public health
The struggle to contain Kennedy
News broke late Friday that the Food and Drug Administration's top vaccine regulator, Peter Marks, had been forced out of his post by Robert F. Kennedy Jr. Marks, in his resignation letter, made clear that he had clashed with the HHS secretary over vaccine safety.
Concerns are mounting about what Marks' resignation means for the FDA's vaccine policies, and who might step into his shoes. Marks was an architect of the first Trump administration's Operation Warp Speed; his ouster signals that it truly is RFK Jr.'s FDA now, Matthew Herper writes.
His ouster also lays bare how much Sen. Bill Cassidy (R-La.) is struggling to keep Kennedy in line on vaccine policy, according to John Wilkerson.
In return for voting to confirm Kennedy, Senate health committee Chair Cassidy secured commitments aimed at ensuring Kennedy doesn't undermine the public's trust in vaccines. But those commitments have been difficult to enforce, and Kennedy has tested the limits of what he can get away with at every turn.
Read John's story for more on how things are playing out between Cassidy and Kennedy. Plus, more details on Marks' departure (and the full resignation letter) from an all-star team of STATians.
industry intel
Marks' ouster has industry on edge
The biopharmaceutical industry, which has so far hedged in its comments about Kennedy, is officially getting nervous.
Marks' resignation, and his letter explaining it, "should shake us all" and is a "huge setback" for biotech, industry executives said to STAT's Jason Mast and Adam Feuerstein. There's building concern about what this means for vaccines made with messenger RNA, in particular. Kennedy has publicly questioned the safety of mRNA Covid-19 vaccines, and several states have already moved to limit the technology.
More on what the industry is saying so far.
FDA regulations
Judge axes FDA's lab test regulations
A federal judge in Texas squashed the FDA's plan to regulate lab-developed tests on Monday, ruling in favor of lab trade groups that said the agency was overstepping its bounds.
The agency announced under President Biden that it planned to more actively regulate the tests under its device authorities, and gave labs until 2028 to comply. The move came after Congress tried and failed to give FDA more explicit authority in 2022.
The trade groups argued that only Congress can give the FDA that power, though, and the judge sided with them. More from Lizzy Lawrence.
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