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Posted 12 June 2013 | By Alexander Gaffney, RAC,
Companies with a product pending before an advisory committee often spend a lot of time thinking about the makeup of the committee, including who's on it and how they might vote in regards to the company's product. But according to a new study, companies would do well to worry about how those members are seated as well.
The study, published in the June 2013 edition of the American Journal of Therapeutics by researchers David Broniatowski and Christopher Magee, notes that the US Food and Drug Administration (FDA) has long been worried about perceptions of bias in its advisory committees.
FDA's advisory committees are generally composed of experts who offer their opinions on a particular subject-the safety of a drug or device, the need for a new guidance document or a relaxed approach to risk strategies, for example-and then vote as a panel to offer a non-binding but influential recommendation.
But despite FDA's efforts, the authors hypothesized that it had not addressed several major sources of social influence on the committees, including the effects of proximity on voting behavior. Broniatowski and Magee decided to look at transcripts for the Circulatory Systems Devices Panel from 1997 to 2005 for votes in which a device was undergoing a premarket approval assessment and the committee was not unanimous in its decision.
The results, they said, were clear. "Committee members who are assigned to speak later are significantly more likely to be in the voting minority (P < 0.001)," they found. "This effect holds for meetings with sequential voting (P = 0.0058) and for meetings with simultaneous voting (P = 0.045)."
"A weaker effect shows that, for meetings with sequential voting, committee members who vote later are significantly more likely to be in the voting minority (P = 0.018)," they added.
What does this have to do with seating? Simple, the researchers said: The order in which a panel member speaks is determined by his or her seating location.
"This suggests the presence of a possible social dynamic that is not addressed by existing FDA committee procedures," they said.
"Someone has to speak first - and this person will likely exert some degree of influence," Broniatowski said in an accompanying statement. "Instead of trying to eliminate these sources of influence, we would do better to understand how they work, and how best to use them to improve the decision-making process. This doesn't just apply to the FDA, but to any setting where panels of experts must meet to make decisions about complex technical systems."
Does Seating Location Impact Voting Behavior on Food and Drug Administration Advisory Committees?
Tags: advisory committee