2017-2018 Petrie-Flom Center Student Fellowship
Harvard Law School

Deadline: August 11, 2017

The deadline for applications for the 2017-2018 fellowship is now closed.  The Center and Student Fellowship. The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is an interdisciplinary… Read More

AVAILABLE FOR PREORDER: Big Data, Health Law, and Bioethics

Cambridge University Press, Forthcoming, March 2018
by Edited by I. Glenn Cohen (Faculty Director), Holly Fernandez Lynch (former Executive Director), Urs Gasser, and Effy Vayena

About the Book: When data from all aspects of our lives can be relevant to our health - from our habits at the grocery store and our Google searches to our FitBit data and our medical records - can we… Read More

FDA-Approved Digital Pill Causes Concerns

KJZZ Radio, November 28, 2017
by Steve Goldstein, interviewing I. Glenn Cohen (Faculty Director)

The first so-called digital pill has been approved by the Food and Drug Administration. It’s a version of the antipsychotic drug Abilify and contains a tiny sensor that will send a signal to a patch… Read More

Germ-Line Gene Editing and Congressional Reaction in Context

Journal of Law and Health, Vol. 30 (2017), Issue 1
by Russell A. Spivak, I. Glenn Cohen (Faculty Director), and Eli Y. Adashi

Abstract: On December 18, 2015, President Obama signed into law a policy rider forestalling the therapeutic modification of the human germ line. The rider, motivated by the science’s potential unethical… Read More

Federal Tax Plan Could Cause Problems For Puerto Rico’s Medical Manufacturers And Hurricane Recovery

NPR, November 27, 2017
by Greg Allen and Marisa Penaloza

[...] after Hurricane Maria, manufacturers in Puerto Rico are now facing what some are calling a potential man-made disaster. It's a provision in the tax bill that recently passed the House that would… Read More

Gene Therapy Hits a Peculiar Roadblock: A Virus Shortage

New York Times, November 27, 2017
by Gina Kolata

Eager to speed development of revolutionary treatments, the Food and Drug Administration recently announced that it would expedite approval of experimental gene therapies. But the regulatory process may… Read More

Digital pill offers chance of new life to old drugs

Financial Times, November 22, 2017
by FT Staff, quoting I. Glenn Cohen (Faculty Director)

From the article: Amid broader concerns about how medical information may be used, Proteus says that its product complies with “all applicable laws and standards” on data protection. Patients… Read More

First Digital Pill Approved to Worries About Biomedical ‘Big Brother’

New York Times, November 13, 2017
by Pam Belluck, featuring I. Glenn Cohen (Faculty Director)

For the first time, the Food and Drug Administration has approved a digital pill — a medication embedded with a sensor that can tell doctors whether, and when, patients take their medicine. The approval,… Read More

Corporate Paralegal or Junior Attorney (entry level)
Addgene

Deadline: Open until filled.

General Information: Addgene is a thriving, non-profit organization that facilitates biomedical research and discovery. Addgene assists scientists by archiving their plasmid DNA samples and distributing… Read More

Artificial wombs are coming. They could completely change the debate over abortion.

Vox, August 23, 2017
by I. Glenn Cohen (Faculty Director)

From the article: There’s a scientific development on the horizon that could upend the abortion debate: artificial wombs. The research remains preliminary, but in April a group of scientists at the… Read More

Questions About The FDA’s New Framework For Digital Health

Health Affairs Blog, August 16, 2017
by Nathan G. Cortez, Nicolas Terry, and I. Glenn Cohen (Faculty Director)

From the article: In June 2017, the new Food and Drug Administration (FDA) commissioner Scott Gottlieb pre-announced his agency’s Digital Health Innovation Action Plan that indicates… Read More

The One Time Congress Let the Public Comment on an Upcoming Bill

Pacific Standard, August 14, 2017
by Francie Diep, quoting Rachel E. Sachs (Academic Fellow Alumna)

[...] Congress doesn't typically ask for public comments on the bills it's considering. But, in January of 2015, the House Energy and Commerce Committee did just that, for a first draft of the 21st… Read More

Bernie Sanders Tells Big Pharma

International Business Times, August 7, 2017
by Josh Keefe, quoting Rachel E. Sachs (Academic Fellow Alumna)

[...] Other experts told IBT federal support of drug development goes well beyond just funding research. “It’s not so much the money we are actually spending through NIH. We are providing huge… Read More

Who’s Actually Using ‘Right-To-Try’ Laws?

RAPS, August 4, 2017
by Zachary Brennan, quoting Rachel E. Sachs (Academic Fellow alumna)

'The record with state-level right-to-try laws also suggests lackluster interest from industry. "It's telling that although 37 states have adopted these laws, when asked to provide examples of… Read More

Public Participation in Drafting of the 21st Century Cures Act

The Journal of Law, Medicine & Ethics, July 14, 2017
by Thomas J. Hwang, Rachel E. Sachs (Academic Fellow Alumna), Aaron S. Kesselheim

Abstract The 21st Century Cures Act is a major act of legislation that contains numerous changes to drug and device regulation. The House of Representatives passed the Act after considerable interest group… Read More

Associate Director of Research
Consortium on Law and Values in Health, Environment, & the Life Sciences, University of Minnesota

Deadline: Open until filled

Opportunity The University of Minnesota’s Consortium on Law and Values in Health, Environment & the Life Sciences (consortium.umn.edu) is seeking a highly qualified individual to collaborate… Read More

Book Review: I Contain Multitudes - The Microbes Within us and a Grander View of Life

Journal of Law and the Biosciences, June 2017
by Rachel E. Sachs (Academic Fellow Alumna)

From the review by Rachel E. Sachs: Ed Yong's I Contain Multitudes: The Microbes Within us and a Grander View of Life is a thoughtful, readable, and even humorous look at the rapidly evolving… Read More

Call for Papers: Data-driven Health Care Conference
Ewha Institute for Biomedical Law & Ethics, South Korea

Deadline: June 15, 2017

1.   Conference Description The Ewha Institute for Biomedical Law & Ethics (EIBLE) is seeking submissions for its annual conference to be held on September 23, 2017 in Seoul. This year’s… Read More

Pre-order now and get 30% off! Specimen Science

MIT Press, September 2017
by Edited by Holly Fernandez Lynch (Executive Director), Barbara E. Bierer, I. Glenn Cohen (Faculty Director), and Suzanne M. Rivera

Pre-order through MIT Press and receive 30% off using discount code MSPECIMEN30: Order now! This edited volume stems from a conference in 2015 that brought together leading experts to address key… 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 Petrie-Flom Center and Harvard Law School in partnership with Duke University and Stanford University, has… Read More

Regulating Research with Biospecimens under the Revised Common Rule

The Hastings Center Report, May/June 2017
by Holly Fernandez Lynch (Executive Director) and Michelle N. Meyer (Academic Fellow Alumna)

From the paper: Since 2011, the research community had waited with bated breath as regulators contemplated for the first time bringing secondary research with nonidentifiable biospecimens under the Common… Read More

Reading the Fine Print in DNA Kits

NBC Boston, May 23, 2017
by Interview featuring I. Glenn Cohen (Faculty Director)

DNA kits are very popular these days with people wanting to know what countries their ancestors came from. But before seeking out the secrets of your family tree, make sure you read the fine print. Watch… 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 Pensions marked up the proposed Food and Drug Administration (FDA) user fee reauthorization bill and… 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 therapies? "So there are pros and there are cons," said Rachel Sachs, a law professor at Washington University in… Read More

Babies from skin cells? New fertility technology raises ethical questions

The Current, May 19, 2017
by Lara O'Brien and Karin Marley, interviewing I. Glenn Cohen (Faculty Director)

From the article: Women producing sperm. Or, for that matter, men producing eggs. Those could, in theory, be some of the results of a new reproductive technology that's looming on the horizon,… Read More

Call for Papers
Beazley Institute for Health Law and Policy at Loyola University Chicago School of Law

Deadline: June 16, 2017

General Description The Beazley Institute for Health Law and Policy at Loyola University Chicago School of Law and Annals of Health Law invite original research paper submissions for presentation… Read More

Babies From Skin Cells? Prospect Is Unsettling to Some Experts

New York Times, May 16, 2017
by Tamar Lewin, citing I. Glenn Cohen (Faculty Director)

From the article: Three prominent academics in medicine and law sounded an alarm about the possible consequences in a paper published this year. “I.V.G. may raise the specter of ‘embryo farming’… Read More

ORDER NOW & GET 20% OFF! Law, Religion, and Health in the United States

Cambridge University Press, July 2017
by Holly Fernandez Lynch (Executive Director), I. Glenn Cohen (Faculty Director), and Elizabeth Sepper

About the Book: While the law can create conflict between religion and health, it can also facilitate religious accommodation and protection of conscience. Finding this balance is critical to addressing… 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 for new drugs and enormous price hikes on old drugs have focused public ire on the pharmaceutical… Read More

Should We Study Human Embryos Beyond 14 Days?

NOVA Next, April 26, 2017
by Jenny Morber, quoting I. Glenn Cohen (Faculty Director)

From the article: [...] Some critics view calls to re-evaluate the 14-day rule as a pernicious moving of the goalposts. How meaningful can they be, the line of reasoning goes, if scientists want to change… Read More

Science Needs Your Cells

New York Times, April 21, 2017
by Holly Fernandez Lynch (Executive Director) and Steven Joffe

Biospecimens are essential to medical progress, but just medical waste to patients. Let's promote the science. From the op-ed: Many aspects of Ms. Lacks’s story reflect genuine injustice: the… Read More

PFC Spotlight: Student Fellow Alumnus Matthew Baum

Petrie-Flom Center, April 13, 2017

Matthew Baum was a Student Fellow for the 2013-2014 academic year, as a second year MD-PhD student in the Health Science and Technology combined program of Harvard and MIT. Then Academic Fellow… 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 Rachel Sachs, a health law professor at Washington University in St. Louis. “That would make insurers… 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 brought up all the time,” says Rachel Sachs, an innovation and health law professor at Washington… 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 Journal of Medicine perspective, Rachel Sachs, a Washington University associate professor of law who studies… 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 Bill Improving Access to Affordable Prescription Drugs Act was introduced this week.  You can read the summary of the bill here.  Rachel Sachs… 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 offering dueling approaches to Gottlieb and the challenges he may face, if confirmed. — "An FDA Commissioner… 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, and Pensions conducted the confirmation hearing for Dr. Scott Gottlieb, President Trump’s nominee… Read More

Prohibiting sperm donor anonymity in the US and possible effects on recruitment and compensation

BioNews, April 3, 2017
by Andrew Hellman and I. Glenn Cohen (Faculty Director)

From the article: Many children conceived using donor sperm or eggs want to know their biological parents. In the US, some clinics make the identity of the sperm donor available to… 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 Food and Drug Administration (FDA). As compared with some of the other people whose names were floated… Read More

Executive Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics
Harvard Law School

Deadline: This position has been filled.

Duties & Responsibilities The Executive Director works in partnership with the Faculty Director on strategic planning and vision for the Center, and oversees the Center’s staff, activities, and… Read More

Addressing the ethical issues raised by synthetic human entities with embryo-like features

eLife, March 21, 2017
by John Aach, Jeantine Lunshof, Eswar Iyer, and George M. Church

On November 7, 2016, the Petrie-Flom Center hosted the conference "The Ethics of Early Embryo Research & the Future of the 14-Day Rule," which convened experts in bioethics, stem cell research,… Read More

Final Revisions to the Common Rule

U.S. Department of Health and Human Services

On January 19, 2017, federal regulators published the Final Rule to amend and update the Federal Policy for the Protection of Human Subjects (“the Common Rule”).  Key provisions govern… Read More

2018 Brocher Foundation Call for Proposals
Brocher Foundation, Switzerland

Deadline: May 07, 2017

Call for proposals for the 2018 events is launched! The Brocher Foundation offers to researchers the opportunity to organize a one and a half day multidisciplinary symposium or a two or three day… Read More

Call for Papers
European Pharmaceutical Law Review (EPLR)

Deadline: Various

Calll for Papers The European Pharmaceutical Law Review (EPLR) provides a forum to discuss, comment and review all issues raised by the development and implementation of the law and policy governing the… Read More

Mitochondrial Replacement Therapy: Unmade in the USA

The JAMA Forum, February 14, 2017
by Eli Y. Adashi and I. Glenn Cohen (Faculty Director)

From the article: Mitochondrial replacement therapy, an experimental approach that takes aim at maternally inherited mitochondrial diseases, is on the verge of being implemented in the United Kingdom,… 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, often on a monthly basis, and have become such a stress on the public that they came up repeatedly among both… 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 innovative ideas: patents and trade secrecy. But accounts of this choice underexplore the role of the… Read More

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

Gizmodo, January 13, 2017
by 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… 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. 17-1480 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… 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 administration and Congress work with FDA and the Centers for Medicare & Medicaid Services (CMS) to… Read More

The Legality of Biometric Screening of Professional Athletes

The American Journal of Bioethics , 2017, Vol. 17, Issue 1
by Jessica L. Roberts, I. Glenn Cohen (Faculty Director), Christopher R. Deubert (Senior Law & Ethics Associate) & Holly Fernandez Lynch (Executive Direc

From the article: In their thoughtful article, “Tracking U.S. Professional Athletes: The Ethics of Biometric Technologies,” Katrina Karkazis and Jennifer Fishman do an excellent job of outlining… 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 and expert in innovation policy, said the government had every right to seek price concessions. She noted… Read More

Academic Fellow Alumna Michelle N. Meyer Named in Forbes List of 10 Favorite

Forbes, December 15, 2016
by 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… Read More

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 in the United States — which is to say, anonymously. That’s largely because anonymity can… Read More

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, yet there is little regulatory oversight of these medical procedures in the United States. In a field marked… 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 regulations and bills over holiday weekends, the “final” text of the 21st Century Cures bill… 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 Century Cures: some bad provisions are gone, some remain, & some to watch. http://blogs.harvard.edu/billofhealth/2016/11/25/the-newest-21st-century-cures-draft-moderates-but-doesnt-eliminate-controversy/ … 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 matters. And it matters not just for politics. For regulatory affairs folks in in the pharmaceutical and medical… 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 courses in January 2017!                        … 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 devoted little time and attention to the question of pharmaceutical pricing. Now, after a series of highly… Read More

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 Harvard Ed Portal as part of his online EdX course "Bioethics: The Law, Medicine, and Ethics of Reproductive… Read More

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 discoveries in science, we are able to do amazing things. However, these new developments have brought… Read More

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 Harvard Medical School. Then Academic Fellow and now Faculty Director I. Glenn Cohen served as his… Read More

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 and Human Services, together with other federal agencies, announced proposed changes to the rules governing… Read More

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 Genetics An introduction to the study of bioethics and the application of legal and ethical reasoning. Course begins on September… Read More

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 possible they had filed away plans for a generic version in case a significant competitor arose. Rachel Sachs,… Read More

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 foods containing genetically engineered materials. The measure preempts state laws, like Vermont’s,… Read More

Post-Doctoral Fellow for Law and Ethics of Assistive Technology in Aging
University of Ottawa: Centre for Health Law, Policy and Ethics

Deadline: October 08, 2016

Brief Job Description: We are seeking a skilled and enthusiastic postdoctoral fellow (PDF) to pursue an innovative research program at the intersection of law/ethics/technology with a focus on aging. We… Read More

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 addressing recent legislation preventing the FDA from approving any research "in which a human embryo… Read More

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 results could offer clarity for disputes over any of the estimated million or so frozen embryos in the US.… Read More

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 embryos than they intend to implant immediately. The technology often requires multiple attempts to reach… Read More

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, says it’s “very common” for researchers to take tissue and use it for research. These… Read More

New EdX Course: Bioethics: The Law, Medicine, and Ethics of Reproductive Technologies and Genetics
Taught by Petrie-Flom Faculty Director Glenn Cohen

Deadline: September 06, 2016

About this course Bioethics provides an overview of the legal, medical, and ethical questions around reproduction and human genetics and how to apply legal reasoning to these questions. This law course… Read More

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 conflict. It examines four particular intersections: The first involves religiously motivated denials of service,… Read More

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

Deadline: July 17, 2016

Terms of reference: Title: Policy Advocacy Manager Based: Geneva Duration: Long term contract – Full time position Reporting to: Head of Policy Advocacy Starting date: September… Read More

Call for Papers: Tenth Annual Symposium on Health Law and Policy
Beazley Institute for Health Law and Policy, Loyola University

Deadline: May 31, 2016

The Beazley Institute for Health Law and Policy at Loyola University Chicago School of Law and Annals of Health Law invite original research paper submissions on innovations in life sciences and stakeholder… Read More

Call for Harvard Student and Postdoc Submissions to the JLB
Journal of Law and the Biosciences

Deadline: September 09, 2016

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School collaborates with Stanford and Duke Universities to publish the Journal of  Law… Read More

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 optimal use of healthcare products also requires good information about the likely effects of products in… Read More

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, Biotechnology, and Bioethics were joined by Harvard Law School's Dean Martha Minow and several prominent… Read More

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 inventions to processes, procedures to communication, our job is to meet people where they are and provide… Read More

Associate Editor - Ethics
American Medical Association Journal of Ethics

Deadline: May 27, 2016

Associate Editor – Ethics The American Medical Association (AMA), the nation’s largest professional association of physicians, has a dynamic opportunity for the right individual.  You… Read More

Academic Fellow Alumnus W.Nicholson Price II to Join Faculty at University of Michigan School of Law

Petrie-Flom Center, March 31, 2016

We are pleased to announce that Petrie-Flom Center Academic Fellow Alumnus W. Nicholson Price II has been appointed an Assistant Professor at the University of Michigan School of Law. Nicholson… Read More

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 Rewrite the Human Genome?" on March 24, 2016. The gene editing tool CRISPR has revolutionized… Read More

FDA - Food

U.S. Food and Drug Administration

Website for the U.S. Food and Drug Administration, one of the agencies responsible for regulating the safety of the U.S. food supply.  Read More

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 food. 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, including information about food safety programs, manufacturing processes, industry systems, and import/export… Read More

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 crops.  Read More

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 government by providing them with a technical and legal basis for regulating the retail and food service segment… Read More

Food from Genetically Engineered Plants

Food and Drug Administration

This FDA site includes consumer information about food from genetically engineered plants, as well as FDA regulatory guidelines on these plants.  Read More

HHS Announces Proposal to Improve Rules Protecting Human Research Subjects

U.S. Department of Health and Human Services

The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have announced proposed revisions to the regulations for protection of human subjects in research. A… Read More

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 egg products. Read More

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 biobank. Read More

Foodborne Outbreaks

Centers for Disease Control

This site outlines the CDC’s role in investigation, surveillance, and prevention of food safety outbreaks.  Read More

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 for the global biomedical research community. Read More

Food Safety

FoodSafety.gov

Describes provisions of the Food Safety Modernization Act of 2011 and their role in strengthening the food safety system.  Read More

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 implications.  Read More

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 establishment, research focus, collections, and organizational structure. Read More

Codex Alimentarius

World Health Organization

The Codex, administered by WHO and the U.N. Food and Agriculture Organization, establishes international food safety benchmarks to promote consumer safety.  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 industry’s commitment to responsible data sharing. 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 their potential impact on patient care. 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 at advancing responsible clinical trial data sharing. 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 for the ethical use of human biological materials in biobanks, as well as the ethical use of data… Read More

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 fertility treatment? Host Dawn Davenport, Executive Director of Creating a Family, the national infertility… Read More

Food and Drug Law Institute

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

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 persons with experience in academic medicine, government, and medical publishing, as well as the pharmaceutical… Read More

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 repositories, and research that uses identifiable health information in repositories and databases. Read More

Ethicist
Trillium Health Partners

Deadline: March 08, 2016

Position: Ethicist Status: Full Time File#: 2016-4494 Dept/Health System: Ethics Site: Trillium Health Partners Hours Of Work/Shifts: Primarily Monday to Friday – some weekend day shifts Posted:… Read More

Harvard Food Law and Policy Clinic

The Harvard Law School clinic focused on seeking to increase access to healthy foods, reduce food waste, and utilize law and policy to impact the food system. Read More

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 advancing medical knowledge and promoting health. Read More

Global Directory of Biobanks, Tissue Banks, and Biorepositories

Specimen Central

An extensive listing of biobanks, tissue banks, and biorepositories, with links to all institutions. 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 basically involves the transfer of a healthy donor stool to the bowel of a patient infected with C. difficile,… Read More

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, ethical, and regulatory challenges of future reproductive breakthroughs. The lessons learned from the… Read More

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 Petrie-Flom Center and Harvard Law School in partnership with Duke University and Stanford University, has… Read More

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 article [...] Moreover, if a drug company cannot ascertain the problem for which a prescription is written, it lacks the means by which it can enforce its new patent. Therefore, it cannot recoup,… Read More

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 by the human microbiome, the community of microbes that live within each of our bodies and outnumber… Read More

Academic Fellow Rachel E. Sachs to Join Faculty at Washington University School of Law

Petrie-Flom Center, February 17, 2016

We are pleased to announce that Petrie-Flom Center Academic Fellow Rachel E. Sachs has been appointed an Associate Professor at the Washington University in St. Louis School of Law.  At Washington… Read More

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 Recommendations on Mitochondrial Replacement Therapy (MRT). Now here is my take on the report. But keep in mind… Read More

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 most. As Rachel Sachs wrote in an email: In my view, Sovaldi is a drug that shouldn’t exist… Read More

“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 and Faculty Director I. Glenn Cohen will participate in a plenary session at the 2016 MAGI Clinical Research… Read More

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. Description In biomedical research, the analysis of large datasets (Big Data) has become a major driver of innovation and success. ‘Biomedical Big Data’… Read More

Health Law, Policy, and Bioethics: Cross-Registration Opportunity for Harvard Students
Harvard Medical School

Deadline: January 15, 2016

Cross-registration is available for "Health Law, Policy, and Bioethics," a new course being offered as part of the HMS Master’s program in bioethics. A course description is provided below. Interested… Read More

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 we could, than to treat it once it developed. Yet economic incentives encourage researchers to focus on… Read More

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 and medical community is also starting to take note. The Lancet reviewed Big Pharma in October,… Read More

Regulating Secrecy

Washington Law Review, 2015 (Forthcoming)
by W. Nicholson Price II (Academic Fellow Alumnus)

Abstract:       Regulation interacts with intellectual-property exclusivity in socially problematic ways by encouraging secrecy at the expense of innovation, efficiency, and… Read More

Postdoctoral Fellowship
McCoy Family Center for Ethics in Society, Stanford University

Deadline: December 7, 2015

For 2016-2017, we seek up to three new postdoctoral fellows. We welcome candidates with substantial normative research interests from philosophy or political science. We are especially interested in candidates… Read More

Call for Applications: OneStart Accelerator Programme
OneStart, London & Boston

Deadline: December 01, 2015

Translate your research into the real world. Join us at our official Boston Launch Night to learn about OneStart, the world's largest life sciences and healthcare accelerator programme, and the chance… Read More

Innovations in Health Law and Policy: Regulatory Challenges and Strategies for Change Conference

UNH School of Law, October 26, 2015
by W. Nicholson Price II (Academic Fellow Alumnus)

Innovations in Health Law and Policy: Regulatory Challenges and Strategies for Change When: Monday, October 26, 2015 Where: UNH School of Law 2 White Street Concord, New Hampshire Presented by the Health… Read More

Law and Neuroscience

International Encyclopedia of Social and Behavioral Sciences (2nd Edition), 2015
by Owen D. Jones and Matthew R. Ginther

This encyclopedia entry discusses how the intersection of perennial legal questions and new neuroscientific advances has fueled the emergence of a new field: Law & Neuroscience. It provides an overview… Read More

How Patent Law Can Block Even Lifesaving Drugs

New York Times, September 28, 2015
by Austin Frakt, quoting Benjamin Roin (Former Faculty Co-Director & Academic Fellow; Current Affiliated Faculty)

From the article: To see evidence of this, just look at the behavior of pharmaceutical firms. When Benjamin Roin, assistant professor of technological innovation, entrepreneurship, and strategic management… Read More

How Prescription Drugs Get So Wildly Expensive

WIRED, September 23, 2015
by Nick Stockton, quoting Rachel E. Sachs (Academic Fellow)

From the article: [...] With all that in mind, here’s the important question: Is Shkreli an industry outlier, or was he just unlucky enough to be found out? “There’s one aspect… Read More

Healthcare Compliance Certification Program 2016 Health Law Student Scholarship
Seton Hall Center for Health & Pharmaceutical Law & Policy

Deadline: January 29, 2016

The Center for Health & Pharmaceutical Law & Policy: Healthcare Compliance Certification Program 2016 Health Law Student Scholarship The Healthcare Compliance Certification Program and the… Read More

Call for Abstracts: 2016 Petrie-Flom Annual Conference: Big Data, Health Law, and Bioethics
Petrie-Flom Center, Harvard Law School

Deadline: December 01, 2015

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2016 annual conference, entitled: “Big Data, Health Law, and… Read More

FDA in the 21st Century

Columbia University Press, September 2015
by Holly Fernandez Lynch (Executive Director) and I. Glenn Cohen (Faculty Director), eds.

Just out from Columbia University Press, FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies! This volume, co-edited by Petrie-Flom Center Executive… Read More

Complexifying Commodification, Consumption, ART, and Abortion

Journal of Law, Medicine and Ethics , July 2015, Vol. 43, Issue 2
by I. Glenn Cohen (Faculty Director)

Abstract:  This commentary on Madeira's paper complicates the relationships between commodification, consumption, abortion, and assisted reproductive technologies she draws in two ways. First,… Read More

Princeton Journal of Bioethics: Call for Papers

Deadline: August 31, 2015

The Princeton Journal of Bioethics is currently soliciting articles for its 2015-2016 issue. We are a nonpartisan, annual publication, edited by Princeton University students and a technical review board… Read More

How Champion-Pony Clones Have Transformed the Game of Polo

Vanity Fair, August 2015
by Haley Cohen, quoting I. Glenn Cohen (Faculty Director)

From the article:  [...] In horses, as in other species, certain experiences and conditions can cause changes to the way the DNA works in their cells. Though it has never been proved scientifically,… Read More

Black Box Medicine

Harvard Journal of Law & Technology, Vol. 28, No. 2 Spring 2015
by W. Nicholson Price II (Academic Fellow alumnus)

Petrie-Flom Academic Fellow alumnus Nicholson Price, now an Assistant Professor at the University of New Hampshire School of Law, has recently published an article in the Harvard Journal… Read More

More than meets the IRB: On human subjects research and regulation: perspectives on the future

More Than Meets the IRB Podcast , May 2015, No. 11
by Holly F. Lynch (Executive Director), I. Glenn Cohen (Faculty Director), Michael Leary

In this eleventh installment of “More Than Meets the IRB,” we talk with I. Glenn Cohen (JD, Professor of Law, Harvard Law School and Faculty Director, Petrie-Flom Center for Health… Read More

DEADLINE EXTENDED: Journal of Law and the Biosciences (JLB)
Call for Harvard Student Submissions

Deadline: September 30, 2015

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School collaborates with Stanford and Duke Universities to publish  the Journal  of  Law  and… Read More

This is Your Brain on Human Rights: Moral Enhancement and Human Rights

Law and Ethics of Human Rights, Vol 9, Issue 1, pp. 1-41 (2015) Symposium, Human Rights and Human Minds, 2015
by I. Glenn Cohen (Faculty Director)

Faculty Director I. Glenn Cohen has authored a new paper on the use of moral enhacement to increase the respect for human rights. Abstract: It seems fair to say that human rights law takes the… Read More

Fall 2015 Course: Drug Product Liability Litigation
Harvard Law School

Deadline: September 08, 2015

Drug Product Liability Litigation Mr. Peter Grossi Fall 2015 Course Meets: T, W 5:00pm - 7:00pm 2 classroom credits Prerequisites: None Exam Type: Any-Day Take-Home Course Requirements: Class… Read More

Innovation Law and Policy

U. C. Davis Law Review, Forthcoming 2016
by Rachel E. Sachs

Academic Fellow Rachel E. Sachs has a new article forthcoming in 2016 on law and the future of personalized medicine. From the article: Personalized medicine is the future of health care, and as such incentives… Read More

NOW ONLINE: I. Glenn Cohen Discusses Modern Fertility Technologies and Benefits

Chronicle (WCVB/ABC Boston), April 13, 2015
by Shayna Seymour, interviewing I. Glenn Cohen (Faculty Director)

Show Abstract: The birds and the bees are still important – but today's couples eager to start a family can also rely on Big Data to get them to parenthood. Tonight Shayna Seymour discovers… Read More

Are trade secrets delaying biosimilars?

Science, April 10, 2015
by W. Nicholson Price II (Academic Fellow Alumnus) and Arti K. Rai

Petrie-Flom Academic Fellow alumnus Nicholson Price, now an Assistant Professor at the University of New Hampshire School of Law, has recently published an article in Science on the cost and… Read More

Transatlantic Lessons in Regulation of Mitochondrial Replacement Therapy

Science, April 10, 2015
by I. Glenn Cohen (Faculty Director), with Eli Adashi and Julian Savulescu

Cambridge, Mass., April 9, 2015 – A paper forthcoming on Friday in Science discusses the regulation of a new technology that gives hope to women who carry genetic disease. Mutant mitochondrial DNA… Read More

Trio contrast approaches taken by Britain versus the US concerning mitochondrial replacement therapy

MedicalXpress, April 10, 2015
by Bob Yirka, citing I. Glenn Cohen (Faculty Director) et al.

Glenn Cohen, with Harvard University, Julian Savulescu, with the University of Oxford and Eli Adashi with Brown University have together written and published a Perspectives piece in the journal Science,… Read More

Is UK evaluation of reproductive tech a model for US?

MedicalXpress, April 10, 2015
by David Orenstein, citing I. Glenn Cohen (Faculty Director) et al.

When the United Kingdom resoundingly approved mitochondrial replacement therapy in February, it became the first country to give people this new medical option. In parallel it gave the United… Read More

“My Body, My Bank”

Texas Law Review, Vol. 93, No. 4, 2015
by I. Glenn Cohen (Faculty Director)

Abstract:       This essay reviews Kara Swanson’s "Banking on the Body: The Market in Blood, Milk, and Sperm in Modern America" (Harvard University Press, 2014) and… Read More

Academic Fellow Rachel Sachs Presents at 2015 Works-in-Progress in Intellectual Property Colloquium

Petrie-Flom Center, February 7, 2015

Petrie-Flom Academic Fellow Rachel Sachs presented her paper, "Innovation Law and Policy: Preserving the Future of Personalized Medicine," at the 2015 Works-in-Progress in Intellectual Property (WIPIP)… Read More