No Conflicts? Not Possible

FROM THE EDITORS

FDA has taken several steps to improve its advisory committee process, including asking the question, “Is it possible to have advisory panels with no financial conflicts?” The agency has released a report that highlights the difficulty in finding qualified panel members who have no such conflicts. The report suggests that attempting to find experts with no conflicts would “represent an uncertain and potentially substantial additional burden on the cost and timeliness of advisory panel operations.” The bottom line is that no one is free from conflict.

FDA was interested in whether it is possible to assemble advisory committee meetings composed of highly qualified individuals, none of whom require a waiver for potential conflict of interest. FDA commissioned Eastern Research Group (ERG) Inc. of Lexington, MA, to conduct the study. The study had the following four objectives:

The 55-page report, “Measuring Conflict of Interest and Expertise on FDA Advisory Committees,” found that other candidates might exist, but that many of these would also require the waivers granted to existing panel members. The report found that those with waivers tend to have higher levels of expertise than those without waivers.

According to the report, FDA is concerned that by excluding members who require waivers, the agency will lose the most qualified experts, and thus “diminish the quality of scientific advice regarding important public health decisions.”

The report notes that putting together a committee with no financial ties to industry would require starting with a much larger pool of candidates than FDA now uses. Additional screening would certainly take more time and could adversely affect not only the logistics of putting a panel together, but also the panel's ultimate responsiveness. The additional time “could significantly delay committee meetings and related FDA actions on major public health issues,” the report says.

“We conclude that the ability to create a ­conflict-free panel is speculative, and that, even if possible, recruiting and screening costs would be much higher than current expenditures,” ERG says. “Furthermore, the additional time required to screen candidates could significantly delay FDA decisions on major public health issues.”

The report makes another important point: A conflict of interest is a condition—not a behavior—and does not imply that a person will act in a biased manner. Many in mainstream media are quick to believe that conflicts of interest on FDA panels lead to inherent biases on the part of panel members.

In addition to the report, FDA has issued two new draft guidances and has formalized its operating procedures. These steps will surely help it avoid the appearance of conflict of interest. The report, however, should make the doubters take notice. Conflicts are clearly inevitable. It is up to FDA to ensure that going forward the process is transparent and consistent.

Sherrie Conroy for the Editors

Note: A copy of the report is available at www.fda.gov/oc/advisory/ERGCOIreport.pdf.