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President Obama, Please Retain Commissioner Hamburg


With President Obama’s re-election, many people are sitting back and assuming that the U.S. Food and Drug Administration (FDA) won’t change much. In FDA Matters’ view, it doesn’t need to: Commissioner Hamburg is doing a good job; the agency is moving forward to improve food, drug and device safety; more rational and predictable review processes are being implemented; and there are at least three relatively new laws that need ongoing attention.

However, year five of an incumbent presidency almost always involves changes in personnel and policies, not the continuity one might expect. FDA may not be touched, but it seems short-sighted to think there won’t be any changes. And that could start at the top with Commissioner Hamburg.

The unwritten rule of senior political appointees is that you leave by the end of year three or you wait until after the election. Thou shalt not create vacancies during the campaign!

So, the list of who might be leaving now or over the next few months includes everyone who would have left anytime in the last year. There have been rumors that Commissioner Hamburg fits into this category….and equally plausible rumors that this is nonsense. Don’t ask me the answer on this; I have no idea. She may want to stay or she may have had enough of the job.

Then there is the matter of President Obama’s preferences. While those departing will be going to specific jobs or to pursue new (unspecified) opportunities, some will be truly voluntary departures and some will have been pushed out the door. At the moment, the focus is on Secretary of State (Hilary Clinton having said long ago that she would leave after the election) and other very high visibility jobs.

The next rung (individuals such as Health and Human Services Secretary Kathleen Sebelius) and the rung beyond that (FDA Commissioner Margaret Hamburg) will be playing out over the next two to eight months. Each individual will be evaluated—at least informally—and decisions made as to whether they fit into the President’s second term plans.  I would presume that they do fit—and that Secretary Sebelius and Commissioner Hamburg are welcome to stay if they want.

However, unless you have been at the table when White House, HHS and FDA have interacted AND been party to conversations among White House staff as to who they count on and trust, then you really have no idea what President Obama’s intended or evolving  position will be on the continuation of Commissioner Hamburg.  There are always surprises about who will be part of the second term team. Presuming a continuing role for Hamburg is just that—a presumption.

As stated at the outset, I hope that Commissioner Hamburg wants to stay and that President Obama chooses to keep her.  There are positive, agency-affirming reasons supporting this.

In contrast, the Commissioner’s departure, for whatever reason, would be bound to have negative consequences for the agency. Her successor, regardless of the quality of his/her credentials, would face a U.S. Senate confirmation hearing that is likely to be painful. To appreciate why requires an understanding of the confirmation process and its true goal.

The vast majority of Presidential appointees requiring Senate confirmation are clearly qualified to carry out the duties of the position for which they have been nominated. If competence were the primary criteria, then most nominees could be approved with just a staff-level review of their record and positions and an FBI check for character and national security.

Why hold confirmation hearings? In most cases, the purpose is for members of the Senate (acting on their own behalf, as well as those of various stakeholders) to restrict the appointee’s discretionary decisionmaking once in office. In the case of a newly-appointed FDA commissioner, that would mean running a gauntlet of questions about product approvals, medical device policy, unrestricted access to plan B “day-after” contraceptives, how to name biosimilars, etc.

A talented nominee can fend off most of the hardest questions with non-committal answers. However, at the end of the process (when the nominee is confirmed) they are certain to have provided a number of answers that restrain their ability to make the best medical and public health decisions.  Equally important, a new Commissioner will mean a new leadership team and an extended learning curve.

For the FDA, this IS the time for continuity. Let’s hope that Commissioner Hamburg and President Obama will deliver it.


A version of this article appeared in the December 3, 2012 online edition of Scrip Regulatory Affairs.

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