The Prasad Shield Is Gone and Makary Is Next in the Crosshairs

Gone in 60 Seconds

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For months, FDA Commissioner Marty Makary operated with a kind of political insulation. When things went sideways in the biologics world — Huntington’s patients left without a therapy, rare disease companies blindsided by reversed guidance — there was always someone to absorb the heat. That someone was Vinay Prasad.

That shield is now gone.

With Prasad’s departure from CBER announced last Friday, the deflection strategy has run out of runway and Congress is just getting started. Senate Republicans who spent the fall politely writing letters are now talking subpoenas. The White House, which already forced one Prasad reversal on camera, has watched the political fallout from the QURE situation land squarely on the commissioner’s desk. And on the same day all of this is coming to a head, the FDA announced an approval that perfectly captures everything that is broken about Makary’s leadership: leucovorin (a drug he and Trump publicly promised would help “hundreds of thousands” of kids with autism) was approved Tuesday for a condition affecting fewer than one person per million. The gap between the promise and the reality could not be wider. Makary is now the last man standing and the walls are closing in.