Aaron Kesselheim
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Aaron Kesselheim
@akesselheim.bsky.social
590 followers 66 following 64 posts
Professor of Medicine, Brigham and Women's Hospital/Harvard Medical School; Director, Program On Regulation, Therapeutics, And Law (PORTAL)
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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...
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.
www.statnews.com
November 21, 2025 at 10:44 PM
What he said
medpagetoday.com MedPage Today @medpagetoday.com · 23d
Gutting funding for key health agencies & terminating thousands of workers does nothing to ensure the future of the biotech industry, experts & Democratic lawmakers argued during a Senate health committee hearing on Wednesday. @akesselheim.bsky.social
Read more: www.medpagetoday.com/washington-w...
October 31, 2025 at 10:22 PM
Reposted by Aaron Kesselheim
marklemley.bsky.social
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
September 22, 2025 at 8:38 PM
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
September 13, 2025 at 7:55 PM
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
September 10, 2025 at 2:58 PM
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
August 9, 2025 at 3:49 PM
Reposted by Aaron Kesselheim
yalecrrit.bsky.social
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.
July 21, 2025 at 3:35 PM
Superman. See it.
July 13, 2025 at 1:59 AM
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
July 4, 2025 at 10:40 AM
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
July 4, 2025 at 10:37 AM
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
July 4, 2025 at 9:44 AM
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
June 28, 2025 at 4:55 PM
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
June 26, 2025 at 7:51 PM
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
June 11, 2025 at 6:05 PM
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
May 15, 2025 at 6:31 PM
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
May 8, 2025 at 4:57 PM
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
April 24, 2025 at 1:10 PM
Interesting new op-ed! Very proud of Max: thehill.com/opinion/5180...
thehill.com
March 7, 2025 at 6:20 PM
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
February 16, 2025 at 4:15 PM
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
February 16, 2025 at 4:13 PM
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
February 14, 2025 at 3:48 PM
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
February 14, 2025 at 3:38 PM
a philadelphia eagles logo with the words " it 's a win " below it
ALT: a philadelphia eagles logo with the words " it 's a win " below it
media.tenor.com
February 10, 2025 at 12:47 PM
Reposted by Aaron Kesselheim
mbarber.bsky.social
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.
February 7, 2025 at 1:31 PM
Reposted by Aaron Kesselheim
portalresearch.org
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
February 6, 2025 at 3:53 PM