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

Device Regulation Alert: Safety, Compliance and Reimbursement News, August 18, 2008

Outside specialists cannot participate in 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. The agency will limit the number of waivers it grants.

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

• Change the advisory committee voting process from sequential to simultaneous
• Post individual advisory committee members’ voting records 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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