The form used to look like this:

Now it just asks if the patient was assigned Male or Female at birth.

Some companies might want to update their training and SOPs in 2025 to instruct their management staff to not *fight the FDA inspectors* coming to their facility.

One of the wildest warning letters I've ever read:

www.fda.gov/inspections-...

There's a portion of this TIME Magazine interview with Donald Trump that talks about vaccines, and it's.... not comforting for public health and regulatory officials.

time.com/7201565/pers...

And for AgencyIQ subscribers, I have an in-depth look at all the ways that RFK Jr. could potentially use FDA authority to disrupt how vaccines are regulated.

This piece is considerably more nuanced than any other I have seen to date:

home.agencyiq.com/article/0000...

The basic issue is this: The case zeroes in on whether FDA improperly modified a key guidance document.

Guidance documents are non-binding documents commonly used by FDA to guide the development of regulated products.

If SCOTUS says FDA can't change its mind, FDA might shy away from them.

A new FDA Warning Letter today to an Indian drug manufacturer is one for the ages.

I mean, who among us doesn't hide batch production records on the roof during an FDA inspection?

www.fda.gov/inspections-...

Another notable angle is how lots of groups *aren't* taking action -- or at least not yet.

This lede from POLITICO's @danielpayne.bsky.social really captures a lot of the caution right now among advocacy groups, industry groups and lobbyists:

www.politico.com/news/2024/11...

Some groups are keeping their metaphorical powder dry for now on Trump's intended nominee for HHS Secretary, Robert F. Kennedy Jr.

But not everyone. My POLITICO colleague @meganmesserly.bsky.social reports that some Dem-aligned groups are assembling a "war room."

www.politico.com/live-updates...

Drops in drug overdose deaths may mostly be thanks to... the very cartels supplying the drugs in the first place?

A fascinating find here from my POLITICO colleague Carmen Paun:

www.politico.com/newsletters/...

At a time when Musk is trying to identify about $2 trillion in budget cuts, the risk is that not only is FDA unlikely to be spared, but that it might be *targeted* based on Musk and Ramaswamy's prior experience with the agency.

That has led both Musk and Ramaswamy to criticize the FDA in recent weeks (although not always fairly):

To understand why, you need to look at the regulatory history that both Elon Musk and Vivek Ramaswamy have with the FDA (hint: it's not pleasant):

I'm out with a new piece this morning for AgencyIQ that takes a novel look at the new "DOGE" effort (Department of Government Efficiency).
As my analysis shows, there are some major risks for the FDA and life sciences industry:
home.agencyiq.com/article/0000...

In remarks yesterday, FDA Commissioner Robert Califf offered a reminder that HHS has the authority to overrule the FDA.

I went back through AgencyIQ's archives to find examples of cases where that happened, and... it happened quite a bit during Trump's last term.

www.agencyiq.com/blog/the-tru...

So this just seems like a duplication of resources and and efforts, which is by definition inefficient.

As a heads-up to the FDA journalists who follow me, this FOIA request from the Heritage Foundation - the same folks behind Project 2025 - to the FDA shows how some requests for information can be searched for and made public.

(This is from FDA's publicly available FOIA logs from 2023)