FDA Commissioner Appointed – Check. Deputy Appointed – Check. Now What?

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Well the long era of suspense is over given the choices by the Obama Administration for the FDA and for HHS – in fact, the appointment game is winding down across the board, and federal agencies are getting down to the business of functioning government.

In the case of the FDA, what does that mean?  There has been a great deal of speculation that the dual appointment of Dr. Margaret Hamburg and Dr. Joshua Sharfstein as Commissioner and Deputy Commissioner, respectively, signals an intent to break the agency into two components – food and drugs.  There does not, however, seem to be anything substantive to that rumor – it would seem that the best that could be said for it is that it is speculation.

Does the agency need to be split into two merely to make it more functional?  Would the disruption and significant expense that would entail such a split actually be worth it?  And why in the world would you move FDA to its new headquarters, which are astonishingly large, only to then split the agency in half.  It would certainly be the biggest overhaul of domestic government since the creation of Homeland Security that ripped apart several agencies and put them under one roof.  

But splitting the agencies aside, what is it that FDA really needs?  It is important to recall that for the past 8 years under the Bush Administration, most of domestic government in general was dramatically scaled back in terms of fulfilling missions and exerting proper regulatory oversight.  The Justice Department and the Environmental Protection Agency, to name just a few, all had what could be charitably called, a scaleback in enforcement.  A statistic I've many times cited, with respect to the FDA is that the number of warning letters issued by DDMAC during the Clinton years numbered well over 100 per year – while the last years of the Bush Administration saw only about 20-25 per year.  

That is not to say that Drs. Hamburg and Sharfstein need to come in and start issuing Warning Letters to prove moxy or signal a new course.  The agency has not had true and sustained leadership for many many years.  Splitting it up isn't going to address that.  What will address the problems is the expression of true leadership and vision.

What that means is this.  Dr. Hamburg needs to be just as good of a communicator as she will be physician and administrator.  She needs to have vision and she needs to enunciate that vision in an articulate fashion with action that backs it up.  She needs to convey to stakeholders, including policy makers that she is in charge and that she is taking the agency to a new height.  Together, she and Dr. Sharfstein need to hold up some mirrors at the agency.  This is where we are – this is where we want to be – and this is what is standing in our way.  This is how we will move to the next level.  

Nature hates a vacuum.  The vacuum in leadership has mean that members of Congress have stepped in to fill the void with a host of reforms.  Dr. Hamburg should announce her own reforms and begin executing them, outflanking the Congress.  When true leadership at the agency is expressed,  those outside the agency who are exerting so much influence, will have to step aside.  
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4 Responses to FDA Commissioner Appointed – Check. Deputy Appointed – Check. Now What?

  1. bette43 says:

    Mark to you think you could get Dr. Hamburg and Sharfstein to articulate a little of their vision here? I’m intuiting from your comments that you don’t expect them to be in favor of splitting up the agency.

  2. Mark Senak says:

    That is probably more sway with FDA than I think I am capable of, but I’m flattered that you think I could. I’m afraid we shall have to sit and wait. But I would say that if Dr. Hamburg digs in on the drug side of things, it would be an indication that the agency is not bent on splitting. And you are correct, I think there is no evidence of an imminent split, only unsubstantiated rumor.

  3. JS says:

    One small point: I don’t think CFSAN was ever intended to move to White Oak.

  4. Mark Senak says:

    Thanks – I was not aware of that! Interesting.