The Case of the Missing Advisory Committee Transcripts…..

Usually, I love a good mystery.  And they are good summer reading especially.  But this one is a bit perplexing.

Whenever an advisory committee serving the Food and Drug Administration has a meeting, someone has the unenviable task of transcribing the entire event and producing a transcript document.  As part of its commitment to transparency, the FDA generally publishes the transcripts on the FDA Web site in the meeting materials section for each advisory committee meeting – usually within about 3 weeks of the meeting, but many times closer to 4-6 weeks.  The publication of the transcripts is important for those of us just geeky enough to want to go back and read what we missed, or confirm what it was we thought we heard.

But actually, while the regular posting of such transcripts is the rule, there are many, many exceptions.

For example, aA meeting of the Antiviral Drugs Advisory Committee back on June 2 – no transcript, no minutes.  A July 22 meeting of the Drug Safety and Risk Management Advisory Committee – no transcript.  A June 18 meeting of the Reproductive Drugs Advisory Committee.

It is true even when we travel back in time.  A December 3, 2008 meeting of the Anti-infective Drugs Advisory Committee, no transcript.  Here is one from November 2008 which was a joint meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee for a two day meeting to consider two different new drug applications for pain control medication, a category which is actually quite interesting to review from the regulatory perspective.  But if you wanted to review the two days' worth of meetings you would be out of luck.  There is a transcript for only one of the days.  Piecing together what happened is like playing a game of Clue.  

I found this just be scratching the surface and looking around for a few minutes on the FDA's Web site.  So what?  Who cares if someone can't find a transcript or if it is ever posted.  Well obviously, I do.  

But beyond that, I think it is symbolic of something else – something I alluded to when I asked in a posting not long ago whether or not the FDA is, in fact, a sustainable entity.  There is a lot to keep up with at such a large agency spanning such a broad range of responsibility and managing a Website that, by the looks of it, has become unmanageable.  Things are going to fall through the cracks, or in the case of the missing transcripts, a lot of things will fall through.  

But when it happens, and happens often, and is connected with other dots where there are things that fall through the cracks (like the missing connections to the CVs of advisory committee members when the agency is committed to a better screening process for advisory committee members) – when those things begin to add up, then it does begin to affect credibility.  

And, moreover, the FDA is persistently asking for an increased scope of authority in regulation, most recently this week as FDA Commissioner Hamburg pointed up the need for more authority in the face of the salmonella egg recall.  Which leads back to the question that may be a much bigger question than the location of the missing transcripts, and that is how big can a big agency get and still keep up with its mandate and commitments?  

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