The Readout Loud 348: Cuts, ousters and drama at the FDA
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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.
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Scope of Layoffs
- The FDA layoffs were broad, affecting administrative staff, communications, and policy roles.
- Leaders across several FDA centers were also let go.
Impact of User Fee Cuts
- User fees fund various FDA activities, not just reviewers and inspectors.
- Cutting non-reviewer user-fee-funded staff can still slow drug reviews.
McCary's First Address
- In his first address to FDA staff, Commissioner McCary focused on broad health goals and transparency.
- He only briefly mentioned the layoffs and didn't discuss specific FDA duties or vaccines.