Holly Fernandez Lynch
@hollylynchez.bsky.social
Academic lawyer/bioethicist studying pharmaceutical policy, access to investigational medicines, IRB quality (www.aereo.org), and clinical research ethics and regulation, with a splash of psychedelics.
🚨 BIG BIG DEAL 🚨
The spokesperson's claim this delay is not political but bc "comprehensive scientific reviews take the time necessary to get the science right" is absurd. They claim to have figured out leucovorin + COVID vax deaths already. But they need more time on a drug as well studied as mife?
The spokesperson's claim this delay is not political but bc "comprehensive scientific reviews take the time necessary to get the science right" is absurd. They claim to have figured out leucovorin + COVID vax deaths already. But they need more time on a drug as well studied as mife?
The best reading of this article: Trump is going to use FDA to restrict medication abortion, but he wants to wait until after the midterms so the Republicans don't experience blowback. But that just makes the midterms more important. www.bloomberg.com/news/article...
FDA Slow Walking a Long-Awaited Abortion Pill Safety Study
The Food and Drug Administration has delayed a promised review of safety data for the abortion drug mifepristone at Commissioner Marty Makary’s request to put it off until after the midterm elections,...
www.bloomberg.com
December 8, 2025 at 11:40 PM
🚨 BIG BIG DEAL 🚨
The spokesperson's claim this delay is not political but bc "comprehensive scientific reviews take the time necessary to get the science right" is absurd. They claim to have figured out leucovorin + COVID vax deaths already. But they need more time on a drug as well studied as mife?
The spokesperson's claim this delay is not political but bc "comprehensive scientific reviews take the time necessary to get the science right" is absurd. They claim to have figured out leucovorin + COVID vax deaths already. But they need more time on a drug as well studied as mife?
And 2. This policymaking via journal article has to stop. This should be guidance w/ opportunity for public comment not just peer review. Guidance docs also have the benefit of being easily searchable on FDA's website.
By all means, write an article after a guidance, but stop flipping the order.
By all means, write an article after a guidance, but stop flipping the order.
December 8, 2025 at 6:30 PM
And 2. This policymaking via journal article has to stop. This should be guidance w/ opportunity for public comment not just peer review. Guidance docs also have the benefit of being easily searchable on FDA's website.
By all means, write an article after a guidance, but stop flipping the order.
By all means, write an article after a guidance, but stop flipping the order.
From CBER in JAMA:
Evidence-Based Trial Design for Chimeric Antigen Receptor T-Cell Therapy in Oncology
jamanetwork.com/journals/jam...
A few observations:
1. This is one of the 1st comments discussing accelerated approval/confirmatory studies I've seen out of this FDA (albeit limited to CAR-T)
Evidence-Based Trial Design for Chimeric Antigen Receptor T-Cell Therapy in Oncology
jamanetwork.com/journals/jam...
A few observations:
1. This is one of the 1st comments discussing accelerated approval/confirmatory studies I've seen out of this FDA (albeit limited to CAR-T)
Advancing CAR T-Cell Therapy
This Viewpoint discusses the recent decision by the US Food and Drug Administration to eliminate Risk Evaluation and Mitigation Strategies requirements for chimeric antigen receptor (CAR) T-cell thera...
jamanetwork.com
December 8, 2025 at 6:28 PM
From CBER in JAMA:
Evidence-Based Trial Design for Chimeric Antigen Receptor T-Cell Therapy in Oncology
jamanetwork.com/journals/jam...
A few observations:
1. This is one of the 1st comments discussing accelerated approval/confirmatory studies I've seen out of this FDA (albeit limited to CAR-T)
Evidence-Based Trial Design for Chimeric Antigen Receptor T-Cell Therapy in Oncology
jamanetwork.com/journals/jam...
A few observations:
1. This is one of the 1st comments discussing accelerated approval/confirmatory studies I've seen out of this FDA (albeit limited to CAR-T)
Reposted by Holly Fernandez Lynch
Justice Jackson to Solicitor General Sauer (just now, in Trump v. Slaughter arguments):
December 8, 2025 at 4:21 PM
Justice Jackson to Solicitor General Sauer (just now, in Trump v. Slaughter arguments):
Here, here.
"Congress must now also exercise its oversight responsibilities to ensure repairs to FDAs current and future capabilities, infrastructure, human resources, and reputation begin as soon as possible."
Big deal coming from investors/companies.
www.nopatientleftbehind.org/evidence-bas...
"Congress must now also exercise its oversight responsibilities to ensure repairs to FDAs current and future capabilities, infrastructure, human resources, and reputation begin as soon as possible."
Big deal coming from investors/companies.
www.nopatientleftbehind.org/evidence-bas...
Supporting the Call for Evidence-Based Policy and Public Health Security — No Patient Left Behind
www.nopatientleftbehind.org
December 7, 2025 at 8:58 PM
Here, here.
"Congress must now also exercise its oversight responsibilities to ensure repairs to FDAs current and future capabilities, infrastructure, human resources, and reputation begin as soon as possible."
Big deal coming from investors/companies.
www.nopatientleftbehind.org/evidence-bas...
"Congress must now also exercise its oversight responsibilities to ensure repairs to FDAs current and future capabilities, infrastructure, human resources, and reputation begin as soon as possible."
Big deal coming from investors/companies.
www.nopatientleftbehind.org/evidence-bas...
Excited to work with @pzettler.bsky.social and @reshmagar.bsky.social on this new project supported by @arnoldventures.bsky.social with the goal of developing a principles-based approach to rebuilding and re-envisioning FDA.
moritzlaw.osu.edu/ohio-state-a...
moritzlaw.osu.edu/ohio-state-a...
Ohio State and Partners Secure Grant to Inform Future Vision of FDA
Researchers at The Ohio State University Moritz College of Law and partner universities were recently awarded a grant from Arnold Ventures to support a multi-faceted research project, titled “A Princi...
moritzlaw.osu.edu
December 7, 2025 at 8:52 PM
Excited to work with @pzettler.bsky.social and @reshmagar.bsky.social on this new project supported by @arnoldventures.bsky.social with the goal of developing a principles-based approach to rebuilding and re-envisioning FDA.
moritzlaw.osu.edu/ohio-state-a...
moritzlaw.osu.edu/ohio-state-a...
Reposted by Holly Fernandez Lynch
This is just some petty and cruel shit. I was very proud to serve alongside Rachel Levine. She has more leadership, integrity, and expertise in her little finger than the entire RFK HHS crew does all together. www.npr.org/sections/sho...
HHS changed the name of transgender health leader on her official portrait
Admiral Rachel Levine was the first transgender person to be confirmed by the Senate to serve in the federal government. Her official portrait at HHS headquarters has been altered.
www.npr.org
December 5, 2025 at 10:56 PM
This is just some petty and cruel shit. I was very proud to serve alongside Rachel Levine. She has more leadership, integrity, and expertise in her little finger than the entire RFK HHS crew does all together. www.npr.org/sections/sho...
Reposted by Holly Fernandez Lynch
DFA applauds the 12 former FDA commissioners who came together to jointly publish this powerful NEJM article reaffirming the core principles of vaccine oversight. We commend and are encouraged by their strong statement defending scientific integrity.
www.nejm.org/doi/ful...
www.nejm.org/doi/ful...
December 5, 2025 at 8:50 PM
DFA applauds the 12 former FDA commissioners who came together to jointly publish this powerful NEJM article reaffirming the core principles of vaccine oversight. We commend and are encouraged by their strong statement defending scientific integrity.
www.nejm.org/doi/ful...
www.nejm.org/doi/ful...
Reposted by Holly Fernandez Lynch
I can't stop thinking about the purported drug smugglers being murdered by the US military. The punishment for drug offenses isn't the death penalty. This is just bloodlust and men in suits playing with lives they don't care about. It's truly grotesque and gravely compromises this country.
December 5, 2025 at 4:12 PM
I can't stop thinking about the purported drug smugglers being murdered by the US military. The punishment for drug offenses isn't the death penalty. This is just bloodlust and men in suits playing with lives they don't care about. It's truly grotesque and gravely compromises this country.
Reposted by Holly Fernandez Lynch
90% of senior FDA staff are gone. bsky.app/profile/pear...
Here's a link to the full BioSpace post: www.biospace.com/fda/pazdurs-...
Pazdur’s Sudden Exit Leaves Just Three Veterans in FDA’s Senior Ranks
Nearly 90% of senior leaders who were at the FDA a year ago are no longer with the agency, a BioSpace analysis shows. None remain from the Office of the Commissioner.
www.biospace.com
December 4, 2025 at 7:14 PM
90% of senior FDA staff are gone. bsky.app/profile/pear...
Reposted by Holly Fernandez Lynch
Not to detract from the important content of this essay, but I am so fascinated by its process.
Anyone who’s ever collaborated with a group knows how hard it can be to get coauthors to respond or contribute - let alone in the span of a weekend - and something from idea to print this fast!
Anyone who’s ever collaborated with a group knows how hard it can be to get coauthors to respond or contribute - let alone in the span of a weekend - and something from idea to print this fast!
12 former commissioners of the FDA came together to write a Perspectives piece for the New England Journal of Medicine; raising our concerns about recent changes to vaccine approval policy at the FDA and its implications for patients and public health.
December 4, 2025 at 11:32 AM
Not to detract from the important content of this essay, but I am so fascinated by its process.
Anyone who’s ever collaborated with a group knows how hard it can be to get coauthors to respond or contribute - let alone in the span of a weekend - and something from idea to print this fast!
Anyone who’s ever collaborated with a group knows how hard it can be to get coauthors to respond or contribute - let alone in the span of a weekend - and something from idea to print this fast!
Reposted by Holly Fernandez Lynch
Breaking news: A dozen former leaders of the FDA warned that plans for a stricter approach to vaccine approvals risks undermining the nation’s ability to fight infectious diseases and could threaten the health of vulnerable Americans.
A dozen former FDA commissioners condemn plan to tighten vaccine approvals
In a New England Journal of Medicine article, the former FDA commissioners wrote they were “deeply concerned” by the top vaccine regulator’s approach to raising the bar for approvals.
wapo.st
December 3, 2025 at 10:06 PM
Breaking news: A dozen former leaders of the FDA warned that plans for a stricter approach to vaccine approvals risks undermining the nation’s ability to fight infectious diseases and could threaten the health of vulnerable Americans.
Reposted by Holly Fernandez Lynch
Imagine doing something at work so troubling that virtually every person alive who ever had your boss’s job spent their Thanksgiving weekend writing something that explained to the world how wrong you are and how harmful—deadly, even—it would be if you weren’t stopped.
December 4, 2025 at 12:27 AM
Imagine doing something at work so troubling that virtually every person alive who ever had your boss’s job spent their Thanksgiving weekend writing something that explained to the world how wrong you are and how harmful—deadly, even—it would be if you weren’t stopped.
Story now updated w/ the answer:
"Three sources close to Pazdur told STAT that concerns about the legality of a new drug review program, Makary and Prasad inserting themselves into drug review decisions, and Makary’s efforts to handpick hires for CDER contributed to Pazdur’s decision to leave."
"Three sources close to Pazdur told STAT that concerns about the legality of a new drug review program, Makary and Prasad inserting themselves into drug review decisions, and Makary’s efforts to handpick hires for CDER contributed to Pazdur’s decision to leave."
Was it Prasad's Friday vaccine email? Was it the politicized review process established for the national priority voucher products? Or some other bridge too far that hasn't yet come to light? A huge loss for the American public, which was set to benefit from a quarter century of Pazdur's experience.
BREAKING scoop: Top drug regulator Rick Pazdur filed papers to retire from the FDA at the end of this month, according to agency sources. He alerted leaders at the drug center this morning. He could still withdraw the papers. www.statnews.com/2025/12/02/r...
December 2, 2025 at 10:53 PM
Story now updated w/ the answer:
"Three sources close to Pazdur told STAT that concerns about the legality of a new drug review program, Makary and Prasad inserting themselves into drug review decisions, and Makary’s efforts to handpick hires for CDER contributed to Pazdur’s decision to leave."
"Three sources close to Pazdur told STAT that concerns about the legality of a new drug review program, Makary and Prasad inserting themselves into drug review decisions, and Makary’s efforts to handpick hires for CDER contributed to Pazdur’s decision to leave."
Reposted by Holly Fernandez Lynch
Smack between a Scaramucci and a head of lettuce.
BREAKING scoop: Top drug regulator Rick Pazdur filed papers to retire from the FDA at the end of this month, according to agency sources. He alerted leaders at the drug center this morning. He could still withdraw the papers. www.statnews.com/2025/12/02/r...
Top drug regulator Richard Pazdur set to leave FDA
Top drug regulator Richard Pazdur filed papers to retire from the Food and Drug Administration at the end of this month, but could withdraw them.
www.statnews.com
December 2, 2025 at 6:53 PM
Smack between a Scaramucci and a head of lettuce.
Was it Prasad's Friday vaccine email? Was it the politicized review process established for the national priority voucher products? Or some other bridge too far that hasn't yet come to light? A huge loss for the American public, which was set to benefit from a quarter century of Pazdur's experience.
BREAKING scoop: Top drug regulator Rick Pazdur filed papers to retire from the FDA at the end of this month, according to agency sources. He alerted leaders at the drug center this morning. He could still withdraw the papers. www.statnews.com/2025/12/02/r...
Top drug regulator Richard Pazdur set to leave FDA
Top drug regulator Richard Pazdur filed papers to retire from the Food and Drug Administration at the end of this month, but could withdraw them.
www.statnews.com
December 2, 2025 at 5:37 PM
Was it Prasad's Friday vaccine email? Was it the politicized review process established for the national priority voucher products? Or some other bridge too far that hasn't yet come to light? A huge loss for the American public, which was set to benefit from a quarter century of Pazdur's experience.
Reposted by Holly Fernandez Lynch
This Giving Tuesday, we are so close to our stretch goal! Help support the American Society of Law, Medicine & Ethics as it produces this journal, puts on great events like the Health Law Professors Conference, and otherwise supports the field.
#GivingTuesday
aslme.org/donations/
#GivingTuesday
aslme.org/donations/
Giving Tuesday - ASLME
This Giving Tuesday, help us reach our fundraising goal of $15,000 (we’re almost there!) Thanks to generous donations, we have […]
aslme.org
December 2, 2025 at 2:31 PM
This Giving Tuesday, we are so close to our stretch goal! Help support the American Society of Law, Medicine & Ethics as it produces this journal, puts on great events like the Health Law Professors Conference, and otherwise supports the field.
#GivingTuesday
aslme.org/donations/
#GivingTuesday
aslme.org/donations/
Reposted by Holly Fernandez Lynch
Kelly: He runs around on stage talking about lethality and the warrior ethos.. That’s not the message that should be coming from the Secretary of Defense… He runs around on a stage like he’s a 12 year old playing army. It’s embarrassing.
December 1, 2025 at 9:12 PM
Kelly: He runs around on stage talking about lethality and the warrior ethos.. That’s not the message that should be coming from the Secretary of Defense… He runs around on a stage like he’s a 12 year old playing army. It’s embarrassing.
W/o showing his work, Prasad blames at least 10 pediatric deaths on the COVID vax.
Meanwhile, a "2023 JAMA paper said that during the 12 months ending in July 2022, 821 people aged 19 and under died of Covid." The authors also indicated that was an underestimate.
www.statnews.com/2025/11/29/c...
Meanwhile, a "2023 JAMA paper said that during the 12 months ending in July 2022, 821 people aged 19 and under died of Covid." The authors also indicated that was an underestimate.
www.statnews.com/2025/11/29/c...
Experts say top FDA official’s claim that Covid vaccines caused kids’ deaths requires more evidence
The FDA’s top vaccine regulator asserted in a staff email that the Covid vaccine caused at least 10 kids' deaths, but experts told STAT they are skeptical of the “extraordinary” claim because it was n...
www.statnews.com
November 30, 2025 at 12:13 PM
W/o showing his work, Prasad blames at least 10 pediatric deaths on the COVID vax.
Meanwhile, a "2023 JAMA paper said that during the 12 months ending in July 2022, 821 people aged 19 and under died of Covid." The authors also indicated that was an underestimate.
www.statnews.com/2025/11/29/c...
Meanwhile, a "2023 JAMA paper said that during the 12 months ending in July 2022, 821 people aged 19 and under died of Covid." The authors also indicated that was an underestimate.
www.statnews.com/2025/11/29/c...
Reposted by Holly Fernandez Lynch
November 29, 2025 at 2:05 PM
Great opportunity for the right person!
🚨We're hiring! A tenure track position at McGill University in the area of #bioethics and / or philosophy of science, with a special focus on the ethics of medical technologies. Please share widely. #philsky #ethics #philsci philjobs.org/job/show/30402
Assistant Professor (Tenure Track), Department of Equity, Ethics, and Policy and Department of Philosophy, McGill University
- PhilJobs:JFP
Assistant Professor (Tenure Track), Department of Equity...
An international database of jobs for philosophers
philjobs.org
November 25, 2025 at 4:33 PM
Great opportunity for the right person!
Must read from @sarahkarlin-smith.bsky.social.
Prasad will pause+review all basic science research happening at CBER initiated before he came, insinuating its researchers haven't been doing "honest work." How much more abuse can FDA staff be expected to take?
insights.citeline.com/pink-sheet/a...
Prasad will pause+review all basic science research happening at CBER initiated before he came, insinuating its researchers haven't been doing "honest work." How much more abuse can FDA staff be expected to take?
insights.citeline.com/pink-sheet/a...
CBER Poised for Research Shakeup As Prasad Makes Unproven Claims About ‘Polluted Science’
In an email to staff filled with unsupported accusations about the quality of the center’s research, CBER Director Vinay Prasad said no resources or time should be spent on ongoing projects started be...
insights.citeline.com
November 24, 2025 at 11:40 PM
Must read from @sarahkarlin-smith.bsky.social.
Prasad will pause+review all basic science research happening at CBER initiated before he came, insinuating its researchers haven't been doing "honest work." How much more abuse can FDA staff be expected to take?
insights.citeline.com/pink-sheet/a...
Prasad will pause+review all basic science research happening at CBER initiated before he came, insinuating its researchers haven't been doing "honest work." How much more abuse can FDA staff be expected to take?
insights.citeline.com/pink-sheet/a...
“You are taking the decision away from the reviewers, and you’re putting it in the hands of the political leaders of FDA,” Fernandez Lynch said.
It doesn't take an expert to understand how bad this is. More great reporting from @lizzylawrence.bsky.social
www.statnews.com/2025/11/21/t...
It doesn't take an expert to understand how bad this is. More great reporting from @lizzylawrence.bsky.social
www.statnews.com/2025/11/21/t...
FDA review staff was excluded from voting on whether to approve first priority voucher drug
Top officials like Vinay Prasad and George Tidmarsh voted on the drug, a major break from the FDA's typical practice.
www.statnews.com
November 24, 2025 at 4:31 PM
“You are taking the decision away from the reviewers, and you’re putting it in the hands of the political leaders of FDA,” Fernandez Lynch said.
It doesn't take an expert to understand how bad this is. More great reporting from @lizzylawrence.bsky.social
www.statnews.com/2025/11/21/t...
It doesn't take an expert to understand how bad this is. More great reporting from @lizzylawrence.bsky.social
www.statnews.com/2025/11/21/t...
Terrible if true. I worked for Dr. Dieffenbach in my first job as a card-carrying bioethicist in the Human Subjects Protection Branch at DAIDS in 2009. He was thoughtful about ethical challenges in int'l HIV treatment/prevention research and valued our role even when we asked hard questions.
Hearing news that Carl Dieffenbach, the Director of the Division of AIDS at #NIH (NIAID), has been removed from his position because he was "not aligned with HHS/OMB."
Russell Vought continues to remove great scientists as part of the Project 2025 mission to politicize and destroy NIH.
🧪 1/
Russell Vought continues to remove great scientists as part of the Project 2025 mission to politicize and destroy NIH.
🧪 1/
November 24, 2025 at 4:43 AM
Terrible if true. I worked for Dr. Dieffenbach in my first job as a card-carrying bioethicist in the Human Subjects Protection Branch at DAIDS in 2009. He was thoughtful about ethical challenges in int'l HIV treatment/prevention research and valued our role even when we asked hard questions.
The FDA news just will not stop.
I hope Pazdur is able to (last long enough) to draw on his vast regulatory experience to protect the FDA's core mission.
I hope Pazdur is able to (last long enough) to draw on his vast regulatory experience to protect the FDA's core mission.
exclusive: Rick Pazdur, the official just tapped by Trump administration to be FDA's top drug regulator has privately warned that some of the agency's new initiatives could be illegal and dangerous.
w @rachelroubein.bsky.social
w @rachelroubein.bsky.social
Top FDA drug regulator raises alarms about expediting approvals
Richard Pazdur, who assumed his new role this month, has warned that new Trump administration initiatives could be illegal and pose a risk to public health.
www.washingtonpost.com
November 21, 2025 at 10:59 PM
The FDA news just will not stop.
I hope Pazdur is able to (last long enough) to draw on his vast regulatory experience to protect the FDA's core mission.
I hope Pazdur is able to (last long enough) to draw on his vast regulatory experience to protect the FDA's core mission.