Alexander Gaffney

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.”

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.”

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’ ...

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...

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.

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).

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.

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 ...

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...

The form used to look like this:

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

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 ...

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...

‘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.

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...

FDA approves leeches as medical devices

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...

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...

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...

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...

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...

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.

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...

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.

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.

Thank you for the kind words!

Thanks for sharing, Holly!

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

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 ...

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...

Unknown disease kills 143 in southwest Congo, local authorities say An unknown disease killed 143 people in Democratic Republic of the Congo's southwestern province in November, local authorities told Reuters.

Well, that does not sound good at all...

www.reuters.com/business/hea...

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...

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...

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 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 ...

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...

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

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.

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 ...

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...