public static function News, Resources, and Events Tagged "Regulation" | 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

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

Genetically Modified People Are Walking Among Us

New York Times, December 1, 2018
by Carl Zimmer, quoting I. Glenn Cohen (Faculty Director)

From the article: Like the New Jersey fertility doctors before him, Dr. He was roundly condemned for his secretive recklessness. The organizers of the Hong Kong meeting issued a statement Thursday calling… 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

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

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

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

Overshadowed By Opioids, Meth Is Back And Hospitalizations Surge

Kaiser Health News, November 26, 2018
by Anna Gorman

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

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

NPR, November 26, 2018
by Mara Gordon

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

FDA plans overhaul of decades-old medical device system

STAT, November 26, 2018
by Associated Press

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

EXCLUSIVE: Chinese scientists are creating CRISPR babies

MIT Tech Review, November 25, 2018
by Antonio Regolado

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

Overdoses, bedsores, broken bones

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

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

Your Medical Devices Are Not Keeping Your Health Data to Themselves

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

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

Losing Embryos, Finding Justice

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

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

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

Forbes, November 19, 2018
by Bruce Japsen

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

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

Machine learning in medicine: Addressing ethical challenges

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

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

Canada debates assisted death laws after woman is forced to end life early

The Guardian, November 6, 2018
by Leyland Cecco

For weeks, Audrey Parker had been organizing what she called her “beautiful death”, carefully planning every detail of her final days, and even writing her own obituary. Parker, a television… 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

Consortium Seeks to Evaluate, Enhance HRPP Effectiveness

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

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

​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

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

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

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

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

Trump Administration Wants TV Drug Ads To Include A Price

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

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

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

Rachel Sachs of Washington University on the USMCA

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

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

Requiring Price Info in Drug Ads May Strain Agency Authority

Bloomberg Law, October 17, 2018
by Dana A. Elfin, quoting Rachel Sachs

From the article: “I’m skeptical of HHS’ arguments that [the Center for Medicare and Medicaid Services] has the authority to issue this reg,” Rachel Sachs, associate professor of… Read More

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

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

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

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

Politico, October 15, 2018
by Sarah Karlin-Smith

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

Controversial former aide to Maine’s LePage to run Medicaid

Politico, October 15, 2018
by Dan Diamond and Brianna Ehley

The Trump administration has tapped Mary Mayhew — the architect of Maine's aggressive conservative reforms to the social safety net — to oversee the national Medicaid program. She has been… Read More

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

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

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

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

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

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

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

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

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

Drugmakers may have to disclose prices of medicine in television ads

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

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

Drugmakers may have to disclose prices of medicine in television ads

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

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

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

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

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

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

U.K. Appoints Minister for Suicide Prevention

New York Times, October 10, 2018
by Ceylan Yeginsu

LONDON — Months after appointing its first minister for loneliness, Britain named a minister for suicide prevention as part of a new push to tackle mental health issues. Prime Minister… Read More

DOJ Clears CVS-Aetna Deal Once Medicare Drug Plans Are Unloaded

Forbes, October 10, 2018
by Bruce Japsen

The U.S. Justice Department Wednesday agreed to allow CVS Health's acquisition of health insurance giant Aetna once Aetna's Medicare Part D prescription drug plan business for individuals… 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

FDA Carts Away Thousands Of Documents After Surprise Inspection Of Juul Headquarters

Kaiser Health News, October 3, 2018

KHN Morning Briefing: Summaries of health policy coverage from major news organizations Juul has come under fire recently as more and more young people turn to e-cigarettes as an alternative to traditional… Read More

When Your Dreams of Motherhood Are Destroyed

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

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

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

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

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

When Markets Fail: Patents and Infectious Disease Products

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

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

Gilead to launch authorized generics of two HCV drugs

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

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

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

E.P.A. Places the Head of Its Office of Children’s Health on Leave

New York Times, September 26, 2018
by Coral Davenport and Roni Caryn Rabin

WASHINGTON — The Environmental Protection Agency on Tuesday placed the head of its Office of Children’s Health Protection on administrative leave, in an unusual move that several observers… Read More

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

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

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

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

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

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

Trump administration launches review of scientific research involving fetal tissue

STAT, September 25, 2018
by Megan Thielking

The Trump administration has launched a comprehensive review of all research that involves fetal tissue, reopening an issue that has galvanized anti-abortion activists but worried scientists who fear… 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

The Ethics of Smart Pills and Self-Acting Devices

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

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

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

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

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

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

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

Watchdog slams safeguards for foster kids on psych drugs

AP News, September 17, 2018
by Ricardo Alonso-Zaldivar

WASHINGTON (AP) — Thousands of foster children may be getting powerful psychiatric drugs prescribed to them without basic safeguards, says a federal watchdog agency that found a failure to care for… 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

Gottlieb pitches ‘subscriptions’ to incentivize pharma to make new antibiotics

STAT, September 14, 2018
by Ike Swetlitz

ASHINGTON — The Food and Drug Administration is talking with other federal agencies and even the private Bill and Melinda Gates Foundation about new ways to encourage drug makers to develop more antibiotics,… Read More

How the Centers for Disease Control and Prevention responds to a hurricane like Florence

LA Times, September 14, 2018
by Melissa Healy

For all the political chatter about the human toll of hurricanes, one lesson of past monster storms is clear and increasingly urgent: Hurricanes claim lives and erode health before, during and after the… Read More

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

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

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

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

Are Fraud and Abuse Laws Stifling Value-Based Care?

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

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

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

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

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

A Dangerous Brain

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

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

How Regulation Can Improve Surgery

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

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

Petrie-Flom Welcomes New Precision Medicine Fellow!

Petrie-Flom Center, August 16, 2018

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

We Have to Be Smart About Artificial Intelligence in Medicine

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

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

Drug Pricing Policy

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

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

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

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

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

Perspective: Will Courts Allow States to Regulate Drug Prices?

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

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

Report blames gaming of patent system for high drug prices

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

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

CMS’ plan to lower drug spending in Medicare Advantage

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

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

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

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

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

Administering Health Innovation

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

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

Drug Approval in a Learning Health System

Minnesota Law Review, 2018
by W. Nicholson Price

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

Drug Approval in a Learning Health System

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

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

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

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

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

Patent term restoration for top-selling drugs in the USA

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

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

Medical Liability and Treatment Relationships

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

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

Bioethics and Public Health Law

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

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

Personhood Seeking New Life with Republican Control

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

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

Moratoria and Innovation in the Reproductive Sciences

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

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

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

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

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

The News on Drug Prices? Nothing Good

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

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

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

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

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

Understanding the Development Challenges Associated with Emerging Non-Traditional Antibiotics

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

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

Regulation of Stem Cell Therapy Travel

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

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

Tempering Expectations of Breakthrough Therapy Designated Drugs

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

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

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

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

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

JAMA Forum: The Risks and Benefits of Expedited Drug Reviews

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

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

Vermont legislators pass a drug importation law. So what?

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

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

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

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

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

HIPAA and Protecting Health Information in the 21st Century

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

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

Trump official on defensive as critics scoff at drug plan

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

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

Trump spoke on lowering drug prices. The tweets rolled in

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

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

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

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

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

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

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

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

Circumvention Medical Tourism and Cutting Edge Medicine

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

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

How to Make a Dent in Crazy-High Drug Prices

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

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

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

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

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

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

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

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

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

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

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

What your government can’t tell you about drug prices

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

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

Vaccine against Meningitis

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

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

Supreme Court rules that patent reviews detested by pharma are constitutional

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

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

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

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

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

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

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

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

Assessing the FDA’s Breakthrough Drug Program After Six Years

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

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

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

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

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

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

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

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

The Work of the Supreme Court

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

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

Prevalence of Publicly Available Expanded Access Policies

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

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

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

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

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

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

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

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

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