Health Law and Policy Commons^™

The Power To Block The Affordable Care Act: What Are The Limits?, John D. Kraemer, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Though Supreme Court upheld most parts of the Affordable Care Act (ACA), Congress’ goals in enacting it could still be frustrated by non-implementation. During his campaign for president, Governor Romney promised “to issue Obamacare waivers to all fifty states.” While such blanket waivers would likely violate the Constitution’s Take Care Clause, the ACA does permit other waivers. To be lawful, however, they must meet certain requirements designed to enhance access and lower cost. A president who opposes the ACA might be able to limit its implementation by refusing to issue premium subsidies in federally operated insurance exchanges, and this might …

Emergency Preparedness And Public Health: The Lessons Of Hurricane Sandy, Tia Powell, Dan Hanfling, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

When Hurricane Sandy hit downtown Manhattan, three neighboring hospitals each made different decisions about when to evacuate. Across the metro region, more than five hospitals and over 20 nursing and assisted living facilities were evacuated, making this the central public health challenge of this calamitous event. It is a familiar story—a super storm comes ashore, infrastructure is overwhelmed, and healthcare facilities evacuate patients, with major delays in returning to normal functioning. Afterwards, policy makers evaluate lessons learned for the next disaster, but similar missteps are often repeated.

Although not identical, it is instructive to compare Hurricane Katrina with the still …

Reducing Unlawful Prescription Drug Promotion: Is The Public Health Being Served By An Enforcement Approach That Focuses On Punishment?, Vicki W. Girard

Georgetown Law Faculty Publications and Other Works

Despite the imposition of increasingly substantial fines and recently successful efforts to impose individual liability on corporate executives under the Park doctrine, punishing pharmaceutical companies and their executives for unlawful promotional activities has not been as successful in achieving compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) as the protection of the public health demands. Over the past decade, the Food and Drug Administration (FDA) and the Department of Justice (DOJ) have shifted their focus from correction and compliance to a more punitive model when it comes to allegedly unlawful promotion of pharmaceuticals. The shift initially focused …

What’S Right About The Medical Model In Human Subjects Research Regulation, Heidi Li Feldman

Georgetown Law Faculty Publications and Other Works

Critics of Institutional Review Board (IRB) practices often base their charges on the claim that IRB review began with and is premised upon a "medical model" of research, and hence a "medical model" of risk. Based on this claim, they charge that IRB review, especially in the social and behavioral sciences, has experienced "mission creep". This paper argues that this line of critique is fundamentally misguided. While it remains unclear what critics mean by "medical model", the point of contemporary human research subjects regulation remains the same across all domains of research. That point is to protect the autonomy of …

Ethical Challenges Of Preexposure Prophylaxis For Hiv, Jonathan S. Jay, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

On July 16, 2012, emtricitabine/tenofovir (Truvada) became the first drug approved by the US Food and Drug Administration for preexposure prophylaxis (PrEP) of human immunodeficiency virus (HIV) for adults at high risk. While PrEP appears highly effective with consistent adherence, effective implementation poses ethical challenges for the medical and public health community. For PrEP users, it is necessary to maintain adherence, safe sex practices, and routine HIV testing and medical monitoring, to maximize benefits and reduce risks. On a population level, comparative cost-effectiveness should guide priority-setting, while safety measures must address drug resistance concerns without burdening patients' access. Equitable distribution …

Justice Roberts’ America, Robin West

Georgetown Law Faculty Publications and Other Works

Less than a week after the Roberts Court issued its decision in National Federation of Independent Business v Sebelius, Jeffrey Toobin, writing in The New Yorker, compared the first part of Chief Justice John Roberts's opinion, in which he found that the Commerce Clause did not authorize Congress to enact the "individual mandate" section of the Affordable Care Act (ACA) that requires all individuals to buy health insurance, with an Ayn Rand screed, noting that the pivotal sections of the argument were long on libertarian rhetoric but short on citations of authority. Roberts held (although "held" might be …

Bridging International Law And Rights-Based Litigation: Mapping Health-Related Rights Through The Development Of The Global Health And Human Rights Database, Benjamin Mason Meier, Oscar A. Cabrera, Ana Ayala, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

The O'Neill Institute for National and Global Health Law at Georgetown University, the World Health Organization, and the Lawyers Collective have come together to develop a searchable Global Health and Human Rights Database that maps the intersection of health and human rights in judgments, international and regional instruments, and national constitutions. Where states long remained unaccountable for violations of health-related human rights, litigation has arisen as a central mechanism in an expanding movement to create rights-based accountability. Facilitated by the incorporation of international human rights standards in national law, this judicial enforcement has supported the implementation of rights-based claims, giving …

Pillars For Progress On The Right To Health: Harnessing The Potential Of Human Rights Through A Framework Convention On Global Health, Eric A. Friedman, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Ever more constitutions incorporate the right to health, courts continue to expand their right to health jurisprudence, and communities and civil society increasingly turn to the right to health in their advocacy. Yet the right remains far from being realized. Even with steady progress on numerous fronts of global health, vast inequities at the global and national levels persist, and are responsible for millions of deaths annually. We propose a four-part approach to accelerating progress towards fulfilling the right to health: 1) national legal and policy reform, incorporating right to health obligations and principles including equity, participation, and accountability in …

Global Health Justice: A Perspective From The Global South On A Framework Convention On Global Health, Lawrence O. Gostin, Ames Dhai

Georgetown Law Faculty Publications and Other Works

A global coalition of civil society and academics recently launched the Joint Action and Learning Initiative on National and Global Responsibilities for Health (JALI), which is developing a post-Millennium Development Goal (MDG) framework for global health. JALI’s mission is the achievement of a global health treaty based on the right to health—a Framework Convention on Global Health (FCGH). The FCGH proposes establishing fair terms of international co-operation, with agreed-upon mutually binding obligations to create enduring health system capacities, meet basic survival needs, and reduce unconscionable inequalities in global health. States that bear a disproportionate burden of disease have the least …

A Framework Convention On Global Health: Health For All, Justice For All, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Health inequalities represent perhaps the most consequential global health challenge and yet they persist despite increased funding and innovative programs. The United Nations is revising the Millennium Development Goals (MDGs) that will shape the world for many years to come. What would a transformative post-MDG framework for global health justice look like? A global coalition of civil society and academics—the Joint Action and Learning Initiative on National and Global Responsibilities for Health (JALI)—has formed an international campaign to advocate for a Framework Convention on Global Health (FCGH). Recently endorsed by the UN Secretary-General, the FCGH would reimagine global governance for …

Affordable Care Act Litigation: The Supreme Court And The Future Of Health Care Reform, Lawrence O. Gostin, Kelli K. Garcia

Georgetown Law Faculty Publications and Other Works

In Florida v. HHS, a lawsuit brought on behalf of 26 states challenging the constitutionality of the Patient Protection and Affordable Care Act (ACA), the Supreme Court will determine the future direction of health care reform in the United States. During the unprecedented 5-1/2 hours of oral arguments, the Court will hear 4 issues: the individual purchase mandate, severability, the Medicaid expansion and the Anti-Injunction Act.

The states challenging the ACA maintain that the purchase mandate uniquely penalizes individuals for failing to purchase insurance. Uninsured individuals, however, rarely do nothing. Instead, they self-insure, rely on family, and cost-shift to …

Marketing Pharmaceuticals: A Constitutional Right To Sell Prescriber-Identified Data?, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Pharmaceutical companies have strong economic interests in influencing physician-prescribing behaviors. They advertise direct-to-the-consumer and to the physician. Beyond general marketing, manufacturers promote their drugs to physicians through “detailing”—sales representatives (“detailers”) visiting medical offices to persuade physicians to prescribe their products.

By law, pharmacies receive specific information with every prescription, including the physician’s name, the drug, and the dose. Pharmacies sell these records to Prescription Drug Intermediaries (data miners), who use advanced computing to analyze prescriber-identified information (which physicians prescribe what drugs, in what dose, and with what prescribing patterns). Data miners, in turn, lease sophisticated reports to pharmaceutical companies to …

The Limits Of Government Regulation Of Science, John D. Kraemer, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

The recent controversy over the National Science Advisory Board for Biosecurity’s (NSABB) request that Science and Nature redact key parts of two papers on transmissible avian (H5N1) influenza reveal a troubled relationship between science and security. While NSABB’s request does not violate the First Amendment, efforts to censor the scientific press by force of law would usually be an unconstitutional prior restraint of the press absent a compelling state interest. The constitutional validity of conditions on grant funding to require pre-publication review of unclassified research is unclear but also arguably unconstitutional.

The clearest case where government may restrict publication is …

Health Care And The Illegal Immigrant, Patrick J. Glen

Georgetown Law Faculty Publications and Other Works

The question of whether illegal immigrants should be entitled to some form of health coverage in the United States sits at the uneasy intersection of two contentious debates: health reform and immigration reform. Befitting this place, the rhetoric surrounding the issue has been exponentially heightened by the multiplying effects of combining two vitriolic debates. On one side, it is argued that the United States has a moral obligation to provide health care to all those within its borders needing such assistance. On the other, it is argued with equal force that those illegally present in this country should not be …

The Fda, Preemption, And Public Safety: Antiregulatory Effects And Maddening Inconsistency, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Most people think of preemption as a technical constitutional doctrine, but it is pivotally important to health and safety, while also opening the door to broad judicial discretion. The Rehnquist and Roberts Courts’ pro-business/pro-preemption jurisprudence is distinctly antiregulatory, invalidating major state public health rules, such as in occupational safety, tobacco control, and motor vehicle safety. Apart from the antiregulatory effects, there is maddening inconsistency. Consider three relatively recent Supreme Court cases. In Riegel v. Medtronic, Inc. (2008), the Court held that federal law bars injured consumers from challenging the safety or effectiveness of FDA-approved medical devices. A year later, …

Mandatory Hpv Vaccination And Political Debate, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Vaccinations are among the most cost-effective and widely used public health interventions, but have provoked popular resistance, with compulsion framed as an unwarranted state interference. When the FDA approved a human papillomavirus (HPV) vaccine in 2006, conservative religious groups strongly opposed a mandate, arguing it would condone pre-marital sex, undermine parental rights, and violate bodily integrity. Yet, Governor Rick Perry signed an executive order in 2007 making Texas the first state to enact a mandate — later revoked by the legislature.

Mandatory HPV vaccination reached the heights of presidential politics in a recent Republican debate. Calling the vaccine a "very …

Who’S Pandemic Influenza Preparedness Framework: A Milestone In Global Governance For Health, Lawrence O. Gostin, David P. Fidler

Georgetown Law Faculty Publications and Other Works

In May 2008, the World Health Organization (WHO) adopted the Pandemic Influenza Preparedness Framework for the Sharing of Influenza Viruses and Access to Vaccines and Other Benefits (PIP Framework). The PIP Framework’s adoption ended years of difficult negotiations, which began after Indonesia refused to share samples of avian influenza A (H5N1) with WHO in late 2006. Indonesia justified its actions on the need to create more equitable access for developing countries to benefits, such as vaccines and antivirals, derived from research and development on shared influenza virus samples. The global health community feared that failure to share influenza virus samples …

Food And Drug Administration Regulation Of Food Safety, Lawrence O. Gostin, Katie F. Stewart

Georgetown Law Faculty Publications and Other Works

Food-borne illness remains a major public health challenge in the United States, causing an estimated 48 million illness episodes and 3000 deaths annually. The FDA Food Safety Modernization Act (FSMA), enacted in 2011, gives the Food and Drug Administration (FDA) new tools to regulate food safety. The act emphasizes prevention, enhanced recall authority, and oversight of imported food.

The FSMA brings the FDA’s food safety regulation in line with core tenets of public health by focusing on preventing outbreaks, rather than reacting to them, and differentiating between foods and food producers based on the degree of risk they pose. The …

Dangerous People Or Dangerous Weapons: Access To Firearms For Persons With Mental Illness, Lawrence O. Gostin, Katherine L. Record

Georgetown Law Faculty Publications and Other Works

The recent attempted assassination of Rep. Gabrielle Giffords has once again focused the nation’s attention on the danger of the wide availability of firearms.  The Supreme Court has ruled that gun restrictions may only be imposed on those deemed “prohibited persons” under the Gun Control Act of 1968.  Although some are easily identifiable (e.g., children, convicted felons), one widely inclusive group is not – the mentally ill.

The current system designed to bar the mentally ill from purchasing or possessing firearms is ineffectual due to a lack of reporting and the existence of loopholes.  What’s more, no state has developed …

Turning Citizens Into Subjects: Why The Health Insurance Mandate Is Unconstitutional, Randy E. Barnett

Georgetown Law Faculty Publications and Other Works

In 2010 something happened in this country that has never happened before: Congress required that every person enter into a contractual relationship with a private company. While the author realizes that writers make lots of factual claims that readers are wise to be skeptical about, he proves that an economic mandate like this one is unprecedented. If this mandate had ever happened before, everyone reading this passage would know all the contracts the federal government requires them to make, upon pain of a penalty enforced by the Internal Revenue Service (IRS). No reader, however, can recite any such mandate and …

Health Insurance Reform And Intimations Of Citizenship, Nan D. Hunter

Georgetown Law Faculty Publications and Other Works

This article considers the implications of the Patient Protection and Affordable Care Act (PPACA) for social meanings of civic belonging in American society and for possible new forms of individual engagement with the health care system. Once fully implemented, PPACA will have many of the governance characteristics of other social insurance systems, in that it will define membership in a collective undertaking, establish a mechanism for collective security against a shared risk, and channel, incentivize and penalize specific behaviors. The article considers the extent to which PPACA has the potential to also produce new narratives and understandings of social solidarity …

The Who Global Code Of Practice On The International Recruitment Of Health Personnel: The Evolution Of Global Health Diplomacy, Allyn L. Taylor, Ibadat S. Dhillon

Georgetown Law Faculty Publications and Other Works

The May 2010 adoption of the World Health Organization Global Code of Practice on the International Recruitment of Health Personnel created a global architecture, including ethical norms and institutional and legal arrangements, to guide international cooperation and serve as a platform for continuing dialogue on the critical problem of health worker migration. Highlighting the contribution of non-binding instruments to global health governance, this article describes the Code negotiation process from its early stages to the formal adoption of the final text of the Code. Detailed are the vigorous negotiations amongst key stakeholders, including the active role of non-governmental organizations. The …

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 …

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 …

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 …

Is Health Care Reform Unconstitutional?, David Cole

Georgetown Law Faculty Publications and Other Works

No abstract provided.

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 …

Mapping The Issues: Public Health, Law And Ethics, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

The field of public health is typically regarded as a positivistic pursuit and, undoubtedly, our understanding of the etiology and response to disease is heavily influenced by scientific inquiry. Public health policies, however, are shaped not only by science but also by ethical values, legal norms, and political oversight. Public Health Law and Ethics: A Reader (expanded and updated 2nd ed., 2010) probes and seeks to illuminate this complex interplay, through a careful selection of government reports, scholarly articles, and court cases together with discussion and analysis of critical problems at the interface of law, ethics, and public health. The …

Redressing The Unconscionable Health Gap: A Global Plan For Justice, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Consider two children—one born in sub-Saharan Africa and the other in the United States. The African child is twenty-five times more likely to die in the first five years of life; if she lives to child-bearing age, she is a two hundred times more likely to die in labor; and overall, she will die thirty years earlier than the American child. The international community is deeply resistant to taking bold remedial action—more concerned with their geostrategic interests than the health of the poor. The scale of foreign aid is both insufficient and unsustainable and fails to address the key determinants …

Health Care Reform In Transition: Incremental Insurance Reform Without An Individual Mandate, Lawrence O. Gostin, Elenora E. Connors

Georgetown Law Faculty Publications and Other Works

A major access problem exists in the private insurance market for individuals with preexisting conditions, who are either denied coverage or charged exorbitant premiums. In effect, individuals are denied coverage for exactly what they need, which jeopardizes their health and the financial security of their family. Before health reform passed, discussions surrounding incremental reform took place, including perhaps the most politically compelling – prohibiting insurers from denying coverage to those with preexisting health conditions. Insurance is based upon the principles of spreading risk of individuals across a population to ensure that everyone can afford medical care when he or she …