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Posted On: 12/11/2006

Deputy Commissioner for Medical & Scientific Affairs Leaving FDA

PharmaManufacuring.com

Scott Gottlieb, M.D., Deputy Commissioner for Medical and Scientific Affairs at the Food and Drug Administration, announced on Dec. 11 that he will leave the agency effective January 16, 2007, to return to the American Enterprise Institute, a Washington-based think tank where he was a Resident Fellow prior to joining the FDA.

Dr. Gottlieb joined the FDA as Deputy Commissioner in July 2005. Since that time he has worked on a number of significant policy initiatives including efforts to improve the advisory committee process and to make the agency's approaches regarding communication of risk information to the public more effective. Dr. Gottlieb also helped to facilitate implementation of important new regulations and policies, including the new drug and biologic products labeling rule and the expanded access rules to help patients with life-threatening conditions gain access to drugs under development. An internist, Dr. Gottlieb continued to practice medicine during his tenure as a public health official.

"Throughout Scott's tenure at both FDA and the Centers for Medicare and Medicaid Services (CMS), he has served the public health with tireless dedication,” said FDA Commissioner Dr. Andrew von Eschenbach. "Scott joined the agency at a critical time and helped to create a forward-thinking policy agenda that bolstered our efforts to transparently provide more timely information to patients and providers so they can have the tools they need to make informed medical decisions. In addition, he worked with other senior leaders at the agency, and in the private and academic sectors to advance the Critical Path for bringing new effective medical innovations to patients who can safely benefit from them."


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