Senior career FDA officials are viewing the selection of FDA Commissioner-nominee Margaret Hamburg with open minds. From the perspective of the core of FDA's drug regulatory activities, the staff view Hamburg's relative lack of experience as creating a clean slate.

The nomination of Hamburg, a former New York City health commissioner, as FDA commissioner and Baltimore Health Commissioner Joshua Sharfstein as principal deputy commissioner were long awaited (¹ Also see "FDA Commissioner Hamburg: White House Close To Formal Announcement" - Pink Sheet, 9 March, 2009., p. 9)

In conversations with a number of current and former FDA officials, career staff are taking a wait-and-see attitude with Hamburg. Her nomination is not likely to prompt an immediate exodus of senior officials, as might the selection of a commissioner who is a more known quantity and elicits strong reactions.

"This was not the case of people sitting on the sidelines," waiting for a nomination decision so they could decide whether to stay or leave the agency, said one FDA official.

To those that know her, Hamburg has a likeable, intellectual personality. As the former health commissioner of New York, she has experience running a large public health agency, and - barring any unforeseen snags - is not expected to experience any problems with the Senate confirmation process.

Sharfstein was an early candidate for the top job; at one point, he and Duke University cardiologist Robert Califf were final candidates (² [A#00710030001], p. 3). Califf's candidacy was greeted favorably by some FDA professional staff: FDA has worked closely with Califf and Duke on drug development and regulatory science issues for years. As deputy commissioner, Sharfstein will not face a confirmation hearing.

The early word is that Hamburg will focus her attention on food safety and tobacco - should FDA gain regulatory authority over from Congress - while Sharfstein will oversee drug, biologic and medical device issues (³ Also see "FDA Commissioner Hamburg: White House Close To Formal Announcement" - Pink Sheet, 9 March, 2009., p. 9).

One drug/biologic-related area in which Hamburg is likely to have an interest from her previous work is in vaccines and pandemic preparedness. Hamburg has worked on preparedness planning for bioterrorism and natural threats.

On the surface, the split-responsibility approach would appear to be a classic political compromise, given that the two biggest FDA powerbrokers in Congress each got their top picks: Senate Health, Education, Labor, & Pensions Committee Chairman Ted Kennedy with Hamburg, and House Energy and Commerce Chairman Henry Waxman, who threw his support behind Sharfstein.

But there are also mixed opinions on whether a bifurcated leadership is still in the cards - and concerns over the effectiveness of an agency with that unusual arrangement. And it is also unclear how the partnership - if it is implemented - would play out practically in the day-to-day operations of the agency.

Commissioner And Division Director

Career FDA officials have two overriding concerns related to the incoming team: 1) that the Office of the Commissioner will micromanage the drug review process and final decision-making; and 2) that Sharfstein's ties to Waxman, a frequent FDA critic, will serve as an open backchannel for all internal agency business. Sharfstein earlier served on Waxman's staff.

"People don't want the commissioner to micromanage their decisions and act as commissioner and division director," said one FDAer.

For example, former FDA Commissioner Andrew von Eschenbach was understood to be completely hands off when it came to the pre-market drug review process, choosing instead to focus on bigger picture policy issues.

"We're wondering," one FDAer said in reference to Sharfstein's link to Waxman.

The Future of FDA's Scientific Managers

With the search for new FDA leadership drawing to a close, attention now turns to the future of senior scientific managers who effectively run the day-to-day operations of the agency: Center for Drug Evaluation & Research Director Janet Woodcock, Center for Biologics Evaluation & Research Jesse Goodman, Office of New Drugs Director John Jenkins, and Office of Medical Policy Director Bob Temple.

The administration's apparent decision to bypass a more controversial candidate in favor of Hamburg for FDA's top post likely means that core group will remain intact.

Woodcock: More Important Or Reduced Role?

Perhaps the FDA official that will be most closely watched as Hamburg joins the agency is CDER Director Woodcock. There are two schools of thought on how Woodcock will react under a Hamburg-led FDA.

On the one hand, Woodcock could gain even greater importance inside FDA by focusing on managing the sprawling drug center's many regulatory responsibilities - specifically premarket drug review and postmarket controls implementation and active surveillance - while Hamburg and Sharfstein take on the task of rebuilding the image of FDA as the pre-eminent public health agency by leveraging their robust public health backgrounds.

Under former Commissioner von Eschenbach's watch, Woodcock acted as the voice of FDA in drug regulation and policy. She appeared before congressional panels on issues ranging from drug safety and follow-on biologics to tainted heparin. Once Hamburg assumes the commissioner's office, that is unlikely to be the case.

An opposing argument could be made that Woodcock's strong voice will be less prominent relative to the team of Hamburg and Sharfstein, both of whom have a political mandate of reforming FDA.

A permanent reduced role would be somewhat of an anomaly for Woodcock. She acted as von Eschenbach's principal deputy for four years and took on management of CDER as acting director following the departure of Steve Galson to become acting Surgeon General in September 2007. Woodcock was made permanent CDER director in spring 2008 with the Bush Administration entering its final months in power (⁴ Also see "Woodcock Stays At CDER: Drug Center’s Gain Is FDA Science Program’s Loss" - Pink Sheet, 17 March, 2008., p. 9).

At the beginning of the Obama Administration transition, Woodcock was considered a top candidate for the FDA post by Sen. Kennedy then swung his support towards Duke's Califf, but eventually settled on Hamburg.

- Ramsey Baghdadi (r.baghdadi@elsevier.com)

Hamburg, Sharfstein Nominations Shift Focus To Career FDAers’ Plans

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