FDA Can Find Unconflicted Advisory Committee Members, Groups Say

December 5, 2007

The FDA could easily find qualified experts without conflicts of interest to serve on its advisory committees, several public interest groups told agency Commissioner Andrew von Eschenbach after reanalyzing a study of advisory committee members.

In that study, the consulting firm Eastern Research Group (ERG) found that experienced advisory committee members were more likely to have received financial conflict-of-interest waivers. Creating advisory committees devoid of conflict may not be possible and would pose an additional burden on the cost and timeliness of committee operations, the report says.

However, that conclusion does not follow the data in the study, argues a letter to von Eschenbach signed by the Center for Medical Consumers, the Center for Science in the Public Interest, Consumers Union, the National Physicians Alliance, U.S. Public Interest Research Group and the Union of Concerned Scientists.

The ERG study looked at 16 advisory committee meetings held between December 2005 and Oct. 26, 2007. Thirty-two of the 124 advisory committee members received conflict-of-interest waivers. ERG then examined four advisory committee meetings with the greatest number of waivers, identifying 17 members receiving conflict-of-interest waivers.

In their letter to von Eschenbach, the groups pointed out that ERG found 70 potential committee members with equivalent or greater experience than the 17 members who received waivers. Although nearly half of the 70 individuals had publicly declared conflicts of interest, 30 reported they did not have any conflicts. Finding these 70 potential members took 88 employee-hours, according to ERG.

ERG’s report on conflicts of interest can be seen at www.fda.gov/oc/advisory/ERGCOIreport.pdf.