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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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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FDA Regulation of Mobile Health Technologies

NEJM, July 24, 2014
by Nathan G. Cortez, J.D., I. Glenn Cohen, J.D., and Aaron S. Kesselheim, M.D., J.D., M.P.H.

Petrie-Flom Faculty Director I. Glenn Cohen has published a new co-authored article in the New England Journal of Medicine on FDA regulation of new mobile health technologies. From the article: Medicine…

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Reconsideration of the Lifetime Ban on Blood Donation by Men Who Have Sex With Men

JAMA, July 23, 2014
by I. Glenn Cohen, JD (Faculty Director); Jeremy Feigenbaum, JD; Eli Y. Adashi, MD, MS

Faculty Director I. Glenn Cohen has co-authored a new Viewpoint piece in the July 23/30, 2014 issue of JAMA, arguing for the end of the FDA's lifetime ban on blood…

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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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Lapses at high-security CDC labs reveal culture of negligence:

Christian Science Monitor, July 16, 2014
by Noelle Swan

Revelations of safety breaches at federal biosecurity laboratories reveal gaping holes in safety protocols, a lack of independent oversight, and an apparent culture of hubris among researchers who work with…

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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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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 Bolder Effort by Big Tobacco on E-Cigarettes

New York Times, June 17, 2014
by Matt Richtel

Electronic cigarettes, promoted as a healthier alternative to tobacco, are getting powerful new backers with an unhealthy reputation: big tobacco companies. The development points to ways Big Tobacco is moving…

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Food industry groups sue to block Vermont’s GMOs labeling law

CBS News, June 13, 2014

MONTPELIER, Vt. -- The Grocery Manufacturers Association and other industry groups challenged a new Vermont law in federal court Thursday that requires the labeling of food made with genetically modified organisms.…

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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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The Health Data Revolution Enters An Awkward Adolescence

NPR, June 3, 2014
by Nancy Shute

The crowd in a hotel ballroom in Washington, D.C., was rocking on Monday, the 2,000 people shrieking with excitement over federal health-care databases. That could only happen at Health Datapalooza,…

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When Doctors Need Advice, It Might Not Come From A Fellow Human

Kaiser Health News, June 2, 2014
by Daniela Hernandez

Long Island dermatologist Kavita Mariwalla knows well how to treat acne, burns and rashes. But when a patient came in with a potentially disfiguring case of bullous pemphigoid—a rare skin…

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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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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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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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Where Will Calorie Labels Appear?

NPR, April 25, 2014
by Associated Press

WASHINGTON (AP) — Diners could soon see calorie counts on the menus of chain restaurants. But will they be able to get that same clear information at grocery stores, convenience…

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FDA approves genetic test as first U.S. alternative to Pap smear

Washington Post, April 24, 2014
by Matthew Perrone

Federal health regulators have cleared a genetic test from Roche as the first U.S.-approved alternative to the Pap smear, the decades-old mainstay of cervical cancer screening. The Food and Drug…

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FDA outlines plan to regulate e-cigarettes

Washington Post, April 24, 2014
by Brady Dennis

The Food and Drug Administration said Thursday that it intends for the first time regulate the booming market of electronic cigarettes, as well as an array of other products such…

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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
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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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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New Directions for Food Safety:
The Food Safety Modernization Act and Beyond

Friday, February 21, 2014 8:30 AM - 4:30 PM
Conferences
2013-2014
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
Conferences
2013-2014
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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