CALL FOR ABSTRACTS: 2017 Annual Conference
Transparency in Health and Health Care: Legal and Ethical Possibilities and Limits

Friday, April 28, 2017
Conferences
2016-2017
Wasserstein Hall, Milstein East ABC (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

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

Read More

The Battle to Regulate Cosmetics

"On Point," WBUR (NPR Boston), August 17, 2016
by Tom Ashbrook, Interviewing

What’s in your cosmetics and can it be harmful to your health? We’ll look at the new ca...

Read More

The FDA Wants To Make It Harder To Buy And Sell Poop

BuzzFeed, August 13, 2016
by by Nidhi Subbaraman, quoting Rachel Sachs (Academic Fellow alumna)

[...] Depending on how the approval is handed down, Rebiotix could very well put outfits like OpenB...

Read More

DEA Rejects Attempt To Loosen Federal Restrictions On Marijuana

NPR, August 10, 2016
by Carrie Johnson

The Obama administration has denied a bid by two Democratic governors to reconsider how it treats m...

Read More

Zika-Fighting GMO Mosquito Gets FDA Approval For Testing

NPR, August 6, 2016
by Greg Allen

The FDA has approved field trials of a genetically engineered mosquito designed to combat Zika and...

Read More

The FDA is prohibited from going germline

Science, August 5, 2016
by I. Glenn Cohen (Faculty Director) and Eli Y. Adashi

Petrie-Flom Faculty Director I. Glenn Cohen has co-authored a new article in Science magazine&...

Read More

This Could Have Been The First Poop Pill To Hit The Market, But It Failed Clinical Trials

BuzzFeed Science, July 29, 2016
by Nidhi Subbaraman, quoting Rachel Sachs (Academic Fellow alumna)

[...] “I think it is a big deal,” said Rachel Sachs, a professor of health and law...

Read More

F.D.A. Says 2 Florida Counties With Zika Cases Should Suspend Blood Donations

New York Times, July 28, 2016
by Associated Press

MIAMI — Federal officials want to suspend blood donations in two Florida counties where offic...

Read More

Farm to fork:

"Reveal," NPR, Updated July 23, 2016
by Julia B. Chan

UPDATE, July 23, 2016: We followed up on what’s happened since we first told you about t...

Read More

Sperm Banks Accused of Losing Samples and Lying About Donors

New York Times, July 21, 2016
by Tamar Lewin

[...] The Robertsons’ case is part of a new wave of lawsuits against sperm banks, highli...

Read More

Generic Crestor Wins Approval, Dealing a Blow to AstraZeneca

New York Times, July 20, 2016
by Andrew Pollack

The Food and Drug Administration said Wednesday that it had approved generic versions of...

Read More

Lower-cost biotech drug gets thumbs up from FDA panel

Washington Post, July 12, 2016
by Matthew Perrone, AP

WASHINGTON — The second-biggest selling drug in the world could get some cheaper competition...

Read More

Elizabeth Holmes of Theranos Is Barred From Running Lab for 2 Years

New York Times, July 8, 2016
by Andrew Pollack

Federal regulators have barred Elizabeth Holmes, chief executive of Theranos, from owning or operat...

Read More

Juno Halts Cancer Trial Using Gene-Altered Cells After 3 Deaths

New York Times, July 7, 2016
by Andrew Pollack

Three patients in a study testing the use of genetically engineered cells as a treatment for c...

Read More

A Trojan Horse?

Ohio State Law Journal, 2017 (forthcoming)
by Christopher T. Robertson (Academic Fellow alumnus)

Abstract:      
Scholars, advocates, and courts have begun to recogni...

Read More

Need For Blood In Orlando Raises Questions About Wisdom Of Banning Donors Due To Sexual Orientation

Forbes, June 14, 2016
by Rita Rubin, reviewing article by I. Glenn Cohen (Faculty Director), Jeremy Feigenbaum, and Eli Y. Adashi

Excerpt from the article:

[...] In a 2014 “viewpoint” article in the Journal of t...

Read More

FDA Regulations Limit Blood Donations From Gay Men

CBS San Francisco, June 14, 2016
by Holly Quan, featuring I. Glenn Cohen (Faculty Director)

Excerpt from the article:

On World Blood Donation Day and in the wake of the Orlando mass shooting...

Read More

After The Orlando Massacre, Many In The LGBTQ Community Are Turned Away From Giving Blood

Greater Boston (WGBH), June 14, 2016
by Nikki Blank, interviewing I. Glenn Cohen (Faculty Director)

Excerpt from interview:

Early in the 1980's, there was a lifetime ban or deferral for any man...

Read More

Preventing Mitochondrial DNA Diseases: One Step Forward, Two Steps Back

Journal of the American Medical Association, June 9, 2016
by I. Glenn Cohen (Faculty Director) and Eli Y. Adashi

From the article:

On February 3, 2016, the Institute of Medicine (IOM) released its Ethical a...

Read More

FDA’s Punt on Finalizing the Generic Drug Labeling Rule: Experts Debate

Regulatory Affairs Professionals Society, May 19, 2016
by Zachary Brennan, featuring Rachel E. Sachs (Academic Fellow)

From the article: 

Rachel Sachs, JD, an academic fellow at the Petrie-Flom Center for Health...

Read More

Regulatory Specialist

...

Regulatory Specialist
Partners HealthCare

Deadline: Open until filled.

As a not-for-profit organization, Partners HealthCare is committed to supporting patient care, rese...

Read More

What’s next for opioid legislation?

Politico Pulse, April 22, 2016
by Dan Diamond, referencing Rachel E. Sachs (Academic Fellow)

Excerpt from article:

[...] HEALTH WONK RECAP — PULSE flagged a few interesting st...

Read More

Prizing Insurance: Prescription Drug Insurance as Innovation Incentive,

Harvard Journal of Law and Technology, Vol. 30, No. 1 (forthcoming)
by Rachel E. Sachs

Abstract: 

A problem perennially facing scholars of both intellectual property and health law...

Read More

Book Review: FDA in the Twenty-First Century:The Challenges of Regulating Drugs and New Technologies

Journal of Law and the Biosciences, Vol. 3, Issue 1 (April 1, 2016)
by Ryan Abbot, reviewing book edited by Holly Fernandez Lynch (Executive Director) and I. Glenn Cohen (Faculty Director)

From the review: 

FDA in the 21st Century is an excellent edited volume based on th...

Read More

Chinese Market Offers New Life to Many Drugs

Dow Jones Business News, March 29, 2016
by Fanfan Wang, quoting I. Glenn Cohen (Faculty Director)

Excerpt from Article:

[...] But the new trend also raises the question of whether China has become...

Read More

Feeling Better: What is the FDA doing, and how is it doing it?

The Weekly Standard, March 21, 2016
by by Devorah Goldman, reviewing FDA in the 21st Century by Holly F. Lynch (Executive Director) and I. Glenn Cohen (Faculty Director)

Excerpt from the article:

[...] In his last State of the Union address, Barack Obama asked, &...

Read More

FDA - Food

U.S. Food and Drug Administration

Website for the U.S. Food and Drug Administration, one of the agencies responsible for regulating t...

Read More

Title 21: Food and Drugs

Code of Federal Regulations

In Chapter I, Subchapter B, Parts 100-190, the regulations applicable to FDA’s oversight of f...

Read More

FDA - Guidance and Regulation

U.S. Food and Drug Administration

Section of the FDA website containing FDA guidance and regulatory information applicable to food, i...

Read More

Planned Parenthood And Fetal Tissue Sale: Manufactured Controversy And The Real Ethical Debate

Health Affairs Blog, March 9, 2016
by I. Glenn Cohen (Faculty Director)

From the article:

[...] Planned Parenthood received US $528 million of government money...

Read More

Food Code

U.S. Food and Drug Administration

The FDA’s Food Code is a model that assists food control jurisdictions at all levels of gover...

Read More

USDA - Food Safety

U.S. Department of Agriculture, Food Safety and Inspection Service

Website for FSIS, an agency of the USDA responsible for ensuring food safety for meat, poultry, and...

Read More

Foodborne Outbreaks

Centers for Disease Control

This site outlines the CDC’s role in investigation, surveillance, and prevention of food safe...

Read More

Food Safety

FoodSafety.gov

Describes provisions of the Food Safety Modernization Act of 2011 and their role in strengthening t...

Read More

Codex Alimentarius

World Health Organization

The Codex, administered by WHO and the U.N. Food and Agriculture Organization, establishes internat...

Read More

Food Labeling Litigation

by Nicole E. Negowetti

Report on food labeling class action lawsuits and FDA regulatory authority. 

... Read More

Food and Drug Law Institute

Non-profit site providing a space for discussion of food and drug law, including conferences and pu...

Read More

Harvard Food Law and Policy Clinic

The Harvard Law School clinic focused on seeking to increase access to healthy foods, reduce food w...

Read More

Fecal Transplants to Treat C. difficile: FDA Seeks Comment on What IND Requirements to Waive

Regulatory Affairs, February 29, 2016
by Zachary Brennan, citing Rachel E. Sachs (Academic Fellow)

From the article: 

[...] The draft guidance comes as over the past few years, FMT, which basi...

Read More

Food Safety News

Website providing coverage on food safety issues, including contributions from the FDA.

... Read More

A Tool to Help Address Key Ethical Issues in Research

Journal of Medical Ethics Blog, February 22, 2016
by Rebecca H. Li & Holly Fernandez Lynch (Executive Director)

From the article: 

One of the most important responsibilities of a clinical project lead at a...

Read More

The Unpatentable Microbiome

New England Regional Junior Faculty Scholarship Workshop, February 12, 2016
by Rachel E. Sachs (Academic Fellow)

Presentation Abstract: 

Scientists have recently begun to appreciate the important role playe...

Read More

Food and Drug Law

Peter Hutt et al., 2013

Introductory casebook on administrative and other key issues in food and drug law. 

... Read More

Expert Committee: FDA Should Allow Mitochondrial Replacement Trials Under Certain Conditions

Regulatory Affairs, February 3, 2016
by Zachary Brennan, quoting I. Glenn Cohen (Faculty Director)

From the article:

Glenn Cohen, faculty director of the Petrie-Flom Center for Health Law Policy, B...

Read More

Fourth Annual Health Law Year in P/Review

Friday, January 29, 2016 8:00 AM - 5:00 PM
Conferences
2015-2016
Wasserstein Hall, Milstein West AB
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Couldn't attend in person? Learn more about the event:

  • Learn more about the presentations...

Read More

“FDA in the 21st Century: A Panel Discussion”:

MAGI, May 2, 2016, 8:30 - 10:00 AM
by Holly Fernandez Lynch (Executive Director) and I. Glenn Cohen (Faculty Director)

On Monday, May 2, 2016, from 8:30 to 10:00am, Petrie-Flom Executive Director Holly Fernandez Lynch...

Read More

Why Preventing Cancer Is Not the Priority in Drug Development

The Upshot, New York Times, December 28, 2015
by Austin Frakt, citing Ben Roin (former Academic Fellow and Faculty Co-Director)

From the article: 

Most people would agree that it would be better to prevent cancer, if...

Read More

FDA Says Gay Men Can Give Blood — But Only If They Don’t Have Sex for a Year

VICE News, December 22, 2015
by VICE News Staff, quoting I. Glenn Cohen (Faculty Director)

From the article:

[...] Harvard Law School bioethics and the law professor I. Glenn Cohen told VIC...

Read More

FDA eases blood donation ban on gay men

CBS News, December 21, 2015
by Interview with I. Glenn Cohen (Faculty Director)

The FDA is easing its restrictions on gay and bisexual men who want to make a blood donation. But t...

Read More

FDA’s Pathway for Regulation of Fecal Microbiota Transplants

Journal of Law and the Biosciences, October 26, 2015
by Margaret F. Riley and Bernat Olle, in response to Rachel Sachs (Academic Fellow)

From the article: 

[...] A recent article by Rachel Sachs and Carolyn Edelstein inthe Journal...

Read More

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 - 3:30 PM
Conferences
2015-2016
Pound Hall, Room 102
Harvard Law School, 1536 Massachusetts Ave., Cambridge, MA

Description

The debate over antibiotic use in animal agriculture combines elements of science, eth...

Read More

Neuroethics Seminar: Brain Hacking to Boost Your A-Game:
The Ethics of Cognitive Enhancement in Gaming and Competition

Wednesday, October 21, 2015 4:30 - 6:00 PM
Lectures and Panels
2015-2016
Armenise Building, D Amphitheatre
Harvard Medical School, 210 Longwood Ave., Boston, MA

Event Description

This event was free and open to the public. 

Personal enhancement isn'...

Read More

Blood Illuminated: Panel Discussion of FDA Blood Ban From Gay and Bisexual Men

YouTube Video of Event at Katzen Arts Center, American University, October 6, 2015
by I. Glenn Cohen (Faculty Director)

From a description of the event on Out Magazine:

Dating back to a policy enacted during the height...

Read More

Innovations in Health Law and Policy: Regulatory Challenges and Strategies for Change Conference

UNH School of Law, October 26, 2015
by W. Nicholson Price II (Academic Fellow Alumnus)

Innovations in Health Law and Policy: Regulatory Challenges and Strategies for Change

When: Monday...

Read More

How Patent Law Can Block Even Lifesaving Drugs

New York Times, September 28, 2015
by Austin Frakt, quoting Benjamin Roin (Former Faculty Co-Director & Academic Fellow; Current Affiliated Faculty)

From the article:

To see evidence of this, just look at the behavior of pharmaceutical firms. When...

Read More

How Prescription Drugs Get So Wildly Expensive

WIRED, September 23, 2015
by Nick Stockton, quoting Rachel E. Sachs (Academic Fellow)

From the article:

[...] With all that in mind, here’s the important question: Is S...

Read More

FDA in the 21st Century:

Columbia University Press, September 2015
by Holly Fernandez Lynch (Executive Director) and I. Glenn Cohen (Faculty Director), eds.

Just out from Columbia University Press, FDA in the Twenty-First Century: The Challenges...

Read More

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...

Read More

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...

Read More

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...

Read More

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...

Read More

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 ...

Read More

Countdown to Cures

The Medicine Maker, June 25th, 2015, Issue #0615
by Stephanie Sutton, quoting Rachel Sachs (Academic Fellow)

From the article: 

[...] According to Rachel Sachs, an academic fellow at the Petrie-Flom Cen...

Read More

Food Law and Policy Clinical Fellow

...

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...

Read More

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...

Read More

Drug Product Liability Litigation Course

...

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.

.. Read More

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...

Read More

“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...

Read More

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...

Read More

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...

Read More

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...

Read More

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...

Read More

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

Thursday, April 09, 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...

Read More

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 and&nb...

Read More

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...

Read More

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...

Read More

Research Project Grant Funding Opportunity

...

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...

Read More

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...

Read More

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...

Read More

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...

Read More

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...

Read More

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...

Read More

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...

Read More