When Transparency is Easy – Advisory Committee Transparency

There has been a good deal of talk coming out of the FDA these days about improving transparency.  For example, there has been set up a Transparency Task Force, and on June 24, the FDA held a Transparency Meeting which can be viewed on the Web site.  And they have even begun a Transparency Blog.  There is no reason to believe that these efforts are anything other than sincere efforts to bring more transparency to the agency and its decision-making process.

With respect to the workings of the FDA Advisory Committees, last August the agency issued a heap of guidance and statement to make more apparent potential committee conflicts of interest and issued new standards.  But in fact, information about the committee members has been harder, not easier to come by.

It used to be that when you went to the FDA Web site to look at a particular advisory committee, there would be hotlinks from the name of the committee member that took you to their CV.  In this way, one could learn a great deal about the committee as a whole – determining their research backgrounds and associations that can be very informative when a sponsor is bringing a presentation before the committee – sponsors who, by the way, pay a good deal in user fees to support the regulatory process.  And such information was particularly useful for the media when the Reproductive Drugs Advisory Committee was found to have several ultra-conservative members when considering Plan B for OTC approval.  Then, the makeup of committee rosters was very transparent.  

But today, if you visit the roster pages of the Advisory Committees, here is what you'll see:

And this is just looking at CDER.  Of the 143 sitting members of CDER Advisory Committees, there is only information available about for about half of them – specifically 78 of them.  That's not very transparent.

J0427695 Some of the time, transparency is about putting into force new standards, new regulations, calling for public meetings and starting blogs.  But sometimes, transparency is about the doing the simple things that you should be doing all along and it doesn't necessarily require all that hoopla.  It isn't necessarily about setting up new systems of transparency – it is about fixing the old ones.  

 
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2 Responses to When Transparency is Easy – Advisory Committee Transparency

  1. James says:

    Did you post this concern on the FDA Transparency Blog?

  2. Mark Senak says:

    not yet, but i plan to.