Of the leading candidates for FDA commissioner in the Obama administration, Margaret Hamburg seemed among those with the least relevant experience - an illustrious career to be sure, but one that lacked a decision-making role involving medical products.

But if history is indicative of anything, Hamburg will have no trouble overcoming that hole in her resume, just as she proved in New York that the lack of a masters of public health is no impediment to great accomplishments as commissioner of health.

"There was a great deal of skepticism when she came to New York because she didn't have her MPH, and yet she was able to not only convince them to follow her, but was able to achieve some extraordinary outcomes while there," said Georges Benjamin, executive director of the American Public Health Association.

There, not only did she come out victorious against budget woes and low morale - two major issues FDA is struggling with - but she also significantly curbed HIV incidence rates, instituted the first-ever public health bioterrorism defense program, and created a tuberculosis plan that slashed TB rates in the city.

Government Experience Will Pay Off

Hamburg comes to FDA with a set of skills and experiences that, while not an exact match for the challenges she'll face as commissioner, provide a solid foundation for accomplishment.

Despite not having much regulatory experience, and never having worked within FDA, Hamburg has plenty of familiarity working within government agencies - something her peers and former colleagues stress will serve her well as commissioner.

Having experience in government already, having experience at a scientifically based organization, and having that breadth of range of dealing with public health issues, I think are things that will really make her able to function faster in her job," said former FDA commissioner Jane Henney.

Focusing on AIDS research, Hamburg worked at U.S. Office of Disease Prevention and Health Promotion from 1986 to 1988, and spent the following two years as assistant director of NIH's National Institute of Allergy and Infectious Diseases.

She left NIH in 1990 and for the next six years served as the health commissioner for New York City. After that, Hamburg was selected by President Clinton to be assistant secretary for policy and evaluation at the Department of Health and Human Services.

"She clearly was heavily engaged when she served as assistant secretary for planning and evaluation in broader-based policy issues, so I think that's a real strength that she brings," Henney said.

In 2001, she took a post as vice president of the Biological Programs at the Nuclear Threat Initiative's Global Health and Security Initiative. NTI is a Washington-based non-profit aimed at closing the gap between the global threats from nuclear, biological and chemical weapons.

Hamburg was also one of the youngest people ever elected into the Institute of Medicine, where she has focused much of her research on bioterrorism defense.

Henney, who served as FDA commissioner at the end of the Clinton administration, also noted that Hamburg's experience working in governmental agencies gives her a head start compared to many past commissioners that come from academic backgrounds.

"Many commissioners have come into this role having spent their whole career in academic institutions and they don't have a real good feel for several months as to how a federal agency functions," Henney said.

Although Henney served at FDA from 1992 to 1994 as deputy commissioner for operations under then-commissioner David Kessler, she stressed that Hamburg's pre-commissioner resume is not so different than her own.

"I think that both Peggy and I were very much advantaged in that, not only in knowing how government works in general, but how specific agencies within the Department of Health and Human Services function," she said. Henney spent nine years at the National Cancer Institute.

"Because you not only are responsible for the FDA but it has to interface with many agencies of government, so I think that those will be real boons to her," Henney said.

But a background in government only goes so far. Even with all her scientific accomplishments and public health acumen, Hamburg acknowledged in a recent interview with reporters that she was a little overwhelmed by the new areas of responsibility.

"I must say my head is spinning from trying to understand all of the specifics. ... What's the difference between a dietary supplement and a special dietary ingredient and a food and a drug," she said. "There are many layers and many different frameworks for review."

"I've been being briefed to death," she noted, so much so that "I don't have any time to eat lunch. They have me scheduled back to back."

Even so, Hamburg does not seem intimated by the responsibilities or the learning curve. "I've really been in a mode of collecting information and learning, still asking the dumb questions, but really having the chance to be exposed to the really extraordinary range of activities here at the FDA."

Plays Nice With Others

Something else Hamburg has going for her, colleagues say, is her ability to work and communicate with a variety of different people on both sides of the aisle - something President Obama has continued to stress as necessary for achieving health reform.

"She is someone I think can bring together people from a diversity of perspectives," said Patrick Kelley, Director of the Board on Global Health, and Director of the Board on African Science Academy Development at the Institute of Medicine. "She's very focused on public health and on doing what's best for populations and I think can work with a range of people."

Nothing captures this sentiment better than the fact her time as commissioner in New York City spanned two mayorships - one Democratic and one Republican.

"It was evident in New York City when she worked for [David] Dinkins and then for [Rudy] Giuliani and Giuliani kept her on," said Kelley. "Though she's been in a lot of political appointee types of jobs, she's very effective at working with people on both sides of the center."

Kelley, who has worked with Hamburg in a number of bioterrorism defense capacities, mostly at the Institute of Medicine, noted that she is also adept at working with people from a number of different professions: "She's comfortable with researchers and average citizens, she's comfortable with government officials, and she's comfortable with people in business."

Indeed, Hamburg has already announced collaboration is a key tool she plans to use to lead the agency beyond its role as regulator. "We expect to collaborate with other federal agencies and outside partners to address problems that the agency cannot solve alone," she wrote in a May 26 New England Journal of Medicine article co-authored with Principal Deputy Commissioner Josh Sharfstein.

Behind-The-Scenes Accomplishments

"For a person who is as accomplished as she is, she's not someone who is driven by a big ego," Kelley said. "She's truly a collaborative sort - somebody who I think tries to bring people together, listens to them, finds good solutions."

"I don't think she's doing this because she wants to be the next secretary of HHS," he continued. "I can't read the president's mind, but I think he picked her because of her commitment to public health and her track record, not because she was banging on the door looking to make a name for herself."

Benjamin related a story that he felt characterized this well: At the end of the Clinton administration, Hamburg recognized that there needed to be stronger focus at HHS on bioterrorism preparedness and she put together a work group to begin thinking about how the government should do that.

The result was a recommendation for the creation of a new position - an assistant secretary for public heath affairs at HHS.

"If you can imagine, this is at the end of the administration and those kinds of reports, while they go to the new administration, I'm not quite sure that they had a lot of legs," said Benjamin.

"For me, the lesson learned was that she had the experience within the department and recognized the importance of creating an office that focused on that area, and she carried it through to fruition and I think she did it in a marvelous way," he said.

"The political challenge we all knew - being at the end of an administration - this is something she should have easily said, 'Hey, this is the end of an administration, we don't have to do this.'"

Kelley couldn't agree more: "We have demanded a lot of her at the Institute of Medicine and there's some 'glory' in some of the jobs here, but most of what she did was very much behind the scenes. She served on a lot of activities that were relatively behind-the-scenes activities and I think it's because she believes in the organization. I value that character trait of hers."

Priorities at FDA

Putting some of that work ethic and drive to use, Hamburg has already outlined FDA's top priorities. In the article co-published with Sharfstein, the two laid out a vision for defining FDA's mission based on public health outcomes rather than regulatory actions (¹ Also see "Public Health Trumps User Fee Goals, FDA Leaders Say – But That May Be Good News For Sponsors" - Pink Sheet, 1 June, 2009.).

"I thought it was very good for her to communicate and signal very early both in her own testimony and then in that publication to the broader scientific community exactly what she wants to establish, what she thinks are the important issues, where she wants to spend both her time, energy and effort," said Henney.

Some of those priorities include improving the agency's ability to be proactive by identifying risks; taking preventive measures; working with international partners to build oversight; working with NIH, industry and academia to develop therapies; working with scientific leaders to further develop personalized medicine; and working with the Centers for Medicare and Medicaid Services to speed patients access to drugs.

"If you aren't clear in articulating that, you can just get drawn in many different directions because the scope of the agency is so broad," she added.

But Hamburg's first major step as FDA commissioner - creating an internal Transparency Task Force - not only signifies a new era of openness for the agency, but also may be exactly what the doctor ordered to help boost its morale.

Hamburg, who was sworn in by the Senate May 18, announced the creation of the task force June 2 alongside Sharfstein, who will head up the internal group. The group will solicit stakeholder and public input as to how the agency can make certain information more available and accessible to the public (² Also see "PhRMA Wants FDA To Explain When Decisions Depart From Committee Votes" - Pink Sheet, 29 June, 2009.).

The prominent role for Sharfstein underscores the significant role he will play at the agency; Hamburg fielded questions about him at her confirmation hearing.

Asked during the interview with reporters about working with him, Hamburg said, "I had not had the opportunity to work directly with Dr. Sharfstein, although we both share in common a couple of key features of personal and professional life."

"We both obviously were local health officers, and that's an important bond. We also are both the children of psychiatrists, for better or for worse. People have noted that, although I don't think it's highly influential in terms of how we ended up working together," she said.

"But I'd heard of him and his work, and I must say I've enjoyed working with him in this role, and he's been very helpful both in terms of being able and willing to come into the agency earlier than I, since I did have to go through the confirmation process, but also I think we are proving to be a pretty effective team."

Hamburg's Most Challenging Tasks

Right now, two of FDA's biggest challenges - which may also prove to be Hamburg's biggest challenges as commissioner - are its limited resources and poor morale.

"Clearly, FDA is always stressed by the resource questions, but I do think there are a number of things going for the agency and for Dr. Hamburg as she assumes her responsibility," said Henney.

"Clearly the president himself has already signaled not only his interest in the agency, but has backed that up with requests for increases in resources for the agency and you just can't ask for better backing than that," she continued. "Now as Peggy is going to the Hill ... I think that she will find that she has very strong support both in the Senate and House committees that really want the agency to function well."

Henney pointed out that it's not lack of funding that's the issue, but what money buys in an agency like the FDA, which is the ability to recruit and retain able people. Nearly 80 percent of the resources in the agency are consumed by personnel.

"You have to have personnel to do the inspections and enforcement actions, you need personnel to do the new product reviews and if you don't have the best and the brightest doing those kinds of functions, you can't perform well," Henney said.

As far as boosting agency morale, some speculate Hamburg and Sharfstein's co-authored article was a good start. NEJM is notorious for being critical of FDA, and by publishing an article outlining the agency's commitment to public health excellence on her first day on the job, Hamburg demonstrated that her leadership style is more than just talking about establishing credibility.

"They feel that their science is not well-respected and so to the extent that she can build credibility in the organization, make them feel that the work they are doing is important, and give them a firm direction, I think their morale will improve," Benjamin said.

"I think as far as morale goes, she'll be seen as someone who listens, someone who will set some priorities, someone who smiles easily and can laugh," said Kelley, alluding to her lighter side.

Despite outlining her immediate priorities for the agency, Henney warns that "there are still going to be those day-to-day kinds of issues that drift in from left field that you have to deal with."

Right now, Henney said, those include getting her own team recruited and together, and also connecting with all the people who have served the agency over a number of years - making a connection with the career staff who are charged with doing much of the day-to-day work.

One big decision will be selecting a chief of staff following the departure of Susan Winckler (³ Also see "FDA Chief of Staff Vacancy Lets Hamburg Shape Leadership Team" - Pink Sheet, 19 June, 2009.). Given Hamburg's successful tenure in the New York health department, it is not surprising that Mark Barnes, who served as her associate commissioner for medical and legal policy there, is said to be the top candidate for the FDA post. Barnes, perhaps most known for his AIDS advocacy work, also held several appointments in the Clinton administration, including serving on the ill-fated National Health Care Reform Task Force.

Once Hamburg fills the chief of staff post and names a director for the not-quite-created Center for Tobacco Products (submit your resume by July 9), her leadership team will be complete (see chart: " ⁴ Hamburg's Right Hands ").

Creating the tobacco center, of course, will be a significant undertaking, but Hamburg is confident that the process can be handled smoothly. Former FDA associate commissioner Bill Hubbard, an oft-quoted critic of the agency, left his position at the advocacy group Alliance for a Stronger FDA to return to the office of commissioner as advisor, and is said to be focusing mainly on tobacco issues.

Hamburg told reporters, "I would obviously be disingenuous to say that adding a whole new set of responsibilities is not going to put some additional demands on the agency, but I think that it is a very manageable task, and there is a lot of energy around actually being able to take on this important public health problem."

"We have a lot of resources about how to approach this problem from other work within FDA," she said, "and I think that it's going to be very complementary for a lot of what we do, and it's going to strengthen our overall public health mission."

"There may be some people that move from one area or another, and in fact there's a lot of opportunity for some synergy, because there are lessons to be learned from how we do review and regulation in other parts of FDA for how we go about approaching tobacco regulation. But there's not going to be brain drain."

That optimism stands in marked contrast to the concerns FDA has expressed about the resources that will be provided as part of the food safety bill that is wending its way through Congress (⁵ Also see "FDA Resources Maintain Upward Trajectory In House Appropriations Committee Bill" - Pink Sheet, 19 June, 2009.).

That dichotomy illustrates the challenges that face Hamburg as she makes her plans for FDA - that even the best strategy, be it on biomarkers or supply globalization, can very easily be overtaken by events.

Hamburg acknowledged that "FDA needs to make some significant strides forward in terms of really being able to accomplish its mission in a globalized world. ... I'm going to be putting a lot of time and attention into how to really define strategically what our global footprint needs to be and how we're going to accomplish that."

The 21 commissioner of food and drugs has a lot to do to optimize the agency for the 21 century.

- Lauren Smith (lauren.smith@elsevier.com)

Commissioner Margaret Hamburg: Moving FDA Beyond A Regulatory Agency

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