Marty Makary formally resigned on May 12, ending a 14-month tenure at FDA that the agency’s rank-and-file reportedly received with relief. The acting director of CDER, the acting director of CBER, the FDA chief of staff, and the chief AI officer all departed within the same week.
The full personnel accounting shows some staying at the agency in different capacities, which is what orderly-transition language looks like. The harder question: who’s signing off on active drug submissions while the senior tier rebuilds? Kyle Diamantas, FDA’s deputy commissioner for food, is now acting commissioner.
If the biotech industry had its pick, it would put Richard Pazdur in the commissioner’s office. I read the endorsement: nearly 400 biotech CEOs and investors signed a letter backing him. Pazdur is the former longtime oncology regulator who briefly served as CDER director before departing, reportedly unhappy with the direction the agency was headed in under the Trump administration.
The structural problem: Pazdur’s name on an industry letter isn’t a White House appointment. He left CDER in December precisely because the administration’s speed expectations conflicted with how he thought review decisions should be made. It’s not obvious that calculus has changed, and drug sponsors can’t treat PDUFA timelines as stable until the center-director slots are filled by people who actually hold confirmed roles.
Worth watching who fills the CDER and CBER director positions before assuming review cadence returns to normal.
Rebecca Lauren