Data Safety and Monitoring Boards (DSMBs) were introduced in the 1960s to monitor data in clinical trials to ensure subject safety. It was thought important that DSMB members be experts in the field(s) of interest, but not otherwise involved in the study (e.g., sponsors and investigators) in order to maximize objectivity. Since then, the use of DSMBs has increased dramatically, and their scope has expanded to include scientific issues — in particular, to avoid bias that can result when trials are stopped early because of evidence that one treatment has greater efficacy or causes greater harm than another; or that no treatment is likely to do better than any other.

Following the widespread occurrence of birth defects from the use of thalidomide to treat nausea during pregnancy in the 1960s and 1970s, the Food and Drug Administration (FDA) became particularly vigilant about the use of therapeutic agents during pregnancy and in women of childbearing potential. The FDA developed a list that categorizes an agent according to the known (and potential unknown) risks to a fetus. The drug thalidomide falls into Category X: agents that have demonstrated clear risk of fetal abnormalities and whose risks outweigh the benefits of use during pregnancy.

Another Category X drug is isotretinoin, commonly known by its trade name Accutane. Isotretinoin is an oral medication prescribed for severe recalcitrant, nodular acne in patients who are unresponsive to conventional therapy. Isotretinoin has been available since 1982, and it remains the only effective treatment for this condition.

Despite the enormous progress made in the advancement of health technologies over the last century, infectious diseases continue to cause significant morbidity and mortality in developing countries. Neglected diseases are a subset of infectious diseases that lack treatments that are effective, simple to use, or affordable. Neglected diseases primarily affect populations in poor countries that do not constitute a lucrative market sector, thus failing to provide incentives for the pharmaceutical industry to conduct R&D for these diseases. Of the treatments that do exist for neglected diseases, most are completely out-dated, with poor side-effect profiles, cumbersome logistics of administration, and inadequate efficacy. Historically, the impetus for a majority of neglected disease research was driven by early 20th-century colonialism, and in the post-colonial era, these diseases have been virtually ignored. Of the 1556 New Chemical Entities (NCEs) brought to market during the 30-year period from 1975 to 2004, only 20 — less than 0.02% — were for neglected diseases.

This paper is one of four interrelated papers resulting from the National Summit on Legal Preparedness for Obesity Prevention and Control (Summit) convened in June 2008 by the Centers for Disease Control and Prevention (CDC), the Robert Wood Johnson Foundation, and the American Society of Law, Medicine, Ethics. Each of the papers deals with one of the four core elements of legal preparedness: (1) laws and legal authorities for public health practitioners; (2) legal competencies public health practitioners and legal and policy decision makers need for use of these laws and authorities; (3) crossdisciplinary and cross-jurisdiction coordination of law-based public health actions; and (4) information on public health law best practices. Collectively, they are referenced as the “white papers.”

Our purpose is to offer action options that will help to improve the legal competencies of public health practitioners and policy decision makers with respect to drafting, interpreting.

Devising appropriate oversight for nanotechnology is a challenge. The field spans many scientific disciplines and product areas, capitalizing on the unusual properties and capabilities of material at the atomic scale. The critical feature of nanotechnology is not only the size at which manufacture occurs (˜1-100 nanometers), but also the ability to control and manipulate the novel chemical, physical, and mechanical properties that emerge at this scale, including increased conductivity, optical properties, and reactivity. As nano-products enter the research and development (R&D) phase, hit the market, and enter consumer households, debate has emerged on oversight approaches. Regulators, manufacturers, and commentators are considering whether existing oversight systems are sufficient, those oversight systems need adjustment, or new oversight systems are needed.

The pre-emption doctrine as applied to food and drug law argues that manufacturers whose products gain Food and Drug Administration (FDA) marketing approval are immune from tort liability in state court solely on the basis of their FDA approval. This pre-emption protection applies both to claims of direct damages caused by the product and as well as indirect (failure to warn/labeling) damages claims.

The recent 8-1 U.S. Supreme Court decision in Riegel v. Medtronic, Inc. upheld the manufacturer’s contention that the pre-emption provision in the 1976 Medical Device Amendments of 1976 (MDA) to the 1938 Federal Food, Drug and Cosmetic Act (FDCA) completely precluded civil damages suits by injured plaintiffs in state court. Justice Ginsburg was the lone dissenter.

This paper is the companion to the “Assessment of Coordination of Legal-Based Efforts across Jurisdictions and Sectors for Obesity Prevention and Control” paper, and the third of four papers outlining action options that policymakers can consider as discussed as part of the National Summit on Legal Preparedness for Obesity Prevention and Control. The goal of this paper is to identify potential action and policy strategies related to coordination across jurisdictions and sectors that can be adopted by policymakers and implemented by practitioners to address the obesity epidemic. The paper examines collaboration among four sectors — community agencies and organizations (with a special focus on enhancing the built environment), schools, health care institutions, and workplaces — and examines collaboration from both vertical and horizontal perspectives. Additionally, the paper is structured around three legal themes — which are posed as questions — to frame the policy action discussion:

Over the past decades the mortality rate in the United States has decreased and life expectancy has increased. Yet a number of recent studies have drawn Americans attention to the fact that racial and ethnic disparities persist in health care. It is clear that the U.S. health care system is not only flawed for many reasons including basic injustices, but may be the cause of both injury and death for members of racial and ethnic minorities.

In 2002, an Institute of Medicine (IOM) report requested by Congress listed more than 100 studies documenting a wide range of disparities in the United States health care system. This report found that people belonging to racial and ethnic minorities often receive lower quality of health care than do people of European descent, even when their medical insurance coverage and income levels are the same as that of the latter.

The Human Papillomavirus (HPV) vaccine burst onto the market and the legislative scene nearly simultaneously. Marketed as an amazing medical breakthrough, the vaccine GARDASIL prevents infection with four strains of Human Papillomavirus in nave populations; these four strains are responsible for 70% of cervical cancers and 90% of genital warts. Although most agreed that the vaccine was a wonderful medical advancement with the potential to save women's lives, there was strong disagreement about and a vocal public response to legislative attempts to require girls to receive HPV vaccines for school attendance.

The strong public response to HPV vaccine mandates partially stemmed from the sense that this vaccine is different from previously mandated vaccines because it attempts to prevent disease whose sole route of transmission is through sexual contact. Most other diseases covered by mandated vaccines are spread through the air, with little an individual can do in altering their behavior to prevent infection.

Medicalized Death and the Right to Die Movement Prior to the 20th Century, most Americans died at home, surrounded by family, friends, and neighbors. Religion, not medicine, governed the death bed for there was little physicians could do for the dying. Eventually, however, advances in medicine and technology would lead to dramatic changes in the timing and location of death: patients not only began living longer, they were also dying longer, and unlike their predecessors, were more likely to die alone, in institutions, and among strangers. Modern medicine, in its zeal to conquer death, had become obsessed with its curative function and ability to extend the lives of the dying. To many in the medical community, death represented failure and was something to be avoided at all costs, and like many other social problems in the United States, had become medicalized.

This paper is the companion to “Assessment of Information on Public Health Law Best Practices for Obesity Prevention and Control,” and the fourth of four action papers produced as part of the National Summit on Legal Preparedness for Obesity Prevention and Control, convened June 2008 by the Centers for Disease Control and Prevention, the Robert Wood Johnson Foundation, and the American Society for Law, Medicine Ethics. The four action papers present options to address gaps in the four core elements of public health legal preparedness as outlined in the relevant companion papers. The four core elements are: (1) laws and legal authorities; (2) legal competencies for public health professionals to apply those laws and authorities; (3) coordination of law-based efforts across jurisdictions and sectors, and (4) information on public health law best practices.

How should we oversee new and emerging technologies and their products? What lessons can we discern from existing regulatory examples and from past mistakes? How do these lessons learned translate into informed recommendations for adequate oversight for nanotechnology to avoid repeating the mistakes of the past? The investigators of this interdisciplinary project undertook this endeavor intending to answer these questions among others.

In parallel with the project team putting together this symposium, another, very different process on the oversight of nanotechnology took place. An international coalition of non-governmental organizations (NGOs) formed to address the nanotech policy dialogue. The first goal of this NGO group was to agree upon and draft fundamental principles of oversight, which it completed in 2007-08. These principles close with a call for their adoption and/or internalization by all relevant actors and bodies. In effect, they serve a function in the policy dialogue similar to that of this project’s forthcoming recommendations.

During the last 115 years, the National Conference of Commissioners of Uniform State Laws (NCCUSL) has promulgated more than 300 uniform or model acts. These acts have been drafted to produce uniformity among state laws, and to provide clarity and stability in critical areas of the law. Uniform Anatomical Gift Acts were promulgated in 1968 and again in 1987. The third and most recent revision of the Act was promulgated in 2006 and amended in 2007. This act (UAGA 2006) was placed on NCCUSL’s target list; that is, commissioners were asked to make its enactment a priority in their home states. In 2007, 20 states enacted UAGA 2006; by mid-2008, UAGA 2006 had been introduced or enacted in over a dozen more states and the District of Columbia. NCCUSL’s goal for UAGA 2006 is enactment in all states by 2009.

Nanotechnology is the latest in a growing list of emerging technologies that includes nuclear technologies, genetics, reproductive biology, biotechnology, information technology, robotics, communication technologies, surveillance technologies, synthetic biology, and neuroscience. As was the case for many of the technologies that came before, a key question facing nanotechnology is what type of regulatory oversight is appropriate for this emerging technology. As two of us wrote several years ago, the question facing nanotechnology is not whether it will be regulated, but when and how.

Yet, appropriate regulation of nanotechnology will be challenging. The term “nanotechnology” incorporates a broad, diverse range of materials, technologies, and products, with an even greater spectrum of potential risks and benefits. This technology slashes across the jurisdiction of many existing regulatory statutes and regulatory agencies, and does so across the globe. Nanotechnology is developing at an enormously rapid rate, perhaps surpassing the capability of any potential regulatory framework to keep pace. Finally, the risks of nanotechnology remain largely unknown, both because of the multitude of variations in the technology and because of the limited applicability of traditional toxicological approaches such as structure-activity relationship (SAR) to nanotechnology products.

In long Midwestern winters, two things are certain: snow and basketball. But two things that you cannot count on are snow day school closures and a home-team collegiate basketball championship. In Kansas last winter, we had both. Winter precipitation was much above average, resulting in a rare invocation of the University's inclement weather policy to cancel classes in early February. And the Kansas Jayhawks basketball team brought home the National Collegiate Athletic Association championship trophy for the first time in two decades. The Chancellor commemorated the achievement with a campuswide celebration, including all-day class cancellation. This is all well and good. I am all for respecting Mother Nature's forces and celebrating remarkable athletic accomplishments.

But the combination of events does leave law professors nearing the end of the semester in a bit of a quandary. How to make up the cancelled classes to ensure compliance with American Bar Association accreditation instructional hours requirements? How to cover the missed course content? How to find mutually agreeable make-up class times and locations with a group of busy, upper-level law students?