Petrie-Flom Welcomes 2018-2019 Student Fellows

Petrie-Flom Center, September 10, 2018

We are so excited to welcome a new crop of Student Fellows to the Petrie-Flom Center family. These six students are a fantastic cohort of health law policy, biotechnology, and bioethics scholars who join us from Harvard Law School, the…

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Petrie-Flom Welcomes New Precision Medicine Fellow!

Petrie-Flom Center, August 16, 2018

We are excited to announce that Sara Gerke is joining the Petrie-Flom Center's Project on Precision Medicine, Artificial Intelligence, and Law (PMAIL) as our Precision Medicine Fellow. As the…

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A pharma exec raised the price of antibiotic by 400 percent — and the government can’t do much about

Stat Plus, September 11, 2018
Ike Swetlitz and Nicholas Florko, quoting Rachel Sachs (Academic Fellow Alumnus)

From the article:  Three years after Martin Shkreli became the poster boy of pharmaceutical company greed, another drug company executive is setting himself up for a similar infamy. And now, just as then, there is little the government…

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Capitol Checkup: Medicare indication coverage; pre-existing conditions battle

S&P Global Market Intelligence, September 4, 2018
Donna Young, quoting Rachel Sachs (Academic Fellow Alumna)

From the article:  "Allowing for indication-based coverage could result in some drugs not being available for some indications, but it could also result in drugs that aren't being covered now becoming available for higher-value uses," Coukell…

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A Setback For Massachusetts In States’ Drive To Contain Medicaid Drug Spending

NPR Shots/WBUR, September 12, 2018
Martha Bebinger, quoting Rachel Sachs (Academic Fellow Alumna)

From the article:  States serve as "laboratories of democracy," as U.S. Supreme Court Justice Louis Brandeis famously said. And states are also labs for health policy, launching all kinds of experiments lately to temper spending on pharmaceuticals. …

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Study: Generic Drug Industry Embraces Faster, Cheaper Pathway For Challenging Patents

Intellectual Property Watch, September 6, 2018
William New, quoting Jonathan Darrow (Student Fellow Alumnus)

From the article:  A newly released study shows that generic drug companies win nearly half the time when challenging patents on United States government-approved pharmaceutical products through the Patent Trial and Appeal Board (PTAB) process. …

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Generic Drugmakers Embrace Inter Partes Review Process

RAPS Regulatory Focus , September 4, 2018
Zachary Brennan. quoting Jonathan Darrow (Student Fellow Alumnus)

From the article:  [Generic Drugmakers Embrace Inter Partes Review Process]Thanks to Congress’ administrative alternative to court litigation of patents, generic drug manufacturers have embraced a new process, known as inter partes review (IPR),…

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Is Medical Tourism Safe?

The Doctors, featuring I. Glenn Cohen (Faculty Director)

The Doctors welcomed Medical Tourism Association President Renee-Marie Stephano and Harvard professor and author of “Patients with Passports” Glenn Cohen to discuss just how safe going to other countries for medical procedures is.

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Listening to NFL Players On Mental Health: New report highlights key findings from interviews with players and family members

Journal of Clinical Sport Psychology, Volume 12 Issue 3, September 2018
Sarah A. McGraw, Christopher R. Deubert, Holly Fernandez Lynch, Alixandra Nozzolillo, Lauren Taylor, I. Glenn Cohen (Faculty Director)

When it comes to their careers, current and former NFL players express satisfaction – and frustrations – about their lives both on and off the field. “Life on an Emotional Roller Coaster: NFL Players and Their Family Members’ Perspectives on Player Mental Health” covers…

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Petrie-Flom is Hiring! Call for Applications: Petrie-Flom Center Student Internship Program

Petrie-Flom Center, September 2018

General information The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is seeking student interns for the Fall 2018. Availability to start immediately…

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Who’s to blame when a machine botches your surgery?

Quartz, September 10, 2018
Robert David Hart (quoting W. Nicholson Price II, Academic Fellow Alumnus)

From the article:  Determining the levels of legal responsibility for AIs as a whole is a fairly new area and one that has yet to be seriously tested in court. What’s more, in a health care context, AIs’ current status as “decision aides”…

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FDA confronts its limits in push on drug pricing

Biopharmadive, August 27, 2018
Ned Pagliarulo, quoting Rachel Sachs (Academic Fellow Alumna)

From the article:  Drugmakers like AbbVie, which makes the best-selling biologic Humira (adalimumab), have reached settlement deals with makers of approved biosimilars to push off market entry. In the case of Humira, a low-cost option likely won't…

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Drug Prices in Ads: Senate Passes Amendment

RAPS Regulatory Focus, August 24, 2018
Zachary Brennan, quoting Rachel Sachs (Academic Fellow Alumna)

From the article:  Earlier this month, CMS also announced plans to begin using what’s called step therapy to try to lower the spend on Part B drugs by about 20% in Medicare Advantage plans. The announcements are beginning to add up to a wider…

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HHS offers scant evidence Trump’s drug blueprint putting brakes on price hikes

S&P Global Market Intelligence, August 22, 2018
Donna Young, quoting Rachel Sachs (Academic Fellow Alumna)

From the article:  Health and Human Services provided scant evidence, filled with caveats, to back up its chief's claim that drugmakers were responding to the Trump administration's plan to lower Americans' costs for prescription medicines by…

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A Dangerous Brain: Can neuroscience predict how likely someone is to commit another crime?"

The Marshall Project, August 14, 2018
Andrew R. Calderon, quoting Francis Shen (Visiting Scholar)

From the article:  To date, neuroprediction has not been admitted into the courtroom or parole hearings. Some scholars, like Thomas Nadelhoffer, a fellow at the Kenan Institute for Ethics at Duke University, who popularized the term neuroprediction, argue…

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How Regulation Can Improve Surgery

The Regulatory Review, August 22, 2018
Benjamin Barsky, quoting Jonathan Darrow (Student Fellow Alumnus)

From the article:  Thousands of American lives are in surgeons’ hands every day. But, according to a recent article by a Harvard professor, these patients have good reason to worry about mistakes in the operating room and their…

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Student Fellow Alumnus Zach Shapiro Named Solomon Center Research Fellow

Solomon Center for Health and Policy at Yale Law School , August 20, 2018

The Solomon Center for Health Law and Policy at Yale Law School announced new fellows and staff for the 2018-2019 academic year, including the appointment of Student Fellow Alumnus Zach Shapiro as a Research…

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We Have to Be Smart About Artificial Intelligence in Medicine: When the technology is complicated, opaque, changing, and absolutely vital to the health of a patient, how do we make sure it works as promised?

Slate, August 15, 2018
W. Nicholson Price II (Academic Fellow Alumnus)

From the article: For millions of people suffering from diabetes, new technology enabled by artificial intelligence promises to make management much easier. Medtronic’s Guardian Connect system promises to alert users 10 to 60 minutes before they hit…

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Drug Pricing Policy: HHS Introduces Step Therapy In Medicare Advantage

Health Affairs Blog, August 14, 2018
Rachel E. Sachs (Academic Fellow Alumna)

From the post:  Last Tuesday, the Centers for Medicare and Medicaid Services (CMS) took its latest action in the area of drug pricing. CMS gave Medicare Advantage (MA) plans the ability to use step therapy, in which a patient may be required by their…

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The Trump admin has another pretty good, pretty modest plan to lower drug costs

Vox, August 13, 2018
Dylan Scott, quoting Rachel E. Sachs (Academic Fellow Alumna)

From the article: “My concern is that once again, the administration’s rhetoric is out of step with its actual policy moves,” Sachs said. “The administration…

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