The Readout Loud
348: Cuts, ousters and drama at the FDA
Apr 3, 2025
Lizzy Lawrence, STAT’s FDA reporter, shares insights into the upheaval within the FDA, revealing how Robert F. Kennedy Jr.'s actions led to high-level resignations amidst a chaotic transition. Joining her is Sharon Barr, R&D executive at AstraZeneca, who discusses the promising results of a new PCSK9 pill that significantly reduces cholesterol, framing it as crucial for AstraZeneca’s growth strategy. The conversation also touches on the broader implications of leadership changes and market pressures in the biotech sector.
31:10
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Quick takeaways
- The recent leadership turmoil and layoffs at the FDA have severely impacted staff morale and raised concerns about the agency's functioning.
- AstraZeneca is committed to innovative R&D, including its promising PCSK9 inhibitor, to drive revenue growth despite ongoing regulatory challenges.
Deep dives
FDA Layoffs and Emotional Impact
Recent layoffs at the FDA have had a profound emotional impact on employees, with reports of distressing scenes as staff arrived to find their badges no longer worked. Approximately 3,500 FDA positions were eliminated, affecting a wide range of administrative roles, including those essential for regulatory decisions and guidance creation. The manner in which these cuts were executed, particularly the lack of communication and preparation, has left employees feeling traumatized and uncertain about their futures. This situation has raised concerns about the overall functionality of the FDA, especially given its critical role in public health and drug approvals.
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