FDA's Woodcock: I'm not going anywhere

Center for Drug Evaluation and Research Director Janet Woodcock

In a short-lived game of telephone, speculation about who will replace FDA drug chief Janet Woodcock when she retires evolved into whispers that her retirement was imminent. Now, the Center for Drug Evaluation and Research boss has set things straight, denying she has any plans to get out of Silver Spring, MD.

It all started with a Thursday Reuters report, culled from more than two dozen interviews with people in and around the FDA, which reasonably described the 20-plus-year agency veteran's retirement as "at least a year away." By mid-afternoon, that even-handed look at the expansive shadow Woodcock casts at the FDA made it back to her in the form of a farewell.

"I want to assure you that I am not planning to retire as erroneously reported in the media today," Woodcock wrote in an email to CDER staff. "... The inaccuracy of the media has unnecessarily raised concerns among center staff, and even among my own family. My daughter emailed me this morning to ask if I'm retiring!"

While it's definitely for the best that Woodcock set things straight among her immediate relations, surely she's planning to retire someday, and her vehemence doesn't address the point of the initial Reuters piece: Woodcock is an irreplaceable aspect of how CDER does business, and the agency doesn't seem have a plan for life after the 65-year-old's tenure.

Woodcock is the whirring engine at the center of CDER's expansive operation, Reuters reports, darting in and out of more than a dozen meetings a day and shouldering heavy responsibility due to what former colleagues describe as a difficulty with delegation. But her breakneck pace has been a boon to biotech: Last year, the agency approved 39 new drugs, the most since 1996, and industry leaders have applauded its efforts in speeding up the process for breakthrough therapies.

However, with no heir apparent waiting in the wings, the worry, shared by agency and industry, is that Woodcock's departure will leave an unfillable hole in CDER's operation, Reuters reports.

"The thought of bringing someone in and expecting them to take over from Janet Woodcock any time soon is the ultimate absurdity," a former FDA official told the news agency.

- read the Reuters story

Special Report: The 25 most influential people in biopharma today - Dr. Janet Woodcock

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