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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DRAFT AGENDA NOW AVAILABLE: Post-Trial Responsibilities:
Ethics and Implementation

Thursday, September 18, 2014 8:00 AM - 5:30 PM
Conferences
2014-2015
Wasserstein Hall, Milstein East AB
1585 Massachusetts Ave., Cambridge, MA

Registration for the conference is open now! Register online. Law, policy, and guidance are vague, sometimes conflicting, and generally lacking…

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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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Politicians’ Prescriptions for Marijuana Defy Doctors and Data

New York Times, June 26, 2014
by Catherine Saint Louis

New York moved last week to join 22 states in legalizing medical marijuana for patients with a diverse array of debilitating ailments, encompassing epilepsy and cancer, Crohn’s disease and Parkinson’s.…

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Summer Program on Emerging Issues in Food and Drug Law

Summer Program on Emerging Issues in Food and Drug Law
O'Neill Institute for National and Global Health Law, Georgetown University

Deadline: July 14 - 18, 2014

Please join the O’Neill Institute for National and Global Health Law at Georgetown University for a one-week intensive summer institute exploring the domestic and international legal, regulatory, and policy framework shaping the safety and availability…

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Medical Marijuana 101:

CommonHealth, WBUR (NPR, Boston), June 23, 2014
by Martha Bebinger

[...] The Massachusetts Medical Society opposed the statewide ballot question that made marijuana legal for medical purposes. But the society offered this course because the drug is legal now for…

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Shortage Of Saline Solution Has Hospitals On Edge

NPR, June 22, 2014
by April Dembosky

[...] But it's difficult to ramp up production, explains Capt. Valerie Jensen, the director of the drug shortage program at the Food and Drug Administration. She says it's challenging to…

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Dementia is ‘one of greatest enemies of humanity’ - PM

BBC News, June 19, 2014

A "big, bold global push" is needed to beat dementia, David Cameron has told a summit in London. He pledged to accelerate progress on dementia drugs, by increasing funding and…

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Report: Government warnings about antidepressants may have led to more suicide attempts

Washington Post, June 18, 2014
by Brady Dennis

Government warnings a decade ago about the risks associated with children and adolescents taking antidepressants appear to have backfired, causing an increase in suicide attempts and discouraging many depressed young…

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A Chinese Chemical Company And A ‘Bath Salts’ Epidemic

NPR, June 16, 2014
by Frank Langfitt

[...] Shanghai has a big, legitimate pharmaceutical industry. Power — who never actually ordered the mephedrone — says factories like Chang's branched out into recreational drugs in response to orders…

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Patrick airs $20m plan to combat opioid use:

Boston Globe, June 10, 2014
by Brian MacQuarrie

Governor Deval Patrick unveiled plans Tuesday to upgrade treatment for opioid addicts, expand insurance coverage, and coordinate with the other five New England governors to stem an epidemic that has…

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Under Health Law, States Serve As Testing Grounds For Innovation

Kaiser Health News, June 9, 2014

Media outlets report on a range of issues related to the measure's implementation, including how some states are finding opportunities in the overhaul to pursue their own health system changes. Also in the news, the…

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Hospitals Put Pharmacists In The ER To Cut Medication Errors

NPR, June 9, 2014
by Lauren Silverman

In the emergency department at Children's Medical Center in Dallas, pharmacists who specialize in emergency medicine review each medication to make sure it's the right one in the right dose.…

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Judge Voids Expansion of Discount Drug Program

New York Times, June 8, 2014
by Robert Pear

WASHINGTON — A federal judge has struck down a new rule requiring drug companies to offer certain drugs at discounted prices, saying the Obama administration had no authority to issue…

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‘Millions denied end-of-life drugs’:

BBC News, June 2, 2014
by Tulip Mazumdar

Figures suggest almost 18 million people - mainly in developing countries - died in unnecessary pain in 2012. In Ethiopia, there are reports of cancer patients throwing themselves in front…

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A Cholera Vaccine Halts New Cases In A Guinea Epidemic

NPR, May 28, 2014
by Richard Knox

There's new evidence that an oral cholera vaccine might help stop an epidemic in its tracks. That's the encouraging message from a study that tested a two-dose vaccine during a…

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Pfizer Drops $119 Billion Bid For AstraZeneca

NPR, May 27, 2014
by Elizabeth Blair

It would have been the biggest deal the pharmaceutical industry has seen in more than a decade. But for now, it's off the table. Pfizer has withdrawn its offer to…

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California Counties Sue 5 Narcotics Makers

Here & Now, NPR, May 22, 2014
by Robin Young interviewing I. Glenn Cohen (Faculty Director)

Two counties in California — Orange and Santa Clara — are suing five major drug companies, accusing them of causing the growing prescription drug epidemic across the country. The complaint,…

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Defeating the ‘Superbugs’:

Al Jazeera America, May 22, 2014
by Kat McGowan

In the battle against disease-causing microbes, the bugs now seem to be winning. Antibiotic drugs, which were once so good at eliminating bacterial infections of all kinds, are rapidly losing…

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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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FDA Dangles Golden Ticket To Spur Drugs For Neglected Diseases

NPR, May 16, 2014
by Scott Hensley

When the Food and Drug Administration gave the OK to a new treatment for a parasitic disease called leishmaniasis in late March, the Canadian company that owns the medicine got…

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Novartis, Sun Pharma settle dispute over generic Gleevec

Reuters, May 15, 2014

(Reuters) - Novartis (NOVN.VX) won a seven-month reprieve from generic competition to its blockbuster leukemia drug Gleevec after reaching a settlement on Thursday with Sun Pharmaceutical Industries Ltd(SUN.NS). Competition from…

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Medicare Reverses Denial Of Costly Treatment For Hepatitis C Patient

Kaiser Health News, May 15, 2014
by Richard Knox

Walter Bianco, an Arizona man denied access to new drugs to cure his hepatitis C infection, will get the costly medications after all. After Kaiser Health News and NPRdescribed his plight…

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Advocating Pill, U.S. Signals Shift to Prevent AIDS

New York Times, May 14, 2014
by Donald G. McNeil Jr.

Federal health officials recommended Wednesday that hundreds of thousands of Americans at risk for AIDS take a daily pill that has been shown to prevent infection with the virus that…

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Labs Are Told to Start Including a Neglected Variable: Females

New York Times, May 14, 2014
by Roni Caryn Rabin

For decades, scientists have embarked on the long journey toward a medical breakthrough by first experimenting on laboratory animals. Mice or rats, pigs or dogs, they were usually male: Researchers…

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In $100 billion Astra Pfizer fight, R&D site marks political frontline

Reuters, May 1, 2014
by Ben Hirschler

In Pfizer's $100 billion (59.21 billion pounds) battle to win British drugmaker AstraZeneca, business and politics meet in a grassy field on the edge of the historic university city of Cambridge. This…

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For more states, execution means improvisation as drug supplies dwindle

Washington Post, April 30, 2014
by Brady Dennis and Lena H. Sun

Oklahoma’s bungled execution of convicted murderer Clayton Lockett on Tuesday was, in some ways, a medical experiment gone wrong. In recent years, as pharmaceutical companies have halted sales of drugs used in…

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WHO calls for urgent action to preserve power of antibiotics and make new ones:

The Guardian, April 30, 2014
by Sarah Boseley

Pneumonia will again become a feared killer, surgery risky and diarrhoea fatal if urgent action is not taken to preserve the power of currentantibiotics as well as develop new ones, the World…

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Public Workshop: Strategies for Responsible Sharing of Clinical Trial Data

Institute of Medicine, National Academies, May 5, 2014
by Featuring a presentation by I. Glenn Cohen (Faculty Director)

Petrie-Flom Center Faculty Director I. Glenn Cohen will participate in a session on "Operational Principles for the Governance for Sharing Clinical Trial Data" on Monday, May 5, at 1:30pm. From the workshop…

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Low T Business Is Booming, Despite Questions About Risks

Kaiser Health News, April 28, 2014
by Sarah Varney

It is perhaps the biggest men's health craze since Rogaine or Viagra: so-called low testosterone clinics, which have rapidly grown in cities and suburbs all across the country. But these "low…

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The Mega Costs Of Miracle Drugs

"On Point" on WBUR (NPR), April 25, 2014

We all know drugs can be super-expensive in the USA, but how about this for a pharmacy bill?  The hottest new treatment for hepatitis C costs $1,000 a pill.  Eighty-four…

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FDA Reviews Psychiatric Side Effects Of Chantix

NPR, April 25, 2014
by Associated Press

WASHINGTON (AP) — The Food and Drug Administration announced Friday it will hold a public meeting in October to review the risks of psychiatric and behavioral side effects with Pfizer's…

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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
2013-2014
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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Mass. limits use of the potent painkiller Zohydro:

Boston Globe, April 23, 2014
by Milton J. Valencia

Saying the state faces a continuing public health crisis, Governor Deval Patrick’s administration imposed sweeping restrictions Tuesday on prescribing the powerful painkiller Zohydro, just before a ban on the controversial…

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Missouri plans execution after Oklahoma stay over drug secrecy

Reuters, April 22, 2014
by Carey Gillam

Lawyers for a Missouri death row inmate on Tuesday were seeking to halt his execution over concerns about the state's secret lethal injection drugs a day after an Oklahoma court…

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Once in limbo, promising Duchenne muscular dystrophy drug back on track toward approval

Washington Post, April 21, 2014
by Brady Dennis

For much of last fall and winter and into this spring, scientists at the Food and Drug Administration wavered over what to do about a potential new drug to slow the progression…

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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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Free Drug Samples Prompt Skin Doctors To Prescribe Costlier Meds

NPR, April 16, 2014
by Michaeleen Doucleff

Every "free" sample comes with a price. Dermatologists who accept free tubes and bottles of brand-name drugs are likelier to prescribe expensive medications for acne than doctors who are prohibited…

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US judge blocks Mass. ban on painkiller:

Boston Globe, April 15, 2014
by Milton J. Valencia

A federal judge struck down the state’s first-of-its-kind emergency ban on Zohydro on Tuesday, saying Massachusetts had no authority to overrule a federal decision to approve the powerful, controversial painkiller.…

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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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