SAVE THE DATE: Third Annual Health Law Year in P/Review

Friday, January 30, 2015 9:00 AM - 5:00 PM
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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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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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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Dangerous Dietary Supplements Return to Store Shelves

New York Times, October 21, 2014
by Anahad O'Connor

The Food and Drug Administration frequently recalls dietary supplements that are found to contain banned substances. But a new study suggests that many of these products return to store shelves…

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Emerging Issues and New Frontiers for FDA Regulation

Monday, October 20, 2014 8:00 AM - 5:00 PM
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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​Nudging the FDA

The American Interest, October 17, 2014
by W. Nicholson Price II (Academic Fellow alumna) 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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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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Newsmax Panel: Experimental Ebola Drugs Have Run Out

Newsmax TV, October 6, 2014
by America's Forum, interviewing I. Glenn Cohen (Faculty Director)

From the article: [...] The Liberian man diagnosed with Ebola in Dallas is not receiving an experimental drug because there is a dearth of supply, according to Harvard law professor…

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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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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
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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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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Soda Makers Coca-Cola, PepsiCo and Dr Pepper Join in Effort to Cut Americans’ Drink Calories

New York Times, September 23, 2014
by Stephanie Strom

The three largest soda companies — Coca-Cola, PepsiCo and the Dr Pepper Snapple Group — have pledged to cut the number of sugary drink calories that Americans consume by one-fifth…

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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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FDA Proposal for Regulating Laboratory Diagnostics Could Improve Patient Care

Hastings Center Bioethics Forum, September 4, 2014
by Rachel Sachs (Academic Fellow)

From the article: [...] [T]he FDA's proposal [to regulate laboratory-developed tests] ... could improve patient care by collecting, for the first time, clinical validity data on tens of thousands of…

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World Health Organization Urges Stronger Regulation of Electronic Cigarettes

New York Times, August 26, 2014
by David Jolly and Sabrina Tavernise

Governments should ban the use of electronic cigarettes in public places and outlaw tactics to lure young users, the World Health Organization said in a report released on Tuesday that calls for…

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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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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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Teen suicide victim’s eyes were rejected by FDA as donor organs because he was gay

Mail Online, August 15, 2014
by Mail Online Reporter, quoting I. Glenn Cohen (Faculty Director)

From the article: The FDA has blocked the donation of a teen suicide victim's eyes because he was gay, it has emerged. Alexander 'A.J.', Betts Jr., 16, of Pleasant Hills, Iowa,…

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After suicide, gay teen’s eye donation rejected

Washington Post, August 14, 2014
by Ryan Weber, quoting I. Glenn Cohen (Faculty Director)

From the article: In the Journal of the American Medical Association, Glenn Cohen, a bioethics law professor at the Harvard Law School, wrote that the United States should repeal the rules…

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Ethical issues over experimental Ebola drug

CCTV America, August 13, 2014
by Asieh Namdar, interviewing I. Glenn Cohen (Faculty Director)

Faculty Director I. Glenn Cohen appeared on CCTV America to discuss ethical questions about who is receiving an experimental drug to treat Ebola. From the interview: [...] Usually when we think about what's ethical,…

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29 States Seek Tighter E-Cigarette Regulations

New York Times, August 8, 2014
by Elizabeth A. Harris

Twenty-nine state attorneys general on Friday urged the Food and Drug Administration to strengthen its proposed regulations on electronic cigarettes, a business that has exploded into a $2.5 billion industry…

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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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In New Calculus on Smoking, It’s Health Gained vs. Pleasure Lost

New York Times, August 6, 2014
by Sabrina Tavernise

WASHINGTON — Rarely has the concept of happiness caused so much consternation in public health circles. Buried deep in the federal government’s voluminous new tobacco regulations is a little-known cost-benefit calculation that…

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First federal gluten-free regulation takes effect

Los Angeles Times, August 1, 2014
by Mary Macvean

Regulations that tell consumers just what it means when a product is labeled “gluten free” take effect on Friday — a “major milestone,” says one of the leading experts on…

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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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Johnson & Johnson Praised for Taking Uterine Surgery Tools Off Market

New York Times, July 31, 2014
by Katie Thomas

Johnson & Johnson, which has come under withering criticism for its response to problems with some of its medical devices, won cautious praise from critics on Thursday for its decision…

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F.D.A. Acts on Lab Tests Developed In-House

New York Times, July 31, 2014
by Andrew Pollack

The Food and Drug Administration announced on Thursday that it would start regulating medical laboratory testing, saying that tests used to make important treatment decisions must be vetted and validated…

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Experts urge lifting ban on blood donations by gay men

CBS News, July 25, 2014
by Dennis Thompson , quoting I. Glenn Cohen (Faculty Director)

The United States should repeal a 30-year policy that bans blood donations from gay and bisexual men, according to a team of medical and legal experts writing this week in…

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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
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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