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.
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...
Reposted by Holly Fernandez Lynch
Long story, short: We found that looking at years of new drug and biologic approvals, that just over half were based on single pivotal trials and only a few explicitly or implicitly referenced confirmatory evidence supporting that single pivotal trial. (4/8)
November 3, 2025 at 6:35 PM
Long story, short: We found that looking at years of new drug and biologic approvals, that just over half were based on single pivotal trials and only a few explicitly or implicitly referenced confirmatory evidence supporting that single pivotal trial. (4/8)
Bad to much worse:
www.statnews.com/2025/11/03/g...
When NYT broke news of Tidmarsh's leave, it seemed maybe he was being retaliated against for criticizing commissioner's vouchers. Now it seems he may have used his FDA role for personal vendettas+possible extortion. The civil complaint is shocking.
www.statnews.com/2025/11/03/g...
When NYT broke news of Tidmarsh's leave, it seemed maybe he was being retaliated against for criticizing commissioner's vouchers. Now it seems he may have used his FDA role for personal vendettas+possible extortion. The civil complaint is shocking.
Lawsuit against top FDA drug regulator is packed with incendiary texts, emails
A lawsuit filed against George Tidmarsh, who resigned from a top FDA post on Sunday, includes a series of incendiary texts and emails
www.statnews.com
November 3, 2025 at 5:47 PM
Bad to much worse:
www.statnews.com/2025/11/03/g...
When NYT broke news of Tidmarsh's leave, it seemed maybe he was being retaliated against for criticizing commissioner's vouchers. Now it seems he may have used his FDA role for personal vendettas+possible extortion. The civil complaint is shocking.
www.statnews.com/2025/11/03/g...
When NYT broke news of Tidmarsh's leave, it seemed maybe he was being retaliated against for criticizing commissioner's vouchers. Now it seems he may have used his FDA role for personal vendettas+possible extortion. The civil complaint is shocking.
The details here get worse and worse. To state the obvious, this is not how a functioning agency works.
Exclusive details in the STAT story, with this tidbit from an email:
“Let me be clear,” FDA CBER's Vinay Prasad wrote. “If you continue to choose not to do what I tell you. I will spend all of my political capital gets [sic] you fired.”
“Let me be clear,” FDA CBER's Vinay Prasad wrote. “If you continue to choose not to do what I tell you. I will spend all of my political capital gets [sic] you fired.”
Story has more details now about Tidmarsh's feud with biotech investor Kevin Tang. Tang's company sued Tidmarsh today, accusing him of a "longstanding personal vendetta":
November 3, 2025 at 12:44 AM
The details here get worse and worse. To state the obvious, this is not how a functioning agency works.
Tidmarsh posted on LinkedIn w/ fair concerns abt how FDA uses surrogate endpts. But the drug example he named didn't make sense, except maybe for Tidmarsh's personal connection to that drugmaker's board chair...who has now filed a complaint w/ FDA, after the post caused the co's stock to drop 16%.
November 2, 2025 at 10:17 PM
Tidmarsh posted on LinkedIn w/ fair concerns abt how FDA uses surrogate endpts. But the drug example he named didn't make sense, except maybe for Tidmarsh's personal connection to that drugmaker's board chair...who has now filed a complaint w/ FDA, after the post caused the co's stock to drop 16%.
FDA has fallen so far, so quickly.
www.nytimes.com/2025/11/02/h...
www.nytimes.com/2025/11/02/h...
F.D.A. Drug Unit Chief Is Placed on Leave, and Cites a ‘Toxic’ Environment
www.nytimes.com
November 2, 2025 at 9:53 PM
FDA has fallen so far, so quickly.
www.nytimes.com/2025/11/02/h...
www.nytimes.com/2025/11/02/h...
Ah yes, the American health care system. Where you just ring up your friend the president for help scheduling your IV.
"I will ask President Trump if he can get Kaiser of Northern California to respond and schedule it for Monday."
Rest assured, Trump is "on it."
"I will ask President Trump if he can get Kaiser of Northern California to respond and schedule it for Monday."
Rest assured, Trump is "on it."
Trump says he will help ‘Dilbert’ creator @ScottAdamsSays get cancer drug after report of access issue. Via @chelseacirruzzo.bsky.social
www.statnews.com/2025/11/02/s...
www.statnews.com/2025/11/02/s...
Trump says he will help ‘Dilbert’ creator get cancer drug
Trump posted on Truth Social that he will help Scott Adams of ‘Dilbert’ fame access Pluvicto.
www.statnews.com
November 2, 2025 at 8:27 PM
Ah yes, the American health care system. Where you just ring up your friend the president for help scheduling your IV.
"I will ask President Trump if he can get Kaiser of Northern California to respond and schedule it for Monday."
Rest assured, Trump is "on it."
"I will ask President Trump if he can get Kaiser of Northern California to respond and schedule it for Monday."
Rest assured, Trump is "on it."
"We crave simple solutions to complex problems. When data disappoint, we substitute belief. . . . Regulators see public demand and think, why stand in the way? The phrase 'worth a try' becomes federal policy."
www.statnews.com/2025/11/02/q... via @statnews.com
www.statnews.com/2025/11/02/q... via @statnews.com
A sports device to ‘protect the brain’ illustrates a major problem with the FDA de novo pathway
“This is not just about one device. It’s about what happens when institutions grow comfortable living in their own ambiguity and hiding behind opacity.”
www.statnews.com
November 2, 2025 at 1:39 PM
"We crave simple solutions to complex problems. When data disappoint, we substitute belief. . . . Regulators see public demand and think, why stand in the way? The phrase 'worth a try' becomes federal policy."
www.statnews.com/2025/11/02/q... via @statnews.com
www.statnews.com/2025/11/02/q... via @statnews.com
Fantastic article about efforts to create global deregulatory zones for medical research, which seem best at creating conditions to exploit wealthy medical tourists and very bad at producing a shred of decent clinical evidence.
I went to a pop-up city on an island off the coast of Honduras, which bills itself as a hub for fast-tracking longevity drugs. I wrote about what I found there for @newrepublic.com: newrepublic.com/article/2011...
The Island Where People Go to Cheat Death
In a pop-up city off the coast of Honduras, longevity startups are trying to fast-track anti-aging drugs. Is this the future of medical research?
newrepublic.com
November 1, 2025 at 10:55 AM
Fantastic article about efforts to create global deregulatory zones for medical research, which seem best at creating conditions to exploit wealthy medical tourists and very bad at producing a shred of decent clinical evidence.
Reposted by Holly Fernandez Lynch
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.
October 29, 2025 at 8:38 PM
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.
These recurring stories are heartbreakingly awful every single time.
A Teen in Love With a Chatbot Killed Himself. Can the Chatbot Be Held Responsible? www.nytimes.com/2025/10/24/m...
A Teen in Love With a Chatbot Killed Himself. Can the Chatbot Be Held Responsible?
www.nytimes.com
October 27, 2025 at 3:50 PM
These recurring stories are heartbreakingly awful every single time.
Reposted by Holly Fernandez Lynch
Looking forward to Health Law Profs 2026! See you in Atlanta.
The Call for Abstracts for the 2026 Health Law Professors Conference is now open! Proposals are due by January 31, 2026. We've added a new format called Round Tables.
The conference will be held June 3–5, 2026, at Georgia State University College of Law in Atlanta.
forms.office.com/Pages/Respon...
The conference will be held June 3–5, 2026, at Georgia State University College of Law in Atlanta.
forms.office.com/Pages/Respon...
Microsoft Forms
forms.office.com
October 23, 2025 at 1:43 PM
Looking forward to Health Law Profs 2026! See you in Atlanta.
This is a fantastic, well-supported 3-year post-doc in our Division of Medical Ethics at Penn. Please share (and apply if interested!)
1/ Thrilled to announce that @pennmehp.bsky.social is recruiting for our NHGRI-funded postdoctoral fellowship in the ethical, legal, and social implications (ELSI) of genomics. Please share widely.
Details at medicalethicshealthpolicy.med.upenn.edu/elsipostdoc
Details at medicalethicshealthpolicy.med.upenn.edu/elsipostdoc
Penn Medical Ethics and Health Policy | ELSI Genomics Postdoctoral Training Program
About the Fellowship
The mission of the 3-year Penn Postdoctoral Training Program in the Ethical, Legal and Social Implications (ELSI) of Genetics and Genomics, supported by a training grant from...
medicalethicshealthpolicy.med.upenn.edu
October 23, 2025 at 9:45 AM
This is a fantastic, well-supported 3-year post-doc in our Division of Medical Ethics at Penn. Please share (and apply if interested!)
This is a screen grab from yesterday's FDA Direct podcast with Makary + Prasad. The rest of the podcast was off the wall, but this part gets it exactly right. I just want to understand how they square this with what Makary did for leucovorin.
www.fda.gov/news-events/...
www.fda.gov/news-events/...
October 22, 2025 at 1:02 PM
This is a screen grab from yesterday's FDA Direct podcast with Makary + Prasad. The rest of the podcast was off the wall, but this part gets it exactly right. I just want to understand how they square this with what Makary did for leucovorin.
www.fda.gov/news-events/...
www.fda.gov/news-events/...
Reposted by Holly Fernandez Lynch
My department is hiring in Bioethics at the rank of Associate or Full Prof... Please take a look.
philjobs.org/job/show/30182
philjobs.org/job/show/30182
Associate or Full Professor of Philosophy, Vanderbilt University
- PhilJobs:JFP
Associate or Full Professor of Philosophy, Vanderbilt University
An international database of jobs for philosophers
philjobs.org
October 21, 2025 at 9:15 PM
My department is hiring in Bioethics at the rank of Associate or Full Prof... Please take a look.
philjobs.org/job/show/30182
philjobs.org/job/show/30182
Reposted by Holly Fernandez Lynch
Wow. Harvard nuking its PhD programs
- Science PhD admissions reduced by more than 75%
- Arts & Humanities reduced by about 60%
- Social Sciences by 50–70%
- History by 60%
- Biology by 75%
- The German department will lose all PhD seats
- Sociology from six PhD students to zero
- Science PhD admissions reduced by more than 75%
- Arts & Humanities reduced by about 60%
- Social Sciences by 50–70%
- History by 60%
- Biology by 75%
- The German department will lose all PhD seats
- Sociology from six PhD students to zero
Harvard FAS Cuts Ph.D. Seats By More Than Half Across Next Two Admissions Cycles | News | The Harvard Crimson
The Faculty of Arts and Sciences slashed the number of Ph.D. student admissions slots for the Science division by more than 75 percent and for the Arts & Humanities division by about 60 percent for th...
www.thecrimson.com
October 21, 2025 at 5:11 PM
Wow. Harvard nuking its PhD programs
- Science PhD admissions reduced by more than 75%
- Arts & Humanities reduced by about 60%
- Social Sciences by 50–70%
- History by 60%
- Biology by 75%
- The German department will lose all PhD seats
- Sociology from six PhD students to zero
- Science PhD admissions reduced by more than 75%
- Arts & Humanities reduced by about 60%
- Social Sciences by 50–70%
- History by 60%
- Biology by 75%
- The German department will lose all PhD seats
- Sociology from six PhD students to zero
Looking forward to joining this panel discussion on November 5.
petrieflom.law.harvard.edu/events/detai...
petrieflom.law.harvard.edu/events/detai...
October 20, 2025 at 10:44 PM
Looking forward to joining this panel discussion on November 5.
petrieflom.law.harvard.edu/events/detai...
petrieflom.law.harvard.edu/events/detai...