Financial conflict of interest disclosure and voting patterns at Food and Drug Administration Drug Advisory Committee meetings

JAMA : the Journal of the American Medical Association
Peter LurieSidney M Wolfe

Abstract

In January 2002, the US Food and Drug Administration (FDA) issued a draft guidance requiring more detailed financial conflict of interest disclosure at advisory committee meetings. To characterize financial conflict disclosures at drug-related meetings, and to assess the relationship between conflicts and voting behavior at meetings that considered specific products. Cross-sectional study using agendas and transcripts from all FDA Drug Advisory Committee meetings (2001-2004) listed on the FDA Web site. Conflict rates, type, and size. The relationship between having a conflict and voting in favor of the index drug was described for each voter using Mantel-Haenszel relative risks and Monte Carlo simulations; Spearman rho was used for a meeting-level analysis comparing rates of conflict with voting patterns. The impact of the removal of persons with conflicts of interest on the vote margins was also evaluated. A total of 221 meetings held by 16 advisory committees were included in the study. In 73% of the meetings, at least 1 advisory committee member or voting consultant disclosed a conflict; only 1% of advisory committee members were recused. For advisory committee members (n = 1957) and voting consultants combined (n = 990), 28...Continue Reading

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