FDA is likely entering another extended period with Deputy Commissioner Lester Crawford, PhD, at the helm following Commissioner McClellan's move to the Centers for Medicare & Medicaid Services.

Crawford will head a reorganized agency following the Feb. 20 announcement that McClellan has been tapped by President Bush to lead CMS (see ¹ Also see "FDA’s McClellan To Head CMS: Will Greater FDA/CMS Cooperation Ensue?" - Pink Sheet, 23 February, 2004. ).

McClellan is expected to remain at FDA for several more weeks. He will likely not serve in an "acting" capacity at CMS prior to his official confirmation.

Selection and confirmation of a new permanent commissioner is unlikely before the November elections, and the length of recent searches for FDA commissioners suggests the agency could have acting leadership for some time.

Crawford, who served as acting FDA commissioner from February 2002 until McClellan joined in November 2002, had been a candidate for the permanent job.

Much of the existing senior leadership of the agency (including Crawford) joined during the Bush Administration, and announcements about McClellan's departure emphasize the agency's commitment to his strategic plan.

In a management reshuffling aimed at ensuring a smooth transition, FDA is implementing a three-deputy commissioner structure on an acting basis, effective immediately.

Principal Associate Commissioner Murray Lumpkin, MD, becomes deputy commissioner for special programs. Lumpkin will continue his work on international initiatives.

Associate Commissioner for Legislation Amit Sachdev will work more closely with HHS through an expanded role as deputy commissioner for policy. Sachdev joined FDA in September 2002 from the House Energy & Commerce Committee staff (² Also see "FDA Legislative Affairs Head Sachdev Joins From Energy & Commerce Staff" - Pink Sheet, 23 September, 2002., p. 28).

Center for Drug Evaluation & Research Director Janet Woodcock, MD, will serve as deputy commissioner for operations. Woodcock will pick up more day-to-day responsibilities while continuing work on implementation of the agency's strategic plan. She has been on detail to the commissioner's office since October (³ [A#00650410001], p. 3). Steven Galson, MD, will continue to serve as CDER acting director.

Woodcock has been working on the agency's draft guidance on generic biologics, which is due in the spring (⁴ Also see "FDA Follow-On Biologics Guidance Due In Spring; Woodcock Leads Effort" - Pink Sheet, 26 January, 2004., p. 25). The topic will likely be among the most contentious that the agency will face in the near future.

As part of the reorganization, Senior Advisor for Medical Technology Scott Gottlieb, MD, will become director of medical policy development, coordinating with device, drug and biologics centers.

Gottlieb joined the agency last March from the American Enterprise Institute as part of a team to implement McClellan's strategic plan (⁵ [A#00650150001], p. 3).

Susan Bond, special assistant to the deputy commissioner, becomes director of scientific policy development and will be coordinating with the Center for Food Safety & Applied Nutrition, the National Center for Toxicological Research and the Center for Veterinary Medicine.

Special Assistant to the Commissioner Mary-Lacey Reuther will coordinate FDA's interactions with HHS and other cabinet departments as director of departmental & interdepartmental relations.

In a Feb. 20 email announcing his departure to FDA employees, McClellan emphasized the continuity of the agency and expressed his feelings about his departure.

"This is a very difficult email for me to send. As I have said to many of you many times, I love my job as Commissioner of Food and Drugs," McClellan said.

"With our highly motivated and committed senior leadership team firmly in place, I am confident that the FDA our various stakeholders saw last month is the same agency they can expect to see tomorrow."

Crawford Will Lead A Reorganized FDA As McClellan Leaves For CMS

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