Why Did That Drug Price Increase 6,000%? It’s The Law

Forbes, February 10, 2017
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 is an “outlier.” This is one of their own – although…

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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
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From the article: As far as what existing regulations if repealed would be considered part of the “two out” part of the EO, OMB notes, “Any existing regulatory action that imposes costs and the repeal or revision of which will produce verifiable…

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E&C delays vote on drug pricing bill

Politico, February 6, 2017
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 generics to really make a difference,” said Rachel Sachs…

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What You Don’t Know About the Cost of Grandma’s Prescription

Pacific Standard, February 3, 2017
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 and intellectual property laws affect food and drug regulation…

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NFL Team Doctors: In Whose Interest?

Radio Health Journal, February 5, 2017
Nancy Benson, interviewing I. Glenn Cohen (Faculty Director)

From the interview: Injured NFL players are treated by doctors employed by teams, but a Harvard study claims there is an inherent conflict of interest in that arrangement, which might mean putting players on the field before they’re recovered. One of the study’s…

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A New Day For Oversight Of Human Subjects Research

HealthAffairs, February 6, 2017
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,…

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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
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 major parties…

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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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