The Petrie-Flom Center and Edmond J. Safra Center for Ethics Fellow-in-Residence
Petrie-Flom Center, Harvard Law School, and Edmond J. Safra Center, Harvard University

Deadline: November 15, 2018

Each year the Edmond J. Safra Center for Ethics at Harvard University hosts several fellows-in-residence. For 2019-20, they are concentrating their fellowships on the Ethics of Technological… Read More

Call for Abstracts: 2019 Petrie-Flom Center Annual Conference: Consuming Genetics
Petrie-Flom Center, Harvard Law School

Deadline: Closed.

The call for abstracts for the 2019 annual conference is now closed. The conference agenda will be posted in late fall 2018 to the conference website. Consuming Genetics: The Ethical and Legal Considerations… Read More

FDA: Young-blood transfusions provide ‘no proven clinical benefit’ for aging, Alzheimer’s

STAT, February 19, 2019
by Rebecca Robbins

he quest to rejuvenate aging people with the blood of young donors has generated paying customers, captured the popular imagination, and, now, prompted a warning from the Food and Drug Administration.… Read More

World Health Organization Forms Committee To Guide Editing Of Human Genes

NPR, February 14, 2019

The World Health Organization Thursday announced the formation of an international committee aimed at establishing uniform guidelines for editing human DNA in ways that can be passed down to future generations.… Read More

House committee weighs drug pricing proposals

Endpoints News, February 14, 2019
by by Michael Mezher, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: "Mark Miller, executive vice president of health care at Arnold Ventures, told the committee that moving to a flat fee-per-prescription model for Medicare Part B could help to curb some… Read More

Sanders to Gables pharma firm: Why are you charging $375,000 for life-saving drug?

Miami Herald, February 6, 2019
by by Rob Wile, quoting W. Nicholson Price (Academic Fellow Alumnus)

From the article: "Nicholson Price, an assistant professor at the University of Michigan who specializes in law surrounding innovation in the life sciences, said Catalyst would likely counter by saying… Read More

Shadow health records meet new data privacy laws

Science, February 1, 2019
by by W. Nicholson Price (Academic Fellow Alumnus), Margot E. Kaminski, Timo Minssen (Former Visiting Scholar), Kayte Spector-Bagdad

From the article: "Large sets of health data can enable innovation and quality measurement but can also create technical challenges and privacy risks. When entities such as health plans and health care… Read More

Court allows House Democrats to join Obamacare’s defense

Politico, February 14, 2019
by Alice Miranda Ollstein

A federal appeals court is allowing House Democrats to defend Obamacare in a lawsuit threatening the future of the health care law. The 5th Circuit Court of Appeals today granted the House’s petition… Read More

F.D.A. Panel Recommends New Depression Treatment

New York Times, February 12, 2019
by Benedict Carey

In a move that may clear the way for the first new treatment in years for depression, an expert panel recommended on Tuesday that federal regulators approve a nasal spray that delivers the active ingredients… Read More

American Travelers Seek Cheaper Prescription Drugs In Mexico And Beyond

NPR, February 11, 2019
by Bram Sable-Smith

[...] The U.S. government estimates that close to 1 million people in California alone cross to Mexico annually for health care, including to buy prescription drugs. And between 150,000 and 320,000… Read More

Can You Sue An Algorithm For Malpractice?

Forbes AI, February 11, 2019
by by Forbes AI, interviewing W. Nicholson Price (Academic Fellow Alumnus)

From the article: "What’s in the box? The “black box,” that is. Increasingly, doctors are relying on sophisticated, and at times inscrutable, algorithms to make healthcare recommendations—a… Read More

Shrinking Medicaid Rolls In Missouri And Tennessee Raise Flag On Vetting Process

Kaiser Health News, February 8, 2019
by Phil Galewitz

[...] Ward and her children are among tens of thousands of Medicaid enrollees who were dropped by Missouri and Tennessee last year as both states stepped up efforts to verify members’ eligibility.… Read More

Supreme Court Blocks Louisiana Abortion Law

New York Times, February 7, 2019
by Adam Liptak

WASHINGTON — The Supreme Court on Thursday blocked a Louisiana law that its opponents say could have left the state with only one doctor in a single clinic authorized to provide abortions.… Read More

Trump Highlights Health Agenda With Vow To Lower ‘Unfair’ Drug Prices

Kaiser Health News, February 6, 2019
by Julie Rovner

It was not the centerpiece, but health was a persistent theme in President Donald Trump’s State of the Union address at the Capitol on Tuesday night. Although the administration has focused more… Read More

More light needed on medical “shadow records” and “black box” tools, U-M experts say

IHPI News Blog, February 6, 2019
by by IHPI, quoting W. Nicholson Price (Academic Fellow Alumnus)

From the post: "When shadow record elements from many people are pooled together and used by academic researchers or industry, they can fuel progress in health care research and innovation, says the international… Read More

How Trump’s Latest Plan to Cut Drug Prices Will Affect You

New York Times, February 5, 2019
by By Katie Thomas and Reed Abelson, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: "The Trump administration says that a lot will depend on how companies react. If the plan takes effect next year, it could cost the government an extra $2.8 billion to $13.5 billion that… Read More

Trump wants to slash drug rebate deals. Will it make a difference?

ABC News, February 4, 2019
by by Jay Hancock, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: "In any event, it’s hardly a pure win for seniors or patients in general. Consumers are unlikely to collect the full benefit of eliminated rebates. At the same time, the change… Read More

The Fight To Lower Soaring Drug Prices Turns Bitter Between States And The Feds

Huffington Post, February 4, 2019
by By Michael Ollove, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: "According to the National Institute on Money and Politics, a nonprofit that collects campaign finance data, the pharmaceutical industry in 2018 contributed nearly $19 million to state… Read More

Winners And Losers Under Bold Trump Plan To Slash Drug Rebate Deals

Kaiser Health News, February 1, 2019
by By Jay Hancock, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: "In any event, it’s hardly a pure win for seniors or patients in general. Consumers are unlikely to collect the full benefit of eliminated rebates. At the same time, the change… Read More

The rebate rule is here

POLITICO Pulse, February 1, 2019
by by Dan Diamond, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: "Pharmacy benefit managers are likely to fight efforts to change the kickback exemption, which has been in place since Medicare Part D’s inception, said Sean Dickson of Pew Charitable… Read More

A User-Focused Transdisciplinary Research Agenda for AI-Enabled Health Tech Governance

AI-Health Working Group White Paper, January, 2019
by David Arney, Max Senges, Sara Gerke et al

From the abstract:   AI-enabled health technology holds significant promise for improving health outcomes and clinical workflows. However, it also generates challenges for health data governance… Read More

Trump proposal would upend drug industry by overhauling rebates in Medicare

CNN, January 31, 2019
by By Tami Luhby, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: "The Trump administration unveiled a proposal Thursday that could radically change the way many drugs are priced and paid for in Medicare and Medicaid. The plan calls for effectively… Read More

Drugmakers Drag Feet as Congress Drills Into Prescription Prices

Bloomberg Government, January 31, 2019
by By Alex Ruoff and Jeannie Baumann, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: "'Pharmaceutical companies look at what happened to Martin Shkreli and Heather Bresch at Mylan and they don’t want their company to be the face of this year’s drug pricing… Read More

Luxturna: FDA documents reveal the value of a costly gene therapy

Drug Discovery Today, January 31, 2019
by by Jonathan J. Darrow (Student Fellow Alumnus)

From the article: "In 2017, the US Food and Drug Administration (FDA) approved voretigene neparvovec‐rzyl (Luxturna), a gene therapy used to treat a rare form of inherited blindness. Widely described… Read More

Power, Politics and Knowledge Claims: Sexual and Reproductive Health and Rights in the SDG Era

Global Policy , January 28, 2019
by by Alicia Ely Yamin (Senior Fellow for GHRP)

From the article: "The selection of Sustainable Development Goals (SDGs) , targets and indicators for sexual and reproductive health and rights (SRHR) can only be understood in the light of struggles to… Read More

Congress has 7 big ideas to cut drug prices. Here’s how they work.

Vox, January 17, 2019
by by Dylan Scott, quoting Rachel Sachs

From the article: "One irony of the ongoing drug prices debate, says Rachel Sachs, an associate professor at Washington University in St. Louis, is that the drug industry opposition to more modest proposals… Read More

In Blockbuster Alliance, Walgreens And Microsoft To Develop ‘New Healthcare Models’

Forbes, January 15, 2019
by Bruce Japsen

In a potentially blockbuster partnership,  Walgreens Boots Alliance said it has formed a strategic alliance with Microsoft Corp. to "develop new health care delivery models, technology… Read More

The Lumbering Crawl Toward Human Germline Editing

Journal of Law, Medicine & Ethics, January 10, 2019
by by Eli Y. Adashi and I. Glenn Cohen (Faculty Director)

From the article:  It is in the nature of novelty that consensus is hard to come by. Such is clearly the lot of groundbreaking biomedical advances. History is no stranger to this phenomenon. The prospect… Read More

Democrats examine drug prices, a first step in Congress’ path to cut prescription costs

USA Today, January 14, 2019
by by Maureen Gropps, quoting Rachel Sachs

From the article: "Republican Sen. Chuck Grassley, the new chairman of the Senate Finance Committee, has said he will try to find solutions. 'It’s one of the top concerns I hear from Iowans,' Grassley recently… Read More

Grassley is not pharma’s worst nightmare

Axios Vitals, January 14, 2019
by by Caitlin Owens, quoting Rachel Sachs

From the article: "What he's saying: In an interview with my colleague Jonathan Swan and me, Grassley made clear he is no radical when it comes to pharma. The 3 bills at the center of… Read More

Congress is about to renew its ban on creating CRISPR babies in the US

MIT Technology Review, January 10, 2019
by by Antonio Regalado, quoting I. Glenn Cohen (Faculty Director)

From the article: "By blocking any-and-all DNA changes to an embryo, I. Glenn Cohen, a professor at Harvard Law School, says American legislation has taken a "meat axe" approach when what's… Read More

How Chummy Are Junk Food Giants and China’s Health Officials?

New York Times, January 9, 2019
by Andrew Jacobs

Happy 10 Minutes, a Chinese government campaign that encouraged schoolchildren to exercise for 10 minutes a day, would seem a laudable step toward improving public health in a nation struggling with alarming… Read More

Perspectives on Gene Editing

Harvard Gazette, January 9, 2019
by by Mary Todd Bergman, quoting I. Glenn Cohen (Faculty Director)

From the article: "Progress in this field has been so rapid that the dialogue around potential ethical, societal, and safety issues is scrambling to catch up. This disconnect was brought into stark relief… Read More

House Democrats defend Obamacare as courts weigh in

USA Today, January 9, 2019
by by Maureen Groppe, quoting Rachel Sachs

From the article: "Following through on Trump’s promise to reduce the cost of prescription drugs, the administration rolled out various proposals that analyst Rachel Sachs of Washington University… Read More

‘Left behind’

STAT, January 8, 2019
by Apoorva Mandavili, with photos by Michael Starghill Jr.

[...] Vergel, 59, attributes most of these conditions to his low CD4 count, a key marker of immune function in HIV-positive people. He is what’s known as an immunologic non-responder (INR) —… Read More

All seven of the FDA’s recent commissioners agree it should be independent

STAT, January 7, 2019
by Ike Swetlitz

WASHINGTON — Nearly every person who’s run the Food and Drug Administration in recent history agrees the agency should break free from its political supervisors — a rare consensus from… Read More

FDA Accuses Juul and Altria of Backing Off Plan to Stop Youth Vaping

New York Times, January 4, 2019
by Sheila Kaplan

WASHINGTON — The Food and Drug Administration is accusing Juul and Altria of reneging on promises they made to the government to keep e-cigarettes away from minors. Dr. Scott Gottlieb, the agency’s… Read More

Prescription Drug Policy

Health Affairs blog, January 3, 2019
by by Rachel Sachs (Academic Fellow Alumna)

From the article:  This past year was once again filled with health policy news. Unlike 2017's congressional efforts to repeal the Affordable Care Act (ACA), 2018's news focused… Read More

An export-only exception to pharmaceutical patents in Europe: should the United States follow suit?

Nature Biotechnology, January 3, 2019
by Timo Minssen (Former Visiting Scholar), Aaron S. Kesselheim, and Jonathan Darrow (Student Fellow Alumnus)

From the article: "A new European Union policy could increase the supply of legitimate pharmaceuticals in developing countries and thereby minimize the problem of counterfeit medicines, but many challenges… Read More

How The Government Shutdown Affects Health Programs

Kaiser Health News, January 3, 2019
by Shefali Luthra

There seems to be no end in sight for the current partial government shutdown, the third since the beginning of the Trump administration. For the vast majority of the federal government’s public… Read More

With Senate votes, Trump gets a permanent drug czar — and his first science adviser

STAT, January 2, 2019
by Lev Facher

WASHINGTON — In the final hours of a lame-duck Congress, lawmakers on Wednesday confirmed the Trump administration’s nominees for science adviser and “drug czar,” following nearly… Read More

Carpus Dicit: Special Report

Harvard Medicine, Winter 2019
by by Monique Brouillette, quoting I. Glenn Cohen (Faculty Director)

From the article: "For I. Glenn Cohen, the James A. Attwood and Leslie Williams Professor of Law at Harvard Law School, the degree of worry over our data should vary depending on which data are being considered.… Read More

Legal weed is everywhere — unless you’re a scientist

Politico, December 25, 2018
by Sarah Owermohle

Americans can legally buy high quality marijuana in most states, but when scientists want to study pot in a lab, they’re basically stuck with schwag. A little-known research facility at the University… Read More

U.S. Surgeon General Calls For Aggressive Plans To Fight Youth Vaping In Rare Advisory

Kaiser Health News, December 19, 2018

KHN Morning Briefing: Summaries of health policy coverage from major news organizations As e-cigarrettes become more popular among teens and worries rise about a new generation that could become hooked… Read More

Set It and Forget It - How Better Contraception Could Be a Key to Reducing Poverty

New York Times, December 18, 2018
by Margot Sanger-Katz

When a woman of childbearing age goes to the doctor in most places, she gets standard queries about her smoking, drinking, seatbelt use and allergies. In Delaware, she is now also asked: “Do you… Read More

VA Still Arbitrarily Cutting Caregivers From Program, Even As It Aims To Expand

NPR, December 18, 2018
by Quil Lawrence

[...] The program was set up to support family members of Iraq and Afghanistan veterans. They're mostly wives and mothers who receive a VA stipend to provide home health care that would otherwise cost… Read More

Hatch’s Swan Song: A Bill to Block Generic Companies’ IPR Filings

RAPS Regulatory Focus, December 14, 2018
by by Zachary Brennan, quoting Jonathan Darrow (Student Fellow Alumnus)

From the article:  Retiring Sen. Orrin Hatch (R-UT) and two Republican colleagues in the House and Senate proposed a bill earlier this week to prevent generic drug applicants from taking advantage… Read More

Appeals court blocks Trump birth control rules in five states

The Hill, December 13, 2018
by Jessie Hellmann

A U.S. appeals court on Thursday blocked Trump administration rules that would allow businesses to claim moral and religious exemptions to ObamaCare's contraception mandate.  The ruling only applies… Read More

Nearly 20 Percent Fewer New People Have Signed Up For Health Law Plans Than At This Time Last Year

Kaiser Health News, December 13, 2018

KHN Morning Briefing: Summaries of health policy coverage from major news organizations Though there has been a surge in sign-ups over the past week as the Dec. 15 deadline closes in, overall, enrollment… Read More

N.I.H. to Scrutinize Private Donations to Scientific Research Projects

New York Times, December 13, 2018
by Roni Caryn Rabin

Six months after halting a study of moderate drinking that was underwritten by donations from the alcohol industry, the National Institutes of Health outlined a series of steps to prevent similar… Read More

Big data and black-box medical algorithms

Science Translational Medicine, December 12, 2018
by by W. Nicholson Price (Academic Fellow Alumnus)

From the article: "Machine-learning algorithms have been predicted to come into widespread use in the areas of prognosis, radiology, and pathology within the next few years, and diagnosis within the next… Read More

Freeze on fetal tissue procurement may impede work at NIH cancer lab, agency says

STAT, December 12, 2018
by Ike Swetlitz

WASHINGTON — The National Institutes of Health freeze on fetal tissue procurement is threatening to hamper work at an agency lab conducting cancer research, the latest sign that a Trump administration… Read More

Of Parachutes and Participant Protection:

Journal of Empirical Research on Human Research Ethics, December 12, 2018
by by Holly Fernandez Lynch (Former Executive Director), Stuart Nicholls, Michelle N. Meyer, and Holly A. Taylor

From the abstract:  There are several reasons to believe that Institutional Review Boards (IRBs) and Human Research Protection Programs (HRPPs) contribute to ethical research and the protection of… Read More

Health as a Human Right, Medicare for All, and the Evolution of the American Health Care Debate

Take Care Blog, December 11, 2018
by By Carmel Shachar (Executive Director), Alex Pearlman (Communications Manager) and I. Glenn Cohen (Faculty Director)

From the article: The United States famously does not have an explicit federal constitutional right to health. By contract, the “enjoyment of the highest attainable standard of health”… Read More

A groundbreaking antitrust lawsuit is ensnaring the generic drug industry

Vox, December 10, 2018
by By Dylan Scott, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: "The exact damages are difficult to know but likely total in the billions of dollars if the allegations are true. These artificially high prices led to health plans and government programs… Read More

Investigation of generic ‘cartel’ expands to 300 drugs

Washington Post, December 9, 2018
by Christopher Rowland

Executives at more than a dozen generic-drug companies had a form of shorthand to describe how they conducted business, insider lingo worked out over steak dinners, cocktail receptions and rounds of golf.… Read More

More Salt, Fewer Whole Grains

NPR, December 7, 2018
by Allison Aubrey

School lunches are healthier than they were five years ago. But Agriculture Secretary Sonny Perdue says schools need more flexibility in serving meals that kids will eat. "If kids are not eating what is… Read More

Democrats are suddenly eyeing a valuable pharma asset: its patents

Stat, December 7, 2018
by by Lev Facher, quoting Rachel Sachs (Academic Fellow Alumna)

From this article: "Democrats, newly empowered in D.C. and on the hunt for bigger and bolder ways to lower drug prices, are suddenly taking aim at a far more central part of pharma’s monopoly power:… Read More

Democrats are suddenly eyeing a valuable pharma asset: its patents

Stat, December 7, 2018
by by Lev Facher, quoting Rachel Sachs (Academic Fellow Alumna)

From this article: "Democrats, newly empowered in D.C. and on the hunt for bigger and bolder ways to lower drug prices, are suddenly taking aim at a far more central part of pharma’s monopoly power:… Read More

AVAILABLE FOR PRE-ORDER! Transparency in Health and Health Care in the United States

Cambridge University Press, Forthcoming June 2019
by Holly Fernandez Lynch, I. Glenn Cohen, Carmel Shachar, and Barbara J. Evans (eds.)

This edited volume stems from the Petrie-Flom Center’s 2017 annual conference, which brought together leading experts to reach better understandings of this health policy buzzword, recognizing… Read More

An Inside Look at Apple’s Biggest Step Yet in Health Care

Time, December 6, 2018
by by Alex Fitzpatrick, quoting W. Nicholson Price (Academic Fellow Alumnus)

From the article: "In the long run, however, it’s privacy concerns that have the biggest potential to hamper tech companies’ health dreams. News of data breaches that expose consumers’… Read More

Drug Maker Pays $360 Million to Settle Investigation Into Charity Kickbacks

New York Times, December 6, 2018
by Katie Thomas

The drug maker Actelion Pharmaceuticals has agreed to a $360 million settlement stemming from an investigation into whether the company illegally funneled kickbacks through a patient-assistance charity, federal… Read More

The Ethics of Heritable Genome Editing

JAMA, December 3, 2018
by Eli Y. Adashi and I. Glenn Cohen (Faculty Director)

From the article:  Editing the genome of human gametes or embryos is a disruptive unactualized technology and continues to be the subject of a wide range of concerns. The chief concern is the… Read More

Feds Order More Weekend Inspections Of Nursing Homes To Catch Understaffing

Kaiser Health News, November 30, 2018
by Jordan Rau

The federal government announced plans Friday to crack down on nursing homes with abnormally low weekend staffing by requiring more surprise inspections be done on Saturdays and Sundays. The federal Centers… Read More

Something Happened to U.S. Drug Costs in the 1990s

New York Times, November 12, 2018
by Austin Frakt quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: “Other countries decline to pay for a drug when the price is too high,” said Rachel Sachs, who studies drug pricing and regulation as an associate professor of law at Washington… Read More

Regulatory Collaboration Is Key to Public Health Success

The Regulatory Review, October 26, 2018
by Benjamin Barsky, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: "Federal policymakers have recently made a push to address excessive drug price increases and slow medicine development as part of their health care agenda. But the… Read More

Administration Proposes Strategies To Lower Pharmaceutical Prices In Medicare Part D

Health Affairs, November 28, 2018
by by Rachel Sachs (Academic Fellow Alumna)

From the article: "On Monday, the Trump administration proposed a set of changes that have the potential to lower the prices of some pharmaceuticals paid for through Medicare Part D.… Read More

On Repugnance, Distribution, and the Global Kidney Exchange: Comment

Journal of Institutional and Theoretical Economics (JITE), November 27, 2018
by I. Glenn Cohen (Faculty Director)

From the article:  Krawiec opens the article by quoting Alvin Roth’s framing of repugnance as a “distaste for certain kinds of transactions [that] can be a real constraint on markets and… Read More

Overshadowed By Opioids, Meth Is Back And Hospitalizations Surge

Kaiser Health News, November 26, 2018
by Anna Gorman

The number of people hospitalized because of amphetamine use is skyrocketing in the United States, but the resurgence of the drug largely has been overshadowed by the nation’s intense focus on opioids.… Read More

For Doctors Who Want To Provide Abortions, Employment Contracts Often Tie Their Hands

NPR, November 26, 2018
by Mara Gordon

Doctors who are opposed to abortions don't have to provide them. Since the 1970s, a series of federal rules have provided clinicians with "conscience protections" that help them keep their… Read More

FDA plans overhaul of decades-old medical device system

STAT, November 26, 2018
by Associated Press

WASHINGTON — U.S. health officials said Monday they plan to overhaul the nation’s decades-old system for approving most medical devices, which has long been criticized by experts for failing… Read More

EXCLUSIVE: Chinese scientists are creating CRISPR babies

MIT Tech Review, November 25, 2018
by Antonio Regolado

When Chinese researchers first edited the genes of a human embryo in a lab dish in 2015, it sparked global outcry and pleas from scientists not to make a baby using the technology, at least for the present.… Read More

Overdoses, bedsores, broken bones

Washington Post, November 25, 2018
by Peter Whoriskey and Dan Keating

[...] Under the ownership of the Carlyle Group, one of the richest private-equity firms in the world, the ManorCare nursing-home chain struggled financially until it filed for bankruptcy in March.… Read More

Can OSHA Regulation Rescue NFL Players?

Regulatory Review, November 21, 2018
by by Grace Gale, quoting I. Glenn Cohen (Faculty Director)

From the article: "According to a recent article, the answer is 'yes.' The Occupational Safety and Health Administration (OSHA) should issue rules to make football safer, say the… Read More

Your Medical Devices Are Not Keeping Your Health Data to Themselves

ProPublica, November 21, 2018
by Derek Kravitz and Marshall Allen

Medical devices are gathering more and more data from their users, whether it’s their heart rates, sleep patterns or the number of steps taken in a day. Insurers and medical device makers… Read More

Losing Embryos, Finding Justice

Annals of Internal Medicine, November 20, 2018
by I. Glenn Cohen (Faculty Director), Dov Fox, and Eli Y. Adashi

From the article:  On 3 March 2018, a liquid nitrogen storage tank broke down at University Hospitals Fertility Center in Cleveland, Ohio. More than 950 patients lost over 4000 eggs and embryos (also… Read More

Obamacare’s Looking So Good Insurers Are Fighting To Sell It

Forbes, November 19, 2018
by Bruce Japsen

News last week that Oscar Health filed a federal lawsuit accusing Florida Blue of a “monopoly” in selling individual health coverage under the Affordable Care Act is the latest signal… Read More

Machine learning in medicine: Addressing ethical challenges

PLOS Medicine, November 6, 2018
by Effy Vayena, Alessandro Blasimme, and I. Glenn Cohen (Faculty Director)

From the article:  A recent United Kingdom survey reports that 63% of the adult population is uncomfortable with allowing personal data to be used to improve healthcare and is unfavorable to artificial… Read More

Colorado Supreme Court Quotes I. Glenn Cohen

by Justice William W. Hood III, quoting I. Glenn Cohen (Faculty Director)

The Colorado Supreme Court in a dissent by Justice Hood, joined Coats and Samour, quotes I. Glenn Cohen.  From the dissent:  For the non-consenting donor, there are several harms that may… Read More

Colorado Supreme Court creates rules for divorced couples divided over fate of their frozen embryos

The Denver Post, October 29, 2018
by Elise Schmelzer, quoting I. Glenn Cohen (Faculty Director)

From the article:  While other states have considered similar cases, the guidelines issued by the Colorado court are some of the most specific created by any state on the issue, said Glenn Cohen,… Read More

The Health 202: There will be a big fight over Trump’s new proposal to lower drug prices

Washington Post, October 26, 2018
by Paige Winfield Cunningham, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: But the plan does signify the administration is serious about taking action on drug prices. The Obama administration made a similar effort, which it ultimately abandoned under… Read More

Administration Outlines Plan To Lower Pharmaceutical Prices In Medicare Part B

Health Affairs, October 26, 2018
by Rachel Sachs (Academic Fellow Alumna)

From the article: Yesterday, the Trump Administration outlined a plan that, if implemented, could significantly lower the prices of pharmaceuticals through Medicare Part B. The plan… Read More

Trump leans into midterms with a pitch to un-rig Medicare drug prices

CNN Politics, October 25, 2018
by Tami Luhby and Lauren Fox, quoting Rachel Sachs (Academic Fellow Alumna)

From the article:  While Trump officials could use an Obamacare-created innovation center to pilot new payment proposals, it would have to take a hard stance on prices. "We don't negotiate because… Read More

Coming today: Trump’s most aggressive drug pricing move yet

Politico, October 25, 2018
by Dan Diamond, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: Some policy experts cheered Trump's ideas, although they had questions about how the plan would work — "If companies won't sell to Medicare at the benchmark price,… Read More

Consortium Seeks to Evaluate, Enhance HRPP Effectiveness

AAHRPP Advance, October 23, 2018
by AAHRPP featuring work by Holly Fernandez Lynch (Former Executive Director) and colleagues

From the article: What are the outcomes of an effective HRPP? Can they be empirically evaluated—and, if so, can that data help drive best practices? Those are just some of the questions being tackled… Read More

Advance notice of mysterious rule puts drug-pricing people on edge

Politico Prescription Pulse, October 22, 2018
by Sarah Karlin-Smith, featuring Holly Fernandez Lynch (Former Executive Director)

From the article:  Holly Fernandez Lynch, a medical ethicist at the University of Pennsylvania, wonders whether FDA will audit third-party invoices to make sure manufacturers aren’t profiting… Read More

Trump Administration Wants TV Drug Ads To Include A Price

WFPL, October 20, 2018
by Lisa Gillespie, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: Rachel Sachs, an associate professor of law and a drug regulation expert at Washington University, said that the proposal is very narrow and doesn’t do anything for transparency… Read More

Rachel Sachs of Washington University on the USMCA

SiriusXM Radio, October 18, 2018
by Joe Madison the Black Eagle, interviewing Rachel Sachs

From the article: NAFTA (the North American Free Trade Agreement) has become the USCMA (U.S., Mexico, and Canada Agreement). What does that mean for you? Professor Rachel Sachs of Washington University… Read More

5 questions on the Trump admin’s bid to mandate prices in drug ads

Biopharma Dive, October 16, 2018
by Ned Pagliarulo and Andrew Dunn, quoting Rachel Sachs

From the article: HHS argues that it has the authority to require price disclosures in ads through the Social Security Act, which tasks it with the "efficient" administration of the Medicare and Medicaid… Read More

Trump issues rule to require drug prices in TV ads, rejecting industry plan

Politico, October 15, 2018
by Sarah Karlin Smith, quoting Rachel Sachs

From the article: A majority of voters tends to support the transparency move but remains skeptical of whether it will lead to lower drug costs. A July POLITICO/Harvard poll found 63 percent of Americans… Read More

Should TV Drug Ads Be Forced To Include A Price? Trump’s Team Says Yes

NPR's Morning Addition, October 15, 2018
by Shefali Luthra and Sarah Lane Tribble, quoting Rachel Sachs

From the article: "It is noteworthy that the government is unwilling to take enforcement action," said Rachel Sachs, an associate professor of law at Washington University in St. Louis and an expert… Read More

Pharma’s new plan to put more info — but not drug list prices — in TV ads

Vox, October 15, 2018
by Dylan Scott, quoting Rachel Sachs

From the article: Policy experts were already unimpressed with the Trump administration’s idea of requiring list prices to be included in ads, mostly because there is no real mechanism to lower prices… Read More

Drugmakers may have to disclose prices of medicine in television ads

Washington Post, October 15, 2018
by Amy Goldstein and Carolyn Y Johnson, quoting Rachel Sachs

From the article: Rachel Sachs, an associate professor of law at Washington University in St. Louis School of Law, said that it is unclear how or why disclosures would reduce drug prices. “The administration… Read More

Drugmakers may have to disclose prices of medicine in television ads

Washington Post, October 15, 2018
by Amy Goldstein and Carolyn Y Johnson, quoting Rachel Sachs

From the article: Rachel Sachs, an associate professor of law at Washington University in St. Louis School of Law, said that it is unclear how or why disclosures would reduce drug prices. “The administration… Read More

Senators question basis for FDA’s digital health pre-cert pilot

Medical Design and Outsourcing, October 12, 2018
by Chris Newmarker, featuring work by I. Glenn Cohen (Faculty Director)

From the article:  In another post on Aug. 16, 2017, on Health Affairs, Nathan G. Cortez, Nicolas Terry, and I. Glenn Cohen described the pre-cert program as “an experiment… Read More

The exciting new idea hospitals have to bring down drug prices

Vox, October 8, 2018
by Dylan Scott, quoting Rachel Sachs (Academic Fellow Alumna)

From the article:  To fully appreciate the scope of the generic drug pricing problem, remember that the Justice Department and 45 states are currently in court accusing generic drug makers of… Read More

When Your Dreams of Motherhood Are Destroyed

Marie Claire, October 1, 2018
by Kayla Webley Adler, quoting I. Glenn Cohen (Faculty Director)

From the article:  Neither major political party is expected to push for more regulation. Democrats aren’t likely to touch fertility because of how close the issue is to the abortion debate.… Read More

Yes, PTAB proceedings against Orange Book patents are on the up. No, they’re not wiping them out

IAM Media, October 1, 2018
by Adam Houldsworth, featuring work by Jonathan Darrow

From the article: Further data has emerged showing that the Patent Trial and Appeal Board (PTAB) is far from the “death squad” that many in the US life sciences industries fear that it may… Read More

When Markets Fail: Patents and Infectious Disease Products

Food and Drug Law Journal, September 2018, Volume 73, Number 3
by Jonathan J. Darrow, Michael S. Sinha, and Aaron S. Kesselheim

From the abstract:  New antibiotics and vaccines aimed at treating or preventing infectious diseases can be highly valuable public health innovations, particularly when these products address… Read More

Gilead to launch authorized generics of two HCV drugs

Chemical and Engineering News, September 26, 2018
by Lisa M. Jarvis, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: The effect on costs for patients and overall spending remains to be seen. “It’s unlikely this will result in lower government spending because this is what governments were… Read More

Petrie-Flom Center and Edmond J. Safra Center for Ethics Fellow-in-Residence

Petrie-Flom Center, Applications Due: November 15, 2018

Each year the Edmond J. Safra Center for Ethics at Harvard University hosts several fellows-in-residence. For 2019-20, they are concentrating their fellowships on the Ethics of Technological… Read More

Researchers Point to R&D Treaty to Spur New Infectious Disease Treatments

RAPS Regulatory Focus , September 24, 2018
by Zachary Brennan, quoting Jonathon Darrow (Student Fellow Alumnus)

From the article:  As current incentives to promote the development of new infectious disease treatments have yet to reach their potential, researchers in a new Food and Drug Law Journal paper… Read More

Big questions raised by big data

Harvard Law Today, September 20, 2018
by Lewis Rice, featuring Carmel Shachar (Executive Director) and I. Glenn Cohen (Faculty Director)

From the article:  During the introduction to the book launch event for “Big Data, Health Law, and Bioethics,” one of the editors, Harvard Law School Professor I. Glenn… Read More

The Ethics of Smart Pills and Self-Acting Devices

American Journal of Bioethics, September 20, 2018
by Craig M. Klugman, Laura B. Dunn, Jack Schwartz, and I. Glenn Cohen (Faculty Director)

From the abstract:  Digital medicine is a medical treatment that combines technology with drug delivery. The promises of this combination are continuous and remote monitoring, better disease management,… Read More

Smart pills can transmit data to your doctors, but what about privacy?

New Scientist, September 19, 2018
by I. Glenn Cohen (Faculty Director) and Alex Pearlman (Communications Manager)

From the article:  Abilify MyCite, a pill-app combination that can be used to track the ingestion of drugs for bipolar disorder and schizophrenia, was the first such product approved by the US Food… Read More

Study: Generic Drug Industry Embraces Faster, Cheaper Pathway For Challenging Patents

Intellectual Property Watch, September 6, 2018
by William New, quoting Jonathan Darrow (Student Fellow Alumnus)

From the article:  A newly released study shows that generic drug companies win nearly half the time when challenging patents on United States government-approved pharmaceutical products through the… Read More

Are Fraud and Abuse Laws Stifling Value-Based Care?

NEJM Catalyst , September 12, 2018
by Carmel Shachar (Executive Director)

From the article:  While health care delivery and financing should not be a free-for-all, designing the exemptions to explicitly conform to specific regulatory programs does not best serve the system.… Read More

HHS offers scant evidence Trump’s drug blueprint putting brakes on price hikes

S&P Global Market Intelligence, August 22, 2018
by Donna Young, quoting Rachel Sachs (Academic Fellow Alumna)

From the article:  Health and Human Services provided scant evidence, filled with caveats, to back up its chief's claim that drugmakers were responding to the Trump administration's plan… Read More

A Dangerous Brain

The Marshall Project, August 14, 2018
by Andrew R. Calderon, quoting Francis Shen (Visiting Scholar)

From the article:  To date, neuroprediction has not been admitted into the courtroom or parole hearings. Some scholars, like Thomas Nadelhoffer, a fellow at the Kenan Institute for Ethics at Duke… Read More

How Regulation Can Improve Surgery

The Regulatory Review, August 22, 2018
by Benjamin Barsky, quoting Jonathan Darrow (Student Fellow Alumnus)

From the article:  Thousands of American lives are in surgeons’ hands every day. But, according to a recent article by a Harvard professor, these patients have good… Read More

Petrie-Flom Welcomes New Precision Medicine Fellow!

Petrie-Flom Center, August 16, 2018

We are excited to announce that Sara Gerke is joining the Petrie-Flom Center's Project on Precision Medicine, Artificial Intelligence, and Law (PMAIL) as our Precision Medicine Fellow. As the Fellow,… Read More

We Have to Be Smart About Artificial Intelligence in Medicine

Slate, August 15, 2018
by W. Nicholson Price II (Academic Fellow Alumnus)

From the article: For millions of people suffering from diabetes, new technology enabled by artificial intelligence promises to make management much easier. Medtronic’s Guardian Connect system promises… Read More

Drug Pricing Policy

Health Affairs Blog, August 14, 2018
by Rachel E. Sachs (Academic Fellow Alumna)

From the post:  Last Tuesday, the Centers for Medicare and Medicaid Services (CMS) took its latest action in the area of drug pricing. CMS gave Medicare Advantage (MA) plans the ability… Read More

The Trump admin has another pretty good, pretty modest plan to lower drug costs

Vox, August 13, 2018
by Dylan Scott, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: “My concern is that once again, the administration’s rhetoric is out of step with its actual policy moves,” Sachs said. “The administration is promoting this move… Read More

Perspective: Will Courts Allow States to Regulate Drug Prices?

NEJM, August 8, 2018
by Christopher Robertson (Academic Fellow Alumnus)

From the article: Pharmaceuticals are consuming increasingly large portions of U.S. state budgets, and high prices are preventing patients from getting, and adhering to, essential medicines. In mid-May… Read More

Report blames gaming of patent system for high drug prices

Med City News, August 9, 2018
by Alaric Dearment, quoting W. Nicholson Price II (Academic Fellow Alumnus)

[...] The report, “Overpatented, Overpriced: How Excessive Pharmaceutical Patenting is Extending Monopolies and Driving up Drug Prices,” was released last week by the nonprofit Initiative… Read More

CMS’ plan to lower drug spending in Medicare Advantage

Politico Pulse, August 8, 2018
by Brianna Ehley, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Some viewed the step as a bit of a letdown, since HHS Secretary Alex Azar has been touting more sweeping changes to drug prices in Medicare Part B, like letting the private sector insurance… Read More

Here’s what’s behind the ads accusing Bob Hugin of ‘killing off cancer patients’

northjersey.com, August 7, 2018
by Herb Jackson, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: "They're resorting to tactics the FDA criticized. Under the guise of patient safety, this is really about preserving a monopoly position," said law professor Rachel Sachs, who teaches at… Read More

Administering Health Innovation

Cardozo Law Review, Volume 39, Issue 6 (July 2018)
by Rachel E. Sachs (Academic Fellow Alumna)

From the article: Scholars and policymakers have recently begun to focus on the role federal agencies charged with health-related missions can play in the development of innovative health technologies… Read More

Drug Approval in a Learning Health System

Minnesota Law Review, 2018
by W. Nicholson Price

From the abstract: The current system of FDA approval seems to make few happy. Some argue FDA approves drugs too slowly; others too quickly. Many agree that FDA — and the health system generally… Read More

Drug Approval in a Learning Health System

Minnesota Law Review, Forthcoming, July 30, 2018
by W. Nicholson Price (Academic Fellow Alumnus)

From the article: The current system of FDA approval seems to make few happy. Some argue FDA approves drugs too slowly; others too quickly. Many agree that FDA—and the health system generally—should… Read More

A Fear of Lawsuits Really Does Seem to Result in Extra Medical Tests

The New York Times, July 23, 2018
by Margot Sanger-Katz, featuring Michael Frakes (Academic Fellow Alumnus)

From the article:  Mr. Gruber and Michael D. Frakes, a Duke economist and lawyer, looked at the health care system for active-duty members of the military. Under longstanding law, such patients get… Read More

Patent term restoration for top-selling drugs in the USA

Drug Discovery Today, July 25, 2018
by Reed F. Beall, Jonathan Darrow (Former Student Fellow), and Aaron S. Kesselheim

From the article:  Patents temporarily protect brand-name drugs from generic competition, but some of the 20-year patent term is used up before marketing approval. To compensate for patent life lost… Read More

Medical Liability and Treatment Relationships

Wolters Kluwer, Fourth edition, 2018
by Mark A. Hall, David Orentlicher, Mary Anne Bobinski, Nicholas Bagley, I. Glenn Cohen (Faculty Director)

From the description:  Medical Liability and Treatment Relationships is based on Part I, “The Provider and the Patient,” of parent book Health Care Law and Ethics, and adds… Read More

Bioethics and Public Health Law

Wolters Kluwer, Fourth edition, 2018
by Mary Anne Bobinski, David Orentlicher, I. Glenn Cohen (Faculty Director), Mark A. Hall

From the description:  Financial and ethical issues are integrated into this concise and engaging treatment of Bioethics and Public Health Law. The complex relationship between patients,… Read More

Personhood Seeking New Life with Republican Control

Indiana Law Journal, April 2017
by Jonathan F. Will, I. Glenn Cohen (Faculty Director) and Eli Y. Adashi

From the abstract:  Just three days prior to the inauguration of Donald J. Trump as president of the United States, Rep. Jody B. Hice (R-GA) introduced the Sanctity of Human Life Act (H.R. 586), which,… Read More

Moratoria and Innovation in the Reproductive Sciences

Journal of Health & Biomedical Law, 2018
by Russell Spivak, I. Glenn Cohen (Faculty Director) and Eli Y. Adashi

From the abstract:  As progress in the biosciences soldiers forth, new breakthroughs can often be swept up in a common narrative, that is, the narrative of science as a disruptive threat. Responding… Read More

The Health 202: ‘ACA’ removed from swaths of Medicaid.gov website, watchdog reports

Washington Post, July 12, 2018
by By Colby Itkowitz, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: As The Post’s Damian Paletta also noted, the announcement was an example of Trump’s successful use of the presidential bully pulpit. “This is not an industry… Read More

The News on Drug Prices? Nothing Good

The New York Times, July 17, 2018
by By The Editorial Board, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: “It takes away a substantial tool that a lot of states were hoping to use,” says Rachel Sachs, a law professor and drug policy expert at Washington University in St. Louis.… Read More

Donald Trump’s phony war on high prescription drug prices, explained

Vox, July 13, 2018
by By Dylan Scott, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: Pfizer ended up agreeing to postpone its price hikes for now. The president was happy to take credit for that news, even if all he had really won was a temporary delay. Certainly not… Read More

Understanding the Development Challenges Associated with Emerging Non-Traditional Antibiotics

Duke-Margolis Center for Heath Policy, June 14, 2018
by Webcast featuring Jonathan J. Darrow (Student Fellow Alumnus)

From the webcast: Convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, this public event will focus on the range of… Read More

Regulation of Stem Cell Therapy Travel

Current Stem Cell Reports, July 2018
by I. Glenn Cohen and Shelly Simana

From the abstract: Purpose of Review Stem cell therapies (hereinafter: SCT) hold tremendous promise for the treatment of a variety of diseases. Yet, alongside the medical potential, they pose significant… Read More

Tempering Expectations of Breakthrough Therapy Designated Drugs

Journal of Clinical Pathways, June 10, 2018
by Interviewing Jonathan J. Darrow (Student Fellow Alumnus)

From the interview: A recent study published in the Journal of Clinical Oncology (online June 20, 2018; doi:10.1200/JCO/2017.77.1592) sought to evaluate the United States Food and Drug Administration… Read More

IRB Oversight of Patient-Centered Outcomes Research: A National Survey of IRB Chairpersons

Journal of Empirical Research on Human Research Ethics, June 14, 2018
by Joel S. Weissman, Eric G. Campbell, I. Glenn Cohen, Holly Fernandez Lynch, Emily A. Largent, Avni Gupta, Ronen Rozenblum, Melissa Abraham, Karen Spike

From the abstract:  Patient-centered outcomes research (PCOR) is becoming increasingly common. However, there is little evidence regarding what novel ethical challenges, if any, are posed by PCOR… Read More

JAMA Forum: The Risks and Benefits of Expedited Drug Reviews

JAMA Forum, May 23, 2018
by Austin Frakt, citing paper co-authored by Jonathan J. Darrow (Student Fellow Alumnus)

From the article: The US Food and Drug Administration (FDA) oversees several programs that expedite approval of certain drugs that treat serious conditions and address unmet medical needs. On average,… Read More

Vermont legislators pass a drug importation law. So what?

Salon, May 27, 2018
by Shefali Luthra, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: Importation backers — including the National Academy for State Health Policy (NASHP), which helped craft Vermont’s bill and has worked with state lawmakers — hope he’ll… Read More

Criticism of ‘right to try’ law for experimental drugs after it passes in US

Chemistry World, June 5, 2018
by Anthony King, quoting Jonathan J. Darrow (Student Fellow Alumnus)

From the article:  The US government has controversially announced that it will allow unapproved, experimental drugs to be given to terminally ill patients. The ‘right to try’ law passed… Read More

HIPAA and Protecting Health Information in the 21st Century

JAMA, May 24, 2018
by I. Glenn Cohen (Faculty Director) and Michelle M. Mello

Faculty Director I. Glenn Cohen has co-authored a new opinion piece in JAMA that addresses the adequacy of HIPAA in protecting electronic health data in light of the launch of the Trump administration's… Read More

Trump official on defensive as critics scoff at drug plan

The Hill , May 19, 2018
by Peter Sullivan, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: President Trump's health chief is struggling to show that the administration is serious about taking on drug companies after its proposals for lowering prices last week left big companies… Read More

Trump spoke on lowering drug prices. The tweets rolled in

Stat, May 11, 2018
by Andrew Joseph, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: Given that President Trump is famous for his Earth-shaking tweets, it seems appropriate to comb through Twitter reactions to his administration’s new drug pricing plan, which… Read More

FDA website to post names of drug makers blocking development of cheaper generics

Marketplace, May 17, 2018
by Dan Gorenstein, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: The FDA plans to unveil a website today naming pharmaceutical companies that have blocked the development of generic drugs by failing to provide samples to competitors. This public posting… Read More

Trump’s Drug Pricing Speech Breaks Little New Ground, Largely Spares Industry

Health Affairs Blog, May 14, 2018
by Rachel Sachs (Academic Fellow Alumna)

From the article: On Friday, President Donald Trump delivered a highly anticipated speech about drug pricing. The speech, coupled with the release of a “blueprint” providing more detail on… Read More

Circumvention Medical Tourism and Cutting Edge Medicine

Indiana Journal of Global Legal Studies, May 12, 2018
by I. Glenn Cohen (Faculty Director)

From the article: “Medical Tourism” is the travel of patients from a home country to a destination country for the primary purpose of receiving health care. “Circumvention Tourism”… Read More

How to Make a Dent in Crazy-High Drug Prices

Bloomberg, May 11, 2018
by By Austin Frakt, citing Rachel Sachs (Academic Fellow Alumna)

From the article: There’s no good reason to pay a lot for prescription drugs that don’t work well. But that’s what lots of Americans are doing. Some drug prices far outweigh any reasonable… Read More

Do NFL Safety Concerns Mean Regulators Should Get in the Game?

Bloomberg Environment, April 26, 2018
by Fatima Hussein, featuring report by the Law and Ethics Initiative of the Football Players Health Study at Harvard University

From the article: Concussions involving NFL players have been an increasing worry. Now a debate has resurfaced about whether federal safety regulators should be able to fine teams found guilty of inflicting… Read More

Drug made famous by Shkreli’s 5,000% price hike is still $750 a pill

Ars Technica, May 4, 2018
by Beth Mole, quoting W. Nicholson Price II (Academic Fellow Alumnus)

From the article: Disgraced ex-pharmaceutical executive and hedge fund manager Martin Shkreli is now behind bars, facing a seven-year prison sentence for securities fraud. Yet the drug-price hike… Read More

For Shame: ‘Pharma Bro’ Shkreli Is In Prison, But Daraprim’s Price Is Still High

Washington Post, May 4, 2018
by Shefali Luthra, quoting W. Nicholson Price II (Academic Fellow Alumnus)

From the article: The continued high price of the drug is a cautionary tale to those who hope that public shaming of a few “bad actors” can curb escalating drug prices, because the problem… Read More

What your government can’t tell you about drug prices

CBC News, May 3, 2018
by Kelly Crowe, Suit brought by Jean-Christophe Belisle Pipon (Visiting Researcher)

From the article: It took three years of fighting for access to confidential drug information, but a Quebec bioethicist has punched a tiny hole in the iron wall of secrecy surrounding patented drug prices.… Read More

Vaccine against Meningitis

La Presse, April 25, 2018
by Marie-Claude Malboeuf, Suit brought by Jean-Christophe Belisle Pipon (Visiting Researcher)

From the article: Quebec has agreed to pay twice as much as the United Kingdom for a new vaccine against meningitis, the effectiveness of which seemed uncertain. The disclosure of the price paid by Quebec… Read More

Supreme Court rules that patent reviews detested by pharma are constitutional

STAT, April 24, 2018
by Ed Silverman, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: In a blow to the pharmaceutical industry, the U.S. Supreme Court ruled that a controversial procedure for reviewing patent disputes does not violate the constitutional rights of patent… Read More

Federal Appeals Court Finds State’s Drug Price-Gouging Law Unconstitutional

Shots: Health News From NPR, April 17, 2018
by Shefali Luthra, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: States are continuing to do battle with budget-busting prices of prescription drugs. But a recent federal court decision could limit the tools available to them — underscoring the… Read More

The breakthrough therapy designation for promising cancer drugs is good for patients

STAT, April 27, 2018
by Jeff Allen, quoting Jonathan J. Darrow (Student Fellow Alumnus)

From the article: One exciting component of the Food and Drug Administration Safety and Innovation Act was the creation of the breakthrough therapy designation. It allows an all-hands-on-deck… Read More

Assessing the FDA’s Breakthrough Drug Program After Six Years

ASH Clinical News, April 25, 2018
by ASH Clinical News, quoting Jonathan J. Darrow (Student Fellow Alumnus)

From the article: In the first four years of the U.S. Food and Drug Administration’s (FDA) breakthrough-therapy designation program, the agency approved 31 “breakthrough” drugs, but many… Read More

Parenting of the future: Many embryos, each with DNA profile

The Washington Post , April 18, 2018
by Malcolm Ritter, quoting I. Glenn Cohen (Faculty Director)

From the article: Once the genetic profile is done, could it come back to haunt a child if, say, a life insurer or nursing home demanded to see it to assess disease risk? How would the large number of… Read More

New Article Examines the Possibility of Applying Workplace Safety Rules to the NFL

Part of the Law and Ethics Initiative of the Football Players Health Study at Harvard University, April 17, 2018
by Article authored by Adam M. Finkel, Chris Deubert, Orly Lobel, I. Glenn Cohen (Faculty Director), and Holly Fernandez Lynch (Former Executive Director

Could occupational health and safety laws be applied to better protect NFL players? A new analysis, published on April 17 in the Arizona Law Review, explores this very possibility. The article, written… Read More

The Work of the Supreme Court

Hosted by the Department of Global Health and Social Medicine at Harvard Medical School, April 11, 2018

PLEASE NOTE: A Harvard ID is required in order to attend this event.  Harvard affiliates: RSVP now! Read More

Prevalence of Publicly Available Expanded Access Policies

Clinical Pharmacology & Therapeutics, March 23, 2018
by Emily Jung (Petrie-Flom Student Intern), Patricia J. Zettler, Aaron S. Kesselheim

From the Article: The Food and Drug Administration's expanded access program allows patients with serious or immediately life‐threatening conditions to seek access to experimental drugs and treatments… Read More