FDA Vet Bumped Up to Top Spot by Biden Admin on Interim Basis

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Janet Woodcock, the longtime director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) is set to take over the top spot of the regulatory agency on an interim basis following the presidential inauguration of Joe Biden.

Woodcock first joined the FDA in 1986 and has served in CDER since 1994 in a variety of leadership roles. For the past 10 months, Woodcock shifted her focus from regulatory approvals to the ongoing COVID-19 crisis. In May 2020, she temporarily stepped away from her CDER duties to assist Operation Warp Speed and the federal government’s efforts to rapidly develop vaccines against the novel coronavirus.

With two vaccines now authorized for use in the United States and more likely to come within the next several months, Woodcock will be free to return to the FDA and offer her steady, guiding hand onto the agency’s rudder. News she was singled out by the Biden administration for the temporary role was first reported by Informa and BioCentury. According to the reports, the incoming Biden administration requested Woodcock to take over on an interim basis until a new FDA commissioner could be named and approved by the U.S. Senate.

Woodcock will take over the reins from FDA Commissioner Stephen Hahn, who was tapped in November 2019 by the administration of Donald Trump and then confirmed in December of that year. He replaced Scott Gottlieb, who served two years in the role as Trump’s first FDA Commissioner.

Unlike Gottlieb’s term as commissioner that focused on the opioid epidemic and vaping, much of Hahn’s tenure was focused on the COVID-19 pandemic. Not only was Hahn’s time as commissioner defined by the pandemic, it was also defined by constant public struggles with the demands of the Trump White House to approve untested treatment options, particularly as the 2020 election neared. In August, Hahn was forced to walk back efficacy statements made about convalescent plasma for COVID-19 during a White House briefing. More recently, Hahn was reportedly threatened with termination by White House Chief of Staff Mark Meadows if the FDA didn’t authorize the Pfizer and BioNTech vaccine following overwhelming support of the product from the FDA’s Vaccines and Related Biological Products Advisory Committee.

As a career regulator, Woodcock will be seen as a steady hand for the agency until the Biden administration can name a new commissioner. According to reports, Joshua Sharfstein, the dean for Public Health Practice and Community Engagement at Johns Hopkins Bloomberg School of Public Health, is the frontrunner for the appointment. Sharfstein previously served as a deputy commissioner in the FDA before his tenure at Johns Hopkins. Another name that has been bandied about for the role is former FDA Commissioner David Kessler, who served in the role from 1990 to 1997.

Woodcock will be no stranger to the commissioner’s office. From 2005 until 2008, she held several positions in that office, including Deputy Commissioner and Chief Medical Officer, Deputy Commissioner for Operations, and Chief Operating Officer. 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.