Health Law and Policy Commons^™

The Rutabaga That Ate Pittsburgh: Federal Regulation Of Free Release Biotechnology, Michael P. Vandenbergh

Michael Vandenbergh

When the Environmental Protection Agency (EPA) first approved a field test of a bioengineered microbe,' one EPA official remarked: "We're not expecting this to be the rutabaga that eats Pittsburgh.' 2 But regulators cannot afford to be wrong. Bioengineered microbes may serve many useful purposes, but they may also cause harm to the environment and to human health.3 Although the risks of an accident stemming from the deliberate release of bioengineered microbes into the environment may be low, the resulting damage could be substantial. This note examines the possible consequences of two recent trends in biotechnology-the development of bioengineered microbes …

Hospital Mergers And Public Accountability: Tennessee And Virginia Employ A Certificate Of Public Advantage, Erin C. Fuse Brown

Erin C. Fuse Brown

No abstract provided.

Learning From California’S Experience With Small Water System Consolidations: A Workshop Synthesis, Nell Green Nylen, Camille Pannu, Michael Kiparsky

Nell Green Nylen

California recognizes a human right to safe, affordable drinking water. However, small and disadvantaged communities can find it especially challenging to fund the water systems necessary to achieve this goal. Small water systems are responsible for the bulk of the state’s drinking water quality violations, and an estimated 300 disadvantaged communities in California are served by systems that fail to meet state drinking water standards.

Water system consolidations can create economies of scale that help address persistent water system inadequacies in small and disadvantaged communities. More than 100 consolidation projects have been completed or are ongoing in California, and many …

Avoiding Prolonged Dementia, Norman L. Cantor

Norman Cantor

הורות משפטית מן הדין ומן הצדק - Legal Parenthood - Law And Justice, Yehezkel Margalit

Hezi Margalit

The Drug Debate: Data Exclusivity Is The New Way To Delay Generics, Srividhya Ragavan

Srividhya Ragavan

The article discusses the protection regime for clinical trial data internationally and outlines the applicable protection regime. In doing so, this article outlines how the data exclusivity regime can operate in parallel with the patent regime to add a layer of protection for the data. Such protection operates at a regulatory level to delay the entry of generic medications. Internationally, the data exclusivity regime, which has become an important contemporary tool in trade negotiations with poorer nations, works to detrimentally affect access to medication

Khachaturova V. Rourke - Dismissal Of Injunction.Pdf

Khachaturova V. Rourke - Dismissal of Injunction

Fda Flip-Flops On Antibiotic Hazard, David A. Wirth

David A. Wirth

No abstract provided.

Fda On Food Additives And Salt, David A. Wirth

David A. Wirth

No abstract provided.

Alienage Classifications And The Denial Of Health Care To Dreamers, Fatma E. Marouf

Fatma Marouf

In the Affordable Care Act (“ACA”), passed in 2010, Congress provided that only “lawfully present” individuals could obtain insurance through the Marketplaces established under the Act. Congress left it to the Department of Health and Human Services (“HHS”) to define who is “lawfully present.” Initially, HHS included all individuals with deferred action status, which is an authorized period of stay but not a legal status. After President Obama announced a new policy of Deferred Action for Childhood Arrivals (“DACA”) in June 2012, however, HHS amended its regulation specifically to exclude DACA recipients from the definition of “lawfully present.” The revised …

Marijuana Agriculture Law: Regulation At The Root Of An Industry, Ryan Stoa

Ryan B. Stoa

Marijuana legalization is sweeping the nation. Recreational marijuana use is legal in eight states. Medical marijuana use is legal in thirteen states. Only three states maintain an absolute criminal prohibition on marijuana use. Many of these legalization initiatives propose to regulate marijuana in a manner similar to alcohol, and many titles are variations of the "Regulate Marijuana Like Alcohol Act." For political and public health reasons the analogy makes sense, but it also reveals a regulatory blind spot. States may be using alcohol as a model for regulating the distribution, retail, and consumption of marijuana, but marijuana is much more …

Comparative Cannabis: Approaches To Marijuana Agriculture Regulation In The United States And Canada, Ryan Stoa

Ryan B. Stoa

The United States and Canada may be friends and allies, but the two countries' approaches to the regulation of marijuana agriculture have not evolved in tandem. On the contrary, their respective paths toward legalization and regulation of marijuana agriculture are remarkably divergent. In the United States, where marijuana remains a federally prohibited and tightly-controlled substance, legalization and regulation have remained the province of state legislatures and their administrative agencies for decades. In Canada, a succession of court cases paving the way toward medicinal marijuana use has prompted the federal government to develop a national framework committed to "legalize, regulate, and …

Modernizing The Emergency Medical Treatment And Labor Act To Harmonize With The Affordable Care Act To Improve Equality, Quality And Cost Of Emergency Care, Katharine A. Van Tassel

Katharine Van Tassel

This Article will propose a very simple, two-step way to modernize EMTALA [Emergency Medical Treatment and Active Labor Act (1986)] to deal with this cascade of problems. This solution converts EMTALA into a powerful tool to enhance equal access to healthcare while at the same time changing EMTALA so that it works in tandem with, instead of against, the efforts of the Affordable Care Act, Medicare and Medicaid to improve healthcare quality, cost and equal access.

This solution also works across systems to resolve the conflict between the tort, licensure and hospital peer review systems that all discourage evidence-based treatment …

The Growing Consumer Exposure To Nanotechnology In Everyday Products: Regulating Innovative Technologies In Light Of Lessons From The Past, Katharine Van Tassel

Katharine Van Tassel

This Article discusses the public health, regulatory, legal, and ethical issues raised by the developing appreciation of the negative physical effects and potential health risks associated with nanotech products, and is arranged as follows. After this Introduction, this Article describes the present scientific understanding of the health risks associated with the consumption of nanoparticles. Next, a summary of the existing FDA regulatory structure that governs food, dietary supplements, cosmetics, and sunscreens is provided along with an explanation of why these regulations fail to protect public health when applied to regulate the nanotech versions of these products. The Article goes on …

Harmonizing The Affordable Care Act With The Three Main National Systems For Healthcare Quality Improvement: The Tort, Licensure, And Hospital Peer Review Hearing Systems, Katharine Van Tassel

Katharine Van Tassel

.. [W]hile the ACA [Affordable Care Act] has at least some provisions addressing the need to make changes in the medical malpractice and licensure systems to encourage the use of evidence-based standards of care, the ACA completely ignores the hospital peer review system. This article makes specific suggestions for how to revise all three major systems [the tort, licensure, and hospital peer review] so that they can work in tandem with federal law to encourage physicians to adopt [an] evidence-based model of medical practice in order to improve healthcare quality, cost, and access. This article starts by explaining the difference …

Genetically Modified Plants Used For Food, Risk Assessment And Uncertainty Principles: Does The Transition From Ignorance To Indeterminacy Trigger The Need For Post-Market Surveillance?, Katharine Van Tassel

Katharine Van Tassel

In the context of GM foods, a genetic modification changes the biochemical cross-talk between genes, creating genetic material that has never existed before in nature. This novel genetic material can create unintended health risks, as seen with the case of the GM peas that contained a novel and unexpected allergenic protein and primed test mice to react to other allergens.6 The bottom line is that the scientific acceptance of the existence of the networked gene establishes that the FDA’s presumption that GM plant food is bioequivalent to traditional plant food is no longer scientifically supportable and that a new system …

Using Clinical Practice Guidelines And Knowledge Translation Theory To Cure The Negative Impact Of The National Hospital Peer Review Hearing System On Healthcare Quality, Cost, And Access, Katharine Van Tassel

Katharine Van Tassel

This Article starts with a history of the growth of hospital peer review and then examines the merits of the rationales that motivated the passage of the Health Care Quality Improvement Act of 1986 ('HCQIA'), which catapulted peer review into the national system that exists today. The Article next explains how the peer review hearing process works and how HCQIA turns private hospitals into small, individual quasi-regulatory agencies. The Article goes on to critique the 'bad apples' approach taken by hospital peer review in light of the growing body of empirical research that supports a systems improvement approach to dealing …

Hospital Peer Review Standards And Due Process: Moving From Tort Doctrine Toward Contract Principles Based On Clinical Practice Guidelines, Katharine A. Van Tassel

Katharine Van Tassel

This Article proposes a solution to the problems associated with the current use of vague standards in peer review. This Article will examine the proposal that medical staffs switch from ad hoc judicial decision-making to rule-making. This switch will allow medical staffs to abandon the troublesome practice of applying vague 'standard of care' measures ex post facto. In its stead, express contractual terminology could be adopted, such as 'expectations of performance,' which incorporates specifically chosen and uniquely tailored clinical practice guidelines ('CPGs') directly into the medical staff by-laws. Describing the expectations of physician performance in express contractual terms enables physicians …

Regulating In Uncertainty: Animating The Public Health Product Safety Net To Capture Consumer Products Regulated By The Fda That Use Innovative Technologies, Including Nanotechnologies, Genetic Modification, Cloning, And Lab Grown Meat, Katharine A. Van Tassel

Katharine Van Tassel

This Article will use nanotechnology as an example that highlights how regulation based on novelty rather than hazard achieves the proper balance between protecting public health while encouraging innovation through the animation of the public health product safety net. In Part II, this Article starts by explaining what nanotechnology is and the remarkable growth of its use in everyday consumer products. It then summarizes the steadily increasing number of studies that suggest that there are likely to be serious health risks associated with the use of nanotech consumer products. Next, it explains how the FDA [Food and Drug Administration] is …

The Introduction Of Biotech Foods To The Tort System: Creating A New Duty To Identify, Katharine Van Tassel

Katharine Van Tassel

This Article examines the question of whether an unsuspecting consumer who dies from an allergic or toxic reaction to an undisclosed biotech ingredient in food can recover damages through the tort system. The surprising answer is that recovery is very unlikely. This Article outlines why this is the case, then evaluates the merits of several potential solutions to this problem including the possible creation of a common law 'duty to identify' biotech ingredients in food.

This Article is arranged as follows. First, a brief primer on the nature of biotech foods is provided. For the reader unfamiliar with the regulatory …

Intellectual Property And Public Health: A White Paper, Katharine A. Van Tassel

Katharine Van Tassel

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions. Led by the moderator, participants at the Forum focused generally on three broad …

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, Jim Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Kathy Strandburg, Kara Swanson, Andrew Torrance, Katharine Van Tassel

Katharine Van Tassel

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …

Intellectual Property And Public Health - A White Paper, Ryan Vacca, James Ming Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Katherine J. Strandburg, Kara W. Swanson, Andrew W. Torrance, Katharine Van Tassel

Katharine Van Tassel

On October 26, 2012, The University of Akron School of Law's Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants, and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …

Special International Zones In Practice And Theory, Tom W. Bell

Tom W. Bell