Religious groups to back Obamacare contraceptive mandate: Face dilemma over freedom, government rules on women

Washington Post, February 4, 2014
Tom Howell, Jr. quoting Holly Fernandez Lynch (Petrie-Flom Executive Director)

[...] In its filing, the AJC said the case presents a rare instance in which they see a clash between religious liberty and the equal rights of women. They said the government’s mandate ultimately promotes women’s health “in the least restrictive means available.” …

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Ethics and Ontology in Deep Brain Stimulation

Neuroscience, January 30, 2014
Michael J. Young (Petrie-Flom Student Fellow)

Rapid advancements in the fields of neurology and neuroscience over the past decade have enabled unprecedented progress toward the development of brain-modulating technologies and therapeutics. Central to these advancements are cross-disciplinary translational research efforts to engineer systems…

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Legal Aspects of Biobanking as Key Issues for Personalized Medicine & Translational Exploitation

Timo Minssen (Petrie-Flom Visiting Scholar) and Jens Schovsbo

Abstract: This perspective-article provides an overview on selected legal aspects of biobanking. It discusses these issues with a focus on public biobanks in a university setting and the specific challenges posed by personalized medicine (PM). We conclude that any decisions as…

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NEW BOOK: Science and Technology in International Economic Law: Balancing Competing Interests

Routledge, 2014
Bryan Mercurio and Kuei-Jung Ni (Petrie-Flom Visiting Scholar), editors

Science and technology plays an increasingly important role in the continued development of international economic law. This book brings together well-known and rising scholars to explore the status and interaction of science, technology and international economic law. The book reviews the place of…

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Defining mental illnesses: can values and objectivity get along?

BMC Psychiatry 13:346, December 24, 2013
Dominic Sisti, Michael Young (PFC Student Fellow), and Arthur Caplan

Abstract Background The creation of each edition of the Diagnostic and Statistical Manual (DSM) of psychiatry has proven enormously controversial. The current effort to revise the ‘bible’ of disorder definitions for the field of mental health is no exception. The controversy…

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Do Fixed Patent Terms Distort Innovation?: Evidence from Cancer Clinical Trials

Public Health Law & Policy e-Journal 5, no. 64, December 4, 2013
Eric B. Budish, Benjamin N. Roin, and Heidi Williams

Abstract: Patents award innovators a fixed period of market exclusivity, e.g., 20 years in the United States. Yet, since in many industries firms file patents at the time of discovery ("invention") rather than first sale ("commercialization"), effective patent terms vary: inventions…

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Petrie-Flom Center to collaborate with Harvard Catalyst: on second Clinical and Translational Science Award

Official Press Release:  Harvard Law School's Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics will launch a novel Ethics and Law initiative as part of the Regulatory Foundations, Ethics, and Law Program of Harvard…

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The Jurisdiction of the D.C. Circuit

Cornell Journal of Law and Public Policy, Vol. 23, No. 1, 2013
Eric M. Fraser, David K. Kessler, Matthew J.B. Lawrence, and Stephen Calhoun

Abstract: The U.S. Court of Appeals for the D.C. Circuit is unique among federal courts. It is well known for its unusual caseload, which is disproportionally weighted toward administrative law. What explains the unusual caseload? This Article explores the inputs into the D.C.…

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Now Available: Bioethical Prescriptions: To Create, End, Choose, and Improve Lives

Oxford University Press, 2013
Frances Kamm

Bioethical Prescriptions collects Frances M. Kamm's articles on bioethics, which…

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Announcing the New Journal of Law and the Biosciences

Oxford University Press, Forthcoming 2014
Petrie-Flom Center and HLS, Duke University, and Stanford University

The Petrie-Flom Center and Harvard Law School are delighted to announce our partnership with Duke University, Stanford University, and Oxford University Press to launch a new peer-reviewed, open access, online journal in 2014: Journal…

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VIDEO NOW AVAILABLE: Stem Cell Therapies:: Opportunities for Assuring the Quality and Safety of Unregulated Clinical Offerings

Institute of Medicine, November 18, 2013
Co-organized by I. Glenn Cohen

Stem cells hold tremendous potential to advance health and medicine. Through replacement of damaged cells and organs or supporting intrinsic repair, stem cell offer promising treatments for debilitating diseases and conditions such as Parkinson’s disease, diabetes, and spinal cord injury. Currently,…

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Informed consent for return of incidental findings in genomic research

Genetics in Medicine, October 24, 2013
Paul S. Appelbaum, Cameron R. Waldman, Abby Fyer, Robert Klitzman, Erik Parens, Josue Martinez, W. Nicholson Price II, & Wendy K. Chung

Purpose: Researchers face the dilemma of how to obtain consent for return of incidental findings from genomic research. We surveyed and interviewed investigators and study participants, with the goal of providing suggestions for how to shape the consent process. Methods: We…

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Plan B: access to emergency contraception in the legal and political cross hairs

Association of Reproductive Health Professionals, Contraception Journal, October 2013
I. Glenn Cohen, Lisa Sullivan, Eli Y. Adashi

The 8-year legal feud over access to emergency contraception between reproductive health advocates and the Food and Drug Administration (FDA) took multiple unexpected turns before coming to an abrupt end on June 10, 2013.1,2,3 On that day, after mounting legal setbacks and obstacles, the US Attorney…

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Can You Buy Sperm Donor Identification?: An Experiment

Journal of Empirical Legal Studies, October 23, 2013
I. Glenn Cohen and Travis G. Coan

In the United States, most sperm donations are anonymous. By contrast, many developed nations require sperm donors to be identified, typically requiring new sperm (and egg) donors to put identifying information into a registry that is made available to a donor-conceived child once he or she reaches…

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Perceptions of Efficacy, Morality, and Politics of Potential Cadaveric Organ Transplantation Reforms

Law and Contemporary Problems, Forthcoming
Christopher T. Robertson, David V. Yokum, and Megan S. Wright

We sought to explore the political feasibility of potential policy reforms to address the shortage of cadaveric organs for transplantation in America. We recruited 730 human subjects from an online population and assigned them to writing tasks that experimentally manipulated the salience of moral…

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Anonymity, the Production of Goods, and Institutional Design

Fordham Law Review, Forthcoming
Jeffrey Skopek

Abstract: In this article, I demonstrate that anonymity has been misconceived as an aspect of privacy, and that understanding this mistake reveals a powerful and underutilized set of legal tools for facilitating and controlling the production of information and other social…

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Making Do in Making Drugs: Innovation Policy and Pharmaceutical Manufacturing

Boston College Law Review, forthcoming
W. Nicholson Price II

Abstract:   Drug recalls, contamination events, and shortages are on the rise, but drug companies still rely on decades-old manufacturing plants and processes. Contrary to widespread perceptions, drug manufacturing is typically expensive, inefficient, and non-innovative.…

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When Truth Cannot Be Presumed: The Regulation of Drug Promotion under an Expanding First Amendment

Boston University Law Review, 2014
Christopher T. Robertson

Abstract:       The Food, Drug, and Cosmetic Act (“FDCA”) requires that, prior to marketing a drug, the manufacturer must prove that it is safe and effective for the manufacturer’s intended uses, as shown on the proposed label.…

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The Globalization of Health Care: Legal and Ethical Issues

Oxford University Press, 2013
I. Glenn Cohen, ed. (Faculty Director)

The Globalization of Health Care: Legal and Ethical Issues, edited by I.…

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Do Damages Caps Reduce Medical Malpractice Insurance Premiums?: A Systematic Review of Estimates and the Methods Used to Produce Them

Research Handbook on the Economics of Torts, Edward Elgar Publishers, November 21, 2012
Kathryn Zeiler (Academic Fellow Alumna) & Lorian Hardcastle

Abstract:       Despite common claims made in policy debates, the theoretical connection between tort reform and medical malpractice insurance premiums is ambiguous. Simple models suggest reforms such as statutory damages caps reduce premiums. More elaborate models…

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