Aaron Kesselheim

It’s possible he’s just going to Tahoe again for a week, and this is how FDA stretches its funds now now that the government isn’t giving it sufficient budget

If only accelerated approvals were so reliably confirmed!

“Anonymous FDA official” LOL. There’s only one!

2026 STAT Madness 2026 bracket Welcome to STAT Madness, a bracket-style contest to find the best innovation in science and medicine. Explore groundbreaking innovations from

Vote for PORTAL in the STAT Madness contest for best scientific "innovation" of 2025: discovering improper drug patents listed w/ FDA that FTC later forced mfrs to delist, helping timely generic availability (under MGB logo on the lower right bracket at the bottom): www.statnews.com/feature/stat...

One Pivotal Trial, the New Default Option for FDA Approval — Ending the Two-Trial Dogma | NEJM This Sounding Board announces a new FDA policy that the default requirement for FDA approvals will be one robust pivotal trial plus confirmatory evidence, rather than two trials.

This is just needless, self-destructive, and problematic as regulatory policy. Also there never was and isn’t a two trial “dogma.” Bad headline, NEJM.
www.nejm.org/doi/full/10....

Experts argue recent FDA expert panels may violate FACA requirements The US Food and Drug Administration@s (FDA) increasing reliance on holding expert panels, rather than advisory committees, for external expert advice may violate the Federal Advisory Committee Act (FA...

Great coverage of Joseph Daval and my article in JAMA on the highly problematic new FDA use of “expert panels”: www.raps.org/news-and-art...

Stigma, Scarcity and the Price of Legitimacy: Chronic Pain Advocacy and the Politics of Pharmaceutical Partnerships in Canada This study examines how chronic pain advocates in Canada navigated fraught relationships with pharmaceutical companies amid escalating concerns about the adverse public health impacts of opioids. Dra...

Stigma, Scarcity & the Price of Legitimacy: Chronic Pain Advocacy & the Politics of Pharmaceutical Partnerships in Canada

Daniel Eisenkraft Klein, Benjamin Hawkins, Quinn Grundy, Robert Schwartz

onlinelibrary.wiley.com/doi/full/10....

I think findings here potentially transferable to obesity...

Pitfall…had a sequel?! What more to the story was there?

The Trump administration is turning drug review into make-a-deal “FDA decision-making may be reduced to a sequence of ‘make-a-deals’ with Trump, his FDA, or even political allies,” experts warn.

With the problematic national priority review voucher in the news again today (FDA staff not involved in decisionmaking? Really?), here’s our overview of how it opens the FDA up to corruption and moves us further and further away from “gold standard” reviews: www.statnews.com/2025/11/21/f...

What he said

I filed an amicus brief on behalf of 24 professors challenging the interim PTO director's illegal policy of blocking IPRs for any patent that is more than a few years old.

drive.google.com/file/d/1NhrG...

9 answers to burning questions about pharmaceutical ads Got questions about the FDA’s new plans around pharmaceutical ads? We’ve got answers.

Reprint of my Substack with @ylepidemiologist.bsky.social today in @statnews.com. Check it out if you’re interested in recent “moves” the FDA is making on drug ads. As with most claims this admin makes … IBIWISI: www.statnews.com/2025/09/13/p...

Pharmaceutical ads in the U.S.: Top questions answered The Administration's order and what can actually be done

Another fun collaboration with @ylepidemiologist.bsky.social in Substack with a post on DTC drug ads and the new administration announcement claiming to seek greater enforcement: yourlocalepidemiologist.substack.com/p/pharmaceut...

homer simpson says that 's bad in front of a bookshelf ALT: homer simpson says that 's bad in front of a bookshelf

CBER bein’ like

High brand-name drug prices fall once a generic enters the market. In a new @journalgim.bsky.social article, Ravi Gupta, CRRIT Co-Director @jsross119.bsky.social, and colleagues from @portalresearch.org assess associations between patents, revenue, and generic competition.

Superman. See it.

FDA publishes rejection letters sent to drugmakers, with a big caveat The FDA published more than 200 letters that it sent to companies when it rejected their medicines, but the letters came with a caveat.

<10% of these were not previously published (via STAT). Remember Sniglets? What term can we create for something that is self-promoted as a major step forward but is not really in reality even close to that?

www.statnews.com/2025/07/10/f...

Trump’s Ongoing Tariff Chaos Will Make Medications Less Affordable And Harder To Find | Health Affairs Forefront In his first term, Trump made a lot of noise about lowering drug prices but accomplished little of consequence. The noise continues, but it is now accompanied by new ill-conceived initiatives, includi...

New @healthaffairs.bsky.social Forefront covering the recent EOs on drug prices and tariffs -- little good news for prices or access -- www.healthaffairs.org/content/fore...

PORTAL Post | July 2025 New faculty members, the ORPHAN Cures Act, “hyaluronidase hopping,” and more from PORTAL

New PORTAL Post from @portalresearch.org for June. Sign up to receive these directly to your inbox!

mailchi.mp/eb7d1808132b...

Data manipulation within the US Federal Government A US Department of Veterans Affairs dataset compiling veteran health-care use in 2021 was quietly amended on March 5, 2025. A column titled gender was renamed sex, and the words were also switched in ...

Unrecorded manipulation of large datasets has been common in the US government since Trump's election -- bad for science, trust, and transparency -- in @thelancet.com from Janet Freilich and myself: www.thelancet.com/journals/lan...

Language is now back in the Senate version of the OBBA that would undermine Medicare price negotiation for drugs with Orphan Drug Act designation. Here's our HA Forefront published yesterday (!) from Helen Mooney and @benro.me on why it is a very bad idea:
www.healthaffairs.org/do/10.1377/f...

Legal Challenges for the Advisory Committee on Immunization Practices This Perspective offers an analysis of the legal foundations in the context of these and other challenges to the role of the Advisory Committee on Immunization Practices.

New in @jama.com, Joseph Daval and I discuss legal issues surrounding ACIP including its role in setting government policy and dealing with politically-motivated agendas arising from its new membership: jamanetwork.com/journals/jam...

Thanks to the 2024 peer reviewers for @jlme-journal.bsky.social, with a list here: www.cambridge.org/core/journal...

Your top 10 FAQ on drug prices Some clarity for this wildly confusing topic.

I helped Your Local Epidemiologist answer some of her pressing Substack subscriber questions on drug prices. yourlocalepidemiologist.substack.com/p/your-top-1...

A classic!

New Health Affairs Forefront post on the Medicare negotiation "biologic bonus" and the massive financial hit to patients and the health care system of delaying small molecule negotiation from 9 to 13 years, led by Chris Cai and @benro.me: www.healthaffairs.org/content/fore...

Opinion | It’s not hard to see through RFK Jr.’s ‘radical transparency’ pledge So far, what’s been released is little more than tactics in pursuit of Kennedy’s own agenda.

New op-ed with @drjoshs.bsky.social and Peter Lurie about the agenda-driven reality of 'radical transparency' -- www.washingtonpost.com/opinions/202...

Interesting new op-ed! Very proud of Max: thehill.com/opinion/5180...

Spending After Sacubitril-Valsartan vs Renin-Angiotensin System Blockers for Heart Failure This cohort study assesses health care costs after initiating sacubitril-valsartan compared to an angiotensin-converting enzyme inhibitor or an angiotensin II receptor-blocker in Medicare patients bei...

Analysis from former @portalresearch.org fellow Catherine Hwang and @benro.me showing the extent of out-of-pocket costs associated with starting brand-name Entresto over ACEI/ARB for heart failure and implications for overall spending: jamanetwork.com/journals/jam...

Out of Pocket Getting Out of Hand — Reducing the Financial Toxicity of Rapidly Approved Drugs | NEJM The FDA often exercises flexibility in deciding whether to approve highly promising drugs for patients in desperate need of treatment options. But it doesn’t consider a drug’s likely financial toxi...

New in @nejm.org from Peter Ubel, Astrid Grouls and myself on "financial toxicity" and how to consider it in the context of new drugs @portalresearch.org: www.nejm.org/doi/abs/10.1...