Dark times ahead at the FDA

I was at the annual American Society of Gene & Cell Therapy (ASGCT) meeting in Boston when news broke last week that Food and Drug Administration Commissioner Marty Makary was being ousted. The general reaction from my colleagues seemed to be a resigned sense that chaos is the new norm.

And then we learned that it wasn’t just Makary. Tracy Beth Høeg was also fired last week as Center for Drug Evaluation and Research (CDER) leader, and Katherine Szarama was removed from being acting Center for Biologics Evaluation and Research (CBER) director shortly after she had started that role.

All at once, three of the most crucial posts at the FDA have only acting leaders, with extra instability at CBER with its revolving-door leadership. This feels like an unprecedented ideological purge.

It’s confusing, though, because Makary’s and Høeg’s philosophies largely seemed to match the administration’s views. One more disturbing possibility is that the administration just finally got around to intentionally breaking the FDA, Project 2025-style.

Sure, you could argue the FDA was already partially hobbled with so many key staff...