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GPI would deliver human rights, image

GPI would deliver human rights,

Alicia Ely Yamin and Joel Curtain
Time for Global Public Investment

Preimplantation sex selection via in vitro fertilization: time for a reappraisal image

Preimplantation sex selection via in vitro fertilization: time for a reappraisal

Vitaly A. Kushnir, Eli Y. Adashi, I. Glenn Cohen
F&S Reports

In recent years, there has been rapid increase in the availability of elective sex selection via genetic testing of preimplantation embryoscreated through in vitro fertilization. We explore the…

The New European Medical Device Regulation image

The New European Medical Device Regulation: Balancing Innovation and Patient Safety

Michael Bretthauer and Sara Gerke
Annals of Internal Medicine

The European Union has introduced stricter provisions for medical devices under the new Medical Device Regulation (MDR). The MDR increases requirements for clinical trial testing for many devices before they…

Extending the US Food and Drug Administration’s Postmarket Authorities image

Extending the US Food and Drug Administration’s Postmarket Authorities

Holly Fernandez Lynch, Rachel E. Sachs, and Sejin Lee
JAMA Health Forum

Under current FDA approaches to drug approval, patients, clinicians, and payers may be left with little confidence about a drug’s benefit not only when it first enters the…

The Challenges for Regulating Medical Use of ChatGPT and Other Large Language Model image

The Challenges for Regulating Medical Use of ChatGPT and Other Large Language Model

Timo Minssen, Effa Vayena, and I. Glenn Cohen
JAMA

The introduction of artificial intelligence (AI) into medical devices, decision support, and clinical practice is not new, with a particular uptick in investment and deployment within the past decade. What…

2023 Petrie-Flom Center Annual Conference image

2023 Petrie-Flom Center Annual Conference: Health Law as Private Law

June 23, 2023
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Conference Description The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2023 annual conference: “Health Law as Private…

HIPPA is Misunderstood and Inadequate Tool for Protecting Medical Data image

HIPPA is Misunderstood and Inadequate Tool for Protecting Medical Data

Charmel Shachar, Romain Cadario, I. Glenn Cohen, and Carey K. Morewedge
Nature Medicine

Patients, physicians, and hospital administrators in the USA are often unaware of how legislation governs medical data—but agree that rights over such data should be expanded for patients…

Skating the line between general wellness products and regulated devices: strategies and implications

I. Glenn Cohen (Faculty Director), Carmel Shachar (Executive Director), and David Simon (Research Fellow)
Journal of Law and the Biosciences

Health technology is advancing at a rapid clip, with many of these technologies appearing on consumer products like smartphones and tablets. Federal regulators have responded to these changes with a…

2022 Petrie-Flom Center Annual Conference image

Videos now available! 2022 Petrie-Flom Center Annual Conference: Diagnosing in the Home: The Ethical, Legal, and Regulatory Challenges and Opportunities of Digital Diagnostics and Therapeutics Outside of Traditional Clinical Settings

June 15, 2022
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Even prior to the COVID-19 pandemic, health care delivery was already shifting away from the clinic and into the home, utilizing telehealth, wearable sensors, ambient surveillance, and other products. The…

At the Cutting Edge image

At the Cutting Edge

David A. Simon (Research Fellow, Digital Home Health)
Regulation and Innovation in the Biosciences Junior Scholars Workshop at the University of Iowa College of Law

Delivered talk for “At the Cutting Edge,” the Regulation and Innovation in the Biosciences Junior Scholars Workshop at the University of Iowa College of Law.

When Is a Change Significant? The Update Problem of Apps in Medical and Behavioral Research image

When Is a Change Significant? The Update Problem of Apps in Medical and Behavioral Research

Carmel Shachar (Executive Director), Sara Gerke (Former Research Fellow), Walker Morrell, Aaron Kirby, I. Glenn Cohen (Faculty Director)
Ethics & Human Research

Digital applications (apps) are commonly used across the research ecosystem. While apps are frequently updated in the course of clinical and behavioral research, there is limited guidance as to when…

Allocating Scarce Medical Resources image

Video now available! Allocating Scarce Medical Resources: Equity and Justice Concerns

May 05, 2022
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Online Viewing View the conversation at Twitter @PetrieFlom using #CrisStanCare. Watch the fully captioned recording.  Event Description Crisis standards of care are guidelines that inform health care systems…

Medical Justice and the Carceral State, Part 3 image

Video now available! Medical Justice and the Carceral State, Part 3: The Doctor's White Coat vs. The Officer's Uniform: Who Calls the Shots?

May 03, 2022
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Online Viewing View the conversation on Twitter @PetrieFlom using #MedicalJustice.  Watch the fully captioned event recording. Event Description Who decides when people in prison will receive…

FDA’s breakthrough device program, meant to benefit patients, is delivering the biggest gains for companies image

FDA’s breakthrough device program, meant to benefit patients, is delivering the biggest gains for companies

Katie Palmer and Mario Aguilar, featuring Jonathan J. Darrow (Former Student Fellow)
STAT+

Five years ago, the Food and Drug Administration launched a new program with the best of intentions: to speed the development and review of cutting-edge and potentially lifesaving medical devices,…

A Macro View of Microdosing image

Video now available! A Macro View of Microdosing

April 13, 2022
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View the conversationon Twitter @PetrieFlom using #POPLAR. Watch the fully captioned event recording.  Event Description Microdosing psychedelics involves consuming doses that are one-twentieth to one-tenth the size of standard…

Lucky IP image

Lucky IP

Patrick R. Goold and David A. Simon (Research Fellow, Digital Home Health)
Oxford Journal of Legal Studies

A person naturally owns the fruits of their intellectual labour; so goes the labour argument for intellectual property (IP). But what should happen when a creator gets ‘lucky’…

Setting a National Psychedelic Policy Agenda image

Video now available! Setting a National Psychedelic Policy Agenda

March 24, 2022
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View the conversation on Twitter @PetrieFlom using #POPLAR. View the fully captioned event video.  Event Description As the psychedelic renaissance unfolds, groups are forming to identify national policy…

Controversial Alzheimer’s drug approval ignites FDA reform debate image

Controversial Alzheimer’s drug approval ignites FDA reform debate

Cailtin Owens, featuring Rachel Sachs (Former Academic Fellow)
Axios

The FDA's conditional approval of a controversial Alzheimer's drug last year has sparked heightened scrutiny and an attempted overhaul of a popular regulatory pathway used to fast-track…

Health Care Fraud: The Leading Violation of the False Claims Act image

Health Care Fraud: The Leading Violation of the False Claims Act

Eli Y. Adashi and I. Glenn Cohen (Faculty Director)
The American Journal of Medicine

It is a sign of the times when the lion's share of the schemes intent on defrauding the federal government are in the health care arena. Data reported by…

Intellia Stock Has Tumbled. There Are Issues With Gene-Editing Patents. image

Intellia Stock Has Tumbled. There Are Issues With Gene-Editing Patents.

Bill Alpert, featuring Jacob S. Sherkow (Former Edmond J. Safra/Petrie-Flom Centers Joint Fellow-in-Residence)
Barron's

Shares of gene-editing leader Intellia Therapeutics have dropped 35% since late February, when the U.S. Patent and Trademark Office decided it would not grant patents that Intellia relied on in…

Article supports FDA review of lab-developed tests image

Article supports FDA review of lab-developed tests

Kate Madden Yee, featuring I. Glenn Cohen (Faculty Director)
LabPulse.com

This change drew "wide-ranging expressions of concern" about the future safety of LDTs, according to authors Dr. Eli Adashi of Brown University in Providence, RI, and I. Glenn Cohen of…

It’s Time for American Feminists to Learn From Latin America’s Abortion-Rights Movement image

It’s Time for American Feminists to Learn From Latin America’s Abortion-Rights Movement

Amy Littlefield, featuring Alicia Ely Yamin (Senior Fellow in Global Health and Rights)
The Nation

“You guys left the streets,” Mexican feminist Verónica Cruz told me last September. We were speaking eight days after a law took effect in Texas that…

So, just how much are those CRISPR patents actually worth? image

So, just how much are those CRISPR patents actually worth?

Jason Mast, featuring Jacob S. Sherkow (Former Edmond J. Safra/Petrie-Flom Centers Joint Fellow-in-Residence)
Endpoints News

There was a single question conspicuously absent in all the discussion over last week’s CRISPR patent ruling (a single number, really): How much are the patents actually worth?

SARS-CoV-2 Laboratory-Developed Tests image

SARS-CoV-2 Laboratory-Developed Tests: Integrity Restored

Eli Y. Adashi and I. Glenn Cohen (Faculty Director)
JAMA

On November 15, 2021, the US Department of Health and Human Services (HHS) rescinded a Trump-era policy that had directed the US Food and Drug Administration (FDA) to discontinue the premarket reviews…

Mitigating Racial Bias in Machine Learning image

Mitigating Racial Bias in Machine Learning

by Kristin M. Kostick-Quenet, I. Glenn Cohen (Faculty Director), Sara Gerke, et al.
Journal of Law, Medicine and Ethics

When applied in the health sector, AI-based applications raise not only ethical but legal and safety concerns, where algorithms trained on data from majority populations can generate less accurate or…

Introduction: Health Law and Anti-Racism: Reckoning and Response image

Introduction: Health Law and Anti-Racism: Reckoning and Response

Michele Goodwin and Holly Fernandez Lynch (Former Executive Director)
Journal of Law, Medicine and Ethics

Law and racism are intertwined, with legal tools bearing the potential to serve as instruments of oppression or equity. This Special Issue explores this dual nature of health law, with…

Reflections on Paul Farmer’s legacy: a clarion call for transformative human rights praxis in global health image

Reflections on Paul Farmer’s legacy: a clarion call for transformative human rights praxis in global health

Alicia Ely Yamin (Senior Fellow in Global Health and Rights)
OpenGlobalRights

Paul Farmer’s far-too-early passing on February 21, 2022 is an incalculable loss to those of us who knew and loved him, to students and patients around the globe, to the…

Crispr Patent Ruling Picks Winners in Dispute Over Gene-Editing Technology image

Crispr Patent Ruling Picks Winners in Dispute Over Gene-Editing Technology

Amy Dockser Marcus, featuring Jacob S. Sherkow (Former Edmond J. Safra/Petrie-Flom Centers Joint Fellow-in-Residence)
The Wall Street Journal

In the latest twist in a long-running legal dispute over a popular gene-editing tool, U.S. patent authorities ruled that the Broad Institute deserves the credit for inventing a way…

Travel restrictions and variants of concern: global health laws need to reflect evidence image

Travel restrictions and variants of concern: global health laws need to reflect evidence

Benjamin Mason Meier et al., including Alicia Ely Yamin (Senior Fellow in Global Health and Rights)
The Bulletin of the World Health Organization

As the coronavirus disease 2019 (COVID-19) spread in the early days of the pandemic, governments neglected World Health Organization (WHO) guidance and imposed travel restrictions. These public health measures employed varied…

How can the government successfully engage the private sector in health for equitable distribution of COVID-19 vaccines? image

How can the government successfully engage the private sector in health for equitable distribution of COVID-19 vaccines?

Featuring Alicia Ely Yamin (Senior Fellow in Global Health and Rights)
Health Systems Governance Collaborative

Alicia Ely Yamin teaches courses related to global health and human rights at Harvard Law School and Harvard TH Chan School of Public Health. She is also Senior Advisor on…

The Jackson Ruling That Reverberates In Drug Pricing Debate image

The Jackson Ruling That Reverberates In Drug Pricing Debate

Adam Lidgett, featuring Jacob S. Sherkow (Former Edmond J. Safra/Petrie-Flom Centers Joint Fellow-in-Residence)
Law360

CRISPR’s Nobel Prize winners defeated in key patent claim for genome editor image

CRISPR’s Nobel Prize winners defeated in key patent claim for genome editor

Jon Cohen, featuring Jacob S. Sherkow (Former Edmond J. Safra/Petrie-Flom Centers Joint Fellow-in-Residence)
Science

According to a ruling by an appeal board of the U.S. Patent and Trademark Office (USPTO), a different group, led by the Broad Institute of MIT and Harvard, made…

CRISPR Ruling Invalidates Some Biotech Company Patents image

CRISPR Ruling Invalidates Some Biotech Company Patents

Angelica Peebles, featuring Jacob S. Sherkow (Former Edmond J. Safra/Petrie-Flom Centers Joint Fellow-in-Residence)
TIME

The Broad Institute was the first to invent CRISPR-Cas9 technology for use in animal cells, the U.S. Patent and Trademark Office said, siding against two Nobel laureates in a…

Episode 22: The Decriminalization of Abortion in Colombia image

Episode 22: The Decriminalization of Abortion in Colombia

Featuring Alicia Ely Yamin (Senior Fellow in Global Health and Rights)
Faculty Voices

Abortion is no longer a crime in Colombia. Alicia Yamin, who heads up Harvard’s Global Health and Rights Project, discusses the hemispheric impact of the recent Colombian Constitutional…

UC Berkeley loses CRISPR gene editing patent case image

UC Berkeley loses CRISPR gene editing patent case

by Lisa M. Krieger, featuring Jacob S. Sherkow (Former Edmond J. Safra/Petrie-Flom Centers Joint Fellow-in-Residence)
The Mercury News

It’s a major blow for UC, representing a potential loss of $100 million to $10 billion in U.S. licensing revenues, according to Jacob Sherkow, a professor at the University…

UC Berkeley loses CRISPR patent case, invalidating patent rights it granted gene-editing companies developing human therapies image

UC Berkeley loses CRISPR patent case, invalidating patent rights it granted gene-editing companies developing human therapies

Megan Molteni, featuring Jacob S. Sherkow (Former Edmond J. Safra/Petrie-Flom Centers Joint Fellow-in-Residence)
STAT+

Ending the latest chapter in a years-long legal battle over who invented CRISPR, the U.S. Patent and Trademark Office ruled on Monday that the revolutionary genome editing technology belongs…

Broad prevails in crucial ruling over CRISPR licensing image

Broad prevails in crucial ruling over CRISPR licensing

Megan Molteni, featuring Jacob S. Sherkow (Former Edmond J. Safra/Petrie-Flom Centers Joint Fellow-in-Residence)
The Boston Globe

Ending the latest chapter in a years-long legal battle over who invented CRISPR, the US Patent and Trademark Office ruled on Monday that the revolutionary genome editing technology belongs to…

The ‘Green Wave’ fighting to legalise abortion across Latin America image

The ‘Green Wave’ fighting to legalise abortion across Latin America

Julian Morrow, featuring Alicia Ely Yamin (Senior Fellow in Global Health and Rights)
Sunday Extra

Colombia has decriminalised abortion in the first 24 weeks of pregnancy after a 5-4 majority ruling by the nation’s constitutional court. It’s the latest victory of the '…

Psychedelics and Trauma image

Video now available! Psychedelics and Trauma

February 24, 2022
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View the conversation on Twitter @PetrieFlom using #POPLAR. Watch the fully captioned event video. Event Description Psychedelic substances such as psilocybin, MDMA, and ketamine are being used increasingly in research…

Earth BioGenome Project plans to sequence genome of every known eukaryotic organism image

Earth BioGenome Project plans to sequence genome of every known eukaryotic organism

Sonora Slater, featuring Jacob S. Sherkow (Former Edmond J. Safra/Petrie-Flom Centers Joint Fellow-in-Residence)
The California Aggie

Jacob Sherkow, a professor of law at the University of Illinois, is the lead author of a paper for the special feature that detailed ethical, legal and social issues…

Transparency and the Doctor–Patient Relationship — Rethinking Conflict-of-Interest Disclosures image

Transparency and the Doctor–Patient Relationship — Rethinking Conflict-of-Interest Disclosures

Eli Y. Adashi, I. Glenn Cohen (Faculty Director), and Jacob T. Elberg
The New England Journal of Medicine

To reduce the harm associated with improper financial relationships between manufacturers and physicians, practitioners could be required to disclose such relationships directly to patients.

Incarceration and its Impact on Health image

Incarceration and its Impact on Health: Equity and Social Justice Series & Medical Justice and the Carceral State Series Webinar

February 15, 2022

In light of the COVID-19 pandemic, this panel discussion will be held virtually, as an online webinar. To ensure that you will receive access to the livestream and be kept…

Automating the Administrative State image

Automating the Administrative State: 52nd Annual Administrative Law Symposium

February 12, 2022

Agenda 11:00 - 11:05 ET/8:00 - 8:05 PT, Welcome 11:05 - 11:35 ET/8:05 – 8:35 PT, Introductory Keynote Cass R. Sunstein Robert Walmsley University Professor, Harvard Law School Symposium Article: Governing by Algorithm? No Noise and …

An Ethics Checklist for Digital Health Research in Psychiatry: Viewpoint image

An Ethics Checklist for Digital Health Research in Psychiatry: Viewpoint

Francis Shen (Former Senior Fellow in Law and Applied Neuroscience) et al.
Journal of Medical Internet Research

Background: Psychiatry has long needed a better and more scalable way to capture the dynamics of behavior and its disturbances, quantitatively across multiple data channels, at high temporal resolution in…

Fast Drug Approvals to Get Lawmaker Focus in FDA Fee Plan Review image

Fast Drug Approvals to Get Lawmaker Focus in FDA Fee Plan Review

Celine Castronuovo, featuring Jonathan J. Darrow (Former Student Fellow)
Bloomberg Law

User fees may “hide some of the federal government’s budget and shift the burden to other parties,” said Jonathan Darrow, an assistant professor of medicine at…

Coalition Building to Unlock the Therapeutic Effects of Psychedelics image

Coalition Building to Unlock the Therapeutic Effects of Psychedelics

February 02, 2022

Event Description The Solomon Center for Health Law and Policy welcomes you to join them for their first event of the year! This panel invited experts and change-makers from various…

Understanding Medicare’s Aduhelm Coverage Decision image

Understanding Medicare’s Aduhelm Coverage Decision

Rachel Sachs (Former Academic Fellow)
HealthAffairs

Yesterday, the Centers for Medicare and Medicaid Services (CMS) issued a draft National Coverage Determination (NCD) proposing that monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s…

Direct participation of people with communication disabilities in research on poverty and disabilities in low and middle income countries image

Direct participation of people with communication disabilities in research on poverty and disabilities in low and middle income countries: A critical review

Caroline Jagoe, Caitlin McDonald, Minerva Rivas (Visiting Scholar), and Nora Groce
PLOS One

An estimated 1 billion people with disabilities live in low and middle income countries, a population that includes people with communication disabilities (PwCD). PwCD are a heterogenous group with a wide…

Pharmacies shouldn’t be the only place to get Paxlovid, the new Covid pill image

Pharmacies shouldn’t be the only place to get Paxlovid, the new Covid pill

Holly Fernandez Lynch (Former Executive Director) and Keith Hamilton
STAT News

It’s easy to feel like we’re in a pandemic “Groundhog Day” loop as the U.S. faces yet another Covid-19 surge with overwhelmed hospitals,…

The Supreme Court and vaccine mandates: Three questions image

The Supreme Court and vaccine mandates: Three questions

Peter Grier and Noah Robertson, featuring Carmel Shachar (Executive Director)
The Christian Science Monitor

“The court is not inherently opposed to vaccine mandates or requirements, but they want to see it very closely tied to a strong reasoning and to agencies that handle…

The controversial Alzheimer’s drug isn’t getting much love from Medicare image

The controversial Alzheimer’s drug isn’t getting much love from Medicare

Rachel Roubein and Alexandra Ellerbeck, featuring Rachel Sachs (Former Academic Fellow)
The Washington Post

Access restricted: Medicare is proposing to only cover the new, pricey Alzheimer’s drug for patients enrolled in certain clinical trials, a condition that would severely limit its use. …

A new Alzheimer’s drug shows why the FDA’s speedy approval process is broken image

A new Alzheimer’s drug shows why the FDA’s speedy approval process is broken

Holly Fernandez Lynch (Former Executive Director) and Christopher T. Robertson (Former Academic Fellow)
The Washington Post

Whether it’s covid or cancer, when you’re a patient facing a life-threatening disease without good treatment options, your risk tolerance is bound to be pretty high.…

Curbside Consults in Clinical Medicine: Empirical and Liability Challenges image

Curbside Consults in Clinical Medicine: Empirical and Liability Challenges

Rachel L. Zacharias, Eric A. Feldman, Steven Joffe, and Holly Fernandez Lynch (Former Executive Director)
Journal of Law, Medicine & Ethics

Abstract In most U.S. jurisdictions, clinicians providing informal “curbside” consults are protected from medical malpractice liability due to the absence of a doctor-patient relationship. A recent Minnesota…

Make or break for Biogen: How the national coverage decision for amyloid-targeted Alzheimer’s drugs will shake out image

Make or break for Biogen: How the national coverage decision for amyloid-targeted Alzheimer’s drugs will shake out

Zachary Brennan, featuring Rachel Sachs (Former Academic Fellow)
Endpoints News

Ever since Biogen’s controversial Alzheimer’s drug Aduhelm won an accelerated approval in June, despite scant evidence of clinical benefit, the country has turned its attention to…

A looming decision on Medicare coverage for Biogen’s Alzheimer’s drug could shock state Medicaid programs image

A looming decision on Medicare coverage for Biogen’s Alzheimer’s drug could shock state Medicaid programs

Ed Silverman, featuring Rachel Sachs (Former Academic Fellow)
STAT News

Shortly after the controversial Biogen drug Alzheimer’s was approved in the U.S. last year, a pair of state Medicaid directors tried to ring alarm bells.

Medicare must soon say whether it will cover the pricey new Alzheimer’s drug image

Medicare must soon say whether it will cover the pricey new Alzheimer’s drug

Rachel Roubein and Alexandra Ellerbeck, featuring Rachel Sachs (Former Academic Fellow)
The Washington Post

It’s a massive week for the pricey, new Alzheimer’s drug. Medicare officials are bumping up against a critical Wednesday deadline to issue a proposal on whether …

Podcast: Prescription Drug Policy, Drug Pricing & Aduhelm With Rachel Sachs image

Podcast: Prescription Drug Policy, Drug Pricing & Aduhelm With Rachel Sachs

Rachel Sachs (Former Academic Fellow) and Chris Fleming
HealthAffairs

While COVID-19 shallowed many headlines in the health care space, a lot of movement was made in various health policy areas, including prescription drug pricing. On today's episode of…

CMS officially tosses ‘Most-Favored Nation’ drug pay model image

CMS officially tosses ‘Most-Favored Nation’ drug pay model

Maya Goldman, featuring Rachel Sachs (Former Academic Fellow)
Modern Healthcare

Buckle Up: Wild Ride Awaits Health, Life Sci Policy In 2022 image

Buckle Up: Wild Ride Awaits Health, Life Sci Policy In 2022

Jeff Overley and Adam Lidgett, featuring Rachel Sachs (Former Academic Fellow)
Law360

The Right to Health: The Potential and Limits of Catalysing Systemic Change through the Courts image

The Right to Health: The Potential and Limits of Catalysing Systemic Change through the Courts

Alicia Ely Yamin (Senior Fellow in Global Health and Rights)
The Oxford Handbook of Constitutional Law in Latin America

This chapter focuses on the judicialization of health rights in Latin America. It begins by outlining the constitutional provisions in relation to health rights in five countries: Argentina, Brazil, Colombia,…

PORTAL Fellowship, Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital Department of Medicine and Harvard Medical School

Deadline: January 28, 2022
Ameet Sarpatwari, Ph.D., J.D.

The Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital Department of Medicine and Harvard Medical School invites its 2022 round of applications for postdoctoral fellows in pharmaceutical…

A Divisive Ruling on Devices — Genus Medical Technologies v. FDA image

A Divisive Ruling on Devices — Genus Medical Technologies v. FDA

Patricia J. Zettler, Eli Y. Adashi, and I. Glenn Cohen (Faculty Director)
The New England Journal of Medicine

The FDA has long taken the legal position that regulated devices could also be categorized as drugs. But according to a recent case, products meeting the definition of a device …

Alzheimer’s experts call on FDA to pull Biogen’s Aduhelm image

Alzheimer’s experts call on FDA to pull Biogen’s Aduhelm

Zachary Brennan, featuring Rachel Sachs (Former Academic Fellow)
Endpoints News

Alzheimer’s disease researchers along with medical professors from Harvard and Johns Hopkins issued a formal statement Monday asking the FDA to quickly pull Biogen’s Aduhelm from…

Biogen Quickly Cuts Alzheimer’s Drug Cost After Payer Pushback image

Biogen Quickly Cuts Alzheimer’s Drug Cost After Payer Pushback

Angelica Peebles and John Tozzi, featuring Rachel Sachs (Former Academic Fellow)
Bloomberg

Biogen Inc. said it would cut the list price of its Alzheimer’s disease drug Aduhelm in half in the U.S., a move that comes after the treatment…

Deadly Legacy—The 510(k) Path to Medical Device Clearance image

Deadly Legacy—The 510(k) Path to Medical Device Clearance

Eli Y. Adashi, Katina M. Robison, I. Glenn Cohen (Faculty Director)
JAMA Surgery

On December 29, 2020, the US Food and Drug Administration (FDA) issued final guidance to the effect that laparoscopic power morcellators (LPMs) should be used “only with a tissue containment system…

Warning: Oregon Legalized Supported Adult Use of Psilocybin, Not Psychedelic Therapy image

Warning: Oregon Legalized Supported Adult Use of Psilocybin, Not Psychedelic Therapy

Mason Marks (Senior Fellow and Project Lead on the Project on Psychedelics Law and Regulation)
Chacruna

During the 2020 presidential election, over 55 percent of Oregon voters approved Measure 109, also called the Oregon Psilocybin Services Act. With this historic vote, Oregon became the first state to legalize the…

Every drug should be labelled to tell you how well it works image

Every drug should be labelled to tell you how well it works

Jonathan J. Darrow (Former Student Fellow)
Mail+

When buying over- the-counter drugs or being prescribed medication by your GP, what’s the one thing you want to know? The answer is obvious, of course: how well…

Changes in the Use of Hydroxyprogesterone Caproate Injection After Confirmatory Trial Failure image

Changes in the Use of Hydroxyprogesterone Caproate Injection After Confirmatory Trial Failure

Rachel E. Sachs (Former Academic Fellow), Kyle A. Gavulic, Julie M. Donohue
JAMA Internal Medicine

The US Food and Drug Administration (FDA) accelerated approval pathway allows new drugs with uncertain clinical benefits to be approved on the basis of clinical trials involving surrogate end points.…

Challenges in confirming drug effectiveness after early approval image

Challenges in confirming drug effectiveness after early approval

Holly Fernandez Lynch (Former Executive Director) and Christopher T. Robertson (Former Academic Fellow)
Science

It’s easy to understand the urge to make potentially beneficial drugs quickly available to patients in need. It’s also easy to go too far. Through its 2021…

Vaccines, Regulation, and Patents: A Conversation with Harvard Medical School Professor Dr. Jonathan J. Darrow image

Vaccines, Regulation, and Patents: A Conversation with Harvard Medical School Professor Dr. Jonathan J. Darrow

James R. Jolin, featuring Jonathan J. Darrow (Former Student Fellow)
Harvard Health Policy Review

HHPR Senior Editor James Jolin interviewed Jonathan Darrow, S.J.D., LL.M., J.D., M.B.A, an Assistant Professor of Medicine at Harvard Medical School and a Faculty…

Hastings Center Welcomes 24 New Fellows image

Hastings Center Welcomes 24 New Fellows

The Hastings Center

The Hastings Center is pleased to announce the election of 24 new fellows. Hastings Center fellows are a group of more than 200 individuals of outstanding accomplishment whose work has informed scholarship…

“We measure what we can measure”: Struggles in defining and evaluating institutional review board quality image

“We measure what we can measure”: Struggles in defining and evaluating institutional review board quality

Holly Fernandez Lynch (Former Faculty Director), Whitney Eriksen, and Justin T. Clapp
Social Science and Medicine

There has been a persistent lack of clarity regarding how to define and measure the quality of Institutional Review Boards (IRBs). To address this challenge, we interviewed 43 individuals designated as…

Medicare Coverage of Aducanumab — Implications for State Budgets image

Medicare Coverage of Aducanumab — Implications for State Budgets

Rachel E. Sachs (Former Academic Fellow) and Nicholas Bagley
The New England Journal of Medicine

CMS is considering whether and under what circumstances Medicare will pay for aducanumab for Alzheimer’s disease. A restrictive coverage determination could save the federal government money, but it…

Ecosystem effectuation: creating new value through open innovation during a pandemic image

Ecosystem effectuation: creating new value through open innovation during a pandemic

Agnieszka Radziwon, Marcel L.A.M. Boger, Henry Chesbrough, and Timo Minssen (Former Visiting Scholar)
R&D Management

The severity of the COVID-19 pandemic confronts us with a global grand challenge representing an unprecedented crisis for health, economies, and societies. While digital champions are thriving, a large number…

Ethics in Psychedelic Therapy and Research image

Video now available! Ethics in Psychedelic Therapy and Research

November 18, 2021
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Watch the fully captioned event recording. View the conversation on Twitter @PetrieFlom using #POPLAR. Event Description Psychedelic substances like psilocybin, MDMA, and ketamine are increasingly used in research and clinical…

Let’s Make a Deal…on Drug Prices image

Let’s Make a Deal…on Drug Prices

Featuring Rachel E. Sachs (Former Academic Fellow)
Tradeoffs

Democrats are on the brink of passing a historic set of drug price reforms. How will they impact patients, insurers and the drug industry?

Regeneron, Janssen Drugs Fit Profile Targeted in Spending Bill image

Regeneron, Janssen Drugs Fit Profile Targeted in Spending Bill

Alex Ruoff, Jasmine Ye Han, and Valerie Bauman, featuring Rachel E. Sachs (Former Academic Fellow)
Bloomberg Law

The idea that drugmakers get a government-backed monopoly for a period of time to recoup their investment in new drugs and then must face competition has long been the &ldquo…

Opinion: The drug pricing deal isn’t really a victory for Dems, or a loss for PhRMA. But it could be a harbinger of change image

Opinion: The drug pricing deal isn’t really a victory for Dems, or a loss for PhRMA. But it could be a harbinger of change

Zachary Brennan, featuring Rachel E. Sachs (Former Academic Fellow)
Endpoints News

Rachel Sachs, a law professor at Washington University in St. Louis who studies drug pricing and innovation, said she didn’t think companies potentially bringing in more competition prior…

Simplify drug labelling to show benefits clearly image

Simplify drug labelling to show benefits clearly

Jonathan J. Darrow (Former Student Fellow)
Nature

Aducanumab, an Alzheimer’s disease treatment, was approved by the US Food and Drug Administration (FDA) in June this year despite a lack of robust evidence that it actually…

Democrats are trying to cut drug costs for employers, too image

Democrats are trying to cut drug costs for employers, too

Caitlin Owens, featuring Rachel E. Sachs (Former Academic Fellow)
Axios

By the numbers: Applying inflation caps to the commercial market would generate more than $150 billion in revenue for the federal government by 2030, according to an estimate by West Health. The…

Understanding The New Drug Price Reform Deal image

Understanding The New Drug Price Reform Deal

Rachel E. Sachs (Former Academic Fellow)
HealthAffairs

Yesterday, the text of the Democratic deal on prescription drug pricing reform was released. These drug pricing reforms are intended to move forward as part of a broader reconciliation package…

Editorial: Can a Pandemic Law-Making Exercise Promote Global Health Justice? image

Editorial: Can a Pandemic Law-Making Exercise Promote Global Health Justice?

Alicia Ely Yamin (Senior Fellow in Global Health and Rights), Joelle Grogan, and Pedro A. Villarreal
Verfassungsblog

Amid the unfolding "moral catastrophe" of COVID-19, and across the entries in this symposium, we see a clamor for any pandemic law-making exercise to promote more justice in global health. …

Advocates express tempered optimism for Dems’ drug pricing deal image

Advocates express tempered optimism for Dems’ drug pricing deal

Peter Sullivan, featuring Rachel E. Sachs (Former Academic Fellow)
The Hill

But Rachel Sachs, a health policy expert at Washington University in St. Louis, argued that the industry would have a negative reaction regardless of the scale of the drug pricing…

Dems resurrect a scaled back plan for Medicare drug price negotiations image

Dems resurrect a scaled back plan for Medicare drug price negotiations

Zachary Brennan, featuring Jonathan Darrow (Former Student Fellow)
Endpoints News

Only a few days after President Joe Biden seemed to signal that drug pricing reforms were left for dead, Democrats are already circulating plans for a scaled-back version of what…

Problematic Interactions Between AI and Health Privacy

Nicholson Price (Former Academic Fellow)
Utah Law Review

The interaction of artificial intelligence (AI) and health privacy is a two-way street. Both directions are problematic. This Essay makes two main points. First, the advent of artificial intelligence weakens…

Pelosi working to gather support for last-minute, last-ditch drug pricing policy

Rachel Cohrs
STAT News

WASHINGTON — House Speaker Nancy Pelosi’s office is working to gather support for a last-ditch proposal to lower prescription drug costs after the White House shunned the issue…

Cross-Border Transfers of Personal Data after Schrems II: Supplementary Measures and New Standard Contractual Clauses (SCCs) image

Cross-Border Transfers of Personal Data after Schrems II: Supplementary Measures and New Standard Contractual Clauses (SCCs)

Marcelo Corrales Compagnucci, Mateo Aboy, and Timo Minssen (Former Visiting Scholar)
SSRN

This article analyses the legal challenges of international data transfers resulting from the recent Court of Justice of the European Union (CJEU) decision in Case C-311/18 Data Protection Commissioner v…

FDA Drug Approval and the Ethics of Desperation image

FDA Drug Approval and the Ethics of Desperation

Emily A. Largent, Andrew Peterson, and Holly Fernandez Lynch (Former Executive Director)
JAMA Internal Medicine

In justifying the accelerated approval of aducanumab (Aduhelm; Biogen), US Food and Drug Administration (FDA) officials emphasized that many patients with Alzheimer disease and their families “made it clear…

Steps toward a System of IRB Precedent: Piloting Approaches to Summarizing IRB Decisions for Future Use image

Steps toward a System of IRB Precedent: Piloting Approaches to Summarizing IRB Decisions for Future Use

Andrea Seykora, Carl Coleman, Stephen J. Rosenfeld, Barbara E. Bierer, and Holly Fernandez Lynch (Former Executive Director)
Ethics & Human Research

Institutional review boards (IRBs) have been criticized for inconsistency and lack of transparency in decision-making, problems that undermine both trust in their ability to protect human research participants and respect…

German Pharmaceutical Pricing: Lessons for the United States image

German Pharmaceutical Pricing: Lessons for the United States

Marc A. Rodwin and Sara Gerke (Former Research Fellow in Medicine, Artificial Intelligence, and Law)
International Journal of Health Services

To control pharmaceutical spending and improve access, the United States could adopt strategies similar to those introduced in Germany by the 2011 German Pharmaceutical Market Reorganization Act. In Germany, manufacturers sell…

A Strategy for Rescheduling Psilocybin image

A Strategy for Rescheduling Psilocybin

Mason Mark (Senior Fellow and Project Lead on the Project on Psychedelics Law and Regulation), featuring I. Glenn Cohen (Faculty Director)
Scientific American

Public and scientific interest in psychedelics such as psilocybin and MDMA is expanding. Once off-limits because of federal prohibition, a trickle of research from the 1990s has grown into a…

Collaboration in times of crisis: A study on COVID-19 vaccine R&D partnerships

Louise C. Druedahl, Timo Minssen, W. Nicholson Price (Former Academic Fellow)
Vaccine

Collaboration is central for initiatives and efforts in the race to fight COVID-19, with particular focus on fostering rapid development of safe and effective COVID-19 vaccines. We investigated the types…

Beyond Security Patches—Fundamental Incentive Problems in Health Care Cybersecurity image

Beyond Security Patches—Fundamental Incentive Problems in Health Care Cybersecurity

Genevieve P. Kanter, Jack Kufahl, and I. Glenn Cohen (Faculty Director)
JAMA

With ransomware attacks now targeting critical US infrastructure, hospitals and health systems are under serious threat. In May 2021, at least 1 US health system and multiple hospitals overseas were victims of…

To Incentivize COVID-19 Vaccination, Give Vaccinated Individuals A Discount On Their Insurance Premiums image

To Incentivize COVID-19 Vaccination, Give Vaccinated Individuals A Discount On Their Insurance Premiums

Ian T.T. Liu and Jonathan Darrow (Former Student Fellow)
HealthAffairs

Although Covid-19 vaccines have been available in the US under Emergency Use Authorization since December 11, 2020, more than 119 million (36 percent) of the US population of 332 million have not received a dose…

Health experts discuss high drug prices and potential for reform at virtual Penn event image

Health experts discuss high drug prices and potential for reform at virtual Penn event

Anushka Dasgupta, featuring Rachel Sachs (Former Academic Fellow)
The Daily Pennsylvanian

Penn’s Leonard Davis Institute of Health Economics hosted a virtual seminar in which panelists discussed high drug prices and possibilities for reform in the present political climate. The…

Picking Embryos With Best Health Odds Sparks New DNA Debate image

Picking Embryos With Best Health Odds Sparks New DNA Debate

Carey Goldberg, featuring Michelle N. Meyer
Bloomberg

Rafal Smigrodzki won’t make a big deal of it, but someday, when his toddler daughter Aurea is old enough to understand, he plans to explain that she likely…

Tracking the FDA advisory panel meeting on Covid-19 booster shots

Helen Branswell and Matthew Herper
STAT News

Do most Americans already need Covid-19 booster shots, or at least will they soon? Those questions have been hotly debated in the public square over the past few weeks. But…