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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(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...

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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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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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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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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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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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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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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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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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Prop 61: Californians appear to say no to lowering drug costs

STAT News, November 9, 2016
by Rebecca Robbins, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article

:

Rachel Sachs, a law professor who studies health policy at Washington University...

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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...

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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...

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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...

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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,...

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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...

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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...

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Behind the EpiPen controversy are questions about patents granted to drugmaker

St. Louis Post-Dispatch, September 4, 2016
by Samantha Liss, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article

:

[...] Usually, insurance carriers decide if the update is meaningful. If the upda...

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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...

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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...

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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...

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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...

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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...

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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...

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Social Media & Health Law

The Week in Health Law Podcast, Episode 58, June 5, 2016
by By Nicolas Terry & Frank Pasquale, featuring Rachel E. Sachs (Academic Fellow), Ed Silverman, Ross Silverman and Nicholas Bagley

Fresh from ASLME's Health Law Professors' Conference in Boston: a special TWIHL! P...

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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...

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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...

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Petrie-Flom, 10 years on:

Harvard Law Today, April 14, 2016

On March 29, current and former affiliates of the Petrie-Flom Center for Health Law Policy, Biotechn...

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CRISPR, Are We Ready to Rewrite the Human Genome?

ECUSA Boston, March 24, 2016
by Speaker: Rachel Sachs (Academic Fellow)

Rachel Sachs (Academic Fellow) was a speaker at the ECUSA Boston event "CRISPR, Are We Ready to Rewr...

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Fecal Transplants to Treat C. difficile: FDA Seeks Comment on What IND Requirements to Waive

Regulatory Affairs, February 29, 2016
by Zachary Brennan, citing Rachel E. Sachs (Academic Fellow)

From the article: 

;

[...] The draft guidance comes as over the past few years, FMT, which basic...

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Fourth Annual Health Law Year in P/Review

Friday, January 29, 2016 8:00 AM - 5:00 PM
Conferences
2015-2016
Wasserstein Hall, Milstein West AB
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

>Couldn't attend in person? Learn more about the event

:
  • Learn more about the presentations -...

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Does it break the law to charge a lot for a cure?

The Incidental Economist Blog, January 28, 2016
by Nicolas Bagley, quoting Rachel E. Sachs (Academic Fellow)

>From the article

:

[...] Talk about sending the wrong signals about what sorts of drugs we value mos...

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Big Pharma, the game, makes it “easy to be villainous”

STAT, November 11, 2015
by Ike Swetlitz, referencing Rachel Sachs (Academic Fellow)

Excerpt from Article

:

[...] While Wicksteed made the game for the general public, the scientific an...

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Translational Microbiome Workshop: Patent Law and Microbiome-Based Technologies

MIT Center for Microbiome Informatics and Therapeutics, November 6, 2015
by Rachel Sachs (Academic Fellow)

 Researchers from OpenBiome, the first and largest public stool bank, and the MIT Center for Mi...

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FDA’s Pathway for Regulation of Fecal Microbiota Transplants

Journal of Law and the Biosciences, October 26, 2015
by Margaret F. Riley and Bernat Olle, in response to Rachel Sachs (Academic Fellow)

From the article: 

;

[...] A recent article by Rachel Sachs and Carolyn Edelstein inthe Journal...

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Review of Innovation Law and Policy: Preserving the Future of Personalized Medicine

Written Description Blog, July 27, 2015
by Lisa Ouellette

From the review

:

I highly recommend two recently posted articles on declining innovation incentives...

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PAPER NOW AVAILABLE

Journal of Law & the Biosciences, July 6, 2015 (Published Online)
by Rachel Sachs (Academic Fellow) and Carolyn Edelstein

Academic Fellow ;Rachel E. Sachs has a new article on the regulatory challenges o...

Read More

Countdown to Cures

The Medicine Maker, June 25th, 2015, Issue #0615
by Stephanie Sutton, quoting Rachel Sachs (Academic Fellow)

From the article: 

;

[...] According to Rachel Sachs, an academic fellow at the Petrie-Flom Cent...

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The Future of Personalized Medicine

Hosted by The Future Society at the Harvard Kennedy School, January 28, 2015
by Rachel E. Sachs

On January 28, 2015, Academic Fellow Rachel E. Sachs spoke to the Future Society at the Harvard Kenn...

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The New Model of Interest Group Representation in Patent Law

Yale Journal of Law and Technology, October 1, 2014
by Rachel Sachs (Academic Fellow)

From the article

:

Traditional public choice theory postulates that interest group representation is...

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Welcome 2014-2016 Academic Fellow Rachel Sachs!

Petrie-Flom Center, April 17, 2014

The Petrie-Flom Center is pleased to announce the new 2014-2016 Academic Fellow, Rachel Sachs. ...

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