FDA’s Impact on Pharmaceutical Innovation:
A lecture by Neil Flanzraich

Tuesday, April 14, 2015 12:00 PM
Lectures and Panels
2014-2015
TBD

The Petrie-Flom Center will host a lecture by Neil Flanzraich, who graduated from HLS in 1968 and was appointed by Dean Martha Minow…

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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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REGISTER NOW: Third Annual Health Law Year in P/Review

Friday, January 30, 2015 8:00 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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Charges in pharmacy case indicate US sees crime ring:

Boston Globe, December 18, 2014
by Milton J. Valencia

Federal prosecutors allege that the pharmacists who ran the New England Compounding Center essentially ran the company like a criminal enterprise, engaging in a conspiracy to defraud customers with shoddy…

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Even With Coverage Expansion, Access To Mental Health Services Poses Challenges

Kaiser Health News, December 18, 2014
by Lisa Gillespie

Even though more Americans have access to health insurance because of the health law, getting access to mental health services can still be challenging. A new report concludes that despite the 2008…

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Houston doctor sued for trading prescriptions for sex

Houston Chronicle, December 12, 2014
by St. John Barned-Smith, quoting I. Glenn Cohen (Faculty Director)

[...] Legal experts who specialize in medical ethics said the allegations and actions captured on film were "egregious." Medical standards prohibit doctors from engaging in sexual relationships with patients. "This…

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Drastic drop in global malaria deaths:

Al Jazeera America, December 9, 2014

Malaria deaths have dropped dramatically since 2000 and cases are falling steadily thanks to more people being diagnosed and treated, the World Health Organization (WHO) said on Tuesday. Yet progress…

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Nursing Homes Rarely Penalized For Oversedating Patients

NPR, December 9, 2014
by Ina Jaffe

Antipsychotic drugs have helped many people with serious mental illnesses like schizophrenia or bipolar disorder. But for older people with Alzheimer's or other forms of dementia, they can be deadly.…

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‘Superbugs’ Kill India’s Babies and Pose an Overseas Threat

New York Times, December 3, 2014
by Gardiner Harris

AMRAVATI, India — A deadly epidemic that could have global implications is quietly sweeping India, and among its many victims are tens of thousands of newborns dying because once-miraculous cures no…

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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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In a First, Mass. Town May Prohibit Tobacco Sales

Boston Globe, October 28, 2014
by Kay Lazar

The Central Massachusetts town of Westminster would become the first community in the state, and perhaps the nation, to ban all tobacco sales under a proposal made public Monday that regulators…

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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 alumnus) 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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A Drug Naming Dispute, with Billions on the Line

Washington Post, August 21, 2014
by Jason Millman

[...] With a new wave of cheaper versions of biologic drugs expected to soon become available in the United States, the health-care industry is still fighting over key ground rules…

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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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Legal Marijuana for Parents, but Not Their Kids

New York Times, August 18, 2014
by Tara Parker-Pope

[...] Antidrug advocates say efforts to legalize marijuana have created new challenges as they work to educate teenagers and their parents about the unique risks that alcohol, marijuana and other…

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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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