Tomorrow! Food & Drug Law: Past, Present & Future

Food & Drug Law: Past, Present & Future
Celebrating Peter Barton Hutt’s 20 Years (thus far) at HLS

Thursday, January 17, 2013
Wasserstein 2019; Milstein West AB

Harvard Law School
4:00pm (reception to follow)

Peter Barton Hutt has worked at the Washington, DC law firm of Covington & Burling, specializing in Food and Drug Law, for more than five decades. He has represented clients in administrative, legislative, executive, and judicial settings. He began his law practice with the firm in 1960 and is now Senior Counsel; between 1971 to 1975, he was Chief Counsel for the Food and Drug Administration. The Best Lawyers in America selected Mr. Hutt as the 2013 FDA Lawyer of the Year for Washington, DC. Since 1994, Mr. Hutt has taught Food and Drug Law during Winter Term at Harvard Law School, covering all aspects of government regulation of food and drugs from ancient times to present.

Introductions and Welcome

Martha Minow, HLS Dean

Tributes to Professor Hutt

  • I. Glenn Cohen, Assistant Professor, Harvard Law School; Faculty Co-Director, Petrie-Flom Center
  • Theodore Ruger, Professor of Law, Penn Law School
  • Lewis Grossman, Professor of Law, American University Washington College of Law

Reflections
Peter Barton Hutt

Questions and Discussion

Dean Minow and Audience

For questions, contact petrie-flom@law.harvard.edu, 617-496-4664

Co-sponsored by the Petrie-Flom Center and the HLS Dean’s Office

 

Upcoming Event 01/17 – Food & Drug Law: Past, Present & Future

SAVE THE DATE!

Food & Drug Law: Past, Present & Future
Celebrating Peter Barton Hutt’s 20 Years (thus far) at HLS

Thursday, January 17, 2013
Wasserstein 2019; Milstein West AB

Harvard Law School
4:00pm (reception to follow at 5:30)

Peter Barton Hutt has worked at the Washington, DC law firm of Covington & Burling, specializing in Food and Drug Law, for more than five decades. He has represented clients in administrative, legislative, executive, and judicial settings. He began his law practice with the firm in 1960 and is now Senior Counsel; between 1971 to 1975, he was Chief Counsel for the Food and Drug Administration. The Best Lawyers in America selected Mr. Hutt as the 2013 FDA Lawyer of the Year for Washington, DC. Since 1994, Mr. Hutt has taught Food and Drug Law during Winter Term at Harvard Law School, covering all aspects of government regulation of food and drugs from ancient times to present.

Introductions and Welcome

Martha Minow, HLS Dean

Tributes to Professor Hutt

  • I. Glenn Cohen, Assistant Professor, Harvard Law School; Faculty Co-Director, Petrie-Flom Center
  • Theodore Ruger, Professor of Law, Penn Law School
  • Lewis Grossman, Professor of Law, American University Washington College of Law

Reflections
Peter Barton Hutt

Questions and Discussion

Dean Minow and Audience

For questions, contact petrie-flom@law.harvard.edu, 617-496-4664

Co-sponsored by the Petrie-Flom Center and the HLS Dean’s Office

 

Conference: The Governance of Tobacco in the 21st Century, February 26-27

The Harvard Global Health Institute will be co-hosting a conference on The Governance of Tobacco in the 21st Century: Strengthening National and International Policy for Global Health and Development at Harvard on February 26-27, 2013.  The conference program is available here, and additional information can be found here. Space is limited.  Please register by January 10.

For further information, contact Monique Bertic mbertic@hsph.harvard.edu

Save the Date: Health Law Year in P/Review, Friday 2/1/13

Friday, February 1, 2013
1:00-5:00pm
Wasserstein Hall 2036, Milstein East C, Harvard Law School

Health Law Year in P/Review
Please save the date for an upcoming panel on several recent developments and developments to come in the world of health law. This event is co-sponsored with the New England Journal of Medicine. Presentations and speakers will include:

Upcoming Event – Stem Cell Therapy and Medical Tourism: Of Promise and Peril? 11/28/12

Wednesday, September 28, 2012
3-4:30 pm (reception to follow)
Austin 111, Harvard Law School

Experimental breakthroughs within the field of regenerative medicine are reported in the media on a daily basis worldwide.  Despite this progress, the overwhelming majority of clinical problems for which stem cell-based intervention offers hope remain therapeutically unproven, and a major gap exists between current public understanding and the availability of innovative therapies.

This event will feature a distinguished panel of speakers addressing various aspects of medical tourism for stem cell therapy.  Presentations will cover the state of stem cell science, historical context and comparisons related to earlier instances of medical utopianism, empirical data on the nature of stem cell tourism, how to address patient hopes in the realm of unproven therapies, and special issues related to stem cell tourism by parents for their children.

The event will be moderated by M. William Lensch, Harvard Stem Cell Institute.  Speakers and topics include:

  • Brock Reeve, Harvard Stem Cell Institute
    Welcome and Introductions 
  • George Q. Daley, Harvard Stem Cell Institute
    Stem Cells: The Gap Between Current Science and Clinical Implementation 
  • Jill Lepore, Harvard University
    Resurrection, Past and Present 
  • Tim Caulfield, University of Alberta
    Stem Cell Tourism: Is the Problem Getting Worse? 
  • Insoo Hyun, Case Western Reserve University School of Medicine
    Therapeutic Hope and Its Challenges for Rational Ethical Discourse 
  • I. Glenn Cohen, Petrie-Flom Center, Harvard Law School
    Stem Cell Tourism, Children, Abuse, and Reporting

There will be substantial time set aside for audience Q&A, and the conversation will continue after the event at an open reception.

This event is free and open to the public.  Co-sponsored by the Harvard Stem Cell Institute and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

Reminder, TODAY – The Guatemala STD Inoculation Studies: What Should We Do Now?

TODAY
12:30-2:00
Wasserstein Hall, Classroom 3019
Harvard Law School

In the late 1940s, US and Guatemalan researchers conducted a host of experiments on vulnerable Guatemalan subjects, purposefully exposing them to, and infecting them with a number of STDs without their consent.  The experiments were kept hidden for more than half a century, until they were discovered and exposed only recently by historian Susan Reverby.  The US government has since apologized for what happened, but a class action suit brought on behalf of the Guatemalan subjects was dismissed in June and efforts to directly compensate the victims have not been forthcoming.   Please join Harvard Law School’s Petrie-Flom Center and Human Rights Program for a panel discussion of the study and possible legal and political responses that may be available now, both domestically and from an international human rights perspective.  Panelists will include:

  • Susan Reverby, Marion Butler McLean Professor in the History of Ideas, Professor of Women’s and Gender Studies, Wellesley College
  • I. Glenn Cohen, Assistant Professor of Law, Faculty Co-Director, Petrie-Flom Center, Harvard Law School
  • Holly Fernandez Lynch, Executive Director, Petrie-Flom Center, Lecturer on Law, Harvard Law School
  • Wendy Parmet,  George J. and Kathleen Waters Matthews Distinguished University Professor of Law, Northeastern University School of Law
  • Fernando Ribeiro Delgado, Clinical Instructor and Lecturer on Law, Human Rights Program, Harvard Law School

This event is free and open to the public.  Lunch and refreshments will be served.

Upcoming Event – The Guatemala STD Inoculation Studies: What Should We Do Now?

Tuesday, November 13, 2012
12:30-2:00
Wasserstein Hall, Classroom 3019
Harvard Law School

In the late 1940s, US and Guatemalan researchers conducted a host of experiments on vulnerable Guatemalan subjects, purposefully exposing them to and infecting them with a number of STDs without their consent.  The experiments were kept hidden for more than half a century, until they were discovered and exposed only recently by historian Susan Reverby.  The US government has since apologized for what happened, but a class action suit brought on behalf of the Guatemalan subjects was dismissed in June and efforts to directly compensate the victims have not been forthcoming.   Please join Harvard Law School’s Petrie-Flom Center and Human Rights Program for a panel discussion of the study and possible legal and political responses that may be available now, both domestically and from an international human rights perspective.  Panelists will include:

  • Susan Reverby, Marion Butler McLean Professor in the History of Ideas, Professor of Women’s and Gender Studies, Wellesley College
  • I. Glenn Cohen, Assistant Professor of Law, Faculty Co-Director, Petrie-Flom Center, Harvard Law School
  • Holly Fernandez Lynch, Executive Director, Petrie-Flom Center, Lecturer on Law, Harvard Law School
  • Wendy Parmet,  George J. and Kathleen Waters Matthews Distinguished University Professor of Law, Northeastern University School of Law
  • Fernando Ribeiro Delgado, Clinical Instructor and Lecturer on Law, Human Rights Program, Harvard Law School

This event is free and open to the public.  Lunch and refreshments will be served.

 

Reminder, TODAY – Advances in HIV Prevention: Legal, Clinical, and Public Health Issues

TODAY!
12-1:30pm
Austin Hall, Room 111
Harvard Law School

On July 3, 2012, FDA approved OraQuick, the first at-home HIV test available for sale directly to consumers, allowing individuals to self-test and receive confidential results in about 20 minutes. Then on July 16, FDA approved once-daily Truvada, an already-approved HIV therapy, as the first agent approved for pre-exposure prophylaxis in uninfected, at-risk adults. These developments represent dramatic changes in the fight against HIV, and raise a host of legal, clinical, and public health issues. Please join us for a panel discussion of these issues with some of the preeminent leaders in the field, moderated by Robert Greenwald, Director of the Center for Health Law and Policy Innovation at Harvard Law School:

  • Douglas A. Michels, President and CEO, OraSure Technologies, Inc.
  • David Piontkowsky, Senior Director for Medical Affairs, HIV and HIV Global Medical Director, Gilead Sciences, Inc.
  • Kenneth H. Mayer, Medical Research Director, Co-Chair of The Fenway Institute
  • Kevin Cranston, Director, Bureau of Infectious Disease, Massachusetts Department of Public Health
  • Mark Barnes, Senior Associate Provost, University Chief Research Compliance Officer, Harvard University

This event is free and open to the public. Lunch and refreshments will be served. Co-sponsored by the Petrie-Flom Center, the Center for Health Law and Policy Innovation, and the Fenway Institute.

Reminder: Tomorrow, Institutional Financial Conflicts of Interest in Research Universities

Friday, November 2, 2012
8:30am – 6:30pm (reception to follow)
Milstein Conference Rooms, 2nd Floor
Wasserstein Hall
1585 Massachusetts Avenue
Cambridge, MA

The Petrie-Flom Center and the Edmond J. Safra Center for Ethics will be co-sponsoring a day-long symposium organized by Dr. David Korn on institutional financial conflicts of interest in research universities. The speaker line-up is incredible, including Derek Bok and Zeke Emanuel, among other experts from academia and government.

For more information, and to register (attendance is free), check out the symposium webpage.  We hope to see you there!

Upcoming Event – Advances in HIV Prevention: Legal, Clinical, and Public Health Issues

Monday, November 5, 2012
12-1:30 pm
Austin Hall, Room 111
Harvard Law School

On July 3, 2012, FDA approved OraQuick, the first at-home HIV test available for sale directly to consumers, allowing individuals to self-test and receive confidential results in about 20 minutes. Then on July 16, FDA approved once-daily Truvada, an already-approved HIV therapy, as the first agent approved for pre-exposure prophylaxis in uninfected, at-risk adults. These developments represent dramatic changes in the fight against HIV, and raise a host of legal, clinical, and public health issues. Please join us for a panel discussion of these issues with some of the preeminent leaders in the field, moderated by Robert Greenwald, Director of the Center for Health Law and Policy Innovation at Harvard Law School:

  • Douglas A. Michels, President and CEO, OraSure Technologies, Inc.
  • David Piontkowsky, Senior Director for Medical Affairs, HIV and HIV Global Medical Director, Gilead Sciences, Inc.
  • Kenneth H. Mayer, Medical Research Director, Co-Chair of The Fenway Institute
  • Kevin Cranston, Director, Bureau of Infectious Disease, Massachusetts Department of Public Health
  • Mark Barnes, Senior Associate Provost, University Chief Research Compliance Officer, Harvard University

This event is free and open to the public. Lunch and refreshments will be served. Co-sponsored by the Petrie-Flom Center, the Center for Health Law and Policy Innovation, and the Fenway Institute.

Reminder, TODAY – Open Access to Health Research

TODAY!
12:00-1:30pm
Wasserstein Hall 3019
Harvard Law School

If you’re in town, come join us for a discussion and some practical advice about open access to health research.  There’s a great group of panelists lined up:

The panel will be moderated by Scott LapinskiHMS Digital Resources and Services Librarian and Open Access Liaison, and June Casey, Librarian for Open Access and Scholarly Communication.  It will be followed by two brief “101″ sessions on individual-level implementation of both the NIH’s Public Access and Harvard’s Open Access mandates.

Reminder – Symposium on Institutional Financial Conflicts of Interest in Research Universities

Friday, November 2, 2012
8:30am – 6:30pm (reception to follow)
Milstein Conference Rooms, 2nd Floor
Wasserstein Hall
1585 Massachusetts Avenue
Cambridge, MA

Just a reminder that next week the Petrie-Flom Center and the Edmond J. Safra Center for Ethics will be co-sponsoring a day-long symposium organized by Dr. David Korn on institutional financial conflicts of interest in research universities. The speaker line-up is incredible, including Derek Bok and Zeke Emanuel, among other experts from academia and government.

For more information, and to register (attendance is free), check out the symposium webpage.  We hope to see you there!

Upcoming Event – Open Acccess to Health Research: Future Directions for the NIH Public Access Policy

Wednesday, October 24, 2012
12:00-1:30pm
Wasserstein Hall 3019
Harvard Law School

In 2008, the NIH Public Access Policy entered into force, requiring “that all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine’s PubMed Central an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication.”  Four years later, about 25% of NIH-funded manuscripts are not being made publicly accessible.  This not only limits important progress in health research and clinical practice, but also means that academic institutions must rely on highly expensive journal subscriptions to access tax-funded research. Importantly, Harvard’s Open Access Mandate has not yet been extended to Harvard Medical School or the Harvard School of Public Health. In May, the Harvard Library Faculty Advisory Council issued a public letter calling on faculty to promote open access scholarly publishing, noting that “Many large journal publishers have made the scholarly communication environment fiscally unsustainable and academically restrictive.”

In recognition of Open Access Week 2012, four distinguished panelists will explore the challenges and opportunities for increasing NIH Public Access Policy compliance and open access efforts at Harvard.

The panel will be moderated by Scott LapinskiHMS Digital Resources and Services Librarian and Open Access Liaison, and June Casey, Librarian for Open Access and Scholarly Communication.  It will be followed by two brief “101″ sessions on individual-level implementation of both the NIH’s Public Access and Harvard’s Open Access mandates.

Co-sponsored by the Petrie-Flom CenterOffice of Scholarly CommunicationsRight to Research CoalitionUniversities Allied for Essential Medicines, and HLS Advocates for Human Rights.

Upcoming Event: Human Rights and the Social Determinants of Health, November 1-2, 2012 at Northeastern University

Human Rights and the Social Determinants of Health
Thursday, November 1, 2012, 1-5:30pm
Friday, November 2, 2012, 12-1:30pm
Northeastern University School of Law
Dockster Hall
65 Forsyth Street, Boston

The Program on Human Rights and the Global Economy (PHRGE) and the Program on Health Policy and Law at Northeastern University School of Law are hosting an event entitled “Human Rights and the Social Determinants of Health” on November  1 and November 2, 2012. The keynote speaker will be Dr. Ichiro Kawachi, from the Harvard School of Public Health. The event will also feature a special presentation by Sir Michael Marmot of University College London. Marmot is known internationally as a pioneer in the field of the social determinants of health.  For further information, please contact Sasha Varasano

 

Call for Papers – Petrie-Flom Center Annual Conference: The Food and Drug Administration in the 21st Century

We are pleased to announce plans for our annual conference, this year entitled: “The Food and Drug Administration in the 21st Century.”  This one and a half day event will take place Friday and Saturday, May 3-4, 2013, at Harvard Law School in Cambridge, Massachusetts. For details on the event and the call for proposals, see the Call for Papers/Presentations. Abstracts are due no later than December 10, 2012.

Reminder, TODAY – Patients with Passports: Medical Tourism, Law, and Ethics

TODAY!
4:00pm
Radcliffe Gymnasium
18 Mason Street
Cambridge, MA

Please join us for a presentation of the 2012-2013 Radcliffe Fellows Series.

Petrie-Flom Faculty co-Director I. Glenn Cohen will discuss the growing phenomenon of medical tourism, the practice of citizens of one country traveling to seek medical care in another country. He will examine the emerging legal and ethical issues brought up by the many varieties of medical tourism—for services that are legal in the destination and home country, for services that are illegal in the home country but legal in the destination country, and for services that are illegal in both places.

Upcoming Event – Patients with Passports: Medical Tourism, Law, and Ethics

Wednesday, October 10, 2012
4:00pm
Radcliffe Gymnasium
18 Mason Street
Cambridge, MA

Please join us for a presentation of the 2012-2013 Radcliffe Fellows Series.

Bill of Health Co-Editor I. Glenn Cohen will discuss the growing phenomenon of medical tourism, the practice of citizens of one country traveling to seek medical care in another country. He will examine the emerging legal and ethical issues brought up by the many varieties of medical tourism—for services that are legal in the destination and home country, for services that are illegal in the home country but legal in the destination country, and for services that are illegal in both places.

TOMORROW: Glenn Cohen on Action Speaks! Diamond v. Chakrabarty

Tomorrow, Wednesday, October 3 at 5:30 pm, Bill of Health co-editor I. Glenn Cohen will participate in a live national broadcast on Actionspeaksradio.org regarding Diamond v. Chakrabarty, the 1980 case that first established the right to patent life.

For information on how to listen or attend the recording live in Providence, RI, click here. And for some background from Glenn on the case and current issues, click here and here.