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Reposted by Program On Regulation, Therapeutics, And Law (PORTAL)

Adam Raymakers @araymakers.bsky.social · May 12

Lots of talk about international reference pricing today. With that in mind, sharing this great article by @leah-rand.bsky.social and @akesselheim.bsky.social from @portalresearch.org!

www.valueinhealthjournal.com/article/S109...

International Reference Pricing for Prescription Drugs in the United States: Administrative Limitations and Collateral Effects

Many countries use international (or external) reference pricing—benchmarking prices against those in other countries—to manage spending on prescription drugs. By contrast, the United States (US) allo...

www.valueinhealthjournal.com

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Program On Regulation, Therapeutics, And Law (PORTAL) @portalresearch.org · Apr 30

@akesselheim.bsky.social @benro.me @wbfeldman.bsky.social @leah-rand.bsky.social @araymakers.bsky.social @kellyanderson.bsky.social @harvardmed.bsky.social

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Program On Regulation, Therapeutics, And Law (PORTAL) @portalresearch.org · Apr 30

⭐Out now from Dr. Jerry Avorn— RETHINKING MEDICATIONS: Truth, Power, and the Drugs You Take

In his new book, Dr. Avorn explains why some of the medications we take are poorly evaluated, overpriced, or pose unwarranted risks—and how we fix that.

📖 Grab a copy today: rethinkmeds.info

Home

Truth, Power, and the Drugs You Take

rethinkmeds.info

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Program On Regulation, Therapeutics, And Law (PORTAL) @portalresearch.org · Apr 30

@akesselheim.bsky.social @benro.me @wbfeldman.bsky.social

Reposted by Program On Regulation, Therapeutics, And Law (PORTAL)

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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Program On Regulation, Therapeutics, And Law (PORTAL) @portalresearch.org · Apr 9

View his full testimony before the Health Subcommittee: waysandmeans.house.gov/event/health...

Read his written testimony: waysandmeans.house.gov/wp-content/u...

waysandmeans.house.gov

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Program On Regulation, Therapeutics, And Law (PORTAL) @portalresearch.org · Apr 9

And, on strategies to improve the biosimilar market, including by implementing policies to facilitate biosimilar interchangeability, clear patent thickets, and preventing biosimilar rebate gaming by PBMs.

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Program On Regulation, Therapeutics, And Law (PORTAL) @portalresearch.org · Apr 9

On protecting Medicaid - “Cutbacks planned for the Medicaid program will force states to severely limit their drug coverage, which will inevitably lead to patient deaths.”

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Program On Regulation, Therapeutics, And Law (PORTAL) @portalresearch.org · Apr 9

WATCH: @akesselheim.bsky.social testifies before @waysmeanscmte.bsky.social

On NIH cuts - "...the next generation will look back at this moment & ask what we were doing while the Trump administration systematically disposed of 1000s of research projects that could've helped patients."

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Reposted by Program On Regulation, Therapeutics, And Law (PORTAL)

The Journal of Law, Medicine and Ethics @jlme-journal.bsky.social · Apr 8

At 10am Eastern Time, watch as our Editor-in-Chief, @akesselheim.bsky.social , gives testimony to the House Ways and Means Committee on "Lowering Costs for Patients: The Health of the Biosimilar Market." www.youtube.com/watch?v=x_rh...

Health Subcommittee Hearing on Lowering Costs for Patients: The Health of the Biosimilar Market

YouTube video by Ways and Means Committee Republicans

www.youtube.com

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Program On Regulation, Therapeutics, And Law (PORTAL) @portalresearch.org · Apr 8

@waysmeanscmte.bsky.social

Program On Regulation, Therapeutics, And Law (PORTAL) @portalresearch.org · Apr 8

Tune in TODAY at 10am ET as PORTAL Director Aaron Kesselheim @akesselheim.bsky.social testifies before the House Ways & Means Health Subcommittee:

He'll discuss the biosimilar market, threats to US biomedical research funding, & the need to protect & expand Medicare drug price negotiation.

Health Subcommittee Hearing on Lowering Costs for Patients: The Health of the Biosimilar Market

YouTube video by Ways and Means Committee Republicans

youtu.be

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Reposted by Program On Regulation, Therapeutics, And Law (PORTAL)

NEJM.org @nejm.org · Mar 26

Starting in January 2025, various government health datasets were removed, restored, manipulated, or not posted as planned. The authors of a new Perspective write that the consequences of these changes could be far-reaching. Read the full Perspective: nej.md/4bYvujL

#MedSky #HealthPolicy

Perspective
"Without access to accurate and timely data, scientists’ work will become more difficult, and we will understand less about the world."

"Disappearing Data at the U.S. Federal Government" by Janet Freilich, J.D., W. Nicholson Price II, J.D., Ph.D., and Aaron S. Kesselheim, M.D., J.D., M.P.H.

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Reposted by Program On Regulation, Therapeutics, And Law (PORTAL)

Eddie Cliff @eddiecliff.bsky.social · Apr 6

Just out @jama.com

Led by Dr Hwang we show when oncology drugs withdrawn due to negative trials are still accessible off-abel, prescribing plummets anyway

Romidepsin a notable exception, unsurprising to lymphoma docs who use it in TFH lymphomas

jamanetwork.com/journals/jam... @portalresearch.org

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Program On Regulation, Therapeutics, And Law (PORTAL) @portalresearch.org · Apr 3

Check out the latest research from the PORTAL team in the April edition of our newsletter, featuring analysis on generic drug 'skinny labeling,' the expansion of the 340B program, a new form of product hopping, and much more! 🛟🧪

mailchi.mp/57ccd5e0b342...

PORTAL Post | April 2025

Skinny labeling, 340B expansion, patent games, and more analysis from the PORTAL team.

mailchi.mp

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Program On Regulation, Therapeutics, And Law (PORTAL) @portalresearch.org · Mar 28

@akesselheim.bsky.social @nicholson.bsky.social

Program On Regulation, Therapeutics, And Law (PORTAL) @portalresearch.org · Mar 28

NEW in @nejm.org: Janet Freilich & couthors discuss the sudden removal of critical health datasets by US federal health agencies—undermining research, public health, & policy-making. Though lawsuits have restored some data, the authors call for broader action to keep taxpayer-funded data public. 🛟

Disappearing Data at the U.S. Federal Government | NEJM

Starting in January 2025, various government health datasets were removed, restored, manipulated, or not posted as planned. The consequences of these changes could be far-reaching.

www.nejm.org

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Reposted by Program On Regulation, Therapeutics, And Law (PORTAL)

William Feldman @wbfeldman.bsky.social · Feb 22

Our latest in @nejm.org on the dilemmas of treating patients with chronic lung disease.

www.nejm.org/doi/full/10....

The Moral Injury of Inhaler Prescribing | NEJM

Many inhalers that are vital for patients with asthma or COPD are associated with societal harms that can worsen the very diseases the products are designed to treat. How can this dilemma be resolved?

www.nejm.org

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Program On Regulation, Therapeutics, And Law (PORTAL) @portalresearch.org · Feb 17

They conclude: "If the FDA is going to continue to exercise maximal flexibility in considering when to approve highly promising drugs for patients in desperate need of treatment options, we believe policymakers should also protect patients from the economic implications of those decisions."

Program On Regulation, Therapeutics, And Law (PORTAL) @portalresearch.org · Feb 17

New perspective in @nejm.org from Peter Ubel, Astrid Grouls, & @akesselheim.bsky.social on the financial toxicity patients face from high-cost drugs with uncertain clinical benefits, & the remedies available to policymakers to mitigate financial harms while drugs undergo further review.

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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Reposted by Program On Regulation, Therapeutics, And Law (PORTAL)

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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Reposted by Program On Regulation, Therapeutics, And Law (PORTAL)

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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Reposted by Program On Regulation, Therapeutics, And Law (PORTAL)

Aaron Mitchell @thewonkologist.bsky.social · Feb 14

Physicians who receive money from inhaler manufacturers prescribe more inhalers in the future. New findings from Hasan Nadeem, @wbfeldman.bsky.social &co:

pubmed.ncbi.nlm.nih.gov/39937634/

Association Between Industry Payments and Prescription of Inhaled Medications - PubMed

Association Between Industry Payments and Prescription of Inhaled Medications

pubmed.ncbi.nlm.nih.gov

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Program On Regulation, Therapeutics, And Law (PORTAL) @portalresearch.org · Feb 11

🔎 New in JAMA IM: Avik Ray, @wbfeldman.bsky.social & colleagues assess the comparative effectiveness of diabetes drugs in COPD patients.

They find GLP-1s & SGLT-2s are associated with lower risks of moderate or severe COPD exacerbations vs. DPP-4s during follow-up: jamanetwork.com/journals/jam...

Glucose-Lowering Medications and Risk of Chronic Obstructive Pulmonary Disease Exacerbations in Patients With Type 2 Diabetes, JAMA Internal Medicine.

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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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