a pill in place of a model globe

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

By Ameet Sarpatwari, Beatrice Brown, 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 May. The selections feature topics ranging from an analysis of the impact of generic drug spikes on Medicaid spending, to an evaluation of where drugs are tested for FDA approval and subsequent time to marketing approval in these countries, to an assessment of how net prices of diabetes drugs are affected by brand competition. A full posting of abstracts/summaries of these articles may be found on our website.

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Civil Commitment for Opioid Misuse: The Need for an Ethical Use Framework

Cross posted from the Journal of Medical Ethics Blog

By John C Messinger, Daniel J Ikeda, and Ameet Sarpatwari

In the 12 months prior to September 2020, there were over 66,000 fatal opioid overdoses in the United States, a 36% increase over the previous year. Many scholars have hypothesized that this dramatic rise was driven at least in part by conditions brought on by the COVID-19 pandemic, including increased barriers to accessing treatment for opioid use disorder and loss of social support.

As the crisis has worsened, states have scrambled to devise interventions to slow the loss of life. One strategy that has gained favor in recent years is the use of civil commitment, which enables others to petition a court to forcibly detain individuals whose opioid misuse presents a clear and convincing danger to themselves or others. Between 2015 and 2018, 25 states amended or passed new legislation related to involuntary commitment for substance misuse generally. More recently, now-President Joe Biden offered support for expansion of “mandatory rehab” on the campaign trail.

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Home innovation technology concept illustration.

Call for Abstracts — 2022 Petrie-Flom Center Annual Conference: Diagnosing in the Home

Contribute to the 2022 Petrie-Flom Center Annual Conference and subsequent book project!

Through October 14, 2021, the Petrie-Flom Center is accepting abstracts for its annual conference. The 2022 annual conference will focus on ethical, legal, and regulatory challenges and opportunities around at home digital health technology.

This conference will engage with the vision for a 21st century health care system that embraces the potential of at home digital products to support diagnoses, improve care, encourage caregivers, maximize pandemic resilience, and allow individuals to stay within the home when preferable. The goals of this conference and subsequent book project are to consider the ethical, sociological, regulatory, and legal challenges and opportunities presented by the implementation of digital products that support clinical diagnosis and/or treatment in patients’ homes over the next decade.

Interested in submitting an abstract, but want to know more about what we’re looking for? Read through the following frequently asked questions.

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LONDON, UNITED KINGDOM- 1 APRIL 2015: A newspaper rack holding several international newspapers, such as The International New York Times, USA Today, Irish Times, Londra Sera and Corriere Della Sera.

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 February. The selections feature topics ranging from an evaluation of utilization and spending on different formulations of opioid use disorder medication buprenorphine, to an analysis of the impact of the 2012 circuit court ruling in United States v. Caronia on subsequent government enforcement of off-label marketing restrictions, to an assessment of key features of the relationship between public and private actors in the context of biomedical innovation during the COVID-19 pandemic. A full posting of abstracts/summaries of these articles may be found on our website.

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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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