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

State AGs Ask For Emergency Court Order To Keep Trump From Cutting Off Insurer Subsidies

Kaiser Health News, October 19, 2017

KHN Morning Briefing: Summaries of health policy coverage from major news organizations "It's long past time President Donald Trump learn that he doesn't get to pick and choose which laws… Read More

Cutting Off Insurer Payments Increases Number Of People Who Get Help Through Other Subsidies

Kaiser Health News, October 19, 2017

KHN Morning Briefing: Summaries of health policy coverage from major news organizations Stopping insurer subsidies is like pushing down on one end of a see-saw only to see the other end go up because… Read More

Despite GOP Efforts To Corral Medicaid Spending, States Expand Benefits

Kaiser Health News, October 19, 2017
by Phil Galewitz

While congressional Republicans and President Donald Trump have been seeking major cuts in federal funding of Medicaid, 26 states this year expanded or enhanced benefits and at least 17 plan to do so next… Read More

Diabetes Technology Moves Closer To Making Life Easier For Patients

NPR, October 18, 2017
by Miriam E. Tucker

[...] Both continuous glucose sensing and fast-acting insulin are critical components to the development of so-called "closed-loop" or artificial pancreas systems, which aim to automate insulin delivery… Read More

F.D.A. Approves Second Gene-Altering Treatment for Cancer

New York Times, October 18, 2017
by Denise Grady

The Food and Drug Administration on Wednesday approved the second in a radically new class of treatments that genetically reboot a patient’s own immune cells to kill cancer. The new therapy, Yescarta,… Read More

Justice Department reveals charges against Chinese fentanyl distributors

Washington Post, October 17, 2017
by Matt Zapotosky and Sari Horwitz

U.S. prosecutors have charged two Chinese nationals who sold fentanyl to American customers over the Internet in a massive international conspiracy case, the Justice Department announced Tuesday. The case… Read More

Patents for Restasis Are Invalidated, Opening Door to Generics

New York Times, October 16, 2017
by Katie Thomas

A federal judge in Texas invalidated four key patents for the dry-eye treatment Restasis on Monday, dealing a blow to its manufacturer, Allergan, which had sought to protect its patents by transferring… Read More

Stunner On Birth Control

Kaiser Health News, October 16, 2017
by Julie Rovner

Few people were surprised last week when the Trump administration issued a rule to make it easier for some religious employers to opt out of offering no-cost prescription birth control to their female… Read More

It’s Not Likely Court Will Order Administration To Pay Subsidies

Kaiser Health News, October 16, 2017

KHN Morning Briefing: Summaries of health policy coverage from major news organizations Nearly 20 states have sued over President Donald Trump's decision to stop the insurer subsidies. But, “Forcing… Read More

Trump’s Move To End Insurer Subsidies May Force Congress To Act After Months Of Stagnation

Kaiser Health News, October 16, 2017

KHN Morning Briefing: Summaries of health policy coverage from major news organizations Uncertainty over the payments to insurers has loomed over Congress for months, and senators have been trying… Read More

NHS patients to be asked about sexuality

BBC News, October 15, 2017

Health professionals in England are to be told to ask patients aged 16 or over about their sexual orientation, under new NHS guidelines. NHS England said no-one would be forced to answer the question but… Read More

The Drug Industry’s Triumph over the DEA

Washington Post, October 15, 2017
by Scott Higham and Lenny Bernstein

In April 2016, at the height of the deadliest drug epidemic in U.S. history, Congress effectively stripped the Drug Enforcement Administration of its most potent weapon against large drug companies suspected… Read More

New York HIV Health Care Shifts to Primary-Care Model

Wall Street Journal, October 15, 2017
by Melanie Grayce West

The changes at New York City organizations like Alliance for Positive Change mirror those happening in medical care for those living with HIV and AIDS in the state as a whole. Experts say care is moving… Read More

Anti-doping agency to ban all gene editing in sport from 2018

New Scientist, October 9, 2017
by Michael Le Page

The battle between sports cheats and testers is poised to enter a whole new arena. The World Anti-Doping Agency has extended its 2003 ban on “gene doping” to include all forms of gene editing… Read More

Trump’s Order Advances GOP Go-To Ideas To Broaden Insurance Choices, Curb Costs

Kaiser Health News, October 12, 2017
by Julie Appleby

The Trump administration Thursday advanced a wide-ranging executive order aimed at expanding lower-cost insurance options, allowing employers to give workers money to buy their own coverage and slowing… Read More

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

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

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

Battle over drug prices shifts back to the states

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

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

Letter to Allergan plc

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

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

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

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

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

India’s Supreme Court Rules Sex With Child Brides Is Rape

Time, October 11, 2017
by Eli Meixler

India's Supreme Court ruled Wednesday that sex with an underage wife constitutes rape, in a landmark ruling that campaigners say could affect millions of girls. The decision overturned a previous clause that… Read More

Why Chicago’s soda tax fizzled after two months — and what it means for the anti-soda movement

Washington Post, October 10, 2017
by Caitlin Dewey

About two months after the country’s largest soda tax went into effect, embattled lawmakers in Cook County, Ill. — the home of Chicago — have decided to repeal it. The tax has… Read More

In New Test for Obamacare, Iowa Seeks to Abandon Marketplace

New York Times, October 10, 2017
by Abby Goodnough

WASHINGTON — With efforts to repeal the Affordable Care Act dead in Congress for now, a critical test for the law’s future is playing out in one small, conservative-leaning state. Iowa is anxiously… Read More

Washington Is Latest State To Sue Trump Administration Over Contraception Mandate Rollback

Kaiser Health News, October 10, 2017

KHN Morning Briefing: Summaries of health policy coverage from major news organizations Washington state Attorney General Bob Ferguson says that the new rules violate the First Amendment by “requiring… Read More

Trump’s Cuts to Health Law Enrollment Efforts Are Hitting Hard

New York Times, October 9, 2017
by Robert Pear

WASHINGTON — Michigan Consumers for Health Care, a nonprofit group, has enrolled thousands of people in health insurance under the Affordable Care Act and was honored last year as one of the nation’s… Read More

As Cancer Tears Through Africa, Drug Makers Draw Up a Battle Plan

New York Times, October 7, 2017
by Donald G. McNeil, Jr.

NAIROBI, Kenya — In a remarkable initiative modeled on the campaign against AIDS in Africa, two major pharmaceutical companies, working with the American Cancer Society, will steeply discount the… Read More

In Puerto Rico, Health Concerns Grow Amid Lack of Clean Water, Medical Care

The Wall Street Journal, October 4, 2017
by Daniela Hernandez

In the aftermath of Hurricane Maria, many Puerto Ricans are grappling with growing health concerns due to a lack of reliable access to medical care, supplies and clean water. Maggie Reuteman,… Read More

IBM to Congress

STAT, October 4, 2017
by Casey Ross and Ike Swetlitz

To the public, IBM trumpets its Watson supercomputer as the next big thing in medicine, a new kind of machine that melds human expertise with digital speed to give patients personalized… Read More

Why Price’s conservative imprint on HHS is likely to endure

Politico, October 3, 2017
by Paul Demko, David Pittman, and Brianna Ehley

Tom Price may be gone as Health and Human Services secretary, but his efforts to put a conservative stamp on the $1.1 trillion agency, from promoting faith groups to scrapping Obamacare implementation,… Read More

Trump Administration Set to Roll Back Birth Control Mandate

New York Times, October 5, 2017
by Robert Pear

WASHINGTON — The Trump administration is poised to roll back the federal requirement for employers to include birth control coverage in their health insurance plans, vastly expanding exemptions for… Read More

How to Reduce Mass Shooting Deaths?

New York Times, October 5, 2017
by Margot Sanger-Katz and Quoctrung Bui

Whenever a mass shooting shocks America, people ask if tighter gun-control measures could have prevented the slaughter. Gun violence researchers say that no law can eliminate the risk of mass shootings,… Read More

CHIP Funding Measure Passes Through Committees, But It’s Not Smooth Sailing Ahead For Bill

Kaiser Health News, October 5, 2017

KHN Morning Briefing: Summaries of health policy coverage from major news organizations The provisions Republicans want to add to reauthorize funds for the Children's Health Insurance Program… Read More

Hurricane Damage in Puerto Rico Leads to Fears of Drug Shortages Nationwide

New York Times, October 4, 2017
by Katie Thomas and Sheila Kaplan

Federal officials and major drugmakers are scrambling to prevent national shortages of critical drugs for treating cancer, diabetes and heart disease, as well as medical devices and supplies, that are… Read More

California Bill Would Compel Drugmakers To Justify Price Hikes

NPR, October 4, 2017
by April Dembosky

Insurers, hospitals and health advocates are waiting for Gov. Jerry Brown to deal the drug lobby a rare defeat, by signing legislation that would force pharmaceutical companies to justify big… Read More

FDA’s Approval Of A Cheaper Drug For Hepatitis C Will Likely Expand Treatment

NPR, October 4, 2017
by Michelle Andrews

[...] The recent approval of a less expensive drug that generally cures hepatitis C in just eight weeks may make it easier for more insurers and correctional facilities to expand treatment. The… Read More

House passes 20-week abortion ban, citing disputed science of ‘fetal pain’

STAT, October 3, 2017
by Lev Facher

[...] The issue of fetal pain, scientifically, is relatively unsettled. The Journal of the American Medical Association wrote in 2005: “Evidence regarding the capacity for fetal pain is limited but… Read More

With Health Care At Pivotal Crossroads, HHS Pick Could Signal What Path Trump Wants To Take

Kaiser Health News, October 2, 2017

KHN Morning Briefing: Summaries of health policy coverage from major news organizations Some of the names getting attention are Centers for Medicare & Medicaid Services chief Seema Verma, Fla.… Read More

U.S. states are waging a civil war over donated livers. Will a new proposal finally resolve it?

STAT, October 2, 2017
by Casey Ross

[...] All were writing in a response to a proposal that would change the geographic lines that determine access to donor livers in communities across the United States. The public comment period,… Read More

Thousands Rally in Dublin Against Ireland’s Abortion Ban

New York Times, September 30, 2017
by Megan Specia

Thousands of people marched in Dublin on Saturday to demand an end to the country’s constitutional ban on abortion, one of the strictest such laws in the Western world. The March for Choice is an… Read More

WHO tells governments to reject Philip Morris-funded smoking foundation

Reuters, September 28, 2017
by Tom Miles

GENEVA (Reuters) - The World Health Organization told governments on Thursday not to get involved in a foundation funded by tobacco firm Philip Morris International to look at ways of reducing the harm… Read More

Now What? 5 Looming Challenges For The Affordable Care Act

NPR, September 26, 2017
by Julie Rovner

Republicans officially pulled the plug on their last-ditch effort to repeal and replace the Affordable Care Act on Tuesday. "We don't have the votes," said Sen. Bill Cassidy, R-La., after a closed-door… Read More

Lawmakers ‘On The Verge’ Of Striking Bipartisan Deal To Stabilize Marketplaces, Schumer Vows

Kaiser Health News, September 29, 2017

KHN Morning Briefing: Summaries of health policy coverage from major news organizations Sens. Lamar Alexander (R-Tenn.) and Patty Murray (D-Wash.), the chairman and ranking member of the Health, Education,… Read More

Here’s how the Trump administration is hurting enrollment in Obamacare

Washington Post, September 28, 2017
by Philip Bump

At its heart, the Affordable Care Act — Obamacare — is about figuring out how to pay to provide more people with insurance coverage. Before the policy was enacted, insurers balked at covering… Read More

Some States Make It Hard For Teen Moms To Get Pain Relief In Childbirth

NPR, September 28, 2017
by Esther Honig

[...] Throughout the U.S., minors are generally required to have permission from their parents or legal guardian before they can receive most medical treatment. However, each state has established… Read More

More than 25 million unsafe abortions performed worldwide each year

STAT, September 27, 2017
by Megan Thielking

[...]  Here’s a look at the findings: There are 55.7 million abortions every year across the globe. About 55 percent of those were considered safe abortions. Almost all abortions in developed… Read More

‘This Is Like in War’

New York Times, September 26, 2017
by Luis Ferre-Sadurni, Frances Robles, and Lizette Alvarez

[...] The hospitals have been crippled by floods, damage and shortages of diesel. The governor said that 20 of the island’s hospitals are in working order. The rest are not operational, and… Read More

McConnell Says Republicans Are Giving Up on Health Bill

New York Times, September 26, 2017
by Thomas Kaplan

WASHINGTON — Senator Mitch McConnell on Tuesday officially pulled the plug on the latest plan to repeal the Affordable Care Act, telling senators they will not vote on the measure and effectively… Read More

After Collins Officially Declares Opposition, Passing Health Bill Becomes ‘Nearly Impossible’

Kaiser Health News, September 26, 2017

KHN Morning Briefing: Summaries of health policy coverage from major news organizations Sen. Susan Collins (R-Maine) joins Sens. John McCain (R-Ariz.) and Rand Paul (R-Ky.) in opposition of Republicans'… Read More

With Clock Ticking, Senators Tweak Health Plan To Shift Money To Reluctant Senators’ States

Kaiser Health News, September 25, 2017

KHN Morning Briefing: Summaries of health policy coverage from major news organizations The changes would send money to Alaska and Maine, homes of Republican Sens. Lisa Murkowski and Susan Collins.… Read More

Movie’s Ads Protest Rules Restricting Gay Men From Donating Blood

New York Times, September 24, 2017
by Brooks Barnes

LOS ANGELES — The last “Saw” movie, released by Lionsgate in 2010, was advertised as “the final chapter.” But you didn’t think a franchise with roughly $1 billion in… Read More

For GOP, Political Incentive Is ‘As Much Of A Reason As The Substance’ To Pass Repeal Bill

Kaiser Health News, September 21, 2017

KHN Morning Briefing: Summaries of health policy coverage from major news organizations The driving force behind this last-ditch attempt for many lawmakers it the simple fact that they promised their… Read More

Majority Of States Would Lose ‘Jaw-Dropping’ Amounts Of Funding Under Graham-Cassidy Bill

Kaiser Health News, September 21, 2017

KHN Morning Briefing Summaries of health policy coverage from major news organizations A new study by Avalere Health finds that red states would disproportionately benefit, while 34 states would be hit… Read More

Insurance Industry Comes Out Against Graham-Cassidy Trumpcare Bill

Forbes, September 20, 2017
by Bruce Japsen

The nation’s Blue Cross Blue Shield plans and the powerful insurance lobby America's Health Insurance Plans on Wednesday joined mounting opposition from health-care providers, patient advocates… Read More

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

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

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

41 States To Investigate Pharmaceutical Companies Over Opioids

NPR, September 19, 2017
by Yuki Noguchi

The attorneys general of 41 U.S. states said Tuesday that they're banding together to investigate the makers and distributors of powerful opioid painkillers that have, over the past decade, led to… Read More

GOP Says It’s Close On Graham-Cassidy Bill, But Those Last Votes Have Always Been A Struggle

Kaiser Health News, September 18, 2017

KHN Morning Briefing: Summaries of health policy coverage from major news organizations The measure from Sens. Bill Cassidy (R-La.) and Lindsey Graham (R-S.C.) is the party's last-ditch effort… Read More

Rural Hospitals Struggle To Stock Expensive Drugs That Could Save Lives

NPR, September 15, 2017
by Sarah Jane Tribble

[...] Langston fears others could die because of an unintended bias against rural hospitals built into the U.S. health law. An obscure Obamacare provision forces rural hospitals like Langston's to… Read More

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

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

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

Democrats Worry Compromising For Short-Term Wins Will Lead To Long-Term Evisceration Of Law

Kaiser Health News, September 11, 2017

KHN Morning Briefing: Summaries of health policy coverage from major news organizations Democratic lawmakers want the insurer subsidies to be paid. But to get that, they have to give up on something… Read More

How to Protect a Drug Patent? Sell it to a Native American Tribe

New York Times, September 8, 2017
by Katie Thomas

The drugmaker Allergan announced Friday that it had transferred its patents on a best-selling eye drug to the Saint Regis Mohawk Tribe in upstate New York — an unusual gambit to protect the drug… Read More

Meningitis B Vaccine’s High Price Tag Poses A Health Care Conundrum

Kaiser Health News, September 8, 2017
by Shefali Luthra

Four years ago, when meningitis B, an extremely rare but potentially lethal form of the infection, sickened a small number of college students at Princeton and the University of California-Santa Barbara,… Read More

The Breakthrough: Hopelessness and Exploitation Inside Homes for Mentally Ill

ProPublica, September 8, 2017
by Joaquin Sapien

In the 1960s, New York began to clear out its scandal-ridden psychiatric hospitals. In their place, a new system emerged. Thousands of mentally ill New Yorkers moved into “adult homes,” large… Read More

FDA Accuses EpiPen Maker of Failing to Investigate Malfunctions

New York Times, September 7, 2017
by Katie Thomas

The Food and Drug Administration this week accused the drugmaker Pfizerof failing to properly investigate reports of malfunctioning EpiPens, including incidents when patients died or became… Read More

A Tone Shift On Capitol Hill As Lawmakers Try To Come Up With Bipartisan Health Solution

Kaiser Health News, September 6, 2017

KHN Morning Briefing: Summaries of health policy coverage from major news organizations Republicans are now in the position to have to work with Democrats so make sure the marketplace doesn't… Read More

Kentucky Could Become The Only State Without A Clinic That Performs Abortions

NPR, September 6, 2017
by Sarah McCammon

Kentucky is down to only one clinic that performs abortions: the EMW Women's Surgical Center in Louisville. A trial kicking off Wednesday morning in federal court in Louisville… Read More

Deporting ‘Dreamers’ May Hit Home Health Care Especially Hard

New York Times, September 6, 2017
by Noam Scheiber and Rachel Abrams

When the Trump administration announced on Tuesday that it would endan Obama-era program that shielded young undocumented immigrants from deportation, Sherwin Sheik quickly sized up the potential… Read More

Influence, integrity, and the FDA: An ethical framework

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

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

Obamacare survives its latest threat: Bare counties

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

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

Questions About The FDA’s New Framework For Digital Health

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

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

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

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

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

Administering Health Innovation

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

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

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

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

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

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

Dickinson Law, Penn State University, August 1, 2017

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

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

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

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

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

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

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

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

Petrie-Flom Center, July 21, 2017

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

Public Participation in Drafting of the 21st Century Cures Act

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

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

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

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

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

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

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

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

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

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

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

Panel: Weighing the Risks of Randomized Controlled Trials and Alternatives

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

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

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

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

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

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

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

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

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

Deadline: Open until filled.

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

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

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

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

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

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

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

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

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