FDA Making Transparency Increasingly Clear

This week a number of people took note when the FDA announced the issuance of a report that outlined eight new proposals to increase transparency by allowing greater access to the agency’s compliance and enforcement data.  The eight proposals are draft and are open for public comment.  These actions are part of a larger effort launched in June 2009 aimed at increasing transparency at the agency.

Accompanying that June 2009 announcement, there were a number of transparency elements established at FDA to demonstrate that the agency was set to make clear a commitment in this regard, for example, by starting a transparency blog.

Shortly after that time, an examination of transparency respecting advisory committees published here showed that there was an uneven application when it came to providing background information on advisory committee members.  It was common practice for the rosters of the advisory committees to link to the CVs of each member.  However a thorough examination in July 2009 showed that this was done only about half the time. Subsequent and periodic examinations saw some slight improvement, but huge gaps remained by November 2009 and even as late as April 2011.

Such a state of transparency regarding one of the most important functions at the agency led to the question whether or not FDA was indeed serious about transparency or was merely putting up window dressing on the topic.  After all, if the agency could not connect a link to a CV with a name on the Web site, which was easy, how could it manage the harder stuff when it comes to transparency.

But here is the news on that front.  A check in yesterday of each and every advisory committee for the Center for Drug Evaluation and Research (CDER) showed that of the over 160 advisory committee members currently sitting, there were only 4 without links to their backgrounds.  That means that the agency went from a roster with nearly 50% of the links missing to one with nearly 25% of the links missing to the current status where only about 2%.

The links may not be a big deal to some.  But the agency’s progress to change the status quo does demonstrate both a willingness and ability to turn the FDA into a more transparent agency.  Its a big ship, and it does appear to be turning.  Well done FDA.

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