A newly created FDA Office of the Chief of Staff will serve as the major point of contact between FDA centers and offices, and the Commissioner, according to an Aug. 30 Federal Register notice.

While more a codification than a reshuffling in top positions, the changes create a strong formal role for Chief of Staff Susan Winckler, who has been serving in an acting capacity since the beginning of the year (¹ 'The Pink Sheet' Dec. 11, 2006, In Brief).

[Editor's note: The original version of this story incorrectly stated that Winckler joined FDA at the beginning of 2007. She joined the agency from the American Pharmacists Association in September 2006 and was director for policy communications before becoming acting chief of staff.]

The Office of the Commissioner has been restructured to include four deputy-level offices, including those of Scientific & Medical Programs; Policy, Planning and Preparedness; International & Special Programs; and Operations. Deputy Commissioners of each office will report to Commissioner Andrew von Eschenbach through Winckler.

FDA said that in addition to the newly established positions, the reorganization will consolidate the current reporting structure, realign programs of similar or overlapping functions and operational activities, and bring together offices and programs working in related areas.

The reorganization results in eight fewer FDA offices reporting directly to von Eschenbach. No longer reporting directly to the FDA commissioner are the FDA Offices of Legislation; Management; Crisis Management; Policy and Planning; External Relations; Science and Health Coordination; Counterterrorism; and the National Center for Toxicological Research.

"This has been in development for a long time," said Scott Gottlieb, resident fellow at the American Enterprise Institute and former FDA Deputy Commissioner for Medical and Scientific Affairs. "I think it aligns the agency on paper with the way it's been operating already, and fundamentally reflects the desire of Andy [von Eschenbach] to have senior career scientists and clinicians overseeing core operations in the agency, people like Janet [Woodcock], Mac [Murray Lumpkin] and Randy [Lutter]."

Chief Medical Officer and Deputy Commissioner Janet Woodcock will serve as head of the Office of Scientific & Medical Programs. Reporting to Woodcock will be the Offices of Critical Path Programs, Science and Health Coordination, and the National Center for Toxicological Research.

Murray Lumpkin will serve as the Deputy Commissioner of the Office of International and Special Programs, to which will report the offices of Combination Products, International Programs, and Pediatric Therapeutics.

Shedding his "acting" title, Randall Lutter becomes the Deputy Commissioner for the Office of Policy, Planning and Preparedness, which includes the Offices of Counterterrorism and Emerging Threats; Integrity and Accountability; and Policy and Planning. Previously a resident scholar at AEI, Lutter joined FDA in 2003 as chief economist in the Office of Planning and became an acting deputy after Gottlieb returned to AEI.

John Dyer, another relatively recent addition to FDA, is serving as Deputy Commissioner and Chief Operating Officer of the Office of Operations (² Also see "FDA’s Implementing Visionary: A Conversation With COO John Dyer" - Pink Sheet, 30 July, 2007., p. 28). Dyer oversees the Offices of Information Management; Management; Executive Operations; and Crisis Management.

Reporting directly to Chief of Staff Winckler are the Offices of the Executive Secretariat; External Relations; Legislation; and Public Affairs.

Gottleib said reorganization "better aligns programs together, so for example counterterrorism activities, which involve a lot of operational planning issues and cross government interactions, are aligned as a preparedness function with the policy and planning offices."

The revised structure will be tested as the agency implements the pending FDA Revitalization Act, which tweaks the user fee program and gives the agency a host of new powers and responsibilities.

The new structure also in a sense completes the transition from former FDA Commissioner Lester Crawford's organizational scheme. With the arguable exception of Lumpkin, the top leadership at FDA is now either different or playing different roles than it did at the time of Crawford's abrupt departure.

One bit of unfinished business in the reorganization, however, is the post of deputy commissioner in von Eschenbach's immediate office. Created as part of the new structure, the post is currently vacant.

- Jamie Hammon (j.hammon@elsevier.com)

FDA Re-Org Makes Chief Of Staff Liaison Between Centers And Commissioner

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