FDA Commissioner Margaret Hamburg, M.D., recently announced a reorganization of the agency that is intended to better align budget commitments with measurable outcomes.  The reorganization may help address the concerns of Congress, which has requested that the FDA focus on planning and budgeting. 

As part of the proposed reorganization, the Office of Policy, Planning and Preparedness is being dissolved and a new Office of Policy, Planning and Budget will be created, housing the Office of Policy, the Office of Planning and a newly-created Office of Budget, to be headed by an associate commissioner for budget.  Currently, the budget functions are handled in the Office of Operations, which is being trimmed down and re-launched as the Office of Administration.

In addition, Michael Taylor, J.D., an experienced former FDA leader and a nationally recognized food safety expert, will return to serve as senior advisor to the commissioner.  Commissioner Hamburg said that Taylor would work closely and collaboratively with her office and with the management of the FDA’s Center for Food Safety and Applied Nutrition, Center for Veterinary Medicine, the Office of Regulatory Affairs, Congress, and the Obama Administration.

Specifically, Taylor will work to: assess current food program challenges and opportunities; identify capacity needs and regulatory priorities; develop plans for allocating fiscal year 2010 resources; develop the FDA’s budget request for fiscal year 2011; and plan implementation of new food safety legislation.

Also as part of the reorganization, the Office of Chief Scientist will be streamlined to focus on innovation and integrity issues, and a new Office of Special Medical Programs will be created.  The proposal also adds an Office of External Affairs and elevates the agency's crisis management functions.

The new structure may involve the departures of the last members of the senior leadership team tapped by the Bush administration: Randall Lutter, the current deputy commissioner for policy, planning and preparedness, and John Dyer, the chief operations officer.