Emerging Issues and New Frontiers for FDA Regulation

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

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Food and Drug Law Institute are pleased to…

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DRAFT AGENDA NOW AVAILABLE: Post-Trial Responsibilities:
Ethics and Implementation

Thursday, September 18, 2014 8:00 AM - 5:30 PM
Wasserstein Hall, Milstein East AB
1585 Massachusetts Ave., Cambridge, MA

Registration for the conference is open now! Register online. Conference Description:Law, policy, and guidance are vague, sometimes conflicting, and generally…

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Arkansas Weighs Plan To Make Some Medicaid Enrollees Fund Savings Accounts

Kaiser Health News, July 22, 2014
by Michele Andrews

If all goes according to plan, next year many Arkansas Medicaid beneficiaries will be required to make monthly contributions to so-called Health Independence Accounts. Those that don't may have to…

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Three person IVF plans ‘progress’ in UK:

BBC News, July 22, 2014

A public review into the three person IVF technique has been broadly supportive, says the Department of Health. But a number of technical and scientific details need to be finalised…

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Big Data Peeps At Your Medical Records To Find Drug Problems

NPR, July 21, 2014
by Nell GreenfieldBoyce

No one likes it when a new drug in people's medicine cabinets turns out to have problems — just remember the Vioxx debacle a decade ago, when the painkiller was…

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California Halts Injection of Fracking Waste, Warning it May Be Contaminating Aquifers:

ProPublica, July 18, 2014
by Abraham Lustgarten

California officials have ordered an emergency shut-down of 11 oil and gas waste injection sites and a review more than 100 others in the state's drought-wracked Central Valley out of…

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Petrie-Flom Center Launches New Book on Human Subjects Research Regulation

MIT Press, August 2014
by I. Glenn Cohen (Faculty Director) and Holly Fernandez Lynch (Executive Director), eds.

The Petrie-Flom Center is pleased to announce publication of Human Subjects Research Regulation: Perspectives on the Future (MIT Press 2014), co-edited by Petrie-Flom Center Faculty Director, I. Glenn Cohen, and Executive…

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EEOC Announces Tougher Rules Protecting Pregnant Workers

NPR, July 16, 2014
by Bill Chappell

Discrimination against female workers who might get pregnant in the future, or have been pregnant in the past, is against the law, the Equal Employment Opportunity Commission said this week.…

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Misjudgements will drive social trials underground:

Nature, July 16, 2014
by Michelle Meyer (Academic Fellow Alumna) et al.

Former Petrie-Flom Academic Fellow Michelle N. Meyer has joined with a group of other scholars to defend the recently publicized social contagion experiment conducted by Facebook, arguing that the experiment…

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Lapses at high-security CDC labs reveal culture of negligence:

Christian Science Monitor, July 16, 2014
by Noelle Swan

Revelations of safety breaches at federal biosecurity laboratories reveal gaping holes in safety protocols, a lack of independent oversight, and an apparent culture of hubris among researchers who work with…

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Cigarette maker Reynolds to buy Lorillard for $27.4 billion

LA Times, July 15, 2015
by Bloomberg

ynolds American Inc., the producer of Camel and Pall Mall cigarettes, agreed to buy rival Lorillard Inc. for $27.4 billion including debt in a deal that reduces the 400-year-old U.S.…

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Abortion Clinic Protections Proposed in Massachusetts

New York Times, July 14, 2014
by Jess Bidgood

BOSTON — Massachusetts lawmakers expressed support for a bill filed on Monday that they say would address safety concerns that arose when theUnited States Supreme Court last month struck down 35-foot buffer zones…

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Women forced to travel as Deep South closes doors on abortion clinics:

Al Jazeera America, July 12, 2014
by Ashley Cleek

BIRMINGHAM, Ala. – When Kew found out she was pregnant, she knew immediately that she wanted to have an abortion. So she did a web search for “abortion clinic in…

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US disease labs ‘made dangerous pathogen transport errors’:

BBC News, July 11, 2014

This year alone, workers mishandled samples of anthrax and the highly-infectious H5N1 avian flu. In response, the Centers for Disease Control and Prevention (CDC) has closed the two labs involved.…

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Synthetic cannabis ‘not medicinal’, EU top court says

BBC News, July 10, 2014

The EU's top court says designer drugs that mimic cannabis, which are already illegal in many countries, cannot be classed as medicinal. If a drug is not "medicinal" then it…

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VIDEO NOW AVAILABLE: Using Big Data To Transform Care

HealthAffairs, July 9, 2014
by Featuring I. Glenn Cohen (Faculty Director)

The application of big data to transform health care delivery, health research, and health policy is underway, and its potential is limitless.  The July 2014 issue of Health Affairs, "Using Big…

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Race Is On to Profit From Rise of Urgent Care

New York Times, July 9, 2014
by Julie Cresswell

[...] But what is happening here is also playing out across the nation, as private equity investment firms, sensing opportunity, invest billions in urgent care and related businesses. Since 2008, these investors…

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Last-Resort Antibiotics In Jeopardy As Use Rises Globally

NPR, July 9, 2014
by Michaeleen Doucleff

The total doses of antibiotics sold in clinics and pharmacies around the world rose 36 percent from 2000 to 2010, scientists reported Wednesday. The finding, published in The Lancet Infectious Disease, comes from the first…

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Study: Hospitals Using Electronic Medical Records Not Bilking Medicare

Kaiser Health News, July 8, 2014
by Eric Whitney

A new study says there's no need to worry about hospitals using their new electronic medical records to generate bigger bills and boost their income. It's been a concern since…

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Some Insurance Companies Ask Their Customers to Cross the Border for Care:

New Republic, July 7, 2014
by Adam Teicholz and I. Glenn Cohen (Faculty Director) and

Faculty Director I. Glenn Cohen has co-authored a new piece in New Republic on the practice adopted by some insurance companies of sending clients across the border for less expensive care. From…

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Coming to U.S. for Baby, and Womb to Carry It:

New York Times, July 5, 2014
by Tamar Lewin

[...] In an era of globalization, the market for children crosses national borders; witness the longtime flow of Americans who have gone overseas to adopt babies from South Korea, China,…

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Berkeley mulls proposal to provide free medical marijuana:

Al Jazeera America, July 3, 2014

If a new proposal passes a final City Council vote next week in Berkeley, California, poor and low-income medical marijuana users in the city will no longer have to worry…

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Politicians’ Prescriptions for Marijuana Defy Doctors and Data

New York Times, June 26, 2014
by Catherine Saint Louis

New York moved last week to join 22 states in legalizing medical marijuana for patients with a diverse array of debilitating ailments, encompassing epilepsy and cancer, Crohn’s disease and Parkinson’s.…

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New York’s Ban on Big Sodas Is Rejected by Final Court

New York Times, June 26, 2014
by Michael M. Grynbaum

The Bloomberg big-soda ban is officially dead. The state’s highest court on Thursday refused to reinstate New York City’s controversial limits on sales of jumbo sugary drinks, exhausting the city’s…

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Summer Program on Emerging Issues in Food and Drug Law

Summer Program on Emerging Issues in Food and Drug Law
O'Neill Institute for National and Global Health Law, Georgetown University

Deadline: July 14 - 18, 2014

Please join the O’Neill Institute for National and Global Health Law at Georgetown University for a one-week intensive summer institute exploring the domestic and international legal, regulatory, and policy framework shaping the safety and availability…

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Using Big Data To Transform Care:

Health Affairs, July 9, 2014, 9:00am - 12:30pm
by Featuring I. Glenn Cohen (Faculty Director)

The application of big data to transform health care delivery, health research, and health policy is underway, and its potential is limitless.  The July 2014 issue of Health Affairs, "Using…

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Medical Marijuana 101:

CommonHealth, WBUR (NPR, Boston), June 23, 2014
by Martha Bebinger

[...] The Massachusetts Medical Society opposed the statewide ballot question that made marijuana legal for medical purposes. But the society offered this course because the drug is legal now for…

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Doctors pushed to reject role in executions

"The Rachel Maddow Show," MSNBC, June 17, 2014
by Rachel Maddow, interviewing I. Glenn Cohen (Faculty Director)

Faculty Director I. Glenn Cohen appeared on The Rachel Maddow Show to discuss his recent opinion piece in JAMA, coauthored with Robert D. Truog and Mark A. Rockoff (both of Harvard Medical School), on “Physicians,…

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California lawmakers reject sugary drink warning labels:

Al Jazeera America, June 17, 2014

A California bill to require sugary soft drinks to carry labels warning of obesity, diabetes and tooth decay died in the Legislature on Tuesday, the latest in a string of…

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A Bolder Effort by Big Tobacco on E-Cigarettes

New York Times, June 17, 2014
by Matt Richtel

Electronic cigarettes, promoted as a healthier alternative to tobacco, are getting powerful new backers with an unhealthy reputation: big tobacco companies. The development points to ways Big Tobacco is moving…

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Lawmakers Caution Dr. Oz on Weight-Loss Tips:

Time, June 17, 2014
by Becca Stanek

Lawmakers warned the TV personality Dr. Mehmet Oz on Tuesday to proceed with caution when offering weight-loss tips. Missouri Democratic Senator Claire McCaskill called the host of The Dr. Oz Show to…

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Direct-to-Patient Laboratory Test Reporting:

JAMA, June 16, 2014
by Michael J. Young, MPhil (Petrie-Flom Student Fellow); Ethan Scheinberg, BTL; Harold Bursztajn, MD

In February 2014, the Department of Health and Human Services (HHS) issued a landmark ruling allowing patients direct access to completed medical laboratory reports. The ruling took effect April 7, 2014,…

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A Chinese Chemical Company And A ‘Bath Salts’ Epidemic

NPR, June 16, 2014
by Frank Langfitt

[...] Shanghai has a big, legitimate pharmaceutical industry. Power — who never actually ordered the mephedrone — says factories like Chang's branched out into recreational drugs in response to orders…

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Food industry groups sue to block Vermont’s GMOs labeling law

CBS News, June 13, 2014

MONTPELIER, Vt. -- The Grocery Manufacturers Association and other industry groups challenged a new Vermont law in federal court Thursday that requires the labeling of food made with genetically modified organisms.…

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Patrick airs $20m plan to combat opioid use:

Boston Globe, June 10, 2014
by Brian MacQuarrie

Governor Deval Patrick unveiled plans Tuesday to upgrade treatment for opioid addicts, expand insurance coverage, and coordinate with the other five New England governors to stem an epidemic that has…

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Audit Reveals Vast Scale Of VA Waitlist Issues

NPR, June 9, 2014
by Quil Lawrence

Before former Veterans Affairs Secretary Eric Shinseki stepped down, he ordered an audit of the VA system, hoping to find how many hospitals were lying about wait times. The audit…

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Under Health Law, States Serve As Testing Grounds For Innovation

Kaiser Health News, June 9, 2014

Media outlets report on a range of issues related to the measure's implementation, including how some states are finding opportunities in the overhaul to pursue their own health system changes. Also in the news, the…

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Marijuana isn’t harmless, top health official says

CBS News, June 5, 2014
by Dennis Thompson

States joining the march toward marijuana legalization need to take a step back and consider the drug's adverse effects on health, the U.S. drug "czar" argues in a new paper. Marijuana is potentially…

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New York City Soda Fight, in Court, Tests Agency’s Power

New York Times, June 4, 2014
by Michael M. Grynbaum

ALBANY — New York City’s battle over sugary drinks is entering its endgame. But much more than soda is at stake. A plan to limit the sale of large, high-calorie…

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‘Millions denied end-of-life drugs’:

BBC News, June 2, 2014
by Tulip Mazumdar

Figures suggest almost 18 million people - mainly in developing countries - died in unnecessary pain in 2012. In Ethiopia, there are reports of cancer patients throwing themselves in front…

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The Health Data Revolution Enters An Awkward Adolescence

NPR, June 3, 2014
by Nancy Shute

The crowd in a hotel ballroom in Washington, D.C., was rocking on Monday, the 2,000 people shrieking with excitement over federal health-care databases. That could only happen at Health Datapalooza,…

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Health Experts See Benefits in Push to Cut Pollution

New York Times, June 2, 2014
by Denise Grady

The Obama administration contends that its new plan to cut carbon pollution from power plants will not just fight climate change, but will also quickly improve public health, preventing up to…

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GOP House Backs State Medical Marijuana Laws

New York Times, May 30, 2014
by Associated Press

WASHINGTON — The GOP-controlled House voted early Friday in favor of blocking the federal government from interfering with states that permit the use of medical marijuana. The somewhat surprising 219-189 vote…

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VA Chief Shinseki Apologizes And Says He Is Replacing Leadership At Troubled Phoenix VA Hospital

Kaiser Health News, May 30, 2014

Two days after a preliminary Inspector General report confirmed secret waiting lists at a Phoenix veterans hospital, Veterans Affairs Secretary Eric Shinseki addresses a conference on homeless veterans and says…

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Stem Cell Therapies:

Institute of Medicine and the National Academy of Sciences, 2014
by Adam C. Berger, Sarah H. Beachy, and Steve Olson, featuring I. Glenn Cohen (Faculty Director)

Stem cells offer tremendous promise for advancing health and medicine. Whether being used to replace damaged cells and organs or else by supporting the body's intrinsic repair mechanisms, stem cells…

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Biostatistics and FDA Regulation:
The Convergence of Science and Law

Tuesday, May 20, 2014 8:00 AM - 5:00 PM
Wasserstein Hall, Milstein West AB
1585 Massachusetts Ave., Cambridge, MA

Symposium Presented by the Drug Information Association (DIA), the Food and Drug Law Institute (FDLI), and the Petrie-Flom Center for Health Law Policy, Biotechnology, and…

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Health Science Administrator (Deputy Director, OHRP)

Health Science Administrator (Deputy Director, OHRP)
Office of the Secretary, Office of the Asst. Secretary for Health (OASH), Office for Human Research Protections (OHRP)

Deadline: June 13, 2014

The Office for Human Research Protections (OHRP) is pleased to announce the following job vacancy within the Office of the Assistant Secretary for Health (OASH). OHRP is actively seeking to fill a vacancy for its…

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Trial Over Alabama Abortion Law Begins

ABC News, May 19, 2014
by Philip Rawls

The operators of three of Alabama's five abortion clinics testified Monday they use out-of-town doctors who wouldn't be able to admit patients to local hospitals as required under a new…

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