Biden appoints veteran Woodcock as interim FDA commissioner

Agency veteran Dr Janet Woodcock is the new interim FDA commissioner appointed by president Joe Biden to replace outgoing Trump appointee Stephen Hahn.

Woodcock has most recently been working with the Operation Warp Speed coronavirus vaccine and drug project started by the Trump administration.

While this work will continue, the Operation Warp Speed name has been dropped and Woodcock will take a leading role at the agency she first joined in 1984.

Dr Janet Woodcock

Holding a Bachelor of Science in chemistry from Bucknell University and a Doctor of Medicine at Northwestern University Medical School, Woodcock first served as director of the division, covering new drugs at the FDA’s Center for Biologics Evaluation and Research (CBER).

She held several other roles at CBER before being named as director of the FDA’s Center for Drug Evaluation and Research in 1994 and staying in that role until 2005.

Between 2005 and 2008 she had several other roles at the FDA commissioner’s office, including deputy commissioner, chief medical officer and chief operating officer, before returning as head of CDER in 2008.

According to press reports, the Biden administration has not yet nominated a permanent commissioner.

In a tweet, Woodcock said that she will continue to recuse herself from work relating to the therapeutics developed by Operation Warp Speed, although this does not apply to vaccines.

She added that Julia Tierney, a 12-year veteran of the agency, has agreed to serve as acting chief of staff.

https://twitter.com/DrWoodcockFDA/status/1351999546210058255

According to the New York Times, advisers to the Biden administration’s transition team, Woodcock is one of the candidates under consideration for the permanent position.

Insiders said that other candidates under review are principal deputy commissioner Dr Amy Abernethy and former agency official Dr Joshua Sharfstein, who is vice dean for public health practice and community engagement at Johns Hopkins University.

Hahn’s resignation is a formality as senior political appointees are expected to leave their roles when a new administration takes over.

In a farewell note to FDA staff, Hahn praised the organisation’s employees for their response to the coronavirus crisis.

He noted the scientific advances that have been achieved since the pandemic began, such as the authorisation of the first non-prescription over-the-counter coronavirus test, authorisation of the first antiviral agent and the first two FDA authorised COVID-19 vaccines.

But Hahn’s tenure was marked by miss-steps as the FDA came under political pressure from the previous administration, such as the Emergency Use Authorization for the drug hydroxychloroquine despite a lack of scientific evidence.