FDA Commissioner Margaret Hamburg is reorganizing her direct staff reports to streamline the development and tracking of the agency's budget.
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, the Office of Budget. It will 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 the Office of Administration.
The new structure will be accompanied by new faces at FDA. It may also involve departures: Randall Lutter, the current deputy commissioner for policy, planning and preparedness, and John Dyer, the chief operations officer are absent from the proposed organizational chart included in a memo outlining the proposed changes.
The departure of Lutter and Dyer would noteworthy because they are the last members of senior leadership team tapped by the Bush administration. Former Chief of Staff Susan Winckler departed June 19.
In the memo making the case for the new organization, Hamburg states, "Our program directors have been concerned for some time that we must be more successful in aligning our budget commitments with measurable outcomes."
"I intend to make the development and presentation of the agency's funding needs and performance goals among my highest personal priorities," Hamburg notes.
A focus on planning and budgeting has been one of the requests of congressional appropriators, and FDA's reorganization may help address the concerns of the purse string holders on Capitol Hill.
Appropriations and authorizing committees have expressed willing to provide FDA with more resources, and even as the agency's budget has gone up in recent years, the increases have been accompanied by comments that FDA needs a better plan for spending the funds.
Among the other features of the reorganization is a new deputy commissioner for foods, who will oversee the Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine. "There is no higher priority than assuring the public that we intend to make the food safety program at FDA successful," Hamburg said.
Former FDA Deputy Commissioner for Policy Michael Taylor is seen as the likely candidate for the post.
He is an experienced former FDA leader and recognized food safety expert. His resume includes posts as the administrator of the Food Safety and Inspection Services at the U.S. Department of Agriculture; vice president for public policy at Monsanto Corp.; and a senior fellow at Resources for the Future, where he focused on food safety. He is currently a research professor at George Washington University's Health Policy Department.
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 crises management functions.
- M. Nielsen Hobbs (n.hobbs@elsevier.com) and Elizabeth Crawford (e.crawford@elsevier.com)
[Editor's Note: For more in-depth coverage of the reorganization and FDA's new leaders, see tomorrow's edition of "The Pink Sheet" DAILY. Not a subscriber? Visit www.thepinksheetdaily.com for a free 30-day trial.]
