Welcome to another edition of Supplemental Filings, where US-based Pink Sheet reporters offer bonus, quick-hit analysis and insights we think you should know about, but didn't make it into full-length stories.
Supplemental Filings: FDA Can't 'Plug' All Shortage Holes, New Jobs For Billy Dunn, Lisa Parks & Heidi Rebello
From infant formula to drugs, Califf can't get away from shortage work. Plus, the revolving door brings new jobs for some top pharma folks.
More from US FDA
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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.
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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.
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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
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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.
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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.
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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.