Stacks of books against a burgundy wall

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

By Ameet SarpatwariBeatrice Brown, Neeraj Patel, 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.

Below are the citations for papers identified from the month of November. The selections feature topics ranging from an analysis of Medicare Part D spending on inhalers from 2012 to 2018, to an overview of vaccine development and regulations to better understand how COVID-19 vaccines will be evaluated, to an analysis of the ethical implications of emergency authorization of COVID-19 drugs for patient care. A full posting of abstracts/summaries of these articles may be found on our website.

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Doctor, DNA, microscope concept illustration.

Legislative Success in FL Suggests Time is Ripe for Further Genetic Nondiscrimination Protections

By Anna C F Lewis and Anya E R Prince

On July 1, a law banning the use of genetic information by life, long-term care, and disability income insurers took effect in Florida.

Florida’s success marks a potential turning point of bipartisan appeal for this issue.

The passage of this law, which we explore in a recent article published in Genetics in Medicine, the official journal of the American College of Medical Genetics and Genomics (ACMG), was propelled by a campaign that argued that an individual’s DNA should not be weaponized against them, that affordable insurance shouldn’t just be for the genetic elite, and that an individual should be able to keep their genetic data private.

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Senior citizen woman in wheelchair in a nursing home.

Seniors’ Perspectives on Dementia and Decision-Making

By James Toomey

In order to make a decision recognized in law — to enter into or enforce a contract, buy or sell property, or get married or divorced — an individual must have the mental capacity the law requires for the decision. As people, especially older adults, develop dementia, their decision-making abilities are increasingly compromised, and the law begins to find that they lack capacity for particular decisions.

The standards governing capacity determinations, however, are notorious for being vague, inconsistently applied, and excessively curtailing the rights of those with dementia. Part of the problem, I think, is the lack of an agreed-upon normative theory for when in the course of dementia the law ought to intervene in individual decision-making. That is why, here on Bill of Health, I’ve previously called for understanding the perspectives of seniors — the population affected by the doctrine of capacity most closely and most often — on this normative question.

In my recent publication “Understanding the Perspectives of Seniors on Dementia and Decision-Making” in AJOB Empirical Bioethics, I’ve begun to do so, reporting the results of an empirical study that I conducted with the Petrie-Flom Student Fellowship in the 2018-19 academic year. The study, which involved an online survey of and interviews with older adults, revealed a heterogeneity of ways of thinking about the problem, supporting a flexible legal doctrine that would assist people in making their own choices. Notwithstanding the diversity, however, the data reveal several conclusions and tensions of interest to academics and healthcare and legal practitioners.

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books

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

By Ameet SarpatwariBeatrice Brown, Neeraj Patel, 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.

Below are the citations for papers identified from the month of October. The selections feature topics ranging from a commentary calling for reconsideration of the FDA’s risk evaluation and mitigation strategy (REMS) program for mifepristone, to an analysis of clinical development times for biosimilars seeking FDA approval, to an editorial describing the challenges of using the Defense Production Act to address drug shortages. A full posting of abstracts/summaries of these articles may be found on our website.

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Assessing legal responses to COVID-19 graphic.

New Report Assesses Legal Responses to COVID-19

Assessing Legal Responses to COVID-19 is a new, in-depth analysis of U.S. legal and policy responses to the pandemic.

In the report, 50 top national experts offer a new assessment of the U.S. policy response to the crisis. The research details the widespread failure of the country’s leadership in planning and executing a cohesive, national response, and how the crisis exposed weaknesses in the nation’s health care and public health systems.

The report’s authors also offer recommendations on how federal, state and local leaders can better respond to COVID-19 and future pandemics. Their proposals recommend how to strengthen executive leadership for a stronger emergency response; expand access to public health, health care, and telehealth; fortify protections for workers; and implement a fair and humane immigration policy.

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Young male doctor in telehealth concept

Call for Abstracts: Looking Forward to a Post-Pandemic Landscape

By Carmel Shachar and Katie Kraschel

The COVID-19 pandemic has disrupted virtually every facet of day-to-day life.

This disruption has forced us to examine baseline choices and assumptions about how to deliver health care, participate in public discourse, provide access to education, and support the workforce. This “great revision” will continue in several iterative stages: an immediate response to the crisis, a modulation as the pandemic continues, and a resolution into a “new normal.”

The Petrie-Flom Center and the Solomon Center for Health Law Policy are interested in tracking when crisis settles into the new normal and articulating how public policy and law should respond to that evolution.

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Stacks of books against a burgundy wall

Announcing The Journal of Philosophy of Disability 

The Journal of Philosophy of Disability (JPD) is a new journal devoted to the philosophical study of disability.

Disability is central to human life. As the slogan from disability studies goes: “disability is everywhere, once you know how to look for it.” After a steady stream of scholarship from the 1990s onward, work in the field of philosophy of disability has expanded exponentially. Despite this explosion, there has never been a peer-reviewed journal devoted to scholarship in the field of philosophy of disability. Until now.

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Photograph of colorful academic journals on a library shelf

Making an Impact: Journal of Law and the Biosciences Scores High

The Journal of Law and the Biosciences is the first fully open-access, peer-reviewed, legal journal focused on the advances at the intersection of law and the biosciences. JLB is co-edited by Profs. I. Glenn Cohen (Harvard Law School), Nita Farahany (Duke University School of Law), and Hank Greely (Stanford Law School). JLB contains original and response articles, essays, and commentaries on a wide range of topics, including bioethics, neuroethics, genetics, reproductive technologies, stem cells, enhancement, patent law, and food and drug regulation. JLB is published as one volume with three issues per year, with new articles posted online on an ongoing basis.

The Journal of Law and the Biosciences recently received a journal impact factor of 2.431, making it one of the most cited, influential journals in its fields. In fact, JLB ranks 14 out of 148 law journals and is ranked third out of sixteen in the areas of both medical ethics and legal medicine.

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hand reaching for blue pills

Author Q&A: Reducing High-Dose Opioid Prescribing

Sara Heins, PhD
Sara Heins, PhD, Associate Policy Researcher, RAND Corporation

From 1999 to 2017, almost 218,000 people died in the United States from overdoses related to prescription opioids. Overdose deaths involving prescription opioids were five times higher in 2017 than in 1999, according to the CDC.

Previous research has indicated that patients who receive higher doses of prescription opioids have an increased risk of overdose and mortality. In response, several states have established Morphine Equivalent Daily Dose (MEDD) thresholds that convert opioid prescriptions to their equivalent dose in morphine and divides the total prescription by the number of days the prescription is intended to last, allowing for comparison among different opioid formulations and strengths. MEDD policies set thresholds for prescribers, which may only be exceeded in limited circumstances, such as when being prescribed to certain patient groups or as short-courses.

Sara Heins, PhD, an associate policy researcher at RAND Corporation, used policy surveillance to track MEDD policies through June 1, 2017 (data are available on LawAtlas.org). She published an article in Pain Medicine on March 13 that describes U.S. MEDD policies.

We asked Dr. Heins a few questions about her work and this recent publication. Read More

Bird's eye view of a town with identical looking-houses lined up close together

Housing Law and Health Equity: No Bliss in Ignorance

By Katie Moran-McCabe and Scott Burris

Florence Nightingale once said, “The connection between health and the dwellings of the population is one of the most important that exists” — a statement that is as true today as it was at the turn of the 20th century. A decent dwelling and diverse communities, where there is access to transportation, good schools, shops, parks, socioeconomic mixture, social capital and collective efficacy, and economic opportunity are all features necessary for both a high-level and equitable distribution of well-being.

The promise of healthy housing and communities, however, falls short in the United States. Much of the housing in the U.S. is expensive, unsafe, and inadequate in supply. Read More