FDA Launches Investigation of FDA

J0284911 The FDA announced on Friday that it was initiating an assessment of the new drug review process.  This, needless to say, is going to be tricky.

According to the FDA press release, this review will be led by senior management of the FDA.  The scope of the review "will include the processes for nominating Members, choosing consultants with expertise specific to the meeting topic, developing competing product lists, screening for conflict of interests, and utilizing special government employees outside of an advisory committee meeting."

The effort is probably a good one from a communications perspective.  It is important that the agency, amid the wash of current criticism it has faced, engage in a review to either confirm or question and modify current practices.  This kind of survey is a standard tonic for what ails a public image.

However, the FDA is making a real mistake given the lack of independence in the review process – i.e., using senior management at CDER.  This can and will most likely dilute any real restorative public image impact from the effort.  It is standard practice that when you are seeking this sort of validation or assessment, one goes outside to independent, credible third parties.  One does not assess oneself and think that skeptics will rush to embrace the outcome. 

Also, the agency press release quotes both Dr. Scott Gottlieb and Dr. Steve Galson, not Dr. Andrew von Eschenbach.  This might have been an opportunity for Dr. von Eschenbach to indicate that he is going to do some housecleaning here and re-establish the credibility of the agency as its new leader.  Instead, the use of Dr. Galson, who is closely linked with the Plan B fiasco in which the agency finds itself, is probably not the most appropriate spokesperson on this issue.  Can you see a headline that says something like "CDER investigates the way CDER handled Plan B and judges its actions appropriate…" See posting of May 1, 2005 – FDA Health Thyself.

Needless to say, it would have been better for the agency to engage an outside, independent review of its practices in this regard.  Using existing staff, and Dr. Galson, diminishes the value of the exercise.  If the agency is going to undertake these kinds of efforts, and it should, they should be executed and communicated in a way that maximizes, not undermines, the effect. 

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