The biopharmaceutical industry likely will feel the impact of the Trump Administration’s weekend purge of hundreds of US Food and Drug Administration probationary employees in many ways over the coming weeks and months.
US FDA Staff Cuts: Biopharma Industry Braces For Impact, But First Wants Clarity On Losses
Stakeholders are waiting for the dust to settle to better understand who was laid off as part of the Trump Administration's cuts at the FDA, the reductions' impact on applications currently under review and broader drug development efforts.
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The former principal deputy commissioner said the “decapitation” of senior leadership will make resolving internal disputes more difficult, which will slow application reviews. Woodcock also called the FDA layoffs a slow-moving catastrophe.
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The forced departure of CBER Director Peter Marks is a milestone event for the agency, as center directors now are likely to be treated as political positions subject to change with each new administration.
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Product reviews for drugs, biologics, devices, tobacco and foods could be consolidated into one office at the FDA, as part of a restructuring plan circulating that was obtained by Pink Sheet.
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Pink Sheet reporter and editors discuss how the massive layoffs will reshape the FDA and its impact on the drug and biologics industries.
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Pink Sheet reporter and editors discuss how the massive layoffs will reshape the FDA and its impact on the drug and biologics industries.
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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.