FDA shakeup finally gets Nicole Verdun; bros, politics & AI to rule?

Someone at the FDA has placed Nicole Verdun, the Super Director of The Office of Therapeutic Products at the agency, and her deputy, Rachael Anatol, on administrative leave as of yesterday.

The agency continues to shed key, experienced leadership, most of the departures have been forced.

What are Commissioner Marty Makary and newly promoted CBER Director Vinay Prasad thinking? How much might be driven by RFK Jr.?

Either way, Verdun and Anatol being put on leave is another negative milestone for an agency that has lost vast experience in a short time.

Note that Prasad, entirely new to the agency, just also became the FDA’s chief medical and science officer.

Nicole Verdun just garnered big praise at FDA Cell and Gene Therapy Roundtable

There’s no good reason for these changes.

It was only two weeks ago that participants in an FDA Cell and Gene Therapy roundtable praised Verdun.

Four or five separate speakers mentioned her by name, all positively. The impression was that Verdun was the essential person making things happen and working well with sponsors. More generally, I have only heard great things about her over the years.

As I watched that roundtable two weeks ago, I thought, “Why is she one of the few survivors at this point?” I worried it wouldn’t last.

Why is Verdun probably being pushed out?

It didn’t. Per STAT, Verdun communicated:

“Rachael and I have been placed on administrative leave and told that we are being relieved of our duties, for now, and we were escorted out,” Verdun told staff on an emergency call convened around 5:30 p.m., adding, “That’s all we’ve been told. We don’t have any additional information.”

The likely reason?

Perhaps Prasad, Makary, or RFK Jr. viewed her as too attached to data standards. I bet she wouldn’t play their political games too.

Further, my sense from recent news is that Makary and Prasad have also probably bought into some wild idea that AI can take the place of experienced human leadership.  That’s a bad bet. You can’t AI your way to replace highly experienced people.

Politics, AI, and bro culture to rule the FDA?

Whoever pulled the trigger here, this is an unwise move by top leadership.

What leaders does the FDA still have with major experience in biologics? Almost no one.

In terms of impact, this is more discouraging news for the cell and gene therapy field from the new FDA. It was about two months ago that I wrote that the FDA purge was bad news for biotech and the purge continues. It just continues. Sponsors reaching out to the agency and to CBER more specifically are unlikely to get the information you need. Decisions will linger or be made too quickly via politics and AI, not a great combo.

Finally, I can’t help but notice there could be a bro culture emerging here. In the healthcare and biomedical sphere of the government, we have Makary, Prasad, Oz, Kennedy, and Bhattacharya. They’ve basically said they are buddies and hang out together. Maybe that’s not such a good thing.