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

Is This Hospital Takeover Permitted? Ask the Catholic Church

Wall Street Journal, May 14, 2018
by Melanie Evans

This article is behind a paywall. Harvard affiliates can access the full text via Hollis. It isn't just the Federal Trade Commission scrutinizing U.S. health-care mergers these days. The Vatican… 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

Trump Administration Imposes New Abortion Restrictions On Federally Funded Family Planning Clinics

Kaiser Health News, May 18, 2018

KHN Morning Briefing: Summaries of health policy coverage from major news organizations The policy would mirror similar restrictions in place during the Reagan administration. The policy has been… 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

After controversy over industry funding, NIH halts enrollment in moderate drinking study

STAT, May 17, 2018
by Andrew Joseph

The National Institutes of Health has suspended enrollment in a studyaimed at investigating whether moderate alcohol consumption helps cardiovascular health following concerns over the alcoholic beverage… Read More

HHS Secretary Clarifies Trump Administration’s Plan To Reduce Prescription Drug Prices

NPR, May 17, 2018
by Alison Kodjak

[...] KELLY: First start just by reminding us what this proposal is. The president came out and made an announcement about drug prices last Friday in the Rose Garden. What exactly did he say? KODJAK:… Read More

‘Will You Be My Emergency Contact?’ Takes on a Whole New Meaning

New York Times, May 17, 2018
by Heather Murphy

Will you be my emergency contact? When you’re dating, the question is a sign that you’ve made it to the this-is-really-serious category. When you’re friends, it’s a sign that you’re… Read More

F.D.A. Names and Shames Drug Makers to Encourage Generic Competition

New York Times, May 17, 2018
by Sheila Kaplan

Pharmaceutical companies that spend billions of dollars to develop new drugs do not want competitors to profit from inexpensive generic copies of blockbuster medicines. To avoid rivals, they fight for… 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

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

F.D.A. Moves to Stop Rogue Clinics From Using Unapproved Stem Cell Therapies

New York Times, May 9, 2018
by Denise Grady and Sheila Kaplan

The Food and Drug Administration said on Wednesday that it was seeking court orders to stop two clinics from using unapproved stem cell treatments that in some cases have seriously harmed patients. The… Read More

As Opioid Liability Rises, Accreditor Seeks Credential For Pharma’s Educators

Forbes, May 9, 2018
by Bruce Japsen

As the U.S. grapples with the deadly opioid epidemic and public outrage over drug costs, an accreditor of medical affairs professionals and pharmaceutical sales representatives is grabbing the attention… 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

De Blasio Moves to Bring Safe Injection Sites to New York City

New York Times, May 3, 2018
by William Neuman

Mayor Bill de Blasio is championing a plan that would make New York City a pioneer in creating supervised injection sites for illegal drug users, part of a novel but contentious strategy to combat the… Read More

​After Arrest Using DNA Database Ethicists Left Wondering

Kaiser Health News, April 30, 2018

KHN Morning Briefing: Summaries of health policy coverage from major news organizations Genetic testing and genealogy sites are widely popular these days, but the case of the Golden State Killer calls… Read More

How A Drug Company Under Pressure For High Prices Ratchets Up Political Activity

Kaiser Health News, April 30, 2018
by Jay Hancock and Elizabeth Lucas

Business looked challenging for Novo Nordisk at the end of 2016. As pressure mounted over the pharma giant’s soaring insulin prices, investors drove its stock down by a third on fears that policymakers… 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

Ronny Jackson Withdraws As VA Nominee

NPR, April 26, 2018
by Jessica Taylor and Brian Naylor

Rear Adm. Ronny Jackson, President Trump's embattled nominee to lead the Department of Veterans Affairs, has withdrawn from consideration for the post amid allegations he had fostered a hostile work… Read More

The $3 Million Research Breakdown

ProPublica, April 26, 2018
by Jodi S. Cohen

This story was co-published with The Chronicle of Higher Education. For nearly two decades, the University of Illinois at Chicago has touted child psychiatrist Mani Pavuluri as one of its stars: She founded… 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

Administration’s Teen Pregnancy Prevention Funding Rules Favor Abstinence-Focused Programs

Kaiser Health News, April 24, 2018

KHN Morning Briefing: Summaries of health policy coverage from major news organizations The new rules for the funding do not exclude programs that provide information about contraception and protected… Read More

F.D.A. Cracks Down on Sales of E-Cigarettes to Minors

New York Times, April 24, 2018
by Kate Zernike and Sheila Kaplan

The Food and Drug Administration announced on Tuesday that it was cracking down on the sales of e-cigarettes to minors, especially the popular vaping Juul brand, and said it had issued warning… 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

Federal Appeals Court Puts Chill On Maryland Law To Fight Drug Price-Gouging

Kaiser Health News, April 17, 2018
by Shefali Luthra

States continue to battle budget-busting prices of prescription drugs. But a federal court decision could limit the weapons available to them — underscoring the challenge states face as they, in… 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

Nursing homes routinely refuse people on addiction treatment — which some experts say is illegal

STAT, April 17, 2018
by Allison Bond

Nursing facilities routinely turn away patients seeking post-hospital care if they are taking medicine to treat opioid addiction, a practice that legal experts say violates the Americans with Disabilities… Read More

Canada To Measure Marijuana Use By Testing Sewage

NPR, April 13, 2018
by Menaka Wilhelm

[...] Statistics Canada has already begun testing sewage for signs of drugs. Canada joins several countries in Europe that sample wastewater for drugs annually. New Zealand has been collecting data from… Read More

Objective Intent: SSRN Reading List February and March

Objective Intent, April 13, 2018
by Erika Lietzan, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: In this careful and thorough article forthcoming in the Minnesota Law Review, Professor Sachs argues that drug pricing concerns could be addressed in part if insurers were not required… Read More

FDA Launches Criminal Investigation Into Unauthorized Herpes Vaccine Research

Kaiser Health News, April 12, 2018
by Marisa Taylor

The Food and Drug Administration has launched a criminal investigation into research by a Southern Illinois University professor who injected people with his unauthorized herpes vaccine, Kaiser Health… Read More

Administration Relaxes Essential Benefits Regulations, Creates New Mandate Exemptions

Kaiser Health News, April 10, 2018

KHN Morning Briefing: Summaries of health policy coverage from major news organizations Overall, the Trump administration's rules addressing the standards for insurers planning to participate… Read More

The Disappearing Doctor

New York Times, April 7, 2018
by Reed Abelson and Julie Creswell

[...] The new deals involving major corporations loom over doctors’ livelihoods, intensifying pressure on small practices and pushing them closer to extinction. The latest involves Walmart and… Read More

Medical Marijuana’s ‘Catch-22’

NPR, April 7, 2018
by Marisa Taylor and Melissa Bailey

[...] Although 29 states have legalized marijuana to treat pain and other ailments, the growing number of Americans like Owen who use marijuana and the doctors who treat them are caught in the middle of… 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

FDA Commissioner Says Enforcement Power Could Be Used In Right-To-Try, E-Cigarettes

Forbes, March 28, 2018
by Matthew Herper and Ellie Kincaid

The commissioner of the Food and Drug Administration has a single answer to many of the challenges the FDA is likely to face: enforcement. Speaking at the CNBC Healthy Returns conference, FDA commissioner… 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

Medicare Is Cracking Down on Opioids. Doctors Fear Pain Patients Will Suffer.

New York Times, March 27, 2018
by Jan Hoffman

Medicare officials thought they had finally figured out how to do their part to fix the troubling problem of opioids being overprescribed to the old and disabled: In 2016, a staggering one in three… Read More

With Premiums Likely To Spike Just Before Midterms, Lawmakers Are Bracing For Blame Game Battle

Kaiser Health News, March 26, 2018

KHN Morning Briefing: Summaries of health policy coverage from major news organizations Language on abortion threw a wrench in both sides' plans to add money to stabilize the marketplace into… Read More

SEC greenlights shareholder proposals for several big drug makers over pricing

STAT, March 26, 2018
by Ed Silverman

The Securities and Exchange Commission agreed to allow shareholders in five large drug makers to vote on a proposal demanding the companies compile reports about the risks created by high prices and also… Read More

Spending Bill Lets CDC Study Gun Violence; But Researchers Are Skeptical It Will Help

NPR, March 23, 2018
by Nell Greenfieldboyce

Government health agencies have spent more than two decades shying away from gun violence research, but some say the new spending bill, signed by President Trump on Friday, will change that. That is because,… Read More

Prominent AIDS Researcher Named As CDC Chief Despite Concerns Over Misconduct Investigation

Kaiser Health News, March 22, 2018

KHN Morning Briefing: Summaries of health policy coverage from major news organizations Dr. Robert Redfield "has dedicated his entire life to promoting public health and providing compassionate care… Read More

Medical Research, Drug Treatment And Mental Health Are Winners In New Budget Bill

NPR, March 22, 2018
by Alison Kodjak

The big budget deal reached this week in the House doesn't include a long-sought-after provision to stabilize the Affordable Care Act marketplaces. But the $1.3 billion plan, set to fund the government… Read More

Brain Scans in the Courts: Prosecutor’s Dream or Civil Rights Nightmare?

Inside Science, March 14, 2018
by James Gaines, quoting Francis Shen (Senior Fellow in Law and Applied Neuroscience)

From the article:  One of the foundations of the U.S. legal system is the Bill of Rights, which enshrines the idea that there are certain individual liberties and inalienable freedoms that governments… Read More

FDA Takes ‘Historic First Step’ Toward Cutting Nicotine In Cigarettes To Non-Addictive Levels

Kaiser Health News, March 16, 2018

KHN Morning Briefing: Summaries of health policy coverage from major news organizations The move garnered praise from anti-smoking advocates. “There is no other single action our country can… Read More

Abortion, free speech collide in Supreme Court dispute

ABC News, March 16, 2018
by Mark Sherman, Associated Press

Even as it advertises "free pregnancy services" and promises in signs on its door and inside to discuss all options with pregnant women, Informed Choices exists to steer women away from abortion. The state… Read More

Billions of Dollars on the Line as Insurers Await Obamacare Ruling

Wall Street Journal, March 15, 2018
by Stephanie Armour

This article is behind a paywall. Harvard affiliates can access the full text via Hollis +. Health insurers and the Trump administration face a court decision shortly that will determine whether the government… Read More

Risk and Resilience in Health Data Infrastructure

Colorado Technology Law Journal, Volume 16, Issue 1 (2017)
by W. Nicholson Price II (Academic Fellow Alumnus)

From the journal article: Today’s health system runs on data. However, for a system that generates and requires so much data, the health care system is surprisingly bad at maintaining, connecting,… Read More

Elizabeth Holmes, Theranos C.E.O. and Silicon Valley Star, Accused of Fraud

New York Times, March 14, 2018
by Katie Thomas and Reed Abelson

[...] On Wednesday, the Securities and Exchange Commission charged Ms. Holmes, now 34, with widespread fraud, accusing her of exaggerating — even lying — about her technology while raising… Read More

Why Are U.S. Health Costs The World’s Highest?

WBUR (NPR Boston), March 13, 2018
by Richard Knox

Why is U.S. health care by far the most expensive on the planet? At more than $10,000 a year per person, and nearly 18 percent of all goods and services, health care in America consumes roughly… Read More

Congress Races The Clock In Quest To Bring Stability To Individual Insurance Market

Kaiser Health News, March 2, 2018
by Julie Rovner

[...] The lawmakers are up against not just the legislative clock, but also the insurance companies’ timeline. Insurers have until summer to decide if they want to continue to sell policies… Read More

Big Pharma, Big Data

New York Times, March 1, 2018
by Reuters

LONDON — Drugmakers are racing to scoop up patient health records and strike deals with technology companies as big data analytics start to unlock a trove of information about how medicines perform… Read More

Senators Push For Leadership At Indian Health Service

NPR, March 1, 2018
by Eric Whitney

[...] The Trump administration hasn't named a new nominee to lead IHS, which has been without a permanent leader since 2015. Democrats and Republicans on the Senate Committee on Indian Affairs… Read More

Payments to Study Participants: Experts Discuss Potential Framework

RAPS, February 27, 2018
by Michael Mezher, featuring NEJM article produced as part of the Harvard Catalyst Project

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… Read More

A Framework for Ethical Payment to Research Participants

NEJM, February 22, 2018
by Luke Gelinas (Clinical Research Ethics Fellow), Emily A. Largent (Student Fellow Alumna), I. Glenn Cohen (Faculty Director), Susan Kornetsky, Barbara

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

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

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

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

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

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

Deadline: Position has been filled.

Duties & ResponsibilitiesThis 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

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

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

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

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

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

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

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

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

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

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

NOW AVAILABLE! 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

This edited volume stems from the Petrie-Flom Center’s 2016 annual conference, which brought together leading experts to identify the various ways in which law and ethics intersect with… 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

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

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

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 NeuroscienceThe Project on Law and Applied Neuroscience, now… 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