Incoming FDA Commissioner Margaret Hamburg faces a number of regulatory challenges in her new role, but her first task may be establishing her singular leadership over the agency alongside a high profile deputy.

Hamburg and Baltimore Health Commissioner Joshua Sharfstein were officially nominated by President Obama March 14 during his weekly radio and Internet address, though the selections were finalized more than a week earlier ("The Pink Sheet," March 9, 2009, p. 9).

Hamburg will be commissioner while Sharfstein will be principal deputy. However, the simultaneous announcement of the two appointments—especially since Sharfstein was previously floated as the likely commissioner nominee—raises the possibility that FDA will operate with a two-headed leadership team.

Based on the two candidates’ backgrounds (as well as on President Obama’s description of them in announcing the nomination), a logical divide would have Hamburg concentrating on food safety and tobacco regulation, with Sharfstein more focused on medical product regulation.

Administration officials, however, are working to tamp down any suggestion of a division of FDA’s portfolio between the two appointees.

Hamburg is likely to be asked to address that perception head on in the confirmation process, and will make clear that there is no formal or explicit division of labor atop FDA.

A Two-Headed Monster?

The issue, however, is unlikely to be resolved quickly or easily, in part because the dual announcement is the product of a compromise between key political patrons for FDA. Sharfstein is closely associated with Rep. Henry Waxman (D-Calif.), while Hamburg was championed by Sen. Edward Kennedy (D-Mass.).

“On the division of labor, I think it is going to be more muddled than people realize, and I think the Administration is prepared to let them work it out,” says one food and drug lawyer. 

Hamburg isn’t about to give up final say over critical drug related issues, he notes. But neither is Sharfstein likely to be content with working on lower priority items. “Sharfstein has sharp elbows, and he knows food,” the lawyer says. “He shut down his fair share of restaurants in Baltimore.”

The perception of a two-headed FDA, warranted or not, undermines the incoming commissioner’s ability to navigate the agency in deliberate fashion towards meeting those hurdles. Complicating matters is the fact that Sharfstein will begin work almost immediately at FDA while Hamburg must wait to be confirmed by the Senate before moving permanently to the FDA White Oak campus.

The regulatory challenges facing FDA are numerous: restoring public confidence in food safety after the national peanut recall; lingering questions over FDA’s import inspection capabilities stemming from an episode involving tainted heparin; modernizing the agency to keep pace with evolving science in the context of limited resources; putting in place FDA’s Sentinel active surveillance program; ending the perception that the agency is too close to the industries it regulates; proceeding with implementation of the FDA Amendments Act and new drug safety tools; developing an abbreviated follow-on biologics approval pathway; and the likely integration of tobacco product regulation.

Moreover, the Government Accountability Office flagged many of FDA’s activities as “high risk” and unable to carry out its overall mission (“The Pink Sheet,” February 2, 2009, p. 36).

Addressing those concerns forcefully will require that the agency move forward as one entity with a single vision for how best to rebuild public confidence in FDA.

True or False: Hamburg Does Foods, Sharfstein Does Drugs?

Among FDA stakeholders—ranging from those close to the transition team, drug industry representatives, patient advocates, and current and former FDA officials—it was taken as settled that Hamburg would focus on food issues and prepare for the possible integration of tobacco regulation while Sharfstein would oversee medical products, including drugs, biologics, and devices.

However, the Administration has gone out of the way to underscore there will be no formal or informal division of labor. Hamburg is the commissioner and Sharfstein is her deputy, end of story.

Nevertheless, overt assurances from the incoming leadership are unlikely to preclude Hamburg or Sharfstein from deviating towards their areas of professional expertise once day to day operations of the agency stabilize under their leadership.

As a current senior scientist at the Nuclear Threat Initiative, and former HHS Assistant Secretary for Planning & Evaluation, New York City Health Commissioner, and Associate Director of NIH’s National Institute for Allergy & Infectious Diseases, Hamburg has almost peerless knowledge of public health infrastructure, import, and securitization issues.

That background aligns perfectly with the overriding emphasis on food safety that is setting the climate for the relatively speedy FDA appointments.

Sharfstein, on the other hand, has focused on drug oversight as a public health issue, most recently as the lead voice in a March 2007 citizen petition that called for FDA to review the pediatric doses of cough/cold products. That petition led to the voluntary recall by manufacturers of those products.

He also has a long record as a monitor and an investigator of the drug industry, both in and outside of Congress, where he served as a staffer.

“It’s a reasonable supposition that they will spend much time in their respective strike zones but of course have duties that extend outward from there,” says one FDA observer with close ties to Capitol Hill and HHS.

“It’s also reasonable to assume that no commissioner would accept the job if there were an explicit derogation, demarcation, or abrogation of her authority to correspondingly raise the stature or responsibilities of her deputy, but that a commissioner would readily accept a deputy who could help advance her agenda in a given area of expertise with his own native abilities.”

“There are some calls that no one but the commissioner can make,” he concludes. “Delegating a whole functional area to a deputy commissioner? Unheard of and unwise.”

Unprecedented Circumstances

The last time a principal deputy commissioner took on such a high profile role was in 2001 when HHS Secretary Tommy Thompson’s choice for FDA commissioner was veterinarian Lester Crawford; however, the choice did not have strong support from the Bush White House.

Crawford was named deputy commissioner and acting FDA commissioner while the administration searched for a candidate more to their liking—eventually health economist and physician Mark McClellan.

But even that case was very different. The White House wanted someone other than the HHS Secretary’s selection. With Hamburg and Sharfstein, the arrangement was forged through political necessity and dealmaking—and without anything but cursory input from the HHS Secretary nominee Kathleen Sebelius.

Under then HHS Secretary-designate Tom Daschle, Duke cardiologist Robert Califf and Sharfstein were understood to be the two finalists for the FDA job; Daschle interviewed both men for the job.

It’s unclear whether Daschle’s withdrawal or the peanut recall—or both—spurred the administration to consider other candidates with a food background, but nonetheless, Hamburg shot to the head of shortlist after her name was pushed by Obama transition team co-chair John Podesta.

While the Obama Administration was in the middle of its search to replace Daschle, the political pieces of the FDA puzzle were put together.

Kennedy shifted his support to Hamburg after initially putting his political weight behind FDA Center for Drug Evaluation & Research Director Janet Woodcock, followed by Califf (“The Pink Sheet,” March 16, 2009, p. 8). In the meantime, Waxman stood behind Sharfstein, who served as an investigator on his staff on the House Oversight & Government Reform Committee for over four years.

Illinois Senator Richard Durbin, who is particularly close to President Obama and who has taken a high-level interest in food and dietary supplement regulation, is also understood to have played a key role in crafting the new FDA leadership. Hence, the Hamburg-Sharfstein team was formed.

Still, the process creates a power structure with mixed loyalties: Hamburg to Kennedy, Sharfstein to Waxman, and neither to Sebelius.

Two heads may be better than one, but this is a case where FDA may find itself with two headaches instead.