Former US Food and Drug Administration Principal Deputy Commissioner Josh Sharfstein is no longer in strong contention to be President Joe Biden’s FDA Commissioner, but surprisingly that doesn’t mean Acting Commissioner Janet Woodcock is a shoo-in for the job, three former FDA officials told the Pink Sheet.
US FDA Commissioner Race Shrinks And Widens: Biden Team Trying To Woo Reluctant Dems On Woodcock While Exploring New Options
White House is trying to overcome some Senate Democrats’ opposition to Janet Woodcock as FDA Commissioner, while also looking for other candidates for the job. Josh Sharfstein, long thought to be Woodcock’s main competition, is not a strong contender.
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One CDRH employee said the cuts already are having a major effect on morale.
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.
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.
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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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.
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.
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.