FDA commissioner to resign January 20

Inauguration Day, Jan. 20, will be the final day for Dr. Andrew von Eschenbach to serve as Commissioner for the US Food and Drug Administration. His successor will be named by the incoming administration. President-elect Barack Obama is considering a list of candidates that includes Baltimore health commissioner Dr. Joshua Sharfstein, a pediatrician handling FDA issues for the transition team; Duke University physician Robert Califf; Cleveland Clinic's Steven Nissen, and several former and current FDA officials.

Von Eschenbach, 67, a prostate cancer specialist and cancer survivor, was appointed in 2005 by President Bush after the FDA was the target of criticism about lax oversight of prescription drug safety. Von Eschenbach was director of the National Cancer Institute before coming to the FDA.

During the past three years, Von Eschenbach has been responsible for seeing through a major increase in funding that Congress mandated for FDA's drug safety office. His other role was tightening up international pharmaceutical regulations after the recall of tainted heparin, a blood thinner produced in a China factory with lax oversight. In the past month, three FDA inspection offices opened in China. Washington insiders say that Von Eschenbach played a significant role in easing tensions between the agency's drug safety and drug approval offices.

FDA's future mandates will most likely involve food safety regulations after the salmonella outbreaks this past summer and the melamine baby formula and dairy situation that still lingers. According to John Avellanet, Managing Director, Cerulean Associates LLCFDA for Pharmaceutical Processing(http://www.pharmpro.com/default.html) , priorities for the coming year include, but are not limited to, GMP compliance; increased focus on accountability for direct-to-consumer advertising and marketing, overseas enforcement and executive accountability.

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