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Duke researcher Califf one of top two in line for FDA post

By Emily Ford
eford@salisburypost.com
KANNAPOLIS ó The author of Duke University’s long-term medical study at the N.C. Research Campus is one of two finalists for the top job at the U.S. Food and Drug Administration, according to a former FDA staffer.
Dr. Rob Califf, the author of Duke’s MURDOCK Study and a cardiologist, could land the appointment as early as Valentine’s Day, said Peter Pitts, a former FDA associate commissioner who has advised the Obama administration.
Califf could not be reached for comment.
Pitts said he believes Califf and Dr. Joshua Sharfstein, Baltimore’s city health commissioner, are the only two candidates who remain under serious consideration.
“What Rob brings to the party is science, organizational skills and his familiarity with the agency,” said Pitts, current president of the Center for Medicine in the Public Interest.
Pitts said if it were up to him, Califf would get the nod.
“He’s got tremendous respect of the senior staff at the agency, and that is critically important,” he said. “He’d be one of my top picks.”
Califf leads the MURDOCK Study, or Measurement to Understand Reclassification of Disease Cabarrus/Kannapolis, which is attempting to personalize medicine using genomic tools.
The FDA is nearing a crisis point. The Government Accountability Office recently pointed out problems at the FDA with foreign drug inspections and the presentation of clinical trial results.
Califf, Duke’s vice chancellor for clinical research, has extensive experience in both areas.
“We need tools for 21st century drug regulation,” Pitts said. “Rob excels at that. That puts him almost over the top.”
The new FDA commissioner, who must be approved by Congress, will work closely with “brother and sister agencies” around the world, Pitts said. “He is well-respected overseas.”
Califf has served on the FDA’s Cardio-Renal Advisory Committee and on committees and panels at the Institute of Medicine.
He has advised the Obama administration and reportedly has a good relationship with former U.S. Sen. Tom Daschle, who was named last fall as President Barack Obama’s choice for health secretary.
“I am so excited for him and the potential impact he could have in that kind of role,” said Victoria Christian, chief operating officer for the MURDOCK Study who has worked with Califf for more than 20 years.
The study would continue as planned if Califf gets the FDA post, Christian said. Duke is preparing to launch a registry next month that will eventually include 50,000 residents of Kannapolis and Cabarrus County.
Duke is buzzing with anticipation and excitement, although the news has been bittersweet for many, Christian said.
“It’s hard to imagine a Duke without Rob,” she said.

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