Reflecting on Dementia and Democracy: America’s Aging Judges and Politicians

By Gali Katznelson

This month, the Petrie-Flom Center collaborated with the Center for Law, Brain & Behavior  to host a panel entitled Dementia and Democracy: America’s Aging Judges and Politicians.” The panelists, Bruce Price, MD, Francis X. Shen, JD, PhD, and Rebecca Brendel, JD, MD, elucidated the problems, as well as potential solutions, to the challenges of America’s judiciary and elected politicians getting older. Reconciling dementia with democracy is a pressing matter. As Dr. Price explained, age is the single largest risk factor for dementia, a risk that doubles every five years after the age of 65, and America is a country with five of the nine Supreme Court Justices over the age of 67, a 71-year-old president, a 75-year-old Senate Majority Leader, and a 77-year-old House Minority Leader.

In his talk “Dementia in Judges and Elected Officials: Challenges and Solutions,” Dr. Shen defined the complex problem. While most other jobs are not retaining workers into old age, many judges and elected officials continue to serve well into their 80s. To complicate matters further, without widespread regulations or metrics to identify how dementia impedes one’s work, the media assumes the position of speculating the cognitive statuses and fates of judges and elected officials. Dr. Shen’s key point was, “Surely we can do better than speculation.”

Dr. Shen proposed several solutions to address dementia in elected officials and judges. Currently, we leave the open market and colleagues to regulate individuals, which remains a valid approach as we consider other options. Another default position is to diagnose based on publicly available data, a solution that introduces the specific ethical concerns that Dr. Brendel addressed in her talk (discussed below). There are, however, novel solutions. We could consider requiring cognitive testing and disclosure (which could be overseen by an internal review board), or we could simply impose an age limit for service. For judges, if such an age limit were imposed, we could create a rebuttable presumption in which a judge can continue to serve by completing an evaluation. Alternatively, perhaps judges can be limited to adjudicating specific cases based on their cognitive status.

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REGISTER NOW (12/12)! Sixth Annual Health Law Year in P/Review

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

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TODAY, 11/27 at 5 PM: Health Law Workshop with Vardit Ravitsky

November 27, 2017 5-7 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Presentation: “The Shifting Landscape of Prenatal Testing: Between Reproductive Autonomy and Public Health”

This paper is not available for download. To request a copy in preparation for the workshop, please contact Jennifer Minnich at

Vardit Ravitsky is an Associate Professor in Bioethics Programs in the Department of Social and Preventive Medicine at the University of Montreal School of Public Health, where she researches reproductive technologies, genetics, prenatal testing, research ethics, and health policy. She is the lead researcher on the Pegasus project, exploring ethical, legal, and social implications related to the implementation of non-invasive prenatal testing in Canada.

REGISTER NOW! Behind Bars: Ethics and Human Rights in U.S. Prisons

Behind Bars: Ethics and Human Rights in U.S. Prisons
November 30 – December 1, 2017
Harvard Medical School campus
Longwood Medical Area, Boston, MA

The United States leads the world in incarceration. The “War on Drugs” and prioritizing punishment over rehabilitation has led to mass imprisonment, mainly of the nation’s most vulnerable populations: people of color, the economically disadvantaged and undereducated, and those suffering from mental illness. Although these social disparities are striking, the health discrepancies are even more pronounced. What can be done to address this health and human rights crisis?

This conference will examine various aspects of human rights and health issues in our prisons. In collaboration with educators, health professionals, and those involved in the criminal justice system—including former inmates, advocates, and law enforcement—the conference will clarify the issues, explore possible policy and educational responses, and establish avenues for action.

Registration for the conference is required. To learn more and to register, please visit the HMS Center for Bioethics website.

This event is cosponsored by the Center for Bioethics at Harvard Medical School, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and the Human Rights Program at Harvard Law School.

Roche and City of Hope Claim Pfizer Biosimilar Version of Trastuzumab Will Infringe “At Least” 40 Patents

By James Love

On November 17, 2017, Genentech, a subsidiary of the giant Swiss drug company Roche, together with City of Hope, a charity, filed a complaint in a U.S. District Court, seeking an injunction to block introduction of a Pfizer biosimilar version of Herceptin (INN: trastuzumab), as well as other remedies to infringement, including compensation for Roche’s lost profits if competition occurs. The complaint (Genentech vPfizer, 17-cv-1672, U.S. District Court, District of of Delaware (Wilmington), filed November 17, 2017) illustrates the complexity of the patent landscape on a drug placed on the market more than 19 years ago and the need for compulsory licensing of patents.

Trastuzumab is a very important drug for the treatment of breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2+). My wife was treated with trastuzumab for several years, and is currently on a follow-on Roche treatment named Kadcyla, which is a combination of trastuzumab and the small molecule DM1. (DM1 is an NIH funded drug now off patent).

The early development of trastuzumab was dramatic, and documented in such accounts as Robert Bazell’s very readable book, Her-2: The Making of Herceptin, a Revolutionary Treatment for Breast Cancer, published in 1998, and the 2008 movie Living Proof, starting Harry Connick, Jr..  Bazell’s book was referred in the New York Times and the New England Journal of Medicine. The Bazell book and the Living Proof movie provide a dramatic account of the unwillingness of Genentech to invest in the research that led to the approval of trastuzmab, and the role of the Revlon Foundation to support Dr. Dennis Slamon’s critical work at UCLA.

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TODAY, 11/20 at 5 PM: Health Law Workshop with Thaddeus Pope

November 20, 2017 5-7 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

“From Informed Consent to Shared Decision Making: How Patient Decision Aids Can Improve Patient Safety and Reduce Medical Liability Risk.”  Download the presentation here.

Thaddeus Mason Pope is Professor of Law and Director of the Health Law Institute at the Mitchell Hamline School of Law. Pope joined Hamline University School of Law in January 2012 after serving as associate professor of law at Widener University School of Law. There, his research focused on medical futility, internal dispute resolution, tort law, public health law, and normative jurisprudence. He authors a blog on medical futility, reporting and discussing legislative, judicial, regulatory, medical, and other developments concerning end-of-life medical treatment.

Pope also taught at Albany Medical College and the University of Memphis. Prior to joining academia, he practiced at Arnold & Porter and clerked on the U.S. Court of Appeals for the Seventh Circuit. Pope earned a JD and PhD in philosophy and bioethics from Georgetown University.

The NHS in England: Running to Stand Still?

By John Tingle

The Health and Social Care Regulator of the NHS in England, the Care Quality Commission (CQC) has published its latest annual report on the state of health and adult social care in England 2016/17.When reading the report ,the reader is left wondering whether the NHS as currently established can cope adequately with current future health and social care demands. The NHS turns seventy years of age next year and there is much to celebrate but there is also a lot of increasing concern about NHS efficiency, sustainability, safety and quality. The number of people aged 65 is projected to increase in all regions of England by an average of 20 % between mid-2014-and mid-2024.People are also increasingly presenting with complex, chronic or multiple conditions. The total number of people with Dementia is projected to reach one million by 2027.We are also living longer. Life expectancy at birth, 2013-2015 is 79 years for men and 83 for women. All these factors test the model of NHS care that we have and its long-term sustainability.

Like the previous year’s annual report,this year’s warns that the health and care system is operating at full stretch and that care quality in some areas is deteriorating. The situation can only get worse unless more resources are made available or new ways of the NHS operating are devised. The NHS faces an infinite public demand for its finite resources. Continue reading

The Illusion of Choice in Health Care Consumerism

By Aobo Dong

The rhetoric of “choice” has been pervasive in U.S. health care reforms and the consumerist health care culture for a long time. The idea is that giving patients more choices over doctors and insurance plans would increase competition in the industry and consequently improve the quality of health care patients receive. However, Allison Hoffman made a convincing case debunking this seemingly intuitive idea in this week’s HLS health law workshop. She argued that reform efforts aimed at increasing consumer choice often fail to empower patients to make better health care choices, and instead, create a wasteful market bureaucracy that is anathema to free market ideals. Her argument reminds me of one of my earlier blog posts on U.S. drug prices, where I compared insurance companies to the Central Planner in a socialist economy. Indeed, there are ironically many institutions and features in the so-called market-driven U.S. health care system that resemble authoritarian and technocratic practices that are directly against the principles of a laissez-faire health care economy.

I will expand Professor Hoffman’s argument by making a few additional points. First, her presentation discusses a number of revealing ways in which the market-based competition creates a false sense of choice in health care. Even Obamacare, which is supposed to offer patients more choices in the Exchange, fails to transcend the falsity of consumer choice. Most patients do not make the best available choice, even when they’re “nudged” by experts in the decision-making process. I’d like to also point out that even if consumers are capable of making the best choice for themselves, whether by thinking with perfect rationality or by accepting “expert opinions,” the choice they ultimately make could still be suboptimal or even disastrous. To understand why this might be the case, it is important to realize that the target population for Obamacare is the minority of people who do not have adequate employer-sponsored plans. Thus, many people enrolled in Obamacare may not have stable jobs and income levels. Nonetheless, the mechanism that determines how much premium for which one qualifies is predicated on an estimation of that individual’s projected annul earnings – a number that is hard to know in advance for those without stable income levels. Hence, a person who made the “right choice” by selecting a silver plan with only $100 monthly premium after receiving a $900 subsidy to cover a $1,000 plan at the beginning of a year may find herself owing the federal government thousands of dollars at the end of the tax year, if she happens to end up with a much higher income level. Had she known the future outcome, she would have chosen a less expensive plan to begin with, but either choice would be a gamble for her. This arbitrariness must be attended to in future health reforms. Continue reading

Leo Beletsky on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

This week features another return visit from Leo Beletsky, our friend and Northeastern University School of Law professor. Leo is a fearless critic of misguided approaches to the opioid crisis. His take is far more nuanced, using a public health frame to understand the crisis and employing evidence-based analysis to determine appropriate responses. Our wide-ranging conversation included analysis of attempts to combat crisis though law enforcement and interdiction, the inapplicability of the “vector” epidemic frame to opioids, and primary, secondary, and tertiary public health interventions.

We briefly mentioned Frank’s talk in Berlin at the Friedrich Ebert Stiftung (the think tank of Germany’s Social Democratic Party) discussing the interaction of black hat search engine optimization and addiction rehab referral.

Our lightning round discussed the latest legislative attacks on the ACA (this time through a potential individual mandate repeal), as well as some additional health policy issues.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at Apple Podcasts, listen at Stitcher Radio Tunein, or Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at If you have comments, an idea for a show or a topic to discuss you can find us on Twitter @nicolasterry @FrankPasquale @WeekInHealthLaw.

The Mexico City Rule and Maternal Death

By Clíodhna Ní Chéileachair

The ‘Mexico City Rule’ is a Reagan-era regulation which bars US funding to worldwide NGOs which provide counselling relating to abortion, or referrals for abortion services, or which advocate for the expansion of abortion access. The regulation is a sticking point for the two-party reality of US politics, and has been rescinded by every Democratic president since Reagan, and reinstated by each Republican president. Trump is no exception, and his administration’s approach to the policy has been exceedingly expansionist; where the policy traditionally only applied to aid tied to family planning projects, the policy now extends to all international health care aid provided by the US government, amounting to almost $9 billion every year, and covering US aid policies in the areas of family planning and reproductive health, infectious diseases, TB treatment, children’s health, nutrition, HIV/AIDS prevention, water and sanitation programs, and tropical diseases.

The effect of the policy extends past the years in which it is actively in place. Population Action International reports on a reluctance on the part of US governmental officials and non-governmental partners to enter into agreements with organizations that may be ineligible for funding in the future based on the putative reinstatement of the policy, in effect operationalizing the policy beyond the times in which it is in active effect. Beyond the expanded remit given to the policy by the Trump administration, and the temporal expansion based on likely reinstatement, the wording of the policy itself goes some way to expanding the scope of the policy beyond what might be necessary in a vacuum. The structural effect of the policy is to prevent the funding of abortion access with US aid money (an outcome which is illegal regardless through the Helms Amendment) and abortion advocacy. The policy contemplates a neat categorization of organizations such that it is possible to carve out the aspects of a healthcare organization that deal with abortion care as an aspect of reproductive health and justice. Continue reading

What does the Orphan Drug Tax Credit tell us about the Costs of Clinical Trials?

By James Love


  • The number of patients enrolled in the trials used to support the registration of novel orphan product are significantly smaller that non-orphan products.  One measure of this is the difference in the enrollment of trials cited in the FDA drug trials snapshots.
  • Since 2015, the average number of trials cited in the FDA trials snapshots for novel drugs were 439 for orphan products, and 2,736 for non-orphans.
  • Data from the Orphan Drug Tax Credit provides insights into the costs of drug development, or more specially, the costs of the clinical trials used to support an FDA approval.
  • From 2010 to 2016, the average qualifying trial costs claimed for the orphan drug credit was $86 million to $102 million, per FDA approved orphan indication (assuming 2 to 3 year average years of lag between the credit claimed and the approval date).  Companies were able to take a credit of $43 to $51 million, on average, for each FDA approval.
  • The $86 to $102 million in pre-credit outlays is far lower than the average of $965 million on trial costs for a new drug approval, estimated by DiMasi and others in 2016.  Some of the differences are explained by the smaller trials for orphan drugs and other differences in methodologies, although both figures include the costs of failed trials and exclude pre-clinical or cost of capital costs.
  • In 2013, the last year for which we have actual rather than projected data on the credit (from the IRS Statistics of Income), the total amount of the credit from all 132 corporate tax returns that claimed the credit was just over $1 billion, nearly the same amount as the DiMasi estimate of $965 million for a single drug. But in 2013, the FDA granted 265 orphan designations and approved 33 orphan indications, including 8 novel products which were approved for an orphan drug lead indication.
  • The data from the orphan drug tax credit illustrates the large gap between the known facts about the costs for R&D for orphan drug development, and the astronomically larger R&D costs claimed by DiMasi (and frequently quoted by other researchers, policy makers and journalists) as averages that should guide policy making.
  • These data underline the need for greater transparency of R&D costs, and more sophistication and realism by policy makers regarding the costs of research and development for drugs qualifying as orphan products.
  • The data from the orphan drug tax credit also provides additional perspective on the estimates of drug development costs provided by Vinay Prasad and Sham Mailankody in their 2017 JAMA paper.

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Save The Date! 2/22/18: The Jaharis Symposium on Health Law and Intellectual Property

On February 22, 2018, join DePaul University, located in downtown Chicago, for The Jaharis Symposium on Health Law and Intellectual Property: Technological and Emergency Responses to Pandemic Diseases.

Hosted by DePaul University’s Mary and Michael Jaharis Health Law Institute and the Center for Intellectual Property Law and Information Technology (CIPLIT®), this one day conference will focus on “best practices” in response to emerging pandemic diseases.

Connect with keynote speakers Lawrence Gostin–University Professor and Faculty Director, O’Neill Institute for National and Global Health Law, Georgetown University– and Richard Wilder–Associate General Counsel, Global Health Program, Bill and Melinda Gates Foundation.  They will be joined by other esteemed panelists during this timely and important discussion.


Dementia and Democracy: America’s Aging Judges and Politicians

Dementia and Democracy: America’s Aging Judges and Politicians
November 15, 2017 12:00 PM
Pound Hall, Room 102
Harvard Law School, 1563 Massachusetts Ave., Cambridge, MA

Our judiciary and our elected officials are getting old. Five of the nine Supreme Court Justices are 67 or older, with two over age 80. The President is 71, the Senate Majority Leader is 75, and the House Minority Leader is 77. Does the public have a right to know whether these officials have been screened for dementia? If the individuals don’t self-report their dementia status, should experts continue to adhere to the “Goldwater Rule” and refrain from offering an armchair diagnosis? As the nation reflects on its midterm elections, and prepares for the 2020 election cycle, these questions are timely and challenging.

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REGISTER NOW (12/12)! Sixth Annual Health Law Year in P/Review

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

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TODAY, 11/13 at 5 PM: Health Law Workshop with Allison Hoffman

November 13, 2017 5-7 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Presentation: “Health Care’s Market Bureaucracy”

To request a copy of the paper in preparation for the workshop, please contact Jennifer Minnich at

Allison K. Hoffman joined the faculty of the University of Pennsylvania Law School in fall 2017. Hoffman’s research examines the role of regulation and the welfare state in promoting health, as well as how regulation affects conceptions of risk and responsibility. Her recent work includes “Reimagining the Risk of Long Term Care” in the Yale Journal of Health Policy Law and Ethics—an article that argues for a more capacious vision of how we think about long-term care risk—and the Oxford Handbook of U.S. Health Law (2017), a volume co-edited with I. Glenn Cohen and William M. Sage. She also contributed a chapter to this volume entitled “What Health Reform Reveals about Health Law,” which explores the Affordable Care Act as a window into the idiosyncrasies of U.S. health care law and the values that have shaped this field. Her work and commentary has been featured in top media outlets, including the New York Times, The Huffington Post, the Wall Street Journal, Reuters, Morningstar, CNBC, the New York Daily News, Marketplace by American Public Media, Jotwell, and Penn Law’s Regulatory Review (formerly RegBlog).

Hoffman received her AB summa cum laude from Dartmouth College and her JD from Yale Law School. After graduating from law school, she practiced law at Ropes & Gray LLP, where she focused on health care regulation. Previously, she provided strategic advice to corporations and nonprofit organizations as a consultant at The Boston Consulting Group and The Bridgespan Group. Prior to joining the Penn faculty, Hoffman was a faculty member at UCLA Law School. She was previously an Academic Fellow at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

Vinay Prasad on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

Renowned hematologist-oncologist, researcher, and writer Vinay Prasad joins us to discuss his views on modern clinical and research practice. A prolific scholar, Prasad has been upending conventional wisdom for years. We discuss the effectiveness (or not) of cancer screening, a more realistic take on the cancer moonshot, and continual conflicts of interest issues in medicine. Be sure to follow Vinay on Twitter @VinayPrasad82.

Our lightning round focused on work requirements for Medicaid (and 1115 waivers in general), scoring the individual mandate, the alchemy of precious metal tiers in an age of Trump, and why the shopping metaphor is so misguided in health care.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at Apple Podcasts, listen at Stitcher Radio Tunein, or Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at If you have comments, an idea for a show or a topic to discuss you can find us on Twitter @nicolasterry @FrankPasquale @WeekInHealthLaw.

Housing Equity Week in Review

Here’s the latest news from housing law and equity, for the week of November 6-10, 2017:

  • The Public Health Institute released a study that calculates the number of children with lead poisoning in the United States.
  • A new law in Seattle will prevent landlords from screening tenants based on their criminal history, via The Regulatory Review.
  • “It’s time to stop ignoring our crumbling housing code enforcement” — coverage of APHA2017 sessions on housing code enforcement, featuring CPHLR Director Scott Burris and the Five Essential Public Health Law Services Framework developed in collaboration with ChangeLab Solutions and the Network for Public Health Law, via Public Health Newswire.
  • San Jose has a new plan to get downtown landlords to clean up their vacant storefronts using a pilot program that would create a registry of vacant buildings and fine property owners who are neglecting their properties, via NextCity.
  • Civil rights groups are fighting the suspension of a HUD rule they say helps low-income families move to better neighborhoods, via CityLab.
  • Texans voted to loosen some of the tightest home lending restrictions in the country. via Governing.

Bioethics in Islam: Principles, Perspectives, Comparisons

An important questions in Islam, recurrent across time and space, is whether Islamic political theory recognizes rights claims against the state as distinct from rights claims against other members of the community. This continues to be an important subject today, intersecting the fields of law, religion, and moral philosophy. The classical tradition is divided on the matter, with the legal theory of the Shafi’i school of jurisprudence saying that rights are to be accorded viareligious authority, while the Hanafi school emphasized the universality of the notion of human inviolability (dhimma)—and the innate rights that derive from it—as God-given, universal, and applicable to all societies from the beginning of time.

Whereas in Western law there is generally a separation between law and ethics, in the Islamic tradition, there is more of a dialectical tension between the two: Where religious inwardness is more highly developed, attitude and intention are weighed more heavily, whereas in its absence however formalism and legalism are advanced as the ethical ideal.

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AI Citizen Sophia and Legal Status

By Gali Katznelson

Two weeks ago, Sophia, a robot built by Hanson Robotics, was ostensibly granted citizenship in Saudi Arabia. Sophia, an artificially intelligent (AI) robot modelled after Audrey Hepburn, appeared on stage at the Future Investment Initiative Conference in Riyadh to speak to CNBC’s Andrew Ross Sorkin, thanking the Kingdom of Saudi Arabia for naming her the first robot citizen of any country. Details of this citizenship have yet to be disclosed, raising suspicions that this announcement was a publicity stunt. Stunt or not, this event raises a question about the future of robots within ethical and legal frameworks: as robots come to acquire more and more of the qualities of human personhood, should their rights be recognized and protected?

Looking at a 2016 report passed by the European Parliament’s Committee on Legal Affairs can provide some insight. The report questions whether robots “should be regarded as natural persons, legal persons, animals or objects – or whether a new category should be created.” I will discuss each of these categories in turn, in an attempt to position Sophia’s current and future capabilities within a legal framework of personhood.

If Sophia’s natural personhood were recognized in the United States, she would be entitled to, among others, freedom of expression, freedom to worship, the right to a prompt, fair trial by jury, and the natural rights to “life, liberty, and the pursuit of happiness.” If she were granted citizenship, as is any person born in the United States or who becomes a citizen through the naturalization process, Sophia would have additional rights such as the right to vote in elections for public officials, the right to apply for federal employment requiring U.S. citizenship, and the right to run for office. With these rights would come responsibilities: to support and defend the constitution, to stay informed of issues affecting one’s community, to participate in the democratic process, to respect and obey the laws, to respect the rights, beliefs and opinions of others, to participate in the community, to pay income and other taxes, to serve on jury when called, and to defend the country should the need arise. In other words, if recognized as a person, or, more specifically, as a person capable of obtaining American citizenship, Sophia could have the same rights as any other American, lining up at the polls to vote, or even potentially becoming president. Continue reading

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Michael S. Sinha, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of October. The selections feature topics ranging from the trajectories of injectable cancer drug costs after launch in the United States, to the FDA Unapproved Drugs Initiative, to registries supporting new drug applications. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Gordon N, Stemmer SM, Greenberg D, Goldstein DA. Trajectories of Injectable Cancer Drug Costs After Launch in the United States. J Clin Oncol. 2017 Oct 10. [Epud ahead of print]
  2. Gupta R, Dhruva SS, Fox ER, Ross JS. The FDA Unapproved Drugs Initiative: An Observational Study of the Consequences for Drug Prices and Shortages in the United States. J Manag Care Spec Pharm. 2017 Oct;23(10):1066-1076.
  3. Jonker CJ, van der Berg HM, Kwa MSG, Hoes AW, Mol PGM. Registries supporting new drug applications. Pharmacoepidemiol Drug Saf. 2017 Oct 6.
  4. Sarpatwari A, Choudhry NK. Recalibrating Privacy Protections to Promote Patient Engagement. N Engl J Med. 2017 Oct 19;377(16):1509-1511.