Hamburg/Sharfstein Appointments Do Not Signal Split Duties At FDA

FDA top leadership team will not split up duties along food and medical products, sources close to the selection process say.

But observers note the selection of Margaret "Peggy" Hamburg as FDA commissioner and Josh Sharfstein as principal deputy commissioner leaves the administration well positioned in the event that over the longer term a separate food agency is created.

Some observers predicted the two would divide their duties, with Hamburg overseeing food issues and Sharfstein focused on drugs and devices, based in part on the nominees' areas of expertise.

However, the administration has underscored there will be no formal or informal division of labor between Hamburg and Sharfstein with regard to food and drugs: Hamburg is the commissioner and Sharfstein is her deputy.

President Barack Obama announced their selections March 14 (¹ (Also see "Hamburg/Sharfstein Choice Underscores Public Health, Stricter Oversight" - HBW Insight, 16 Mar, 2009.), p. 6).

One food and drug attorney said FDA and the Department of Agriculture, "as configured, are not tenable as long-term solutions in a changing world."

"If and when a division of authority" occurs, with Hamburg and Sharfstein putting FDA's food activities and USDA's Food Safety and Inspection Service "in one basket" and FDA's medical products responsibilities in the other, "the leadership would be in place to give it a running start," the lawyer said.

Powerful Democrats on the hill appear to be moving toward a consensus that a separate food agency may be warranted down the road, but key leaders say that specific food safety concerns can and should be tackled sooner and have back-burnered legislative efforts to create a new agency.

The White House's creation of a food safety working group, announced simultaneously with the FDA leadership, allows a more nimble response to food safety problems compared with the more cumbersome task of establishing a new agency.

That group, comprising representatives of disparate agencies with food safety oversight, will likely hash out the concept of a separate agency and make a recommendation to the president.

Public Health As "North Star"

The Government Accountability Office has said FDA is unable to carry out its overall mission, flagging many of its activities as "high risk."

Both new leaders have served as governmental public health officials: Hamburg has worked in pandemic preparedness and oversaw food safety as New York City health commissioner, and Sharfstein has worked on both over-the-counter drug safety and access for the disabled to prescription drugs as Baltimore's health chief.

"I think it is brilliant to put the agency firmly in the hands of experienced public health leaders with real world experience," said consultant Steven A. Grossman of HPS Group in Silver Spring, Md.

"The answer to every ideological and self-interested question becomes: We will explore what is right from a public health perspective, then act accordingly. Since all the interest groups say they are advancing the public health, it is disarming to use this as the agency's North Star."

"Of course there will be many disputes, but everyone will, quite appropriately, have to build their rationale on public health grounds," he said.

Grossman said a notable impact on activity level at FDA is likely, simply due to the cyclical nature of administration turnover. "The very first thing is that the policy pipeline starts flowing again. There is so much that can't be decided at the end of a presidential term or by people who are acting. It may have the effect of seeming hyperactive when it is mostly driven by the accumulation of decisions that needed to be made.

"I think that 6 months from now, people will see that the agency is being run by steady, pragmatic leaders," Grossman says.

One current FDA staffer says another remaining appointment will possibly shape the direction of the agency more than the commissioner/deputy commissioner announcement. "We're clueless about what it means. I don't think we will really have a clear sense until the new Chief Counsel is selected and we get about three months of experience with the deputy and the new commissioner," the staffer says.

A former Office of Regulatory Affairs district chief agrees that the general counsel "makes a big difference as I personally saw with the previous administration. "

Full Review and Food Safety Working Group

President Obama has promised a "full review" of FDA in the wake of recalls related to contamination at the Peanut Corporation of America's Blakely, Ga. plant (² (Also see "Obama Wants FDA’s “Full Review” As Recall Of Peanut Butter Items Goes On" - HBW Insight, 9 Feb, 2009.), p. 7).

FDA was still issuing new recalls related to PCA's outbreak as of March 20, with more than 300 firms and more than 3,500 products affected by that date.

The president "is the government's default spokesperson on the issue because there is no one in the hierarchy" between him and acting FDA leadership, Grossman said.

Obama announced the creation of the Food Safety Working Group, to be chaired by the secretaries of Health and Human Services and the Department of Agriculture. Kansas Governor Kathleen Sebelius has been nominated for the HHS post, and former Iowa governor Tom Vilsack is the secretary of agriculture. Notably, Vilsack voiced support for a separate agency.

The working group "will bring together cabinet secretaries and senior officials to advise me on how we can upgrade our food safety laws for the 21st century; foster coordination throughout government; and ensure that we are not just designing laws that will keep the American people safe, but enforcing them," Obama said March 14.

He noted the group is tasked with reporting recommendations to him "as soon as possible."

"He is saying to everyone with food safety responsibility: I need you talking with each other, sharing resources and information and acting like there is one federal government responding," Grossman said.

Sharfstein will start work at FDA before Hamburg, as his position is not subject to the confirmation process.

- Christopher Walker ([email protected]), Katie Stevenson ([email protected]), and Denise Peterson ([email protected])