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Aaron Kesselheim

@akesselheim.bsky.social

590 followers 66 following 62 posts

Professor of Medicine, Brigham and Women's Hospital/Harvard Medical School; Director, Program On Regulation, Therapeutics, And Law (PORTAL)

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Aaron Seth Kesselheim is an American physician, attorney, and medical researcher who serves as a professor of Medicine and member of the Center for Bioethics at Harvard Medical School. He is also a member of the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women’s Hospital, where he created and leads the Program On Regulation, Therapeutics, And Law (PORTAL). In 2020, he was inducted into the National Academy of Medicine. .. more

Economics 63%

Pharmacology, Toxicology and Pharmaceutics 14%

Posts Media Videos Starter Packs

Reposted by Aaron S. Kesselheim, Rebecca Tushnet

Mark Lemley @marklemley.bsky.social · 20d

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...

drive.google.com

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Aaron Kesselheim @akesselheim.bsky.social · 29d

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...

9 answers to burning questions about pharmaceutical ads

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

www.statnews.com

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Reposted by Daniel S. Goldberg

Aaron Kesselheim @akesselheim.bsky.social · Sep 10

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...

Pharmaceutical ads in the U.S.: Top questions answered

The Administration's order and what can actually be done

yourlocalepidemiologist.substack.com

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Aaron Kesselheim @akesselheim.bsky.social · Aug 9

CBER bein’ like

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

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

media.tenor.com

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Reposted by Joseph S. Ross, Aaron S. Kesselheim

Yale CRRIT @yalecrrit.bsky.social · Jul 21

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.

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Aaron Kesselheim @akesselheim.bsky.social · Jul 13

Superman. See it.

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Aaron Kesselheim @akesselheim.bsky.social · Jul 11

<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...

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.

www.statnews.com

Reposted by Daniel Aaron

Aaron Kesselheim @akesselheim.bsky.social · Jul 4

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...

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...

www.healthaffairs.org

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Aaron Kesselheim @akesselheim.bsky.social · Jul 4

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

mailchi.mp/eb7d1808132b...

PORTAL Post | July 2025

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

mailchi.mp

Aaron Kesselheim @akesselheim.bsky.social · Jul 4

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...

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 ...

www.thelancet.com

Aaron Kesselheim @akesselheim.bsky.social · Jun 28

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...

Congress Should Remove The Rare Disease Carve-Out From Medicare Drug Price Negotiation, Not Expand It | Health Affairs Forefront

Expansion of the Medicare drug price negotiation rare disease drug carve-out would unnecessarily limit the number of drugs eligible for negotiation, allow for continued high drug prices for products that earn billions of dollars in Medicare, and introduce a new set of misaligned incentives.

www.healthaffairs.org

Aaron Kesselheim @akesselheim.bsky.social · Jun 26

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...

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.

jamanetwork.com

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Aaron Kesselheim @akesselheim.bsky.social · Jun 11

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

Thank You to Our 2024 Peer Reviewers | Journal of Law, Medicine & Ethics | Cambridge Core

Thank You to Our 2024 Peer Reviewers

www.cambridge.org

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Aaron Kesselheim @akesselheim.bsky.social · May 15

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

Your top 10 FAQ on drug prices

Some clarity for this wildly confusing topic.

yourlocalepidemiologist.substack.com

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Aaron Kesselheim @akesselheim.bsky.social · May 13

A classic!

Aaron Kesselheim @akesselheim.bsky.social · May 8

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...

www.healthaffairs.org

Aaron Kesselheim @akesselheim.bsky.social · Apr 24

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

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.

www.washingtonpost.com

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Aaron Kesselheim @akesselheim.bsky.social · Mar 7

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

thehill.com

Aaron Kesselheim @akesselheim.bsky.social · Feb 16

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...

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...

jamanetwork.com

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Aaron Kesselheim @akesselheim.bsky.social · Feb 16

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...

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...

www.nejm.org

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Aaron Kesselheim @akesselheim.bsky.social · Feb 14

Survey of clozapine prescribers shows satisfaction with the REMS but desire for more educational info, led by @asarpatwari.bsky.social & team at @portalresearch.org in collab with FDA, where world class scientists are sadly being censored and forced out of their jobs: jamanetwork.com/journals/jam...

Physician Experiences With and Perspectives on Clozapine Prescribing

This survey study examines physician-prescriber experiences with and perspectives on the clozapine risk evaluation and mitigation strategy.

jamanetwork.com

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Aaron Kesselheim @akesselheim.bsky.social · Feb 14

Interesting use of modeling to predict the timing of patent challenges seeking generic drug entry in PLoS Medicine, led by Ally Memedovich and @portalresearch.org faculty affiliate Reed Beall at Univ Calgary - journals.plos.org/plosmedicine...

Predicting patent challenges for small-molecule drugs: A cross-sectional study

Ally Memedovich and colleagues report on patent challenges within the first year of eligibility among small-molecule drugs approved by the FDA from 2007-2018 and investigate the extent to which market...

journals.plos.org

Reposted by Aaron S. Kesselheim

Melissa Barber @mbarber.bsky.social · Feb 7

Feels v strange to post a paper this week, but @akapczynski.bsky.social, Trudel Pare, Sahil Agrawal, and I wrote a legal roadmap to help states win (and defend) public pharma initiatives.

We've sent it out, so law review folks- check your inboxes! #lawsky

papers.ssrn.com/sol3/papers....

Abstract: The U.S. market for prescription drugs is failing many Americans. Drug prices in the U.S. are nearly three times higher than in comparable countries, and evidence shows that patients regularly forego essential medicines because they cannot afford them. Additionally, shortages of important medicines are common. In partial response, California recently passed a law to enable public manufacture and distribution of medicines, starting with insulin, a drug needed by millions of diabetics in the state. Many other states, as well as the federal government, are considering similar action to drive down prices of older drugs and to help resolve shortages. Public production could yield important benefits, but there are legal obstacles to overcome at every step, from developing the product at the bench to getting it to the patient. This Article maps the primary legal and logistical issues these programs will face and describes how they can be overcome. We focus most of our attention on a major challenge that has not yet been properly described: even if states succeed in manufacturing affordable, high-quality drugs, how can they ensure that the drugs will actually reach the millions of patients who need them? After all, private, generic manufacturers already struggle to enter the market and distribute cheaper alternatives. We propose that states can succeed in ways that private entities cannot because they have unique legislative and regulatory mechanisms to counteract the concentrated power of market intermediaries. Using tools like mandatory contracts and regulatory requirements that require middlemen to carry publicly produced medicines, states can facilitate market entry and ensure that the maximum number of patients can access low-cost public products. This bottleneck, therefore, provides a further justification for public pharma—it can not only mitigate drug pricing and access issues, but possibly improve market access for private firms too.

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Reposted by Aaron S. Kesselheim

Program On Regulation, Therapeutics, And Law (PORTAL) @portalresearch.org · Feb 6

Check out the February edition of the PORTAL Post, featuring analysis on:

- the promise and risk of drug repurposing,
- drug importation to address shortages,
- use of subgroup analysis in cost-effectiveness studies
- biosimilar patent litigation,
- and much more!

#medsky #healthpolicy

PORTAL Post | February 2025

Protecting health agency independence, drug repurposing, academic detailing, and more from the PORTAL team.

mailchi.mp

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Aaron Kesselheim @akesselheim.bsky.social · Feb 4

Criticism of the QALY includes the idea that it'll be used to limit drug access to patient subgroups, but @araymakers.bsky.social shows in J Cancer Policy that no evidence of QALYs in cancer drugs being used to do that -- from @portalresearch.org: www.sciencedirect.com/science/arti...

An empirical investigation into concerns over quality-adjusted life-years: a review of cost-effectiveness analyses in oncology

Health care payers often use cost-effectiveness analyses (CEA) using the quality-adjusted life-year (QALY), as the measure of benefit, to inform reimb…

www.sciencedirect.com

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Aaron Kesselheim @akesselheim.bsky.social · Feb 4

Use of Doxepin for insomnia -- example of potentially useful drug repurposing that seems to be under-prescribed among patients who could benefit because of a problematically high pricing point -- from Chris Cai and @benro.me at @portalresearch.org: jamanetwork.com/journals/jam...

Trends in Fills, Spending, and Prices of Doxepin for Insomnia

This cross-sectional study explores US prescription fills, retail spending, and prices of low-dose doxepin for insomnia and the possible cost savings to patients had they used liquid doxepin, a less e...

jamanetwork.com

Aaron Kesselheim @akesselheim.bsky.social · Feb 1

Recall that RFK pledged to “end” the “FDA’s … aggressive suppression of … hyperbaric therapies”

Aaron Kesselheim @akesselheim.bsky.social · Jan 31

New in @jlme-journal.bsky.social from co-first authors Liam Bendicksen and Mirre Scholte as well as others at @repo4eu.bsky.social, a review of results from research and roundtables on regulatory pathways for drug repurposing in the US & EU: www.cambridge.org/core/journal...

A Regulatory Roadmap for Repurposing: Comparing Pathways for Making Repurposed Drugs Available In The EU, UK, And US | Journal of Law, Medicine & Ethics | Cambridge Core

A Regulatory Roadmap for Repurposing: Comparing Pathways for Making Repurposed Drugs Available In The EU, UK, And US - Volume 52 Issue 4

www.cambridge.org

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Aaron Kesselheim @akesselheim.bsky.social · Jan 31

New piece led by Anushka Bhaskar @portalresearch.org in STAT First Opinion on protecting public health agencies from damaging political interference -- even the threat of which can greatly affect people's behavior: www.statnews.com/2025/01/31/p...

How to protect HHS, FDA, NIH, and other health agencies from political interference

When politicians subordinate scientific institutions to electoral interests, they undermine immediate public health efforts and inflict lasting damage on institutional credibility.

www.statnews.com

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Aaron Kesselheim @akesselheim.bsky.social · Jan 29

From Rosa Ahn-Horst @portalresearch.org -- psychiatric drug innovation over the last decade shows widespread use of clinical endpoints but few new mechanisms of action and 3/16 drugs for which < half the trials submitted to FDA were positive (in JAMA Network Open): jamanetwork.com/journals/jam...

Trials Preceding FDA Approval of Novel Psychiatric Drugs

This cross-sectional study reports on the study design characteristics of clinical trials for novel psychiatric drugs approved by the US Food and Drug Administration.

jamanetwork.com

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