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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A Faster Way to Try Many Drugs on Many Cancers

New York Times, February 25, 2015
by Gina Kolata

[...] The studies of this new method, called basket studies because they lump together different kinds of cancer, are revolutionary, much smaller than the usual studies, and without control groups…

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A Mosquito Solution (More Mosquitoes) Raises Heat in Florida Keys

New York Times, February 19, 2015
by Lizette Alvarez

KEY HAVEN, Fla. — In this bite-size community near Key West, like so many other mosquito-plagued spots up and down the Florida Keys, residents long ago made peace with insecticides…

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Female Libido Pill Fires Up Debate About Women And Sex

NPR, February 16, 2015
by Rob Stein

[...] Women like Price, who see their decreasing sex drive as a problem, are at the center of an intense, emotional debate that's been raging for years over whether the Food…

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Academic Fellow Rachel Sachs Presents at 2015 Works-in-Progress in Intellectual Property Colloquium

Petrie-Flom Center, February 7, 2015

Petrie-Flom Academic Fellow Rachel Sachs presented her paper, "Innovation Law and Policy: Preserving the Future of Personalized Medicine," at the 2015 Works-in-Progress in Intellectual Property (WIPIP) Colloquium.  Held this year…

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Third Annual Health Law Year in P/Review collaborative blogging with Health Affairs

Petrie-Flom, February 5, 2015

The Third Annual Health Law Year in P/Review was a big success!  Video will be posted on our website shortly, but our presenters will be posting on their respective topics…

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Americans are ignoring the science and spending billions on dietary supplements

Washington Post, February 4, 2015
by Jason Millman

Dietary supplement fans got a big "buyer beware" warning this week when the New York attorney general's office ordered GNC, Target, Walgreens and Wal-Mart to pull a number of store-brand products from their shelves,…

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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 The Third Annual Health Law Year in P/Review symposium…

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A “Natural” Experiment:
Consumer Confusion and Food Claims, a lecture by Efthimios Parasidis

Thursday, January 29, 2015 12:00 PM
Lectures and Panels
2014-2015
Wasserstein Hall, Milstein West B
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Video of the lecture and following discussion is available online. What makes food "natural"? Do consumers understand "natural" claims on…

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Outbreak: Developing New Medical Products for Epidemics,
A lecture by Peter Hutt

Thursday, January 15, 2015 12:30 PM
Lectures and Panels
2014-2015
Hauser Hall 102
1575 Massachusetts Avenue, Cambridge, MA

Video of the lecture and following discussion are available online. The recent outbreak of Ebola has called attention to the…

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Research Project Grant Funding Opportunity

Research Project Grant Funding Opportunity
National Institutes of Health (NIH)

Deadline: January 19, 2015

Funding Opportunity Title: Empirical Research on Ethical Issues Related to Central IRBs and Consent for Research Using Clinical Records and Data (R01) Activity Code: R01 Research Project Grant Announcement Type: Reissuance of RFA-OD-14-002 Funding Opportunity Announcement (FOA)…

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F.D.A. Approves Surgical Implant to Treat Obesity

New York Times, January 14, 2015
by Catherine Saint Louis

The Food and Drug Administration on Wednesday approved a surgically implanted device to treat obesity in some adults. Called the Maestro system, the implant is the first to generate an intermittent electrical pulse that…

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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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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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FDA plans to end prohibition on blood donation by gay men, with conditions

PBS News Hour, December 23, 2014
by Gwen Ifill, interviewing I. Glenn Cohen (Faculty Director)

"[...] the ban that we had in place was really outdated. It dates back to 1983, the early days of the HIV crisis, and a few things have changed since…

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F.D.A. Easing Ban on Gays, to Let Some Give Blood

New York Times, December 23, 2014
by Sabrina Tavernise, quoting I. Glenn Cohen (Faculty Director)

[...] “This is a major victory for gay civil rights,” said I. Glenn Cohen, a law professor at Harvard who specializes in bioethics and health. “We’re leaving behind the old…

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FDA Announces Plans to End Lifetime Ban on Gay Men Donating Blood

Vice News, December 23, 2014
by Colleen Curry, quoting I. Glenn Cohen (Faculty Director)

[...] Harvard Law School bioethics and the law professor I. Glenn Cohen told VICE News that while he thought the FDA's proposed policy change is a good first step, it does…

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US lifts ban on gay men donating blood — as long as they don’t have sex with other men

Vox, December 23, 2014
by Sarah Kliff and Julia Belluz, quoting I. Glenn Cohen (Faculty Director)

[...] Glenn Cohen, a Harvard Law professor who wrote about the blood donor rule in JAMA: the Journal of the American Medical Association, sees a one-year deferral as an interim step,…

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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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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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Bioethics Funding Opportunity: Making a Difference in Real-World Bioethics Dilemmas

Bioethics Funding Opportunity: Making a Difference in Real-World Bioethics Dilemmas
The Greenwall Foundation

Deadline: January 12, 2015

New Bioethics Program, Spring 2015 Making a Difference in Real-World Bioethics Dilemmas The Greenwall Foundation will fund a bioethics grants program, Making a Difference in Real-World Bioethics Dilemmas to support research…

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FDA Advisors Not Sold on Lifting Ban on Gay Men Giving Blood

Philly.com, December 3, 2014
by Dennis Thomson, quoting I. Glenn Cohen (Faculty Director)

[...] The FDA first adopted the policy at the dawn of the AIDS crisis. However, changing times and technological advances have rendered the decades-old ban obsolete, according to Glenn Cohen,…

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FDA Revamps System Explaining the Risks of Medicines During Pregnancy

New York Times, December 3, 2014
by Sabrina Tavernise

The Food and Drug Administration on Wednesday changed how drug companies are required to present the risks of taking medicine during pregnancy and while breast-feeding, replacing a system that officials described as confusing and outdated…

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Truvada, A Pill to Fight HIV, Stirs Controversy Among Gays

Los Angeles Times, December 3, 2014
by Eryn Brown and Adolfo Flores

"We want to bring HIV to its knees, and this will help," said Mario Perez, who directs the county's prevention program. But the concept of using the pill — known…

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FDA Considers Allowing Blood Donations from Some Gay Men

NPR, December 2, 2014
by Rob Stein

The Food and Drug Administration is considering revising a ban on blood donations from men who have had sex with other men. An FDA advisory committee Tuesday mulled the issues raised by…

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Decades-old ban on blood donations from gay men to be revisited

MSNBC, December 1, 2014
by Andrea Mitchell interviewing I. Glenn Cohen (Faculty Director)

Petrie-Flom Faculty Director I. Glenn Cohen, who co-wrote the argument against the ban on gay male blood donation in the Journal of the American Medical Association, joins NBC's Andrea Mitchell to…

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Will FDA Lift Gay Blood Donor Ban?

NewsMax Health, December 1, 2014
by Quoting I. Glenn Cohen (Faculty Director)

[...] "They really are out of step with the rest of the world," Glenn Cohen, a Harvard Law School professor, told the Post. In a recent article in the Journal of the…

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US FDA to Consider Lifting Ban on Gay Men Donating Blood:

International Business Times, November 30, 2014
by Hannah Osborne, quoting I. Glenn Cohen (Faculty Director)

[...] Speaking of the forthcoming discussion, Glenn Cohen, a medical ethics professor at Harvard Law School, said: "It's a little crazy that you can shed blood for your country, but you…

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Government could ease 31-year-old ban on blood donations from gay men

Washington Post, November 29, 2014
by Brady Dennis, quoting I. Glenn Cohen (Faculty Director)

[...] “They really are out of step with the rest of the world,” said Glenn Cohen, a Harvard Law School professor who with two colleagues recently argued in the Journal…

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FDA weighs lifting ban on blood donations from gay men

The Hill, November 28, 2014
by Sarah Ferris, quoting I. Glenn Cohen (Faculty Director)

[...] “The public health rationale for this ban has kind of been packed away,” said Glenn Cohen, a medical ethics professor at Harvard Law School who criticized the ban in…

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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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The Changing Regulation of Laboratory-Developed Tests:

Genomic Medicine Case Conference (GMCC) at Massachusetts General Hospital, November 14, 2014
by Rachel Sachs (Academic Fellow)

On November 14, 2014, Academic Fellow Rachel Sachs delivered a talk on the topic of the FDA’s intent to regulate LDTs following the draft guidelines that will be published in the coming…

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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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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
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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​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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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
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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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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