Health-Care Stocks Get Boost From Senate Bill

Wall Street Journal, June 22, 2017
by Amrith Ramkumar and Riva Gold

>This article is behind a paywall. Harvard affiliates can access the full text via Hollis+

.

Health-c...

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 "We...

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...

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...

Read More

Is Competition the Solution to High Drug Prices?

Marketplace, June 14, 2017
by Dan Gorenstein, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article

:

“Biosimilars free up funding in the health care system to pay for other inn...

Read More

Gilead’s HIV prevention pill will be going generic. How far will Teva drop the price?

STAT, June 9, 2017
by Rebecca Robbins

It’s been lauded as an essential public health tool and maligned as “a party drug.&...

Read More

Medical Responses To Opioid Addiction Vary By State, Analysis Finds

Kaiser Health News, June 12, 2017
by Julie Appleby

Location, location, location. That mantra may apply even when it comes to how opioid addiction is tr...

Read More

Label Or Liability: GSK Faces $3M Verdict Over Product It Didn’t Make

Forbes, June 12, 2017
by Stephanie Grimoldby

This spring, a Chicago federal jury awarded $3 million to the widow of a lawyer who committed suicid...

Read More

Seizing on Opioid Crisis, a Drug Maker Lobbies Hard for Its Product

New York Times, June 11, 2017
by Abby Goodnough and Kate Zernike

The ads have been popping up on billboards, buses and subways and in glossy magazines, with portrait...

Read More

This Pharma Company Won’t Commit to Fairly Pricing a Zika Vaccine You Helped Pay For

The Huffington Post, June 9, 2017
by Alexander C. Kaufman, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article

:

“The incentives for any one company to raise its prices or engage in questi...

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...

Read More

Lawmakers Consider Tough New Penalties For Opioid Crimes, Bucking Trend

NPR, June 6, 2017
by Carrie Johnson

For nearly four years now, an unusual coalition of Republicans and Democrats has worked to reduce ma...

Read More

Health officials set to release a list of drugs everyone on Earth should be able to access

STAT, June 5, 2017
by Helen Branswell

Once every two years, the World Health Organization releases a list of medications it thin...

Read More

Tiger Woods and America’s Drugged-Driving Problem

The Atlantic, May 30, 2017
by Olga Khazan

Shortly after being arrested for driving under the influence near his home in Florida Monday, golf l...

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 Pe...

Read More

Express Scripts Sues Maker of Overdose Drug, Intensifying Feud

New York Times, May 31, 2017
by Katie Thomas and Charles Ornstein

A company that manages prescription drug plans for tens of millions of Americans has sued a tiny dru...

Read More

Ohio Sues 5 Major Drug Companies For ‘Fueling Opioid Epidemic’

NPR, May 31, 2017
by Colin Dwyer

The state of Ohio has sued five major drug manufacturers for their role in the opioid epidemic. In t...

Read More

Health Care Groups At A Crossroads Over Trying To Kill GOP Bill Or Help Shape It

Kaiser Health News, May 30, 2017

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

s

Senato...

Read More

Hogan lets drug price-gouging bill, dozens of others become law without signature

Baltimore Sun, May 26, 2017
by Michael Dresser

Gov. Larry Hogan said Friday he will not block a new law giving the Maryland attorney gene...

Read More

FDA User Fee Reauthorization Clears Hurdle In Senate With Bipartisan Support

Health Affairs Blog, May 15, 2017
by Rachel Sachs (Academic Fellow Alumna)

From the article

:

On Thursday, May 11, the Senate Committee on Health, Education, Labor and Pension...

Read More

Angel investors are the first stop in a new era of drug development

Newsworks, May 11, 2017
by Elana Gordon, quoting Rachel Sachs

From the article

:

So is this really the best way to develop new healthcare technologies and therapi..

. 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...

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 t...

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 o...

Read More

Texas leans into unproven stem cell treatments, to the dismay of scientists

STAT, May 16, 2017
by Andrew Joseph

He made the emotional plea to his colleagues: Pass this bill

.

“It might give somebody like my...

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 ...

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...

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 Pro...

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 i...

Read More

Senate Confirms Scott Gottlieb to Head F.D.A.

New York Times, May 9, 2017
by Katie Thomas

The Senate voted 57 to 42 on Tuesday to confirm Dr. Scott Gottlieb as commissioner of the Food and D...

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&nb...

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...

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 Ra...

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...

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 Jo...

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 Bil

l

Improving Access to Affordable Prescription Drugs...

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 READIN

G

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

Read More

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...

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 eHealt...

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, a...

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:...

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...

Read More

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...

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 aud...

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...

Read More

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...

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...

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 par...

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 drugscompe...

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 Rache...

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, ofte...

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.&nbs...

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 regul...

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...

Read More

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...

Read More

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...

Read More

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...

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... 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...

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...

Read More

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...

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 re...

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...

Read More

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...

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 an...

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 c...

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...

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 reg...

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 ta...

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 Cent...

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 matte...

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 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....

Read More

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:...

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...

Read More

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...

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 Aff...

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 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