FDA will create a new position to oversee all food safety activities in response to recent food security problems and as part of a proposed agency-wide reorganization.

FDA Commissioner Margaret Hamburg advocates creating the post of deputy commissioner for food to help address ongoing food security problems, according to an internal ¹ memo she sent June 29 to the secretary of the Department of Health and Human Services.

According to a proposed organizational chart accompanying Hamburg's memo, the deputy commissioner, heading the Office of Foods, reports to the commissioner's office and directly oversees the Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine (see graph ² 'Proposed Office of the Commissioner' ).

"There is no higher priority than assuring the public that we intend to make the food safety program at FDA successful," Hamburg says in the memo.

"The creation of a Deputy Commissioner for Food will do this by unifying and elevating leadership of FDA's food program under a senior official who will be charged with ensuring that FDA has the strategies, scientific and regulatory capacities, programs and will to protect our citizens from unsafe foods."

White House Group On Board For Food Post

The Obama administration's Food Safety Working Group, in a report released July 7, said FDA would create the deputy commissioner for food position this month to clarify responsibilities, improve accountability and work with other agencies.

The deputy commissioner also will work with the Department of Agriculture's Food Safety and Inspection Service to create a new food safety system, according to the working group.

On the same day the working group announced the new position, FDA announced that Michael Taylor, formerly a deputy commissioner of policy, will return to the agency as a "senior advisor to the commissioner" with almost the exact same job description as the new deputy commissioner for food (see ³ Also see "Taylor Prioritizes Establishing Prevention-Based Food Safety At FDA" - Pink Sheet, 13 July, 2009. ).

The deputy commissioner for food will gather currently "fragmented" food safety oversight under one person who will report directly to Hamburg, the commissioner says in the memo.

The new structure creates an extra layer between her office and CFSAN, which manages dietary supplements, cosmetics and foods.

But Hamburg says in the memo that the extra layer, which does not exist between the commissioner's office and other centers, does not diminish the existing food safety organizations within FDA.

Rather, "the creation of this position will empower them to be successful by ensuring that all elements" of FDA's food efforts - CFSAN, CVM and FDA's "essential field force - not only have the tools they need, but are working in a closely integrated fashion to prevent food borne illness and improve the nutritional quality and labeling of the food supply," she says.

Reorganization Makes Space For Tobacco Office

Hamburg's proposed reorganization also would create a new Center for Tobacco Products, as required under the Family Smoking Prevention and Tobacco Control Act (⁴ Also see "Tight 90-Day Countdown To Create Tobacco Center Poses Challenge To FDA" - Pink Sheet, 15 June, 2009.).

The tobacco center's structure is "tentative at this point," according to the memo, but it allows the agency to begin staff recruitment for the "most ambitious new program in decades" (see graph ⁵ 'Current FDA Office of the Commisioner' ).

While the agency has not named the director of the center yet, that leader will work closely with Hamburg.

According to a job posting that closed July 9, the food chief must have "substantial" scientific experience related to tobacco regulation, a "deep familiarity with Congressional operations and policymaking" and a "proven ability to collaborate."

The center's currently tentative structure also will enable the agency to incorporate suggestions solicited in a public comment notice in a July 1 Federal Register.

The notice asked for guidance on how to regulate tobacco, reduce tobacco use, restrict sales and meet the other requirements of the Tobacco Control Act (⁶ 'The Tan Sheet' July 6, 2009).

New Structure Strengthens Science Base

The proposed reorganization also would make the FDA chief scientist a point person "for strengthening the agency's science base" - a goal that currently lacks a "strong, centralized focus," Hamburg says.

Under the Bush administration, critics said politics infiltrated and sometimes overrode science, such as when the emergency contraception Plan B was placed behind-the-counter and restricted to women older than 18 despite scientific support for full over-the-counter access (⁷ Also see "Bush’s “Conscience” Rule Limiting Plan B Access On HHS Chopping Block" - Pink Sheet, 30 March, 2009.).

Hamburg will ask acting chief scientist Jesse Goodman and his staff to improve FDA's science base in part by "fostering innovation, recruiting a new generation of young scientists, better utilizing our toxicological research center and by improving information technology support for our scientific programs," according to the memo.

An organizational chart included with the memo places the office of the chief scientist directly under Hamburg and directly above the offices of scientific integrity, science and innovation, critical path programs and counter-terrorism and emerging threats.

Reorganization Streamlines Budget Offices

The reorganization also seeks to streamline the development and tracking of the agency's budget by merging the Office of Policy, Office of Planning and a newly created Office of Budget under a new Office of Policy, Planning and Budget, which will replace the current Office of Policy, Planning and Preparedness.

The merger marks the likely departures of Randall Lutter, the current deputy commissioner for policy, planning and preparedness, and John Dyer, the chief operations officer. Both men are the last hold-overs from the Bush administration's senior leadership team.

Hamburg says the change will help the agency align budget commitments with measurable outcomes. She adds that the agency's funding needs and performance goals are among her highest personal priorities and she intends to "ensure that we deploy our resources strategically in alignment with our planning for FDA's future."

A byproduct of the merger is the new Office of Administration, which will focus solely on improving the agency's administrative functions, information technology and management systems. Currently these functions are tangled with the budget functions under the Office of Operations, which will no longer exist under Hamburg's proposal.

Better Programs, Communication

Hamburg wants to bring together "formerly disparate" groups that administer "cross-cutting medical programs," under one new office: the Office of Special Medical Programs.

The currently vacant associate commissioner who would run this office also would oversee the offices of bioresearch and monitoring, combination products, orphan products development and pediatric therapeutics, according to the proposed organizational chart.

In addition, the reorganization would create a new Office of External Affairs to improve FDA's communication. It also would elevate "our current crisis management operation" and emergency preparedness matters under a new counselor that would report directly to Hamburg.

In the memo, Hamburg says she "endeavored to redraw the organizational chart for FDA in ways that will concentrate more on our mutual priorities and will be more internally consistent than the current structure."

- Elizabeth Crawford (e.crawford@elsevier.com)

FDA Creates Food Czar In Agency-Wide Reorganization

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