Sign in

Patti Zettler

@pzettler.bsky.social
6K followers 244 following 82 posts

Personal account & personal views. Law Professor | Former HHS Deputy General Counsel & FDA Attorney. linkedin.com/in/patti-zettler

PostsRepliesMedia
Reposted by Patti Zettler
Rachel Sachs @rachelsachs.bsky.social · 05/01/2026
This is a policy choice. As Dr. Gottlieb recently put the issue on CNBC: if we substantially reduce vaccination rates, "we're going to have to build new pediatric hospitals." www.youtube.com/watch?v=e8CJ...
511447
Reposted by Patti Zettler
Timothy Caulfield @caulfieldtim.bsky.social · 28/12/2025
Regulating DTC #microbiome tests academic.oup.com/jlb/article/... "...often misleading to consumers..." "...the tests lack analytical and clinical validity." "...may have many 'false positive' or 'false negatives' and can harm consumers." Needed: more stringent regulation!
academic.oup.com
Is the current regulatory framework for direct-to-consumer microbiome-based tests sufficient to protect consumers from medical, economic, and dignitary harms?
Abstract. This article offers a thorough analysis of an important public health issue–the lack of regulation of companies selling direct-to-consumer (DTC)
02210
Patti Zettler @pzettler.bsky.social · 27/12/2025
“The anti-vaccine movement is not a spontaneous expression of grassroots concern. It’s an industry.”
1159
Reposted by Patti Zettler
Kai Kupferschmidt @kakape.bsky.social · 23/12/2025
"It is going to get so much worse." For the first of two end-of-the-year episodes of @pandemia.bsky.social, I talked to @drdemetre.bsky.social about what happened in 2025 at the CDC and how he thinks about the future of vaccines and public health in the US. A quick 🧪🧵
podcasts.apple.com
Impfen | Es wird noch viel schlimmer werden
Podcast Episode · Pandemia · 22/12/2025 · 40m
5360145
Reposted by Patti Zettler
Sam Bagenstos @sbagen.bsky.social · 18/12/2025
The right answer for marijuana is to legalize and regulate. Instead, we’re going to keep the ridiculous Wild West patchwork gray market we have now for THC (worse w/the new restricted definition of hemp) & both subsidize *and* underregulate CBD, assimilating it to pro-supplement woo.
1254
Patti Zettler @pzettler.bsky.social · 16/12/2025
Very well-deserved congrats, @bridgetdooling.bsky.social, but an even bigger congrats to Ohio State for snagging such a superstar scholar, teacher, and colleague in the first place! We're lucky to have you. (And I-O!)
130
Reposted by Patti Zettler
Kate Starbird @katestarbird.bsky.social · 16/12/2025
Since 2020, our team has iterated on a model for “rapid research” to help surface, analyze, & resolve rumors about election administration. This work demonstrates an innovative role for researchers to support public sensemaking during rapidly unfolding events. uw.pressbooks.pub/rapidresearc...
uw.pressbooks.pub
Being Sensemakers: A Framework for University-Based Rapid Research of Elections, Crisis Events, and Beyond – Simple Book Publishing
A framework for university-based rapid research of elections, crisis events, and beyond
216146
Reposted by Patti Zettler
Rachel Sachs @rachelsachs.bsky.social · 12/12/2025
"One agency source said at least one division is having to pour all of its resources into reviewing drugs that received a voucher, taking time away from other medical products."
085
Reposted by Patti Zettler
Madhu Pai, MD, PhD @madhupai.bsky.social · 11/12/2025
Vaccines cause adults
015359
Reposted by Patti Zettler
Stacie Dusetzina @dusetzinas.bsky.social · 10/12/2025
Summarizing the current state of pricing and coverage for GLP1s in the US with @rachelsachs.bsky.social in @nejm.org this week! Read it before things change (again)! www.nejm.org/doi/full/10....
nejm.org
Insurance Coverage and Pricing of Weight-Loss Drugs in the United States | NEJM
The Trump administration’s agreements regarding glucagon-like peptide 1 receptor agonists could reduce prices and improve access for some patients — and lead to substantial additional spending.
086
Patti Zettler @pzettler.bsky.social · 10/12/2025
I am *really* excited about this work and the opportunity to work with @hollylynchez.bsky.social & @reshmagar.bsky.social, and grateful to @arnoldventures.bsky.social for the support. We're looking to hire a post-doc, please apply or send candidates our way! postdocs.yale.edu/posts/2025-1...
150
Reposted by Patti Zettler
Rachel Sachs @rachelsachs.bsky.social · 09/12/2025
Now up at Health Affairs Forefront, Kristi Martin and I identify important aspects of the 2027 Medicare drug price negotiation cycle, including its interactions with other IRA drug pricing reforms. www.healthaffairs.org/content/fore...
healthaffairs.org
Beyond the Numbers: Insights From The 2027 Medicare Drug Price Negotiation Cycle | Health Affairs Forefront
Important questions have arisen regarding the drug price negotiation program’s interactions with other policies, including political goals of the current administration, in ways that could both streng...
022
Reposted by Patti Zettler
Joseph Ross @jsross119.bsky.social · 08/12/2025
Lots more detail in the paper (jamanetwork.com/journals/jam...), but our findings provide the first evaluation of FDAAA and its enhanced safety-related regulatory authorities, and its impact on drug safety and public health, and informs current PDUFA VII negotiations! @reshmagar.bsky.social (5/5)
jamanetwork.com
Postmarket Drug Safety−Related Actions Before and After the FDA Amendments Act
This cross-sectional analysis assesses whether the US Food and Drug Administration Amendments Act was associated with differences in time to first postmarket drug safety−related action and whether the...
162
Reposted by Patti Zettler
Joseph Ross @jsross119.bsky.social · 08/12/2025
New paper from @yalecrrit.bsky.social out today in @jamainternalmed.com - The 2007 US Food and Drug Administration (FDA) Amendments Act (FDAAA) expanded the agency's safety-related regulatory authorities, including enhanced postmarketing safety surveillance and new clinical study requirements (1/5)
143
Reposted by Patti Zettler
Kate Jackson @katejackson.bsky.social · 04/12/2025
As @bridgetdooling.bsky.social and I argue in a new paper (link below), corporate directors play a role in law enforcement. They have a special duty to ensure their companies don't break the law. It is heartening, therefore, to see a few companies stand up for the rule of law. As they ought.
nbcnews.com
Costco sues the Trump administration, seeking a refund of tariffs
The wholesaler is the latest company to sue a federal agency over the president's signature economic policy.
1217
Reposted by Patti Zettler
Timothy Caulfield @caulfieldtim.bsky.social · 04/12/2025
Love this optimism! #GoTeam! Chris Whitty: Why health misinformation spreads www.bmj.com/content/391/... "Through every single one of the past 160 years there was extensive misinformation about health—and yet the improvements continued." "This is a battle that is winnable."
bmj.com
Chris Whitty: Why health misinformation spreads—and honesty about uncertainty is the answer
England’s chief medical officer said in a recent lecture that misinformation has always accompanied medical progress—and that the battle is winnable if we can talk honestly about uncertainty “Through...
1135
Patti Zettler @pzettler.bsky.social · 04/12/2025
As many others have posted, a must-read by 12 former FDA commissioners laying out what's so deeply troubling about the substance of and process used for recent changes to vaccine policy at FDA: www.nejm.org/doi/full/10.... But @jasonlschwartz.bsky.social perhaps summed it up best 👇
0124
Reposted by Patti Zettler
Rachel Sachs @rachelsachs.bsky.social · 25/11/2025
Congratulations to the CMS career staff for completing the negotiations for the 2027 cycle of the Medicare drug price negotiation program - the negotiated prices are now public. More later, but for now one note on attempts to compare these savings to the 2026 savings. 1/2 www.cms.gov/files/docume...
cms.gov
153
Reposted by Patti Zettler
Bridget Dooling @bridgetdooling.bsky.social · 21/11/2025
It's up! www.yalejreg.com/nc/trump-reg...
yalejreg.com
Trump Regulatory Policy: 2025 Compendium - Yale Journal on Regulation
As part of my prep for this year’s ABA Administrative Law Conference, I put together a list of the regulatory policy documents that have been issued since the start of President Trump’s second term. L...
21610
Reposted by Patti Zettler
Robert Califf @robcaliff.bsky.social · 20/11/2025
Tragic. Critical to promote reliable information from the biomedicine community.
021
Reposted by Patti Zettler
Sam Bagenstos @sbagen.bsky.social · 20/11/2025
Yikes.
412435
Reposted by Patti Zettler
Jennifer Oliva @jennoliva.bsky.social · 19/11/2025
This is going to be a terrific discussion re: AI & health insurance coverage decisions that’s open to the public if you are interested. @umnconsortium.bsky.social
064
Reposted by Patti Zettler
Joshua Sharfstein @drjoshs.bsky.social · 14/11/2025
When the evidence in favor of vaccination is compelling, CDC should make a recommendation ... and the American people deserve to hear it. Our case in @jama.com w/ Tom Frieden and William Scaffner jamanetwork.com/journals/jam...
jamanetwork.com
Shared Clinical Decision-Making for COVID-19 Vaccination
This Viewpoint discusses shared clinical decision-making for COVID-19 vaccination.
065
Reposted by Patti Zettler
Holly Fernandez Lynch @hollylynchez.bsky.social · 11/11/2025
“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.
185
Reposted by Patti Zettler
Timothy Caulfield @caulfieldtim.bsky.social · 10/11/2025
Ridiculous. So maddening. Yes, complex. But there is NO doubt that antivaxx misinformation big part of problem. Canada loses measles elimination status after three decades, health agency says www.reuters.com/business/hea...
reuters.com
Canada loses measles elimination status after three decades, health agency says
Canada has lost its measles elimination status after nearly three decades due to its failure to curb a year-long outbreak, the country's public health agency said on Monday.
39333
Reposted by Patti Zettler
Sarah Gollust @sarahgollust.bsky.social · 08/11/2025
Seems like a good time to do a special issue of @jhppl.bsky.social on the Politics of Private Health Insurance. Call for papers will be out soon, so stay tuned. There’s seem to be, uh, a few politically relevant topics to discuss. @mirandayaver.bsky.social @adrianna.bsky.social
13711
Reposted by Patti Zettler
Kristin E. Hickman @khickmanjd.bsky.social · 08/11/2025
For #adlaw folks: Due to logistical issues from the federal gov't shutdown, ABA Admin Law has replaced its usual fall conference with a shorter but free online event on 11/21. Registration is required, but it's 6.5 hrs of free, quality CLE on admin law topics. events.americanbar.org/event/a13a77...
events.americanbar.org
2025 Administrative Law Fall Conference
045
Patti Zettler @pzettler.bsky.social · 05/11/2025
Thanks again to @stemcellnetwork.ca, and all the speakers, poster presenters, and attendees at #TMM2025 - was a delight to be part of this wonderful event!
030
Reposted by Patti Zettler
Kate Starbird @katestarbird.bsky.social · 04/11/2025
Perhaps relevant today, a framework for understanding how many election rumors mislead.
215074
Patti Zettler @pzettler.bsky.social · 03/11/2025
It has been a great day at @stemcellnetwork.ca's #TMM2025! And I'm looking forward to more tomorrow, including joining @jsnyder.bsky.social, @lr-bg.bsky.social, & @deanshamess.ca first thing, for a discussion on public trust in science and policy decisions.
052
Patti Zettler @pzettler.bsky.social · 31/10/2025
100% (at least in my neighborhood in Columbus, maybe the only one with trick or treat tonight, instead of last night!).
010
Reposted by Patti Zettler
Jake Scott, MD @jakescottmd.bsky.social · 30/10/2025
Thank you, @cidrap.bsky.social, for covering our new @nejm.org review of Covid-19, RSV, and influenza immunizations. Check it out: cidrap.umn.edu/covid-19/meta-analysis-covid-rsv-flu-vaccines-fall-provides-sea-data-showing-efficacy-safety
cidrap.umn.edu
Meta-analysis of COVID, RSV, flu vaccines for fall provides 'sea of data' showing efficacy, safety
210240
Reposted by Patti Zettler
anil oza @aniloza.bsky.social · 29/10/2025
The NIH has insisted there are no banned words But, an analysis by @jeremymberg.bsky.social found over 700 hundred grants changed their titles from '24 to '25 Some see it as a small price to pay to keep their grant, but others are worried about what comes next www.statnews.com/2025/10/29/n...
statnews.com
Scientists had to change more than 700 grant titles to receive NIH funding. Health disparities researchers fear what’s next
The titles of more than 700 multi-year NIH grants have been changed this year, according to an analysis by Jeremy Berg, a former agency official
312969
Patti Zettler @pzettler.bsky.social · 29/10/2025
👇👇 Now in @jama.com: @greerdonley.bsky.social, Lewis Grossman & I explain that these preemption cases, while specifically about mifepristone, have implications for FDA and state drug regulation, biomedical innovation, and patient access more generally. jamanetwork.com/journals/jam...
jamanetwork.com
State Mifepristone Regulation Following GenBioPro v Raynes
This Viewpoint discusses the GenBioPro v Raynes decision and what it could mean for other cases challenging medication abortion restrictions on preemption grounds.
045
Reposted by Patti Zettler
Mark Lemley @marklemley.bsky.social · 24/10/2025
My paper with @patentscholar.bsky.social on how AI increases plagiarism risk in student and academic writing, what law should do about it (nothing), and what schools should do about it (quite a bit) is now published in the University of Chicago Law Review lawreview.uchicago.edu/online-archi...
lawreview.uchicago.edu
Plagiarism, Copyright, and AI | The University of Chicago Law Review
Critics of generative AI often describe it as a “plagiarism machine.” They may be right, though not in the sense they mean. With rare exceptions, generative AI doesn’t just copy someone else’s creativ...
1187
Reposted by Patti Zettler
Rachel Sachs @rachelsachs.bsky.social · 23/10/2025
Excited to see this published as part of @jhppl.bsky.social's 50th anniversary edition! The balance between the role of the government and the private sector even in traditionally public programs has continued to evolve in ways which may become even more important in the future.
073
Patti Zettler @pzettler.bsky.social · 23/10/2025
"The Dahlbergs feel it’s up to them to protect their two surviving children from vaccine-preventable diseases. They can’t rely on their government anymore." Absolutely heartbreaking.
011
Reposted by Patti Zettler
Holly Fernandez Lynch @hollylynchez.bsky.social · 23/10/2025
This is a fantastic, well-supported 3-year post-doc in our Division of Medical Ethics at Penn. Please share (and apply if interested!)
039
Reposted by Patti Zettler
Robert Califf @robcaliff.bsky.social · 22/10/2025
This will be a test of whether key federal agencies (USDA, HHS, etc.) can work with academic communities, especially those with strong vet, med and public health schools, and with states and counties to solve this problem. www.nytimes.com/2025/10/22/h...
nytimes.com
Bird Flu Is Back
154
Reposted by Patti Zettler
Hank Greely @hankgreely.bsky.social · 20/10/2025
New publication from me: Henry T. Greely, Depopulation Hysteria, U.C. Davis On Line Law Review, 59:117-136 (Oct. 2025). I argue that the increasing drumbeat of concern about falling human populations is somewhat exaggerated but also threatens women's rights. lawreview.law.ucdavis.edu/archives/59/...
lawreview.law.ucdavis.edu
Depopulation Hysteria | UC Davis Law Review
195
Reposted by Patti Zettler
Rachel Sachs @rachelsachs.bsky.social · 20/10/2025
ICYMI, in a recent article in @jama.com with @dusetzinas.bsky.social and Thomas Hwang, we explored this issue in detail and argued that "not all combination drugs should be treated separately for negotiation purposes." 4/4 jamanetwork.com/journals/jam...
jamanetwork.com
The Role of Combination Drugs in the Medicare Drug Price Negotiation Program
This Viewpoint explores the concept of pharmaceutical manufacturers reformulating drugs to avoid selection for price negotiation and the importance of distinguishing between biologically active and in...
022
Patti Zettler @pzettler.bsky.social · 20/10/2025
Great take by @hollylynchez.bsky.social & @reshmagar.bsky.social! "Public trust in authorities like the FDA is already depleted. Demanding that the agency greenlight more rare disease drugs, evidence be damned, will make this problem worse — and likely won’t leave rare disease patients better off."
011
Reposted by Patti Zettler
Micah Berman @micahberman.bsky.social · 17/10/2025
"Tiburon could become just the third municipality in the country to ban all sales of tobacco products. The idea originated from a group of high school students in town." www.ktvu.com/news/tiburon...
ktvu.com
Bay Area city moves to ban sale of tobacco products
California already has some of the strictest smoking laws in the country, but this North Bay town will become just the third city — after Beverly Hills and Manhattan Beach — to go this far.
133
Reposted by Patti Zettler
Paul Knoepfler @stemcells.bsky.social · 17/10/2025
FDA secures major win as SCOTUS lets stem cell clinic ruling stand ipscell.com/2025/10/fda-... #stemcells #stemcell RFK Jr.
ipscell.com
FDA secures major win as SCOTUS lets stem cell clinic ruling stand - The Niche
Stem cell biologist discusses how SCOTUS declining to review FDA court victory on clinics affirms fat cells as drugs & implications.
043
Patti Zettler @pzettler.bsky.social · 14/10/2025
Great reporting by @lizzylawrence.bsky.social. Great, insightful quotes from @reshmagar.bsky.social, @nathancortez.bsky.social & @rachelsachs.bsky.social. Not great news, to say the least, for public health, innovation, or any of us.
054
Reposted by Patti Zettler
Angie Rasmussen @angierasmussen.bsky.social · 11/10/2025
For more information about the Friday night massacre at CDC, I wrote up an analysis of who got terminated and what that means for public health. Grateful to @saveamericamvmt.bsky.social for supporting and amplifying. We are in really terrible trouble. rasmussenretorts.substack.com/p/the-death-...
rasmussenretorts.substack.com
The Death of Public Health
Another Friday night massacre, but this time it's not just an essential federal public health agency that will die
14542321
Reposted by Patti Zettler
Timothy Caulfield @caulfieldtim.bsky.social · 11/10/2025
Extracting Drugs from Nature Is Hard www.mcgill.ca/oss/article/... @jonathanjarry.bsky.social "The fact that a natural molecule has some anticancer activity when added to cells in a plastic dish does not mean it will be safe & effective when given to a patient" Reality: most fail in human studies.
mcgill.ca
Extracting Drugs from Nature Is Hard
A video on Facebook with nearly one million views informs me that the avocado tree is a pharmacy in disguise. “Its leaves help regulate blood sugar,” the narrator says, “its seeds target cancer cells,...
0358
Patti Zettler @pzettler.bsky.social · 11/10/2025
Terrible and terrifying news for all of us.
022
Reposted by Patti Zettler
Sarah Karlin-Smith @sarahkarlin-smith.bsky.social · 10/10/2025
Isn't this the opposite of what HHS leadership said their policies would do? A new KFF poll shows public trust in the Centers for Disease Control and Prevention (CDC) is now at its lowest level since the start of the COVID-19 pandemic. www.cidrap.umn.edu/childhood-va...
cidrap.umn.edu
New poll: Public confidence in CDC for vaccine advice tumbles
213642