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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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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FDA Advises Against Morcellator Use in Hysterectomies:

Wall Street Journal, April 17, 2014
by Jon Kamp and Jennifer Levitz, quoting I. Glenn Cohen (Faculty Director)

[...] "The fact that the FDA released this warning makes it more likely that a doctor who went against it will be held to have practiced in a way below the…

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Dallas Buyers Club:
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 were invited to view a free screening of the Academy-award winning film Dallas Buyers Club and participate in…

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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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The Presumption Against Expensive Health Care Consumption

Tulsa Law Review, Vol. 49, Forthcoming, 2014
by Christopher T. Robertson (Affiliate Faculty)

This essay, as part of a symposium in honor of Professor Einer Elhauge, starts with his recognition that, for both epistemic and normative reasons, it remains profoundly difficult to regulate…

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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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E-cig rule coming ‘very soon,’ U.S. FDA chief says

Reuters, April 3, 2014

The U.S. Food and Drug Administration is "pushing very hard" to release a proposed rule that would establish its authority over e-cigarettes, the head of the agency said on Thursday…

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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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Welcome 2014-2016 Academic Fellow Rachel Sachs!

Petrie-Flom Center, April 17, 2014

The Petrie-Flom Center is pleased to announce the new 2014-2016 Academic Fellow, Rachel Sachs. Rachel earned her J.D. in 2013 magna cum laude from Harvard Law School, where she was the Articles Chair 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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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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In California, Chefs Fight For Bare-Hand Contact

NPR, March 23, 2014
by Associated Press

As the happy hour crowd poured in on a recent weeknight, the kitchen and bar staff at Hock Farm restaurant scrambled to meet the incoming orders. One used her hands…

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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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FDA panel recommends HPV test as replacement for Pap smear

CBS News, March 13, 2014
by Steven Reinberg

A U.S. Food and Drug Administration advisory panel voted unanimously on Wednesday that a new HPV test could be used before or instead of the Pap smear as a first…

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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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China Cracks Down on DNA Testing

Forbes, March 3, 2014
by Shu-Ching Jean Chen

Genetic testing has grown to be a business big enough in China to warrant the government’s intervention. Early in February, the government quietly put the brakes on the provision of…

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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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New Nutrition Labels To Highlight Calories, Added Sugar

Kaiser Health News, February 24, 2014

This is part of Kaiser Health News' Daily Report - a summary of health policy coverage from more than 300 news organizations.

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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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VIDEO NOW AVAILABLE: New Directions for Food Safety:
The Food Safety Modernization Act and Beyond

Friday, February 21, 2014 8:30 AM - 4:30 PM
Austin Hall, Ames Courtroom (200)
1515 Massachusetts Ave., Cambridge, MA

This event is free and open to the public, but space is limited and registration is required. To register, please…

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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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FDA Approves Pill Camera to Screen Colon

ABC News, February 3, 2014
by Matthew Perrone

A kinder, gentler approach to one of the most dreaded exams in medicine is on the way: U.S. regulators have cleared a bite-size camera to help screen patients who have…

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FDA launches teen anti-smoking campaign

CNN, February 4, 2014
by Sandra Young

Every day, more than 3,200 kids under the age of 18 smoke a cigarette for the first time. About 700 of those become daily smokers. Those are two reasons, the…

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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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I Had My DNA Picture Taken, With Varying Results

New York Times, December 30, 2013
by Kira Peikoff

[...] I turned to genetic testing, but I wondered if I could trust the nascent field to give me reliable results. In recent years, a handful of studies have found…

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Antibacterial Soaps May Pose Health Risks, FDA Says;

Forbes, December 16, 2013
by Melanie Haiken

There appears to be little or no evidence that antibacterial soaps and household products help prevent us from being exposed to germs, and they may even pose significant health risks,…

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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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Harvard Law School to Host Conference on Food Safety Law

Food Safety News, December 10, 2013
by James Andrews

The Petrie-Flom Center's upcoming conference "New Directions for Food Safety: The Food Safety Modernization Act and Beyond," which will be held at Harvard Law School on Friday, February 21, 2014,…

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Insurers Question Health Benefits Of Some Genetic Tests

Kaiser Health News, December 10, 2013
by Michelle Andrews

The day when a simple blood test or saliva sample can identify your risk for medical conditions ranging from cancer to Alzheimer’s disease seems tantalizingly close. But while advances in…

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‘In Meat We Trust’ Argues We Got The Meat Industry We Asked For

NPR, December 9, 2013
by Jeremy Bernfeld

The meat on your dinner table probably didn't come from a happy little cow that lived a wondrous life out on rolling green hills. It probably also wasn't produced by…

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Anne Wojcicki Speaks Out About the F.D.A. Crackdown on 23andMe

New York Times, December 4, 2013
by Claire Cain Miller

Anne Wojcicki, co-founder and chief executive of 23andMe, the genetic testing company backed by Google, spoke Tuesday night for the first time about the Food and Drug Administration’s crackdown on her company. The…

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Booming Demand For Donated Breast Milk Raises Safety Issues

NPR, November 27, 2013
by Carrie Feibel

The public health message that "breast is best" has been received loud and clear. More mothers in the U.S. are breast-feeding, and they're doing so longer than ever. But those…

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Morning-after pill may not work for overweight women

CNN, November 26, 2013
by Jacque Wilson

An emergency contraceptive manufactured in Europe will come with a new label in 2014, warning that the pill may not be effective for women over a certain weight. The same…

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FDA warns Google-backed 23andMe to halt sales of genetic tests

Reuters, November 25, 2013
by Toni Clarke and Sharon Begley

The U.S. Food and Drug Administration has warned 23andMe, a company backed by Google Inc, to halt sales of its genetic tests because they have not received regulatory clearance. 23andMe, which was…

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Frustration From a Deal on Flawed Hip Implants

The New York Times, November 25, 2013
by Barry Meier

Patients injured by a flawed hip implant sold by Johnson & Johnsonhave directed their anger at myriad places over the years. The regulatory system that allowed the product’s sale. The company…

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New Scrutiny for Medical Devices

New York Times, November 18, 2013

Wayne Schneider’s heart stopped beating late last year while the Minneapolis paramedic was out on an emergency call. Another medic performed CPR for a few minutes, and then used a…

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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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Health and Food Law Opportunities at Harvard Law School

Friday, November 15, 2013 12:00 PM
Lectures and Panels
Wasserstein Hall 3019
1585 Massachusetts Ave., Cambridge, MA

1Ls and 2Ls will have the opportunity to learn more about different classes and extracurricular activities available at Harvard Law…

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In a Bean, a Boon to Biotech

New York Times, November 15, 2013
by Andrew Pollack

A new federal push to purge artery-clogging trans fats from foods could be just what the doctor ordered — not only for public health but for the unpopular biotechnology industry,…

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FDA’s trans fat decision: An opening for regulating salt, sugar?

Los Angeles Times, November 8, 2013
by Melissa Healy

Responding to the Food and Drug Administration's move to banish trans fats from the nation's diet, some public health advocates grumped Thursday that the agency was playing catch-up to a…

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Doctors Fear Losing Leukemia Drug Deemed Risky

New York Times, November 1, 2013
by Denise Grady and Andrew Pollack

People with fatal diseases may be willing to try risky treatments that have a chance of saving their lives. But when is the risk too high? That question was at…

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F.D.A. Moves to Rein in Pain Killers

WBUR, "On Point", October 30, 2013

It’s a familiar scenario: after a surgery or wisdom teeth extraction, the doctor writes a prescription for pain medication. A pill or two would do the trick, but the vial…

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FDA’s shorter approval time for new drugs raises questions

NBC News, October 28, 2013
by Toni Clark

WASHINGTON - New drugs that receive expedited review by the Food and Drug Administration are being tested on fewer patients, leaving many safety questions unanswered even after they are approved,…

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Shoppers move Target to address toxic chemicals

SFGate, October 28, 2013
by Stephanie M. Lee

As consumers nationwide have become more aware of the toxic chemicals in their over-the-counter products, they have pushed manufacturers and retailers to make changes. The message seems to be paying off. The…

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Pharma manufacturing woes dog industry

Chemistry World, October 23, 2013
by Sarah Moulton, quoting W. Nicholson Price II

[...] While many of these problems arise from quality control failures, according to Nicholson Price from Harvard Law School’s Petrie-Flom centre for health law policy, biotechnology and bioethics, this is not the…

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Plan B:

Association of Reproductive Health Professionals, Contraception Journal, October 2013
by I. Glenn Cohen, Lisa Sullivan, Eli Y. Adashi

The 8-year legal feud over access to emergency contraception between reproductive health advocates and the Food and Drug Administration (FDA) took multiple unexpected turns before coming to an abrupt end…

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F.D.A. Seeks Tighter Control on Prescriptions for Class of Painkillers

New York Times, October 24, 2013
by Barry Meier

The Food and Drug Administration on Thursday recommended tighter controls on how doctors prescribe the most commonly used narcotic painkillers. The move, which represents a major policy shift, follows a…

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