Bob Temple Changes His Role At FDA, Again

Bob Temple Changes His Role At FDA, Again

January 31st, 2012 // 1:51 pm @ marquee

Bob Temple, who is widely viewed as an important overseer of regulatory matters, has been asked to give up his role as the acting director of the FDA’s Office of Drug Evaluation 1, so that he can devote more attention to his other position, which is Deputy Center Director for Clinical Science, a job that he assumed in November 2009.

“As Deputy Center Director for Clinical Science, Bob has played and continues to play a major role in directing and executing many cross-cutting CDER functions, which enhance the quality and consistency of our operations,” says Janet Woodcock, who heads the FDA Center for Drug Evaluation and Research, in a statement. “Now, he will have more time to further provide valuable regulatory input and methodological assistance across the center.”

His replacement will be Ellis Unger, who is currently the deputy director of ODE1 and has worked at CDER since 2004. Although Temple will no longer be involved in day-to-day matters, he will remain an acting deputy director at ODE1, suggesting his influence will continue to be felt. And by promoting Unger, the implication is that a degree of continuity will exist.

One FDA watcher called the shift significant, but did not predict an upheaval. “Bob Temple is the dean of drug development and drug review at FDA,” says Ramsey Baghdadi, who tracks pharma for Prevision Policy, a healthcare analysis firm, and is also an editor at The RPM Report. “I always feared this day would come. It means he’s taking a more hands-off approach to reviewing applications in a key disease area.”

“In terms of drug approvals, it’s very good for drug developers that (Temple) is staying at FDA,” says Baghdadi, who adds that he considers Unger to be “one of the top review managers. So that will stay pretty constant. Temple will probably think about some of the bigger picture issues FDA is grappling with now.”

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