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Patti Zettler

@pzettler

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

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Latest posts by Patti Zettler @pzettler

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...

05.01.2026 19:21 πŸ‘ 114 πŸ” 47 πŸ’¬ 4 πŸ“Œ 8
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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)

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!

28.12.2025 15:56 πŸ‘ 21 πŸ” 10 πŸ’¬ 0 πŸ“Œ 0

β€œThe anti-vaccine movement is not a spontaneous expression of grassroots concern. It’s an industry.”

27.12.2025 18:04 πŸ‘ 15 πŸ” 9 πŸ’¬ 1 πŸ“Œ 0
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Impfen | Es wird noch viel schlimmer werden Podcast Episode Β· Pandemia Β· 22/12/2025 Β· 40m

"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 πŸ§ͺ🧡

23.12.2025 11:52 πŸ‘ 362 πŸ” 150 πŸ’¬ 5 πŸ“Œ 24

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.

18.12.2025 12:47 πŸ‘ 25 πŸ” 4 πŸ’¬ 1 πŸ“Œ 0

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!)

16.12.2025 12:55 πŸ‘ 3 πŸ” 0 πŸ’¬ 1 πŸ“Œ 0
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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

Since 2020, our team has iterated on a model for β€œrapid 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...

16.12.2025 00:56 πŸ‘ 162 πŸ” 47 πŸ’¬ 2 πŸ“Œ 9

"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."

12.12.2025 02:20 πŸ‘ 8 πŸ” 5 πŸ’¬ 0 πŸ“Œ 0

Vaccines cause adults

11.12.2025 21:45 πŸ‘ 154 πŸ” 59 πŸ’¬ 0 πŸ“Œ 1
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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 β€” and lead to substantial additional spending.

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....

10.12.2025 23:35 πŸ‘ 8 πŸ” 6 πŸ’¬ 0 πŸ“Œ 1
Never Waste a Crisis: The Past, Present, and Future of FDA Reform | Journal of Health Politics, Policy and Law | Duke University Press

And for background on the project, check our our piece in @jhppl.bsky.social:

read.dukeupress.edu/jhppl/articl...

10.12.2025 19:59 πŸ‘ 1 πŸ” 1 πŸ’¬ 0 πŸ“Œ 0

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...

10.12.2025 19:59 πŸ‘ 5 πŸ” 0 πŸ’¬ 1 πŸ“Œ 0
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...

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...

09.12.2025 17:26 πŸ‘ 2 πŸ” 2 πŸ’¬ 0 πŸ“Œ 0
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Postmarket Drug Safetyβˆ’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 safetyβˆ’related action and whether the...

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)

08.12.2025 22:52 πŸ‘ 5 πŸ” 2 πŸ’¬ 1 πŸ“Œ 0

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)

08.12.2025 22:52 πŸ‘ 3 πŸ” 3 πŸ’¬ 1 πŸ“Œ 0
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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.

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.

04.12.2025 17:51 πŸ‘ 21 πŸ” 7 πŸ’¬ 1 πŸ“Œ 1
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Chris Whitty: Why health misinformation spreadsβ€”and honesty about uncertainty is the answer England’s chief medical officer said in a recent lecture that misinformation has always accompanied medical progressβ€”and that the battle is winnable if we can talk honestly about uncertainty β€œThrough...

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 healthβ€”and yet the improvements continued."

"This is a battle that is winnable."

04.12.2025 20:52 πŸ‘ 14 πŸ” 5 πŸ’¬ 1 πŸ“Œ 0

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 πŸ‘‡

04.12.2025 13:33 πŸ‘ 12 πŸ” 4 πŸ’¬ 0 πŸ“Œ 0

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...

25.11.2025 23:13 πŸ‘ 5 πŸ” 3 πŸ’¬ 1 πŸ“Œ 0
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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...

It's up! www.yalejreg.com/nc/trump-reg...

21.11.2025 15:33 πŸ‘ 16 πŸ” 10 πŸ’¬ 2 πŸ“Œ 4

Tragic. Critical to promote reliable information from the biomedicine community.

20.11.2025 14:04 πŸ‘ 2 πŸ” 1 πŸ’¬ 0 πŸ“Œ 0

Yikes.

20.11.2025 02:29 πŸ‘ 124 πŸ” 35 πŸ’¬ 5 πŸ“Œ 1

I was just walking back to Drinko from a meeting and had the exact same thought.

19.11.2025 18:57 πŸ‘ 1 πŸ” 0 πŸ’¬ 0 πŸ“Œ 0

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

19.11.2025 17:58 πŸ‘ 7 πŸ” 4 πŸ’¬ 0 πŸ“Œ 0
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Shared Clinical Decision-Making for COVID-19 Vaccination This Viewpoint discusses shared clinical decision-making for COVID-19 vaccination.

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...

14.11.2025 01:12 πŸ‘ 7 πŸ” 5 πŸ’¬ 0 πŸ“Œ 0

β€œWe 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.

11.11.2025 23:23 πŸ‘ 8 πŸ” 5 πŸ’¬ 1 πŸ“Œ 0
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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.

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...

10.11.2025 15:42 πŸ‘ 94 πŸ” 34 πŸ’¬ 3 πŸ“Œ 2
Post image

I don’t mind the office view…

10.11.2025 15:24 πŸ‘ 1 πŸ” 0 πŸ’¬ 0 πŸ“Œ 0

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

08.11.2025 22:10 πŸ‘ 37 πŸ” 11 πŸ’¬ 1 πŸ“Œ 0