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COVID-19 Staff Shakeup: Woodcock Moves to Commissioner's Office As Marks Drops Out Of 'Warp'

 
• By Sarah Karlin-Smith

CBER Director Marks will no longer have to recuse himself from COVID-19 product reviews, a move seen as resoundingly positive by former senior FDA leaders. CDER Director Woodcock will now be free to focus solely on COVID-19 and bring her unique depth of agency experience to the Trump Administration's effort to speed development of vaccines, therapeutics and diagnostics for coronavirus.

Restructuring the company to better face the present reality
Key staffing changes are being made at FDA to tackle COVID-19 • Source: Shutterstock

The latest staff shakeup at the US Food and Drug Administration to fight COVID-19 will likely make better use of senior career staffers in tackling the pandemic than a plan laid out just a week earlier, experts say.

More from US FDA

CDRH Staff Cuts Focus On Administrative Workers, Spare Reviewers

 
• By Brian Bossetta and Elizabeth Orr

One CDRH employee said the cuts already are having a major effect on morale.

Updated: US Likely To Lose Its First Approver Advantage After FDA Layoffs

 
• By Sarah Karlin-Smith, Elizabeth Orr, and Derrick Gingery

Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.

Updated: US FDA Commissioner Makary Was Sworn In, Knew Of Plan to Push Out Marks, Sources Say

 
• By Sarah Karlin-Smith

FDA Commissioner Martin Makary was sworn in Friday and knew of the plan that ultimately lead to CBER director Peter Marks' resignation on 28 March.

Peter Marks Resigns From US FDA, Warns Kennedy Does Not Want Truth On Vaccines

 
• By Sarah Karlin-Smith

In his resignation letter, the CBER director said he was willing to work with HHS Secretary Robert F. Kennedy Jr. to address concerns about vaccine safety, but "it has become clear that truth and transparency are not desired by the secretary."

More from Agency Leadership

Newest HHS Staff Cuts Could Stymie CMS Health Plan Oversight

 
• By Leslie Small

A former CMS manager worries casework and other necessary functions could suffer as a result of the 300 staff cuts at the agency that are part of a massive HHS restructuring.

Oncology Center Of Excellence Deputy Directors Kluetz, Theoret Join US FDA Exodus

 
• By Sue Sutter and Sarah Karlin-Smith

The April departures of Paul Kluetz and Marc Theoret follow resignations by other senior agency scientific staff and come on top of HHS’ plans to lay off 3,500 FDA employees.

Power Play: US FDA Likely Losing More Than Just Staff With Restructured Health Department

 
• By Sarah Karlin-Smith

About 3,500 full-time FDA employees are expected to be laid off as part of a restructuring of the Health and Human Services Department and experts questioned whether the cuts could be implemented without harming FDA’s core mission.