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The FDA's morale boost?

Coronavirus Daily
Bloomberg

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FDA may be getting a needed morale boost

Janet Woodcock, a 30-year veteran of the U.S. Food and Drug Administration, is being vetted by the Biden team to serve as head of the agency in a move that could help restore confidence and support the work of drugmakers developing Covid-19 therapies and vaccines.

Woodcock, who has been at the agency since 1986, has the respect of many of her colleagues both in and out of the FDA. She stepped aside as director of the agency's drug center earlier this year to lead an effort to accelerate Covid-19 therapies under Operation Warp Speed.

If chosen by Biden, her tenure and working relationship with FDA staff could be a morale boost for an agency that's been demeaned by the Trump administration for its careful consideration of Covid-19 therapies and vaccines during the pandemic.

Janet Woodcock

Photographer: Tom Williams/CQ-Roll Call Group

While Woodcock has always been perceived as a regulator willing to work with the pharmaceutical industry, her involvement on the Covid-19 drug-development side in recent months could help bolster the FDA's relationship with the National Institutes of Health, which is either running or funding many of the clinical trials on coronavirus therapies.

The Biden team is also considering Joshua Sharfstein, former principal deputy commissioner at the FDA under President Barack Obama, for the top role. Woodcock's detractors who contend her relationship with the industry has become too cozy may find more to like in Sharfstein.

Sharfstein's tenure at the FDA was defined by a focus on drug safety, including working to restrict a controversial diabetes drug called Avandia that was plagued by heart risks.

Meanwhile, Woodcock has been questioned for a decision she made to overrule her own reviewers and approve a drug for a rare, muscle-wasting disease on little evidence that it works. That could hurt Biden's efforts to restore trust in the nation's scientists to help lead Americans out of the pandemic.

But her deep institutional and industry knowledge also could be appealing to the Biden team as health officials release more vaccine doses rather than keeping enough in reserve for people to get their second shots. The new policy will prove more crucial to seamless vaccine manufacturing, an area in which the FDA, and particularly Woodcock, is especially well-versed.—Anna Edney

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