alecgaffney.bsky.social - Profile | ThreadSky | a Reddit-style client for Bluesky

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...

submitted 21 hours ago • 0 comments

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/...

submitted 14 days ago • 1 comment

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.

submitted 16 days ago • 0 comments

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...

submitted 21 days ago • 1 comment

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...

submitted 27 days ago • 1 comment

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...

submitted 32 days ago • 11 comments

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-...

submitted 59 days ago • 0 comments

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...

submitted 80 days ago • 0 comments

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...

submitted 81 days ago • 0 comments

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...

submitted 81 days ago • 0 comments

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.

submitted 87 days ago • 1 comment

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...

submitted 88 days ago • 1 comment

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

submitted 90 days ago • 0 comments

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...

submitted 91 days ago • 1 comment

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...

submitted 91 days ago • 0 comments

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...

submitted 91 days ago • 1 comment

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.

submitted 98 days ago • 0 comments

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).

submitted 102 days ago • 1 comment

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.

submitted 102 days ago • 0 comments

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...

submitted 104 days ago • 1 comment

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...

submitted 104 days ago • 3 comments

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-...

submitted 104 days ago • 0 comments

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...

submitted 105 days ago • 1 comment

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...

submitted 105 days ago • 1 comment

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/...

submitted 105 days ago • 0 comments