FDA tightens advisory group criteria

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A significant number of current FDA advisory committee members would be disqualified from participating in future panel deliberations under new guidelines proposed in an agency draft guidance document.

The FDA says it does not yet have an exact number for how many current panel members would be impacted by the new guidelines, the agency is interested in hearing how the new guidelines will affect current members.

Where current guidelines allow waivers in certain situations, the new guidelines generally disqualify members with financial ties exceeding $50,000—no participation and no voting. Members whose financial ties are less than $50,000 would be allowed to participate but would have suspended voting privileges. Members with no conflicts would be allowed full participation.

The FDA also says it intends to “generally limit participation in certain cases where there may be a perception of a conflict of interest, even though full participation would be permitted under the applicable statutes.”

A CBS News analysis found that since 2002 medical professionals had registered 189 conflicts of interest at 86 advisory committee meetings.

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