Health Law and Policy Commons^™

The Effect Of Generic Market Entry On Antibiotic Prescriptions In The United States, Cecilia Kållberg, Jemma Hudson, Hege Salvesen Blix, Christine Årdal, Eili Klein, Morten Lindbæk, Kevin Outterson, John-Arne Røttingen, Ramanan Laxminarayan

Faculty Scholarship

When patented, brand-name antibiotics lose market exclusivity, generics typically enter the market at lower prices, which may increase consumption of the drug. To examine the effect of generic market entry on antibiotic consumption in the United States, we conducted an interrupted time series analysis of the change in the number of prescriptions per month for antibiotics for which at least one generic entered the US market between 2000 and 2012. Data were acquired from the IQVIA Xponent database. Thirteen antibiotics were analyzed. Here, we show that one year after generic entry, the number of prescriptions increased for five antibiotics (5 …

Designing An Independent Public Health Agency, Jacqueline Salwa, Christopher Robertson

Faculty Scholarship

We believe that Congress should act on a bipartisan basis to fix U.S. public health institutions. Legislators could decide to merely buttress current institutions, as former commissioners have suggested be done for the FDA.1 Alternatively, legislators could consider a broad reorganization of public health functions and create a superagency, whose purview would include everything from the approval of drugs and devices to the maintenance of national stockpiles of protective equipment.

Marijuana Legalization And The Role Of The Massachusetts Legislature, Sean J. Kealy

Faculty Scholarship

The public is often frustrated when Congress or their state legislature is not responsive to their policy priorities. This was especially true during the effort to legalize marijuana in Massachusetts. The legislature consistently refused to take up the issue despite public support. Legalization advocates ultimately bypassed the legislature by turning to the ballot-initiative process on three occasions: first to decriminalize possession of small amounts of marijuana, then to legalize medical marijuana, and most recently to legalize recreational marijuana. After the electorate legalized recreational marijuana, the legislature further frustrated advocates, first by delaying implementation of key parts of the law and …

Medical Cannabis And The Age Of Majority, Katharine B. Silbaugh

Faculty Scholarship

This Essay considers whether commercial cannabis retailers are adequately constrained in the sale of cannabis to 18- to 21-year-olds. It examines the intersection of the medical cannabis market, recreational cannabis market, and underlying status law regulating late adolescents aged 18 to 21. Because the age of majority licenses full medical decision-making, an 18-year-old can access medical cannabis but not recreational cannabis or alcohol. This Essay proceeds on the assumption that medical cannabis is a construct that has eased the process of achieving a legalized commercial cannabis market. The ambiguity around medical claims is comfortable in the libertarian soil of cannabis …

The Impact Of Covid-19 On Immigration Detention, Fatma Marouf

Faculty Scholarship

COVID-19 has spread quickly through immigration detention facilities in the United States. As of December 2, 2020, there have been over 7,500 confirmed COVID-19 cases among detained noncitizens. This Article examines why COVID-19 spread rapidly in immigration detention facilities, how it has transformed detention and deportation proceedings, and what can be done to improve the situation for detained noncitizens. Part I identifies key factors that contributed to the rapid spread of COVID-19 in immigration detention. While these factors are not an exhaustive list, they highlight important weaknesses in the immigration detention system. Part II then examines how the pandemic changed …

The Boston Medical Center Immigrant Task Force: An Alternative To Teaching Immigration Law To Health Care Providers, Sondra S. Crosby, Lily Sonis, George J. Annas

Faculty Scholarship

As healthcare providers engage in the politics of reforming and humanizing our immigration and asylum “system” it is critical that they are able to refer their patients whose health is directly impacted by our immigration laws and policies to experts who can help them navigate the system and obtain the healthcare they need.

The Private Option, Brendan S. Maher

Faculty Scholarship

Health care reform is once again in the air. Virtually all Democrats favor some meaningful expansion of public insurance, whether through single payer or the creation of a “public option” that would allow consumers dissatisfied with the private market to buy into a public program. Republicans, not surprisingly, have pushed back, not only against single payer, but also against the public option, saying it will drive private payors to extinction. All the political jousting implicates a larger and serious policy question; namely, what should be the role of private payors in the nation’s health care system?

Arguments to date on …

Adding Principle To Pragmatism: The Transformative Potential Of "Medicare-For-All" In Post-Pandemic Health Reform, William M. Sage

Faculty Scholarship

“Medicare-for-All” should be more than a badge of political identity or opposition. This Article examines the concept’s potential to catalyze policy innovation in the U.S. health care system. After suggesting that the half century of existing Medicare has been as much “Gilded Age” as “Golden Age,” the Article arrays the operational possibilities for a Medicare-for-All initiative. It revisits America’s recent history of pragmatic rather than principled health policy, and identifies professional and political barriers to more sweeping reform. It focuses on four aspects of health policy that have become apparent: simultaneous inefficiency and injustice in medical care, neglect of the …

California V. Texas: The Role Of Congressional Procedure In Severability Doctrine, Mary Leto Pareja

Faculty Scholarship

The United States Supreme Court is once again considering a case that challenges the constitutionality of the Affordable Care Act (“ACA”). In this round of litigation, plaintiffs argue that because Congress lowered the individual mandate tax penalty to zero in the 2017 Tax Act that makes the individual mandate itself unconstitutional and that, furthermore, the individual mandate cannot be severed from the rest of the ACA. The District Court agreed with the plaintiffs and struck down the entire ACA, and the Supreme Court granted cert to hear this momentous question. A decision is expected by summer of 2021.

The ACA …

A Unified Theory Of Data, William Magnuson

Faculty Scholarship

How does the proliferation of data in our modern economy affect our legal system? Scholars that have addressed the question have nearly universally agreed that the dramatic increases in the amount of data available to companies, as well as the new uses to which that data is being put, raise fundamental problems for our regulatory structures. But just what those problems might be remains an area of deep disagreement. Some argue that the problem with data is that current uses lead to discriminatory results that harm minority groups. Some argue that the problem with data is that it impinges on …

Addressing Public Health’S Failings During Year One Of Covid-19, George J. Annas, Sandro Galea

Faculty Scholarship

By almost any measure, public health fell short during 2020. In retrospect, the list of what public health professionals, including federal and state public health officials, public health practitioners, and academics, could have done better is easy to articulate, and has already been the subject of angry books about the disasterous responses to the pandemic in Europe and the US [1,2]. It falls to all of us to pause, reflect, and ask: how do we move forward? We have five suggestions.

Disposable Lives: Covid-19, Vaccines, And The Uprising, Matiangai Sirleaf

Faculty Scholarship

Two French doctors appeared on television and publicly discussed potentially utilizing African subjects in experimental trials for a tuberculosis vaccine as an antidote to the novel coronavirus (COVID-19). Tedros Adhanom Ghebreyesus, the Director-General of the World Health Organization (WHO), denounced these kinds of racist remarks as a “hangover from ‘colonial mentality’” and maintained that “Africa can’t and won’t be a testing ground for any vaccine.” The fallout on social media was similarly swift, with Samuel Eto’o, a Cameroonian football legend, referring to the doctors as “[d]es assasins” and several others questioning the motives behind testing a vaccine on the African …

Social Justice, Civil Rights, And Bioethics, Kathy Cerminara

Faculty Scholarship

A stunning confluence of events in the United States in the first few months of 2020 have illustrated pervasive systemic prejudice against vulnerable people resulting in increased risk of death. Combined and situated among other, similar incidents too numerous to mention here, they present an opportunity for bioethicists to help change the impact of implicit bias, white privilege, and prejudice in shaping the very ability to live a healthy life in America. The current lack of care and even outright cruelty rendering a variety of vulnerable populations susceptible to early death illustrate why there must be more attention paid to …

Protecting Financial Stability: Lessons From The Covid-19 Pandemic, Howell E. Jackson, Steven L. Schwarcz

Faculty Scholarship

The COVID-19 pandemic has produced a public health debacle of the first order. But the virus has also propagated the kind of exogenous shock that can precipitate-and to a certain degree did precipitate-a systemic event for our financial system. This still not fully resolved systemic shock comes a little more than a decade after the last financial crisis. In the intervening years, much has been written about the global financial crisis of 2008 and its systemic dimensions. Considerable scholarly attention has focused on first devising and then critiquing the macroprudential reforms that ensued, both in the Dodd-Frank Act and the …

Fraud Law And Misinfodemics, Wes Henricksen

Faculty Scholarship

No abstract provided.

The Means And Ends Of Wellness Programs, Laura D. Hermer

Faculty Scholarship

How far should we go in assigning individuals causal responsibility for their own health status and what should the implications of any such assignment be?

Few would deny that most adults have a major role in achieving and maintaining their own health. However, it is not at all clear where one should draw the line between what is freely chosen and what is determined by forces outside a person’s control. Medical care plays only a small role in most people’s overall health, and often social, environmental, and personal factors are far more important. Incentivizing an individual to take better care …

The Need For A Strong And Stable Federal Public Health Agency Independent From Politicians, Jacqueline Salwa, Christopher Robertson

Faculty Scholarship

The COVID-19 pandemic has revealed the precariousness of federal public health institutions in the United States, and how disastrously things can go when those institutions are undermined by political forces. Such institutions can be disbanded, underfunded, populated with incompetent political hacks, manipulated, or sidelined. As a field, public health in particular needs some political space, given that it requires deep scientific expertise and needs to communicate to the public clearly, reliably, and with authority to engender trust. Key public health agencies, such as the Centers for Disease Control and Prevention (CDC) in particular, should be buttressed against future political encroachment, …

Response To: A Telehealth Explosion: Using Lessons From The Pandemic To Shape The Future Of Telehealth Regulation, Joanna K. Sax

Faculty Scholarship

In A Telehealth Explosion: Using Lessons from the Pandemic to Shape the Future of Telehealth Regulation, published in the Texas A&M Law Review, Professor Deborah Farringer tackles the critical issue of the efficacy and implementation of telehealth, using our experience(s) of telehealth during the COVID–19 pandemic as the guide. This is important, as Professor Farringer acknowledges, because while telehealth advocates pre-date the pandemic, barriers prevented the implementation of telehealth in a widespread manner. These barriers included a concern about fraud and a question as to whether telehealth visits could provide effective outcomes compared to in-person visits. Professor Farringer …

Should The U.S. Government Actively Assert Its Own Patents?, Christopher J. Morten, Barry Datlof, Amy Kapczynski, Donna Meuth, Zain Rizvi

Faculty Scholarship

On March 10, 2021, our journal partnered with the Engelberg Center on Innovation Law and Policy to host a symposium addressing the role and impact of U.S. innovation policy on access to medicine. Our 2021 Symposium Issue — Volume 11, Issue 1 — captures that event.

The following article represents the second of four panels. This panel asked, “Should the U.S. government actively assert its own patents?” The panel was moderated by Christopher Morten, Deputy Director of NYU Law’s Technology Law & Policy Clinic. The panelists included Barry Datlof, Chief of Business Development and Commercialization in the Office of Medical …

Transparency Of Regulatory Data Across The European Medicines Agency, Health Canada, And Us Food And Drug Administration, Alexander C. Egilman, Amy Kapczynski, Margaret E. Mccarthy, Anita T. Luxkaranayagam, Christopher J. Morten, Matthew Herder, Joshua D. Wallach, Joseph S. Ross

Faculty Scholarship

Based on an analysis of relevant laws and policies, regulator data portals, and information requests, we find that clinical data, including clinical study reports, submitted to the European Medicines Agency and Health Canada to support approval of medicines are routinely made publicly available.

"Everybody Knows I'M Not Lazy": Medicaid Work Requirements And The Expressive Content Of Law, Kristen Underhill

Faculty Scholarship

In a first for the Medicaid program, the Department of Health and Human Services under President Trump allowed states to establish work requirements for program participants who are considered "able-bodied adults." These mandates were halted by litigation, and President Biden's administration is now in the process of withdrawing the waivers. But early experiences with Medicaid work requirements suggested that they can produce widespread losses of benefits. In addition to affecting access, work requirements and other conditions on public benefits can serve an expressive purpose: they provide a source of information about a state's values, goals, and beliefs about beneficiaries. Beneficiaries …

The Right To Mental Health In Yemen, Waleed Alhariri, Amanda Mcnally, Sarah Knuckey

Faculty Scholarship

Mental health issues are all too common consequences of conflict and atrocity crimes, often causing upwards of one-quarter of the post-conflict, post-atrocity population to suffer from physical and mental sequelae that linger long after weapons have been silenced. After more than six years of ongoing conflict, Yemen’s already weak health care system is on the brink of collapse, and population resilience has been severely stressed by indiscriminate attacks, airstrikes, torture, food insecurity, unemployment, cholera, and now the COVID-19 pandemic. This paper examines Yemen’s responsibilities regarding the right to mental health and details the few actions the government has taken to …

Vaccination Equity By Design, Olatunde C.A. Johnson, Kristen Underhill

Faculty Scholarship

This Essay examines how states’ initial COVID-19 vaccine-distribution strategies tended to disadvantage populations of color, including Black, Latinx, and Native American communities. These dynamics resonate with “inverse equity” effects of other public-health innovations. We argue for a federal regulatory framework to reduce inequity-forcing effects during initial vaccine rollout.

Skirting The Law: Medicaid Block Grants And Per-Capita Caps In A Pandemic, Laura D. Hermer

Faculty Scholarship

To what extent can an administration abridge Medicaid’s entitlement status by administrative fiat? In the final year of the Trump administration, just before the COVID-19 pandemic, the Centers for Medicare and Medicaid Services (CMS) sought to push the outer bounds of this question by announcing the Healthy Adult Opportunity (HAO) initiative. It invited states to submit § 1115 demonstration applications to cover individuals not eligible for Medicaid benefits under the state’ s Medicaid plan—meaning, in many cases, the Affordable Care Act’s (ACA’s) Medicaid expansion population. Spending on those populations would be capped, not by purporting to waive federal law regarding …

The Healthcare System And Pandemics: Where Is The Market Failure?, Sophia S. Helland, Edward R. Morrison

Faculty Scholarship

Barak D. Richman and Steven L. Schwarcz argue that healthcare providers played a central – and failing – role in stemming the fallout from the COVID-19 pandemic. Analogizing to the financial crisis of 2008, they view our healthcare system as a collection of providers, each maximizing returns to its own stakeholders in a laissez-faire regulatory environment that ignored the essential interconnectedness of providers. Because neither hospitals nor regulators were attuned to this interconnectedness, our healthcare system was unprepared for the pandemic, resulting in a reduced standard of care. Just as Dodd-Frank and related legislation view financial institutions as part of …

Getting Real: The Maryland Healthcare Ethics Committee Network’S Covid‑19 Working Group Debriefs Lessons Learned, Norton Elson, Howard Gwon, Diane Hoffmann, Adam M. Kelmenson, Ahmed Khan, Joanne F. Kraus, Casmir C. Onyegwara, Gail Povar, Fatima Sheikh, Anita J. Tarzian

Faculty Scholarship

No abstract provided.

Budgetary Courage To Face The Double Crises Of Covid And Climate Change, Frank Pasquale

Faculty Scholarship

No abstract provided.

The Big Data Regulator, Rebooted: Why And How The Fda Can And Should Disclose Confidential Data On Prescription Drugs And Vaccines, Christopher J. Morten, Amy Kapczynski

Faculty Scholarship

Medicines and vaccines are complex products, and it is often extraordinarily difficult to know whether they help or hurt. The Food and Drug Administration (FDA) holds an enormous reservoir of data that sheds light on that precise question, yet currently releases only a trickle to researchers, doctors, and patients. Recent examples show that data secrecy can be deadly, and existing laws such as the Freedom of Information Act (FOIA) cannot solve the problem. We present here a wealth of new evidence about the urgency of the problem and argue that the FDA must “reboot” its rules to proactively disclose all …

Extending Postpartum Medicaid: State And Federal Policy Options During And After Covid-19, Jamie R. Daw, Emily Eckert, Heidi Allen, Kristen Underhill

Faculty Scholarship

The United States is facing a maternal health crisis with rising rates of maternal mortality and morbidity and stark disparities in maternal outcomes by race and socioeconomic status. Among the efforts to address this issue, one policy proposal is gaining particular traction: extending the period of Medicaid eligibility for pregnant women beyond 60 days after childbirth. The authors examine the legislative and regulatory pathways most readily available for extending postpartum Medicaid, including their relative political, economic, and public health trade-offs. They also review the state and federal policy activity to date and discuss the impact of the COVID-19 pandemic on …

Race, Risk, And Personal Responsibility In The Response To Covid-19, Aziza Ahmed, Jason Jackson

Faculty Scholarship

The COVID-19 crisis has tragically revealed the depth of racial inequities in the United States. This Piece argues that the disproportion­ate impact of the pandemic on racial minorities is a symptom of a failing approach to public health, one that privileges individual behaviors over the structural conditions that generate vulnerability and inequitable health outcomes. Despite clear racial disparities in illness and deaths, the neoliberal ideology of personal responsibility shifts the onus for mitigation of risk away from the social and legal determinants of health and onto the individual. To understand how and why these disparate racial outcomes arise, this Piece …