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Reposted by Alexander Gaffney

Dan Diamond @ddiamond.bsky.social · 29/03/2025

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.”

washingtonpost.com

RFK Jr. forces out Peter Marks, FDA’s top vaccine scientist

Marks, an architect of Operation Warp Speed, warned that a recent measles outbreak shows how confidence in science and public health is being “undermined.”

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Alexander Gaffney @alecgaffney.bsky.social · 03/03/2025

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...

agencyiq.com

A guide to staff reductions FDA has already experienced – and those coming soon | AgencyIQ by POLITICO

AgencyIQ has identified 17 executive orders, policies, legislative initiatives, and scenarios that have already, or will likely soon, negatively impact FDA’ ...

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Alexander Gaffney @alecgaffney.bsky.social · 26/02/2025

I (sadly) need to update that piece to add like another 3 things that have popped up in the last week alone. It's going to be a sobering few months for FDA staff.

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Alexander Gaffney @alecgaffney.bsky.social · 17/02/2025

This is a dream role for someone who loves writing and is an encyclopedia of knowledge about food and chemical regulatory policy (and is gifted at explaining how things work to an audience of both experts and laypersons). The role is based in Rosslyn, VA (3 days a week).

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Alexander Gaffney @alecgaffney.bsky.social · 17/02/2025

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/...

recruiting.ultipro.com

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Alexander Gaffney @alecgaffney.bsky.social · 16/02/2025

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.

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Alexander Gaffney @alecgaffney.bsky.social · 10/02/2025

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...

agencyiq.com

As government reform efforts converge, significant FDA staff cuts are likely | AgencyIQ by POLITICO

President DONALD TRUMP’s administration is advancing a wide array of reforms intended to shrink the federal bureaucracy and otherwise reduce the power and i ...

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Alexander Gaffney @alecgaffney.bsky.social · 04/02/2025

The form used to look like this: Now it just asks if the patient was assigned Male or Female at birth.

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Alexander Gaffney @alecgaffney.bsky.social · 04/02/2025

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...

agencyiq.com

FDA updates guidance language, forms to align with Trump executive order | AgencyIQ by POLITICO

During the past week, the FDA has quietly been making changes to important forms and guidance documents to align with a new executive order that directs age ...

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Reposted by Alexander Gaffney

Alice Miranda Ollstein @alicemiranda.bsky.social · 30/01/2025

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...

politico.com

‘Using the devil's own tools against them': Abortion opponents turn to environmental laws

Several states are trying to curtail abortion medication by claiming mifepristone could contaminate drinking water.

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Alexander Gaffney @alecgaffney.bsky.social · 07/01/2025

I think historically CDRH had regulated them because the mechanism of action of the leeches/maggots was mechanical (extracting blood, consuming dead tissue), rather than biological. They are still submitted as device applications, too. www.nbcnews.com/health/healt...

nbcnews.com

FDA approves leeches as medical devices

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Alexander Gaffney @alecgaffney.bsky.social · 03/01/2025

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-...

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Alexander Gaffney @alecgaffney.bsky.social · 13/12/2024

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...

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Alexander Gaffney @alecgaffney.bsky.social · 13/12/2024

I write a free daily newsletter, FDA Today, focused on life sciences regulation from a US perspective. My group also has a European-focused newsletter, EMA Today, covering the same scope. www.agencyiq.com/subscribe-fd... www.agencyiq.com/subscribe-em...

agencyiq.com

Your Guide to the Latest FDA Regulations & Policies | AgencyIQ by POLITICO

FDA Today is your guide to the latest regulations, policies and actions of the Food and Drug Administration. Subscribers gain actionable and insightful explanations of the latest FDA developments that...

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Alexander Gaffney @alecgaffney.bsky.social · 12/12/2024

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...

ipsos.com

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Alexander Gaffney @alecgaffney.bsky.social · 12/12/2024

I suspect this is going to be an increasing concern as a lot more people look to replace plastic (vinyl) cooking utensils with metal ones in an attempt to limit their exposure to PFAS or other contaminants. Lots of crap in the metal supply chain, too.

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Alexander Gaffney @alecgaffney.bsky.social · 12/12/2024

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...

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Alexander Gaffney @alecgaffney.bsky.social · 06/12/2024

Most of their work is focused on improving patient access to cancer drugs, helping patients meet with regulators, holding meetings to address public health issues (tons of work on opioid policy issues), and writing reports. A bizarre thing to focus on, since they get like $1.6M in FDA funding.

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Alexander Gaffney @alecgaffney.bsky.social · 06/12/2024

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.

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Alexander Gaffney @alecgaffney.bsky.social · 05/12/2024

In particular, I was really frustrated to see analysis that seemed to only look at FDA's role as approving vaccines. No. FDA also informs drug labels, issues warnings, sets indications for use, establishes risk control measures, reviews and clears clinical trial requests, issues guidance, and more

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Alexander Gaffney @alecgaffney.bsky.social · 05/12/2024

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...

agencyiq.com

The Trump Transition: The many ways RFK Jr. could disrupt FDA's regulation of vaccines | AgencyIQ by POLITICO

ROBERT F. KENNEDY JR. is President-elect DONALD TRUMP’s intended nominee to be Secretary of the Department of Health and Human Services. While Kennedy has p ...

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Alexander Gaffney @alecgaffney.bsky.social · 02/12/2024

For example, while this KFF piece is a great primer (seriously, go read it), it misses a *huge* number of the important levers available to RFK to really interfere with vaccines from an FDA perspective. www.kff.org/policy-watch...

kff.org

How HHS, FDA, and CDC Can Influence U.S. Vaccine Policy | KFF

This policy brief highlights areas in which HHS, FDA, and CDC have authority to shape U.S. vaccine policy with a specific focus on vaccine approvals and recommendations for the public. Ultimately, whi...

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Alexander Gaffney @alecgaffney.bsky.social · 02/12/2024

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...

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Alexander Gaffney @alecgaffney.bsky.social · 02/12/2024

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...

agencyiq.com

The Trump Transition: How could Trump’s DOGE affect the FDA? | AgencyIQ by POLITICO

Updated Nov 26, 2024 9:31 AM EST A new effort announced on Nov. 12 by President-elect DONALD TRUMP is intended to make America’s federal bureaucracy leaner ...

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Alexander Gaffney @alecgaffney.bsky.social · 02/12/2024

"Great value-based quarter, guys" is an all-time great chart title, @bobjherman.bsky.social.

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Alexander Gaffney @alecgaffney.bsky.social · 02/12/2024

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.

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Alexander Gaffney @alecgaffney.bsky.social · 02/12/2024

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...

agencyiq.com

E-cigarette lawsuit may imperil FDA’s regulation of medical products | AgencyIQ by POLITICO

The FDA frequently makes use of guidance documents to guide life sciences companies’ development and compliance activities. However, a lawsuit set to go bef ...

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Alexander Gaffney @alecgaffney.bsky.social · 26/11/2024

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.

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Alexander Gaffney @alecgaffney.bsky.social · 22/11/2024

Great job following that. I wonder if it’s USDA or one of the assistant secretary positions…

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Alexander Gaffney @alecgaffney.bsky.social · 21/11/2024

(She could also be talking about USDA nominations, which the MAGA v. MAHA dynamic also includes)

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Alexander Gaffney @alecgaffney.bsky.social · 21/11/2024

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).

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Alexander Gaffney @alecgaffney.bsky.social · 21/11/2024

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.

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Alexander Gaffney @alecgaffney.bsky.social · 19/11/2024

Between Kennedy at HHS and Oz at CMS, FDA might be lucky just to get someone who has a basic understanding of how it works and isn't actively hostile to its existence.

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Alexander Gaffney @alecgaffney.bsky.social · 19/11/2024

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...

politico.com

Trump picks Dr. Oz to be CMS administrator

President-elect Donald Trump has chosen Mehmet Oz, the celebrity physician and TV personality known as Dr. Oz, to be administrator of CMS.

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Reposted by Alexander Gaffney

David Lim @davidlim.bsky.social · 19/11/2024

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...

politico.com

Trump transition closes in on picks for top health posts

Many of the candidates are allies of RFK Jr. and have maligned the agencies they would oversee.

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Alexander Gaffney @alecgaffney.bsky.social · 19/11/2024

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-...

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Alexander Gaffney @alecgaffney.bsky.social · 18/11/2024

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...

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Alexander Gaffney @alecgaffney.bsky.social · 18/11/2024

They're targeting moderate Republicans, as well as other Senators with personal ties to vaccines and health care products. Interesting since RFK is *also* taking flack from the right over his stance on abortion. www.politico.com/live-updates...

politico.com

Pence urges Senate to reject RFK Jr. for HHS over abortion stance

Donald Trump’s former vice president called the nomination of Robert F. Kennedy Jr. to lead the Department of Health and Human Services “deeply concerning to millions of Pro-Life Americans.”

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Alexander Gaffney @alecgaffney.bsky.social · 18/11/2024

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...

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Alexander Gaffney @alecgaffney.bsky.social · 18/11/2024

The MAGA v. MAHA angle in particular is one that I don't think people appreciate enough yet. While those interests were aligned for the election, they are remarkably different governing philosophies which seem almost destined to collide in ways that will likely lead to infighting.

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Alexander Gaffney @alecgaffney.bsky.social · 18/11/2024

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...

agencyiq.com

The Trump Transition Explainer: Everything you need to know about how the election of Donald Trump could affect FDA | AgencyIQ by POLITICO

The election of DONALD TRUMP as the next President of the United States is likely to have major impacts on the FDA and the life sciences industry. In this o ...

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Alexander Gaffney @alecgaffney.bsky.social · 18/11/2024

And let's just say there's a surprising number of countries with small GDPs than the annual sales of a single biologic.

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Alexander Gaffney @alecgaffney.bsky.social · 18/11/2024

When I worked at PwC, I had this slide deck that I put together to quiz our analysts. The gist of the deck was: What's larger: -The entire Gross Domestic Product of [Country], or the annual sales of Humira? -The entire appropriated budget of [Federal Agency], or Humira's annual advertising spend?

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Alexander Gaffney @alecgaffney.bsky.social · 18/11/2024

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/...

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Alexander Gaffney @alecgaffney.bsky.social · 18/11/2024

My assumption would be decreased media spend. Awareness ads are generally shorter since you don't need to account for fair balance. And not all drugs benefit equally from awareness ads, so it might result in less DTC and more prescriber-focused spend.

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Alexander Gaffney @alecgaffney.bsky.social · 18/11/2024

It's been happening for years already, so most companies have at least some familiarity with it. By avoiding any mention of the product, it means companies don't have to include "fair balance" in ads (per FDA regs), which means they can be shorter (costs less $) and more impactful.

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