Revising Advisory Committee Criteria

The FDA has issued a new draft guidance on Advisory Committee criteria in an attempt to quell the rising tide of criticism that advisory committee members are often too tied to industry to be rendering impartial decisions. 

The outline of requirements for participation hinges on the amount of $50,000 in company interests which could disqualify a member from participation on the panel and/or from discussion or voting.

The draft guidance is surely a step in the right direction to restore some lost credibility to the agency, though my own feeling of the $50,000 limit is that it is too low.  The draft guidance, however, does have the appearance of being somewhat hastily written and needs to be smoothed out. 

What has been lacking from the leadership of FDA though that would have made this move have much more weight is an understanding of how this particular bit of the puzzle fits in to an overall plan to improve the agency.  That vision has not been enunciated from the top and lacking that, each step appears piece meal rather than part of a bigger, more sophisticated plan.

And, if the agency is going to continue to commit gaffes, such as the proposed cut and then restoration of funding to the Office of Women’s Health, the positive impact of reforms like this will be further diminished. 

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