A potential return to the helm of the US Food and Drug Administration by David Kessler would be a rare, but not unprecedented event in the history of the agency.
A Return Trip For Kessler At US FDA? It Wouldn’t Be The First Time It’s Happened
Two physicians experienced in agency affairs and operations, former commissioner David Kessler and former principal deputy commissioner Joshua Sharfstein, are reportedly finalists to head Biden’s FDA.
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Former Acting FDA Commissioner Sara Brenner is said to have asked Tracy Beth Høeg, new special assistant to the commissioner, to help reexamine the application. Høeg’s position at the agency is raising concerns about the FDA's ongoing approach to vaccine regulation.
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The departure data emerged along with a Health and Human Services Department memo describing conceptual plans to consolidate and restructure offices at the FDA and other agencies.
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Calley Means defended reductions in force at the Health and Human Services Department that shocked and outraged federal workers and stakeholders.
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Some employees were not impressed with FDA Commissioner Martin Makary's first speech to the agency staff, saying he did not seem to understand the agency's mission.
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The loss of policy analyst, legal, project manager and social scientist positions has experts wondering if the Trump Administration is eyeing a broader effort to limit DTC advertising. The OPDP layoffs are expected to result in delayed reviews of promotional pieces.
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One CDRH employee said the cuts already are having a major effect on morale.
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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.