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Articles 1 - 16 of 16
Full-Text Articles in Law
Introduction And Geographic Availability Of New Antibiotics Approved Between 1999 And 2014, Cecilia Kållberg, Christine Årdal, Hege Salvesen Blix, Eili Klein, Elena Martinez, Morten Lindbæk, Kevin Outterson, John-Arne Røttingen, Ramanan Laxminarayan
Introduction And Geographic Availability Of New Antibiotics Approved Between 1999 And 2014, Cecilia Kållberg, Christine Årdal, Hege Salvesen Blix, Eili Klein, Elena Martinez, Morten Lindbæk, Kevin Outterson, John-Arne Røttingen, Ramanan Laxminarayan
Faculty Scholarship
Despite the urgent need for new, effective antibiotics, few antibiotics of value have entered the market during the past decades. Therefore, incentives have been developed to stimulate antibiotic R&D. For these incentives to be effective, geographic availability for recently approved antibiotics needs to be better understood. In this study, we analyze geographic availability and market introduction of antibiotics approved between 1999 and 2014.
Will Courts Allow States To Regulate Drug Prices?, Christopher Robertson
Will Courts Allow States To Regulate Drug Prices?, Christopher Robertson
Faculty Scholarship
Pharmaceuticals are consuming increasingly large portions of U.S. state budgets, and high prices are preventing patients from getting, and adhering to, essential medicines. In mid-May 2018, President Donald Trump announced a heavily hyped but relatively modest federal plan to bring down drug prices. Meanwhile, several states are moving forward with their own solutions, and Maryland’s approach is particularly ambitious. In 2017, responding to notorious cases such as the 5000% increase in the cost of Daraprim (pyrimethamine) and the 10-fold increase in the cost of EpiPens (epinephrine auto-injectors), Maryland enacted a statute that prohibits manufacturers from “price gouging” on any “essential …
Rural Health, Universality, And Legislative Targeting, Nicole Huberfeld
Rural Health, Universality, And Legislative Targeting, Nicole Huberfeld
Faculty Scholarship
Health disparities are persistent and worsening for rural communities, which have smaller patient populations with higher rates of uninsurance and greater incidence of the diseases and deaths of despair. Hospital closures and provider shortages are more common than in urban areas, also contributing to worsening population health and crises in maternal and infant health. This paper posits that these disparities are tied to the unique rural features of space and population. Efforts to address persistent problems in health care through universal legislation, such as the ACA, have given rural communities important tools to address some long-standing health problems by improving …
What Is Federalism In Health Care For?, Nicole Huberfeld
What Is Federalism In Health Care For?, Nicole Huberfeld
Faculty Scholarship
The Affordable Care Act offers a window on modern American federalism—and modern American nationalism—in action. The ACA’s federalism is defined not by separation between state and federal, but rather by a national structure that invites state-led implementation. As it turns out, that structure was only a starting point for a remarkably dynamic and adaptive implementation process that has generated new state-federal arrangements. States move back and forth between different structural models vis-à-vis the federal government; internal state politics produce different state choices; states copy, compete, and cooperate with each other; and negotiation with federal counterparts is a near-constant. These characteristics …
Race And Assisted Reproduction: Implications For Population Health, Aziza Ahmed
Race And Assisted Reproduction: Implications For Population Health, Aziza Ahmed
Faculty Scholarship
This Article emerges from Fordham Law Review's Symposium on the fiftieth anniversary of Loving v. Virginia,1 the case that found antimiscegenation laws unconstitutional. 2 Inspired by the need to interrogate the regulation of race in the context of family, this Article examines the diffuse regulatory environment around assisted reproductive technology (ART) that shapes procreative decisions and the inequalities that these decisions may engender. 3 ART both centers biology and raises questions about how we imagine our racial futures in the context of family, community, and nation. 4 Importantly, ART demonstrates how both the state and private actors shape family …
On Drugs: Preemption, Presumption, And Remedy, Elizabeth Mccuskey
On Drugs: Preemption, Presumption, And Remedy, Elizabeth Mccuskey
Faculty Scholarship
This essay explores the role of litigation in drug safety regulation and the role of drug safety regulation in litigation, exemplified by the 2017 National Health Law Moot Court Problem. Using the example of failure-to-update claims against generic drug manufacturers, this essay argues that pharmaceutical preemption doctrine would benefit from a tailored application of the presumption against preemption. It proposes a presumption that Congress does not intend to displace historic state remedies for injury without clearly saying so, focusing on the role of remedy to account for the evolving overlap in federal and state police powers over health and to …
Insights Into Early Stage Of Antibiotic Development In Small And Medium-Sized Enterprises: A Survey Of Targets, Costs, And Durations, Kevin Outterson, Christine Ardal, Enrico Baraldi, Ursula Theuretzbacher, Francesco Ciabuschi, Jens Plahte, John-Arne Røttingen
Insights Into Early Stage Of Antibiotic Development In Small And Medium-Sized Enterprises: A Survey Of Targets, Costs, And Durations, Kevin Outterson, Christine Ardal, Enrico Baraldi, Ursula Theuretzbacher, Francesco Ciabuschi, Jens Plahte, John-Arne Røttingen
Faculty Scholarship
Antibiotic innovation has dwindled to dangerously low levels in the past 30 years. Since resistance continues to evolve, this innovation deficit can have perilous consequences on patients. A number of new incentives have been suggested to stimulate greater antibacterial drug innovation. To design effective solutions, a greater understanding is needed of actual antibiotic discovery and development costs and timelines. Small and medium-sized enterprises (SMEs) undertake most discovery and early phase development for antibiotics and other drugs. This paper attempts to gather a better understanding of SMEs’ targets, costs, and durations related to discovery and early phase development of antibacterial therapies.
Quarantine And The Federal Role In Epidemics, Wendy K. Mariner, Michael Ulrich
Quarantine And The Federal Role In Epidemics, Wendy K. Mariner, Michael Ulrich
Faculty Scholarship
Every recent presidential administration has faced an infectious disease threat, and this trend is certain to continue. The states have primary responsibility for protecting the public’s health under their police powers, but modern travel makes diseases almost impossible to contain intrastate. How should the federal government respond in the future? The Ebola scare in the U.S. repeated a typical response—demands for quarantine. In January 2017, the Department of Health and Human Services and the Centers for Disease Control and Prevention issued final regulations on its authority to issue Federal Quarantine Orders. These regulations rely heavily on confining persons who may …
The New Health Care Federalism On The Ground, Nicole Huberfeld, Abbe Gluck
The New Health Care Federalism On The Ground, Nicole Huberfeld, Abbe Gluck
Faculty Scholarship
This essay, part of a symposium investigating methods of empirically evaluating health policy, focuses on American health care federalism, the relationship between the federal and state governments in the realm of health care policy and regulation. We describe the results of a five year study of the implementation of the Patient Protection and Affordable Care Act (ACA) from 2012-2017. Our study focused on two key pillars of the ACA, which happen to be its most state-centered — expansion of Medicaid and the implementation of health insurance exchanges — and sheds light on federalism in the modern era of nationally-enacted health …
Women’S Human Rights And Migration: Sex Selective Abortion Laws In The United States And India, Aziza Ahmed
Women’S Human Rights And Migration: Sex Selective Abortion Laws In The United States And India, Aziza Ahmed
Faculty Scholarship
In her compelling new book, Women's Human Rights and Migration, Sital Kalantry challenges the idea that a women's human rights framework offers a consistent and universal way to address complicated gender issues across countries. She is primarily concerned with the lives of migrant women in countries that respond to their social and cultural practices with harsh regulations designed to bring them in line with dominant ideas about gender equality. Kalantry focuses in on two issues in particular: sex-selective abortion and the veil as worn by Muslim women. Kalantry insightfully identifies a primary problem with these types of laws and …
The New Health Care Federalism On The Ground, Nicole Huberfeld, Abbe Gluck
The New Health Care Federalism On The Ground, Nicole Huberfeld, Abbe Gluck
Faculty Scholarship
This essay, part of a symposium investigating methods of empirically evaluating health policy, focuses on American health care federalism, the relationship between the federal and state governments in the realm of health care policy and regulation. We describe the results of a five year study of the implementation of the Patient Protection and Affordable Care Act (ACA) from 2012-2017. Our study focused on two key pillars of the ACA, which happen to be its most state-centered — expansion of Medicaid and the implementation of health insurance exchanges — and sheds light on federalism in the modern era of nationally-enacted health …
Practice-Based Research Networks And The Mandate For Real-World Evidence, Christopher Robertson
Practice-Based Research Networks And The Mandate For Real-World Evidence, Christopher Robertson
Faculty Scholarship
The 21st Century Cures Act encourages the Food and Drug Administration to consider “real-world evidence” in its regulation of the safety and efficacy of drugs and devices. Many have interpreted this mandate to focus on non-randomized observational research. However, we suggest that regulatory science must also move from rarefied academic hospitals to community-based settings, where the vast majority of patients in fact receive care in the fragmented U.S. healthcare system. This move is especially important if innovations are to reach, and be validated in, more diverse populations. A solution can be found in the 183 Practiced-Based Research Networks (“PBRN”), …
Can Rationing Through Inconvenience Be Ethical?, Nir Eyal, Paul Romain, Christopher Robertson
Can Rationing Through Inconvenience Be Ethical?, Nir Eyal, Paul Romain, Christopher Robertson
Faculty Scholarship
In this article, we provide a comprehensive analysis and a normative assessment of rationing through inconvenience as a form of rationing. By “rationing through inconvenience” in the health sphere, we refer to a non-financial burden (the inconvenience) that is either intended to cause or has the effect of causing patients or clinicians to choose an option for health‐related consumption that is preferred by the health system for its fairness, efficiency, or other distributive desiderata beyond assisting the immediate patient. We argue that under certain conditions, rationing through inconvenience may turn out to serve as a legitimate and, compared to direct …
Ideology Meets Reality: What Works And What Doesn't In Patient Exposure To Health Care Costs, Christopher Robertson, Victor Laurion
Ideology Meets Reality: What Works And What Doesn't In Patient Exposure To Health Care Costs, Christopher Robertson, Victor Laurion
Faculty Scholarship
U.S. policymakers, scholars, and advocates have long displayed an ideological commitment to exposing insured patients to substantial out-of-pocket expenses. These commitments derive from both overt political ideologies, which favor individual responsibility and oppose redistribution of wealth and risks, as well as more-subtle ideological commitments of academic economists, which link observed patterns of consumption to value-claims about welfare. In this symposium contribution, we document those ideological commitments and juxtapose them with a review of the scientific evidence about the actual effects of patient cost-sharing. We find, as economic theory predicts, that patients exposed to healthcare costs consume less healthcare. However, a …
The Body Politic: Federalism As Feminism In Health Reform, Elizabeth Mccuskey
The Body Politic: Federalism As Feminism In Health Reform, Elizabeth Mccuskey
Faculty Scholarship
This essay illuminates how modern health law has been mainstreaming feminism under the auspices of health equity and social determinants research. Feminism shares with public health and health policy both the empirical impulse to identify inequality and the normative value of pursing equity in treatment. Using the Affordable Care Act's federal health insurance reforms as a case study of health equity in action, the essay exposes the feminist undercurrents of health insurance reform and the impulse toward mutuality in a body politic. The essay concludes by revisiting-from a feminist perspective-scholars' arguments that equity in health insurance is essential for human …
A Perspective On Incentives For Novel Inpatient Antibiotics: No One-Size-Fits-All, Kevin Outterson
A Perspective On Incentives For Novel Inpatient Antibiotics: No One-Size-Fits-All, Kevin Outterson
Faculty Scholarship
The need for new “pull” incentives to stimulate antibiotic R&D is widely recognized. Due to the global diversity of health systems, combined with different challenges faced by antibiotics used in different types of healthcare settings, there is no one-size-fits-all solution. Instead, different “pull” incentives should be tailored to local contexts, priorities, and antibiotic types. Policymakers and industry should collaborate to identify appropriate solutions at the local, regional, and global levels.