Guidance on Advisory Committee Conflict of Interest – Is Enough Enough?

Yesterday, the FDA issued a press release stating "new and improved" policies for the management of advisory committee members:

The Food and Drug Administration today announced several improved policies and procedures strengthening its management of FDA advisory committees. The improvements include stricter limits on financial conflicts of interest for committee members, improved voting procedures, and improvements to the processes for disclosing information pertaining both to advisory committee members and to specific matters considered at advisory committee meetings.

The action cements into place a $50,000 cap on the financial interest that an advisory committee member may have in a company as outlined in the Guidance on the topic – Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees.    To most people, that would seem like a lot of money but to the field of academic researchers, it probably would not and it clearly mimics the EMEA’s same number limit on Euros for its advisers.  They also announced new procedures for screening, and will make disclosures available on the posting site for each committee prior to a meeting.  One wonders who many advisory committee members are going to like having personal information posted on the Internet and how transparent transparent must be to satisfy the likes of Congressional reformers. 

The advisory committee process is an important aspect of FDA approval of drugs.  There are those who would eliminate any researchers who have any financial interest at all related to industry.  But considering the bulk of research performed in this country is performed by industry, finding people who have no connections to industry research would also mean finding people who don’t really know much about conducting research in the private sector.  That might not be in the best interest of either pharmaceutical and biotechological advances, nor in the public interest. 

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