FDA Approval Of Hepatitis C Drugs For Kids Is Likely To Speed Treatment

NPR, April 19, 2017
by Michelle Andrews

With the approval this month of two drugs to treat hepatitis C in children, these often overlooked v...

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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 Ra...

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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...

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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 Jo...

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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 Bil

l

Improving Access to Affordable Prescription Drugs...

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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 READIN

G

Writing at Harvard’s “Bill of Health,&rdqu...

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Senate will vote to overturn Planned Parenthood protections

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

From the newsletter

:

What the experts are saying. NEJM posted a pair of perspectives that offe...

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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 eHealt...

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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, a...

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Philadelphia Flooded With New Risperdal Lawsuits; Trials Split But Include Massive Verdict

Forbes, April 10, 2017
by Nicholas Malfitano

Records from the Philadelphia County Court of Common Pleas reveal more than 3,000 new Risperdal...

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 Fo...

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Sanofi, Regeneron ask court to shield Dupixent from Amgen patent attack

FiercePharma, March 21, 2017
by Tracy Staton, citing blog post by Rachel E. Sachs (Academic Fellow Alumna)

From the article

:

[...]Amgen has caught fire for its aggressive stance on its PCSK9 patents, which...

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Trump Slashes Health Spending In Federal Budget Plan

Kaiser Health News, March 16, 2017

KHN Morning Briefing: Summaries of health policy coverage from major news organization

s

The ad...

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Trump, Dems Look For Common Ground On Drug Prices

Kaiser Health News, March 9, 2017
by Sarah Jane Tribble

For years, congressional Democrats have tried to pass legislation to allow Medicare to negotiate pre...

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‘Right-To-Try’ Laws Expose Dying Patients To Exploitation, Ethicists Warn

Kaiser Health News, March 6, 2017
by Carrie Feibel, KQED

[...] “We know some people try to take advantage of our desperation when we’re ill,&rdqu...

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More Than 80 Percent of Patient Groups Accept Drug Industry Funds, Study Shows

New York Times, March 1, 2017
by Katie Thomas

The nation’s largest patient advocacy groups are on the front lines of some of the biggest hea...

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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 aud...

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Deadly, Drug-Resistant ‘Superbugs’ Pose Huge Threat, W.H.O. Says

New York Times, February 27, 2017
by Donald G. McNeil, Jr.

The World Health Organization warned on Monday that a dozen antibiotic-resistant &ldq...

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Advice From Patients On A Study’s Design Makes For Better Science

NPR, February 24, 2017
by Richard Harris

[...] The study has been recruiting patients at a record pace. In its first three months it enr...

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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...

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Call for Papers
European Pharmaceutical Law Review (EPLR)

Deadline: Various

Calll for Paper

s

The European Pharmaceutical Law Review (EPLR) provides a forum to discuss, comment...

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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...

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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 par...

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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 drugscompe...

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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 Rache...

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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, ofte...

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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.&nbs...

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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 regul...

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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...

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The $4,500 injection to stop heroin overdoses

Washington Post, January 27, 2017
by Shefali Luthra, quoting W. Nicholson Price II (Academic Fellow Alumnus)

From the article

:

Thanks to an infusion of public funding to combat opioid overdoses, other institu...

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Fifth Annual Health Law Year in P/Review

Monday, January 23, 2017 8:30 AM - 5:00 PM
Conferences
2016-2017
Wasserstein Hall, Milstein West AB
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

>Couldn't make it to the event? Check out some of the speakers' slides as well as blog posts... Read More

When clinical trials compete: prioritising study recruitment

Journal of Medical Ethics, January 20, 2017 (online)
by Luke Gelinas (Clinical Research Ethics Fellow), Holly Fernandez Lynch (Executive Director), Barbara E. Bierer, and I. Glenn Cohen (Faculty Director)

Abstrac

t

It is not uncommon for multiple clinical trials at the same institution to recruit concurr...

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Mid-Atlantic Health Law Works-in-Progress Retreat
Seton Hall Law School

Deadline: February 03, 2017

Seton Hall Law School’s Center for Health & Pharmaceutical Law & Policy is pleased to...

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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... 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. 17-148
0
UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUI
T  
; AMGEN INC., AMGEN MANUFAC...

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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...

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PFC Spotlight: Faculty Affiliate Ameet Sarpatwari

The Petrie-Flom Center, January 12, 2017

>Ameet Sarpatwari, J.D., Ph.D., is an Instructor in Medicine at Harvard Medical School, an Assoc...

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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 re...

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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...

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If Taxpayers Invent A Drug, Should The Government Just Give It Away?

BuzzFeed News , December 31, 2016
by Dan Vergano, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article

:

The dispute “is not the first time someone has raised questions over NIH&r...

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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 an...

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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 c...

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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...

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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 reg...

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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 ta...

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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 Cent...

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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 matte...

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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 co...

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. Robertso;and Faculty Affiliate ;Aaron S....

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ORDER NOW & RECEIVE 30% OFF: Nudging Health

Johns Hopkins University Press, October 2016
by I. Glenn Cohen (Faculty Director), Holly Fernandez Lynch (Executive Director), and Christopher T. Robertson (Academic Fellow alumnus), eds.

Abstract of the Introduction: 

;

This introductory chapter to the edited volume Nudging Health:...

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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...

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Drug prices: Where do we go after the Election?

The Conversation US, October 30, 2016
by Rachel E. Sachs (Academic Fellow Alumna)

Martin Shkreli. Valeant Pharmaceuticals. Mylan. These names have become big news, but just a year ag...

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...

Read More

Health Law Workshop: W. Nicholson Price II

Monday, October 17, 2016 5:00 PM
Health Law Workshops
2016-2017
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

>Presentation: "Regulating Black-Box Medicine

"

This paper is not available for download. To request...

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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 Aff...

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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 c...

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,...

Read More

EBOLA and FDA: reviewing the response to the 2014 outbreak, to find lessons for the future

Journal of Law and the Biosciences, September 16, 2016
by Emily A. Largent (Student Fellow alumna)

Abstract

:

In 2014, West Africa confronted the most severe outbreak of Ebola virus disease (EVD) in...

Read More

EpiPen Maker Quietly Steers Effort That Could Protect Its Price

New York Times, September 16, 2016
by Eric Lipton and Rachel Abrams, quoting Rachel E. Sachs (Academic Fellow Alumnus)

[...] The idea being advanced is simple: If the EpiPen makes the federal preventive l...

Read More

5 reasons why no one has built a better EpiPen

STAT, September 9, 2016
by Meghana Keshavan, quoting W. Nicholson Price II (Academic Fellow Alumnus)

[...] But critics say Mylan has little incentive to improve EpiPens: “If you’re the...

Read More

How Mylan cornered the consumer epinephrine market

MedCityNews, September 8, 2016
by Pauline Bartolone, quoting W. Nicholson Price II (Academic Fellow Alumnus)

[...] The New York state attorney general’s office announced Tuesday it will investigate...

Read More

Euro Drug Pricing’s Tradeoffs May Limit Appeal In US

Law360, September 8, 2016
by Dani Kass, quoting W. Nicholson Price II (Academic Fellow Alumnus)

[...] Going forward, an influx of bills targeting drug prices could be introduced, but few are...

Read More

EpiPen’s Dominance Driven By Competitors’ Stumbles And Tragic Deaths

NPR, September 7, 2016
by Pauline Bartolone, quoting W. Nicholson Price II (Academic Fellow alumnus)

NPR recently called on Petrie-Flom Academic Fellow alumnus Nicholson Price to help explain how...

Read More

Missouri law professor: Consider price controls after Epipen controversy

Missourinet, September 5, 2016
by Jason Taylor, quoting Rachel E. Sachs (Academic Fellow Alumna)

A Missouri law professor thinks Congress should consider imposing price controls on certain drugs af...

Read More

Mylan’s sudden plans for a generic EpiPen

Modern Healthcare, Vital Signs Blog, August 31, 2016
by Adam Rubenfire, quoting Rachel E. Sachs (Academic Fellow alumna)

From the post

:

Obviously Mylan didn't want to underprice its own branded drug, but it's pos...

Read More

Mylan’s decision to make a cheaper, generic EpiPen ‘baffles’ experts

Business Insider, August 31, 2016
by Lydia Ramsey, featuring blog post by Rachel E. Sachs (Academic Fellow alumna)

From the article

:

"I and others who study these issues full time cannot understand why Mylan though...

Read More

Endpoints News Early Edition

Endpoints News, August 31, 2016
by John Carroll, featuring blog post by Rachel E. Sachs (Academic Fellow alumna)

From the email

:

Don't miss this commentary from Harvard's Rachel Sachs: 

;

I am not sho...

Read More

Mylan’s Lower-Cost EpiPen May Not Hurt Drugmaker’s Sales Much

Bloomberg, August 29, 2016
by Cynthia Koons and Zachary Tracer, quoting Rachel E. Sachs (Academic Fellow alumna)

[...] Meanwhile, by introducing its generic, Mylan will set the market price for subsequent com...

Read More

The FDA Wants To Make It Harder To Buy And Sell Poop

BuzzFeed, August 13, 2016
by by Nidhi Subbaraman, quoting Rachel Sachs (Academic Fellow alumna)

[...] Depending on how the approval is handed down, Rebiotix could very well put outfits like OpenBi...

Read More

The FDA is prohibited from going germline

Science, August 5, 2016
by I. Glenn Cohen (Faculty Director) and Eli Y. Adashi

Petrie-Flom Faculty Director I. Glenn Cohen has co-authored a new article in Science magazine&n...

Read More

This Could Have Been The First Poop Pill To Hit The Market, But It Failed Clinical Trials

BuzzFeed Science, July 29, 2016
by Nidhi Subbaraman, quoting Rachel Sachs (Academic Fellow alumna)

[...] “I think it is a big deal,” said Rachel Sachs, a professor of health and law...

Read More

A Trojan Horse?

Ohio State Law Journal, 2017 (forthcoming)
by Christopher T. Robertson (Academic Fellow alumnus)

Abstract:      
; Scholars, advocates, and courts have begun to recogniz...

Read More

Health Insurance as Innovation Incentive

Jotwell, June 9, 2016
by Amy Monahan, reviewing paper by Rachel E. Sachs (Academic Fellow)

Excerpt from the article

:

In Prizing Insurance: Prescription Drug Insurance as Innovation Incentive...

Read More

The Relationship Between Bioethics and U.S. 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 I. Glenn Cohen (Faculty Director)

>Abstract: ;This chapter explores the way bioethics is taught as part of U.S. health law. It begi... Read More

FDA’s Punt on Finalizing the Generic Drug Labeling Rule: Experts Debate

Regulatory Affairs Professionals Society, May 19, 2016
by Zachary Brennan, featuring Rachel E. Sachs (Academic Fellow)

From the article: 

;

Rachel Sachs, JD, an academic fellow at the Petrie-Flom Center for Health L...

Read More

Divided Infringement and the Doctor-Patient Relationship

IP Theory, 2016 (Forthcoming)
by Rachel E. Sachs (Academic Fellow)

>Abstract: ;     
; With its recent en banc decision in Akamai v. Limeligh... Read More

Resolving Reverse-Payment Settlements with the Smoking Gun of Stock Price Movements

81 Iowa Law Review 1581, 2016
by Thomas G. McGuire, Keith Drake, Einer Elhauge (Founding Faculty Director), Raymond S. Hartman, Martha Starr

>Abstract: ;The Supreme Court recently held that in reverse-payment settlements of drug patent di... Read More

What’s next for opioid legislation?

Politico Pulse, April 22, 2016
by Dan Diamond, referencing Rachel E. Sachs (Academic Fellow)

Excerpt from article

:

[...] HEALTH WONK RECAP — PULSE flagged a few interesting stu...

Read More

Prizing Insurance: Prescription Drug Insurance as Innovation Incentive,

Harvard Journal of Law and Technology, Vol. 30, No. 1 (forthcoming)
by Rachel E. Sachs

Abstract: 

;

A problem perennially facing scholars of both intellectual property and health law...

Read More

Promoting Healthcare Innovation on the Demand Side

U of Michigan Law & Econ Research Paper No. 16-008; U of Michigan Public Law Research Paper No. 503
by Rebecca Eisenberg and W. Nicholson Price II (Academic Fellow Alumnus)

Abstract

:

Innovation policy often focuses on the incentives of firms that sell new products. But op...

Read More