Change Begets Opportunity

At the time that President Obama won the election in November 2008, it was still too early to foresee the vast amounts of change that the nation faced.   His campaign was built on change, but once the economy began to tumble, even before his inauguration he was being pressed to express leadership.  The level of change had risen far beyond what anyone had anticipated.  While a personal and professional challenge, it also provided him with a golden opportunity very early in his Administration to address all of the problems head on and begin dealing with a widely deteriorating situation.  The level of need for change became his pathway to demonstrating leadership.

Similarly, Dr. Hamburg has taken the helm of the FDA at a time when there is a need for great change, both within the agency and without, of that there is no question.  But yesterday, the President signed into law sweeping legislation that provides the FDA with an entirely new portfolio to regulate - tobacco.  It is called the Family Smoking Prevention and Tobacco Control Act.  (It does go beyond families who smoke – I think Family just gets put in front of almost any bill these days to demonstrate one is for families even when, as here, the bill has nothing whatsoever to do with families.)

One is left to wonder whether at the time when Dr. Hamburg contemplated taking on the job of FDA Commissioner and setting it on a new course she also considered that her already full plate might get another heaping in such a short amount of time.

And so she too faces a mandate of change that with it brings an  excellent opportunity to demonstrate her leadership.  There are a number of questions about the tobacco legislation and how FDA will implement it.  Happily, the FDA already carried on its landing page, information (albeit limited) about the tobacco legislation.  Dr. Hamburg's message indicates that those answers will come through a program of public hearings and working with other agencies.  In the past, this has been a laborious and lengthy process. 

Dr. Hamburg has made it quite apparent she is dedicated to the proposition of transparency and her track record at the New York Department of Health indicates that she gets things done.  It will be interesting to watch her seize this opportunity and her efforts can serve as a harbinger of what we can look forward to in the way of reforming the FDA. 

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