US FDA’s Big Transition: Not The Commissioner – The Drug Center

It remains uncertain whether Acting Commissioner Woodcock will be nominated for the post. Regardless, the drug center she has run for most of three decades is going to have to adjust to new management.

photo illustration: shutterstock/FDA
Whatever happens in the US FDA commissioner race, it seems likely that the torch is going to be passed for CDER leadership.

The US Food & Drug Administration is facing a most unusual leadership transition with Acting Commissioner Janet Woodcock seemingly undergoing an informal tryout period that could end with her becoming the first career FDA official to be made commissioner since before the Nixon Administration.

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CDRH Staff Cuts Focus On Administrative Workers, Spare Reviewers

 

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

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

 

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

 

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."

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Newest HHS Staff Cuts Could Stymie CMS Health Plan Oversight

 
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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

 

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

 

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.