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

Business Insider, February 1, 2017
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 as fetal-pain laws. They…

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Trump’s travel ban rattles medical residency programs

Politico Pulse, January 31, 2017
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 passed Congress with bipartisan support — as an example…

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Morning View 01-31-17

Institute for Clinical and Economic Review (ICER), January 31, 2017
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 FDA.  Two articles below, first a general account, then a…

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Vitals

Axios, January 31, 2017
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 Washington University in St. Louis, explains why in this…

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The $4,500 injection to stop heroin overdoses

Washington Post, January 27, 2017
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 institutional buyers may also be able to afford Evzios. Their budgets are larger right now, so they’re less price sensitive, said Nicholson Price, an assistant professor…

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New rules ease consent requirements for scientists using patient specimens

STAT, January 18, 2017
Sharon Begley, quoting Holly Fernandez Lynch (Executive Director)

From the article: Allowing researchers to study such biospecimens without written consent “is the most substantive change from the proposed regulation,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. Although the group…

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

Gizmodo, January 13, 2017
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 Tinder date, never make it past drink one, and a few months…

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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
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 LLC, f/d/b/a AVENTIS, Defendants-Appellants.

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FDA Further Explains Delay on LDT Guidance

Regulatory Affairs Professionals Society, January 13, 2017
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 come up with a new way of regulating LDTs.

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PFC Spotlight: Faculty Affiliate Ameet Sarpatwari

The Petrie-Flom Center, January 12, 2017

Ameet…

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

FiercePharma, January 10, 2017
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,” Schleifer said.

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Could Amgen’s Patent Victory Be Bad For Medicine?

Forbes, January 6, 2017
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 of a competitor. Some patent attorneys reacted with shock. (Read the ruling.) “It’s…

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Behavioral science suggests that Obamacare may not change as much as Republicans claim

STAT, January 3, 2017
Christopher R. Robertson (Academic Fellow Alumnus), I. Glenn Cohen (Faculty Director), & Holly Fernandez Lynch (Executive Director)

From the article: In the waning days of his administration, President Obama encouraged Americans to take advantage of the opportunity to get health insurance in what may be the last open enrollment period under the Affordable Care Act. Given…

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

BuzzFeed News , December 31, 2016
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’s method of giving exclusive rights to promising drugs,” Washington University law professor Rachel Sachs told BuzzFeed News. Since the 1980’s, health…

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How Donald Trump’s Health Secretary Pick Endangers Women

New York Times, December 28, 2016
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 of American women. It is regrettable, but not surprising, that Mr. Trump has nominated…

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What’s Confusing Us About Mental Health Parity

HealthAffairs Blog, December 22, 2016
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 that was more restrictive than how most medical/surgical benefits were limited. This sounds simple…

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

New York Times, December 19, 2016
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 that the government, through Medicare and Medicaid,…

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Academic Fellow Alumna Michelle N. Meyer Named in Forbes List of 10 Favorite: Healthcare Commentaries of 2016!

Forbes, December 15, 2016
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 measured, insightful and pragmatic, embracing complexity and acknowledging uncertainty. The pieces…

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The FDA Should Approve Drugs Based on Evidence, Not Emotions

Slate, December 13, 2016
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 the drug’s manufacturer, Oldham demanded further testing,…

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How Is It Even Possible For Sofía Vergara’s Embryos To Sue Her? A Harvard Law Prof Weighs In

Refinery29, December 8, 2016
I. Glenn Cohen

From the article: The already-unusual legal battleover Modern Family actress Sofía Vergara’s frozen embryos reached a surprising new chapter on Tuesday — when the embryos sued Vergara. Yes: Two unborn, un-gestated frozen pre-embryos…

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