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Study assesses relationship between conflicts of interest and voting patterns at FDA meetings

Disclosures of conflicts of interest at Food and Drug Administration (FDA) drug advisory committee meetings are common, often of considerable financial value, and rarely result in the recusal of advisory committee members, but excluding those with conflicts would not have altered the overall vote outcome at any meeting, according to a study published in the April 26 issue of JAMA.

The Center for Drug Evaluation and Research (CDER) at the FDA approves 25 to 30 new chemical entities each year, according to background information in the article. CDER often relies on the advice of the advisory committees composed of outside scientific experts. In 2001, 21 percent of these approvals were preceded by an advisory committee meeting. The authors note that recent high-profile cases have called attention to the possible vulnerability of committee decisions to financial conflicts of interest. A new FDA policy to disclose potential conflicts of interest for advisory committee meetings discussing specific products went into effect in January 2002. "Prior to any advisory committee meeting, both voting advisory committee members and voting consultants invited by the FDA are required to fill out form FDA 3410 detailing any financial interests they have, have had, or are currently negotiating," the authors write. "Financial conflict types on the form include current investments, employment, patents, and contracts/grants/cooperative research and development agreements (CRADAs), as well as consulting arrangements and speaking/writing arrangements within the last 12 months. Any relevant conflicts of interest are reported at the beginning of the advisory committee meeting in a statement read aloud by the committee executive secretary."

In this study, Peter Lurie, M.D., M.P.H., from Public Citizen's Health Research Group, Washington, D.C., and colleagues, collected data from January 1, 2001, to December 31, 2004 by analyzing agendas and transcripts from all FDA Dr
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Contact: Robert Yule
202-588-7703
JAMA and Archives Journals
25-Apr-2006


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