Pharmaceutical Advertising in Medical Journals

CHEST, Volume 153, Issue 1
Michael S. Sinha, Aaron S. Kesselheim, and Jonathan J. Darrow (Student Fellow Alumnus)

From the article: Marketing efforts across many industries, including the health-care industry, have shifted toward digital advertising through web-based, social media, and mobile application platforms. Still, as recently as 2015, the health-care industry expended…

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Petrie-Flom Center launches Project on Precision Medicine, Artificial Intelligence, and the Law

Harvard Law Today, January 31, 2018
Q & A with I. Glenn Cohen (Faculty Director)

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Center for Advanced Studies in Biomedical Innovation Law (CeBIL) at the University of Copenhagen recently announced a new collaboration, the Project on Precision Medicine, Artificial…

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PFC Spotlight: Academic Fellow Alumnus Matthew J. B. Lawrence

Petrie-Flom Center , January 31, 2018

Matthew J. B. Lawrence was an Academic Fellow from 2010-2013, during which time his research focused on health care reform and health insurance coverage…

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The Petrie-Flom Center Launches the Innovative Funding Models in Translational Research Project

The Petrie-Flom Center, January 29, 2018

January 30, 2018 - The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is launching the

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The Federal Right to Try Act of 2017: A Wrong Turn for Access to Investigational Drugs and the Path Forward

JAMA Internal Medicine, January 22, 2018
Alison Bateman-House and Christopher T. Robertson (Academic Fellow Alumnus)

From the article: In 2017, President Trump said that “one thing that’s always disturbed”1 him is that the US Food and Drug Administration (FDA) denies access to experimental drugs even “for a patient who’s terminal…[who] is…

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The Petrie-Flom Center Launches New Project: Precision Medicine, Artificial Intelligence, and the Law (PMAIL)

Petrie-Flom Center, January 23, 2018

The Project on Precision Medicine, Artificial Intelligence, and the Law will seek to better understand the frontiers of big data in health care diagnostics, through interdisciplinary analysis of important health law and policy issues. January 23, 2018 –…

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Cops, Docs, and Code: A Dialogue between Big Data in Health Care and Predictive Policing

UC Davis Law Review, Vol. 51, No. 437, 2017
I. Glenn Cohen (Faculty Director) and Harry Graver

Abstract: “Big data” has become the ubiquitous watchword of this decade. Predictive analytics, which is something we want to do with big data -- to use of electronic algorithms to forecast future events in real time. Predictive analytics is interfacing…

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Patient-Centered Outcomes Research: Stakeholder Perspectives and Ethical and Regulatory Oversight Issues

The Hastings Center, January-February 2018
Emily A. Largent (Student Fellow Alumna), Joel S. Weissman, Avni Gupta, Melissa Abraham, Ronen Rozenblum, Holly Fernandez Lynch (Academic Fellow Alumn

Abstract:  The Patient-Centered Outcomes Research Institute (PCORI), the leading research institute in the United States for patient-centered outcomes research (PCOR), funded our multiyear mixed-methods project, the Patient Centered Outcomes Research Oversight Study, to begin systematically…

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It’s time to levy penalties for failing to report clinical trial results

STAT, January 17, 2018
Holly Fernandez Lynch (Academic Fellow Alumna and former Executive Director)

From the article: I started my first job as an attorney in the fall of 2007, days after President George W. Bush signed the Food and Drug Administration Amendments Act (FDAAA) into law. As part of my firm’s FDA group, my job was to figure out what…

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Tip of the Iceberg II: How the Intended-Uses Principle Produces Medical Knowledge and Protects Liberty

11 NYU Journal of Law & Liberty 770, January 12, 2018
Christopher T. Robertson (Academic Fellow Alumnus) and Victor Laurien

Abstract In recent years, the Food and Drug Administration’s pre-market approval process has come under increasing scrutiny as an infringement on liberty and a regulation of speech. In the first part of this symposium contribution, we offer a case study of Seroquel XR, showing how the…

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A New Approach to Treat Childhood Leukemia: Novartis’ CAR-T Therapy

The Journal of Law, Medicine & Ethics, January 10, 2018
Frazer A. Tessema and Jonathan J. Darrow (Student Fellow Alumnus)

From the article: On August 30, 2017, the US Food and Drug Administration (FDA) announced the approval of tisagenlecleucel (Kymriah; CTL019), Novartis' new treatment for B-cell acute lymphoblastic leukemia (ALL) in children or young adults who are either unresponsive…

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Federal Right-to-Try Legislation — Threatening the FDA’s Public Health Mission

NEJM, January 10, 2018
Steven Joffe and Holly Fernandez Lynch (Academic Fellow Alumna and former Executive Director)

From the article: The Food and Drug Administration (FDA) is the gatekeeper of the country’s drugs and medical devices. Originally created to prevent the misleading of patients, it was later tasked with ensuring the safety of medical products. In 1962, Congress…

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Drug Policy: The Year In Review, And The Year Ahead

Health Affairs Blog, January 4, 2018
Rachel E. Sachs (Academic Fellow Alumna)

From the article:  Last year was an unquestionably busy time for health care news of all kinds. Media and policy coverage rightly focused on the many attempts to repeal the Affordable Care Act, but it was also…

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Speed, Safety, and Industry Funding — From PDUFA I to PDUFA VI

The New England Journal of Medicine, December 7, 2017
Jonathan J. Darrow (Student Fellow Alumnus), Jerry Avorn, and Aaron S. Kesselheim

From the paper: In August, President Donald Trump signed into law the sixth version of key legislation for the Food and Drug Administration (FDA), known as the Prescription Drug User Fee Act (PDUFA VI). The legislation continues a policy that authorizes the agency…

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The FDA’s Expedited Programs and Clinical Development Times for Novel Therapeutics, 2012-2016

JAMA, Issue 318, no. 21
Thomas J. Hwang, Jonathan J. Darrow (Student Fellow Alumnus), Aaron S. Kesselheim

From the paper: The US Food and Drug Administration (FDA) has 4 expedited programs to speed the development and review of drugs treating serious diseases: (1) priority review leads to FDA review in 6 months (vs 10 months for standard review); (2) accelerated approval…

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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…

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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…

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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…

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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…

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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…

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