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

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

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

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

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

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

Congressional Clock Is Ticking On Efforts To Shore Up Obamacare Insurance Markets

Kaiser Health News, August 18, 2017

KHN Morning Briefing: Summaries of health policy coverage from major news organizations Though some senators say they are cautiously optimistic, it is not yet clear if lawmakers will be able to reach… Read More

A Cancer Conundrum

New York Times, August 18, 2017
by Gina Kolata

With the arrival of two revolutionary treatment strategies, immunotherapy and personalized medicine, cancer researchers have found new hope — and a problem that is perhaps unprecedented in medical… Read More

India threatens Philip Morris with ‘punitive action’ over alleged violations

Reuters, August 18, 2017
by Aditya Kalra

NEW DELHI (Reuters) - The Indian government has threatened Philip Morris International Inc with "punitive action" over the tobacco giant's alleged violation of the country's anti-smoking laws,… Read More

Trump Threat to Obamacare Would Send Premiums and Deficits Higher

New York Times, August 15, 2017
by Robert Pear and Thomas Kaplan

WASHINGTON — Premiums for the most popular health insurance plans would shoot up 20 percent next year, and federal budget deficits would increase by $194 billion in the coming… Read More

Trump Administration Extends Deadline For Insurers To Decide On Obamacare Markets

NPR, August 14, 2017
by Alison Kodjak

The Trump administration is giving insurance companies an extra three weeks to decide whether to offer insurance plans through the Affordable Care Act markets, and how much to charge. The extension comes… Read More

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

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

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

Administering Health Innovation

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

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

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

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

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

Massachusetts Officials Take Control Of Health Insurance Co-Op Formed By ACA

Kaiser Health News, August 4, 2017

KHN Morning Briefing: Summaries of health policy coverage from major news organizations Minuteman Health Inc., which served customers in Massachusetts and New Hampshire, was one of the small customer-owned… Read More

Senate Passes F.D.A. Funding and ‘Right to Try’ Drug Bills

New York Times, August 3, 2017
by Robert Pear and Sheila Kaplan

WASHINGTON — The Senate on Thursday gave final approval to legislation to finance the Food and Drug Administration, clearing the measure for President Trump and tapping drug manufacturers once… Read More

To Grow Market Share, A Drugmaker Pitches Its Product To Judges

NPR, August 3, 2017
by Jake Harper

[...] More than 130,000 Americans will go through drug courts this year, according to the National Association of Drug Court Professionals. Drug courts are designed to allow some people whose crimes stem… Read More

Major Gene Editing Breakthrough Raises Concerns About Ethics Of ‘Designer Babies’

Kaiser Health News, August 3, 2017

KHN Morning Briefing: Summaries of health policy coverage from major news organizations For the first time, scientists have edited genes in embryos to fix a disease-causing mutation. The milestone… Read More

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

Dickinson Law, Penn State University, August 1, 2017

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

Maine Raises Smoking Age to 21 After Lawmakers Override Veto

New York Times, August 2, 2017
by Matthew Haag

Maine will become the fourth state to raise the smoking age to 21 and will adopt stricter regulations on the sale of electronic cigarettes after lawmakers on Wednesday voted overwhelmingly to override… Read More

Senators To Hold Bipartisan Hearings To Try To Protect Insurer Subsidies Threatened By Trump

Kaiser Health News, August 2, 2017

KHN Morning Briefing: Summaries of health policy coverage from major news organizations The Senate Committee on Health, Education, Labor and Pensions will hold sessions beginning the week of Sept.… Read More

States Allowed To Intervene Over Federal Subsidy Payments Case, Court Of Appeals Rules

Kaiser Health News, August 2, 2017

KHN Morning Briefing: Summaries of health policy coverage from major news organizations The case, which dates back to the Obama administration, was filed by the Republican-led House against the government… Read More

Insurer Subsidies Provide Trump With Powerful Tool He’s Not Hesitating To Wield

Kaiser Health News, August 1, 2017

KHN Morning Briefing: Summaries of health policy coverage from major news organizations If President Donald Trump cut off the subsidy payments to insurers, which he can decide to do, it would devastate… Read More

White House not letting go of Obamacare repeal

Politico, July 31, 2017
by Burgess Everett and Josh Dawsey

The White House is trying to rebuild momentum for Obamacare repeal after it stalled, yet again, in the GOP Senate last week. Sen. Bill Cassidy (R-La.) met Monday with top aides to President Donald Trump… Read More

Trump’s Opioid Commission Calls for a State of Emergency

The Atlantic, July 31, 2017
by Olga Khazan

A government opioid commission chaired by New Jersey Governor Chris Christie has called for President Trump to declare a state of emergency in dealing with the opioid epidemic, which now kills more… Read More

How to Repair the Health Law (It’s Tricky but Not Impossible)

New York Times, July 29, 2017
by Reed Abelson, Abby Goodnough, and Katie Thomas

Republicans have failed to repeal and replace the Affordable Care Act. Now, can it be repaired? The seven-year-old law has survived Supreme Court decisions and aggressive attempts to extinguish it by Republicans… Read More

F.D.A. Delays Rules That Would Have Limited E-Cigarettes on Market

New York Times, July 28, 2017
by Sheila Kaplan

Electronic-cigarette makers won a major reprieve on Friday when the Food and Drug Administration delayed regulations that could have removed many of their products from the market and opened the door to… Read More

FDA Announces Plan To Cut Level Of Nicotine Allowed In Cigarettes

NPR, July 28, 2017
by Rob Stein and Robert Siegel

The Food and Drug Administration is proposing sweeping changes to how it regulates cigarettes and related products, including e-cigarettes. One big change: It's planning to reduce the amount of nicotine… Read More

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

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

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

McCain Rejects ‘Skinny Plan’ And Helps Derail GOP’s Repeal Efforts In Stunning Late-Night Vote

Kaiser Health News, July 28, 2017

KHN Morning Briefing: Summaries of health policy coverage from major news organizations The so-called "skinny plan" kept most of the Affordable Care Act in place, only rolling back some provisions… Read More

China and India File Rival Claims Over Tibetan Medicine

New York Times, July 27, 2017
by Mike Ives

HONG KONG — China and India have jockeyed for centuries over the Himalayas. The Chinese military invaded Tibet in 1950. India granted asylum to the Dalai Lama, the Tibetan spiritual… Read More

Hospitals Face Growing Cybersecurity Threats

NPR, July 26, 2017
by Lauren Silverman

In the neonatal intensive care unit of Cook Children's Hospital in Fort Worth, Texas, a father is rocking a baby attached to a heart monitor. While doctors roam the halls trying to prevent infections,… Read More

AP Interview: China to lead in organ transplants by 2020

ABC News, July 26, 2017
by Christopher Bodeen, AP

China is on track to lead the world in organ transplant surgeries by 2020 following its abandonment of the much-criticized practice of using organs from executed prisoners, the architect of the country's… Read More

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

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

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

Celgene to Pay $280 Million to Settle Fraud Suit Over Cancer Drugs

New York Times, July 25, 2017
by Katie Thomas

The pharmaceutical company Celgene has agreed to pay $280 million to settle claims that it marketed the cancer drugs Thalomid and Revlimid for unapproved uses, the company said on Tuesday.… Read More

Senate Parliamentarian Tosses Another Roadblock Onto Already Bumpy Path To Health Vote

Kaiser Health News, July 24, 2017

KHN Morning Briefing: Summaries of health policy coverage from major news organizations Senate parliamentarian Elizabeth MacDonough says Republicans would need 60 votes to maintain abortion-related… Read More

DEA solicited applications to grow marijuana for research. It hasn’t approved one

STAT, July 24, 2017
by Andrew Joseph

Almost a year after the Drug Enforcement Administration announced it would consider granting additional licenses to cultivate cannabis for research purposes — and despite drawing… Read More

NHS set to ban homeopathy for patients because it is ‘not evidence based [...]’

Independent, July 21, 2017
by Katie Forster

Doctors should stop prescribing homeopathic medicine to NHS patients, the health service has said. The change has been proposed because "at best, homeopathy is a placebo and a misuse… Read More

A Drug Maker Spends Big in Washington to Make Itself Heard

New York Times, July 21, 2017
by Jay Hancock, Elizabeth Lucas, and Sydney Lupkin

[...] This year, the company left the industry trade group Pharmaceutical Research and Manufacturers of America, or PhRMA, after the group threatened to kick out companies that did not spend enough… Read More

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

Petrie-Flom Center, July 21, 2017

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

Open Burns, Ill Winds

ProPublica, July 20, 2017
by Abraham Lustgarten

[...] More than three decades ago, Congress banned American industries and localities from disposing of hazardous waste in these sorts of “open burns,’’ concluding that such uncontrolled… Read More

Unapproved stem-cell treatments touted on federal database ClinicalTrials.gov, study says

Washington Post, July 19, 2017
by Laurie McGinley

Stem cell clinics offering unapproved treatments for ailments from hip pains to autism to erectile dysfunction increasingly are using a federal clinical-trials database as a marketing tool — a strategy… Read More

Public Participation in Drafting of the 21st Century Cures Act

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

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

Trump administration suddenly pulls plug on teen pregnancy programs

Reveal, from the Center for Investigative Reporting, July 14, 2017
by Jane Kay

The Trump administration has quietly axed $213.6 million in teen pregnancy prevention programs and research at more than 80 institutions around the country, including Children’s Hospital of Los Angeles… Read More

Transgender Health Care Targeted In Crusade To Undo ACA

Kaiser Health News, July 13, 2017
by Shefali Luthra

[...] Before the ACA, Medicaid operated under its own anti-discrimination requirements. However, many state programs were vague in describing gender-transition benefits. This made it difficult for… Read More

Exclusive: Documents reveal Philip Morris’ campaign to subvert the world’s anti-smoking treaty

Reuters, July 13, 2017
by Aditya Kalra, Paritosh Bansal, Duff Wilson and Tom Lasseter

NEW DELHI/LAUSANNE, Switzerland (Reuters) - Philip Morris International Inc (PM.N) is waging a secret campaign to subvert the World Health Organization's anti-smoking treaty, which was designed to… Read More

Marijuana Shortage Prompts Emergency In Nevada; Tax Officials Weigh Changes

NPR, July 12, 2017
by Bill Chappell

Sales of recreational marijuana have blown past expectations in Nevada, threatening to leave some dispensaries with empty shelves. After Gov. Brian Sandoval endorsed a statement of emergency in the first… Read More

Your Credit Score Soon Will Get A Buffer From Medical-Debt Wrecks

Kaiser Health News, July 11, 2017
by Michelle Andrews

For many consumers, an unexpected health care calamity can quickly burgeon into a financial calamity. Just over half of all the debt that appears on credit reports is related to medical expenses,… Read More

F.D.A. Deal Would Relax Rules on Reporting Medical Device Problems

New York Times, July 11, 2017
by Sheila Kaplan

WASHINGTON — Makers of cardiac defibrillators, insulin pumps, breast implants and other medical devices might be able to delay reporting dangerous malfunctions to the Food and Drug Administration… Read More

Georgia’s Health Commissioner Named to Lead C.D.C.

New York Times, July 7, 2017
by Sheila Kaplan

The Trump administration on Friday named Dr. Brenda Fitzgerald, the public health commissioner of Georgia, as the head of the Centers for Disease Control and Prevention, the nation’s top… Read More

To solve organ shortage, states consider ‘opt-out’ organ donation laws

STAT, July 6, 2017
by Leah Samuel

The shortage of organs for transplantation is a thorny problem. Nearly 118,000 people in the U.S. are on waiting lists for transplants of kidneys, hearts, livers, and other organs; an estimated… Read More

Trump’s Surgeon General Pick Built Name Fighting HIV And Opioids In Indiana

Kaiser Health News, July 7, 2017
by Emily Forman

Several weeks before President Donald Trump nominated Indiana’s state health commissioner Jerome Adams to be the next U.S. surgeon general, Adams toured the Salvation Army Harbor Light… Read More

John Morgan sues state for blocking the smoking of medical marijuana

Miami Herald, July 6, 2017
by Mary Ellen Klas

TALLAHASSEE -- Arguing that Florida legislators violated voters’ intent when they prohibited smoking for the medical use of marijuana, the author of the state’s medical marijuana amendment… Read More

Opioid prescribing is falling in the US, but not everywhere

ABC News, July 6, 2017
by Mike Stobbe

Overall opioid prescription rates have been falling in recent years, but the powerful drugs have become more plentiful in more than than 1 in 5 U.S. counties, a report released Thursday finds. The amount… Read More

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

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

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

Women graduates ‘desperately’ freeze eggs over ‘lack of men’

BBC News, July 5, 2017

Professional women are freezing their eggs due to a "dearth of educated men to marry", a US study has claimed. Yale University researchers suggested an "oversupply" of graduate women left them struggling… Read More

As Seniors Get Sicker, They’re More Likely To Drop Medicare Advantage Plans

National Public Radio, July 5, 2017
by Fred Shulte

When Sol Shipotow enrolled in a new Medicare Advantage health plan earlier this year, he expected to keep the doctor who treats his serious eye condition. "That turned out not to be so," said Shipotow,… Read More

British baby at end of life support draws in pope, Trump

Washington Post, July 4, 2017
by Danica Kirka and Nicole Winfield

LONDON — A terminally ill British child has attracted the attention of both the president of the United States and the pope. More than 1.3 million pounds ($1.68 million) has been raised to help 11-month-old… Read More

Is Alcohol Good for You? An Industry-Backed Study Seeks Answers

New York Times, July 3, 2017
by Roni Caryn Rabin

It may be the most palatable advice you will ever get from a doctor: Have a glass of wine, a beer or a cocktail every day, and you just might prevent a heart attack and live longer. But the mantra that… Read More

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

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

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

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

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

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

Panel: Weighing the Risks of Randomized Controlled Trials and Alternatives

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

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

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

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

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

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

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

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

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

Deadline: Open until filled.

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

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

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

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

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

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

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

New Issue of the Journal of Law and the Biosciences

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Babies From Skin Cells? Prospect Is Unsettling to Some Experts

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

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

Harvard Study Looks At Ways NFL Can Bolster Player Health

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

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

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

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

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

Harvard’s Advice for NFL Player Health and Safety

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

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

Harvard study suggests some NFL health and safety changes

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

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

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

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

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

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

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

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

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

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

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

Promoting demand-side innovation: prizes for payers

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

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

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

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

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

Revised ‘Common Rule’ Shapes Protections For Research Participants

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

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

Value-Based Pricing For Pharmaceuticals In The Trump Administration

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

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

Should We Study Human Embryos Beyond 14 Days?

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

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

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

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

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

Nonexceptionalism, Research Risks, and Social Media

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

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

Science Needs Your Cells

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

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

Institutions as an Ethical Locus of Research Prioritisation

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

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

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

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

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

Congress and FDA nominee heap love on ‘adaptive trials’

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

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

Scott Gottlieb: Conflicts surround Trump’s FDA pick

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

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

ICER Weekly View 03-31-17

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

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

Anthem inches closer to full Obamacare exit

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

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

Price doesn’t satisfy Congress on appropriations

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

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

Scott Gottlieb’s FDA Commissioner Confirmation Hearing: Remarkably Unremarkable

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

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

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

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

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

(Health) Law and Order

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

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

An FDA Commissioner for the 21st Century

NEJM, March 29, 2017
by Amitabh Chandra and Rachel E. Sachs (Academic Fellow Alumna)

President Donald Trump has named Scott Gottlieb as his nominee to be the next commissioner of the Food and Drug Administration (FDA). As compared with some of the other people whose names were floated… Read More

Regulating Black-Box Medicine

Michigan Law Review, March 21, 2017
by W. Nicholson Price II (Academic Fellow Alumnus)

From the abstract: Data drive modern medicine. And our tools to analyze those data are growing ever more powerful. As health data are collected in greater and greater amounts, sophisticated algorithms… Read More

Addressing the ethical issues raised by synthetic human entities with embryo-like features

eLife, March 21, 2017
by John Aach, Jeantine Lunshof, Eswar Iyer, and George M. Church

On November 7, 2016, the Petrie-Flom Center hosted the conference "The Ethics of Early Embryo Research & the Future of the 14-Day Rule," which convened experts in bioethics, stem cell research,… Read More

The ethics of recruiting study participants on social media

Medical Xpress , March 16, 2017
by Heather Zeiger, citing Luka Gelinas (Fellow in Clinical Research Ethics)

From the article:  In the recent issue of the American Journal of Bioethics, the target article addresses the ethics of finding participants for clinical trials on social media sites. The authors,… Read More

UPCOMING! Annual Health Law Conference: Between Complacency & Panic

Northeastern University School of Law, April 14, 2017
by Holly Fernandez Lynch (Executive Director)

From the event:  Emerging infectious diseases (EIDs) such as Ebola and the Zika virus pose potentially grave threats to human health. They can also incite overreations that lead to the scapegoating… Read More

The Original Lie About Obamacare

New York Times, March 14, 2017
by David Leonhardt, quoting Michael Anne Kyle (Student Fellow Alumna)

From the article: At that point, Obama faced a second choice – between forging ahead with a substantively bipartisan bill and forgetting about covering the uninsured. The kumbaya plan for which pundits… Read More

Maryland Goes a Step Further to Rein in Drug Price Spikes

Regulatory Affairs Professionals Society (RAPS), February 27, 2017
by Zachary Brennan, citing Rachel E. Sachs (Academic Fellow Alumna)

[...] The bill has drawn criticism from industry groups and others who say such independent audits would be overly burdensome for industry and that the $2500 threshold might include too many drugs… Read More

The NFL Combine: Pro football’s intrusive, and mandatory, job interview

Washington Post, February 26, 2017
by Rick Maese, quoting Glenn Cohen (Faculty Director)

From the article: While there could be a gray area between tests that measure performance and those that examine health, Glenn Cohen, a Harvard law professor who co-authored the study, says the list of… Read More

Ethical Considerations for Zika Virus Human Challenge Trials

National Institute of Allergy and Infectious Diseases (NIAID) at NIH and the Walter Reed Army Institute of Research (WRAIR), February 2017
by Seema K. Shah, Jonathan Kimmelman, Anne Drapkin Lyerly, Holly Fernandez Lynch (Executive Director), et al.

From the report: Zika virus is an emerging infectious disease that was first identified in 1947, and that has more recently become a major public health threat around the world. Zika virus has recently… Read More

Lawmakers urge US Army not to issue exclusive license to Sanofi for a Zika vaccine

Stat, February 22, 2017
by Ed Silverman, quoting Rachel E. Sachs (Academic Fellow Alumna)

This article is behind a paywall. Read More

Express Scripts CEO addresses drug pricing ‘misinformation’

St. Louis Post-Dispatch, February 17, 2017
by Samantha Liss, quoting Rachel E. Sachs (Academic Fellow Alumna)

[...] Typically, after dispensing drugs to patients, a drug manufacturer will write Express Scripts a rebate check. That timing can expose some patients, especially those with high deductibles, to the… Read More

Why Did That Drug Price Increase 6,000%? It’s The Law

Forbes, February 10, 2017
by Matthew Herper, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Marathon is a member of the Pharmaceutical Research and Manufacturers of America (PhRMA), the drug industry trade group. Drug companies cannot use their usual argument of saying this… Read More

Trump’s ‘Two Out, One In’ Regulatory Policy May Apply to Some FDA Guidance

Regulatory Affairs Professionals Society (RAPS), February 6, 2017
by Zachary Brennan, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: As far as what existing regulations if repealed would be considered part of the “two out” part of the EO, OMB notes, “Any existing regulatory action that imposes… Read More

E&C delays vote on drug pricing bill

Politico, February 6, 2017
by Sarah Karlin-Smith, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: On cost: studies have found that it usually takes a handful of generic drugscompeting for market share for prices to drop. “You usually need to get to something like three or four… Read More

What You Don’t Know About the Cost of Grandma’s Prescription

Pacific Standard, February 3, 2017
by Carson Leigh Brown, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: To grapple with how and why the process works this way, we talked with Rachel Sachs, an associate professor of law at Washington University in St. Louis. Sachs studies how health… Read More

Common Rule Revisions: Impact of Public Comment, and What’s Next?

The Hastings Center Blog, February 8, 2017
by By Holly Fernandez Lynch (Executive Director), I. Glenn Cohen (Faculty Director) and Barbara E. Bierer

From the blog post: On January 19, the day the final revisions to the Federal Policy for the Protection of Human Subjects were published in the Federal Register, our essay “Public Engagement,… Read More

Advanced and end of life care: cautionary suggestions

Journal of Medical Ethics, February 7, 2017 (online)
by Frances Kamm (former Senior Fellow)

Abstract: This article considers some clinical and population level approaches to advanced care of chronic conditions and end of life care. One approach aims to follow patient values and preferences about… Read More

A New Day For Oversight Of Human Subjects Research

HealthAffairs, February 6, 2017
by Holly Fernandez Lynch (Executive Director)

Editor’s note: This post is part of a series stemming from the Fifth Annual Health Law Year in P/Review event held at Harvard Law School on Monday, January 23rd, 2017. The… Read More

What Experts in Law and Medicine Have to Say About the Cost of Drugs

The Health Care Blog, February 2, 2017
by Andy Oram, on PFC's 5th Annual Health Law Year in P/Review Conference

From the article; Pharmaceutical drug costs impinge heavily on consumers’ consciousness, often on a monthly basis, and have become such a stress on the public that they came up repeatedly among both… Read More

Traveling for Assisted Suicide

In Euthanasia and Assisted Suicide: Global Views on Choosing to End Life (Michael J. Cholbi, ed.), Praeger, 2017 (forthcoming)
by I. Glenn Cohen (Faculty Director)

This book addresses key historical, scientific, legal, and philosophical issues surrounding euthanasia and assisted suicide in the United States as well as in other countries and cultures. Euthanasia was… Read More

The Trump-era Supreme Court could erode abortion access with a ‘death by 1,000 cuts’

Business Insider, February 1, 2017
by Rebecca Harrington, quoting I. Glenn Cohen (Faculty Director)

From the article: Glenn Cohen, a health-law expert and professor at Harvard Law School, said two kinds of laws provide the most likely paths for SCOTUS to overturn or undermine Roe. The first are known… Read More

Trump’s travel ban rattles medical residency programs

Politico Pulse, January 31, 2017
by Dan Diamond, featuring blog post by Rachel Sachs (Academic Fellow alumna)

From the article: Trump's order on regulations is a 'terrible idea' for rulemaking. That's according to law professor Rachel Sachs, who uses the 21st Century Cures Act — which… Read More

Morning View 01-31-17

Institute for Clinical and Economic Review (ICER), January 31, 2017
by Mitchell Stein, featuring blog post by Rachel Sachs (Academic Fellow alumna)

From the article: The President issued an Executive Order basically saying that for every new regulation, two old regulations must be eliminated.  This order will have a significant impact on the… Read More

Vitals

Axios, January 31, 2017
by David Nather, featuring blog post by Rachel Sachs (Academic Fellow alumna)

From the article: The executive order could have an especially big impact on implementing the 21st Century Cures law, which just passed in the last Congress. Rachel Sachs, a health care legal expert at… Read More

Public Engagement, Notice-and-Comment Rulemaking, and the Common Rule

IRB: Ethics & Human Research, January-February 2017, Vol. 39, Issue 1
by Holly Fernandez Lynch (Executive Director), I. Glenn Cohen (Faculty Director), and Barbara E. Bierer

Abstract: At the federal level in the United States, development of regulations is governed by the Administrative Procedure Act (APA), the statute by which Congress authorized various federal agencies… Read More

Regulating Secrecy

Washington Law Review, 2016, Vol. 91, Nr. 4
by W. Nicholson Price II (Academic Fellow Alumnus)

Abstract: Inventors face a stark choice between two intellectual property systems of protecting innovative ideas: patents and trade secrecy. But accounts of this choice underexplore the role of the… Read More

Promoting healthcare innovation on the demand side

Journal of Law and the Biosciences, January 16, 2017 (online first)
by W. Nicholson Price II (Academic Fellow Alumnus) and Rebecca S. Eisenberg

Abstract: Innovation policy often focuses on fortifying the incentives of firms that develop and sell new products by offering them lucrative rights to exclude competitors from the market. Regulators also… Read More

A New Fertility Technique Could Make ‘Designer Babies’ a Reality

Gizmodo, January 13, 2017
by Kristen V. Brown, quoting I. Glenn Cohen (Faculty Director)

From the article: In vitro gametogenesis, or IVG, is a technique that could allow any kind of cell to be programmed into a sperm or an egg cell. This means, theoretically, that you could go on a terrible… Read More

Federal Circuit Court Appeal Cites Rachel E. Sachs

U.S. Court of Appeals for the Federal Circuit, January 13, 2017, No. 17-1480
by Paul D. Clement et al., citing work by Rachel E. Sachs (Academic Fellow Alumna)

No. 17-1480 UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT   AMGEN INC., AMGEN MANUFACTURING, LTD., and AMGEN USA, INC., Plaintiffs-Appellees, v. SANOFI, SANOFI-AVENTIS U.S. LLC, AVENTISUB… Read More

FDA Further Explains Delay on LDT Guidance

Regulatory Affairs Professionals Society, January 13, 2017
by Zachary Brennan, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Several praised the move to delay the final guidance, particularly as a new administration and Congress work with FDA and the Centers for Medicare & Medicaid Services (CMS) to… Read More

Regeneron CEO: Amgen’s disruptive Praluent-blocking patent move hurts patients

FiercePharma, January 10, 2017
by Carly Helfand, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article:  Now, Regeneron and Sanofi will ask the Federal Circuit “to quickly review if we can have a stay, and frankly, the merits of the entire case as quickly as possible,”… Read More

Could Amgen’s Patent Victory Be Bad For Medicine?

Forbes, January 6, 2017
by Matthew Herper, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Last night, in a nearly unprecedented move, a federal judge ordered a cholesterol medicine that is on the market and used by patients to be withdrawn because it infringes on the patents… Read More

How Donald Trump’s Health Secretary Pick Endangers Women

New York Times, December 28, 2016
by Allison K. Hoffman (Academic Fellow Alumna) and Jill R. Horwitz

LOS ANGELES — With the selection of Representative Tom Price as secretary of health and human services, President-elect Donald J. Trump has taken a giant step toward undermining the health… Read More

What’s Confusing Us About Mental Health Parity

HealthAffairs Blog, December 22, 2016
by Nathaniel Counts (Student Fellow alumnus), Timothy Clement, Amanda Mauri, Paul Gionfriddo, and Garry Carneal

The Mental Health Parity and Addiction Equity Act (MHPAEA) has been law since 2008. MHPAEA provided that health plans could not limit mental health or substance use disorder benefits in a way… Read More

The Legality of Biometric Screening of Professional Athletes

The American Journal of Bioethics , 2017, Vol. 17, Issue 1
by Jessica L. Roberts, I. Glenn Cohen (Faculty Director), Christopher R. Deubert (Senior Law & Ethics Associate) & Holly Fernandez Lynch (Executive Direc

From the article: In their thoughtful article, “Tracking U.S. Professional Athletes: The Ethics of Biometric Technologies,” Katrina Karkazis and Jennifer Fishman do an excellent job of outlining… Read More

Harnessing the U.S. Taxpayer to Fight Cancer and Make Profits

New York Times, December 19, 2016
by Matt Richtel and Andrew Pollack, quoting Rachel E. Sachs (Academic Fellow alumna)

From the article: Rachel Sachs, an associate law professor at Washington University in St. Louis and expert in innovation policy, said the government had every right to seek price concessions. She noted… Read More

The Oxford Handbook of U.S. Healthcare Law

The Oxford Handbooks, July 2016 (online), January 2017 (print)
by Edited by I. Glenn Cohen (Faculty Director), Allison K. Hoffman (Academic Fellow Alumna), and William M. Sage

Abstract: The Oxford Handbook of U.S. Health Law covers the breadth and depth of health law through the words and insights of the best scholars in the field. The content is valuable to readers with… Read More

What Health Reform Reveals about Health Law

In The Oxford Handbook of U.S. Healthcare Law, I. Glenn Cohen, Allison K. Hoffman, and William M. Sage, eds., July 2016 (online), January 2017 (print)
by Allison K. Hoffmann (Academic Fellow Alumna)

Chapter Abstract: This chapter describes the arc of health reform in the U.S. over the Twentieth Century and explores how the most-recent major reform, the Patient Protection and Affordable Care Act,… Read More

Academic Fellow Alumna Michelle N. Meyer Named in Forbes List of 10 Favorite

Forbes, December 15, 2016
by David Shaywitz

In a year characterized by the extremes of rhetoric, healthcare entrepreneurs have been blessed with a number of thoughtful commentaries representing the opposite extreme. The selections cited below are… Read More

The FDA Should Approve Drugs Based on Evidence, Not Emotions

Slate, December 13, 2016
by Alan Levinovitz, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Unlike many other countries, the United States managed to avoid the thalidomide crisis, thanks to a heroic FDA regulator named Frances Oldham Kelsey. Despite intense pressure from… Read More

PFC Spotlight: Student Fellow Alumnus Alexander Boni-Saenz

by Petrie-Flom Center

Alexander Boni-Saenz was a Student Fellow during the 2006-2007 academic year, while in his second year at Harvard Law School. For his Fellowship project, he researched long-term care insurance… Read More

Travel Abroad for Low-Cost Care

Kiplinger's Personal Finance, December 6, 2016
by Miriam Cross, quoting I. Glenn Cohen (Faculty Director)

From the article: Why the extra effort to court foreign patients? A couple of reasons, according to Patients With Passports (Oxford University Press), by I. Glenn Cohen: to make money (from the… Read More

Senate committee calls for ban on surgeons conducting simultaneous operations

Boston Globe, December 6, 2016
by Jonathan Salzman and Jenn Abelson

From the article: A powerful Senate committee wants all hospitals to explicitly ban surgeons from overseeing two simultaneous operations, weighing in on a controversy that has roiled Massachusetts General… Read More

Review of Human Subjects Research Regulation: Perspectives on the Future

American Journal of Bioethics, Vol. 16, Issue 12 (2016)
by Erin Phinney Johnson

From the review: Overall, the editors present an intriguing look at the concerns currently facing human subjects research regulation and provide a number of suggestions for how to go about solving some… Read More

Should We Ban Anonymous Sperm Donation?

Vocativ, November 30, 2016
by Tracy Clark-Flory, quoting I. Glenn Cohen (Faculty Director)

From the article: There’s a push underway to change the way that most sperm is donated in the United States — which is to say, anonymously. That’s largely because anonymity can… Read More

Funding for Cures Bill Remains Sticking Point for Health Groups

Bloomberg, November 28, 2016
by Anna Edney and Zachary Tracer, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: The Cures bill will fund some prevention efforts, said Lynne Weil, a spokeswoman for Representative Diana DeGette, a Democrat from Colorado who helped shape the House’s original… Read More

Morning View 11-28-16: Pharmaceuticals News

Institute for Clinical and Economic Review's Morning View, November 28, 2016
by Mitchell Stein, citing Bill of Health post by Rachel E. Sachs (Academic Fellow Alumna)

From the article: On Friday, building on the long-standing DC tradition of releasing gargantuan regulations and bills over holiday weekends, the “final” text of the 21st Century Cures bill… Read More

House lines up biotech lollipops as support grows for an epic 21st Century Cures Act

Endpoints News, November 28, 2016
by James Carroll, citing Bill of Health blog post by Rachel E. Sachs (Academic Fellow Alumna)

From the article: According to Kaiser Health News, more than 1,400 lobbyists have taken a crack — for and against — various sections of this bill. And that helps explain why… Read More

Lame duck Congress looks for swift approval of massive medical innovation bill

AJC.com (The Atlanta Journal-Constitution), November 27, 2016
by Jamie Dupree, citing Tweet & Bill of Health post by Rachel E. Sachs (Academic Fellow Alumna)

From the article: (Tweet by Rachel E. Sachs) My 1st thoughts on today's draft of 21st Century Cures: some bad provisions are gone, some remain, & some to watch. http://blogs.harvard.edu/billofhealth/2016/11/25/the-newest-21st-century-cures-draft-moderates-but-doesnt-eliminate-controversy/ … Read More

Israeli couple wins right to produce and raise grandchild from fallen soldier son’s sperm

Times of Israel, November 16, 2016
by Renee Ghert-Zand, quoting I. Glenn Cohen (Faculty Director)

From the article: [...] According to Harvard University law professor I. Glenn Cohen, a leading expert on the intersection of bioethics and law, there are many issues to be considered in… Read More

Using Twitter as an Intelligence Tool: 85 Accounts Worth Following

Regulatory Affairs, November 16, 2017
by Zachary Brennan, citing Twitter accounts of Rachel E. Sachs (Academic Fellow Alumna), Ameet Sarpatwari, Aaron Kesselheim and Amitabh Chandra (Affilia

With the rise of president-elect Donald Trump, it’s become abundantly clear that Twitter matters. And it matters not just for politics. For regulatory affairs folks in in the pharmaceutical and medical… Read More

EVENT POSTPONED: HLS Library Book Talk: Charles Fried on Medical Experimentation

Harvard Law School, TBD
by featuring I. Glenn Cohen (Faculty Director)

Wednesday, November 9, 2016 at noon Harvard Law School Room WCC 2036 Milstein East B/C 1585 Massachusetts Ave., Cambridge Lunch will be provided.   More About Medical Experimentation: Personal… Read More

Online J-Term Health Law Courses
875 Summit Ave. | St. Paul, MN 55105

Deadline: January 02, 2017

The Mitchell Hamline School of Law Health Law Institute is pleased to offer two online health law courses in January 2017!                        … Read More

Cluster Randomized Trials: Ethics, Regulations, Statistics & Design

Harvard Catalyst, November 3, 2016, 1:00 - 4:00pm
by featuring Holly Fernandez Lynch (Executive Director)

Description Please join Harvard Catalyst for a free half-day symposium on the topic of Cluster Randomized Trials: Ethics, Regulations, Statistics & Design. We will provide a general overview of Cluster… Read More

Regulating Off-Label Promotion — A Critical Test

NEJM, November 2, 2016
by Christopher Robertson, JD, PhD (Academic Fellow Alumnus) and Aaron S. Kesselheim, MD, JD, MPH (Faculty Affiliate)

Petrie-Flom Academic Alumnus Christopher T. Robertson and Faculty Affiliate Aaron S. Kesselheim have coauthored a new Perspective article in NEJM on recent judicial decisions regarding… Read More

Proposition 61 Gives California Mandate To Lower Drug Prices, Not Tools

KPBS Midday Edition, October 31, 2016
by Ben Bradford, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: Proposition 61 would require Medi-Cal to get VA prices for about 3 million of its patients (it excludes other Medi-Cal patients, who are on managed care plans). Rachel Sachs, a law professor… Read More

Drug Pricing: Where Do We Go After the Election?

Institute for Public Health, Washington University in St. Louis, October 26, 2016
by Rachel Sachs

From the blog post: Martin Shkreli. Valeant Pharmaceuticals. Mylan. Just a year ago, most Americans devoted little time and attention to the question of pharmaceutical pricing. Now, after a series of highly… Read More

Harvard Medical Ethicists Challenge Court Ruling on Lethal Injection in Alabama Case

FOR IMMEDIATE RELEASE Media Contacts: Ekaterina Pesheva Director, Science Communications and Media Relations 617.432.0441 ekaterina_pesheva@hms.harvard.edu   HARVARD MEDICAL ETHICISTS CHALLENGE COURT… Read More

Rights, Nudging, and the Good of Others

16 American Journal of Bioethics 11, Published online October 17, 2016
by Luke Gelinas (Petrie-Flom/Harvard Catalyst Fellow in Clinical Research Ethics)

Luke Gelinas, the Petrie-Flom/Harvard Catalyst Fellow in Clinical Research Ethics, has a new article commentary out in the American Journal of Bioethics responding to a new article (in the same… Read More

Issues With Tissues

16 American Journal of Bioethics 11, Published online October 17, 2016
by Emily Largent (Student Fellow Alumna)

Student Fellow Alumna Emily Largent has a new article commentary out in the American Journal of Bioethics, in which she responds to a new article (in the same issue) on The ethics of organ donor registration… Read More

The Readout: Speaking of Drug Prices

STAT, October 12, 2016
by Damian Garde and Meg Kesh, featuring Rachel Sachs (Academic Fellow alumna)

From the post: How? Washington University law professor Rachel Sachs and Department of Veterans Affairs economist Austin Frakt suggest tying drug prices to cost-effectiveness. They'd also like society… Read More

Innovation–Innovation Tradeoffs in Drug Pricing

Annals of Internal Medicine, October 11, 2016
by Rachel Sachs (Academic Fellow alumna)

From the article: The uproar over the price of the EpiPen is the latest episode in a longstanding controversy over drug pricing. A common concern is that proposed regulation of drug markets may reduce… Read More

Faculty Director I. Glenn Cohen Joins National Academy of Sciences Committee

Petrie-Flom Center, September 26, 2016

I. Glenn Cohen, Faculty Director of Harvard Law School’s Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics and Robert Truog, Director of the Harvard Medical School Center for… Read More

Petrie-Flom seeks RA for project on human subjects research
Petrie-Flom Center, Harvard Law School

Deadline: October 31, 2016

The Petrie-Flom Center for Health Law and Policy, Biotechnology, and Bioethics seeks a part-time research assistant for a project with Harvard Catalyst (Harvard Clinical and Translational Science… Read More

Generic EpiPen Will Likely Secure Profits For Mylan

Law360, September 22, 2016
by Dani Kass, quoting Rachel Sachs (Academic Fellow alumna)

[...] Many customers are still likely to use the branded products once the generic is released, because copay discount cards and other assistance programs Mylan provides may make the branded drug… Read More

Social Media Use in Research Recruitment

Petrie-Flom Center / Harvard Catalyst, September 21, 2016
by Luke Gelinas (Petrie-Flom/Harvard Catalyst Fellow in Clinical Research Ethics)

Cross-posted at the Petrie-Flom Center's blog Bill of Health. Imagine this scenario: you are a researcher conducting a clinical trial on a promising treatment for a rare but serious heart condition.… Read More

Is Medical Tourism Ethical?

The Greenwall Foundation, September 2016

Petrie-Flom Faculty Director I. Glenn Cohen served as a Greenwall Foundation Faculty Scholar, Class of 2015. The Greenwall Foundation recently published a profile of Cohen's project,… Read More