Health Law and Policy Commons^™

Taxing The Platypygous, James J. White

Articles

This Article maintains that obesity in the United States is an enormous public health issue that causes the health care costs of the obese Americans greatly to exceed those of citizens of normal weight. Recognizing that that much of that cost will be born by publicly financed programs and that the taxes supporting those programs will constitute an externality that the fat impose on the thin, the Article proposes a tax on high calorie food-but only when that food is purchased by the obese. The Article addresses many of the administrative, moral and other objections to a tax aimed at …

Do Graphic Tobacco Warnings Violate The First Amendment?, Nathan Cortez

Faculty Journal Articles and Book Chapters

When Congress passed the nation’s first comprehensive tobacco bill in 2009, it replaced the familiar Surgeon General’s warnings, last updated in 1984, with nine blunter warnings. The law also directed the U.S. Food and Drug Administration ('FDA') to require color graphics to accompany the textual warnings. By law, the warnings would cover the top fifty percent of the front and back of tobacco packaging and the top twenty percent of print advertisements, bringing the United States closer to many peer countries that now require graphic warnings. Tobacco companies challenged the requirement on First Amendment grounds, arguing that the compelled disclosures …

'No Body Left Behind': Re-Orienting School-Based Childhood Obesity Interventions, Lindsay Wiley

Scholarly Articles in Law Reviews & Journals

Although there are now laws on the books in virtually every jurisdiction aimed at addressing childhood obesity in K-12 schools, these efforts are inadequate and may even be misguided in important ways. Efforts aimed at health promotion - through healthier eating and increased physical activity - remain woefully underfunded even as they proliferate at every level of government. It is one thing to enact a requirement that all schools offer a minimum number of minutes of physical education each week or that school lunches include more fruits and vegetables. But it is quite another to make the budgetary commitment to …

Tuskegee Redux: Evolution Of Legal Mandates For Human Experimentation, Robert S. Levine, Jamila C. Williams, Barbara A. Kilbourne, Paul D. Juarez

Sociology Faculty Research

Human health experiments systematically expose people to conditions beyond the boundaries of medical evidence. Such experiments have included legal-medical collaboration, exemplified in the U.S. by the Public Health Service (PHS) Syphilis Study (Tuskegee). That medical experiment was legal, conforming to segregationist protocols and specific legislative authorization which excluded a selected group of African Americans from any medical protection from syphilis. Subsequent corrective action outlawed unethical medical experiments but did not address other forms of collaboration, including PHS submission to laws which may have placed African American women at increased risk from AIDS and breast cancer. Today, anti-lobbying law makes it …

The Fda Sends Smoke Signals To Big Tobacco: Will The Fda Suffer Backlash, Will Alcohol Be Regulated Next, And Will The Health Of Americans Prevail?, Angela Turriciano

Pepperdine Law Review

No abstract provided.

Public Health Regulation: The Impact Of Intersections Between Trade & Investment Treaties In Asia, Locknie Hsu

Research Collection Yong Pung How School Of Law

There has been an explosive growth of free trade agreements (FTAs) in recent years. The World Trade Report 2011 of the World Trade Organization (WTO) shows Asian members to be among the most active in signing preferential trade agreements. This unprecedented growth has attracted much academic and policy discussion on aspects such as their effects on trade liberalization, problems raised by specific trade and investment provisions, dispute settlement, and concerns over “regionalism”. Like such areas, public health regulation has been significantly affected by such treaties. FTAs, together with bilateral investment treaties (BITs), are rapidly forming a source of intersecting state …

Biobanks As A Tissue And Information Semicommons: Balancing Interests For Personalized Medicine, Tissue Donors And The Public Health, Ken Gatter

Journal of Health Care Law and Policy

No abstract provided.

Rethinking The New Public Health, Lindsay Wiley

Scholarly Articles in Law Reviews & Journals

This Article contributes to an emerging theoretical debate over the legitimate scope of public health law by linking it to a particular doctrinal debate in public nuisance law. State and local governments have been largely stymied in their efforts to use public nuisance litigation against harmful industries to vindicate collectively-held, common law rights to non-interference with public health and safety. The ways in which this litigation has failed are instructive for a broader movement in public health that is only just beginning to take shape. In response to evolving scientific understanding about the determinants of health, public health advocates are …

The Drugs Stop Here: A Public Health Framework To Address The Drug Shortage Crisis, Sharona Hoffman

Faculty Publications

Drug shortages are emerging as a major public health threat. Grave concern has been expressed by the medical community and government officials, and the crisis has been highlighted in recent media stories. Nevertheless, little has been written to date in the legal literature about the drug shortage crisis, and this timely article begins to fill this gap. It provides a thorough analysis of the origins and implications of the drug shortage problem and formulates a multi-layered approach to addressing it. The article argues that drug shortages result from a combination of market failures and regulatory constraints. It proposes a blend …

Rethinking The New Public Health, Lindsay F. Wiley

Washington and Lee Law Review

This Article contributes to an emerging theoretical debate over the legitimate scope of public health law by linking it to a particular doctrinal debate in public nuisance law. State and local governments have been largely stymied in their efforts to use public nuisance litigation against harmful industries to vindicate collectively-held, common law rights to non-interference with public health and safety. The ways in which this litigation has failed are instructive for a broader movement in public health that is only just beginning to take shape. In response to evolving scientific understanding about the determinants of health, public health advocates are …

Shifting Public Health Priorities And The Global Effort To Prevent A Bird Flu Pandemic, Robert Gatter

All Faculty Scholarship

Global strategy to control highly pathogenic avian influenza (HPAI) has changed dramatically since 2003 when it was first reported that a confirmed bird flu jumped the species barrier to infect a human in Hong Kong. Evidence of this shift in priorities in the global fight against HPAI can be found most clearly in program funding trends. In late 2008 and into 2009, financial commitments from international donors for all HPAI programs dropped significantly. Meanwhile, within HPAI programs, funding shifted substantially away from animal biosecurity projects and into human response and preparedness work. This Article examines three reasons for this shift …

With Child, Without Rights?: Restoring A Pregnant Woman's Right To Refuse Medical Treatment Through The Hiv Lens, Michael Ulrich

Faculty Scholarship

In Doe v. Division of Youth & Family Services , a hospital employee sought state intervention when an HIV-positive woman refused to comply with treatment recommendations during her pregnancy to drastically reduce the chances of mother-to-child-transmission (MTCT), eventually triggering a lawsuit against the hospital. With an increase in the number of HIV-positive women becoming pregnant and the court avoiding constitutional analysis of the woman’s right to refuse medical treatment, there is a clear void where legal analysis is surely needed. This Article fills this void for the inevitable case where an HIV-positive pregnant woman’s right to refuse medical treatment is …

Sex, Privacy And Public Health In A Casual Encounters Culture, Mary D. Fan

Articles

The regulation of sex and disease is a cultural and political flashpoint and recurring challenge that law's antiquated arsenal has been hard- pressed to effectively address. Compelling data demonstrate the need for attention—for example, one in four women aged fourteen to nineteen is infected with at least one sexually transmitted disease ("STD"); managing STDs costs an estimated $15.9 billion annually; and syphilis, once near eradication, is on the rise again, as are the rates of HIV diagnosis among people aged fifteen to twenty-four. Public health officials on the front lines have called for paradigm changes to tackle the enormous challenge. …

Off-Label Promotion Reform: A Legislative Proposal Addressing Vulnerable Patient Drug Access And Limiting Inappropriate Pharmaceutical Marketing, Tim Mackey, Bryan A. Liang

University of Michigan Journal of Law Reform

Off-label promotion occurs when pharmaceutical manufacturers engage in promotion of unapproved or "off-label" uses of their drugs. These off label uses may lack adequate clinical data to substantiate marketing claims, have led to corporate investigations and penalties, and can endanger public health. However there is adequate evidence to suggest that off-label uses are entirely appropriate for some vulnerable patient populations, and that physicians have accepted such uses as standard. Historically, U.S. law has prohibited direct off-label promotion to physicians and patients. However, failed government guidance, industry-based litigation, and the diminished capacity of regulators to police illegal practices have had dire …

Apologies In The Healthcare System: From Clinical Medicine To Public Health, Michal Alberstein, Nadav Davidovitch

Law and Contemporary Problems

Alberstein and Davidovitch explore the role of apologies in healthcare systems from a broader perspective. The significance of apology in terms of social solidarity is addressed and the ways in which each apology situation entails a clash between cultural identities are demonstrated. The debate on apology is explored by presenting a public health perspective of apologies following collective traumatic events such as the application of sterilization laws or flawed human experimentations in various settings.

Transplant Candidates And Substance Use: Adopting Rational Health Policy For Resource Allocation, Erin Minelli, Bryan A. Liang

University of Michigan Journal of Law Reform

Organ transplant candidates are often denied life saving organs on account of their medical marijuana drug use. Individuals who smoke medicinal marijuana are typically classified as substance abusers, and ultimately deemed ineligible for transplantation, despite their receipt of the drug under a physician's supervision and prescription. However, patients who smoke cigarettes or engage in excessive alcohol consumption are routinely considered for placement on the national organ transplant waiting list. Transplant facilities have the freedom to regulate patient selection criteria with minimal oversight. As a result, the current organ allocation system in the United States is rife with inconsistencies and results …

Sex And Hiv Disclosure, Aziza Ahmed, Beri Hull

Faculty Scholarship

What do you consent to when you have sex with someone? What if the person is a new sexual partner from a night at a bar? What if the person is your spouse or long-term partner? In these two scenarios, people might understand both HIV risk and HIV disclosure differently. Close reflection demonstrates that a purportedly clear set of criminal laws rarely reflects the complexity of sexual interaction.

This article explores how the dynamics of HIV disclosure prior to sex contribute to an ongoing dialogue about disclosure and consent: Does a person have a right to know his or her …

It's In Our Blood: A Critique Of The Fda's Reluctance To Regulate The Use Of Bisphenol A In The Food Supply, Ryan J. Carra

Journal of Health Care Law and Policy

No abstract provided.

Reforming Public Interest Tort Law To Redress Public Health Epidemics, Michael L. Rustad, Thomas H. Koenig

Journal of Health Care Law and Policy

No abstract provided.

Lessons From U.S. Trade With China: How To Use The World Trade Organization To Promote Public Health In Trade Relations With India, Lindsey Mccurdy

Journal of Health Care Law and Policy

No abstract provided.

Ppaca And Public Health: Creating A Framework To Focus On Prevention And Wellness And Improve The Public's Health, Gwendolyn R. Majette

Law Faculty Articles and Essays

On March 23, 2010, President Obama signed the Patient Protection and Affordable Care Act (PPACA), a major piece of health care reform legislation.This comprehensive legislation includes provisions that focus on prevention, wellness, and public health. Some, including authors in this symposium, question whether Congress considered public health, prevention, and wellness issues as mere afterthoughts in the creation of PPACA. As this article amply demonstrates, they did not.This article documents the extent of congressional consideration on public health issues based on personal experience working on the framework for health care reform--specifically, my experience as a Fellow for a member of the …

In Re Miguel M., Jonathan Weinstein

NYLS Law Review

No abstract provided.

Biosafety Concerns Involving Genetically Modified Mosquitoes To Combat Malaria And Dengue In Developing Countries, Graciela R. Ostera, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Malaria and dengue are the most prevalent mosquito-borne infections worldwide. Because traditional vector control methods have proven to be insufficient to control mosquito populations in endemic areas, scientists are actively working in the design of new strategies, such as genetically modified (GM) mosquitoes, to reduce disease transmission. The replacement of natural populations with GM mosquitoes is becoming a tangible possibility, however, many fear that the release of these organisms into the environment could constitute a significant risk to biodiversity and may cause the unintended spread of GM organisms across national borders.

The Cartagena Protocol on Biosafety, an international agreement originally …

Restoring Health To Health Reform: Integrating Medicine And Public Health To Advance The Population's Wellbeing, Lawrence O. Gostin, Peter D. Jacobson, Katherine L. Record, Lorian E. Hardcastle

Georgetown Law Faculty Publications and Other Works

The Patient Protection and Affordable Care Act is a major achievement in improving access to health care services.  However, evidence indicates that the nation could achieve greater improvements in health outcomes, at a lower cost, by shifting its focus to public health.  By focusing nearly exclusively on health care, policy makers have chronically starved public health of adequate and stable funding and political support.  The lack of support for public health is exacerbated by the fact that health care and public health are generally conceptualized, organized, and funded as two separate systems.  In order to maximize gains in health status …

Reforming The World Health Organization, Devi Sridhar, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Director-General Margaret Chan recently called the WHO overextended and unable to respond with speed and agility to today’s global health challenges. Given the importance of global health cooperation, few would dispute that a stronger, more effective WHO would benefit all. In this commentary, we offer 5 proposals for re-establishing WHO’s leadership.
 
(1) Give Real Voice to Multiple Stakeholders
The WHO would be more effective by giving real voice and representation to key stakeholders, including philanthropies, businesses, public/private partnerships, and civil society. Meaningful stakeholder engagement would instill confidence, and spark investment, in the agency.
 
(2) Improve Transparency, Performance and Accountability
Stakeholders …

Ethical Allocation Of Preexposure Hiv Prophylaxis, Lawrence O. Gostin, Susan C. Kim

Georgetown Law Faculty Publications and Other Works

Civil society-led movements transformed global AIDS action from deep skepticism about extending anti-retroviral (ARV) treatment in low and middle-income countries to an historic scaling up of treatment towards universal access. The AIDS movement, however, is at an inflection point due to the interplay of key health and economic determinants—the global financial downturn, tight foreign aid budgets, and intense resource competition. Policy makers will now have to consider implementation of a new intervention—pre-exposure prophylaxis (PrEP), which could mean a diversion of ARVs from treatment to prevention. The principle underlying PrEP is that ARVs could prevent HIV infection among people who are …

The Virginia Gardasil Law: A Constitutional Analysis Of Mandated Protection For Schoolchildren Against The Human Papillomavirus, Christina O. Hud

Washington and Lee Journal of Civil Rights and Social Justice

No abstract provided.

Keeping Prevention In The Crosshairs: A Better Hiv Exposure Law For Maryland, Sara Klemm

Journal of Health Care Law and Policy

No abstract provided.

The Control Of Counterfeit Medicine In Malaysia By Pharmaceutical Enforcement Division., Noraimi Ngarip

Student Works (2010-2019)

This research provided an overview of the control of counterfeit medicine in Malaysia Counterfeit medicine is a major concern due to its impact on the public health, healthcare system, economics and the country at large. This study outlined and described existing methods to curb counterfeit medicine in Malaysia as employed by the Pharmaceutical Enforcement Division, Ministry of Health, with an evaluation of current responses towards counterfeit medicine and suggestions of suitable improvements in the methods of preventing availability of counterfeit medicines. Library-based research and semi-structured interviews were conducted to collect all relevant information during the research. This study revealed a …

The Legal Ecology Of Resistance: The Role Of Antibiotic Resistance In Pharmaceutical Innovation, Kevin Outterson

Faculty Scholarship

Antibiotic effectiveness is a common pool resource that can be prematurely depleted through resistance. Some experts warn that we may face a global ecological collapse in antibiotic effectiveness. Conventional wisdom argues for more intellectual property rights to speed the creation of new antibiotics. Recent theoretical literature suggests that conservation-based approaches may yield superior results. This Article describes a novel typology for organizing these emerging theories, and provides an early empirical test of these models, using proprietary data on the sales of vancomycin, an important hospital antibiotic for the last three decades.

The results challenge the assumptions in several models, and …