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FDA toughens conflict-of-interest rules for advisory board members

Pharma Compliance Alert, August 13, 2008

Outside specialists will be excluded from FDA advisory panels if they have a personal financial stake of more than $50,000 in the company affected by the discussion, according to FDA guidance.

Experts who have a smaller stake in a company would need a waiver from the FDA to serve on any FDA advisory board and the agency will limit the number of waivers it grants.

The FDA pays committee members to meet several times a year to recommend approval, rejection, or further research on medical products. The FDA usually follows the advice of its advisers, though it is not required to do so.

• Change the voting process for advisory committee members from sequential to simultaneous
• Post a record of the votes of individual advisory committee members online
• Post briefing materials online 48 hours before advisory committee meetings
• Change the circumstances under which committees meet to address issues

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