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Patti Zettler

@pzettler.bsky.social

5.7K followers 210 following 62 posts

John W. Bricker Professor of Law @ohiostatelaw.bsky.social, @osucccjames.bsky.social & Ohio State DEPC | Former HHS Deputy General Counsel & FDA Attorney. Views mine alone not necessarily those of my employer. https://moritzlaw.osu.edu/patricia-j-zettler

moritzlaw.osu.edu

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Patti Zettler @pzettler.bsky.social · Jun 9

Check out the latest from me, Steve Cha, @sarahd1.bsky.social & @cspinet.org's @drpeterlurie.bsky.social.

Whatever one thinks of the merits of FDA's decision, the process by which decisions (and policies) are made matters. And the process here spells trouble for public health and innovation.

JAMA @jama.com · Jun 9

Viewpoint: The FDA's non-standard review of Novavax's #COVID19 vaccine raises concerns about regulatory integrity and the influence of political considerations on public health decisions.

https://ja.ma/3TepavL

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Nicholson Price @nicholson.bsky.social · 29d

What does it mean to have a human in the loop of medical AI? Here's a fun place to look: a 2022 FDA guidance that's about what *doesn't* count as a medical device!
Had a blast exploring this quasi-standard, out in the Penn J of Law & Innovation: papers.ssrn.com/sol3/papers....
#MedicalAI #law

An Incidental Standard for Medical AI

<p><span>Medical AI is poised to make a major difference in the provision of health. It brings major challenges, though: how can developers and implementers ens

papers.ssrn.com

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Arghavan Salles, MD, PhD @arghavansallesmd.medsky.social · Aug 31

This should be a bigger story. A government official had the YouTube channel of a private citizen shut down bc he didn’t like what that citizen was saying. This administration’s version of free speech is a joke.

Nikhil Shah @grandmastershah.bsky.social · Aug 31

"He noted that snippets of Prasad’s comments still appeared on anti-vaccine social media accounts, suggesting Prasad was directing his removal demand only at a critic and not anti-vaccine influencers. In the past, Prasad has complained about censorship by social media companies."

Top FDA official demands removal of YouTube videos of himself that criticized Covid vaccines

Doctor who created now-defunct channel says he wanted to ‘preserve’ what Trump health officials said during Covid

www.theguardian.com

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News Eye @newseye.bsky.social · Aug 28

BREAKING: Big moment as CDC staff stage a mass walkout.

They have lined the street outside its HQ to greet and salute the four top officials who have resigned in protest at RFK Jr’s attack on the agency’s science base.

(🎥 AP)

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Demetre Daskalakis @drdemetre.bsky.social · Aug 28

Enough is enough. The health of the country is in danger. Read our resignation letters: insidemedicine.substack.com/p/breaking-n...

Breaking News: Read three top CDC officials' resignation emails.

The end of an era.

insidemedicine.substack.com

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Sam Bagenstos @sbagen.bsky.social · Aug 27

And this makes it much worse. The CDC is losing a swath of outstanding, senior public servants. These are really terrific people who have served the public health with distinction across administrations. An enormous loss.

open.substack.com/pub/insideme...

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Johns Hopkins Berman Institute of Bioethics @bermaninstitute.bsky.social · Jul 18

Funding cuts to the National Institutes of Health and the US Food and Drug Administration could sharply reduce the number of new drugs available to Americans in the coming decades, according to an analysis released on Friday by the Congressional Budget Office. www.nytimes.com/2025/07/18/h...

Health Cuts Would Result in Fewer Drugs for Americans, Budget Office Reports

www.nytimes.com

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Maxwell Smith, PhD @maxwellsmith.bsky.social · Jul 18

My university (@westernu.ca) is offering up to $160,000 CAD in funding to support doctoral students impacted by recent changes in higher ed in the US.

And I'm keen on supervising students who may be interested (and who conduct research in public health ethics). DM me.

grad.uwo.ca/finances/wes...

Doctoral Excellence Award

Western University, in vibrant London, Ontario, delivers an academic and student experience second to none.

grad.uwo.ca

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Dara Purvis @darapurvis.bsky.social · Jul 14

Out today is my review of Allison Whelan's excellent article about pediatric predisposition genetic testing and a right to future privacy. Given my own interests I started thinking about a right to future privacy for transgender children, but I suspect it will be relevant to all sorts of topics!

Jotwell @jotwell.bsky.social · Jul 14

Jotwell Family:
Dara E. Purvis, The Right to Children’s Future Privacy, JOTWELL (July 14, 2025) (reviewing Allison M. Whelan, Poked, Prodded, and Privacy: Parents, Children, and Pediatric Genetic Testing, 109 Iowa L. Rev. 1219 (2024)), family.jotwell.com/the-right-to....

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Sam Bagenstos @sbagen.bsky.social · Jul 8

Really good thread. I'd add two things. (Mini-thread.)

Nick Bednar @nicholasbednar.bsky.social · Jul 8

The Supreme Court has stayed the AFGE case, which prohibited the Trump administration from moving forward with Reductions-in-Force. Several quick notes based on a cursory skim: 1/

www.supremecourt.gov/opinions/24p...

www.supremecourt.gov

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Daniel S. Goldberg @profgoldberg.bsky.social · Jul 7

I just want to re-up this Health Affairs Forefront piece co-authored with @rickweinmeyer.bsky.social. We're working on the concept of a "Public Health Law Vacuum" as a form of governance failure.

Who is creating these vacuums? Why? What are the consequences? And what can we do about it? ⤵️

#PHLaw

Public Health Law Vacuums: A Present And Future Threat | Health Affairs Forefront

The COVID-19 pandemic has led to a dangerous trend: the intentional creation of public health law vacuums, in which no governance efforts are exerted to address a defined public health problem.

www.healthaffairs.org

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STAT @statnews.com · Jul 7

FDA staff are already missing deadlines, and the future consequences could be even more dire as workers head for the exits.
www.statnews.com/2025/07/07/f...

Inside the staff exodus and tanking morale that threaten Makary’s FDA

FDA staff are struggling and missing deadlines, and the future consequences could be even more dire.

www.statnews.com

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Sam Bagenstos @sbagen.bsky.social · Jun 28

As someone who has been on the business end of nationwide injunctions that I thought were improper, I find the question of what rules we should adopt for them to be genuinely hard. But yesterday's decision deserves massive criticism, for at least two reasons. (Thread.)

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Sam Bagenstos @sbagen.bsky.social · Jun 27

The Affordable Care Act's requirement that insurers cover preventive services dodges a bullet in Braidwood. That's good. But the broader effect of the opinion is probably to reinforce RFK and Trump's politicized control over the medical, scientific, and public health professionals who work at HHS.

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Dr. Sven-Eric Jordt #TobRegSky @sejordt.bsky.social · Jun 25

#PedSky #MedSky #EpiSky #policysky #polisky 🧪🛟
Fantastic real time skeeting from the FDA ACIP meeting. Thank you!!!

Walker Bragman @walkerbragman.bsky.social · Jun 25

ACIP meeting in about an hour.

Here we go…

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Patti Zettler @pzettler.bsky.social · Jun 25

"[S]uggesting that there are regularly 6 months of wiggle room in important FDA reviews that prior administrations have missed is a tough pill to swallow. Far more plausible is that speed will be traded for review quality and confidence, despite protestations to the contrary..."

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Patti Zettler @pzettler.bsky.social · Jun 25

Must-read by @hollylynchez.bsky.social on FDA's new "Commissioner's National Priority Voucher" program.

www.medpagetoday.com/opinion/seco...

Opinion | How Fast Is Too Fast for FDA Drug Review?

'Common sense' and the FDA Commissioner's National Priority Voucher Program

www.medpagetoday.com

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Jason L. Schwartz @jasonlschwartz.bsky.social · Jun 25

Kudos to the AAP for taking this step and for speaking with such clarity. Exactly the kind of approach and focus I outlined in NEJM last week.

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Holly Fernandez Lynch @hollylynchez.bsky.social · Jun 25

Everyone’s crisis indeed. Well said, @pzettler.bsky.social and @nathancortez.bsky.social
jamanetwork.com/journals/jam...

The FDA’s Crisis Is Everyone’s Crisis

This Viewpoint discusses the Trump administration’s firings of thousands of US Food and Drug Administration employees and the ramifications of those actions on the agency’s congressionally given publi...

jamanetwork.com

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Patti Zettler @pzettler.bsky.social · Jun 24

Well, two months later I'm not feeling any more optimistic, to put it mildly.

cc: @nathancortez.bsky.social

JAMA @jama.com · Jun 24

"It is not too soon to know that the FDA is in crisis."

This Viewpoint discusses the Trump administration's firing of nearly 20% of FDA employees and the ramifications of those actions.

https://ja.ma/4nfFEBz

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Mark Gongloff @markgongloff.bsky.social · Jun 24

As hot as this summer is, it’s also one of the coolest we’ll ever enjoy again.

Just how much hotter and deadlier summers will get is still up to us. Right now we’re working hard to make them worse

🎁 link to my @opinion.bloomberg.com column:

www.bloomberg.com/opinion/arti...

The Heat Dome Wants a Word With Climate-Change Deniers

The temperatures gripping the US this week were made up to five times more likely by the fact that the atmosphere is simply hotter.

www.bloomberg.com

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Katherine Pearson @kpear.bsky.social · Jun 24

Basic science is essential. "Most drugs don’t begin with research intended to make that drug. In fact, the results of their study showed that 80% of the medicines on their list led back to a discovery from basic research without any intention of creating a new drug" www.chronicle.com/article/in-d...

In Defense of ‘Silly’ Science

Basic research and the value of curiosity.

www.chronicle.com

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Daniel G. Aaron, MD, JD @medlawdan.bsky.social · Jun 24

For those following Loper Bright, the final version of Robin Craig's empirical analysis of the first 6 months of court decisions just came out. Among other findings: in challenges to agency rules, lower federal courts invalidated the rule in ~84% of cases.

minnesotalawreview.org/article/the-...

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Hank Greely @hankgreely.bsky.social · Jun 21

Truly...struggling to find the right word...awful, repugnant, terrible? (Also dumb.) "Worse than a crime, a blunder."
Also, remember to vaccinate boys. Most HPV+ women are infected by men.

Dr Seán DOOLAN 🏴󠁧󠁢󠁳󠁣󠁴󠁿 🇮🇪 @sdinpraxis.bsky.social · Jun 21

ZERO cervical cancer cases have been detected in fully vaccinated girls and women since HPV immunisation at age 12-13 started in Scotland in 2008. That's 17 years of proven success.

RFK Jr is about to scrap that in the US. 🤦‍♂️😬

Prof Gavin Yamey @gavinyamey.bsky.social · Jun 19

OMFG, the HPV vaccine 😩

Having the nation's public health now led by the world's most dangerous, most extreme, & most notorious anti-vaxxer, one who has made a fortune peddling disgusting anti-vaccine lies, is going to get many people killed

www.theatlantic.com/health/archi...

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Rick Weinmeyer @rickweinmeyer.bsky.social · Jun 20

This story, like so many others, is heartbreaking.

"I see what MAHA is offering. It’s not really about making America healthy. It’s about giving people the illusion of agency in a complicated and scary world."

www.nytimes.com/2025/06/20/o...

Opinion | Holy Water Couldn’t Save My Husband. MAHA Wouldn’t Have, Either.

www.nytimes.com

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Patti Zettler @pzettler.bsky.social · Jun 20

Because of FDA approval, this is, of course, in contrast to drugs.

& for more on why we need rigorous premarket effectiveness evidence for drugs, check out my, @rachelsachs.bsky.social, @stevejoffe.bsky.social, & @hollylynchez.bsky.social's recent @jama.com piece:

jamanetwork.com/journals/jam...

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