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.
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.
Reposted by Holly Fernandez Lynch
A reporter asks if Mamdani stands by calling Trump a fascist. Mamdani starts to give a delicate answer.
Trump (smiles, pats Mamdani's arm): "That's OK, you can just say yes. It's easier. I don't mind."
Trump (smiles, pats Mamdani's arm): "That's OK, you can just say yes. It's easier. I don't mind."
November 21, 2025 at 8:53 PM
A reporter asks if Mamdani stands by calling Trump a fascist. Mamdani starts to give a delicate answer.
Trump (smiles, pats Mamdani's arm): "That's OK, you can just say yes. It's easier. I don't mind."
Trump (smiles, pats Mamdani's arm): "That's OK, you can just say yes. It's easier. I don't mind."
When @reshmagar.bsky.social + I called for FDA to diffuse authority for drug approval decisions, this is NOT what we meant.
Approval decisions should be made by those closest to the data regarding safety and effectiveness, with every possible effort to avoid real or perceived political influence.
Approval decisions should be made by those closest to the data regarding safety and effectiveness, with every possible effort to avoid real or perceived political influence.
NEW: FDA review staff was excluded from voting on whether to approve first priority voucher drug. Top leaders like Vinay Prasad, George Tidmarsh, and Tracy Høeg led the vote instead. Read for the full list, and expert reaction from @hollylynchez.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 21, 2025 at 9:30 PM
When @reshmagar.bsky.social + I called for FDA to diffuse authority for drug approval decisions, this is NOT what we meant.
Approval decisions should be made by those closest to the data regarding safety and effectiveness, with every possible effort to avoid real or perceived political influence.
Approval decisions should be made by those closest to the data regarding safety and effectiveness, with every possible effort to avoid real or perceived political influence.
"things happen"
Trump suggests Khashoggi had it coming: "You're mentioning someone that was extremely controversial. A lot of people didn't like that gentleman that you're talking about. Whether you like him or didn't like him, things happen. But he knew nothing about it. You don't have to embarrass our guest."
November 18, 2025 at 8:18 PM
"things happen"
Reposted by Holly Fernandez Lynch
I will never forget having to edit Jamal’s final, posthumous piece for the Washington Post, after he was murdered.
He was calling for free expression in the Arab world. You can read it here :
www.washingtonpost.com/opinions/glo...
He was calling for free expression in the Arab world. You can read it here :
www.washingtonpost.com/opinions/glo...
Opinion | Jamal Khashoggi: What the Arab world needs most is free expression
The Arab world needs a modern version of the old transnational media so citizens can be informed about global events.
www.washingtonpost.com
November 18, 2025 at 6:48 PM
I will never forget having to edit Jamal’s final, posthumous piece for the Washington Post, after he was murdered.
He was calling for free expression in the Arab world. You can read it here :
www.washingtonpost.com/opinions/glo...
He was calling for free expression in the Arab world. You can read it here :
www.washingtonpost.com/opinions/glo...
"This is wrong."
I wanted to share probably the most important sermon I’ve given and it’s while I’m being arrested. It’s torture pure and simple what happens at #Broadview. I’m ok, though I was thrown to the ground and choked with my pectoral cross. A review of the video shows I was peaceful - did I deserve this?
November 17, 2025 at 2:13 PM
"This is wrong."
Context was AI therapy but this is a perfect summation of why strong FDA standards are critical across the healthcare space.
“We like regulation, because we think this is a regulated industry...It’s healthcare, it’s not wellness, and the stakes are incredibly high, and really what we want are national frameworks that help separate the good, evidence-based solutions from the snake oil.”
www.statnews.com/2025/11/05/f...
www.statnews.com/2025/11/05/f...
FDA digital advisers confront risks of therapy chatbots, weigh possible regulation
FDA's digital advisors could nudge the agency to clarify how its rules apply to medical applications of generative AI, including therapy chatbots.
www.statnews.com
November 13, 2025 at 4:27 PM
Context was AI therapy but this is a perfect summation of why strong FDA standards are critical across the healthcare space.
“We like regulation, because we think this is a regulated industry...It’s healthcare, it’s not wellness, and the stakes are incredibly high, and really what we want are national frameworks that help separate the good, evidence-based solutions from the snake oil.”
www.statnews.com/2025/11/05/f...
www.statnews.com/2025/11/05/f...
FDA digital advisers confront risks of therapy chatbots, weigh possible regulation
FDA's digital advisors could nudge the agency to clarify how its rules apply to medical applications of generative AI, including therapy chatbots.
www.statnews.com
November 13, 2025 at 4:26 PM
“We like regulation, because we think this is a regulated industry...It’s healthcare, it’s not wellness, and the stakes are incredibly high, and really what we want are national frameworks that help separate the good, evidence-based solutions from the snake oil.”
www.statnews.com/2025/11/05/f...
www.statnews.com/2025/11/05/f...
This is a strong model for individualized genetic interventions. But setting policy via NEJM article is unwise.
Personalized therapies hold tremendous promise but challenge traditional models of drug and biologic development. The @fda.gov outlines a path to market entry for products where a randomized trial is not feasible. Learn more: nej.md/4nUQdcl
November 13, 2025 at 12:54 AM
This is a strong model for individualized genetic interventions. But setting policy via NEJM article is unwise.
Reposted by Holly Fernandez Lynch
Great article describing how young women cope with ALS in their own way. The Young Women Grappling With an ‘Old Man’s Disease’ www.nytimes.com/2025/11/11/h...
The Young Women Grappling With an ‘Old Man’s Disease’
www.nytimes.com
November 12, 2025 at 3:58 AM
Great article describing how young women cope with ALS in their own way. The Young Women Grappling With an ‘Old Man’s Disease’ www.nytimes.com/2025/11/11/h...
“We can have an active, robust discussion as a group of medical experts spontaneously, and so we’re doing more of that,” Makary said of his preference for convening roundtables.
Guess what roundtables don't have? FACA requirements to occur in public with the opportunity for public comment.
Guess what roundtables don't have? FACA requirements to occur in public with the opportunity for public comment.
November 11, 2025 at 11:23 PM
“We can have an active, robust discussion as a group of medical experts spontaneously, and so we’re doing more of that,” Makary said of his preference for convening roundtables.
Guess what roundtables don't have? FACA requirements to occur in public with the opportunity for public comment.
Guess what roundtables don't have? FACA requirements to occur in public with the opportunity for public comment.
From Paul Kim on leucovorin: "Proffering a proactive guarantee of approval on the basis of a limited, non-trial-based dossier effectively broadcasts that the FDA is prepared to approve new drugs without clinical trials."
www.milbank.org/quarterly/op...
www.milbank.org/quarterly/op...
The New Politics of New Drug Approval | Milbank Memorial Fund
As feared at the start of the second Trump Administration, the Food and Drug Administration (FDA) has proven a willing good soldier in fulfilling the
www.milbank.org
November 11, 2025 at 10:53 AM
From Paul Kim on leucovorin: "Proffering a proactive guarantee of approval on the basis of a limited, non-trial-based dossier effectively broadcasts that the FDA is prepared to approve new drugs without clinical trials."
www.milbank.org/quarterly/op...
www.milbank.org/quarterly/op...
Reposted by Holly Fernandez Lynch
Tell me you don’t understand risk pools without telling me you don’t understand risk pools
November 10, 2025 at 3:02 PM
Tell me you don’t understand risk pools without telling me you don’t understand risk pools
Fellow Pennsylvanians, go vote yes!
Pennsylvania has an important Supreme Court race coming up on Tuesday, November 4. If you live in the Keystone State, or know someone who does, vote YES to retain three justices who will protect your fundamental rights and freedoms.
November 4, 2025 at 12:48 PM
Fellow Pennsylvanians, go vote yes!
Deadline extended to 11/10! Consider nominating yourself or a colleague to join ASLME's board. It's an exciting time for the org and we're looking for "ideas people," those w/ strong governance experience, and committed leaders at the intersection of law, med, and ethics.
aslme.org/nominate-som...
aslme.org/nominate-som...
November 4, 2025 at 12:13 PM
Deadline extended to 11/10! Consider nominating yourself or a colleague to join ASLME's board. It's an exciting time for the org and we're looking for "ideas people," those w/ strong governance experience, and committed leaders at the intersection of law, med, and ethics.
aslme.org/nominate-som...
aslme.org/nominate-som...
Looking forward to discussing these issues tomorrow: petrieflom.law.harvard.edu/events/detai...
November 4, 2025 at 12:06 PM
Looking forward to discussing these issues tomorrow: petrieflom.law.harvard.edu/events/detai...
It perplexes me why those who make med claims for psychedelics sometimes object to holding them to the same standard as other drugs. The unmet need is great but that's true for many diseases. Still impt to prove safety+effectiveness. (Largely agree w/ this piece)
www.statnews.com/2025/10/30/f...
www.statnews.com/2025/10/30/f...
FDA criticism of MDMA-assisted therapy is an opportunity for psychedelic medicine
“The Lykos CRL doesn’t close the door to psychedelic medicine. It shows us what needs to improve.”
www.statnews.com
November 4, 2025 at 11:57 AM
It perplexes me why those who make med claims for psychedelics sometimes object to holding them to the same standard as other drugs. The unmet need is great but that's true for many diseases. Still impt to prove safety+effectiveness. (Largely agree w/ this piece)
www.statnews.com/2025/10/30/f...
www.statnews.com/2025/10/30/f...
"Now, we have FDA ‘Mean Girls’ burn books happening out in the open"
www.statnews.com/2025/11/04/f...
www.statnews.com/2025/11/04/f...
Experts worry FDA’s credibility is being shredded by scandal and 'soap opera'
Experts worry that the FDA’s credibility is being shredded by scandal and "soap opera."
www.statnews.com
November 4, 2025 at 11:40 AM
"Now, we have FDA ‘Mean Girls’ burn books happening out in the open"
www.statnews.com/2025/11/04/f...
www.statnews.com/2025/11/04/f...
We've been here before but let's see how FDA responds this time w/ Prasad wielding his influence. (I'm sure WSJ ed board + Loomer are already drafting their 2 cents...)
"Sarepta's Duchenne confirmatory trial fails, but biotech will ask FDA for full approval anyways"
endpoints.news/duchenne-con...
"Sarepta's Duchenne confirmatory trial fails, but biotech will ask FDA for full approval anyways"
endpoints.news/duchenne-con...
November 4, 2025 at 1:26 AM
We've been here before but let's see how FDA responds this time w/ Prasad wielding his influence. (I'm sure WSJ ed board + Loomer are already drafting their 2 cents...)
"Sarepta's Duchenne confirmatory trial fails, but biotech will ask FDA for full approval anyways"
endpoints.news/duchenne-con...
"Sarepta's Duchenne confirmatory trial fails, but biotech will ask FDA for full approval anyways"
endpoints.news/duchenne-con...