 
that person has potential conflicts of interest prior to nominating him 
or her for advisory committee membership. FDA uses the term screen to 
define the process of evaluating advisory committee members' financial 
interests prior to a committee meeting to determine whether they have 
conflicts of interest based on the advisory committee meeting topic. 

[4] FDA is an agency within HHS and is subject to HHS's advisory 
committee regulations, policies, and guidances. 

[5] The National Academies consist of four private, nonprofit 
organizations that advise the federal government on scientific and 
technical matters: the National Academy of Sciences, the National 
Academy of Engineering, the Institute of Medicine, and the National 
Research Council. 

[6] In 2004, we reviewed the role of federal advisory committees in the 
development of national policies. We identified EPA and the National 
Academies as employing three specific recruitment and prescreening 
methods that could achieve independent and balanced advisory 
committees. The methods included (1) obtaining nominations for 
committee members from the public, (2) using clearly defined processes 
to screen for conflicts of interest, such as requesting public comment 
on proposed committee membership, and (3) prescreening prospective 
members using structured interviews. See GAO, Federal Advisory 
Committees: Additional Guidance Could Help Agencies Better Ensure 
Independence and Balance, [hyperlink, http://www.gao.gov/cgi-
bin/getrpt?GAO-04-328] (Washington, D.C.: Apr. 16, 2004). 

[7] The Web site posting was required by the Agriculture, Rural 
Development, Food and Drug Administration, and Related Agencies 
Appropriations Act for fiscal year 2006 and continued through fiscal 
year 2007. In August 2008, FDA issued a final Guidance for the Public, 
FDA Advisory Committee Members, and FDA Staff: Public Availability of 
Advisory Committees Members' Financial Interest Information and Waivers 
(Rockville, Md.: August 2008). [hyperlink, 
http://www.fda.gov/oc/advisory/GuidancePolicyRegs/ACDisclosureFINAL] 
Guidance080408.pdf (accessed Aug. 5, 2008). 

[8] FDA, Draft 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 (Rockville, 
Md.: March 2007) [hyperlink, 
http://www.fda.gov/oc/advisory/waiver/COIguidedft.html] (accessed Mar. 
18, 2007). This guidance states that it represents FDA's current 
thinking on the topic and does not bind FDA or the public. FDA 
finalized the draft guidance August 2008, [hyperlink, 
http://www.fda.gov/oc/advisory/GuidancePolicyRegs/ACWaiverCriteriaFINALG
uidance080408.pdf] (accessed Aug. 5, 2008). Even after a guidance is 
finalized, FDA staff may use an alternative approach if the approach 
satisfies the requirements of the applicable statutes and regulations. 

[9] See the Food and Drug Administration Amendments Act of 2007 (FDA 
Amendments Act of 2007), Pub. L. No. 110-85, § 701, 121 Stat. 823, 900- 
04 (adding § 712 to the Federal, Food, Drug, and Cosmetic Act) 
(codified at 21 U.S.C. § 379d-1). 

[10] The four final guidances are 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; Guidance for FDA Advisory Committee Members and FDA Staff: 
Voting Procedures for Advisory Committee Meetings; Guidance for the 
Public, FDA Advisory Committee Members, and FDA Staff: Public 
Availability of Advisory Committee Members' Financial Interest 
Information and Waivers; and Guidance for Industry Advisory Committee 
Meetings--Preparation and Public Availability of Information Given to 
Advisory Committee Members. 

[11] 5 U.S.C. app. § 5(b)(2). An FDA official told us that it also 
seeks to achieve gender, ethnic, and geographic balance. 

[12] All federal advisory committees subject to FACA must have a 
charter, although the law does not require the charter to specify the 
number of committee members or their expertise. See 5 U.S.C. app. § 
9(c). An FDA advisory committee charter also provides the committee's 
legal authority and structure, committee meeting frequency and member 
compensation, annual cost estimate and reports, and committee 
termination. Under FACA, FDA advisory committees terminate every 2 
years unless renewed, or the legislation authorizing an advisory 
committee specifies a different period of time. See 5 U.S.C. app. § 14. 
CDRH's Medical Devices Advisory Committee (MDAC) and its 18 panels is, 
by statute, not subject to a renewal review. See 21 U.S.C. § 
360c(b)(1). 

[13] Advisory committees may meet in closed sessions to permit 
discussion of trade secrets, commercial, or financial information 
obtained from a person that is privileged or confidential, or 
information of a personal nature where disclosure would constitute a 
clearly unwarranted invasion of personal privacy. 5 U.S.C. § 552b(c). 

[14] For this report, we refer to a "potential conflict of interest" 
when discussing FDA's review of a member's financial interests for 
possible conflicts of interest prior to granting a waiver or an 
appearance authorization. 

[15] In November 2007, FDA published a draft guidance that recommends 
uniform voting procedures that can be used during advisory committee 
meetings. See FDA, Draft Guidance for FDA Advisory Committee Members 
and FDA Staff: Voting Procedures for Advisory Committee Meetings 
(Rockville, Md.: November 2007), [hyperlink, 
http://www.fda.gov/oc/advisory/VotingGuidance.html] (accessed Jan. 29, 
2008). FDA finalized the draft guidance August 2008, [hyperlink, 
http://www.fda.gov/oc/advisory/GuidancePolicyRegs/ACVotingFINALGuidance0
80408.pdf] (accessed Aug. 5, 2008). 

[16] Six other FDA advisory committees are located in the Center for 
Food Safety and Applied Nutrition (1), the Center for Veterinary 
Medicine (1), the National Center for Toxicological Research (1), and 
the Office of the Commissioner (3). The Risk Communication Advisory 
Committee, established in May 2007, is one of the three advisory 
committees located in the FDA Office of the Commissioner. 

[17] Although CDRH has four advisory committees, its MDAC is the 
umbrella title for 18 statutorily-created advisory panels whose members 
are subject to the same legal and regulatory requirements as other FDA 
advisory committees. FDA counts MDAC and its 18 panels as one advisory 
committee. For our analysis, we treated MDAC's 18 panels' meetings as 
individual advisory committee meetings. 

[18] According to an FDA official, FDA does not consider subcommittee 
meetings to be advisory committee meetings subject to FACA because a 
subcommittee provides advice to the committee rather than to FDA. This 
interpretation is in accordance with the FACA regulations issued by the 
General Services Administration. See 41 C.F.R. § 102-3.35 (2006). 

[19] FACA requires agencies to designate a federal officer or employee-
-the designated federal official--to chair or attend every meeting of 
each advisory committee the agencies convene. Committee meetings may 
not be held without the advance approval of the designated official. 
See 5 U.S.C. app., § 10(e), (f). 

[20] An SGE is statutorily defined as an officer or employee who is 
retained, designated, appointed, or employed by the government to 
perform temporary duties, with or without compensation, for not more 
than 130 days during any period of 365 consecutive days. See 18 U.S.C. 
§ 202(a). In general, FDA compensates advisory committee members who 
are SGEs for their service, reimburses them for travel, and pays them 
an amount for per diem expenses. 

[21] FDA advisory committee members who are federal employees employed 
by other agencies do not receive additional compensation for their 
service on an FDA advisory committee. 

[22] There are circumstances when a standing member may be allowed to 
serve beyond their 4-year membership term including, for example, if a 
member in the fourth year of his or her term is selected to serve as 
the committee’s chair and a special request is granted by HHS. A member 
may also serve less than 4 years; for example, if a member resigned in 
the second year of the term, the new member could serve the remaining 2 
years. 

[23] Consumer representative members on CDRH MDAC panels are by statute 
to serve as nonvoting members. See 21 U.S.C. § 360c(b)(2). 

[24] In this report, when we discuss conflict of interest for committee 
members we are not including industry representatives. 

[25] CBER, CDER, and CDRH are required to have a patient representative 
serve on all their cancer-related advisory committees. These 
representatives are voting members for CBER and CDER committees, and 
nonvoting for CDRH committees. 

[26] Although the general rule is that a meeting quorum consists of the 
majority of current advisory committee members, FDA advisory committee 
charters may allow a committee to meet with less than a majority of its 
members for a specific meeting. See 21 C.F.R. § 14.22(d) (2007). 

[27] Industry representatives, whether they are temporary or standing 
members, are not SGEs. 

[28] FDA officials told us that centers’ consultant pools are lists of 
individuals who FDA has determined have expertise that may be needed in 
the future for a specific advisory committee meeting and usually have 
current SGE appointments. FDA officials also told us that consultants 
may be former FDA advisory committee members. 

[29] A “particular matter” is a matter involving “deliberation, 
decision, or action that is focused upon the interest of specific 
persons, or a discrete and identifiable class of persons.” 5 C.F.R. § 
2640.103(a)(1). 

[30] See 18 U.S.C. § 208. According to FDA, its advisory committee 
meetings generally involve either (1) particular matters involving 
specific parties—typically the consideration of a specific company’s 
drug or medical device—which we refer to as a “specific-parties” topic; 
or (2) particular matters of general applicability—consideration of 
issues that affect a class of person, not specific parties, such as 
clinical trials for a class of drugs—which we refer to as a “non-
specific party” topic. See 5 C.F.R. § 2410.102(l),(m). In addition, FDA 
advisory committee meetings may have topics that are non-particular 
matters—not subject to 18 U.S.C. § 208—typically involving 
consideration of recommendations on broad policy options that are 
directed to the interest of a large and diverse group of persons. 

[31] Because FDA officials determine whether an advisory committee 
meeting may create a conflict of interest by first reviewing the topic 
or topics to be discussed, throughout this report we use the term topic 
instead of the term particular matter as used in the statute. 

[32] See 18 U.S.C. § 208(b)(3). 

[33] See 18 U.S.C. § 208(b)(1). 

[34] If an advisory committee meeting has more than one topic—such as 
both specific-parties and non-specific party topics—FDA may issue a 
conflict of interest waiver to limit the member from voting or 
participating in the discussion of one, while allowing the member to 
discuss and vote on the other. 

[35] See 18 U.S.C. § 208(b)(2). These regulatory exemptions are based 
on a determination by OGE that the interests involved are too remote or 
inconsequential to affect the integrity of the government employee’s 
services. See 5 C.F.R. pt. 2640. For example, under the de minimus 
exception to the application of the law, an advisory committee member 
can participate in a committee meeting despite owning stock in a 
company involved in the matter before the committee, if the stock has a 
market value of less than $15,000. See 5 C.F.R. § 2640.202(a). 

[36] See Food and Drug Administration Modernization Act of 1997, Pub. 
L. No. 105-115, § 120, 111 Stat. 2296, 2318-20 (amending § 505 of the 
Federal Food, Drug, and Cosmetic Act and codified at 21 U.S.C. § 
355(n)). The member must publicly disclose these conflicts—the 
financial interests upon which the waiver is based. FDA refers to these 
waivers as § 355(n)(4) or § 505 waivers; in this report we use § 
355(n)(4). Although the § 355(n)(4) waivers generally were applied to 
CBER or CDER advisory committee meetings, an FDA official told us that 
it is possible there were historically some issued for other centers’ 
meetings, for example, if CDRH had a joint meeting that involved the 
consideration of drugs or biologics. The FDA Amendments Act of 2007 
repealed the § 355(n)(4) waiver provision, and added a new 
provision—referred to as a § 712(c)(2)(B) waiver—which applied the 
prohibition to all FDA advisory committee meetings. See Pub. L. No. 110-
85, § 701, 121 Stat. 823, 900-04 (pertinent provision codified at 21 
U.S.C. § 379d-1(c)(2)(B)). 

[37] In March 2007, FDA issued a draft guidance to generally not grant 
committee members with financial conflicts of interest exceeding 
$50,000 waivers to participate in an advisory committee meeting. The 
FDA Amendments Act of 2007 also requires FDA to reduce the percentage 
of waivers—§ 208 and § 712—granted by 25 percent over 5 years, starting 
in fiscal year 2008. 

[38] See 5 C.F.R. § 2635.502. 

[39] These relationships would include a person who is a member of the 
committee member’s household and any person for whom the committee 
member has served within the past year as a consultant, contractor, or 
employee. See 5 C.F.R. § 2635.502(b)(1). 

[40] See 5 C.F.R. § 2635.502(a). 

[41] See 5 C.F.R. § 2635.502(d). 

[42] The FDA Waiver Criteria 2000 guidance is titled FDA Guidance on 
Conflict of Interest for Advisory Committee Members, Consultants, and 
Experts (February 2000). The 2000 guidance is replaced by FDA’s August 
2008 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. 

[43] We were told by an FDA official that in some cases, FDA centers 
use OGE Form 450--generally used for annual confidential reporting of 
financial interests by certain federal employees--in lieu of FDA Form 
3410. 

[44] An analysis memorandum--an internal FDA document--is prepared by 
FDA staff for a specific advisory committee meeting. Among other 
things, the analysis memorandum may indicate which members attending 
have conflict of interest waivers, which qualify for an exemption from 
the conflict of interest law, as provided for in regulations issued by 
OGE, which reported interests or involvement not requiring a conflict 
of interest determination, and which have been excluded from 
participating in part or all of the meeting because of a conflict of 
interest that FDA decides does not qualify for a conflict of interest 
determination. 

[45] Advisory committee members may decide they have a conflict of 
interest and recuse or disqualify themselves from participating in all 
or part of a meeting. We were told by CDER ACS staff that ACS began 
tracking members' self recusals in 2006 because CDER is often asked why 
members do not participate in some committee meetings. 

[46] Conflict of interest waivers can limit a member's participation 
and voting in a meeting. A member may, for example, be permitted to 
participate in a meeting's discussions but not vote, or participate in 
discussions involving certain topics and only vote on those topics and 
vote only on certain matters. 

[47] EIS typically works with the director of a center's advisory 
committee management staff to provide advice on conflict of interest 
determinations and to review proposed conflict of interest waivers. 

[48] As of August 30, 2007, FDA changed this position title to Deputy 
Commissioner for Policy. 

[49] The Web site posting was required by the Agriculture, Rural 
Development, Food and Drug Administration, and Related Agencies 
Appropriations Act for fiscal year 2006. Pub. L. No. 109-97, § 795, 119 
Stat. 2120, 2164-65. This requirement was continued through fiscal year 
2007. Continuing Appropriations Resolution, 2007, Pub. L. No. 109-289, 
division B, §§ 101(a) and 106(3), 120 Stat. 1257, 1311, 1313 (2006), as 
amended by: Pub. L. No. 109-369, 120 Stat. 2642 (2006); Pub. L. No. 109-
383, § 1, 120 Stat. 2678 (2006); and Pub. L. No. 110-5, § 101, 121 
Stat. 8 (2007). Waivers posted on the Web site may have had information 
redacted; for example, the name of a drug company in which an 
individual owns stock may be redacted. Appearance authorizations are 
not required to be publicly disclosed. The statute--18 U.S.C. § 208(d)-
-provides for the disclosure of waiver information for § 208(b)(1) and 
(b)(3) waivers upon request but allows federal agencies to redact any 
information that would be exempt under the Freedom of Information Act, 
such as an advisory committee member's confidential financial 
information. 

[50] Pub. L. No. 110-85, § 701, 121 Stat. 900-04 (pertinent provision 
codified at 21 U.S.C. § 379d-1(c)(3)). 

[51] FDA, Draft Guidance for the Public, FDA Advisory Committee 
Members, and FDA Staff: Public Availability of Advisory Committee 
Members' Financial Interest Information and Waivers [hyperlink, 
http://www.fda.gov/oc/advisory/waiver/ACdisclosure1007.html] (accessed 
Mar. 18, 2007). FDA finalized the draft guidance August 2008. 

[52] Appearance authorizations and their grounds are not required to be 
publicly disclosed. 

[53] The FDA Amendments Act of 2007 allows FDA to develop a new 
recruitment method through which an entity receiving funding from NIH, 
the Agency for Healthcare Research and Quality, the CDC, or the 
Veterans Health Administration can identify a person whom FDA can 
contact regarding the nomination of individuals to serve on advisory 
committees. Pub. L. No. 110-85, § 701, 121 Stat. 900-04 (pertinent 
provision codified at 21 U.S.C. § 379d-1(b)(1)(B)). 

[54] Most of this information was available on the Web site prior to 
the revision. The revised Web site provides a link to the e-mail 
address to submit individual nominations and self nominations. 

[55] A group of interested consumer organizations, commonly referred to 
as the consumer nominating group, assists FDA with recruiting, 
interviewing, and assessing potential candidates to serve as voting and 
nonvoting consumer representatives. When there is a vacancy for an 
industry representative on an advisory committee, FDA publishes a 
notice in the Federal Register requesting that industry organizations 
send a letter stating their interest in nominating an industry 
representative. FDA instructs that representatives from the interested 
industry organizations consult with each other and select an industry 
representative candidate for each vacancy. See 21 C.F.R. § 14.84(d) 
(2007). 

[56] The FDA Amendments Act of 2007 requires that an individual’s 
expertise and financial disclosure report filed in accordance with the 
Ethics in Government Act of 1978 be reviewed when considering a term 
appointment to an advisory committee. Pub. L. No. 110-85, § 701, 121 
Stat. 900-04 (pertinent provision codified at 21 U.S.C. § 379d-
1(b)(2)). 

[57] FDA’s prescreening form is the Prospective Special Government 
Employee Personal Data Sheet—Preliminary Informal Interview (FDA Form 
2725a). 

[58] GAO, Federal Advisory Committees: Additional Guidance Could Help 
Agencies Better Ensure Independence and Balance, [hyperlink, 
http://www.gao.gov/cgi-bin/getrpt?GAO-04-328] (Washington, D.C.: Apr. 
16, 2004). 

[59] EPA officials told us that candidates complete EPA Form 3110-48. 
National Academies officials told us that provisional study committee 
members fill out financial disclosure Form BI/COI (Background 
Information/Conflicts of Interest) Forms 1, 2, or 3, depending upon the 
type of study on which they will work. 

[60] As of October 1, 2007, candidates for FDA advisory committees are 
required to complete the OGE Form 450 or FDA Form 3410—financial 
disclosure reports that provide information about the individual’s 
financial interest—prior to being appointed as an FDA advisory 
committee member. 

[61] National Academies, EPA, and NIH officials we interviewed did not 
believe that their organizations’ financial disclosure reporting 
requirements acted as a significant barrier to recruiting qualified 
candidates to serve on advisory committees. However, neither EPA nor 
NIH is required to disclose publicly their advisory committee members’ 
conflict of interest waivers like FDA is. An EPA official added that 
she does not believe the agency has granted a conflict of interest 
waiver to an advisory committee member in at least 5 years because the 
agency typically disqualifies individuals with conflicts of interest. 

[62] FDA released a draft guidance in October 2007 that would implement 
new agencywide procedures for the public availability of information 
about advisory committee members’ financial interests and conflicts of 
interest waivers in response to the FDA Amendments Act of 2007. FDA 
finalized this draft guidance August 2008. 

[63] The FDA Amendments Act of 2007 also requires FDA to develop and 
implement strategies to conduct outreach to potential advisory 
committee candidates at universities and colleges, among other 
entities. Pub. L. No. 110-85, § 701, 121 Stat. 823, 900-04 (pertinent 
provision codified at 21 U.S.C. § 379d-1(b)(1)(A)). 

[64] A clinician is an individual qualified in the clinical practice of 
medicine, psychiatry, or psychology as distinguished from one 
specializing in laboratory or research techniques or in theory. 

[65] A clinical trialist is a medical researcher in charge of carrying 
out a clinical trial’s protocol. 

[66] In its comments on the draft report, HHS stated that FDA has not 
found that one particular biomedical specialty yields potential 
advisory committee members with less frequent conflicts of interests. 

[67] HHS, FDA, The Future of Drug Safety - Promoting and Protecting the 
Health of the Public: FDA’s Response to the Institute of Medicine’s 
2006 Report (Rockville, Md.: January 2007), [hyperlink, 
http://www.fda.gov/oc/reports/iom013007.html] (accessed Aug. 6, 2007). 
This report was in response to an Institute of Medicine recommendation 
that FDA include a pharmacoepidemiologist or individual with equivalent 
public health expertise on its drug-product advisory committees. This 
recommendation was included in the Institute of Medicine report, The 
Future of Drug Safety - Promoting and Protecting the Health of the 
Public (Washington, D.C.: 2006). 

[68] For this report, advisory committee meeting participants are the 
standing and temporary members who attended a respective meeting. The 
participant total includes the number of standing and temporary members 
who attended each advisory committee meeting, so individual members may 
be counted more than once. 

[69] The conflict of interest determination totals do not include the 
FDA advisory committees’ industry representatives who are not subject 
to the conflict of interest statutes and regulations applicable to 
federal employees. 

[70] For this analysis, standing or temporary members who were industry 
representatives were not included because they are not SGEs and are not 
subject to the conflict of interest statutes and regulations. 

[71] Some CBER advisory committee meetings used previously granted § 
208(b)(3) waivers—for an earlier CBER advisory committee meeting—as 
waivers for a current meeting. For example, the September 2006 
Transmissible Spongiform Encephalopathies Advisory Committee meeting 
records included five previously granted § 208 (b)(3) waivers dated 
June 2003, September 2004, and January 2005 for members who attended 
the 2006 meeting. We did not analyze whether any CBER advisory 
committee meetings with § 208(b)(3) waivers may have been non-
particular matter meetings, which are not subject to § 208. 

[72] The § 208(b)(1) waivers were granted to federal employees from 
other agencies, such as NIH or CDC, who participated in CDER and CBER 
advisory committee meetings. 

[73] Pub. L. No. 110-85, § 701, 121 Stat. 823, 900-04 (codified at 21 
U.S.C. § 379d-1) (adding section 712 to the Food, Drug, and Cosmetic 
Act). 

[74] See FDA, Draft 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 
(Rockville, Md.: March 2007), [hyperlink, 
http://www.fda.gov/oc/advisory/waiver/COIguidedft.html] (accessed Mar. 
18, 2007). FDA finalized the draft guidance August 2008, [hyperlink, 
http://www.fda.gov/oc/advisory/guidancePolicyRegs/ACWaiverCriteriaFINALG
uidance080408.pdf] (accessed Aug. 5, 2008). 

[75] Pub. L. No. 110-85, § 701, 121 Stat. 901-02 (pertinent provisions 
codified at 21 U.S.C. § 379d-1(c)(2)(B) and (C)). The law provides that 
fiscal year 2007 shall be the base year from which to determine the 
number of waivers that cannot be exceeded to meet the yearly 5 percent 
reductions. 

[76] FDA advisory committees may select temporary members to serve for 
a particular advisory committee meeting to provide additional 
expertise, to ensure a quorum of members is present to conduct a 
meeting, or both. Like standing members, temporary members who are not 
industry representatives are appointed as special government employees. 
They may be members of other FDA advisory committees from the same or a 
different center, or may be members of a center's consultant pool. 
Federal employees from, for example, the Department of Health and Human 
Services, the Centers for Disease Control and Prevention, or the 
National Institutes of Health may also serve as temporary members. 

[77] See FDA, Draft 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 
(Rockville, MD.: March 2007) [hyperlink, 
http://www.fda.gov/oc/advisory/waiver/COIguidedft.html] (accessed Mar. 
18, 2007). FDA finalized the draft guidance August 2008, [hyperlink, 
http://www.fda.gov/oc/advisory/GuidancePolicyRegs/ACWaiverCriteriaFINALG
uidance080408.pdf] (accessed Aug. 5, 2008). 

[78] Pub. L. No. 110-85, § 701, 121 Stat. 900-04 (codified at 21 U.S.C. 
§ 379d-1). 

[79] We identified former CBER, CDER, and CDRH advisory committee 
members to interview by determining which FDA advisory committees in 
each center held the most meetings in 2006, and from these advisory 
committees, which members' service ended during 2006 and 2007. Of these 
former advisory committee members, we contacted those who either did 
not receive a conflict of interest waiver in 2006 or who served as an 
advisory committee chair. Because these criteria yielded fewer former 
CBER advisory committee members than former CDER and CDRH advisory 
committee members, we also contacted former CBER advisory committee 
members who received conflict of interest waivers in 2006. We asked 
these former members whether barriers exist to recruiting qualified 
individuals to serve on FDA advisory committees, particularly those 
without conflicts of interest, and how FDA could improve its 
recruitment process. 

[80] The Web site posting was required by the Agriculture, Rural 
Development, Food and Drug Administration and Related Agencies 
Appropriations Act for fiscal year 2006 and continued through fiscal 
year 2007. In August 2008, FDA issued a final Guidance for the Public, 
FDA Advisory Committee Members, and FDA Staff: Public Availability of 
Advisory Committee Members' Financial Interest Information and Waivers 
(Rockville, Md.: August 2008). [hyperlink, 
http://www.fda.gov/oc/advisory/GuidancePolicyRegs/ACDisclosureFINAL 
Guidance080408.pdf] (accessed Aug. 5, 2008). 

[81] To determine the designation of an advisory committee meeting 
(e.g., non-specific party and specific-parties), we reviewed the 
meeting inventory sheets FDA provided. When the inventory sheets did 
not indicate a designation, we determined the designation from records 
available on FDA's advisory committee Web site [hyperlink, 
http://www.fda.gov/oc/advisory] including Federal Register advisory 
committee meeting notices, advisory committee meeting minutes and 
summary minutes, a meeting's conflict of interest waivers, and advisory 
committee meeting transcripts. If the designation could not be 
determined from the meeting records, we asked FDA to provide the 
designation. 

[82] Conflict of interest waivers--documented in memorandums--describe 
the reasons why a conflict of interest waiver is requested for a 
participant, and indicate if the waiver was granted. The conflict of 
interest checklists are attached to waivers and provide more detail on 
why the participant's conflict of interest waiver was requested, e.g., 
the value of the stock held in a drug company affected by a new drug 
application being considered by the advisory committee. 

[83] An acknowledgement and consent for disclosure of potential 
conflict of interest form is attached to a member's waiver and provides 
a shorter summary of conflicts of interests involved. The member signs 
the form to allow public disclosure of his or her conflict of interest 
information for a particular advisory committee meeting. An FDA 
official stated that these forms are used for specific-parties 
meetings. 

[84] An appearance authorization--also referred to as an appearance 
determination--memorandum describes reasons why a conflict of interest 
appearance determination is requested for an individual and allows him 
or her to participate in the advisory committee meeting despite the 
appearance concerns. 

[85] The Federal Advisory Committee Act (FACA) provides that, unless 
otherwise specified by statute or presidential directive, advisory 
committees shall be utilized solely for advisory functions. 5 U.S.C. 
app. § 9(b). 

[86] CBER's advisory committees are more closely aligned with their 
offices. For this appendix, the term review division is used to include 
both the CDER and CDRH review divisions and CBER's offices. 

[87] We were told that the committee chair is usually selected based on 
FDA's observations of an individual's participation as a member of an 
advisory committee. For example, whether the individual exhibits the 
ability to remain focused on the meeting topic and whether the other 
committee members appear to respect the individual's expertise. 

[88] For example, CDRH conducts an annual closed session, approved by 
the office director, with its standing advisory committee members. 
During this session, the review division updates the members about 
possible upcoming advisory committee meeting topics and devices in 
process for approval. 

[89] See FDA, [hyperlink, 
http://www.fda.gov/ohrms/dockets/ac/cder07.htm#EndocrinologicMetabolic] 
(accessed Oct. 18, 2007) for CDER's July 30, 2007, joint advisory 
committee meeting of its Endocrinologic and Metabolic Drugs Advisory 
Committee and Drug Safety and Risk Management Advisory Committee. 

[90] Additional information is provided to the advisory committee by 
the company at issue in the meeting. For example, a company sponsoring 
a new drug for approval will provide data to support the efficacy and 
safety claims for its product. 

[91] A subcommittee meeting of this type is not subject to FACA because 
the subcommittee is providing information to an advisory committee 
rather than making recommendations to FDA. See 41 C.F.R. § 102-3.35 
(2006). 

[92] A homework assignment can not be given to more than three advisory 
committee members or the assignment would constitute an advisory 
committee meeting, according to an FDA official. 

[93] Temporary members may also be selected to attend an advisory 
committee meeting to ensure there is a meeting quorum. 

[94] A guest speaker may be paid to attend an advisory committee 
meeting. For example, if a CDER review division decides to invite a 
guest speaker who is not a federal employee, the division may pay the 
speaker from its division funds. 

[95] An FDA official told us that patient representatives serve as ad 
hoc members of the advisory committee for a particular advisory 
committee meeting. 

[96] The review division usually looks to the center's consultant pool 
to find alternate experts, but may also go outside FDA. 

[97] See P. Lurie, C. Almeida, N. Stine, A. Stine, and S. Wolfe, 
“Financial Conflict of Interest Disclosure and Voting Patterns at Food 
and Drug Administration Drug Advisory Committee Meetings,” The Journal 
of the American Medical Association, vol. 295, no. 16 (2006). See also 
FDA’s comment on the article at [hyperlink, 
http://www.fda.gov/oc/advisory/analysis.html]. 

[98] See D. Zuckerman, FDA Advisory Committees: Does Approval Mean 
Safety? National Research Center for Women & Families (Washington, 
D.C.: 2006). 

[99] Zuckerman, 3. 

[100] Zuckerman, 1. 

[101] The report used attributed quotations from FDA advisory committee 
meeting transcripts and vote tallies to analyze voting patterns of four 
types of advisory committee meeting participants (physician only, 
physician plus scientific degree, doctorate only, and consumer 
representative). 

[102] See N. Ackerley, J. Eyraud, M. Mazzotta, Measuring Conflict of 
Interest and Expertise on FDA Advisory Committees, Eastern Research 
Group, Inc. (Lexington, Mass.: 2007). 

[103] The Center for Devices and Radiological Health's Medical Devices 
Advisory Committee (MDAC) is the umbrella title for 18 statutorily 
authorized advisory panels whose members are subject to the same legal 
and regulatory requirements as other FDA advisory committees. FDA 
counts MDAC and its 18 panels as one advisory committee. For our 
analysis, MDAC's 18 panels' meetings were treated as individual 
advisory committee meetings. 

[104] This committee, by law, has 5 members who represent governmental 
agencies including state and federal governments, and 10 members who 
represent industry and the public. See 21 U.S.C. § 360kk. 

[End of section] 

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