Wednesday, October 20, 2021

Woodcock to step up to interim FDA chief as she and Sharfstein are vetted for permanent job: reports

FDA veteran Janet Woodcock will take over as commissioner, at least temporarily, according to media reports, and former deputy FDA chief Joshua Sharfstein is at the top of the list for the permanent job.

President-elect Joseph Biden has tapped Woodcock as interim FDA commissioner while his team searches for a permanent replacement, both BioCentury and Pink Sheet reported today.

Woodcock now oversees COVID-19 therapy development as part of Operation Warp Speed and has headed up the Center for Drug Evaluation and Research (CDER) since 2008—and previously from 1994-2005.

Meanwhile, Sharfstein is Biden’s top finalist for the permanent FDA commissionership, the reports say. He served as acting FDA chief and then as principal deputy under FDA Commissioner Peggy Hamburg during President Barack Obama’s first term. He is currently public health dean at the Johns Hopkins Bloomberg School. Woodcock and Sharfstein are both under consideration for the permanent job, Bloomberg reports.

RELATED: Ex-FDA chief Gottlieb pushes for antibody manufacturing scale-up as 2021 pandemic ‘insurance policy’

In the midst of accusations of politicized decisionmaking at the FDA, Sharfstein is seen as a steadying force. In September, he penned an article about the need for the FDA to protect its integrity from politics.

However, Sharfstein may not be the first choice of the pharma industry. A pediatrician by training, he has been a critic of drug industry marketing practices, including advocating for stricter regulations on OTC cough and cold medicines as public health commissioner in Maryland and criticizing the American Medical Association for political donations.

During his deputy commissioner tenure at the FDA, Sharfstein often clashed with drug and device makers over tougher regulations, the Wall Street Journal reported in 2011 when he left the agency.

Woodcock, on the other hand, largely gets industry nods for the speed branded drugs have moved to market during her tenure at CDER. Her own annual review of drug approvals noted her agency approved 90% of new drug candidates in 2019 (43 of 48) on their first try, and 95% (56 of 59) in 2018. The high rate reflects CDER’s close work with applicants, she wrote, but also its “efficiency in getting new therapies to patients as quickly as possible.”

RELATED: 2021 forecast: Hahn heads toward FDA exit after short, dramatic tenure as commissioner

Biden’s FDA commissioner—whether Woodcock, Sharfstein or another contender—will replace current chief Stephen Hahn, whose one-year tenure was fraught from the beginning with the pandemic crashing down only weeks after his official confirmation.

In Fierce Pharma’s end of 2019 reader contest to identify the top FDA commissioner candidate, Sharfstein was voted out in the second round. Commenters noted his solid credentials and general alignment with Biden policy outlook, but others critiqued his management style and previous policy positions.

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