TOMORROW (2/10) Fetal Pain: An Update on the Science and Legal Implications

fetalpain_slideFetal Pain: An Update on the Science and Legal Implications
February 10, 2016 12:00 PM
Wasserstein Hall, Milstein East C
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Amanda Pustilnik, JD and Maureen Strafford MD will discuss fetal pain, including advances in neuroscience and treatment and their implications for the law. Continue reading

NEW EVENT (2/18): Assessing the Viability of FDA’s Biosimilar Pathway

16.02.18, FDA Biosimilars Pathway posterNEW EVENT: Assessing the Viability of FDA’s Biosimilar Pathway
February 18, 2016 12:00 PM
Pound Hall, Room 100
Harvard Law School
1536 Massachusetts Ave., Cambridge, MA

Description

The 2010 passage of the Biologics Price Competition and Innovation Act was intended to create a pathway for the approval of biosimilar drugs, to bring to market less expensive versions of innovators’ biologic therapeutics in the same way the Hatch-Waxman Act has worked so well for FDA approval of generic small-molecule drugs. But the Act has been mired in a host of statutory, regulatory, and scientific complication and delays, and five years later, the FDA has approved just one biosimilar product.  Continue reading

Blinding as a Solution to Bias

Blinding Bias

We’re pleased to announce that a new book by Petrie-Flom Center affiliates Christopher Robertson and Aaron Kesselheim will be available this week.  The edited volume — Blinding as a Solution to Bias: Strengthening Biomedical Science, Forensic Science, and Law — grew from a 2013 conference at Harvard co-sponsored by the Petrie-Flom Center.  From the fascinating history of blinding (starting in Ben Franklin’s living room to test the healing powers of Mesmerism) to the sham surgeries being used today, and the future novel uses of blinding in the courts, the book moves the debate forward.  What are the advantages and limitations of blinding compared to other solutions for biases? How can we quantify the biases in unblinded research? Can we develop new ways to blind decision-makers?  What are the ethical problems with withholding information?  Fundamentally, questions about who needs to know what open new doors of inquiry for the design of scientific research studies, regulatory institutions, and courts.  With a foreword by Larry Lessig, the book surveys the theory, practice, and future of blinding, drawing upon leading authors with a diverse range of methodologies and areas of expertise, including medicine, law, forensic sciences, philosophy, economics, psychology, sociology, and statistics.  It is available for pre-order from the publisher and Amazon.com.

REGISTER NOW! (3/29) The Future of Health Law and Policy: The Petrie-Flom Center’s 10th Anniversary Conference Celebration

PFC 10th Logo-Horizontal-Otlns-FnlThe Future of Health Law and Policy: The Petrie-Flom Center’s 10th Anniversary Conference Celebration
March 29, 2016 8:00 AM – 5:00 PM
Wasserstein Hall, Milstein East ABC
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

The Petrie-Flom Center is celebrating its first decade and kicking off the next by looking at the future of health law and policy!

Please join us as we bring together Petrie-Flom and other prominent Harvard Law School alumni to discuss major trends, developments, and open questions in the fields of health law policy, biotechnology, and bioethics. We’ll hear about the founder’s vision for the Center and the Dean’s perspective on the Center’s influence within the Harvard Law School community and beyond. Center Leadership will discuss what we have accomplished in the first ten years, and more important, our plans for the future. Alan Weil JD ’89, Editor-in-Chief of Health Affairs, will deliver the keynote address.

Agenda

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TOMORROW, 1/29! Fourth Annual Health Law Year in P/Review Symposium


MORE SEATS AVAILABLE! Fourth Annual Health Law Year in P/Review
January 29, 2016 8:00 AM – 5:00 PM
Wasserstein Hall, Milstein West AB 
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

The Fourth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2015 and what to watch out for in 2016. The discussion at this day long event will cover hot topics in such areas as health insurance, health care systems, public health, innovation, and other issues facing clinicians and patients.

In addition to presenting at the conference, many of our speakers will write about their topics for a collaborative blog series that will begin in February 2016 on the Health Affairs Blog.

This year’s Health Law Year in P/Review is sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, the New England Journal of MedicineHealth Affairs, the Hastings CenterHarvard Health Publications at Harvard Medical School, and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund at Harvard University.

Agenda Continue reading

Latest News from the Petrie-Flom Center!

Check out the January 22nd edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.

Featured in this edition:


UPDATED AGENDA: Fourth Annual Health Law Year in P/Review
January 29, 2016 8:00 AM – 5:00 PM
Wasserstein Hall, Milstein East C 
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

The Fourth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2015 and what to watch out for in 2016. The discussion at this day long event will cover hot topics in such areas as health insurance, health care systems, public health, innovation, and other issues facing clinicians and patients.

In addition to presenting at the conference, many of our speakers will write about their topics for a collaborative blog series that will begin in February 2016 on the Health Affairs Blog.

Continue reading

Four Key Issues In Health Law That Are As Relevant As Ever In 2016

Petrie-Flom’s Executive Director Holly Fernandez Lynch has a new post over at the Health Affairs Blog as the first entry in a series that will stem from our Fourth Annual Health Law Year in P/Review conference, to be held at Harvard Law School on Friday, January 29, 2016.

In it, Holly takes stock of which major issues in health law policy remain outstanding from years past, and which are coming down the pike, including:

  • The ACA (and the contraceptives coverage mandate, in particular)
  • The state of health care reform generally
  • Efforts to control health care costs
  • Emerging regulatory pathways to speed patient access to new products
  • And more…

Read the full post here.

TOMORROW, 1/20! A Conversation with Margaret A. Hamburg, FDA Commissioner 2009-2015

A Conversation with Margaret A. Hamburg, FDA Margaret Hamburg, commissioner of the Food and Drug Administration (FDA), speaks during an interview in Washington, D.C., U.S., on Wednesday, May 28, 2014. A new program that lets drugmakers move more quickly through the approval process for breakthrough products may help lower the cost of life-saving treatments, Hamburg, the nation's chief drug regulator, said today. Photographer: Andrew Harrer/Bloomberg via Getty ImagesCommissioner 2009-2015
January 20, 2016 12:30 PM
Wasserstein Hall, Milstein East ABC (2nd floor)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Please join the Petrie-Flom Center for a conversation with former FDA Commissioner (and former New York City Health Commissioner), Dr. Margaret A. Hamburg, led by Peter Barton Hutt, former Chief Counsel to FDA and current Senior Counsel at Covington & Burling LLP and Lecturer on Law at HLS. Topics discussed will include FDA’s role and the changing scientific, legal, political, and economic landscape; the overlap of science, innovation, and cost regarding biomedical products; food safety and nutrition; challenges of globalization, and more.

Speakers:

  • Margaret A. Hamburg, Commissioner of the U. S. Food and Drug Administration, 2009-2015
  • Peter Barton Hutt, Covington & Burling and Harvard Law School

This event is free and open to the public, but seating is limited and registration is required. Register now!

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund.

UPDATED AGENDA: Fourth Annual Health Law Year in P/Review, January 29!


UPDATED AGENDA: Fourth Annual Health Law Year in P/Review
January 29, 2016 8:00 AM – 5:00 PM
Wasserstein Hall, Milstein East C 
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

The Fourth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2015 and what to watch out for in 2016. The discussion at this day long event will cover hot topics in such areas as health insurance, health care systems, public health, innovation, and other issues facing clinicians and patients.

In addition to presenting at the conference, many of our speakers will write about their topics for a collaborative blog series that will begin in February 2016 on the Health Affairs Blog.

This year’s Health Law Year in P/Review is sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, the New England Journal of MedicineHealth Affairs, the Hastings CenterHarvard Health Publications at Harvard Medical School, and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund at Harvard University.

Agenda Continue reading

1/20/16: Register Now! A Conversation with Margaret Hamburg, FDA Commissioner 2009-2015

A Conversation with Margaret A. Hamburg, FDA Margaret Hamburg, commissioner of the Food and Drug Administration (FDA), speaks during an interview in Washington, D.C., U.S., on Wednesday, May 28, 2014. A new program that lets drugmakers move more quickly through the approval process for breakthrough products may help lower the cost of life-saving treatments, Hamburg, the nation's chief drug regulator, said today. Photographer: Andrew Harrer/Bloomberg via Getty ImagesCommissioner 2009-2015
January 20, 2016 12:30 PM
Wasserstein Hall, Milstein East ABC (2nd floor)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Please join the Petrie-Flom Center for a conversation with former FDA Commissioner (and former New York City Health Commissioner), Dr. Margaret A. Hamburg, led by Peter Barton Hutt, former Chief Counsel to FDA and current Senior Counsel at Covington & Burling LLP and Lecturer on Law at HLS. Topics discussed will include FDA’s role and the changing scientific, legal, political, and economic landscape; the overlap of science, innovation, and cost regarding biomedical products; food safety and nutrition; challenges of globalization, and more.

Speakers:

  • Margaret A. Hamburg, Commissioner of the U. S. Food and Drug Administration, 2009-2015
  • Peter Barton Hutt, Covington & Burling and Harvard Law School

This event is free and open to the public, but seating is limited and registration is required. Register now!

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund.

Peeling the Onion: How to Promote Pharmaceutical Innovation and Access to Medicine

As mentioned in my earlier blog post, I decided to conclude this year by publishing a introductory speech that I gave on April 14th, 2015 at the 2015 Broad Institute Innovation & Intellectual Property Symposium. The speech was part of the session “Bringing Therapies to the Patients” and introduced a panel-discussion with Entrepreneur and Professors of Law and Business about the failures of the patent system to support new therapeutics. The text is below:

Peeling the Onion:
How to Promote Pharmaceutical Innovation and Access to Medicine

Speaking about frustrations over the IP system in pharmaceutical innovation, sometimes feels like – to lend the words of the late German Nobel Prize winner Günter Grass – “peeling an onion:” Continue reading

Happy New Year: From “Weltschmerz” to Pharmaceutical Innovation

Gallery

Dear readers and colleagues, I would like to take this opportunity to wish you all a very happy, healthy and peaceful year 2016. Reaching the end of 2015, I cannot stop thinking about the year that has passed. Being a native German, … Continue reading

Lecture Tomorrow, 11/10! Euthanasia in Belgium: The most recent legal developments and policy challenges

Euthanasia in Belgium: The most recent legal developments and policy challenges
November 10, 2015 11:00 AM – 12:15 PM

Conference Room, 1st floor
Center for Bioethics at Harvard Medical School
641 Huntington Ave., Boston, MA [Map]

A lecture by Sigrid Sterckx, Professor of Ethics and Political and Social Philosophy, Ghent University, Belgium; End-of-Life Care Research Group, Vrije Universiteit Brussel & Ghent University, Belgium; Bioethics Institute Ghent, Ghent University, Belgium.

In 2002, euthanasia by a physician (the intentional termination of a patient’s life at his or her request) was depenalized in Belgium for adults and emancipated minors. In 2014, the law was extended to competent minors, without an age limit. The frequency of performance of euthanasia is rising very rapidly, having more than doubled in the last five years (accounting for one death in twenty, about 8 per day in Flanders, the Dutch-speaking region). Moreover, although the prevalence of euthanasia remains highest in patients with cancer, a clear shift is visible in the characteristics of patients who request euthanasia and whose requests are granted. The largest increases are among women, and those aged 80 or older, with lower education levels, and those dying in nursing homes. Continue reading

REGISTER NOW! Specimen Science: Ethics and Policy Implications Symposium, with NEW Lunchtime Talk on “Biospecimens and the NPRM”

testtube_hand_bw_slideSpecimen Science: Ethics and Policy Implications
NEW Lunchtime Talk on “Biospecimens & the NPRM”
Monday,  November 16, 2015, 8:30 AM – 5:00 PM
8:30am-12:40pm: Austin Hall North (100);
12:40-5:30pm, Langdell Hall South, Room 272

Harvard Law School, Cambridge, MA [Map]

Many important advances in human health depend on the effective collection, storage, use, and sharing of biological specimens and their associated data.   However, recent controversies involving specimen-based research have raised important questions about ownership, data-sharing, privacy considerations, group harms, and standards for responsible specimen stewardship.

Please join us for a symposium to discuss the key ethical and policy issues raised by genetics and other research involving human biological materials, covering the entire trajectory from specimen source to new discovery.  The experts at this day-long event will cover key topics, such as historical, legal, and international perspectives; donor attitudes, researcher perspectives, and institutional considerations; broad vs. specific informed consent; privacy, ownership, and control; use of specimens collected through mandatory newborn screening; research with discrete and insular populations; and others.  Conference papers eventually will be published as an edited volume with a major academic press.

Agenda

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TOMORROW, 11/4! Reflections in Honor of the Life and Influence of Professor Alan Wertheimer

Wertheimer_teaching_slideReflections in Honor of the Life and Influence of Professor Alan Wertheimer
November 4, 2015, 1:00 – 5:30 PM
NEW LOCATION:
Wasserstein Hall, Milstein West B (2019)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA [Map]

Please join us for an afternoon of reflection on the life, work, and enduring influence of Professor Alan Wertheimer (1942-2015). Professor Wertheimer was a leading philosopher of law and bioethics, making critical contributions to clinical research ethics; theories of coercion, undue influence, and exploitation; consent in a variety of contexts, and much more. This tribute event will feature leading scholars discussing and engaging with Professor Wertheimer’s many contributions, and exploring how he influenced their own work.

At the time of his death in 2015, Alan Wertheimer was Senior Research Scholar in the Department of Bioethics at the National Institutes of Health. Continue reading

Lunch Talk & Book Launch Tomorrow, 10/28: FDA in the 21st Century

lync17118_frontBook Launch: FDA in the 21st Century
October 28, 2015 12:00 PM
Wasserstein Hall, Milstein East C
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA [Map]

In September 2015, Columbia University Press published FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies, co-edited by Petrie-Flom Center Executive Director Holly Fernandez Lynch and Faculty Director I. Glenn Cohen. This edited volume stems from the Center’s 2013 annual conference, which brought together leading experts from academia, government, and private industry to evaluate the FDA and to begin charting a course for the agency’s future.

This event will provide a discussion of the book, including questions like: How is the agency faring in the 21st century? What are the greatest challenges to the FDA’s success, and what does success look like? What lessons has it learned and how can it best meet the challenges of today? Should we keep the agency we have, pull it apart, or rebuild from scratch?

Panelists: Continue reading

EVENT (11/12-13): The New Health Care Industry – Integration, Consolidation, Competition in the Wake of the Affordable Care Act

SolomonConfLogoThe New Health Care Industry: Integration, Consolidation, Competition in the Wake of the Affordable Care Act

Thursday, November 12 Center Launch, Celebratory Reception with speaker Kathleen Sebelius — former Secretary, Health and Human Services 4:00–6:30pm
Friday, November 13 Inaugural Conference 8:30am–5:00pm
Attendance to both events it free, but registration is required.

This conference marks the launch of the new Solomon Center for Health Policy and Law at Yale Law School. The Solomon Center is the first of its kind to focus on the governance, business, and practice of health care in the United States. This conference will mark the first under the Center, which will focus on bringing together leading experts and practitioners from the public and private sectors to address cutting-edge questions of health law and policy. Continue reading

Pre-Approval Access Symposium: Can Compassion, Business, and Medicine Coexist?

Dates: October 28 – 29, 2015
Location: The New York Academy of Sciences, 7 World Trade Center, NYC
Presented by: NYU School of Medicine and the New York Academy of Sciences
Event URL: www.nyas.org/CompassionateUse

Explore challenges surrounding pre-approval access to investigational medicines through a series of debates featuring prominent representatives of governments, pharmaceutical companies, patient groups, NGOs, and foundations in this two-day colloquium.

Agenda topics include:

  • Perspectives from Patient Advocates on Compassionate Use and Expanded Access
  • The Case of Josh Hardy and Social Media’s Impact
  • Lessons Learned from the Ebola Virus Epidemic on Compassionate Use during a Crisis
  • Key Issues from Stakeholders’ Perspectives When Considering a Compassionate Use Request
  • Legislative or Regulatory Changes on Compassionate Use and Expanded Access

Continue reading