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. 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. To prescreen candidates, FDA  reviewed the candidates’ curricula vitae and usually conducted a  prescreening interview. 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. The FDA  Amendments Act of 2007 modifies FDA’s process for prescreening  candidates for advisory committee membership. 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. 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. 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. 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. 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. 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. 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. We also interviewed officials from  organizations we previously identified as employing specific recruitment  and prescreening methods that could ensure independent and balanced  advisory committees. National Research Center for Women & Families 2006 report: 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.” 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.” 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.
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.