2014-2015 Student Fellowship

2014-2015 Student Fellowship
Petrie-Flom Center, Harvard Law School

Deadline: May 19, 2014

The Center and Student Fellowship.  The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is an interdisciplinary research program at Harvard Law School dedicated to the scholarly research of important issues at the intersection…

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AGENDA NOW AVAILABLE: Biostatistics and FDA Regulation:
The Convergence of Science and Law

Tuesday, May 20, 2014 8:00 AM - 5:00 PM
Conferences
2013-2014
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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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 film Dallas Buyers Club and participate in…

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UK drug company Glaxo ‘paid bribes to Polish doctors’

BBC News, April 13, 2014

Eleven doctors and a GSK regional manager have been charged over alleged corruption between 2010 and 2012. A former sales rep said doctors were paid to promote GSK's asthma drug…

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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 that, for both epistemic and normative reasons, it remains profoundly difficult to regulate…

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European Union Debates Initiative on Embryo Protection

New York Times, April 10, 2014
by James Kanter

BRUSSELS — A packed hearing on a petition calling for the protection of human embryos led to a rare outbreak of raucous exchanges in the European Parliament on Thursday —…

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Judge hits state on painkiller ban:

Boston Globe, April 8, 2014
by Milton J. Valencia

A federal judge said Tuesday that she will probably strike down Governor Deval Patrick’s emergency ban on the sale of Zohydro, a controversial painkiller that has been approved by federal…

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Health Law Workshop: David Gamage

Monday, April 07, 2014 5:00 PM
Health Law Workshops
2013-2014
Hauser 105
1575 Massachusetts Ave., Cambridge, MA

Download David Gamage's paper, "The Evolution of Health Care Reform: Should Risk Adjustment Become the Heart of Obamacare?". David Gamage is…

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FDA Grants Breakthrough Therapy Designation To Novartis’ Meningitis B Vaccine

Forbes, April 7, 2014
by David Kroll

Novartis AG in Basel announced early this morning that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation – a rapid development track – for potential approval of Bexsero®, their innovative vaccine…

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Journal of Law and the Biosciences (JLB) Soliciting Commentaries

Journal of Law and the Biosciences (JLB) Soliciting Commentaries

Deadline: May 05, 2014

Journal of Law and the Biosciences is pleased to solicit Peer Commentaries for the following articles: The Regulation of Cognitive Enhancement Devices, by Hannah Maslen, Thomas Douglas, Roi Cohen Kadosh, Neil Levy,…

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Big pharma fights back from China scandal

Swissinfo.ch (reprint from Financial Times), April 3, 2014
by Andrew Ward and Patti Waldmeir

When Chinese authorities accused GlaxoSmithKline last summer of being the “godfather” at the centre of a network of corruption, big pharma braced for a prolonged period of turmoil in one…

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E-cig rule coming ‘very soon,’ U.S. FDA chief says

Reuters, April 3, 2014

The U.S. Food and Drug Administration is "pushing very hard" to release a proposed rule that would establish its authority over e-cigarettes, the head of the agency said on Thursday…

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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. Rachel earned her J.D. in 2013 magna cum laude from Harvard Law School, where she was the Articles Chair of…

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In California, Chefs Fight For Bare-Hand Contact

NPR, March 23, 2014
by Associated Press

As the happy hour crowd poured in on a recent weeknight, the kitchen and bar staff at Hock Farm restaurant scrambled to meet the incoming orders. One used her hands…

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Selling a Poison by the Barrel:

New York Times, March 23, 2014
by Matt Richtel

A dangerous new form of a powerful stimulant is hitting markets nationwide, for sale by the vial, the gallon and even the barrel. The drug is nicotine, in its potent,…

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Toxic Chemical Dioxane Detected In More Water Supplies

NPR, March 26, 2014
by Elizabeth Shogren

West Virginia's drinking water crisis earlier this year highlighted an unsettling truth about tap water: Treatment plants test for only a fraction of the chemicals in use.

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Disputing Study, U.S. FDA Says Generics From Abroad Safe

Bloomberg News, March 25, 2014
by Anna Edney

A top U.S. regulator is discrediting research published a year ago that found impurities in dozens of generic heart drugs made overseas, saying the investigators contaminated the samples during their…

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FDA panel recommends HPV test as replacement for Pap smear

CBS News, March 13, 2014
by Steven Reinberg

A U.S. Food and Drug Administration advisory panel voted unanimously on Wednesday that a new HPV test could be used before or instead of the Pap smear as a first…

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Maker of OxyContin developing tamper-resistant hydrocodone drug

Washington Post, March 12, 2014
by Brady Dennis

The manufacturer of Oxy­Contin said Wednesday that it had successfully tested a tamper-resistant form of another powerful painkiller, hydrocodone — an announcement that could upend this month’s release of the controversial drug…

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China Cracks Down on DNA Testing

Forbes, March 3, 2014
by Shu-Ching Jean Chen

Genetic testing has grown to be a business big enough in China to warrant the government’s intervention. Early in February, the government quietly put the brakes on the provision of…

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Hospital antibiotic use can put patients at risk, study says

Washington Post, March 4, 2013
by Lena H. Sun

Doctors in some hospitals prescribe up to three times as many antibiotics as doctors at other hospitals, putting patients at greater risk for deadly superbug infections, according to a federal…

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As Full Disclosure Nears, Doctors’ Pay for Drug Talks Plummets

Pro Publica, March 3, 2014
by Charles Ornstein, Eric Sagara, and Ryann Grochowski Jones

Some of the nation’s largest pharmaceutical companies have slashed payments to health professionals for promotional speeches amid heightened public scrutiny of such spending, a new ProPublica analysis shows. Eli Lilly…

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New Nutrition Labels To Highlight Calories, Added Sugar

Kaiser Health News, February 24, 2014

This is part of Kaiser Health News' Daily Report - a summary of health policy coverage from more than 300 news organizations.

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Tough EU smoking rules approved:

BBC, February 26, 2014
by James Gallagher

The rules, voted in by the European Parliament, mean picture health warnings will have to dominate the front and back of all packaging. There will also be a ban on…

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A Hot Debate Over E-Cigarettes as a Path to Tobacco, or From It

New York Times, February 22, 2014
by Sabrina Tavernise

Dr. Michael Siegel, a hard-charging public health researcher at Boston University, argues that e-cigarettes could be the beginning of the end of smoking in America. He sees them as a…

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Generic-Drug Testing Goes Widespread in U.S. FDA Effort

Bloomberg, February 22, 2014
by Anna Edney

Generic drugs that make up almost 80 percent of U.S. prescriptions are being tested in the first widespread safety and quality evaluation run by the Food and Drug Administration. The $20 million effort,…

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New Directions for Food Safety:
The Food Safety Modernization Act and Beyond

Friday, February 21, 2014 8:30 AM - 4:30 PM
Conferences
2013-2014
Austin Hall, Ames Courtroom (200)
1515 Massachusetts Ave., Cambridge, MA

This event is free and open to the public, but space is limited and registration is required. To register, please…

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DEA turns to texting to fight prescription drug abuse

CNN, February 21, 2014
by Jen Christensen

A pharmacy tech who makes $12 an hour but drives a Mercedes. A rumor that a pharmacist may be trading sex for drugs. A prescription note with handwriting that's a…

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Patents Without Patents:
Regulatory Incentives for Innovation in the Drug Industry

Wednesday, February 19, 2014 12:00 PM
Lectures and Panels
2013-2014
Wasserstein Hall 1015
1585 Massachusetts Ave., Cambridge, MA

Watch Event Recordings

In the pharmaceutical industry, patents are the preeminent incentive for innovation in developing new drugs.  But patents aren’t the whole…

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Children with cancer ‘denied drugs because of EU rules’:

BBC, February 10, 2014

The UK's Institute of Cancer Research (ICR) says the current system acts as a disincentive to drug companies who can seek waivers to avoid doing the trials. Of 28 new…

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Health Law Workshop: I. Glenn Cohen

Monday, February 17, 2014 5:00 PM
Health Law Workshops
2013-2014
Hauser 105
1575 Massachusetts Ave., Cambridge, MA

Professor Cohen's papers, "What (if anything) is Wrong with Human Enhancement? What (if anything) is Right With It?" and "This Is…

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Patent Trolling:

by Robin Feldman and W. Nicholson Price II (Petrie-Flom Academic Fellow)

Abstract: Patent trolls — also known variously as non-practicing entities, patent assertion entities, and patent monetizers — are a top priority on legislative and regulatory reform agendas. In the modern…

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Australia genetically modified crops row goes to court:

BBC News, February 11, 2014

Steve Marsh said he lost organic certification on 70% of his farm after GM canola seeds blew over from Michael Baxter's farm in 2010. Mr Baxter's lawyers say the organic…

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West Virginia officials avoid calling state’s water safe:

Al Jazeera America, February 11, 2014
by Robert Ray and Wilson Dizard

[...]  West Virginia's senior senator, Democrat Jay Rockefeller, also had harsh words for how industry in general behaves in the Mountain State, which has seen the economic benefits as well…

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Drug Shortages Continue to Vex Doctors

New York Times, February 10, 2014
by Sabrina Tavernise

Despite efforts by the Obama administration to ease shortages of critical drugs, shortfalls have persisted, forcing doctors to resort to rationing in some cases or to scramble for alternatives, a…

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FDA Approves Pill Camera to Screen Colon

ABC News, February 3, 2014
by Matthew Perrone

A kinder, gentler approach to one of the most dreaded exams in medicine is on the way: U.S. regulators have cleared a bite-size camera to help screen patients who have…

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NIH announces novel venture with drug companies to fight major diseases

Washington Post, February 4, 2014
by Ariana Eunjung Cha

The National Institutes of Health is undertaking an ambitious collaboration with private industry in an attempt to speed up the search for treatments for some of the world’s most devastating…

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FDA launches teen anti-smoking campaign

CNN, February 4, 2014
by Sandra Young

Every day, more than 3,200 kids under the age of 18 smoke a cigarette for the first time. About 700 of those become daily smokers. Those are two reasons, the…

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New rule allows patients to get test results directly from labs, without doctors’ clearance

Washington Post, February 3, 2014
by Sandra Somashekar

Patients may obtain their test results directly from the laboratory that produced them, without having to go through their doctors, under regulations announced Monday by the Obama administration. The rule is…

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Ethics Questions Arise as Genetic Testing of Embryos Increases

New York Times, February 3, 2014
by Gina Kolata

[...]  Genetic testing of embryos has been around for more than a decade, but its use has soared in recent years as methods have improved and more disease-causing genes have…

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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.) At our second Annual Health…

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Judge Rejects Execution Delay Over Use of Compounded Drug

New York Times, January 27, 2014
by Dan Frosch and Sabrina Tavernise

Lawyers for a Missouri inmate said Monday that they would appeal a decision not to grant a delay in his execution, arguing that the drug to be used was likely to…

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FDA halts drug imports from India’s Ranbaxy plant

NBC News, January 23, 2014
by Associated Press

U.S. health regulators said Thursday they are barring imported drugs from an overseas factory operated by Ranbaxy Laboratories, India's largest drugmaker, due to quality control violations. The Food and Drug…

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W.Va. chemical spill poses a new test for lawmakers

Washington Post, January 19, 2014
by Joel Achenbach

There are more than 80,000 chemicals in the United States catalogued by government regulators, and the health risks of most of them are unknown. This became glaringly obvious when, on…

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Surgeon General Adds New Risks To Long List Of Smoking’s Harms:

NPR, January 14, 2014
by Richard Knox

Acting Surgeon General Boris Lushniak is the latest in a long line of surgeons general who have tried to pound the final nails into the coffin of America's smoking habit.…

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Legal Aspects of Biobanking as Key Issues for Personalized Medicine & Translational Exploitation

by Timo Minssen (Petrie-Flom Visiting Scholar) and Jens Schovsbo

Abstract: This perspective-article provides an overview on selected legal aspects of biobanking. It discusses these issues with a focus on public biobanks in a university setting and the specific challenges posed…

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Ohio executes killer despite fears over never-tried drug cocktail:

Al Jazeera America, January 16, 2014

A condemned Ohio inmate appeared to gasp several times and took more than 15 minutes to die Thursday as he was executed with a combination of drugs never before tried in the…

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Bans cut some chemicals, but others replaced them, study finds

NBC News, January 15, 2014
by Maggie Fox

Policies meant to protect people from suspect chemicals in toys and other plastics that have caused widespread public concern reduced levels of some of those chemicals in people’s bodies, researchers…

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With Outbreaks, States Push Back On Anti-Vaccine Movement

WBUR's "On Point", January 9, 2014

The last ten or fifteen years have been a rough road for childhood vaccines and vaccination.  After a century in which they became the great bulwark against all kinds of…

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NEW BOOK: Science and Technology in International Economic Law:

Routledge, 2014
by Bryan Mercurio and Kuei-Jung Ni (Petrie-Flom Visiting Scholar), editors

Science and technology plays an increasingly important role in the continued development of international economic law. This book brings together well-known and rising scholars to explore the status and interaction…

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