Harvard Medical School 2017 Bioethics Conference: The Ethics of "Making Babies"

Friday, April 07, 2017
Conferences
2016-2017

The use of assisted reproductive technologies raises far-reaching ethical and legal implications, ye...

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Health Law Workshop: Kathryn Zeiler

Monday, March 27, 2017 5:00 PM
Health Law Workshops
2016-2017
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

>Kathryn Zeiler is Professor of Law and Nancy Barton Scholar at the BU School of Law. Prior to j... Read More

Cures Act Gains Bipartisan Support That Eluded Obama Health Law

New York Times, December 8, 2016
by Robert Pear

WASHINGTON — With self-congratulatory zeal and smiles all around, huge bipartisan majorities i...

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Should We Ban Anonymous Sperm Donation?

Vocativ, November 30, 2016
by Tracy Clark-Flory, quoting I. Glenn Cohen (Faculty Director)

From the article

:

There’s a push underway to change the way that most sperm is donated&n...

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Call for Abstracts: The Ethics of “Making Babies”
Harvard Medical School

Deadline: January 31, 2017, 5:00 PM

The use of assisted reproductive technologies raises far-reaching ethical and legal implications, ye...

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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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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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Legislation That Would Shape FDA And NIH Triggers Lobbying Frenzy

NPR, November 25, 2016
by Sydney Lupkin

The 21st Century Cures Act now being refined by the lame duck Congress is one of the most-lobbied he...

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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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How Donald Trump May Impact The FDA

Forbes, November 14, 2016
by Jon LaMattina

The election of a new President always sparks discussions around the new policies that the new leade...

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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...

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FDA Faults 12 Hospitals For Failing To Disclose Injuries, Deaths Linked To Medical Devices

Kaiser Health News, October 28, 2016
by Chad Terhune

Federal regulators said 12 U.S. hospitals, including well-known medical centers in Los Angeles, Bost...

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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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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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Professor offers basics of bioethics and the law in 90 minutes:

Harvard Gazette, September 20, 2016
by Deborah Blackwell, reviewing lecture by I. Glenn Cohen (Faculty Director)

On September 13, 2016, Petrie-Flom Faculty Director I. Glenn Cohen delivered a lecture at the Harvar...

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Bioethics and the Law of Reproductive Technology and Genetics

Harvard Ed Portal, Allston, MA, September 13, 2016

Genetic enhancements. Reproductive technologies. Animal-human hybrids. Through new technologies and...

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PFC Spotlight: Student Fellow Alumnus Neel Shah

Petrie-Flom Center, September 8, 2016

>Dr. Neel Shah was a Student Fellow for the 2007-2008 academic year, while in his third year at Harva...

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2016 Petrie-Flom Center Annual Open House

Wednesday, September 07, 2016 5:30 PM
Lectures and Panels
2016-2017
HLS Pub, Wasserstein Hall, 1st floor
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

At this event, faculty, colleagues, and students with shared interests in health law policy, biotech...

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Federal Government’s Proposed Expansion of Regulation of Biospecimen Research Should Be Reconsidered

Biopreservation and Biobanking, September 2016
by Christopher T. Robertson and Jonathan D. Loe

>Note: The full article is behind a paywall

.

Abstract

:

In September, the U.S. Department of Health...

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Bioethics: The Law, Medicine, and Ethics of Reproductive Technologies and Genetics

Petrie-Flom Center, Course begins September 6, 2016. Register now!

>Bioethics: The Law, Medicine, and Ethics of Reproductive Technologies and Genetic

s

An introduction...

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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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The GMO Labeling Fight Is Not Industry Versus Consumers

Forbes, August 26, 2016
by Steve Ansolabahere and Jacob E. Gersen (Director, Food Law Lab)

From the article

:

In late July, President Obama signed a bill requiring some form of labeling of fo...

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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...

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5 ways to avoid fighting over frozen embryos

Futurity, July 18, 2016
by David Orenstein-Brown, citing I. Glenn Cohen (Faculty Director)

[...] In a new paper, two experts review this history and propose five specific guidelines. The resu...

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Embryo Disposition Disputes: Controversies and Case Law

Hastings Center Report, July/August 2016, Vol. 46, Issue 5
by I. Glenn Cohen (Faculty Director) & Eli Y. Adashi

Abstract

:

When prospective parents use in vitro fertilization, many of them hope to generate more e...

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A designer will grow Alexander McQueen’s skin in a lab to use for leather bags and jackets

Quartz, July 16, 2016
by Marc Bain, quoting I. Glenn Cohen (Faculty Director)

[...] Glenn Cohen, an expert on the intersection of bioethics and law at Harvard Law School, sa...

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Religion and Reproductive Technology

In Law, Religion, and Health in the United States (Holly Fernandez Lynch, I. Glenn Cohen, Elizabeth Sepper, eds.), forthcoming 2017, Cambridge University Press, 2017 (forthcoming)
by I. Glenn Cohen (Faculty Director)

Abstract

:

This chapter will examines places where law, religion, and reproductive technology confli...

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Policy Advocacy Manager
DNDi (Drugs for Neglected Diseases initiative), Geneva, Switzerland

Deadline: July 17, 2016

Terms of reference

:

Title: Policy Advocacy Manage
r Based: Genev
a Duration: Long term...

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Petrie-Flom Center Student Fellowship 2016-2017
Petrie-Flom Center, Harvard Law School

Deadline: August 05, 2016

THE PETRIE-FLOM CENTE

R

STUDENT FELLOWSHIP PROGRAM, 2016-201

7

CALL FOR APPLICATION

S

The Center and...

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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...

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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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Health Acceleration Challenge
Harvard Business School & Harvard Medical School

Deadline: May 16, 2016

There are few communities of professionals that are as innovative as those in health care. From inve...

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Associate Editor - Ethics
American Medical Association Journal of Ethics

Deadline: May 27, 2016

Associate Editor – Ethic

s

The American Medical Association (AMA), the nation’s largest...

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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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FDA - Food

U.S. Food and Drug Administration

Website for the U.S. Food and Drug Administration, one of the agencies responsible for regulating th...

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Genetically Modified Crops

Foundation of American Scientists

An introduction to genetically modified crops, including key ecological concerns. 

... Read More

Title 21: Food and Drugs

Code of Federal Regulations

In Chapter I, Subchapter B, Parts 100-190, the regulations applicable to FDA’s oversight of fo..

. Read More

Food, Genetically Modified

World Health Organization

Educational page providing general and technical information on genetically modified foods. 

... Read More

FDA - Guidance and Regulation

U.S. Food and Drug Administration

Section of the FDA website containing FDA guidance and regulatory information applicable to food, in...

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Genetically Engineered Crops in the United States

United States Department of Agriculture, February 2014

Report by the USDA Economic Research Service on recent trends in adoption of genetically engineered...

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Food Code

U.S. Food and Drug Administration

The FDA’s Food Code is a model that assists food control jurisdictions at all levels of govern...

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Food from Genetically Engineered Plants

Food and Drug Administration

This FDA site includes consumer information about food from genetically engineered plants, as well a...

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USDA - Food Safety

U.S. Department of Agriculture, Food Safety and Inspection Service

Website for FSIS, an agency of the USDA responsible for ensuring food safety for meat, poultry, and...

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Genetically Engineered Crops: Past Experience and Future Prospects

National Academy of Science

Website announcing NAS study on the benefits and risks of GE crops. 

... Read More

What is a biobank? Differing definitions among biobank stakeholders

Clinical Genetics, March 2014
by Shaw et al.

An article discussing areas of agreement and difference in determining what constitutes a bioba..

. Read More

Foodborne Outbreaks

Centers for Disease Control

This site outlines the CDC’s role in investigation, surveillance, and prevention of food safet...

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Bioengineered (Genetically Engineered) Crops and Foods

American Medical Association

AMA statement on genetically engineered crops and foods. 

... Read More

Biorepositories and Biospecimen Research Branch

National Cancer Institute

Website for the BBRB, which provides leadership, tools, resources, and policies in biobanking f...

Read More

Food Safety

FoodSafety.gov

Describes provisions of the Food Safety Modernization Act of 2011 and their role in strengthening th...

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GMOs, Herbicides, and Public Health

New England Journal of Medicine, Aug. 20, 2015
by Philip J. Landrigan and Charles Benbrook

Describes the impact of two recent changes in the GMO landscape, and considers their larger implicat...

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Characterizing biobank organizations in the U.S.

Genome Medicine, Jan. 2013
by Henderson et al.

Results from a national survey of U.S. biobanks, including information on location, reason for...

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Codex Alimentarius

World Health Organization

The Codex, administered by WHO and the U.N. Food and Agriculture Organization, establishes internati...

Read More

Principles for Responsible Clinical Trial Data Sharing

PhRMA, EFPIA, Jul. 2013

A joint agreement produced by pharmaceutical trade groups PhRMA and EFPIA, affirming the indust...

Read More

Biobank resources for future patient care: developments, principles and concepts

Journal of Clinical Bioinformation, Sept. 2011
by Ákos Végvári et al

An overview of global biobank development, outlining the critical research role of biobanks and...

Read More

Food Labeling Litigation

by Nicole E. Negowetti

Report on food labeling class action lawsuits and FDA regulatory authority. 

... Read More

Clinical Trial Data Portal Gateway

EFPIA

This site offers a published list of major pharmaceutical companies’ online portals aimed ...

Read More

WMA Declaration on Ethical Considerations Regarding Health Databases and   Biobanks

World Medical Association, March 2015

A supplemental declaration to the Declaration of Helskini, which provides additional principles...

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Fertility Tourism: Options and Ethics

Creating A Family Radio, February 24, 2016
by Dawn Davenport, interviewing I. Glenn Cohen (Faculty Director)

Description

:

What should you consider when going abroad (or coming to the United States) for fertil...

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Food and Drug Law Institute

Non-profit site providing a space for discussion of food and drug law, including conferences and pub...

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Sharing of Clinical Trials Data: Benefits, Risks, and Uniform Principles

Annals of Internal Medicine, 2015
by Michael Rosenblatt et al.

This commentary discusses the benefits and risks of data sharing from the perspective of person...

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Research Repositories, Databases, and the HIPAA Privacy Rule

NIH, January 2004

Discusses the impact of the HIPAA privacy rule on the creation of research databases and reposi...

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Ethicist
Trillium Health Partners

Deadline: March 08, 2016

Position: Ethicis

t

Status: Full Tim

e

File#: 2016-449

4

Dept/Health System: Ethic

s

Site: Trillium...

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Harvard Food Law and Policy Clinic

The Harvard Law School clinic focused on seeking to increase access to healthy foods, reduce food wa...

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Sharing and Reporting the Results of Clinical Trials

JAMA, Jan. 2015
by Kathy L. Hudson and Francis S. Collins

This article advocates for sharing the results of clinical trials as an important means for adv...

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Global Directory of Biobanks, Tissue Banks, and Biorepositories

Specimen Central

An extensive listing of biobanks, tissue banks, and biorepositories, with links to all institut...

Read More

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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Food Safety News

Website providing coverage on food safety issues, including contributions from the FDA.

... Read More

Going Germline: Mitochondrial Replacement as a Guide to Genome Editing

Cell, February 25, 2016, Vol. 164, Issue 5
by By Eli Y. Adashi & I. Glenn Cohen (Faculty Director)

Mitochondrial replacement (MR) serves as a crucial test case and learning guide for the scientific,...

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New Journal of Law & Biosciences featuring Harvard student work

Journal of Law and the Biosciences (JLB), Vol. 3, Issue 1 (April 2016)

The ;Journal of Law and the Biosciences, the open-access journal launched in 2014 by the Pe...

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How to Make the Most of Drugs We Already Have

The Upshot, New York Times, February 22, 2016
by By Austin Frakt, citing Ben Roin (Academic Fellow alumnus)

From the articl

e

[...] Moreover, if a drug company cannot ascertain the problem for which a prescri...

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The Unpatentable Microbiome

New England Regional Junior Faculty Scholarship Workshop, February 12, 2016
by Rachel E. Sachs (Academic Fellow)

>Presentation Abstract: 

;

Scientists have recently begun to appreciate the important role played...

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Food and Drug Law

Peter Hutt et al., 2013

Introductory casebook on administrative and other key issues in food and drug law. 

... Read More

NAM Releases Report on Mitochondrial Replacement Therapy

Bill of Health Blog, February 3, 2016
by I. Glenn Cohen (Faculty Director)

>From the Part II post: 
;
 
;
My last post was a summary of the NAM’s Recom...
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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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“FDA in the 21st Century: A Panel Discussion”:

MAGI, May 2, 2016, 8:30 - 10:00 AM
by Holly Fernandez Lynch (Executive Director) and I. Glenn Cohen (Faculty Director)

On Monday, May 2, 2016, from 8:30 to 10:00am, Petrie-Flom Executive Director Holly Fernandez Lynch a...

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Symposium on “Ethical Risk Assessment in Biomedical Big Data”

Organised by the Oxford Internet Institute, University of Oxford, in association with the Brocher Foundation., March 14-15, 2016
by Featuring I. Glenn Cohen (Faculty Director)

>Please register via the event website

.

Descriptio

n

In biomedical research, the analysis of large d...

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Why Preventing Cancer Is Not the Priority in Drug Development

The Upshot, New York Times, December 28, 2015
by Austin Frakt, citing Ben Roin (former Academic Fellow and Faculty Co-Director)

From the article: 

;

Most people would agree that it would be better to prevent cancer, if...

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