public static function News, Resources, and Events Tagged "Health Law Policy" | Petrie-Flom Center

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

Deadline: November 15, 2018

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

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

Deadline: Closed.

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

2018-2019 Petrie-Flom Center Student Fellowship
Harvard Law School

Deadline: August 10, 2018

The Center and Student Fellowship The Petrie-Flom Center Student Fellowship Program is designed to mentor students seeking to become thought leaders in health law policy and bioethics. The fellowship supports… Read More

2017-2018 Petrie-Flom Center Student Fellowship
Harvard Law School

Deadline: August 11, 2017

The deadline for applications for the 2017-2018 fellowship is now closed.  The Center and Student Fellowship. The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is an interdisciplinary… Read More

Health Law Sign-Ups Down 11% From Last Year With Two Weeks Left In Open Enrollment

Kaiser Health News, December 7, 2018

KHN Morning Briefing: Summaries of health policy coverage from major news organizations In the first five weeks of the enrollment period, 3.2 million Americans signed up for health insurance coverage… Read More

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

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

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

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

New York Times, December 6, 2018
by Katie Thomas

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

The Ethics of Heritable Genome Editing

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

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

Now Mental Health Patients Can Specify Their Care Before Hallucinations and Voices Overwhelm Them

New York Times, December 3, 2018
by Pam Belluck

[...] He completed a psychiatric advance directive, a legal document declaring what treatment he does and doesn’t want. Increasingly, patients, advocates and doctors believe such directives (called… Read More

Feds Order More Weekend Inspections Of Nursing Homes To Catch Understaffing

Kaiser Health News, November 30, 2018
by Jordan Rau

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

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

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

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

Regulatory Collaboration Is Key to Public Health Success

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

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

Overshadowed By Opioids, Meth Is Back And Hospitalizations Surge

Kaiser Health News, November 26, 2018
by Anna Gorman

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

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

NPR, November 26, 2018
by Mara Gordon

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

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

Forbes, November 19, 2018
by Bruce Japsen

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

Expansion of the Medicare 340B Payment Program

JAMA, November 16, 2018
by Peter B. Bach and Rachel E. Sachs (Academic Fellow Alumna)

From the article:  "The 340B program began as a means to lower the cost of outpatient medications for a small set of underresourced health care facilities that served primarily low-income patients,… Read More

Midterm Results Show Health Is Important To Voters But No Magic Bullet

Kaiser Health News, November 7, 2018
by Julie Rovner

Health care proved important but apparently not pivotal in the 2018 midterm elections on Tuesday as voters gave Democrats control of the U.S. House, left Republicans in charge in the Senate and appeared… Read More

Health Care Issues Helped Fuel Democrats’ House Victories

Kaiser Health News, November 7, 2018

KHN Morning Briefing: Summaries of health policy coverage from major news organizations These issues in general, and protecting the Affordable Care Act in particular, were picked early on by Democratic… Read More

Tuesday’s big winner

Politico, November 7, 2018
by Rachana Pradhan and Alice Miranda Ollstein

Obamacare’s Medicaid expansion is set to grow by about a half-million after voters in three deeply red states rebuked Republican leaders to approve ballot measures joining the program and Democrats… Read More

3 More States OK Easing Their Marijuana Laws

NPR, November 7, 2018
by Bill Chappell

Voters in Michigan approved a ballot measure to legalize recreational use of marijuana on Tuesday, and two other states — Missouri and Utah — endorsed medical marijuana laws. Voters in North… Read More

Mass. Voters Say ‘No’ To Nurse Staffing Ballot Question

WBUR (NPR Boston), November 7, 2018
by Martha Bebinger

Massachusetts voters have decided the state will not write nurse-to-patient ratios into law. A ballot question that would have set the maximum number of patients assigned to a nurse in hospitals at any… Read More

Trump prescription medication plan drawing skepticism

Boston Herald, November 3, 2018
by Alexi Cohan, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: Part of the proposal includes adopting an international pricing index for reimbursement that is based off the cost of certain drugs in other countries. This would lower the cost here… Read More

Poor Disaster Oversight Imperiled Nursing Homes, Senate Report Finds

New York Times, November 2, 2018
by Sheri Fink

A Senate inquiry faulted state and federal oversight for fatal heat strokes and chaotic evacuations at nursing homes after last year’s hurricanes, calling for tougher disaster preparedness standards… Read More

Colorado Supreme Court Quotes I. Glenn Cohen

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

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

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

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

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

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

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

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

Administration Outlines Plan To Lower Pharmaceutical Prices In Medicare Part B

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

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

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

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

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

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

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

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

​State Ballot Initiatives

Kaiser Health News, October 22, 2018

KHN Morning Briefing: Summaries of health policy coverage from major news organizations A look at some of the measures that will be in front of voters in Georgia, Massachusetts and California. Read More

Miscarrying at Work

New York Times, October 21, 2018
by Jessica Silver-Greenberg and Natalie Kitroeff

[...] Pregnancy discrimination is widespread in corporate America. Some employers deny expecting mothers promotions or pay raises; others fire them before they can take maternity leave. But for… Read More

‘Transgender’ Could Be Defined Out of Existence Under Trump Administration

New York Times, October 21, 2018
by Erica L. Green, Katie Benner, and Robert Pear

WASHINGTON — The Trump administration is considering narrowly defining gender as a biological, immutable condition determined by genitalia at birth, the most drastic move yet in a governmentwide… Read More

As Billions In Tax Dollars Flow To Private Medicaid Plans, Who’s Minding The Store?

Kaiser Health News, October 19, 2018
by Chad Terhune

[...] The current political debate over Medicaid centers on putting patients to work so they can earn their government benefits. Yet some experts say the country would be better served by asking this question… Read More

Response to Open Peer Commentaries on “The Ethics of Smart Pills and Self-Acting Devices

American Journal of Bioethics, Volume 18, October 2018
by Craig M. Klugman, Laura B. Dunn, Jack Schwartz and I. Glenn Cohen (Faculty Director)

From the article:  We thank all of the insightful authors who wrote open peer commentaries to further the conversation about digital medicine that we raised in our article, “The Ethics of Smart… Read More

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

Politico, October 15, 2018
by Sarah Karlin-Smith

The Trump administration on Monday moved to require drugmakers to disclose prices in consumer ads, just hours after branding a pharmaceutical industry transparency plan as inadequate. HHS said its proposed… Read More

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

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

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

Senate Democrats fail to block Trump’s short-term health plans

Politico, October 10, 2018
by Adam Cancryn and Alice Miranda Ollstein

A long-shot bid to derail the Trump administration’s expansion of short-term health plans died in the Senate on Wednesday, even with Sen. Susan Collinsproviding the lone Republican vote for… Read More

A growing number of states consider legislation to treat pharma as a utility

STAT, October 10, 2018
by Ed Silverman

As prescription drug costs continue to frazzle Americans, lawmakers in several states are pushing to create commissions that would set prices that health plans, pharmacies, and state programs would pay… Read More

No More Secrets

Kaiser Health News, October 10, 2018
by Susan Jaffe

For years, most pharmacists couldn’t give customers even a clue about an easy way to save money on prescription drugs. But the restraints are coming off. When the cash price for a prescription is… Read More

The exciting new idea hospitals have to bring down drug prices

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

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

Addiction Treatment Gap Is Driving A Black Market For Suboxone

NPR, October 5, 2018
by Jake Harper

[...] Buprenorphine is one of just three federally approved medications to treat opioid addiction. It's an opioid itself, so some people misuse it — they snort or inject the medication to… Read More

Outbreak Week: How prepared are we for the next health crisis?

Harvard Law Today, October 5, 2018

From the article:  Outbreak Week, led by the Harvard Global Health Institute, was a unique multidisciplinary effort investigating and engaging with epidemic and pandemic preparedness in the 21st century.… Read More

When Your Dreams of Motherhood Are Destroyed

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

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

When Markets Fail: Patents and Infectious Disease Products

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

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

Gilead to launch authorized generics of two HCV drugs

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

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

Medicare Eases Readmission Penalties Against Safety-Net Hospitals

Kaiser Health News, September 26, 2018
by Jordan Rau

On orders from Congress, Medicare is easing up on its annual readmission penalties on hundreds of hospitals serving the most low-income residents, records released last week show. Medicare is penalizing… Read More

Pharma Dealt A Disappointment Over ‘Doughnut Hole’ Change As Lawmakers Reach Agreement On Opioid Pac

Kaiser Health News, September 26, 2018

KHN Morning Briefing: Summaries of health policy coverage from major news organizations Negotiators for the House and Senate smoothed out the differences between their two versions on the massive… Read More

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

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

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

Oversight of Patient-Centered Outcomes Research: Recommendations From a Delphi Panel

Annals of Internal Medicine, September 25, 2018
by Luke Gelinas (Senior Fellow), Joel S. Weissman, Holly Fernandez Lynch, Avni Gupta, Ronen Rozenblum, Emily A. Largent,I. Glenn Cohen (Faculty Director)

From the abstract:  A key aim of patient-centered outcomes research (PCOR) is to generate data that are important to patients by deliberately and extensively involving them in all aspects of research,… Read More

Parents Are Leery Of Schools Requiring ‘Mental Health’ Disclosures By Students

WUSF (NPR), September 21, 2018
by Julio Ochoa

Children registering for school in Florida this year were asked to reveal some history about their mental health. The new requirement is part of a law rushed through the state legislature after the February shooting… Read More

States ‘On Front Lines’ Of Opioid Crisis Get $1 Billion In Grants From Trump Administration

Kaiser Health News, September 20, 2018

KHN Morning Briefing: Summaries of health policy coverage from major news organizations The vast majority of the funding was approved by Congress earlier this year as part of a budget bill. “Addressing… Read More

GOP lawmakers seeking to use opioids bill to deliver drug industry major victory

STAT + , September 20, 2018
by Lev Facher and Nicholas Forko

This article is behind a paywall. WASHINGTON — Republicans on Capitol Hill are attempting to use a bill to address the opioid crisis to deliver a major victory for the pharmaceutical industry,… Read More

Big questions raised by big data

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

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

Everything You Know About Obesity Is Wrong

HuffPo, September 19, 2018
by Michael Hobbs. Images by Finlay MacKay

[...] For 60 years, doctors and researchers have known two things that could have improved, or even saved, millions of lives. The first is that diets do not work. Not just paleo or Atkins or Weight Watchers… Read More

South Africa’s highest court legalises cannabis use

BBC, September 18, 2018

South Africa's highest court has legalised the use of cannabis by adults in private places. Pro-marijuana activists cheered in the public gallery and chanted "Weed are free now" when the Constitutional… Read More

Trump puts HHS in charge of defense against biological threats

Politico, September 18, 2018
by Sarah Owermohle

President Donald Trump Tuesday morning issued a national biodefense strategythat repeals Bush and Obama administration policies and installs an HHS-led committee to survey gaps in responding to biological… Read More

Industry, Advocacy Groups Sue Administration Over Short-Term Plans

Kaiser Health News, September 17, 2018

KHN Morning Briefing: Summaries of health policy coverage from major news organizations The plans will have much lower premiums than health law-compliant ones because they can turn away customers… Read More

Feds approve Cigna-Express Scripts mega-merger

Politico, September 17, 2018
by Paul Demko

Federal regulators have approved health insurer Cigna’s $52 billion acquisition of drug benefits manager Express Scripts, a mega deal that's the latest evidence of health care giants bulking… Read More

A pharma exec raised the price of antibiotic by 400 percent — and the government can’t do much about

Stat Plus, September 11, 2018
by Ike Swetlitz and Nicholas Florko, quoting Rachel Sachs (Academic Fellow Alumnus)

From the article:  Three years after Martin Shkreli became the poster boy of pharmaceutical company greed, another drug company executive is setting himself up for a similar infamy. And… Read More

A Setback For Massachusetts In States’ Drive To Contain Medicaid Drug Spending

NPR Shots/WBUR, September 12, 2018
by Martha Bebinger, quoting Rachel Sachs (Academic Fellow Alumna)

From the article:  States serve as "laboratories of democracy," as U.S. Supreme Court Justice Louis Brandeis famously said. And states are also labs for health policy, launching all kinds of experiments… Read More

Generic Drugmakers Embrace Inter Partes Review Process

RAPS Regulatory Focus , September 4, 2018
by Zachary Brennan. quoting Jonathan Darrow (Student Fellow Alumnus)

From the article:  [Generic Drugmakers Embrace Inter Partes Review Process]Thanks to Congress’ administrative alternative to court litigation of patents, generic drug manufacturers have embraced… Read More

Is Medical Tourism Safe?

by The Doctors, featuring I. Glenn Cohen (Faculty Director)

The Doctors welcomed Medical Tourism Association President Renee-Marie Stephano and Harvard professor and author of “Patients with Passports” Glenn Cohen to discuss just how safe… Read More

New Medicare Advantage Tool To Control Drug Prices Could Narrow Choices

NPR, September 13, 2018
by Susan Jaffe

Starting next year, Medicare Advantage plans will be able to add restrictions on expensive, injectable drugs administered by doctors to treat cancer, rheumatoid arthritis, macular degeneration and other… Read More

Limiting State Flexibility in Drug Pricing

NEJM, September 13, 2018
by Nicholas Bagley and Rachel E. Sachs (Academic Fellow Alumna)

From the article:  Throughout the United States, escalating drug prices are putting immense pressure on state budgets. Several states are looking for ways to push back. Last year, Massachusetts asked… Read More

Are Fraud and Abuse Laws Stifling Value-Based Care?

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

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

Petrie-Flom is Hiring! Call for Applications

Petrie-Flom Center, September 2018

General information The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is seeking student interns for the Fall 2018. Availability to start immediately… Read More

Who’s to blame when a machine botches your surgery?

Quartz, September 10, 2018
by Robert David Hart (quoting W. Nicholson Price II, Academic Fellow Alumnus)

From the article:  Determining the levels of legal responsibility for AIs as a whole is a fairly new area and one that has yet to be seriously tested in court. What’s more, in a health care… Read More

Call for Applications: Petrie-Flom Center Student Internship Program
Petrie-Flom Center, Harvard Law School

Deadline: September 24, 2018

General information The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is seeking student interns for the Fall 2018 semester. Availability to start immediately… Read More

Petrie-Flom Welcomes 2018-2019 Student Fellows

Petrie-Flom Center, September 10, 2018

We are so excited to welcome a new crop of Student Fellows to the Petrie-Flom Center family. These six students are a fantastic cohort of health law policy, biotechnology, and bioethics scholars who join… Read More

The Generic Drug Industry Embraces a Faster, Cheaper Pathway for Challenging Patents

Applied Health Economics and Health Policy, August 2018, Vol. 14, Issue 73
by Jonathan J. Darrow (Student Fellow Alumnus), Reed F. Beall, Aaron S. Kesselheim

From the abstract:  Background Most new brand-name drugs are protected by patents from generic competition, but these patents are occasionally granted in error. Invalidating such patents has traditionally… Read More

FDA confronts its limits in push on drug pricing

Biopharmadive, August 27, 2018
by Ned Pagliarulo, quoting Rachel Sachs (Academic Fellow Alumna)

From the article:  Drugmakers like AbbVie, which makes the best-selling biologic Humira (adalimumab), have reached settlement deals with makers of approved biosimilars to push off market… Read More

Drug Prices in Ads: Senate Passes Amendment

RAPS Regulatory Focus, August 24, 2018
by Zachary Brennan, quoting Rachel Sachs (Academic Fellow Alumna)

From the article:  Earlier this month, CMS also announced plans to begin using what’s called step therapy to try to lower the spend on Part B drugs by about 20% in Medicare Advantage… Read More

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

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

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

How Regulation Can Improve Surgery

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

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

Professor/Associate Professor
Boston University School of Law

Deadline: Open until filled

From the description:  Boston University School of Law is seeking both entry-level and lateral faculty for positions with a projected start date of July 1, 2019. The search is broad and not limited… Read More

Student Fellow Alumnus Zach Shapiro Named Solomon Center Research Fellow

Solomon Center for Health and Policy at Yale Law School , August 20, 2018

The Solomon Center for Health Law and Policy at Yale Law School announced new fellows and staff for the 2018-2019 academic year, including the appointment of Student Fellow Alumnus Zach Shapiro as… Read More

Petrie-Flom Welcomes New Precision Medicine Fellow!

Petrie-Flom Center, August 16, 2018

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

Revisiting the Limits of Professional Autonomy

Harvard Journal of Law and Gender, Vol. 41, No. 1
by Maayan Sudai (Student Fellow Alumna)

From the paper: Social movements that seek to change biomedical policy face the particularly challenging task of effectively contesting the scientific and normative basis used to justify medical professional… Read More

We Have to Be Smart About Artificial Intelligence in Medicine

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

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

Drug Pricing Policy

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

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

Viewpoint: Promoting Patient Interests in Implementing the Federal Right to Try Act

JAMA, August 13, 2018
by Holly Fernandez Lynch (former Executive Director and Academic Fellow Alumna), Patricia J. Zettler, Ameet Sarpatwari

Former Executive Director and Academic Fellow Alumna Holly Fernandez Lynch has co-authored an opinion piece on the federal Right to Try Act of 2017. From the article: On May 30, 2018, President Trump signed… Read More

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

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

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

Katie Kraschel Named One of ABA’s Top 40 Young Lawyers

Solomon Center for Health Law and Policy at Yale Law School, August 9, 2018
by Honoring Katie Kraschel (Student Fellow Alumna)

Katie Kraschel, Executive Director of the Solomon Center for Health Law and Policy,  has been named among the American Bar Association’s “Top 40 Young Lawyers” for 2018. The… Read More

Perspective: Will Courts Allow States to Regulate Drug Prices?

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

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

CMS’ plan to lower drug spending in Medicare Advantage

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

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

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

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

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

To Tame Prescription Prices, HHS Dips A Toe Into Drug Importation Stream

Kaiser Health News, August 1, 2018
by Rachel Bluth, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: This isn’t the first time officials have suggested importing drugs from other countries to find better prices. Bills have been offered in Congress to allow it, and George… Read More

Administering Health Innovation

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

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

Delinking Reimbursement

Minnesota Law Review, Vol. 102, Issue 6 (July 2018)
by Rachel Sachs (Academic Fellow Alumna)

Introduction: Recently, scholars and policymakers on both sides of the aisle have become interested in the legal and regulatory structures surrounding pharmaceutical approval and reimbursement in this… Read More

Drug Approval in a Learning Health System

Minnesota Law Review, 2018
by W. Nicholson Price

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

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

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

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

Defensive Medicine

National Bureau of Economic Research Working Paper Series , July 2018
by Michael D. Frakes (Former Academic Fellow) and Jonathan Gruber

From the abstract:  We estimate the extent of defensive medicine by physicians, embracing the no-liability counterfactual made possible by the structure of liability rules in the Military Heath System.… Read More

Medical Liability and Treatment Relationships

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

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

Bioethics and Public Health Law

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

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

Personhood Seeking New Life with Republican Control

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

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

The Health 202: This mother’s tweet about drug prices went viral. Trump’s plans are unlikely to help

Washington Post, July 24, 2018
by by Colby Itkowitz, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: “It’s going to take a lot of time and there's a lot of hurdles in the way, but that’s not what you want to explain when you want to show how you’re lowering… Read More

Unpacking the bold — and the bluster — in Trump’s plan to bring down drug prices

STAT, July 23, 2018
by by Erin Mershon, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: The administration says the proposal will save Medicare money, which could translate into lower premiums. It will also mean lower co-pays for any beneficiary who might need a new drug… Read More

The Trump administration finally has one good idea to lower drug prices

Vox, July 20, 2018
by by Dylan Scott, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: Right now, in the above circumstances and when there isn’t an actual drug shortage, “we don’t have a good policy solution,” Scott Gottlieb, the FDA commissioner,… Read More

Update: UK Ministers Quit Over Brexit

BBC, July 9, 2018
by Interview featuring Rachel Sachs (Academic Fellow Alumna)

From the interview: We consider the implications for Brexit as two senior UK ministers resign. David Henig is UK director of the European Centre For International Political Economy. He explains why this… Read More

HHS forced to choose migrants over medicines

Politico, July 18, 2018
by By Dan Diamond, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: Echoing the pharma industry, Verma stressed that the state's request violated current law — the first time she's publicly cited a legal defense. “f you want to go… Read More

What Pfizer, Trump, and consumers got out of a surprising deal — and what they didn’t

STAT, July 11, 2018
by By Erin Mershon and Ike Swetlitz, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: After months of pledging he would get pharmaceutical companies to lower their prices, President Trump can now say that he pressed the CEO of a major drug maker, Pfizer, to back… Read More

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

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

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

The News on Drug Prices? Nothing Good

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

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

Pro-ACA group: Court pick Kavanaugh refused to uphold pre-existing condition ban

PolitiFact, July 18, 2018
by By Jon Greenberg, quoting Allison K. Hoffman (Academic Fellow Alumna)

From the article: For the makers of the ad, this is very simple. "Two judges upheld the Affordable Care Act and its patient protections, and he declined to uphold it," Demand Justice executive director… Read More

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

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

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

Fox News pundit says Brett Kavanaugh is pro-Obamacare. Is he?

PolitiFact, July 11, 2018
by By Jon Greenberg, quoting Allison K. Hoffman (Academic Fellow Alumna)

From the article: In the 2011 case, Blumstein said Kavanaugh showed "a traditional norm of judicial restraint." Mark Hall at Wake Forest University echoed that point. He sees Kavanaugh’s opinions… Read More

As Arkansas ushers in new Trump-era Medicaid rules, thousands fear losing benefits

Reuters, July 10, 2018
by By Yasmeen Abutaleb, quoting Allison K. Hoffman (Academic Fellow Alumna)

From the article: Days after the ruling, Kentucky Governor Matt Bevin cut dental and vision benefits for some 460,000 state Medicaid recipients, saying the benefits were dependent on implementation of… Read More

Abortion row reignites as US Supreme Court justice retires

The Citizen, June 29, 2018
by By AFP, quoting Allison K. Hoffman (Academic Fellow Alumna)

From the article: Allison Hoffman, a law professor at the University of Pennsylvania, says many Supreme Court decisions that fell short of a full repeal of Row vs Wade have nevertheless eroded women’s… Read More

Understanding the Development Challenges Associated with Emerging Non-Traditional Antibiotics

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

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

“What Is PER?” Patient Engagement in Research as a Hit

Canadian Journal of Bioethics / Revue canadienne de bioéthique, July 6, 2018, Vol 1, Issue 2
by By Jean-Christophe Bélisle-Pipon (Visiting Researcher), Claudio Del Grande, and Geneviève Rouleau

From the paper: Engaging patients in research conduct and agenda setting is increasingly considered as an ethical imperative, and a way to transcend views of patients as passive subjects by fostering their… Read More

CMS quit test of pricey cancer treatment amid concerns over industry role

Politico, July 9, 2018
by By Sarah Karlin-Smith and David Pittman, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: “Coming from an administration which has a stated goal of trying to reduce drug pricing, trying to reduce overall drug spending and health care spending … at every turn this… Read More

Viagra goes up AGAIN

Daily Mail, July 2, 2018
by By Mia De Graaf, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: Economists are now calling on the Department of Health and Human Services to clarify what kind of measures they were planning on levying against companies that did not stick to the plan. … Read More

Regulation of Stem Cell Therapy Travel

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

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

Tempering Expectations of Breakthrough Therapy Designated Drugs

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

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

Legislative Attorney (Health Law)
Congressional Research Service (CRS), American Law Division (ALD)

Deadline: Open until filled.

General Description The Congressional Research Service (CRS), American Law Division (ALD), seeks a Legislative Attorney to analyze legal questions that emerge from the work of Congress related to health… Read More

Medical Legal Partnership Research Associate
Solomon Center for Health Law and Policy at Yale Law School

Deadline: Open until filled.

General Description The Solomon Center for Health Law and Policy at Yale Law School seeks applications for a quantitative research associate to contribute to a critical gap in the legal and biomedical… Read More

Call for Proposals Enforcement, Litigation, and Compliance Conference
Food and Drug Law Institute

Deadline: August 09, 2018

The annual Enforcement, Litigation, and Compliance Conference brings together industry, regulators, attorneys, litigators, academics, and consultants to discuss trends and issues in enforcement and compliance,… Read More

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

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

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

Building Capacity for a Global Genome Editing Observatory: Institutional Design

Trends in Biotechnology, June, 2018
by Krishanu Saha, J. Benjamin Hurlbut,Sheila Jasanoff,Aziza Ahmed, Anthony Appiah, Elizabeth Bartholet [...] I. Glenn Cohen (Faculty Director)[...]

Complete author list: Krishanu Saha, J. Benjamin Hurlbut, Sheila Jasanoff, Aziza Ahmed, Anthony Appiah, Elizabeth Bartholet,  Françoise Baylis, Gaymon Bennett, George Church, I. Glenn Cohen, George… Read More

On the Human Right to Health

Human Rights, Democracy, and Legitimacy in a World of Disorder , 2018
by I. Glenn Cohen (Faculty Director)

Faculty Director I. Glenn Cohen has written a chapter in the fortchoming book "Human Rights, Democracy, and Legitimacy in a World of Disorder," (Cambridge University Press, edited by Silja… Read More

Precision Medicines Approved More Quickly, With Less Data

MedPage Today, May 25, 2018
by Shannon Firth, quoting Jonathan J. Darrow (Student Fellow Alumnus)

From the article: Pivotal trials for precision medicines were scarcer, less likely to be controlled or blinded, and had fewer participants than those for other agents, the study found.  The less rigorous… Read More

JAMA Forum: The Risks and Benefits of Expedited Drug Reviews

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

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

Health Insurance’s Secondary Cost Problem

Harvard Law & Policy Review, Forthcoming
by Matthew J.B. Lawrence (Academic Fellow Alumnus)

From the abstract: This Article identifies a fundamental problem with health insurance and, so, contemporary American health care. While competition pushes health insurers to minimize the primary costs… Read More

Trump unveils plan to cut drug prices

The Lancet, June 2, 2018, vol. 391, no. 10136
by Susan Jaffe, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: A trade association that represents PBMs disagrees. Eliminating rebates would leave patients and insurers “at the mercy of drug manufacturer pricing strategies”, according… Read More

Is Trump giving the EU higher drug prices too?

DW, June 1, 2018
by Lindsey Rae Gjording, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: Through single-payer health care systems the EU is able to regulate consumer costs at reasonable levels. It also makes decisions about what new drugs are worth spending taxpayer money… Read More

Trump Wants Medicaid to Push for Lower Drug Prices – But Will Patients Be Hurt?

PEW, May 30, 2018
by Michael Ollove, quoting Rachel Sachs (Academic Fellow Alumna)

From the article: While 74 percent of closed formularies result in lower prices, 21 percent result in price increases, a 2016 report in the American Journal of Managed Care found. And 29… Read More

Vermont legislators pass a drug importation law. So what?

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

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

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

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

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

Pro-life groups cheer Supreme Court’s refusal to hear medication-induced abortion ban in Arkansas

The Washington Times, May 29, 2018
by Alex Swoyer, quoting I. Glenn Cohen (Faculty Director)

From the article: Planned Parenthood of Arkansas and Eastern Oklahoma sued, arguing the law would halt operations at two of the state’s remaining three abortion clinics. The organization said that… Read More

Facebook’s Health Groups Offer A Lifeline, But Privacy Concerns Linger

Huffington Post, May 28, 2018
by Sarah Elizabeth Richards, quoting I. Glenn Cohen (Faculty Director)

From the article: It’s impossible to expect a true sense of privacy among 55,000 people, but users and bioethicists alike have lingering questions about Facebook’s use of data. “How much… Read More

HIPAA and Protecting Health Information in the 21st Century

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

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

Call for Proposals
Policies for Action: Policy and Law Research to Build a Culture of Health

Deadline: June 07, 2018 3:00 PM

General Description Approximately $2.0 million will be awarded through P4A's 2018 CFP, which includes approximately $1,550,000 total for the general CFP, and $450,000 set aside for pre-emption-focused… Read More

Center for Public Health Law Research Fellow
Center for Public Health Law Research, Temple University

Deadline: Open until filled.

General Description The Center for Public Health Law Research (CPHLR) supports the widespread adoption of scientific tools and methods for mapping and evaluating the impact of law on health. The Center… 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

The Ethics of Medicaid’s Work Requirements and Other Personal Responsibility Policies

JAMA, May 7, 2018
by Harald Schmidt and Allison K. Hoffman (Academic Fellow Alumna)

From the paper:  Breaking controversial new ground, the Centers for Medicare & Medicaid Services (CMS) recently invited states to consider establishing work requirements as a condition of receiving… Read More

Grants

Berkeley Technology Law Journal, May 10, 2018
by W. Nicholson Price II (Academic Fellow Alumnus)

From the paper: Innovation is a primary source of economic growth, and is accordingly the target of substantial academic and government attention. Grants are a key tool in the government’s arsenal… 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

Work Requirements Give Republicans Cover to Expand Medicaid

U.S. News, April 23, 2018
by Gabrielle Levy, quoting Allison K. Hoffman (Academic Fellow Alumna)

From the article: While the Medicaid law sets certain mandatory minimums of eligibility and coverage, the waiver program allows states wide latitude to run their programs as they see fit. For state Republican… Read More

HealthAffairs Podcast: Precision Medicine

Health Affairs Podcast, May 8, 2018
by Jonathan J. Darrow (Student Fellow Alumnus), Alan Weil, Geoffrey Ginsburg, Alessandro Blasimme, Kathryn A. Phillips, Daryl Pritchard,

Overview of the Podcast: The May 2018 issue of Health Affairs on "Precision Medicine," contains a timely and comprehensive look at the use of data and genetic information to better diagnose and treat patients.… Read More

Planned Parenthood sues Trump administration over federal funding

The Washington Times, May 2, 2018
by Alex Swoyer, quoting I. Glenn Cohen (Faculty Director)

From the article: Three Planned Parenthood affiliates sued Wednesday to demand taxpayer money keep flowing to the country’s largest abortion network, saying a new Trump administration policy… Read More

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

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

From the article: It was 2015 when Martin Shkreli, then CEO of Turing Pharmaceuticals and the notorious “pharma bro,” jacked up the cost of the lifesaving drug Daraprim by 5,000 percent. Overnight,… Read More

Addressing Financial Barriers to Enrollment in Clinical Trials

JAMA Oncology, April 19, 2018
by Emily A. Largent and Holly Fernandez Lynch (Former Executive Director)

From the article: Shortfalls in clinical trial recruitment and retention constitute a major obstacle to scientific advancement. One means of increasing patient participation rates is to reduce associated… Read More

The FDA Breakthrough-Drug Designation — Four Years of Experience

The New England Journal of Medicine, April 12, 2018
by Jonathan J. Darrow (Student Fellow Alumnus), Jerry Avorn, and Aaron S. Kesselheim,

This article is behind a paywall. Harvard affiliates can access the full text via Hollis +. From the article: In 2012, Congress created the “breakthrough therapy” designation to expedite Food… Read More

THE PRICE OF VACCINES MUST BE DISCLOSED, ORDERS A COURT

La Presse, April 19, 2018
by Marie-Claude Malboeuf, Suit brought by Jean-Christophe Belisle Pipon (Visiting Researcher)

From the article: Pharmaceutical companies doing business with the government will no longer be able to hide how much money they are getting to provide vaccines. This is what the Commission for Access… Read More

Move over right-to-try: FDA looks at improving clinical trial enrollment

Politico, April 16, 2018
by Sarah Karlin-Smith, quoting Jonathan J. Darrow (Student Fellow Alumnus)

From the article: The FDA’s bar for “breakthrough” designation may be too low, Harvard Medical School policy researchers argue in the New England Journal of Medicine. The designation… 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

Is the ‘Breakthrough Therapy’ Process Putting Dangerous Drugs on Store Shelves?

Healthline, April 17, 2018
by Shawn Radcliffe, quoting Jonathan J. Darrow (Student Fellow Alumnus)

From the article: A CNN report last week detailed the deaths of more than 700 patients prescribed an antipsychotic therapy drug for Parkinson’s disease. The Food and Drug Administration… Read More

Is FDA breakthrough therapy really valuable?

Genet, April 13, 2018
by Liu Xuan Tong, quoting Jonathan J. Darrow (Student Fellow Alumnus)

From the article: In the recent New England Journal of Medicine, articles published by Harvard University's Jonathan Darrow, Jerry Avorn, and Aaron Kesselheim point out many of the issues arising from… Read More

When ‘Breakthrough’ Drugs Aren’t Actually Breakthroughs: FDA’s Approval Pathway Can Be Misleading

Kaiser Health News, April 12, 2018
by KHN Morning Briefing, quoting Jonathan J. Darrow (Student Fellow Alumnus)

From the article: In a review of three years of drugs approved by the Food and Drug Administration under a “breakthrough therapy” pathway, researchers argue that some of the compounds are not… Read More

Does the FDA’s ‘breakthrough’ drug program need to be reformed? Harvard skeptics say yes

Endpoint News, April 12, 2018
by John Carroll, quoting Jonathan J. Darrow (Student Fellow Alumnus)

From the article: Of all the expedited review programs that the FDA has set up, none are as popular as the “breakthrough” therapy designation. And a group of high-profile skeptics says that… Read More

Senior Fellow, Solomon Center for Health Law and Policy
Yale Law School

Deadline: April 15, 2018

General Description: Solomon Center for Health Law and Policy at Yale Law School is seeking to hire a recent J.D. to serve as a Senior Fellow for the center beginning in the summer… Read More

Why Scott Gottlieb is the one Trump official everybody seems to like

Vox, April 11, 2018
by Julia Belluz, German Lopez, and Dylan Scott , quoting Rachel Sachs (Academic Fellow Alumna)

From the article: When Scott Gottlieb was appointed commissioner of the Food and Drug Administration last May, some were concerned he’d be a shill for the pharmaceutical industry.… Read More

CALL FOR APPLICATIONS! 2018-2019 Petrie-Flom Center Student Fellowship

Petrie-Flom Center, Harvard Law School, August 10, 2018

Please note that this call for applications is closed: The deadline was August 10, 2018. What do a MacArthur Genius award winner, several health law professors at top schools, executive directors… Read More

FDA-designated ‘breakthrough’ therapies may not actually be scientific breakthroughs

Stat, April 11, 2018
by Ike Swetlitz, quoting Jonathan J. Darrow (Student Fellow Alumnus)

From the article: WASHINGTON — In a review of three years of drugs approved by the Food and Drug Administration under a “breakthrough therapy” pathway, researchers argue that some of… Read More

US FDA’s Breakthrough Program Needs Higher Standard For Comparators, NEJM Says

Pink Sheet, April 11, 2018
by Michael Cipriano, quoting Jonathan Darrow (Student Fellow Alumnus)

This article is behind a paywall. Readers will have to pay for full access to the article.  Executive Summary Harvard Medical School researchers call for inclusion of off-label drugs, accelerated… Read More