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Full-Text Articles in Health Law and Policy

The Power To Block The Affordable Care Act: What Are The Limits?, John D. Kraemer, Lawrence O. Gostin Nov 2012

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 ...


Emergency Preparedness And Public Health: The Lessons Of Hurricane Sandy, Tia Powell, Dan Hanfling, Lawrence O. Gostin Nov 2012

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 ...


Reducing Unlawful Prescription Drug Promotion: Is The Public Health Being Served By An Enforcement Approach That Focuses On Punishment?, Vicki W. Girard Oct 2012

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 on imposing monetary penalties and was arguably justified by the expectation that financial punishment would achieve a level of compliance that would reduce the need for correction. By exacting enormous fines from companies, the agencies presumably hoped that the costs associated with unlawful promotion would be too high to justify the monetary benefits of non-compliance. Unfortunately, however, that approach has not been entirely successful. Despite the growth in settlements and penalties, and the recent efforts to hold individual executives liable for corporate misbehavior, the intended impact of substantially increased compliance has only partially materialized. The upward spiraling of settlement amounts and the trend toward prosecuting repeat offenders indicate that a change in approach is necessary.

This article argues that FDA and DOJ cannot justify a continued emphasis on punishment without more demonstrable improvement in compliance and corporate accountability.

The article goes on to describe several proposals to refocus the agencies’ efforts to effectively address the impact of unlawful promotion on public health by returning to an approach that emphasizes the more traditional goals of correction and compliance. It also argues that any meaningful protection of the public health ultimately requires a broader public understanding of the issues surrounding unlawful promotion of pharmaceutical products and greater participation by patients; physicians; health care professionals; and others with an interest in, and the opportunity to, impact this area. Increasing the public’s ability and interest in monitoring companies’ promotional activities at every level will reinforce the benefits of compliance, which will better serve the public health goals of the FD&C Act.


What’S Right About The Medical Model In Human Subjects Research Regulation, Heidi Li Feldman Oct 2012

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 Jul 2012

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 ...


Justice Roberts’ America, Robin West Jul 2012

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 stating ...


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 Jun 2012

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 ...


Global Health Justice: A Perspective From The Global South On A Framework Convention On Global Health, Lawrence O. Gostin, Ames Dhai Jun 2012

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 ...


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 Jun 2012

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 ...


A Framework Convention On Global Health: Health For All, Justice For All, Lawrence O. Gostin May 2012

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 ...


Health Care And The Illegal Immigrant, Patrick J. Glen Jan 2012

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 Limits Of Government Regulation Of Science, John D. Kraemer, Lawrence O. Gostin Jan 2012

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 ...


Affordable Care Act Litigation: The Supreme Court And The Future Of Health Care Reform, Lawrence O. Gostin, Kelli K. Garcia Jan 2012

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 Jan 2012

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 ...