Fourth Annual Health Law Year in P/Review

Friday, January 29, 2016 8:00 AM - 5:00 PM
Conferences
2015-2016
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 discussin...

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SAVE THE DATE!: Second Annual HLS-UCLA Food Law and Policy Conference:
Drugs, Animals, and Food: Law & Policy of Antibiotics in the Food System

Friday, October 23, 2015 8:30 AM - 5:00 PM
Conferences
2015-2016
Harvard Law School
Cambridge, MA

This conference is free and open to the public, but seating is limited and registration is required...

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Review of Innovation Law and Policy: Preserving the Future of Personalized Medicine

Written Description Blog, July 27, 2015
by Lisa Ouellette

From the review:

I highly recommend two recently posted articles on declining innovation incentive...

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Research, Regulation, and Ethics: Discussion of Human Subjects Research Regulation Book

Science for the People Podcast, July 2015, No. 327
by Desiree Schell

About the podcast:

This week we're learning about the regulatory frameworks that try to balanc...

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Pregnant Women Get More Ultrasounds, Without Clear Medical Need:

Wall Street Journal, July 17, 2015
by Kevin Helliker

[...] In 2014, usage in the U.S. of the most common fetal-ultrasound procedures averaged 5.2 p...

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Review of Human Subjects Research Regulation: Perspectives on the Future

IRB: Ethics & Human Research, July-August 2015, Vol. 37, No. 4
by Christine Grady

Christine Grady, MSN, PhD, the chief of the Department of Bioethics in the Clinical Center of the N...

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Will clinical trial data disclosure reduce incentives to develop new uses of drugs?

Nature Biotechnology, July 2015, Vol. 33, No. 7
by W Nicholson Price II (Academic Fellow alumnus) & Timo Minssen (past Visiting Scholar)

Petrie-Flom Academic Fellow alumnus Nicholson Price, now an Assistant Professor at the&nb...

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Bill To Speed Drug Approvals Process Passes House With Strong Bipartisan Vote

Kaiser Health News, July 13, 2015

KHN Morning Briefing: Summaries of health policy coverage from major news organizations.

The...

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F.D.A. Delays Deadline for Calorie Count on Menus

New York Times, July 9, 2015
by Sabrina Tavernise

WASHINGTON — The Food and Drug Administration delayed by a year the deadline for th...

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PAPER NOW AVAILABLE:

Journal of Law & the Biosciences, July 6, 2015 (Published Online)
by Rachel Sachs (Academic Fellow) and Carolyn Edelstein

Academic Fellow Rachel E. Sachs has a new article on the regulatory challenges ...

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FDA To Food Companies:

NPR, June 16, 2015
by Allison Aubrey and Rob Stein

The Food and Drug Administration on Tuesday announced that food companies have three year...

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A Chinese Ebola Drug Raises Hopes, and Rancor

New York Times, June 11, 2015
by Sheri Fink

After a nurse who contracted Ebola in Sierra Leone was discharged Wednesday fro...

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Panel Tells F.D.A. to Back Second Drug to Help Heart

New York Times, June 10, 2015
by Gina Kolata

An expert committee that advises the Food and Drug Administrationrecommended on Wednesday that...

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Bill To Speed FDA Approvals Includes Rewards For Drugs Designed For Kids

Kaiser Health News, June 8, 2015
by Lisa Gillespie

Advocates for children with rare diseases are watching closely a congressional effort to streamline...

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Food Law and Policy Clinical Fellow

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Food Law and Policy Clinical Fellow
Harvard Food Law and Policy Clinic

Deadline: Open until filled.

The Harvard Food Law and Policy Clinic, a division of the Center for Health Law and Policy Innovati...

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Faculty Director I. Glenn Cohen: New Blood-Donor Policy, Same Gay Stigma

New York Times, May 21, 2015
by I. Glenn Cohen (Faculty Director) and Eli Y. Adashi

Faculty Director I. Glenn Cohen has co-authored an op-ed for the New York Times on the FD...

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Drug Product Liability Litigation Course

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Drug Product Liability Litigation Course
Harvard Law School

Deadline: Open until filled.

Instructor: Mr. Peter Grossi

Semester: Fall 2015 Course

Meets: T, W 5:00pm - 7:00p.

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Innovation Law and Policy:

U. C. Davis Law Review, Forthcoming 2016
by Rachel E. Sachs

Academic Fellow Rachel E. Sachs has a new article forthcoming in 2016 on law and the future of pers...

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FDA’s Impact on Pharmaceutical Innovation:
A lecture by Neil Flanzraich

Tuesday, April 14, 2015 12:00 PM
Lectures and Panels
2014-2015
Griswold Hall, 110
Harvard Law School, 1525 Massachusetts Ave., Cambridge, MA

Neil Flanzraich, Chairman and CEO of Cantex Pharmaceuticals, Inc., discussed the balance between sp...

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“Ending Institutional Corruption” conference, May 1-2

Edmond J. Safra Center for Ethics at Harvard University, April 14, 2015

On Friday, May 1, and Saturday, May 2, several Petrie-Flom Center affiliates will participate in th...

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Are trade secrets delaying biosimilars?

Science, April 10, 2015
by W. Nicholson Price II (Academic Fellow Alumnus) and Arti K. Rai

Petrie-Flom Academic Fellow alumnus Nicholson Price, now an Assistant Professor at the Un...

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Transatlantic Lessons in Regulation of Mitochondrial Replacement Therapy:

Science, April 10, 2015
by I. Glenn Cohen (Faculty Director), with Eli Adashi and Julian Savulescu

Cambridge, Mass., April 9, 2015 – A paper forthcoming on Friday in Science discusses the regu...

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Trio contrast approaches taken by Britain versus the US concerning mitochondrial replacement therapy

MedicalXpress, April 10, 2015
by Bob Yirka, citing I. Glenn Cohen (Faculty Director) et al.

Glenn Cohen, with Harvard University, Julian Savulescu, with the University of Oxford and Eli Adash...

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Is UK evaluation of reproductive tech a model for US?

MedicalXpress, April 10, 2015
by David Orenstein, citing I. Glenn Cohen (Faculty Director) et al.

When the United Kingdom resoundingly approved mitochondrial replacement therapy in Februa...

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Third Annual Health Law Year in P/Review

Friday, January 30, 2015 7:45 AM - 5:00 PM
Conferences
2014-2015
Wasserstein Hall, Milstein East AB
1585 Massachusetts Avenue, Cambridge, MA

Couldn't make it in person? Check out the individual sessions in the videos linked above!

The...

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A “Natural” Experiment:
Consumer Confusion and Food Claims, a lecture by Efthimios Parasidis

Thursday, January 29, 2015 12:00 PM
Lectures and Panels
2014-2015
Wasserstein Hall, Milstein West B
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Video of the lecture and following discussion is available online.

What makes food "natural"? Do c...

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Outbreak: Developing New Medical Products for Epidemics,
A lecture by Peter Hutt

Thursday, January 15, 2015 12:30 PM
Lectures and Panels
2014-2015
Hauser Hall 102
1575 Massachusetts Avenue, Cambridge, MA

Video of the lecture and following discussion are available online.

The recent outbreak of Ebola h...

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Research Project Grant Funding Opportunity

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Research Project Grant Funding Opportunity
National Institutes of Health (NIH)

Deadline: January 19, 2015

Funding Opportunity Title: Empirical Research on Ethical Issues Related to Central IRBs and Co...

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First biosimilar drug set to enter US market:

Nature, January 13, 2015
by Heidi Ledford, quoting W. Nicholson Price II (Academic Fellow Alumnus)

[...] The FDA is expected to make a final decision by May. But even as Sandoz prepares to sell its...

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FDA plans to end prohibition on blood donation by gay men, with conditions

PBS News Hour, December 23, 2014
by Gwen Ifill, interviewing I. Glenn Cohen (Faculty Director)

"[...] the ban that we had in place was really outdated. It dates back to 1983, the early days of t...

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F.D.A. Easing Ban on Gays, to Let Some Give Blood

New York Times, December 23, 2014
by Sabrina Tavernise, quoting I. Glenn Cohen (Faculty Director)

[...] “This is a major victory for gay civil rights,” said I. Glenn Cohen, a law profes...

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FDA Announces Plans to End Lifetime Ban on Gay Men Donating Blood

Vice News, December 23, 2014
by Colleen Curry, quoting I. Glenn Cohen (Faculty Director)

[...] Harvard Law School bioethics and the law professor I. Glenn Cohen told VICE News that while h...

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US lifts ban on gay men donating blood — as long as they don’t have sex with other men

Vox, December 23, 2014
by Sarah Kliff and Julia Belluz, quoting I. Glenn Cohen (Faculty Director)

[...] Glenn Cohen, a Harvard Law professor who wrote about the blood donor rule in JAMA: the J...

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Reconsideration of the Lifetime Ban on Blood Donation by Men Who Have Sex With Men

JAMA, July 23, 2014
by I. Glenn Cohen, JD (Faculty Director); Jeremy Feigenbaum, JD; Eli Y. Adashi, MD, MS

Faculty Director I. Glenn Cohen has co-authored a new Viewpoint piece in the July 23/30, 2014 issue...

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FDA Advisors Not Sold on Lifting Ban on Gay Men Giving Blood

Philly.com, December 3, 2014
by Dennis Thomson, quoting I. Glenn Cohen (Faculty Director)

[...] The FDA first adopted the policy at the dawn of the AIDS crisis. However, changing times and...

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Decades-old ban on blood donations from gay men to be revisited

MSNBC, December 1, 2014
by Andrea Mitchell interviewing I. Glenn Cohen (Faculty Director)

Petrie-Flom Faculty Director I. Glenn Cohen, who co-wrote the argument against the ban on gay...

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Will FDA Lift Gay Blood Donor Ban?

NewsMax Health, December 1, 2014
by Quoting I. Glenn Cohen (Faculty Director)

[...] "They really are out of step with the rest of the world," Glenn Cohen, a Harvard Law School p...

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US FDA to Consider Lifting Ban on Gay Men Donating Blood:

International Business Times, November 30, 2014
by Hannah Osborne, quoting I. Glenn Cohen (Faculty Director)

[...] Speaking of the forthcoming discussion, Glenn Cohen, a medical ethics professor at Harva...

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Government could ease 31-year-old ban on blood donations from gay men

Washington Post, November 29, 2014
by Brady Dennis, quoting I. Glenn Cohen (Faculty Director)

[...] “They really are out of step with the rest of the world,” said Glenn Cohen, a Har...

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FDA weighs lifting ban on blood donations from gay men

The Hill, November 28, 2014
by Sarah Ferris, quoting I. Glenn Cohen (Faculty Director)

[...] “The public health rationale for this ban has kind of been packed away,” said Gle...

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The Changing Regulation of Laboratory-Developed Tests:

Genomic Medicine Case Conference (GMCC) at Massachusetts General Hospital, November 14, 2014
by Rachel Sachs (Academic Fellow)

On November 14, 2014, Academic Fellow Rachel Sachs delivered a talk on the topic of the FDA&rs...

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Emerging Issues and New Frontiers for FDA Regulation

Monday, October 20, 2014 8:00 AM - 5:00 PM
Conferences
2014-2015
Washington, DC

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law...

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​Nudging the FDA

The American Interest, October 17, 2014
by W. Nicholson Price II (Academic Fellow alumnus) and I. Glenn Cohen (Faculty Director)

From the article:

[...] The FDA’s regulation of drugs is frequently the subject of poli...

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Newsmax Panel: Experimental Ebola Drugs Have Run Out

Newsmax TV, October 6, 2014
by America's Forum, interviewing I. Glenn Cohen (Faculty Director)

From the article:

[...] The Liberian man diagnosed with Ebola in Dallas is not receiving an experi...

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FDA Proposal for Regulating Laboratory Diagnostics Could Improve Patient Care

Hastings Center Bioethics Forum, September 4, 2014
by Rachel Sachs (Academic Fellow)

From the article:

[...] [T]he FDA's proposal [to regulate laboratory-developed tests] ... coul...

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Teen suicide victim’s eyes were rejected by FDA as donor organs because he was gay

Mail Online, August 15, 2014
by Mail Online Reporter, quoting I. Glenn Cohen (Faculty Director)

From the article:

The FDA has blocked the donation of a teen suicide victim's eyes because he...

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After suicide, gay teen’s eye donation rejected

Washington Post, August 14, 2014
by Ryan Weber, quoting I. Glenn Cohen (Faculty Director)

From the article:

In the Journal of the American Medical Association, Glenn Cohen, a bioethic...

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Ethical issues over experimental Ebola drug

CCTV America, August 13, 2014
by Asieh Namdar, interviewing I. Glenn Cohen (Faculty Director)

Faculty Director I. Glenn Cohen appeared on CCTV America to discuss ethical que...

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Experts urge lifting ban on blood donations by gay men

CBS News, July 25, 2014
by Dennis Thompson , quoting I. Glenn Cohen (Faculty Director)

The United States should repeal a 30-year policy that bans blood donations from gay and bisexual me...

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FDA Regulation of Mobile Health Technologies

NEJM, July 24, 2014
by Nathan G. Cortez, J.D., I. Glenn Cohen, J.D., and Aaron S. Kesselheim, M.D., J.D., M.P.H.

Petrie-Flom Faculty Director I. Glenn Cohen has published a new co-authored article in the New Engl...

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Call for Submissions: Journal of Law and the Biosciences

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Call for Submissions: Journal of Law and the Biosciences

Deadline: Rolling admission.

Journal of Law and the Biosciences (JLB) is actively soliciting original manuscripts, response...

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FDA Advises Against Morcellator Use in Hysterectomies:

Wall Street Journal, April 17, 2014
by Jon Kamp and Jennifer Levitz, quoting I. Glenn Cohen (Faculty Director)

[...] "The fact that the FDA released this warning makes it more likely that a doctor who went...

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Dallas Buyers Club:
Free Film Screening and Panel Discussion

Wednesday, April 16, 2014 6:00 PM
Lectures and Panels
2013-2014
Wasserstein Hall 1010
1585 Massachusetts Ave., Cambridge, MA

Students from across Harvard were invited to view a free screening of the Academy-award winning fil...

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The Presumption Against Expensive Health Care Consumption

Tulsa Law Review, Vol. 49, Forthcoming, 2014
by Christopher T. Robertson (Affiliate Faculty)

This essay, as part of a symposium in honor of Professor Einer Elhauge, starts with his recognition...

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Welcome 2014-2016 Academic Fellow Rachel Sachs!

Petrie-Flom Center, April 17, 2014

The Petrie-Flom Center is pleased to announce the new 2014-2016 Academic Fellow, Rachel Sachs. ...

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Health Law Year in P/Review

Friday, January 31, 2014 8:30 AM - 5:00 PM
Conferences
2013-2014
Wasserstein Hall, Milstein East B & C
1585 Massachusetts Ave., Cambridge, MA

Watch Event Recordings

Video of this conference is now available at online! (See below for links to specific panels.)

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Health and Food Law Opportunities at Harvard Law School

Friday, November 15, 2013 12:00 PM
Lectures and Panels
2013-2014
Wasserstein Hall 3019
1585 Massachusetts Ave., Cambridge, MA

1Ls and 2Ls will have the opportunity to learn more about different classes and extracurricular act...

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Pharma manufacturing woes dog industry

Chemistry World, October 23, 2013
by Sarah Moulton, quoting W. Nicholson Price II

[...] While many of these problems arise from quality control failures, according to Nicholson...

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Plan B:

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

The 8-year legal feud over access to emergency contraception between reproductive health advocates...

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When Truth Cannot Be Presumed:

Boston University Law Review, 2014
by Christopher T. Robertson

Abstract:      
The Food, Drug, and Cosmetic Act (“FDCA”)...

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The Food and Drug Administration in the 21st Century:
The 2013 Petrie-Flom Center Annual Conference

Friday, May 03, 2013 - May 4, 2013
Conferences
2012-2013
Wasserstein Hall, Milstein East ABC, Harvard Law School
Watch Event Recordings

Conference Description

The Food and Drug Administration, the US government’s oldest comprehe...

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Forum on Food Labeling:
Putting the Label on the Table

Friday, March 08, 2013
Conferences
2012-2013
Austin East and West, Harvard Law School

The Harvard Law School Food Law Society's second annual conference was a part of the Society...

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Personalized Medicine Patenting

Wednesday, March 06, 2013
Lectures and Panels
2012-2013
Austin Hall 111, Harvard Law School
Watch Event Recordings

Pharmaceutical researchers pursue medical treatment and diagnostic methods to target diseases speci...

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Compliance with and Enforcement of US Healthcare Laws:
Evolution of Modern Life Sciences Compliance

Monday, February 18, 2013
Lectures and Panels
2012-2013
Wasserstein Hall, Milstein West A, Harvard Law School
Watch Event Recordings

There have been a number of prosecutions of life sciences companies under the Food, Drug, and Cosme...

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

Thursday, January 17, 2013
Lectures and Panels
2012-2013
Wasserstein 2019, Milstein West AB, Harvard Law School
Watch Event Recordings

Peter Barton Hutt has worked at the Washington, DC law firm of Covington & Burling, specia...

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