Marty Makary is officially out at the FDA. From STAT: Makary departs FDA amid turmoil as Diamantas, agency’s top food official, steps in. But there’s more going on here in what looks like an agency leadership purge.
This is so crazy that it’s hard to imagine a coherent path forward.
Next level chaos: Marty Makary forced out at FDA as part of leadership purge
There were signals for more than a week that Makary’s ouster was in the cards. The WSJ had continually been hammering Vinay Prasad, former CBER director. With Prasad gone, they turned their fire on Makary.
What did The WSJ and conservatives want? Just approve everything they like that comes before the FDA including children-targeted flavored vapes?
And, making matters more chaotic, Tracy Hoeg was fired and the acting CBER director Katherine Szarama is also out from that role, although will stay on in a different position at the agency.
What just happened and why? There’s no transparency.
The FDA is likely going to be far more politically “flexible” moving forward. In the cell and gene therapy (CGT) space that means approving things that don’t merit it. Plus, other products may just sit in limbo when there are sufficient data to progress. It sure doesn’t look good. Stay tuned for more on what this all means.
More recommended reads
- Scientists link boy’s tumor to gene therapy viruses, in rare finding, STAT. “The risks of such treatments need to be weighed against what can be profound benefits, doctors say.” The risk-benefit ratios in this space can be hard to pin down. I’ve written several times that CGTs, even approved ones, still will sometimes pose major risks. This is especially the case as additional flexibilities in oversight come into play. It doesn’t help that the FDA and CBER are so all over the place.
- Novo salvages happy ending for scrapped Parkinson’s cell therapy via deal with AI biotech, Fierce Biotech. The firm here is Cellular Intelligence.
- Biohacking influencers pushing stem cell injections are getting sick with sepsis, New York Post. The article focuses primarily on Jordan Peterson.
- Microbiota from young mice restore the function of aged ISCs, Stem Cell Reports. Young fecal transplants of a sort for old mice.
- Routine vaccines may cut dementia risk—experts have startling hypothesis on how, Ars Technica. It’s so interesting that we still don’t quite know what’s going on with various vaccines lowering dementia risks, but one possibility is unexpected.