A Look At How The Revolving Door Spins From FDA To Industry

NPR, September 28, 2016
by Sydney Lupkin

More than a quarter of the Food and Drug Administration employees who approved cancer and hematology...

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35 States Sue Opioid-Maker Over Its Alleged Tactics For Keeping Generic Version Off Market

Kaiser Health News, September 26, 2016

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

s

The la...

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Generic EpiPen Will Likely Secure Profits For Mylan

Law360, September 22, 2016
by Dani Kass, quoting Rachel Sachs (Academic Fellow alumna)

[...] Many customers are still likely to use the branded products once the generic is released,...

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It’s Not Just For Kids:

Kaiser Health News, September 21, 2016
by Julie Appleby and Mary Agnes Carey

Even as the cost of EpiPens dramatically rose, so too did the number of prescriptions written for pa...

Read More

Tough New Medical Research Rules Strive For Clarity In Previously ‘Opaque’ World

Kaiser Health News, September 19, 2016

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

s

The ne...

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U.N. To Take On Antibiotic Resistance At General Assembly

NPR, September 18, 2016
by Michael Martin, interviewing Keiji Fukuda

The U.N. General Assembly will devote an entire day to the issue of superbugs and antibiotic resista...

Read More

EBOLA and FDA: reviewing the response to the 2014 outbreak, to find lessons for the future

Journal of Law and the Biosciences, September 16, 2016
by Emily A. Largent (Student Fellow alumna)

Abstract

:

In 2014, West Africa confronted the most severe outbreak of Ebola virus disease (EVD) in...

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Black Health Experts Renew Fight Against Menthol Cigarettes

New York Times, September 13, 2016
by Sabrina Tavernise

WASHINGTON — Menthol cigarettes account for about a third of all cigarettes sold in the United...

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5 reasons why no one has built a better EpiPen

STAT, September 9, 2016
by Meghana Keshavan, quoting W. Nicholson Price II (Academic Fellow Alumnus)

[...] But critics say Mylan has little incentive to improve EpiPens: “If you’re the...

Read More

Euro Drug Pricing’s Tradeoffs May Limit Appeal In US

Law360, September 8, 2016
by Dani Kass, quoting W. Nicholson Price II (Academic Fellow Alumnus)

[...] Going forward, an influx of bills targeting drug prices could be introduced, but few are...

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EpiPen’s Dominance Driven By Competitors’ Stumbles And Tragic Deaths

NPR, September 7, 2016
by Pauline Bartolone, quoting W. Nicholson Price II (Academic Fellow alumnus)

NPR recently called on Petrie-Flom Academic Fellow alumnus Nicholson Price to help explain how...

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​FDA Bans Antibacterial Ingredients From Soaps, Says They May Do More Harm Than Good

Kaiser Health News, September 6, 2016

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

s

The in...

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EpiPen Controversy Fuels Concerns Over Generic Drug Approval Backlog

Kaiser Health News, September 6, 2016
by Sydney Lupkin

Consumers and Congress members pushing for cheaper alternatives to the EpiPen and other high-priced...

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Missouri law professor: Consider price controls after Epipen controversy

Missourinet, September 5, 2016
by Jason Taylor, quoting Rachel E. Sachs (Academic Fellow Alumna)

A Missouri law professor thinks Congress should consider imposing price controls on certain drugs af...

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With Tough Warning Label, FDA Aims To Curb Fatal Overdoses From Mixing Opioids, Sedatives

Kaiser Health News, September 1, 2016

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

s

The ag...

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Mylan’s sudden plans for a generic EpiPen

Modern Healthcare, Vital Signs Blog, August 31, 2016
by Adam Rubenfire, quoting Rachel E. Sachs (Academic Fellow alumna)

From the post

:

Obviously Mylan didn't want to underprice its own branded drug, but it's pos...

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Mylan’s decision to make a cheaper, generic EpiPen ‘baffles’ experts

Business Insider, August 31, 2016
by Lydia Ramsey, featuring blog post by Rachel E. Sachs (Academic Fellow alumna)

From the article

:

"I and others who study these issues full time cannot understand why Mylan though...

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Did It Hurt Or Help? Researchers Analyze Ohio’s 2011 Abortion Law

Kaiser Health News, August 30, 2016
by Shefali Luthra

Did a law regulating drug-induced abortions keep women safe or block them from access to this proced...

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Behind the stealth ad campaigns for the EpiPen and other drugs

STAT News, August 29, 2016
by Rebecca Robbins

Mylan Pharmaceuticals has spent millions this year on television ads and celebrity te...

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FDA Calls for Zika Testing of All Blood Donations

Wall Street Journal, August 26, 2016
by Thomas M. Burton

The Food and Drug Administration is calling for Zika testing of all donated blood and blood products...

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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 cal...

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 OpenBi...

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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 ma...

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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 o...

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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&n...

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...

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A Trojan Horse?

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

Abstract:      
; Scholars, advocates, and courts have begun to recogniz...

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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 th...

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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,...

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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 w...

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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 an...

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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 L...

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Regulatory Specialist
Partners HealthCare

Deadline: Open until filled.

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

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 stu...

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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...

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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 the...

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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...

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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, &l...

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FDA - Food

U.S. Food and Drug Administration

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

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 fo..

. 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, in...

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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 i...

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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 govern...

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 safet...

Read More

Food Safety

FoodSafety.gov

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

Read More

Codex Alimentarius

World Health Organization

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

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 pub...

Read More

Harvard Food Law and Policy Clinic

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

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 basic...

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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...

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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 played...

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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, Bi...

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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 -...

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“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 a...

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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...

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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 VICE...

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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 th...

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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...

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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...

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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 Chang

e

When: Monday,...

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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 Sh...

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 o...

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 incentives...

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 balance...

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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 Na...

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&nbs...

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 o...

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 Cent...

Read More

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 Innovatio...

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 FDA...

Read More

Drug Product Liability Litigation Course
Harvard Law School

Deadline: Open until filled.

>Instructor: ;Mr. Peter Gross

i

Semester: Fall 2015 Cours

e

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

m.

..

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 perso...

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 the...

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 Uni...

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 regul... 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 Adashi... 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 Februar...

Read More