The incoming Biden administration will put veteran FDA administrator Janet Woodcock in charge of the agency on an acting basis, until a permanent choice can go through the confirmation process. Sources say Woodcock is also a finalist for permanent leadership of the FDA.
Woodcock’s positions on vaping and FDA regulation of e-cigarettes, if she has any, are unknown. But as a longtime FDA leader, she may be less inclined to wade into pointless political controversies and more likely to allow the agency’s Center for Tobacco Products to do its work without micromanagement.
“No Biden FDA pick is going to magically reform the broken PMTA process,” American Vaping Association President Gregory Conley tweeted, “but Woodcock is at least an institutionalist who will likely respect the autonomy of different divisions. She’d be a better pick for a permanent slot than someone from Bloomberg land.”
In the weeks following the November presidential election, insiders suggested that Biden had settled on two finalists for the FDA job: former commissioner David Kessler and former deputy commissioner Josh Sharfstein, a vocal critic of vaping and major player in the anti-nicotine Bloomberg health empire. The news that Woodcock is a contender for the permanent commissioner position came as a surprise to many; she had not been viewed as a contender.
Now she and Sharfstein appear to be the only names left in the running. A Sharfstein nomination may be opposed by pharmaceutical industry interests. That could mean that Biden, who will not be looking to manufacture conflicts in the pharma world during the coronavirus crisis, will lean toward Woodcock for the commissioner job. Biden’s final choice for FDA commissioner will have to go through the Senate confirmation process.
Current FDA Commissioner Stephen Hahn will leave soon after Biden’s inauguration on Jan. 20.
Woodcock, a Northwestern University-trained medical doctor, has been at the FDA for 34 years. She has filled multiple roles at the agency, including as director of the Center for Drug Evaluation and Research (CDER) since 2008. CDER, which approves drugs and medical devices, is the largest and most important center within the FDA. Since last May she has temporarily been assigned to Operation Warp Speed, working on rapid development of coronavirus vaccines.
Before joining CDER, Woodcock served as director of the Office of Therapeutics Research and Review, and acting deputy director in FDA’s Center for Biologics Evaluation and Research. Between 2008 and 2008, she held several positions in the FDA commissioner’s office.
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