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...

“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...

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.

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."

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.

"things happen"

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...

"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...

This is a strong model for individualized genetic interventions. But setting policy via NEJM article is unwise.

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.

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...

Tell me you don’t understand risk pools without telling me you don’t understand risk pools

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...

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...

"Now, we have FDA ‘Mean Girls’ burn books happening out in the open" 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...

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.

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%.

FDA has fallen so far, so quickly. 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."

"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

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.

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.

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!)

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/...

My department is hiring in Bioethics at the rank of Associate or Full Prof... Please take a look. philjobs.org/job/show/30182

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

Looking forward to joining this panel discussion on November 5. petrieflom.law.harvard.edu/events/detai...

FDA review of drugs is slowing while application delays are growing, analysis finds www.statnews.com/pharmalot/20... via @statnews.com

In this am's @latimes.com, @reshmagar.bsky.social + I have an op-ed raising concerns abt pressure to approve rare disease drugs no matter how weak the evidence. Flexibility is reasonable but FDA approval must mean more than “this drug has not been shown not to work." www.latimes.com/opinion/stor...

Giant copy of the Constitution being carried down Pennsylvania Avenue.

This whole IVF fig leaf is wild to me because there's no way a standalone IVF benefit can make financial sense to employers — it's the opposite of an insurable risk (only people who know they need it will opt in) When built into an health insurance (not standalone) you get some risk pooling

Corrected link here: doi.org/10.1017/jme....

Our article, "Addressing US Demand for Psychedelic Medicines in the Face of Scientific Uncertainty," is out now in @jlme-journal.bsky.social. The thesis is simple: when psychedelics are being pursued for medical use, they should be regulated like other medicines. www.cambridge.org/core/journal...

yes one initial reaction we had was rare disease community was probably going to be disappointed.

Trump's big IVF announcement is a retreat from his campaign promise. It doesn't make IVF available for all. 1. Employers don't have to offer the "fertility benefit" it creates 2. The benefit doesn't have to cover IVF 3. It could cover the conservative alternatives criticized by mainstream med