Research Fellow for Precision Medicine
Petrie-Flom Center, Harvard Law School

Deadline: Open until filled.

Duties & Responsibilities This is a newly created full-time term appointment for a post-doctoral employee needed to support the work of the Petrie-Flom Center on a sponsored research project in collaboration… Read More

In Wake Of Florida Mass Shooting, States Stepping Up To Take Gun Control Into Their Own Hands

Kaiser Health News, February 23, 2018

KHN Morning Briefing: Summaries of health policy coverage from major news organizations Four East Coast states are forming a coalition to better promote and foster gun safety, while other states mull… Read More

Evaluations Of Medicaid Experiments By States, CMS Are Weak, GAO Says

Kaiser Health News, February 23, 2018
by Phil Galewitz

With federal spending on Medicaid experiments soaring in recent years, a congressional watchdog said state and federal governments fail to adequately evaluate if the efforts improve care and save money.… Read More

Preventing Mitochondrial Disease

Obstetrics & Gynecology, March 2018 - Volume 131 - Issue 3
by Eli Y. Adashi and I. Glenn Cohen (Faculty Director)

Abstract: In a possible first, the heritable transmission of a fatal mitochondrial DNA disease (Leigh syndrome) may have been prevented by replacing the mutation-bearing mitochondria of oocytes with donated… Read More

A Larger Role for Midwives Could Improve Deficient U.S. Care for Mothers and Babies

ProPublica, February 22, 2018
by Nina Martin

In Great Britain, midwives deliver half of all babies, including Kate Middleton’s first two children, Prince George and Princess Charlotte. In Sweden, Norway and France, midwives oversee… Read More

A Framework for Ethical Payment to Research Participants

NEJM, February 22, 2018
by Luke Gelinas (Senior Researcher), Emily A. Largent, I. Glenn Cohen (Faculty Director), Susan Kornetsky, Barbara E. Bierer, and Holly Fernandez Lynch

Members of the Petrie-Flom Center's collaboration with the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst | The Harvard Clinical and Translational Science Center at… Read More

Trump Administration Wants To Let Insurers Offer Plans With Fewer Benefits

NPR, February 20, 2018
by Alison Kodjak

The Trump administration wants to allow insurance companies to offer more policies that have limited health benefits and that can reject customers if they have pre-existing medical conditions. Health and… Read More

HHS Chief Wants CDC To Conduct Gun Research, Waving Off Congressional Restrictions

Kaiser Health News, February 16, 2018

KHN Morning Briefing: Summaries of health policy coverage from major news organizations "We believe we've got a very important mission with our work with serious mental illness as well as our… Read More

Trump Promises To Tackle ‘Difficult Issue Of Mental Health’ Following Shooting

Kaiser Health News, February 16, 2018

KHN Morning Briefing: Summaries of health policy coverage from major news organizations As national focus turns to mental health after the mass shooting in Florida, advocates warn against making assumptions… Read More

U.K. Supermarkets To Ban Energy Drinks For Shoppers Under 16

NPR, February 16, 2018
by Menaka Wilhelm

Next month, several chain supermarkets in the U.K. will stop selling energy drinks to customers under 16. Anyone looking to buy a soft drink with more than 150 mg of caffeine per liter — a limit… Read More

Trump fires first salvo on drug prices

The Hill, February 12, 2018
by Peter Sullivan, referencing Rachel Sachs (Academic Fellow Alumna)

From the article: President Trump is beginning to move on high drug prices, unveiling a series of modest proposals in his budget request released Monday. It’s the first time Trump has issued major… Read More

Budget, White Paper Provide Insight Into Trump Administration’s Strategy On Drug Pricing

Health Affairs, February 12, 2018
by Rachel Sachs (Academic Fellow Alumna)

From the article: During his first year in office, President Donald Trump spoke often about the problem of high drug prices but took no action on the subject. President Trump’s new budget proposal and… Read More

Hundreds sign on to letter opposing ‘right to try’ drug bill

The Hill , February 5, 2018
by Rachel Roubein, reporting on Holly Fernandez Lynch (Former Executive Director and Academic Fellow Alumna)

From the Article:  Several hundred "right to try" critics sent a letter to House Energy and Commerce Committee leaders expressing their “strong opposition” to the bill President… Read More

Concussions Can Be Detected With New Blood Test Approved by F.D.A.

New York Times, February 14, 2018
by Sheila Kaplan and Ken Belson

The Food and Drug Administration on Wednesday approved a long-awaited blood test to detect concussions in people and more quickly identify those with possible brain injuries. The test, called… Read More

Idaho Blue Cross Jumps Into Controversial Market For Plans That Bypass ACA Rules

Kaiser Health News, February 14, 2018
by Julie Appleby

That didn’t take long. It’s barely been two weeks since Idaho regulators said they would allow the sale of health insurance that does not meet all of the Affordable Care Act’s requirements… Read More

Budget Deal Stuffed Full Of Health Provisions

Kaiser Health News, February 9, 2018

KHN Morning Briefing: Summaries of health policy coverage from major news organizations In the early hours of Friday morning the House passed a spending deal to very quickly reverse a government shutdown… Read More

ObamaCare enrollment tells tale of two systems

The Hill, February 8, 2018
by Jessie Hellman

Most states that operate their own ObamaCare exchanges saw more people sign up in 2018 than last year, while 29 of the 34 states that rely on the federal government to promote enrollment saw their sign-ups… Read More

Alabama Targets OxyContin Maker Purdue Pharma In Opioid Suit Facebook Twitter Flipboard Email

NPR, February 7, 2018
by Samantha Raphaelson

Alabama filed a lawsuit in federal court on Tuesday against OxyContin producer Purdue Pharma LP claiming the drug company is fueling the opioid epidemic by deceptively marketing prescription painkillers.… Read More

In Sweeping War on Obesity, Chile Slays Tony the Tiger

New York Times, February 7, 2018
by Andrew Jacobs

SANTIAGO, Chile — They killed Tony the Tiger. They did away with Cheetos’ Chester Cheetah. They banned Kinder Surprise, the chocolate eggs with a hidden toy. The Chilean government, facing… Read More

Stalled Health Programs Await A Green Light On The Hill

Kaiser Health News, February 2, 2018
by Shefali Luthra

With the clock ticking on the current stop-gap bill that funds the federal government through Feb. 8, Congress is steeling itself to consider another must-pass budget bill. And, once again, health care… Read More

Trump’s abandoned promise to bring down drug prices, explained

Vox, February 2, 2018
by Dylan Scott, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: One year into Donald Trump’s presidency, as he delivered his first State of the Union address, he has more or less abandoned his outspoken pledges to bring down the cost of America’s… Read More

The Regulatory Accountability Act of 2017 — Implications for FDA Regulation and Public Health

NEJM, February 1, 2018
by Jonathan J. Darrow (Student Fellow Alumnus), Erin C. Fuse Brown, and Aaron S. Kesselheim

From the article: In the past year, federal health policy has been characterized by pervasive uncertainty, but a consistent theme from the Trump administration and some prominent legislators has been opposition… Read More

CDC Chief’s Stock Drama Was An Ethical Blemish New HHS Head Alex Azar Wasn’t Going To Tolerate

Kaiser Health News, February 1, 2018

KHN Morning Briefing: Summaries of health policy coverage from major news organizations Brenda Fitzgerald offered her letter of resignation as the director of the Centers for Disease Control and Prevention… Read More

Indiana’s Brand Of Medicaid Drops 25,000 People For Failure To Pay Premiums

NPR, February 1, 2018
by Phil Galewitz

As the Trump administration moves to give states more flexibility in running Medicaid, advocates for the poor are keeping a close eye on Indiana to see whether such conservative ideas improve or harm care.… Read More

Unnecessary Medical Care Is More Common Than You Think

ProPublica (co-published with NPR’s Shots blog), February 1, 2018
by Marshall Allen

It’s one of the intractable financial boondoggles of the U.S. health care system: Lots and lots of patients get lots and lots of tests and procedures that they don’t need. Women still get annual… Read More

Privacy experts alarmed as Amazon moves into the health care industry

Washington Post, January 30, 2018
by Abha Bhattarai, quoting I. Glenn Cohen (Faculty Director)

From the article: Amazon.com on Tuesday announced a joint partnership with Berkshire Hathaway and JP Morgan to create an independent health-care company for their employees, putting an end to months… Read More

Physicians, ethicists urge Congress not to pass ‘right to try’ legislation

STAT News, February 1, 2018
by Ike Swetlitz reporting on Holly Fernandez Lynch (Former Executive Director and Academic Fellow Alumna)

From the article: Dozens of doctors, medical ethicists, and lawyers are warning Congress that legislation to allow Americans with life-threatening conditions access to unapproved, experimental drugs risks… Read More

Trump Pledges To Lower Drug Costs — Can We Do It?

NPR, January 31, 2018
by Anthony Brooks, interviewing Rachel Sachs (Academic Fellow Alumna)

From the podcast: President Trump says in his State of the Union that going after the high cost of prescription drugs is a top priority. Politicians have promised for years to bring them down. We’ll… Read More

Petrie-Flom Center launches Project on Precision Medicine, Artificial Intelligence, and the Law

Harvard Law Today, January 31, 2018
by Q & A with I. Glenn Cohen (Faculty Director)

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Center for Advanced Studies in Biomedical Innovation Law (CeBIL) at the University of… Read More

The Petrie-Flom Center Launches the Innovative Funding Models in Translational Research Project

The Petrie-Flom Center, January 29, 2018

January 30, 2018 - The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is launching the Innovative Funding Models in Translational Research Project to… Read More

States Becoming Battleground For Health Law As Some Seek To Bolster It While Others Unravel It Furth

Kaiser Health News, January 26, 2018

KHN Morning Briefing: Summaries of health policy coverage from major news organizations Blue states are taking steps to protect certain guarantees created under the health law to protect patients,… Read More

Senate Approves Trump’s HHS Pick Despite Critics’ Qualms About Azar’s Ties To Pharma Industry

Kaiser Health News, January 25, 2018

KHN Morning Briefing: Summaries of health policy coverage from major news organizations Alex Azar will take the helm of the Department of Health and Human Services after the Senate confirmed his nomination… Read More

The Federal Right to Try Act of 2017

JAMA Internal Medicine, January 22, 2018
by Alison Bateman-House and Christopher T. Robertson (Academic Fellow Alumnus)

From the article: In 2017, President Trump said that “one thing that’s always disturbed”1 him is that the US Food and Drug Administration (FDA) denies access to experimental drugs… Read More

F.D.A. Panel Rejects Philip Morris’ Claim That Tobacco Stick Is Safer Than Cigarettes

New York Times, January 25, 2018
by Sheila Kaplan

A federal advisory committee on Thursday recommended that the Food and Drug Administration reject a bid by Philip Morris International to market a smokeless tobacco stick in the United States as safer… Read More

The Petrie-Flom Center Launches New Project

Petrie-Flom Center, January 23, 2018

The Project on Precision Medicine, Artificial Intelligence, and the Law will seek to better understand the frontiers of big data in health care diagnostics, through interdisciplinary analysis of important… Read More

With Health Care For 9 Million Children On The Line, Congress Barrels Toward Shutdown

Kaiser Health News, January 19, 2018

KHN Morning Briefing: Summaries of health policy coverage from major news organizations The House passed the short-term funding bill after threats from the Freedom Caucus died down, but it appears… Read More

Following Creation Of Religious Freedom Division, Advocates Worry LGBT Patients May Forgo Care

Kaiser Health News, January 19, 2018

KHN Morning Briefing: Summaries of health policy coverage from major news organizations Research shows people who identify as LGBT already face significant health care disparities due to stigma and… Read More

Cops, Docs, and Code: A Dialogue between Big Data in Health Care and Predictive Policing

UC Davis Law Review, Vol. 51, No. 437, 2017
by I. Glenn Cohen (Faculty Director) and Harry Graver

Abstract: “Big data” has become the ubiquitous watchword of this decade. Predictive analytics, which is something we want to do with big data -- to use of electronic algorithms to forecast… Read More

Patient-Centered Outcomes Research

The Hastings Center, January-February 2018
by Emily A. Largent (Student Fellow Alumna), Joel S. Weissman, Avni Gupta, Melissa Abraham, Ronen Rozenblum, Holly Fernandez Lynch (Academic Fellow Alumn

Abstract:  The Patient-Centered Outcomes Research Institute (PCORI), the leading research institute in the United States for patient-centered outcomes research (PCOR), funded our multiyear mixed-methods… Read More

It’s time to levy penalties for failing to report clinical trial results

STAT, January 17, 2018
by Holly Fernandez Lynch (Academic Fellow Alumna and former Executive Director)

From the article: I started my first job as an attorney in the fall of 2007, days after President George W. Bush signed the Food and Drug Administration Amendments Act (FDAAA) into law. As part… Read More

Tip of the Iceberg II

11 NYU Journal of Law & Liberty 770, January 12, 2018
by Christopher T. Robertson (Academic Fellow Alumnus) and Victor Laurien

Abstract In recent years, the Food and Drug Administration’s pre-market approval process has come under increasing scrutiny as an infringement on liberty and a regulation of speech. In the first… Read More

In Monumental Policy Shift, Administration Paves Way For States To Impose Medicaid Work Requirements

Kaiser Health News, January 11, 2018

KHN Morning Briefing: Summaries of health policy coverage from major news organizations Adding a work requirement to Medicaid would mark one of the biggest changes to the program since its inception… Read More

A New Approach to Treat Childhood Leukemia: Novartis’ CAR-T Therapy

The Journal of Law, Medicine & Ethics, January 10, 2018
by Frazer A. Tessema and Jonathan J. Darrow (Student Fellow Alumnus)

From the article: On August 30, 2017, the US Food and Drug Administration (FDA) announced the approval of tisagenlecleucel (Kymriah; CTL019), Novartis' new treatment for B-cell acute lymphoblastic… Read More

Federal Right-to-Try Legislation — Threatening the FDA’s Public Health Mission

NEJM, January 10, 2018
by Steven Joffe and Holly Fernandez Lynch (Academic Fellow Alumna and former Executive Director)

From the article: The Food and Drug Administration (FDA) is the gatekeeper of the country’s drugs and medical devices. Originally created to prevent the misleading of patients, it was later tasked… Read More

Trump administration halts ‘evidence-based’ program that evaluates behavioral health therapies

STAT, January 10, 2018
by Sharon Begley

The Trump administration has abruptly halted work on a highly regarded program to help physicians, families, state and local government agencies, and others separate effective “evidence-based”… Read More

Court to weigh if one parent has the right to use frozen embryos if the other objects

Washington Post, January 9, 2018
by Ariana Eunjung Cha, quoting I. Glenn Cohen (Faculty Director)

From the article: On Tuesday, the Colorado Supreme Court will hear oral arguments in the Rookses' case. Although several other cases have made their way to states' high courts, legal… Read More

HHS Nominee Vows To Tackle High Drug Costs, Despite His Ties To Industry

Kaiser Health News, January 9, 2018
by Emmarie Huetteman

[...] Alex M. Azar II, the former president of the U.S. division of Eli Lilly and Trump’s pick to run the Department of Health and Human Services, presented himself as a “problem solver”… Read More

A Big Pharma-funded charity that helps patients pay for drugs just sued the government

Washington Post, January 8, 2018
by Carolyn Y. Johnson, quoting Christopher T. Robertson (Academic Fellow Alumnus)

From the article: These charities help patients out, but they also provide a lucrative philanthropic option for donors. Drug companies get reimbursed by government health programs or private… Read More

Drug Policy: The Year In Review, And The Year Ahead

Health Affairs Blog, January 4, 2018
by Rachel E. Sachs (Academic Fellow Alumna)

From the article:  Last year was an unquestionably busy time for health care news of all kinds. Media and policy coverage rightly focused on the many attempts to repeal the Affordable Care Act, but… Read More

Long-Term Solution For CHIP Funding On Docket As Congress Returns To Jam-Packed Schedule

Kaiser Health News, January 2, 2018

KHN Morning Briefing: Summaries of health policy coverage from major news organizations Right before the Christmas break, Congress plowed $3 billion into the Children's Health Insurance… Read More

India’s Hospitals Are Filling Up With Desperate Americans

Foreign Policy, January 2, 2018
by Daniel Block, quoting I. Glenn Cohen (Faculty Director)

From the article:  Medical tourism thus presents both opportunities and risks. At its best, the industry can help India grow its health care system, using the revenues generated from international… Read More

Researchers Gather Health Data For ‘All Of Us’

NPR, December 31, 2017
by Richard Harris

Federal taxpayers are pouring hundreds of millions of dollars into a quest for blood samples, medical information and fitness readouts from a million Americans. It's called the All of Us precision… Read More

Trump Administration Relaxes Financial Penalties Against Nursing Homes

Kaiser Health News, December 31, 2017
by Jordan Rau

The Trump administration — reversing guidelines put in place under President Barack Obama — is scaling back the use of fines against nursing homes that harm residents or place them in… Read More

Opioid abuse in the U.S. is so bad it’s lowering life expectancy.

Washington Post, December 28, 2017
by Amanda Erickson

For the second year in a row, life expectancy in the United States has dropped. It is not hard to understand why: In 2016, there was a 21 percent rise in the number of deaths caused by drug overdoses,… Read More

E.P.A. Wanted Years to Study Lead Paint Rule. It Got 90 Days.

New York Times, December 27, 2017
by Lisa Friedman

WASHINGTON — A federal appeals court on Wednesday ordered the Environmental Protection Agency to revise its nearly 17-year-old standard for dangerous levels of lead in paint and dust within one year,… Read More

Speed, Safety, and Industry Funding — From PDUFA I to PDUFA VI

The New England Journal of Medicine, December 7, 2017
by Jonathan J. Darrow (Student Fellow Alumnus), Jerry Avorn, and Aaron S. Kesselheim

From the paper: In August, President Donald Trump signed into law the sixth version of key legislation for the Food and Drug Administration (FDA), known as the Prescription Drug User Fee Act (PDUFA VI).… Read More

Will inter partes review speed US generic drug entry?

Nature Biotechnology, Issue 35
by Jonathan J Darrow (Student Fellow Alumnus), Reed F Beall & Aaron S Kesselheim

From the paper: Patents are ubiquitous in the pharmaceutical industry and are used by brand-name drug manufacturers to prevent low-cost generic competition and maintain high drug prices. Patents are granted… Read More

Explaining the Absence of Surgical Procedure Regulation

Cornell Journal of Law and Public Policy, Vol 27, Issue 189
by Jonathan J. Darrow (Student Fellow Alumnus)

From the paper: Each year in the United States, surgeons perform approximately 64 million surgical procedures, ranging from tooth extraction to open heart surgery.2 Yet, notwithstanding the frequency of… Read More

Trump’s zeal for deregulation could gum up the FDA, experts say

STAT, December 20, 2017
by Meghana Keshavan, quoting Jonathan J. Darrow (Student Fellow Alumnus)

From the article: President Trump quite literally cut a stretch of red tape last week to emphasize his slash-and-burn stance on government deregulation. But what would sweeping regulatory change… Read More

As List Of Banned Words Sparks Firestorm, HHS Reiterates Support Of ‘Best Scientific Evidence’

Kaiser Health News, December 18, 2017

KHN Morning Briefing: Summaries of health policy coverage from major news organizations The Trump administration informed the Centers for Disease Control and Prevention and other agencies that they… Read More

ACA Outreach Cutbacks, Shorter Enrollment Window Likely To Hurt Vulnerable Populations

Kaiser Health News, December 18, 2017

KHN Morning Briefing: Summaries of health policy coverage from major news organizations The health law sparked some of the biggest gains in coverage for minority populations. But those same populations… Read More

In Opioid Battle, Cherokee Want Their Day in Tribal Court

New York Times, December 17, 2017
by Jan Hoffman

[...] Across the country, tens of thousands of people are dying from abuse of prescription opioids. Here in the capital of the Cherokee Nation, the epidemic is exacting an additional, deeply painful price.… Read More

Easing the Burden on Caregivers

New York Times, December 15, 2017
by Maureen Towey

[...] A new program in Hawaii, the Kupuna Caregivers Act, is designed to help lift some of the burden on people caring for an elderly family member at home by paying them stipends of up to $70 a day.… Read More

Kellyanne Conway leading an ‘opioids cabinet,’ as she assumes more active policy role

STAT, December 14, 2017
by Lev Facher

WASHINGTON — Kellyanne Conway, counselor to President Trump, has been leading weekly meetings at the White House with officials across a dozen federal departments to develop a plan to respond to… Read More

Encouraging New Uses for Old Drugs

JAMA, December 4, 2017
by Rachel E. Sachs (Academic Fellow Alumna), Paul B. Ginsburg, and Dana P. Goldman

From the paper: US Food and Drug Administration (FDA) approval of a new drug typically coincides with a period of patent protection, during which the manufacturer will often apply for additional indications… Read More

Deadline Is Friday For Most ACA Insurance Sign-Ups, With Important Exceptions

NPR, December 12, 2017
by Michelle Andrews

Open enrollment on the federal health law's marketplace — HealthCare.gov — ends Friday, and most people who want a plan for next year need to meet the deadline. But some consumers who miss… Read More

New CDC head faces questions about financial conflicts of interest

Washington Post, December 11, 2017
by Lena H. Sun and Alice Crites

ATLANTA — After five months in office, President Trump’s new director of the Centers for Disease Control and Prevention has been unable to divest financial holdings that pose potential… Read More

When Buying Prescription Drugs, Some Pay More With Insurance Than Without It

ProPublica, December 9, 2017
by Charles Ornstein, ProPublica, and Katie Thomas, The New York Times

[...] In an era when drug prices have ignited public outrage and insurers are requiring consumers to shoulder more of the costs, people are shocked to discover they can sometimes get better deals… Read More

2017’s Word Of The Year In Health Law And Bioethics: Uncertainty

Health Affairs, December 8, 2017
by Carmel Shachar (Executive Director) and I. Glenn Cohen (Faculty Director)

Note: This post is the first in a series of Health Affairs posts from the Sixth Annual Health Law Year in P/Review event, held at Harvard Law School on Tuesday, December 12, 2017. … Read More

USDA Opens Door For States To Impose New Rules On Food Stamps

NPR, December 7, 2017
by Grant Gerlock

The delivery of federal food benefits for millions of low-income people is likely to change after the U.S. Department of Agriculture announced Tuesday it'll allow states more flexibility in how they… Read More

UnitedHealth to Buy Physician Gp. in Latest Move Promising to Shake Up Traditional Health Landscape

Kaiser Health News, December 7, 2017

KHN Morning Briefing: Summaries of health policy coverage from major news organizations Following on the heels of the announcement of the proposed CVS-Aetna merger, the deal is the latest to show… Read More

Ryan says Republicans to target welfare, Medicare, Medicaid spending in 2018

Washington Post, December 6, 2017
by Jeff Stein

House Speaker Paul D. Ryan (R-Wis.) said Wednesday that congressional Republicans will aim next year to reduce spending on both federal health care and anti-poverty programs, citing the need to reduce… Read More

If CVS’s $69B Deal To Buy Aetna Holds Up To Federal Scrutiny

Kaiser Health News, December 4, 2017

KHN Morning Briefing: Summaries of health policy coverage from major news organizations Together, the companies touch most of the basic health services that people regularly use, and the merger could… Read More

Emergency rooms are monopolies. Patients pay the price.

Vox, December 4, 2017
by Sarah Kliff

[...] There are 141 million visits to the emergency room each year, and nearly all of them (including Saifan’s) have a charge for something called a facility fee. This is the price of walking… Read More

States Sound Warning That Kids’ Health Insurance Is At Risk

NPR, November 30, 2017
by Selena Simmons-Duffin and Ashley Lopez, KUT

This week, Colorado became the first state to notify families that children who receive health insurance through the Children's Health Insurance Program are in danger of losing their coverage.… Read More

Republican Tax Bill Proves Congress Wasn’t Done With Health Policy

Kaiser Health News, December 1, 2017

KHN Morning Briefing: Summaries of health policy coverage from major news organizations The GOP tax plan includes a range of health-related provisions -- key among them is language that would eliminate… Read More

Euthanasia Law Passes in Australia for First Time

New York Times, December 1, 2017
by Adam Baidawi

MELBOURNE, Australia — The Australian state of Victoria on Wednesday became the country’s first to legalize assisted dying. After a two and a half years of debate and amendments, Victoria’s… Read More

How The Loss Of U.S. Psychiatric Hospitals Led To A Mental Health Crisis

NPR, November 30, 2017
by Samantha Raphaelson

A severe shortage of inpatient care for people with mental illness is amounting to a public health crisis, as the number of individuals struggling with a range of psychiatric problems continues to rise.… Read More

The Health 202

The Washington Post, November 30, 2017
by Paige Winfield Cunninghamm, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: If the opioid epidemic was simply a problem of supply – people being able to access drugs too easily – than a targeted new effort in Appalachia announced… Read More

AVAILABLE FOR PREORDER: Big Data, Health Law, and Bioethics

Cambridge University Press, Forthcoming, March 2018
by Edited by I. Glenn Cohen (Faculty Director), Holly Fernandez Lynch (former Executive Director), Urs Gasser, and Effy Vayena

About the Book: When data from all aspects of our lives can be relevant to our health - from our habits at the grocery store and our Google searches to our FitBit data and our medical records - can we… Read More

Health Insurers Are Still Skimping On Mental Health Coverage

NPR, November 30, 2017
by Jenny Gold

It has been nearly a decade since Congress passed the Mental Health Parity And Addiction Equity Act, with its promise to make mental health and substance abuse treatment just as easy to get as care… Read More

FDA-Approved Digital Pill Causes Concerns

KJZZ Radio, November 28, 2017
by Steve Goldstein, interviewing I. Glenn Cohen (Faculty Director)

The first so-called digital pill has been approved by the Food and Drug Administration. It’s a version of the antipsychotic drug Abilify and contains a tiny sensor that will send a signal to a patch… Read More

Heated And Deep-Pocketed Battle Erupts Over 340B Drug Discount Program

Kaiser Health News, November 28, 2017
by Sarah Jane Tribble

A 25-year-old federal drug discount program has grown so big and controversial that it faces a fight for survival as federal officials and lawmakers furiously debate the program’s reach. The program,… Read More

Germ-Line Gene Editing and Congressional Reaction in Context

Journal of Law and Health, Vol. 30 (2017), Issue 1
by Russell A. Spivak, I. Glenn Cohen (Faculty Director), and Eli Y. Adashi

Abstract: On December 18, 2015, President Obama signed into law a policy rider forestalling the therapeutic modification of the human germ line. The rider, motivated by the science’s potential unethical… Read More

Federal Tax Plan Could Cause Problems For Puerto Rico’s Medical Manufacturers And Hurricane Recovery

NPR, November 27, 2017
by Greg Allen and Marisa Penaloza

[...] after Hurricane Maria, manufacturers in Puerto Rico are now facing what some are calling a potential man-made disaster. It's a provision in the tax bill that recently passed the House that would… Read More

Gene Therapy Hits a Peculiar Roadblock: A Virus Shortage

New York Times, November 27, 2017
by Gina Kolata

Eager to speed development of revolutionary treatments, the Food and Drug Administration recently announced that it would expedite approval of experimental gene therapies. But the regulatory process may… Read More

Veterans are key as surge of states okay medical pot for PTSD

STAT, November 26, 2017
by Associated Press

[...] Twenty-eight states plus the District of Columbia now include PTSD in their medical marijuana programs, a tally that has more than doubled in the last two years, according to data compiled by the… Read More

44 state attorneys general want repeal of law that curbed DEA powers

Washington Post, November 14, 2014
by Lenny Bernstein and Scott Higham

Forty-four state attorneys general asked Congress on Tuesday to repeal a law that effectively strips the Drug Enforcement Administration of potent weapons against large drug companies that have allowed… Read More

The Debate over Postmortem Sperm Retrieval of Fallen Soldiers

Jerusalem Post, November 22, 2017
by Avishalom Westreich (Visiting Scholar Alumnus)

This essay is based in part on the workshop the Petrie-Flom Center hosted on October 23, 2017, in which then-Visiting Scholar Avishalom Westreich presented his research-in-progress to a diverse group of… Read More

Digital pill offers chance of new life to old drugs

Financial Times, November 22, 2017
by FT Staff, quoting I. Glenn Cohen (Faculty Director)

From the article: Amid broader concerns about how medical information may be used, Proteus says that its product complies with “all applicable laws and standards” on data protection. Patients… Read More

Years Before Heading Offshore, Herpes Researcher Experimented On People In U.S.

Kaiser Health News, November 21, 2017
by Marisa Taylor

From the article: Three years before launching an offshore herpes vaccine trial, an American researcher vaccinated patients in U.S. hotel rooms in brazen violation of U.S. law, a Kaiser Health News… Read More

Health nominee reaped big earnings from drug industry tenure

Associated Press, November 21, 2017
by Stephen Braun

WASHINGTON (AP) — Newly disclosed financial records show that President Donald Trump’s nominee to become Health and Human Services secretary reaped big earnings during his tenure as a top pharmaceutical… Read More

What The Industry Knew About Sugar’s Health Effects, But Didn’t Tell Us

NPR, November 21, 2017
by Allison Aubrey

Back in the 1960s, the fact that our diets influence the risk of heart disease was still a new idea. And there was a debate about the role of fats and the role of sugar. The sugar industry got involved… Read More

Skin Cancers Rise, Along With Questionable Treatments

New York Times, November 20, 2017
by Katie Hafner and Griffin Palmer

From the article: The New York Times analyzed Medicare billing data for dermatology from 2012 through 2015, as well as a national database of medical services maintained by the American Medical Association… Read More

Marketplace Would Be Fundamentally Rocked With Repeal Of Individual Mandate

Kaiser Health News, November 16, 2017

KHN Morning Briefing: Summaries of health policy coverage from major news organizations Media outlets offer a look at what would happen to the Affordable Care Act exchanges if lawmakers include repeal… Read More

Threat To Medicare Funding In GOP Tax Plan Roils Capitol Hill

Kaiser Health News, November 16, 2017

KHN Morning Briefing: Summaries of health policy coverage from major news organizations The tax bill, a priority for the Republican majority in Congress, would likely raise the deficit and that would… Read More

A patent ploy

The Economist, November 16, 2017
by Economist Staff, citing Rachel E. Sachs (Academic Fellow Alumna)

From the article: [...] The Mohawk tribe argues that it should be treated the same as a state institution. State universities have used sovereign immunity to dismiss challenges brought to the Patent… Read More

First Digital Pill Approved to Worries About Biomedical ‘Big Brother’

New York Times, November 13, 2017
by Pam Belluck, featuring I. Glenn Cohen (Faculty Director)

For the first time, the Food and Drug Administration has approved a digital pill — a medication embedded with a sensor that can tell doctors whether, and when, patients take their medicine. The approval,… Read More

Ohio’s Drug-Pricing Ballot Question Triggers Voter Confusion

Kaiser Health News, November 7, 2017
by By Shefali Luthra, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Drug pricing is complex and already has caused head-scratching among policymakers and academics, noted Rachel Sachs, an associate professor of law at Washington University in St. Louis,… Read More

7 ways biopharma would win — and lose — under the new tax bill

STAT News, November 2, 2017
by Rebecca Robbins, citing Rachel E. Sachs (Academic Fellow Alumna)

From the article: [...] The drug industry has fiercely defended this tax credit in the past, calling it essential to encourage investment in disease areas where patients have few options — even as… Read More

Desperate Quest For Herpes Cure Launched ‘Rogue’ Trial

Kaiser Health News, October 19, 2017
by Marisa Taylor, quoting Holly Fernandez Lynch (Former Executive Director, Academic Fellow Alumna)

From the article: As 20 Americans and Brits flew to a Caribbean island for a controversial herpes vaccine trial, many of them knew there were risks. The lead U.S. researcher, William Halford, openly acknowledged… Read More

Medicaid’s Best-Price Rule May Not Be Such a Big Problem

Physician's Weekly, October 23, 2017
by Physician's Weekly, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Rachel Sachs, J.D., M.P.H., from Washington University in St. Louis, and colleagues discussed Medicaid’s “best-price rule” and the extent to which it might frustrate… Read More

Ohio Issue 2 ballot initiative proponents overstate impact on EpiPen prices

Politifact, October 13, 2017
by Manuela Tobias, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: In addition to the Medicaid program, the state purchases drugs for state employees, prisons, and other state-run programs, but the campaign was unable to pin down the effect of the initiative… Read More

Innovative Contracting for Pharmaceuticals and Medicaid’s Best-Price Rule

Journal of Health Politics, Policy and Law, September 28, 2017
by Rachel E. Sachs (Academic Fellow Alumna), Nicholas Bagley, and Darius N. Lakdawalla

From the paper: In recent years, drug manufacturers and private payers have expressed interest in novel pricing models that more closely link a drug’s price to its value. Indication-based pricing,… Read More

Battle over drug prices shifts back to the states

The Hill, October 11, 2017
by By Rachel Roubein, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: President Trump has derided pharmaceutical companies as “getting away with murder,” but there’s been little action in Washington to rein in the costs of prescription… Read More

Letter to Allergan plc

The House of Representatives Committee on Oversight and Government Reform, October 3, 2017
by By Trey Gowdy, Elijah E. Cummings, Dennis A. Ross, and Peter Welch, citing blog post by Rachel E. Sachs (Academic Fellow Alumna)

From the letter: On September 8, 2017, your company announced the trans r of six patents related to its Restasis drug to the Saint Regis Mohawk tribe. 1 The unconventional maneuver has received considerable… Read More

Absent federal action, states take the lead on curbing drug costs

The Washington Post, September 29, 2017
by By Shefali Luthra, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Critics see these tailored efforts as falling short or potentially opening other loopholes. Requiring companies to report prices past a certain threshold, for example, might encourage… Read More

Your Money or Your Patient’s Life? Ransomware and Electronic Health Records

Annals of Internal Medicine, September 19, 2017
by By I. Glenn Cohen (Faculty Director), Sharona Hoffman, and Eli Y. Adashi

The mugger's demand “Your money or your life” is a familiar one. However, in an era of vast hospital computer networks and electronic health records, a novel risk to worry about is, “Your… Read More

Allergan’s deal with the Mohawks raises troubling questions about the future of generics

STAT , September 11, 2017
by By Ed Silverman, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: [...] Legal experts, however, say that tribal sovereignty may also thwart generic drug makers from filing a conventional lawsuit. If so, the ramifications may be far-reaching and ominous… Read More

Influence, integrity, and the FDA: An ethical framework

Science, Sep 1, 2017: Vol. 357, Issue 6354, pp. 876-877.
by Spencer Phillips Hey, I. Glenn Cohen (Faculty Director), Eli Y. Adashi, & Aaron S. Kesselheim

Summary: Among the core missions of the U.S. Food and Drug Administration (FDA) are protecting public health by assuring the safety and efficacy of drugs, biologics, and medical devices and advancing public… Read More

Obamacare survives its latest threat: Bare counties

POLITICO Pulse, August 21, 2017
by Dan Diamond, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article:  Trump quietly signs FDA reauthorization bill. The president didn't hold a signing ceremony on Friday, even though the bill has been one of the few major pieces of legislation… Read More

Questions About The FDA’s New Framework For Digital Health

Health Affairs Blog, August 16, 2017
by Nathan G. Cortez, Nicolas Terry, and I. Glenn Cohen (Faculty Director)

From the article: In June 2017, the new Food and Drug Administration (FDA) commissioner Scott Gottlieb pre-announced his agency’s Digital Health Innovation Action Plan that indicates… Read More

The One Time Congress Let the Public Comment on an Upcoming Bill

Pacific Standard, August 14, 2017
by Francie Diep, quoting Rachel E. Sachs (Academic Fellow Alumna)

[...] Congress doesn't typically ask for public comments on the bills it's considering. But, in January of 2015, the House Energy and Commerce Committee did just that, for a first draft of the 21st… Read More

Administering Health Innovation

Cardozo Law Review, Forthcoming 2018
by Rachel E. Sachs (Academic Fellow Alumna)

Abstract 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 and promotion… Read More

Who’s Actually Using ‘Right-To-Try’ Laws?

RAPS, August 4, 2017
by Zachary Brennan, quoting Rachel E. Sachs (Academic Fellow alumna)

'The record with state-level right-to-try laws also suggests lackluster interest from industry. "It's telling that although 37 states have adopted these laws, when asked to provide examples of… Read More

Academic Fellow Alum Matthew J. B. Lawrence Joins Faculty at Dickinson Law (Penn State)

Dickinson Law, Penn State University, August 1, 2017

Matthew J.B. Lawrence has joined the faculty of Penn State’s Dickinson Law as assistant professor of law. An expert in the fields of health law and administrative law, Lawrence will teach Health… Read More

How New Technology Could Threaten a Woman’s Right to Abortion

Gizmodo, July 28, 2017
by Kristen V. Brown, quoting I. Glenn Cohen (Faculty Director)

From the article: [...] It could also complicate—and even jeopardize—the right to an abortion in an America in which that right is predicated on whether a fetus is “viable.” “The… Read More

Locked Out Of Asia, Americans Are Turning To Eastern Europe To Hire Gestational Surrogates

HuffPost, July 25, 2017
by Sarah Elizabeth Richards, quoting I. Glenn Cohen (Faculty Director)

From the article: [...] While it’s impossible to know “what’s presented to you versus what’s really occurring,” Harvard Law School Professor I. Glenn Cohen said, fertility… Read More

Petrie-Flom Welcomes New Senior Fellow in Law and Applied Neuroscience!

Petrie-Flom Center, July 21, 2017

We’re excited to announce our 2017–2018 Senior Fellow in Law and Applied Neuroscience, Francis X. Shen! Project on Law and Applied Neuroscience The Project on Law and Applied Neuroscience,… Read More

Public Participation in Drafting of the 21st Century Cures Act

The Journal of Law, Medicine & Ethics, July 14, 2017
by Thomas J. Hwang, Rachel E. Sachs (Academic Fellow Alumna), Aaron S. Kesselheim

Abstract The 21st Century Cures Act is a major act of legislation that contains numerous changes to drug and device regulation. The House of Representatives passed the Act after considerable interest group… Read More

FDA to Speed Review of Generic Drug Applications Until It’s Approved Three of Them

STAT News, June 27, 2017
by Rebecca Robins, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: The Food and Drug Administration on Tuesday moved to try to spur more competition in the market for generic drugs, an effort aimed at driving down prices. In a policy change,… Read More

The FDA May Move to Shorten That Grim List of Side Effects in Every Drug Ad

STAT News, June 28, 2017
by Megan Thielking, quoting Holly Fernandez Lynch (Executive Director)

From the article: Warning: Watching TV drug ads may put you to sleep. That’s no surprise to many of us who’ve heard about the countless ways prescription drugs can harm us. But now, the Food… Read More

The Case for Giving Health-Care Consumers a ‘Nudge’

Wall Street Journal, June 25, 2017
by Lisa Ward, interviewing Christopher T. Robertson (Academic Fellow Alumnus)

The Case for Giving Health-Care Consumers a ‘Nudge:’ A law professor argues that people will make better choices if they’re asked the right way For example, some states encourage child… Read More

Panel: Weighing the Risks of Randomized Controlled Trials and Alternatives

The New York Academy of Sciences, June 21, 2017
by Panel featuring Holly Fernandez Lynch (Executive Director), Amrit Ray, Matthew Rotelli, Steve Usdin, and Robert Walker

On June 21, 2017, Executive Director Holly Fernandez Lynch participated in a panel discussion on "Weighing the Risks of Randomized Controlled Trials and Alternatives," which was part of the conference… Read More

Turning to the States to Solve the National Problem of Drug Pricing

STAT News, June 20, 2017
by Meghana Keshavan, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Drug pricing is a national problem. So a nonprofit wants to help hand off some of that burden to the states. The National Academy for State Health Policy just launched a new center, called… Read More

At Drug Hearing, Senators Discuss Meanings of Price and Value - and Debate Health Reform

Health Affairs Blog, June 20, 2017
by Rachel E. Sachs (Academic Fellow Alumna)

From the article by Rachel E. Sachs, (Academic Fellow Alumna): On Tuesday, June 13, the Senate Health, Education, Labor, & Pensions (HELP) Committee held the first of three planned hearings… Read More

Fellow and Visiting Assistant Professor
Regulatory Science Program, University of Arizona James E. Rogers College of Law

Deadline: Open until filled.

The University of Arizona seeks to hire an early-career scholar (post-doctoral) to support its innovative Regulatory Science Program, a collaboration between the James E. Rogers College of Law and… Read More

How a Supreme Court ruling on printer cartridges could have a big impact on drug prices

STAT News, May 30, 2017
by Meghana Keshavan, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: A Supreme Court ruling on international printer cartridge sales could have major implications for, of all things, drug pricing and global health. The case in question involves patents,… Read More

Legal Roundtable: Discussing abortion restrictions, health care, Supreme Court developments and more

St. Louis Public Radio, May 30, 2017
by Kelly Moffitt, featuring Rachel Sachs (Academic Fellow Alumna)

From the radio episode: On Tuesday’s St. Louis on the Air, Legal Roundtable panel returned to discuss pressing issues of the law. They discussed a number of topics, starting with national issues… Read More

Pre-order now and get 30% off! Specimen Science

MIT Press, September 2017
by Edited by Holly Fernandez Lynch (Executive Director), Barbara E. Bierer, I. Glenn Cohen (Faculty Director), and Suzanne M. Rivera

Pre-order through MIT Press and receive 30% off using discount code MSPECIMEN30: Order now! This edited volume stems from a conference in 2015 that brought together leading experts to address key… Read More

New Issue of the Journal of Law and the Biosciences

Journal of Law and the Biosciences (JLB), Vol. 4, No. 1, April 2017

The Journal of Law and the Biosciences, the open-access journal launched in 2014 by the Petrie-Flom Center and Harvard Law School in partnership with Duke University and Stanford University, has… Read More

The Sean Pendergast Show with Dr. Glenn Cohen, Harvard Law Professor

The TJ Show, AMP Radio 103.3 FM, May 28, 2017
by Interviewing I. Glenn Cohen (Faculty Director)

Harvard Law Professor [I. Glenn Cohen (Faculty Director)] joins Sean to discuss a study he and a Harvard group did on player safety in the NFL, how the game can be made more safe, and the future of… Read More

The Trump administration could bring down drug prices. But it would take guts

STAT News, May 15, 2017
by Ed Silverman, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: “If Price and [President] Trump are interested in lower-priced drugs, they have access to a tool that enables them to do that,” explained Rachel Sachs, an associate professor… Read More

The White House budget director dropped a hint about how Trump could bring drug prices down

Washington Post, May 12, 2017
by Carolyn Y. Johnson, quoting Rachel Sachs (Academic Fellow Alumna)

From the artcile: Trump has repeatedly said that drug prices are too high but has often suggested that increased bidding would be the best way to bring down prices. It has been unclear how that… Read More

New FDA Chief Scott Gottlieb: Medication Reformer or Big Pharma Shill?

The Fix, May 18, 2017
by Paul Gaita, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: Gottlieb's position has earned cautious approval from medical industry observers like Washington University associate professor Rachel Sachs, who wrote, "As someone who understands… Read More

New York state wants its prescription drug money back—or else

USA Today, May 18, 2017
by Julie Appleby, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: New York’s Medicaid program, for example, has seen its drug spending rise on average 8% each year over the past three years, after taking into account existing rebates. The… Read More

Babies From Skin Cells? Prospect Is Unsettling to Some Experts

New York Times, May 16, 2017
by Tamar Lewin, citing I. Glenn Cohen (Faculty Director)

From the article: Three prominent academics in medicine and law sounded an alarm about the possible consequences in a paper published this year. “I.V.G. may raise the specter of ‘embryo farming’… Read More

Harvard Study Looks At Ways NFL Can Bolster Player Health

Law360, May 16, 2017
by Fola Akinnibi, quoting I. Glenn Cohen (Faculty Director) and citing Petrie-Flom's report

Law360, New York (May 16, 2017, 6:03 PM EDT) -- Harvard Law School published a report Monday exploring the National Football League’s health policies and practices, noting that the professional… Read More

New Report from the Law & Ethics Initiative of the Football Players Health Study

Petrie-Flom Center and Football Players Health Study at Harvard University, May 15, 2017

May 15, 2017 – While the NFL’s player health policies and practices are robust in some areas, there are opportunities for improvement in others, according to the findings of a newly released… Read More

Harvard’s Advice for NFL Player Health and Safety

MMQB, Sports Illustrated, May 15, 2017
by Jenny Vrentas, quoting I. Glenn Cohen (Faculty Director) and citing Petrie-Flom's report

From MMQB:  Today’s 255-page report comes from Harvard Law School’s Petrie-Flom Center for health law policy, biotechnology and bioethics, and it compares the NFL’s policies… Read More

Harvard study suggests some NFL health and safety changes

Washington Post, May 15, 2017
by Rick Maese, quoting I. Glenn Cohen (Faculty Director) and citing Petrie-Flom's report

From the Washington Post:  The physical demands are different. The types and severity of injuries are different. And the economics can vary wildly. But there are several common threads shared… Read More

Harvard study: NFL should offer treatment for performance-enhancing drug users

Boston Globe, May 15, 2017
by Travis Anderson, citing Petrie-Flom's report

From the Boston Globe:  The National Football League should consider providing treatment to any player caught using performance-enhancing drugs, according to a new Harvard University study. The recommendation… Read More

There’s a federal law to lower drug prices—and Louisiana may just use it

Ars Technica, May 4, 2017
by Beth Mole, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Rachel Sachs, a law professor at Washington University in St Louis, told the KHN that this makes a good argument for summoning 28 U.S.C. § 1498. “The case is strong,”… Read More

Louisiana proposes tapping a century-old patent law to cut hepatitis C drug prices

Kaiser Health News, May 2, 2017
by Sarah Jane Tribble, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Rachel Sachs, an associate professor of law at Washington University in St. Louis who attended the recent Johns Hopkins meeting, said she believes “the case is strong” in… Read More

Promoting demand-side innovation: prizes for payers

Journal of Law and the Biosciences, May 5, 2017
by Rachel E. Sachs (Academic Fellow Alumna)

From the paper: Promoting Healthcare Innovation on the Demand Side,1 the recent article by Professors Rebecca Eisenberg and Nicholson Price, is a thoughtful, detailed look at an issue that has gone… Read More

ORDER NOW & GET 20% OFF! Law, Religion, and Health in the United States

Cambridge University Press, July 2017
by Holly Fernandez Lynch (Executive Director), I. Glenn Cohen (Faculty Director), and Elizabeth Sepper

About the Book: While the law can create conflict between religion and health, it can also facilitate religious accommodation and protection of conscience. Finding this balance is critical to addressing… Read More

Revised ‘Common Rule’ Shapes Protections For Research Participants

Health Affairs, May 2017, Vol. 36, No. 5
by By Barbara E. Bierer, Mark Barnes, and Holly Fernandez Lynch (Executive Director)

From the article: Research with human participants funded by most federal agencies is governed by a set of rules and procedures designed to protect study participants while enabling the advancement of… Read More

Value-Based Pricing For Pharmaceuticals In The Trump Administration

Health Affairs Blog, April 27, 2017
by Rachel E. Sachs (Academic Fellow Alumna), Nicholas Bagley, and Darius Lakdawalla

From the article: Everyone seems to agree: Drug prices are too damn high. Scandalous prices for new drugs and enormous price hikes on old drugs have focused public ire on the pharmaceutical… Read More

Should We Study Human Embryos Beyond 14 Days?

NOVA Next, April 26, 2017
by Jenny Morber, quoting I. Glenn Cohen (Faculty Director)

From the article: [...] Some critics view calls to re-evaluate the 14-day rule as a pernicious moving of the goalposts. How meaningful can they be, the line of reasoning goes, if scientists want to change… Read More

As a competitor encroached, Mylan took one state to court to push EpiPen sales, documents

STAT News, April 24, 2017
by Ike Swetlitz, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article:  Three lawyers who reviewed the case at the request of STAT said they could not think of another instance when a pharmaceutical company sued to protect the status of its medication… Read More

Nonexceptionalism, Research Risks, and Social Media

American Journal of Bioethics, 17(5):W1-W3, 2017 (Published online April 21, 2017)
by Luke Gelinas (Research Ethics Fellow), Robin Pierce, Sabune Winkler, Glenn Cohen (Faculty Dir), Holly Fernandez Lynch (Executive Dir) & Barbara Bierer

We are grateful for the thoughtful commentaries on our target article “Using Social Media as a Research Recruitment Tool: Ethical Issues and Recommendations” (Gelinas et al. 2017),… Read More

Science Needs Your Cells

New York Times, April 21, 2017
by Holly Fernandez Lynch (Executive Director) and Steven Joffe

Biospecimens are essential to medical progress, but just medical waste to patients. Let's promote the science. From the op-ed: Many aspects of Ms. Lacks’s story reflect genuine injustice: the… Read More

Institutions as an Ethical Locus of Research Prioritisation

Journal of Medical Ethics, April 11, 2017 (Online)
by Luke Gelinas (Fellow in Clinical Research Ethics), Holly Fernandez Lynch (Executive Director), Barbara Bierer, I. Glenn Cohen (Faculty Director)

Introduction Ensuring that clinical trials, once launched, successfully complete and generate useful knowledge is an important and indeed ethically imperative goal, given the risks and burdens borne by… Read More

Death By 1,000 Cuts: How Republicans Can Still Alter Your Coverage

Kaiser Health News, April 10, 2017
by Jay Hancock, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: “It’s the single-biggest problem facing the exchanges,” said Rachel Sachs, a health law professor at Washington University in St. Louis. “That would make insurers… Read More

Congress and FDA nominee heap love on ‘adaptive trials’

Science, April 7, 2017
by Kelly Servick, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: “‘Adaptive clinical trials’ is one of those buzzwords that get brought up all the time,” says Rachel Sachs, an innovation and health law professor at Washington… Read More

Scott Gottlieb: Conflicts surround Trump’s FDA pick

CNN, April 4, 2017
by Sandee LaMotte, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Even some industry watchdogs are cautiously optimistic. In a New England Journal of Medicine perspective, Rachel Sachs, a Washington University associate professor of law who studies… Read More

ICER Weekly View 03-31-17

ICER, March 31, 2017
by Mitchell Stein, featuring blog post and NEJM article co-authored by Rachel E. Sachs (Academic Fellow Alumna)

From the review: Democrats’ New Drug Bill Improving Access to Affordable Prescription Drugs Act was introduced this week.  You can read the summary of the bill here.  Rachel Sachs… Read More

Anthem inches closer to full Obamacare exit

POLITICO, March 31, 2017
by Dan Diamond, featuring blog post by Rachel E. Sachs (Academic Fellow Alumna)

From the newsletter: WHAT WE'RE READING Writing at Harvard’s “Bill of Health,” Rachel Sachs offers reasons to be bullish on Democrats’ drug price legislation but also picks… Read More

Price doesn’t satisfy Congress on appropriations

POLITICO, March 30, 2017
by Darius Tahir, featuring NEJM article co-authored by Rachel E. Sachs (Academic Fellow Alumna)

From the newsletter: The latest issue of the New England Journal of Medicine is full of eHealth-relevant papers. Two articles consider Scott Gottlieb’s nomination for FDA commissioner. One,… Read More

Scott Gottlieb’s FDA Commissioner Confirmation Hearing: Remarkably Unremarkable

Health Affairs Blog, April 7, 2017
by Rachel E. Sachs (Academic Fellow Alumna)

From the post: On Wednesday morning, the United States Senate Committee on Health, Energy, Labor, and Pensions conducted the confirmation hearing for Dr. Scott Gottlieb, President Trump’s nominee… Read More

Release of New FDA Guidance Declines Sharply Following Trump’s Inauguration

Regulatory Affairs , April 11, 2017
by Zachary Brennan, quoting Rachel E. Sachs (Academic Fellow Alumna)

[...] Rachel Sachs, an associate professor of law at Washington University in St. Louis, told Focus: “I think they're waiting for Gottlieb to set his priorities, and they'll move forward… Read More

(Health) Law and Order

Beyond the Microscope Podcast, March 28, 2017
by Mumu Xu, interviewing Rachel E. Sachs (Academic Fellow Alumna)

We’ve got a special episode today for all you STEM/legal nerds. Our guest is Rachel Sachs, an Associate Professor at the Washington University in St. Louis School of Law. Rachel works at… Read More