Breaking: RFK Jr. has forced out PETER MARKS, the nation’s top vaccine regulator. In his resignation letter, obtained by the Post, Marks said he was willing to work with RFK Jr on his vaccine concerns — but said Kennedy wishes “subservient confirmation of his misinformation and lies.”

There has been considerable focus in recent weeks about the impact of firing probationary employees at the FDA. But that's just the tip of the iceberg. I've assembled a list of all the other cuts that are coming next. It's a LONG list. (Free read) www.agencyiq.com/blog/a-guide...

In other news: I'm hiring. My team at AgencyIQ is growing, and I'm looking for a director to lead an existing team of chemicals regulatory analysts and prepare to grow a new team of food regulatory analysts. recruiting.ultipro.com/PER1013PCLL/...

Hearing from FDA staff that layoffs are hitting the agency this evening. One manager told me they don’t even know which of their staff is affected, and supervisors and office directors don’t have that information, either. Not clear yet if user fee-funded staff are affected.

FDA staff are about to come under pressure like never before as the Trump administration and Congress look to make federal agencies leaner. A new piece I published this morning has a thorough accounting of the pressures they'll face. www.agencyiq.com/blog/as-gove...

A scoop from AgencyIQ: The FDA this weekend modified the forms it uses to collect adverse event reports from the public, doctors and sponsors. The changes were made to remove any mention of gender. www.agencyiq.com/blog/fda-upd...

Anti-abortion groups have convinced lawmakers in several states, without evidence that abortion pills are contaminating the water supply. They also have plans for lawsuits & federal legislation cutting off access. They are comparing themselves to Erin Brockovich. www.politico.com/news/2025/01...

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-...

With news today about how RFK allies have petitioned FDA to revoke approval for the polio vaccine, it's a good time to read my in-depth analysis of all the various mechanisms that RFK and his allies could potentially use to disrupt vaccine regulation at the FDA. 👇 www.agencyiq.com/blog/the-tru...

I would caution that these data are essentially garbage since the poll didn't even ask respondents if they knew who these people were. The questions they asked: www.ipsos.com/sites/defaul...

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...

Yeah, so one of the groups in here is the Reagan-Udall Foundation for the FDA, which spearheaded major work which just resulted in FDA overhauling its human foods program to enable a closer look at food chemical safety - a major priority of MAHA.

I've been pretty underwhelmed by the sophistication of some of the analysis I've seen about what RFK Jr. could mean for FDA's regulation of vaccine products, so I decided to do something about it. Free to read, and explains how FDA actually works. www.agencyiq.com/blog/the-tru...

Well, that does not sound good at all... www.reuters.com/business/hea...

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...

Something I've been spending a lot of time thinking about lately is how DOGE - the Department of Government Efficiency - could have an outsized impact on the FDA. I tracked down a *lot* of Ramaswamy and Musk's old posts and statements about the FDA to explain: www.agencyiq.com/blog/the-tru...

The Supreme Court today is hearing the case of FDA v. Wages and White Lion Investments, which focuses on FDA's regulation of ecigarettes. But as I explained in early September, the life sciences industry should pay close attention to this case, too. www.agencyiq.com/blog/e-cigar...

The amusing part about this (to me, at least) is that MAHA's regulatory philosophy is *markedly* different than the one espoused by O'Neill and other libertarians. Hard to imagine how "regulate this way more" and "regulate this way less" approaches work together here.

A dynamic to watch... unclear if this is speaking about potential FDA Commissioner pick Makary, or other folks within HHS (like Assistant Secretary at HHS).

Strong agree with this take. There's only so much attention in Washington. A key question is whether the focus remains on Justice-related appointees, or if it shifts to RFK, Hegseth, and other nominees.

I think at this point, FDA folks should just assume that whoever is nominated to be the next FDA Commissioner is going to be a controversial pick, and likely someone best known for their television presence. www.politico.com/news/2024/11...

The Trump transition is closing in on a number of names for top health posts across HHS. w/ @adamcancryn.bsky.social www.politico.com/news/2024/11...

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-...

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...

While much of what I (and my phenomenal team) at AgencyIQ write is behind a paywall, we have released a few of our election-related insights to our website. Read all about Trump and RFK's impact on user fees, HHS authority, and the incoming MAGA v. MAHA fight. www.agencyiq.com/blog/the-tru...

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/...

Any serious analysis of what RFK could do to pharmaceutical advertising needs to consider two things: - Pharma companies have first Amendment rights, and - Even if a court says they don't, they can still run unbranded "disease-awareness" ads. Really difficult to put the genie back in the bottle.

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...

As it turns out, my explainer here is proving *especially* useful today. My POLITICO colleagues just scooped a few minutes ago that Trump is expected to nominate RFK as HHS Secretary.

For all the great things that Bsky has, it desperately needs a "Save" feature for posts.

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...

I suspect everyone is going to be focused on "lol, DOGE," but: The government already *has* a division focused on governmental efficiency and regulation: The White House Office of Management and Budget and its Office of Information of Regulatory Affairs. www.politico.com/live-updates...

I've been answering lots of questions over the last week about the impact of the election on FDA. The answers to two of those questions are extremely important: - What could HHS do to FDA? - What does the election mean for FDA user fees? www.agencyiq.com/blog/the-tru...

FDA Commissioner Robert Califf earlier today said he felt like the agency "is sort of at peak performance right now" Calling FDA an agency working "at peak performance" is a pretty significant stretch considering they just overhauled most of their divisions *a few weeks ago.*

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)

One of the most common questions I see people asking in recent days in life sciences policy circles is: What would RFJ Jr. mean for the FDA? I did some deep thinking about this issue a week before the election, which you can read for free here: www.agencyiq.com/blog/trump-m...

It's encouraging to see more of the FDA policy-focused Twitter folks over here on Bsky. Twitter has really become a shell of its old self in the last year, which is quite disheartening. I'm going to make more of a point of posting more of my FDA hot takes here on a regular basis.