Will inter partes review speed US generic drug entry?

Nature Biotechnology, Issue 35
Jonathan J Darrow (Student Fellow Alumnus), Reed F Beall & Aaron S Kesselheim

From the paper: Patents are ubiquitous in the pharmaceutical industry and are used by brand-name drug manufacturers to prevent low-cost generic competition and maintain high drug prices. Patents are granted by the US Patent and Trademark Office (USPTO), and it is…

Read More

Explaining the Absence of Surgical Procedure Regulation

Cornell Journal of Law and Public Policy, Vol 27, Issue 189
Jonathan J. Darrow (Student Fellow Alumnus)

From the paper: Each year in the United States, surgeons perform approximately 64 million surgical procedures, ranging from tooth extraction to open heart surgery.2 Yet, notwithstanding the frequency of surgical procedures and their often critical importance to patient…

Read More

Encouraging New Uses for Old Drugs

JAMA, December 4, 2017
Rachel E. Sachs (Academic Fellow Alumna), Paul B. Ginsburg, and Dana P. Goldman

From the paper: US Food and Drug Administration (FDA) approval of a new drug typically coincides with a period of patent protection, during which the manufacturer will often apply for additional indications to expand the market for the product. For example, the tyrosine…

Read More

Regulating Black-Box Medicine

Michigan Law Review, Vol. 116, Issue 3
W. Nicholson Price II (Academic Fellow Alumnus)

From the paper: Data drive modern medicine. And our tools to analyze those data are growing ever more powerful. As health data are collected in greater and greater amounts, sophisticated algorithms based on those data can drive medical innovation, improve the process…

Read More

2017’s Word Of The Year In Health Law And Bioethics: Uncertainty

Health Affairs, December 8, 2017
Carmel Shachar (Executive Director) and I. Glenn Cohen (Faculty Director)

Note: This post is the first in a series of Health Affairs posts from the Sixth Annual Health Law Year in P/Review event, held…

Read More

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

Cambridge University Press, Forthcoming, March 2018
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 really differentiate between big data and health big data? Will…

Read More

Germ-Line Gene Editing and Congressional Reaction in Context: Learning From Almost 50 Years of Congressional Reactions to Biomedical Breakthroughs

Journal of Law and Health, Vol. 30 (2017), Issue 1
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 ends, is only the most recent…

Read More

The Debate over Postmortem Sperm Retrieval of Fallen Soldiers

Jerusalem Post, November 22, 2017
Avishalom Westreich (Visiting Scholar Alumnus)

This essay is based in part on the workshop the Petrie-Flom Center hosted on October 23, 2017, in which then-Visiting Scholar Avishalom Westreich presented his research-in-progress…

Read More

Artificial Intelligence in Health Care: Applications and Legal Issues

The SciTech Lawyer, Vol. 14, no. 1
W. Nicholson Price II (Academic Fellow Alumnus)

From the paper: Artificial intelligence (AI) is rapidly moving to change the healthcare system. Driven by the juxtaposition of big data and powerful machine learning techniques—terms I will explain momentarily—innovators…

Read More

Are There Non-human Persons? Are There Non-person Humans?

TEDx Cambridge, October 12, 2017
I. Glenn Cohen (Faculty Director)

If we want to live a moral life, how should we treat animals or complex artificial intelligence? What kinds of rights should non-humans have? Harvard Law Professor and world-renowned bioethics expert Glenn…

Read More

Talking about Death

Boston Review, October 5, 2017
Frances Kamm (Senior Fellow Alumna)

From the article: We are now seeing projects directed at the general public asking people to consider how they would like to plan for their demise. Such projects can be very worthwhile, since thinking about the matter in advance could lead to better results for everyone.…

Read More

Contraceptive Coverage and the Balance Between Conscience and Access

JAMA, October 19, 2017
Ronit Y. Stahl and Holly Fernandez Lynch (Former Executive Director, Academic Fellow Alumna)

From the article: When the Obama administration included contraception in the essential benefits package to be covered by employer-sponsored health insurance plans under the Affordable Care Act, it sought to preserve access for women while addressing the concerns…

Read More

TEDxCambridge, Featuring Faculty Director I. Glenn Cohen: October 12, 2017

TEDxCambridge, October 12, 2017, Boston Opera House
I. Glenn Cohen (Faculty Director)

On October 12, 2017, Petrie-Flom Faculty Director I. Glenn Cohen was a distinguished speaker at TedX Cambridge at the Boston Opera House. TEDxCambridge curates one of the largest TEDx conferences in the world featuring 2,500 guests,…

Read More

Innovative Contracting for Pharmaceuticals and Medicaid’s Best-Price Rule

Journal of Health Politics, Policy and Law, September 28, 2017
Rachel E. Sachs (Academic Fellow Alumna), Nicholas Bagley, and Darius N. Lakdawalla

From the paper: In recent years, drug manufacturers and private payers have expressed interest in novel pricing models that more closely link a drug’s price to its value. Indication-based pricing, outcome-based pricing, drug licenses, and drug mortgages have…

Read More

Mobile Health Innovation and Interagency Coordination

Annals of Health Law, Vol. 26, Issue 22
Rachel E. Sachs (Academic Fellow Alumna)

From the paper: An app that can tell when a phone’s owner is having a seizure.1 A device that transforms a phone into a mobile EKG machine.2 An app that helps patients track their moles over time—and maybe alerts them when they should see a doctor.3 Just…

Read More

Opportunities for Organ Donor Intervention Research: Saving Lives by Improving the Quality and Quantity of Organs for Transplantation

The National Academic Press, October 10, 2017
By I. Glenn Cohen (Faculty Director) and members of the Committee on Issues in Organ Donor Intervention Research

The organ donation and transplantation system strives to honor the gift of donated organs by fully using those organs to save and improve the quality of the lives of their recipients. While most related research to date has focused on improving transplantation processes and health outcomes for recipients,…

Read More

Paternalism, reasonableness, and neutrality: a response to commentators

Journal of Medical Ethics, September 2017, Vol. 43 No. 9
Frances Kamm (former Senior Fellow)

From the article (from the commentary on Frances Kamm's earlier article, "Advanced Care and End of Life Care: Some Cautionary Suggestions."

Read More

Your Money or Your Patient’s Life? Ransomware and Electronic Health Records

Annals of Internal Medicine, September 19, 2017
By I. Glenn Cohen (Faculty Director), Sharona Hoffman, and Eli Y. Adashi

The mugger's demand “Your money or your life” is a familiar one. However, in an era of vast hospital computer networks and electronic health records, a novel risk to worry about is, “Your money or your patient's life.” This threat, known…

Read More

PFC Spotlight: Student Fellow Alumna Sara Abiola

Petrie-Flom Center, September 7, 2017

Sara Abiola, PhD, JD, was a Student Fellow during the 2006-2007 academic year, while a second-year law student and first-year health policy doctoral candidate. As part of the…

Read More

Influence, integrity, and the FDA: An ethical framework

Science, Sep 1, 2017: Vol. 357, Issue 6354, pp. 876-877.
Spencer Phillips Hey, I. Glenn Cohen (Faculty Director), Eli Y. Adashi, & Aaron S. Kesselheim

Summary: Among the core missions of the U.S. Food and Drug Administration (FDA) are protecting public health by assuring the safety and efficacy of drugs, biologics, and medical devices and advancing public health by…

Read More