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Executive Summary

FDA ADVISORY COMMITTEE INTELLECTUAL CONFLICT-OF-INTEREST procedures are being considered by the agency, Center for Drug Evaluation and Research Deputy Director-Scientific and Medical Affairs Bruce Burlington, MD, indicated in a presentation to the new OTC Drugs Advisory Committee on Dec. 16. Commenting on possible FDA reforms of the advisory committee system, Burlington commented on the intellectual conflict-of-interest issue raised in the recent Institute of Medicine report on FDA's advisory committees ("The Pink Sheet" Dec. 14, p. 20). Burlington defined the issue of intellectual conflict-of- interest as a situation where a member of an advisory committee "may have staked out a position, and by virtue of having staked out a position on an issue that's going to come before the committee, they may find themselves biased and have difficulty in re-evaluating things, and they feel that they are forced to defend the issue that they've already staked out." The FDAer said the agency was not yet ready to give an answer on "how this may play out." He noted that "these things get to be issues....We have to figure out procedures on how to deal with them." "Whether we're worried about published papers, whether we're worried about only editorials and opinions explicitly taken, whether we're worried about interviews with the news media... I'm not going to give you an answer for how we're going to deal with it here," Burlington told the committee, "but I ask you to keep it in mind as you think about how the advisory committee will be conducting its business." The agency also is considering how to streamline the financial conflict-of-interest requirements, which currently mandate that members sign conflict-of-interest waivers if the pharmacy at a hospital in which they work sells a drug product that may come before their committee. "We still are trying to figure out how exactly to deal with all this," Burlington said. Other issues brought to the attention of FDA by the IoM report and other outside panels, such as the Lasagna and Edwards committees, include consistency between committees and "explicit policy and procedures," Burlington said. "Written policy and procedures would help in defining expectations for the members and ...for the agency staff so that we will each know how meetings are supposed to be conducted," he noted, adding: "This will provide hopefully some proof against the accusation that there's manipulation either on the part of industry or on the part of agency review staff." Addressing the issue of advisory committee independence, Burlington stressed that "it is absolutely critical that the meeting be run by the chair." He also noted that "how the agenda is set is in the process of some evolution. We're hoping that the chair and the members will be active participants in selecting which items come up for discussion and what the schedule of those items are." In closing, he promised the committee: "We will have a variety of procedures that we will share with you that will address many of these questions."

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