Winds of Change at FDA

TransparentYesterday the Obama Administration announced a new Task Force at FDA to delve into the issue of transparency.  Later that same day, the FDA opened up a new part of its Web site devoted to FDA transparency and launched a blog, rather unremarkably titled the FDA Transparency Blog.  It's true.  I could barely believe my eyes.  

The first posting is brought to us by none other than Secretary of Health and Human Services Kathleen Sebelius and a note from newly sworn in Commissioner Margaret Hamburg.   The site will have a moderated comment policy though to my friend Brian Reid's point – there is no mention of who will author the blog nor who will be monitoring the comments.  So maybe transparency needs to begin right there.

Is transparency a problem at FDA?  Yes – FDA's embarrassing Plan B fiasco demonstrated that much.  Is it the only problem at FDA?  No.  But it is probably a good place to start.  

In a related development, also occurring yesterday, Congressmen Henry Waxman and Bart Stupak of the House Committee on Energy and Commerce sent Commissioner Hamburg a letter asking that the FDA review its point of view on the role of Bisphenol-A in food containers, particularly baby bottles and sippy cups.  

In an interview with the Associated Press on the same day, FDA stated that the review and decision would take place in a matter of weeks, not months, and would be led by Dr. Jesse Goodman, Acting Chief Medical Officer at FDA.   That was fast work.  But I would not spend much time guessing what the outcome will be….

Nevertheless, yesterday was a busy day.  Not only is there an announcement of a promise for transparency, a Task Force named, a blog launched, but the very first test case for that transparency – the review of Bisphenol-A policy – provides an opportunity for the author of the blog (whoever that may be) to write about the process openly so that we may comment (to be reviewed by whom we know not).  

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