Alexander Gaffney
@alecgaffney.bsky.social
Vice President, Regulatory Policy & Intelligence at POLITICO's AgencyIQ. Writing about how the FDA regulates medical products for 15+ years. Author of the newsletter 'FDA Today'. Signal: AlecGaffney.01
Reposted by Alexander Gaffney
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.”
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.”
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.”
www.washingtonpost.com
March 29, 2025 at 1:14 AM
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.”
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...
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...
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’ ...
www.agencyiq.com
March 3, 2025 at 1:40 PM
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...
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/...
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
February 17, 2025 at 6:17 PM
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/...
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.
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 new piece I published this morning has a thorough accounting of the pressures they'll face.
www.agencyiq.com/blog/as-gove...
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 ...
www.agencyiq.com
February 16, 2025 at 3:18 AM
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.
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 new piece I published this morning has a thorough accounting of the pressures they'll face.
www.agencyiq.com/blog/as-gove...
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 ...
www.agencyiq.com
February 10, 2025 at 8:15 PM
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 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...
www.agencyiq.com/blog/fda-upd...
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 ...
www.agencyiq.com
February 4, 2025 at 6:44 PM
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...
www.agencyiq.com/blog/fda-upd...
Reposted by Alexander Gaffney
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...
They are comparing themselves to Erin Brockovich.
www.politico.com/news/2025/01...
‘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.
www.politico.com
January 30, 2025 at 2:18 PM
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...
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-...
One of the wildest warning letters I've ever read:
www.fda.gov/inspections-...
January 3, 2025 at 7:44 PM
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-...
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...
www.agencyiq.com/blog/the-tru...
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...
Free to read, and explains how FDA actually works.
www.agencyiq.com/blog/the-tru...
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 ...
www.agencyiq.com
December 13, 2024 at 6:55 PM
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...
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...
The questions they asked: www.ipsos.com/sites/defaul...
December 12, 2024 at 5:48 PM
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...
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...
time.com/7201565/pers...
December 12, 2024 at 5:32 PM
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...
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.
Will RFK Jr end the CDC Foundation?
A top Kennedy adviser told Donald Trump Jr this week:
"why does the CDC have a nonprofit that allows pharma to bribe that agency hundreds of millions of dollars? That can be cut immediately"
tinalexander.github.io/notes/2024/1...
A top Kennedy adviser told Donald Trump Jr this week:
"why does the CDC have a nonprofit that allows pharma to bribe that agency hundreds of millions of dollars? That can be cut immediately"
tinalexander.github.io/notes/2024/1...
December 6, 2024 at 9:50 PM
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...
Free to read, and explains how FDA actually works.
www.agencyiq.com/blog/the-tru...
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 ...
www.agencyiq.com
December 5, 2024 at 9:25 PM
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...
Free to read, and explains how FDA actually works.
www.agencyiq.com/blog/the-tru...
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...
This piece is considerably more nuanced than any other I have seen to date:
home.agencyiq.com/article/0000...
December 2, 2024 at 9:20 PM
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...
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...
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 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 ...
www.agencyiq.com
December 2, 2024 at 9:12 PM
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...
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...
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...
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 ...
www.agencyiq.com
December 2, 2024 at 1:53 PM
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...
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.
Hard to imagine how "regulate this way more" and "regulate this way less" approaches work together here.
News: Jim O'Neill is being weighed by Trump for HHS deputy secretary per 3 people familiar with the talks.
He has advocated for people to be able to take drugs once safety, but not effectiveness, is reviewed by the FDA.
w/ @adamcancryn.bsky.social + Lauren Gardner:
www.politico.com/news/2024/11...
He has advocated for people to be able to take drugs once safety, but not effectiveness, is reviewed by the FDA.
w/ @adamcancryn.bsky.social + Lauren Gardner:
www.politico.com/news/2024/11...
Trump weighing O’Neill for HHS deputy secretary
A close adviser to Peter Thiel with ties across Silicon Valley, O'Neill reentered the mix in recent days for the No. 2 HHS job.
www.politico.com
November 26, 2024 at 2:35 AM
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.
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).
November 21, 2024 at 8:34 PM
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.
one thought on implications of Gaetz's withdrawal: it could increase pressure on Trump's other controversial nominees (including RFK Jr on my beat).
Republican senators who only want to cast a few protest votes against Trump picks now don't need to use one on Gaetz.
Republican senators who only want to cast a few protest votes against Trump picks now don't need to use one on Gaetz.
Breaking news: Former congressman Matt Gaetz (R-Florida) announced in a social media post Thursday that he was withdrawing his name from consideration to be attorney general for President-elect Donald Trump’s incoming administration.
November 21, 2024 at 6:40 PM
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...
www.politico.com/news/2024/11...
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.
www.politico.com
November 19, 2024 at 9:53 PM
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...
www.politico.com/news/2024/11...
Reposted by Alexander Gaffney
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...
w/ @adamcancryn.bsky.social
www.politico.com/news/2024/11...
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.
www.politico.com
November 19, 2024 at 6:54 PM
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...
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-...
I mean, who among us doesn't hide batch production records on the roof during an FDA inspection?
www.fda.gov/inspections-...
November 19, 2024 at 4:38 PM
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-...
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...
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...
November 18, 2024 at 9:17 PM
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...
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...
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...
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 ...
www.agencyiq.com
November 18, 2024 at 9:01 PM
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...
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...