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FDA Commissioner To Resign January 20th

By Pharmaceutical Processing | December 16, 2008

By RICARDO ALONSO-ZALDIVAR Associated Press Writer WASHINGTON (AP) – Food and Drug Administration Commissioner Dr. Andrew von Eschenbach, who made progress in stabilizing a troubled agency, has announced his resignation effective Jan. 20, Inauguration Day. His successor will be named by the incoming administration. President-elect Barack Obama is considering a list of candidates that includes Baltimore’s health commissioner, several prominent physicians, and former and current FDA officials.Von Eschenbach, 67, a prostate cancer specialist, was appointed by President Bush in 2005 as the FDA was reeling from widespread criticism about lax oversight of prescription drug safety. His predecessor had resigned under an ethical cloud. A cancer survivor himself, von Eschenbach was director of the National Cancer Institute before coming to the FDA. As commissioner, von Eschenbach has overseen a major increase in funding that Congress mandated for the FDA’s drug safety office. He also directed the agency’s first steps to strengthen its role as an international regulator, opening three offices in China only last month. The global initiative came in the aftermath of a major recall of tainted heparin, a bloodthinner produced in China at a factory that the FDA failed to inspect because of a mix-up. The FDA has continued to receive criticism from Congress and consumer groups, most recently over its handling of the salmonella outbreak this summer. But under von Eschenbach, tensions seem to have eased between the agency’s drug safety office and the much larger division that handles drug approvals. Key lawmakers and consumer advocates, including critics, say they have enjoyed ready access to von Eschenbach during his tenure and found him easy to work with. Industry had no major complaints. “This critical time of opportunity has not been without its significant challenges, but I am firmly convinced that the transformation is under way,” von Eschenbach wrote in an e-mail to FDA employees Monday evening. “I have said it is hard to fall in love with FDA from outside the agency because so few can fully appreciate who you are and what you mean to this country, but it is impossible not to fall in love with the agency…once you are inside.” Von Eschenbach had been expected to resign with the end of Bush administration. He said he will return to Texas, where his family and grandchildren live. Before joining the Bush administration, he held senior medical positions at the University of Texas M.D. Anderson Cancer Center in Houston. Possible successors under an Obama administration include Baltimore health commissioner Dr. Joshua Sharfstein, a pediatrician who is handling FDA issues for the transition team, prominent physicians such as Duke’s Robert Califf and the Cleveland Clinic’s Steven Nissen, and several former and current FDA officials.

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