Health Law Workshop: Rachel Sachs

Monday, April 13, 2015 5:00 PM
Health Law Workshops
2014-2015
Griswold Hall, Room 110
1525 Massachusetts Ave., Cambridge, MA

Presentation Title: "Prescription Drug Reimbursement as Innovation Incentive" Rachel Sachs is an Academic Fellow at the Petrie-Flom Center. She earned her…

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Health Law Workshop: Liran Einav

Monday, February 09, 2015 5:00 PM
Health Law Workshops
2014-2015
Griswold Hall, Room 110
1525 Massachusetts Ave., Cambridge, MA

Presentation Title: "The Response of Drug Expenditure to Non-Linear Contract Design: Evidence from Medicare Part D" (co-authors, Amy Finkelstein and Paul…

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SAVE THE DATE: Third Annual Health Law Year in P/Review

Friday, January 30, 2015 9:00 AM - 5:00 PM
Conferences
2014-2015
Wasserstein Hall, Milstein East AB
1585 Massachusetts Avenue, Cambridge, MA

Please join us for the Third Annual Health Law Year in P/Review symposium, with leading experts discussing major developments during…

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Costly Hepatitis C Treatments Help Drive 12 Percent Drug Spending Jump

Kaiser Health News, November 20, 2014
by Roni Caryn Rabin

After several years of modest increases, American spending on medications is projected to shoot up by 12 percent this year, pushing the nation’s drug bill to between $375 billion and…

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Gilead Buys Shortcut For FDA Drug Review For $125 Million

NPR, November 19, 2014
by Scott Hensley

[...] Duke health economist David Ridley, one of the intellectual architects behind the voucher law, told Shots that he "was delighted" by the sale. "I think we're much closer to…

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Laws Spreading That Allow Terminal Patients Access To Experimental Drugs

Kaiser Health News, November 18, 2014
by Michelle Andrews

Earlier this month, Arizona voters approved a referendum that allows terminally ill patients to receive experimental drugs and devices. It’s the fifth state to approve a “right-to-try” law this year. Supporters say…

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Obamacare May Mean High Drug Costs For Floridians With HIV

Miami Herald, October 31, 2014
by Nicholas Nehamas

[...] Last spring, two nonprofit groups filed a federal civil rights complaint alleging that some Florida insurers were discriminating against people with HIV by charging “inordinately high” rates for HIV…

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Ebola Vaccine, Ready for Test, Sat on the Shelf

New York Times , October 23, 2014
by Denise Grady

Almost a decade ago, scientists from Canada and the United States reported that they had created a vaccine that was 100 percent effective in protecting monkeys against the Ebola virus. The results…

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Emerging Issues and New Frontiers for FDA Regulation

Monday, October 20, 2014 8:00 AM - 5:00 PM
Conferences
2014-2015
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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Prisons Balk at Sovaldi’s $84,000 Cost for Hepatitis C Treatment

San Francisco Chronicle, October 20, 2014
by Stephanie M. Lee and Joe Garofoli

In San Francisco’s jails, no inmates with hepatitis C are receiving Sovaldi, the breakthrough pill that can cure most patients in an unprecedented amount of time. In California’s prisons, the…

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​Nudging the FDA

The American Interest, October 17, 2014
by W. Nicholson Price II (Academic Fellow alumna) and I. Glenn Cohen (Faculty Director)

From the article: [...] The FDA’s regulation of drugs is frequently the subject of policy debate, with arguments falling into two camps. On the one hand, a libertarian view of patients…

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Can Big Data Cure Cancer?

U.S. News, October 15, 2014
by Lindsey Cook, quoting I. Glenn Cohen (Faculty Director)

From the article:  In some ways, the learning health system has been around since the beginning of medicine, says Glenn Cohen, a professor specializing in health law policy at Harvard…

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Will ‘Son of Sovaldi’ Cause State Medicaid Programs to Erect High Hurdles?

Wall Street Journal, October 13, 2014
by Ed Silverman

How might state Medicaid programs cope with a new and equally expensive hepatitis C treatment from Gilead Sciences? A new report released just as the FDA late last week approved Harvoni,…

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Got Insurance? You Still May Pay A Steep Price For Prescriptions

Kaiser Health News, October 13, 2014
by Julie Appleby

[...] Even with insurance, some patients are struggling to pay for prescription drugs for conditions such as cancer, arthritis, multiple sclerosis or HIV/AIDS, as insurers and employers shift more of…

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The Cost of Cancer Drugs

60 Minutes, October 5, 2014
by Lesley Stahl

Cancer is so pervasive that it touches virtually every family in this country. More than one out of three Americans will be diagnosed with some form of it in their…

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As Payments Database Debuts, Doctors Urge Caution

Kaiser Health News, October 1, 2014
by Shefali Luthra

A federal database unveiled Tuesday afternoon details 4.4 million payments from pharmaceutical and medical technology companies to doctors and teaching hospitals, sparking concerns that consumers might misinterpret the information. The Centers for…

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U.S. Will Increase Production of the Ebola Drug ZMapp, but May Not Meet Demand

New York Times, October 1, 2014
by Andrew Pollock

Federal officials are planning to sharply increase production of ZMapp, which is viewed by many experts as the most promising experimental drug for treating people infected with Ebola in West…

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A Conversation with the HHS Office of the Inspector General

Tuesday, September 30, 2014 12:00 PM
Lectures and Panels
2014-2015
Wasserstein Hall, Room 3018
1585 Massachusetts Ave., Cambridge, MA

A conversation with the Boston office of the U.S. Department of Health and Human Services Office of the Inspector General (OIG), Office…

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Health Law Workshop: Benjamin Roin

Monday, September 29, 2014 5:00 PM
Health Law Workshops
2014-2015
Griswold Hall, Room 110
1525 Massachusetts Ave., Cambridge, MA

Download the Presentation Topic Paper: "Solving the Problem of New Uses by Creating Incentives for Private Industry to Repurpose Off-Patent Drugs"…

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4 Years Of Lessons Learned About Drugmakers’ Payments To Doctors

ProPublica, September 29, 2014
by Charles Ornstein, Ryann Grochowski Jones, and Eric Sagara

On Tuesday, the federal government is expected to release details of payments to doctors by every pharmaceutical and medical device manufacturer in the country. The information is being made public…

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FDA Cracks Down on Unproven Ebola Cures

On Sept. 23, the Food and Drug Administration (FDA) issued a warning letter to Rima Laibow and Ralph Fucetola of Natural Solutions Foundationinforming them that the company’s products, including Silver Sol Nano Silver…

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Health Law Workshop: Thomas McGuire

Monday, September 22, 2014 5:00 PM
Health Law Workshops
2014-2015
Griswold Hall, Room 110
1525 Massachusetts Ave., Cambridge, MA

Download the Presentation Topic Paper: Do "Reverse Payment" Settlements of Brand-Generic Patent Disputes in the Pharmaceutical Industry Constitute an Anticompetitive Pay…

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Birth Control Without a Prescription

The Atlantic, September 19, 2014
by Olga Khazan

Let it never be said that Republicans are fighting a Forever War on contraception. In several states, Republican candidates are calling for more birth control—on demand and sold right next to the…

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2015 Health Law Student Scholarship

2015 Health Law Student Scholarship
The Center for Health & Pharmaceutical Law & Policy, Seton Hall University School of Law

Deadline: February 06, 2015

The Center for Health & Pharmaceutical Law & Policy Healthcare Compliance Certification Program 2014 Health Law Student Scholarship: The Healthcare Compliance Certification Program and the Life Sciences Compliance Program are both multi-day educational…

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Post-Trial Responsibilities:
Ethics and Implementation

Thursday, September 18, 2014 7:30 AM - 5:30 PM
Conferences
2014-2015
Wasserstein Hall, Milstein East AB
1585 Massachusetts Ave., Cambridge, MA

Conference Description Who: Clinical research sponsors, investigators, funders, regulators, trial participants, and other stakeholders Introduction / Background:The term “post-trial access” is…

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How Catholic Insurance Companies Outsource Contraceptive Coverage

NPR, September 17, 2014
by Julie Rovner

Catholic and other religious hospitals and universities have been arguing in federal court for much of the past two years that they shouldn't have to offer or facilitate birth control…

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A New Way Insurers are Shifting Costs to the Sick

ProPublica, September 17, 2014
by Charles Ornstein

Health insurance companies are no longer allowed to turn away patients because of their pre-existing conditions or charge them more because of those conditions. But some health policy experts say…

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Patients Vulnerable When Cash-Strapped Scientists Cut Corners

NPR, September 15, 2014
by Richard Harris

[...] Most of the experimental ALS drugs, it turns out, undergo very perfunctory testing in animals before moving into human tests — based on flimsy evidence. Story Landis, director of…

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Maker of Hepatitis C Drug Strikes Deal on Generics for Poor Countries

New York Times, September 15, 2014
by Gardiner Harris

The maker of one of the costliest drugs in the world announced on Monday that it had struck agreements with seven Indian generic drug makers to sell lower-cost versions of…

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An Interview with I. Glenn Cohen on Controversial Health Issues

PBS.org, September 9, 2014
by Tavis Smiley, interviewing I. Glenn Cohen (Faculty Director)

In an interview with PBS.org, Faculty Director I. Glenn Cohen, sat down with Tavis Smiley to discuss important health issues, such as experimental Ebola drugs and prescription opiate use in the U.S.…

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D.E.A. to Allow Return of Unused Pills to Pharmacies

New York Times, September 8, 2014
by Catherine Saint Louis

Concerned by rising rates of prescription drug abuse, the Drug Enforcement Administration announced Monday that it would permit consumers to return unused prescription medications like opioid painkillers to pharmacies. The…

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Experimental Vaccine for Chikungunya Passes First Test

NPR, August 18, 2014
by Michaeleen Doucleff

Scientists have taken the first steps to developing a vaccine for chikungunya — an emerging mosquito-borne virus that has infected more than a half million people in the Western Hemisphere…

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West Africa’s Ebola Epidemic Spreads

On Point , August 18, 2014
by Jane Clayson

More than one thousand people dead, more than two thousand infected. Ebola continues to spread across West Africa: Liberia, Sierra Leone, Guinea and Nigeria. The worst outbreak in history.  And still not…

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Ebola Crisis and Rationing

CCTV Mandarin, August 13, 2014
by CCTV Broadcaster, interviewing I. Glenn Cohen (Faculty Director)

Faculty Director I. Glenn Cohen appeared on CCTV Mandarin to discuss the rationing and usage of experimental drugs for the Ebola outbreak.

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Ethical to use untested Ebola drugs, says WHO:

BBC News, August 12, 2014

The WHO said it was ethical in light of the scale of the outbreak and high number of deaths - more than 1,000 people have died in West Africa. The…

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Medical ethicists to meet on use of experimental Ebola drugs:

Al Jazeera America, August 8, 2014
by Courtney Brooks

Medical ethicists will meet next week to discuss the use of experimental medicines in the West Africa Ebola outbreak. The World Health Organization (WHO) announced the talks in the wake…

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US big-data health network launches aspirin study

Nature, August 6, 2014
by Sara Reardon, quoting I. Glenn Cohen (Faculty Director)

From the article: One of the largest big-data experiments in health care has set its first research target. The leaders of the Patient-Centered Outcomes Research Institute (PCORI) in Washington DC…

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US big-data health network launches aspirin study

Nature, August 6, 2014
by Sara Reardon, quoting I. Glenn Cohen (Faculty Director)

From the article: One of the largest big-data experiments in health care has set its first research target. The leaders of the Patient-Centered Outcomes Research Institute (PCORI) in Washington DC…

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The Recovering Americans and the ‘Top Secret’ Ebola Treatment:

Atlantic, August 4, 2014
by James Hamblin

Because Kent Brantly is a physician who has watched people die of Ebola, there was an especially chilling prescience to his assessmentlast week, between labored breaths: "I am going to die."…

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Executed Arizona Inmate Got 15 Times Standard Dose, Lawyers Say

New York Times, August 1, 2014
by Fernanda Santos

PHOENIX — Lawyers for an inmate who was executed last month by lethal injection said Friday that his executioners injected him with 15 times the standard dose of a sedative and a…

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How patent reform’s fraught politics have left USPTO still without a boss

The Washington Post, July 30, 2014
by Nancy Scola, quoting W. Nicholson Price II (Affiliated Faculty)

From the article: [...] The controversy began in late June when rumors started to trickle out that the White House would nominate Philip S. Johnson to lead the USPTO [...] And so…

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Appeals court rules FDA can continue allowing antibiotics in animal feed:

Al Jazeera America, July 24, 2014
by Marisa Taylor

A federal appeals court ruled Thursday that the U.S. Food and Drug Administration can continue its policy of allowing widespread antibiotic use in animal feed – a practice believed by…

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Arizona Takes Nearly 2 Hours to Execute Inmate

New York Times, July 23, 2014
by Erik Eckhom

In another unexpectedly prolonged execution using disputed lethal injection drugs, a condemned Arizona prisoner on Wednesday repeatedly gasped for one hour and 40 minutes, according to witnesses, before dying at…

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Clinical Trials and the Right to Remain Silent

JAMA, July 21, 2014
by Michelle Mello, JD, PhD, MPhil and I. Glenn Cohen, JD (Faculty Director)

I. Glenn Cohen has coauthored a new Invited Commentary piece in JAMA on access to clinical trial data. From the article: In this issue of JAMA Internal Medicine, Kernan et al chronicle…

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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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Justice Department Indicts FedEx in a Drug-Shipping Inquiry

New York Times, July 17, 2014

WASHINGTON — FedEx, the world’s second-largest package-delivery company, was indicted Thursday in connection with a Justice Department investigation into illegal pharmaceutical shipments, according to a person with knowledge of the…

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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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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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Complaint Says Insurance Plans Discriminate Against HIV Patients

NPR, July 8, 2014
by Michelle Andrews

Four Florida insurers allegedly discriminate against people with HIV/AIDS by structuring their prescription drug benefits so that patients are discouraged from enrolling, according to a complaint filed by health advocacy…

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