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

Tuesday, April 14, 2015 12:00 PM
Lectures and Panels
2014-2015
Griswold Hall, 110
Harvard Law School, Cambridge, MA

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

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

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TODAY: Third Annual Health Law Year in P/Review

Friday, January 30, 2015 7:45 AM - 5:00 PM
Conferences
2014-2015
Wasserstein Hall, Milstein East AB
1585 Massachusetts Avenue, Cambridge, MA

Couldn't make it in person? Join the discussion on Twitter! #2015HealthLawPReview Please join us for the Third Annual Health Law…

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Program Manager

Program Manager
Harvard Multi-Regional Clinical Trials Center

Deadline: Open until filled.

The mission of the MRCT Center at Harvard is to improve the design, conduct, and oversight of multi-regional clinical trials, especially trials sited in or involving the developing world; to simplify research through the use…

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Academic Fellow Rachel Sachs Guest Lecturing in Reading Group at Harvard Law School

Petrie-Flom Center, January 22, 2015

Petrie-Flom Academic Fellow Rachel E. Sachs will be a regular guest lecturer in a reading group at Harvard Law School, co-taught by with Professors Terry Fisher and Mark Wu in Spring 2015, on…

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Supreme Court Rules in Favor of Teva Over Patent for Multiple Sclerosis Drug

New York Times, January 20, 2015
by Reuters

WASHINGTON — The Supreme Court on Tuesday ruled that Teva Pharmaceutical Industries could still benefit from patent protection for a multiple sclerosis drug, dealing a blow to makers of generic…

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Rocketing vaccine cost warning:

BBC News, January 20, 2015
by James Gallagher

A report by the charity says there has been a 68-fold increase in prices between 2001 and 2014. It accused the pharmaceutical industry of overcharging and highlighted cases where rich…

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Gilead’s India Patent Snag May Spur More Low-Cost Sovaldi Copies

Bloomberg, January 15, 2015
by Ketaki Gokhale

The Indian patent office’s rejection of a key patent for Gilead Sciences Inc. (GILD)’s Hepatitis C treatment Sovaldi may pave the way for more low-cost copies in the country, potentially aiding…

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Johnson & Johnson Will Make Clinical Data Available to Outside Researchers

New York Times, January 14, 2015
by Katie Thomas

The health care giant Johnson & Johnson has agreed to make detailed clinical trial data on its medical devices and diagnostic tests available to outside researchers through a collaboration with Yale University, making…

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U.S. Funding of Health Research Stalls As Other Nations Rev Up

NPR, January 13, 2015
by Richard Harris

Though the United States is still leading the world in research related to diseases, it is rapidly losing its edge, according to an analysis in the American Medical Association's flagship journal JAMA. If…

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First biosimilar drug set to enter US market:

Nature, January 13, 2015
by Heidi Ledford, quoting W. Nicholson Price II (Academic Fellow Alumnus)

[...] The FDA is expected to make a final decision by May. But even as Sandoz prepares to sell its drug in the United States, it is embroiled in a…

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In Africa, a Decline in New Ebola Cases Complicates Vaccine Development

New York Times, January 9, 2015
by Andrew Pollack

As authorities and drug companies hurriedly prepare to begin testing Ebola vaccines in West Africa, they are starting to contemplate a new challenge: whether an ebbing of the outbreak could make it…

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Why is it easier to study heroin than marijuana?

Al Jazeera America, January 9, 2015
by Jacob Ward

An enormous number of people are using marijuana. Nearly 20 million people say they've used it in the prior month, according to the 2012 National Survey on Drug Use and Health, making…

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FDA Advisory Panel Backs First Potential ‘Copycat’ Drug

Kaiser Health News, January 8, 2015

KHN Morning Briefing: Summaries of health policy coverage from major news organizations. If the government accepts the recommendation, it could mean millions in savings for consumers who need expensive drugs.…

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Antibiotics:

BBC News, January 7, 2015
by James Gallagher

The decades-long drought in antibiotic discovery could be over after a breakthrough by US scientists. Their novel method for growing bacteria has yielded 25 new antibiotics, with one deemed "very…

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India’s deadly medicine:

Al Jazeera America, January 6, 2015

India has seen a dangerous surge in the abuse of prescription drugs. Pharmacies are selling cocktails of medical-grade drugs to addicts for up to a tenth of the cost of…

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Drug-resistant tuberculosis patients face dwindling treatment options:

Al Jazeera America, December 29, 2014
by Katya Cengel

[...] Once the leading cause of death in the United States, tuberculosis rates in the U.S. have been in decline for decades. Effective drug treatments in the 1940s all but…

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Group Sues Aetna, Claiming Discrimination Against H.I.V. Patients

New York Times, December 22, 2014
by Katie Thomas

A consumer group has sued the health insurer Aetna, claiming that it discriminated against patients with H.I.V. when it required them to obtain medications exclusively through its own mail-order pharmacy. The lawsuit, filed…

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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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