You. Are. Allowed. To. Insult. The. Police. It’s a core First Amendment principle. This is utterly lawless behavior, for which there will be no (short-term) consequences. That he does it so casually, as they are walking away, in front of cameras. Rightly confident in his impunity.

“If you are just focused on [IRB] turnaround time, that doesn’t tell you really anything about quality,” said Holly Fernandez Lynch . . . She added: “It inhibits people from saying, ‘Wait, we need to pause on this. Is this the right thing to do?’” www.nytimes.com/2025/10/04/h...

Among all the lawlessness we're seeing, it's worth noting that those upset over FDA's approval of a third generic version of mifepristone are literally calling on FDA to violate the law. www.politico.com/news/2025/10...

Read the "compact": www.washingtonexaminer.com/wp-content/u... Then this spot on analysis: www.nytimes.com/2025/10/02/o...

It "offers an edge" like a gun wielding mugger offers "an edge" on staying alive if you hand over your $. We're talking about student loans, grants, contracts, visas, nonprofit status - those are the benefits Trump says schools are free to "forego" if they reject the compact. Try surviving w/o them!

Terribly pernicious framing from @washingtonpost.com: "A new proposal from the Trump administration would give colleges funding advantages if they adopt conservative priorities." It's not a funding advantage, it's utter destruction of schools that refuse. www.washingtonpost.com/education/20...

New Yorker cartoon. “. . . and then Randy Quaid yells, ‘Hello, boys, I’m back!,’ and flies his jet right into the alien ship, blowing it up, and I think you all just need to be more like that.”

I work with Veterans. If I told them that they "killed people and broke things for a living" they would (rightfully) tell me to go to hell. Those that have had to kill someone in the line of duty most often view it with sadness, regret, and one of the worst experiences of their lives.

With @pennmedicine.bsky.social MD student, Caleb Rhodes, and @reshmagar.bsky.social, I have a new paper in @natmed.nature.com arguing that drug approval (or rejection) decisions are too complex and high stakes to be left in the hands of individual FDA office or center directors. 1/ rdcu.be/eIEN7

I don't want AI making ethics decisions about research, that's what human IRBs are and should be for. But there's a lot that AI could improve in the IRB space, from better protocol submissions to helping reviewers incorporate the research ethics literature and prior decisions. 1/

Dr. Ramachandran said, “This is backwards. They’re announcing this process for making this change, and then they have the president and secretary go on national television and warn people to not take Tylenol.” (3/3) 🔗 news.bloomberglaw.com/health-law-a...

Everything is still on fire but rescuing a new puppy helps a lot. (As does our older rescue pup but it turns out 2 are better than 1.)

Here's what the experts have to say on the matter. www.acog.org/news/news-re...

"HHS--through the FDA--is conducting its own review of the evidence" re: mifepristone's safety + effectiveness. Signed by RFK and Makary. Given what we just saw w/ tylenol + leucovorin, I'm sure this will be done to the absolute highest scientific standards. democracyforward.org/wp-content/u...

This is what is happening when the cameras are running

Please consider submitting an application - or nominating great candidates - to join the American Society of Law, Medicine, and Ethics Board of Directors. Our organization is in an exciting time of transition and creativity. Join us in shaping ASLME's future. aslme.org/nominate-som...

Heartened by the expert takes on the embargoed data, as reported here: www.statnews.com/2025/09/24/h...

No publication yet but this looks to be amazing news.

DJT: I am using the state to punish criticism and extort people WH: this business decision was driven by DJT: No I am using the state to punish criticism and extort people WH: Unitary executive theory implies that DJT: I SAID I AM USING THE STATE TO PUNISH CRITICISM AND EXTORT PEOPLE FOR MONEY

Agreed. But this should be done *before* FDA approval. Obviously.

“I think this is a dangerous kind of subversion of what F.D.A. approval is supposed to be" www.nytimes.com/2025/09/23/h...

New: RFK Jr. and aides touted leucovorin as a treatment for autism, despite limited evidence. Now, makers of a related supplement, available without a prescription, could try to cash in. Via @tarabannow.bsky.social www.statnews.com/2025/09/23/l...

RFK's FDA, where your approved drugs will have about as much evidence behind them as his favorite supplements.

This is bonkers. FDA is going to change leucovorin's label based on a lit review with data on 40 patients w/ cerebral folate deficiency and comparisons to "known natural history." www.statnews.com/2025/09/22/f...

The government knowingly putting false information in the label of a drug is crossing a Rubicon that should not be taken lightly

All mothers of autistic children were found to brush their teeth daily. So…

Here's our new article reporting findings from stakeholder interviews in which we hoped to learn what it takes to successfully complete rigorous confirmatory studies after accelerated approval. Instead, we mostly heard willingness to trade rigor for feasibility. 1/ academic.oup.com/healthaffair...

Spotted by the Dupont Circle Krispy Kreme. #SandwichGuy @katestarbird.bsky.social

No one would have any confusion about what is happening if they saw it in another country.

ICMYI on Friday...these are really unusual comments from a FDA CDER director on political interference.... "There’s a lot of weight up above me," Tidmarsh said. “And so I can always be overturned, which is fine,” he said. “If that happens, that happens.” insights.citeline.com/pink-sheet/a...

“His rehiring also suggests that the health secretary, Robert F. Kennedy Jr., and the F.D.A. commissioner, Dr. Marty Makary, remain influential enough in the Trump administration to employ someone who had previously expressed disdain for Mr. Trump and his followers.”

Would love to be a fly on a wall for many of the conversations surrounding this wild about-face. But especially the ones involving Sarepta and its lobbying firm.

Shameful. I'm certain they didn't consult the amazing folks at the Clinical Center's Department of Bioethics on this one - not that they should have needed help figuring out how wrong this is.

What should we infer from the fact that the company refuses to release its complete response letter while insisting that FDA is being unreasonable? I agree with @reshmagar.bsky.social: "I’m a little doubtful about the narrative." www.statnews.com/pharmalot/20...

Montana to Become Hub for Patient Exploitation and Harm www.wsj.com/tech/biotech...

Crystal clear op ed on the importance of differentiating between science and policy: "science is evidence, not instruction" www.washingtonpost.com/opinions/202...

Check out our paper in @jamanetworkopen.com, which examined how onc adcom members feel about the difficulty of binary voting. <1/10 statements indicated a difficult vote w/ the most common rationales for difficulty being unconvincing post hoc analysis + unmet pt need. jamanetwork.com/journals/jam...

Our longer take on the new FDA CDER Director includes info on his covid contrarian record, his questionable stint on an FDA expert panel on talc, and his involvement with a drug that drew Republican scrutiny for being non-innovative and adding significant costs to the US system. #healthpolicy

The suggestion that states get to regulate health and safety so they can override FDA is absolutely untenable. This is very bad news for patients well beyond the abortion context. www.washingtonpost.com/health/2025/...

Bhattacharya "declared that one of his top priorities is that 'NIH must ensure that all the experiments we support pose no risk of harm to human populations and meet the highest ethical standards.' Is he awake?" W/ 20 yrs of OHRP service Ivor offers an impt warning. www.statnews.com/2025/07/15/o...

www.nytimes.com/2025/07/13/u... What's at stake here is genuinely deeper than the particular issue of COVID vaccination mandates. Effective policymaking and governance, or for that matter social coexistence, can't survive the rule "you may commit professional fraud if you feel like it."

Join the NASEM Health and Medicine Division on 7/15 for the virtual public release webinar of our new report examining challenges and solutions to better aligning investment in therapeutic development with disease burden and unmet need. Register here: bit.ly/3ICet41

What's up with Justice Jackson? She started making her mark and speaking out early, and some of her dissents are so pointed Kagan and Sotomayor don’t even join them. The far right is out for her, and even Republican justices are getting snarky. So what's up? Here’s my take 🧵

Impt depiction of the paradox we're seeing: rejection of proven products alongside claims pts should make their own decisions about unproven ones. Doing some introspection on my own work as an agency "watchdog." FDA's work is challenging and I've tried to have a strong dose of humility about that.

Phenomenal take on what's (terrifyingly) happening to FDA, by @jeneeninterlandi.bsky.social @nytimes.com (gift link below). Excellent historical context + overview of how and why we've gotten to the current moment. Looking forward to teaching from this resource. www.nytimes.com/2025/07/08/m...

Exactly. The citizens' petition is based predominantly on hope that new people in charge at FDA will come to a different conclusion. But the science hasn't meaningfully changed. It would be much better to push the company to produce high quality science than to push FDA to accept an unproven drug.

A Lost Generation of Researchers: Cuts to the nation’s science funding are forcing future scholars to delay graduate study, continue it abroad, or forgo it entirely. @mzahneis.bsky.social reports www.chronicle.com/article/a-lo...

1. ALS patients have filed a citizens' petition asking FDA to approve an investigational stem cell drug that reviewers eviscerated at a 2023 advisory committee meeting (after they had initially refused to file). www.accessnewswire.com/newsroom/en/...

Given what's been happening, Makary's claim that FDA morale is good and improving simply doesn't pass the laugh test. Glad @lizzylawrence.bsky.social dug into this. It's not too much to ask for feds to be treated w/ dignity + given resources necessary to their work. www.statnews.com/2025/07/07/f...