Academic Fellow W. Nicholson Price II Appointed Asst. Professor at UNH School of Law

Petrie-Flom Center, March 13, 2014

Petrie-Flom Academic Fellow Nicholson Price has been appointed as an Assistant Professor at the University of New Hampshire School of Law, where he will research and teach on intellectual property, innovation policy, and…

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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
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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Reforming Brazilian Pharmaceutical Patent Policy:
Lessons from the Past and the Road for the Future

Wednesday, April 23, 2014 12:00 PM
Lectures and Panels
Wasserstein Hall 1010
1585 Massachusetts Ave., Cambridge, MA

In this lecture by Pedro Paranaguá, he will discuss the report issued by the Brazilian House of Representatives in 2013…

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Free Film Screening and Panel Discussion

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

Students from across Harvard are 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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Idea of New Attention Disorder Spurs Research, and Debate

New York Times, April 11, 2014
by Alan Schwarz

With more than six million American children having received a diagnosis of attention deficit hyperactivity disorder, concern has been rising that the condition is being significantly misdiagnosed and overtreated with…

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Ebola Drug Could Be Ready For Human Testing Next Year

NPR, April 11, 2014
by Richard Harris

The Ebola outbreak in West Africa is terrifying because there's no drug to treat this often fatal disease. But the disease is so rare, there's no incentive for big pharmaceutical companies to…

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WHO Calls For High-Priced Drugs For Millions With Hepatitis C

NPR, April 9, 2014
by Richard Knox

Authors of the first-ever global guidelines for treating hepatitis C went big Tuesday, advocating for worldwide use of two of the most expensive specialty drugs in the world. The new guidelines from…

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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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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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Big pharma fights back from China scandal (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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FDA approves device to combat opioid drug overdose

Washington Post, April 3, 2014
by Brady Dennis

In a move aimed at stemming the tide of deaths caused by the nation’s prescription drug epidemic, the Food and Drug Administration on Thursday approved a new device that would allow family…

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Arizona Limit on Non-Surgical Abortion Allowed by Judge

Bloomberg, April 1, 2014
by Edvard Pettersson

An Arizona law limiting women’s access to drug-induced abortions was allowed by a federal judge to take effect in a defeat to reproductive-rights activists fighting parts of a 2012 state overhaul of…

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Supreme Court to Hear Appeal of Generic Drug Case

New York Times, March 31, 2014
by Andrew Pollack

As the world’s largest maker of generic drugs, Teva Pharmaceutical Industries has been critical of brand-name manufacturers that try to block generic versions of their high-priced medicines. But Teva is…

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Make it Work!:

Harvard Law Review 128, 2014
by I. Glenn Cohen (Faculty Co-Director)

This short essay is part of a Harvard Law Review Symposium honoring Justice Breyer on his 20th Year on The Supreme Court. It examines Breyer's opinions and impact on the…

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New Curbs on Drug Use in Animals

Wall Street Journal, March 26, 2014
by Thomas M. Burton and Kelsey Gee

Almost all companies that make animal drugs have agreed to change their labels to curb the use of antibiotics in cattle, pigs and other farm animals, the Food and Drug…

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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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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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Suit filed to block new Arizona abortion regulations

LA Times, March 5, 2014
by Cindy Carcamo

TUCSON -- Abortion providers have filed suit against Arizona to block a new rule that limits the use of medications to induce abortions. The rule is part of state-mandated abortion…

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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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The “Problem” with the European Problem/Solution Approach to Inventive Step

Los Angeles Intellectual Property Law Association, Wegner's Writings, February 24, 2014
by Harold C. Wegner, reviewing Timo Minssen (Petrie-Flom Visiting Scholar)

From the review: Patent applicants seeking to gain global patent protection beyond their home country borders need a better comparative knowledge of key elements of the patent laws of the several…

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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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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
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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Novartis puts pressure on India over patent abuse

Financial Times, February 16, 2014
by Andrew Ward and Amy Kazmin

Novartis has urged US and European governments to “apply pressure” on India to respect intellectual property and warned New Delhi that its stance on patents is deterring investment. Joe Jimenez,…

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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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DEA needs warrant to access Oregon prescription database, judge says

The Oregonian, February 11, 2014
by Helen Jung

Federal drug investigators can’t access an Oregon-maintained database that records patients’ prescription information without first getting a warrant, a federal judge in Portland ruled. In the opinion issued Tuesday, Senior U.S. District Judge…

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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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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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Health Law Year in P/Review

Friday, January 31, 2014 8:30 AM - 5:00 PM
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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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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Medicare Officials Seek Authority To Ban Harmful Prescribers

NPR, January 6, 2014
by Tracy Weber and Charles Ornstein

Medicare plans to arm itself with broad new powers to better control — and potentially bar — doctors engaged in fraudulent or harmful prescribing, following a series of articles detailing…

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Lack of drug data ‘extreme concern’:

BBC News, January 2, 2014
by James Gallagher

The Public Accounts Committee is calling for all data on drugs being prescribed in the UK to be made available. It also says the government spent £424m stockpiling the antiviral…

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Five pressing health priorities in 2014

The Washington Post, December 28, 2013
by Brady Dennis

As head of the Centers for Disease Control and Prevention, Thomas Frieden oversees an agency with the sprawling mission of reining in diseases in the United States and across the globe.…

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How do Americans waste $28 billion a year?

L.A. Times, December 17, 2013
by Karen Kaplan

Looking for ways to save money in 2014? Here's some advice from doctors: Stop buying vitamins. Time after time, studies have shown that vitamin and mineral supplements don’t prevent disease or death.…

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GlaxoSmithKline to Stop Paying Doctors for Endorsements

The Atlantic, December 17, 2013
by James Hamblin

Many doctors learn about new medications—and new uses for old medications—by listening to formal presentations from expert peers. Pharmaceutical companies pay those peers to give speeches about their products at medical conferences.…

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Scientists Turn To The Crowd In Quest For New Antibiotics

NPR, December 12, 2013
by Alan Yu

Could you dig up the next antibiotic in your backyard? Two scientists would like you and, if they're lucky, millions of other people to give it a try. The researchers…

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HIV Patients Asked to Pay More Under Obamacare

Time, December 10, 2013
by Kate Pickert

[...] Some HIV advocates see the limited offerings as part of an intentional move by insurers to scare away HIV patients in order to keep their risk pools full of healthy people…

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Ketamine ‘should be upgraded to Class B’

BBC News, December 10, 2013

The drug ketamine should be upgraded from a Class C drug to Class B, government advisers have recommended. The Advisory Council on the Misuse of Drugs said new evidence had…

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Do Fixed Patent Terms Distort Innovation?:

Public Health Law & Policy e-Journal 5, no. 64, December 4, 2013
by Eric B. Budish, Benjamin N. Roin, and Heidi Williams

Abstract: Patents award innovators a fixed period of market exclusivity, e.g., 20 years in the United States. Yet, since in many industries firms file patents at the time of discovery ("invention")…

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Thalidomide lawsuit settled in Australia, NZ for $81m

BBC News, December 2, 2013

A lawsuit filed by more than 100 people in Australia and New Zealand who suffered birth defects caused by the drug Thalidomide has been settled. British company Diageo, which did…

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Responsibility and Integrity in the Pharmaceutical Industry

Thursday, November 21, 2013 12:00 PM
Lectures and Panels
Hauser 104
1575 Massachusetts Ave., Cambridge, MA

Watch Event Recordings

Video of this event is now available online: The Petrie-Flom Center hosted a lecture by Neil Flanzraich on responsible pricing strategy, access…

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Health Law Workshop: Aaron Kesselheim

Monday, November 18, 2013 5:00 PM
Health Law Workshops
Hauser 105
1575 Massachusetts Ave., Cambridge, MA

Professor Kesselheim's paper, "Do March-In Rights Protect Public Interests in Medical Products Arising from Federally-Funded Research?", is not available online. Please…

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Senate approves bill to improve safety of compounded drugs

CNN, November 18, 2013
by Ted Barrett

The Senate Monday approved a bill to give the Food and Drug Administration oversight of large compounding pharmacies to insure they meet the agency's strict safety standards. The legislation grew…

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Addiction Treatment With a Dark Side

New York Times, November 16, 2013
by Deborah Sontag

[...] Suboxone is the blockbuster drug most people have never heard of. Surpassing well-known medications like Viagra and Adderall, it generated $1.55 billion in United States sales last year, its success fueled…

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Executions Stall as States Seek Different Drugs

New York Times, November 8, 2013
by Manny Fernandez

HOUSTON — Florida ran out of its primary lethal-injection drug last month and relied on a new drug that no state had ever used for an execution. At Ohio’s next…

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