Sebelius Accepts HHS – If Winter is Near – Can Spring Be Far Away – Who Will Be Obama’s FDA Commissioner?

The news was out on Saturday and carried by the New York Times on Sunday that Governor Kathleen Sebelius of Kansas has accepted offer from President Obama to head Health and Human Services.  (See the previous posting last week on What an Sebelius HHS Would Look Like.)  The move that comes just in time as the White House has slated a Health Summit meeting for Thursday.  It would have been quite a gap not to have an HHS Secretary named as the summit goes on, even as the President's budget has been submitted carrying quite a bit of healthcare baggage without healthcare leadership to speak for it.  (By the way, don't try to find out anything about the summit on – it isn't there.  It is a nice site, but not about news…)

But the next and long-awaited appointment is of course, that of FDA Commissioner.  That, too, really should be appointed before the health care summit.  After all, the FDA regulates one-fourth of the U.S. economy.  It is a central appointment that impacts the future of healthcare.  

The leading candidate for the position appears to be Baltimore's Health Commissioner, Dr. Joshua Sharfstein.  He has many things to recommend him, including the powerful political factor that he is a former staffer for Congressman Henry Waxman, who is a forceful proponent for meaningful FDA and pharma marketing reform and would also have support from Senator Barbara Mikulski.  Dr. Sharfstein himself has a worthy track record on safety, but the Baltimore Health Department is only 800 employees with a budget of $150 million.  The FDA is, well, larger.  Nevertheless, he has been advising the Administration on issues related to FDA during the transition.  Who better to execute on the findings of his assessment than the author of the assessment himself?  The Wall Street Journal Blog published an excellent overview of Dr. Sharfstein that is full of insight.  He seems an excellent candidate.

Would Governor or HHS Secretary Designate Sebelius prefer to to work with another woman?  If so, the Washington Post has reported that another top contender for the position is Margaret Hamburg who, like Dr. Sharfstein, has overseen a large city health department as the New York City Health Commissioner during the 1990s   Also like Dr. Sharfstein, both of her parents were physicians and both have been elected to the Institute of Medicine.  She has also served as Assistant Secretary at HHS in charge of policy and evaluation.  She also worked at the National Institutes of Health (NIH) where her focus was on HIV/AIDS.  These two positions might give her a leg up on Dr. Sharfstein in that she has worked at the federal level before and at two related agencies of the FDA.   As Commissioner of Health in New York City, she would have also overseen a larger department with a bigger budget than Dr. Sharfstein.  The Washington Post also reports that she is viewed favorably by Senator Edward Kennedy.  Margaret Hamburg is also an excellent candidate.

Senator Kennedy also has been reported to back another name that has been often mentioned as a candidate – Dr. Robert Califf, a cardiologist from Duke University.  Like the others, Dr. Califf was elected to the Institute of Medicine and who has sat on the Cariovascular and Renal Drugs Advisory Committee of the FDA.   As the Director of the Duke Clinical Research Institute, Dr. Califf has overseen a budget and a department nearly comparable in size to Dr. Sharfstein.  But nothing in this background would denote experience with food, which could be a significant drawback.  He was also reportedly interviewed by Tom Daschle, as was Dr. Sharfstein, and has been considered for the job before.

The thing that the first two candidates have going for them though is the fact that, as heads of major metropolitan health departments, they both would have had some connection with the regulation of food safety.  And in the wake of a year that has been tumultuous, to say the least, respecting food safety and food labeling, one might prefer to have a candidate who is ready to hit the ground running on that issue as well.   That might well, if I were HHS Secretary, be the factor that makes a difference, unless I were planning to take food away from the jurisdiction of the FDA.  

Several other contenders have been on the list, some inside the FDA and others who might be viewed as "mavericks" (there's a word no one wants to hear again).  However, insiders don't denote the change that has been a central theme of the Administration and the "mavericks" may have too many self-inflicted distractions that come with them to be focused enough on the many jobs at hand.   Some of the other candidates are not M.D.s which might stand in their way.    

In any case, who ever it is, I am sure Acting FDA Commissioner Dr. Frank Torti might be relieved if a choice was made sooner rather than later and the FDA, for the first time in years, gets real and steady leadership.  Let's Play Ball!



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