The National Summit on Legal Preparedness for Obesity Prevention and Control was conceived by the Centers for Disease Control and Prevention (CDC) as a strategic conference to review the current status of legal preparedness for obesity prevention and control, identify potential gaps, and develop specific action options for improving the contribution law can make to reduce the health threat posed by obesity. Working with the collaborating partners and planning committe, the host committe planned and modeled after the Summit CDC’s 2007 conference on public health emergency legal preparedness that resulted in the National Action Agenda for Public Health Emergency Legal Preparedness. The summit was a working meeting that offered invited participants a structured opportunity to deliberate about the laws and legal issues that impact obesity prevention and control from a public health perspective.

U.S. approaches to oversight of research and technological products have developed over time in an effort to ensure safety to humans, animals, and the environment and to control use in a social context. In modern times, regulatory and oversight tools have evolved to include diverse approaches such as performance standards, tradable allowances, consultations between government and industry, and pre-market safety and efficacy reviews. The decision whether to impose an oversight system, the oversight elements, the level of oversight (for example, federal, state, local), the choice of approach (for example, mandatory or voluntary), and its execution can profoundly affect technological development, individual and collective interests, and public confidence in technological products. Oversight is conducted by a range of institutions with various capabilities, cultures, and motives. Avenues for disputing oversight decisions are also important, and some argue that the U.S. operates in an adversarial regulatory culture in which Congress, the media, and stakeholders regularly contest the decisions of federal agencies.

The American public has increasingly identified health care as a key issue of concern. In order to address the multiple problems relating to the access and affordability of health care, President Obama and federal lawmakers across the political spectrum continue to call for major health reform. In any debate on health reform, a predictable set of complex policy, management, economic, and legal issues is likely to be raised. Due to the diverse interests involved, these issues could lead to a series of high-stakes policy debates. Therefore, it is critical that advocates of reform strategies anticipate such issues in order to decrease the likelihood that legally resolvable questions become barriers to substantive health reform. In an effort to frame and study legal challenges and solutions in advance of the heat of political debate, the O’Neill Institute for National and Global Health Law at Georgetown University and the Robert Wood Johnson Foundation have crafted the “Legal Solutions in Health Reform” project.

Acommon theme throughout the greatest public health achievements of the 20th century is the importance of law. From the seminal successes in immunizations and motor vehicle safety to the recognition and control of tobacco as a health hazard, laws have been invaluable. More recently in this century, laws have been fundamental in public health preparedness to address environmental disasters and terrorist threats. In fact, the first National Summit on Legal Preparedness in 2007 focused on these “urgent threats.” It only seemed natural that the second summit would focus on the “urgent realities” posed by the continuing epidemic of obesity — an epidemic that directly attacks our children’s health and drains our nation’s wealth.

Recognized worldwide as an energy imbalance resulting from excess caloric intake and reduced energy expenditure, obesity contributes to diabetes, heart disease, other multiple chronic diseases, impaired quality of life, and premature mortality.

As the quote above indicates, economists generally are more comfortable with self interest as a motivating force for social benefit than with altruism. This is because in most instances in a market economy, self interest will lead agents to provide benefits for others. Ultimately this is because the butcher or baker will not get paid unless he does something that others are willing to pay for. This is the source of the famous “invisible hand,” also discussed by Adam Smith.

This might sound trivial, except that in discussing aspects of medicine we seem to lose sight of this mechanism and rely on other tools to provide benefits. These tools do not work as well as naked self interest would. Some might say that medicine and medical progress is too important to depend on the market.

The concept of vulnerability has long played a central role in discussions of research ethics. In addition to its rhetorical use, vulnerability has become a term of art in U.S. and international research regulations and guidelines, many of which contain specific provisions applicable to research with vulnerable subjects. Yet, despite the frequency with which the term vulnerability is used, little consensus exists on what it actually means in the context of human subject protection or, more importantly, on how a finding of vulnerability should affect the process of research ethics review.

The Common Rule, the centerpiece of the U.S. human subject protection regulations, uses the word vulnerable three times. First, it provides that institutional review boards (IRBs) that regularly review research involving a vulnerable category of subjects should consider including one or more individuals who are knowledgeable about and experienced in working with these subjects.

Only 19 new molecular entities and 3 biologics were approved by the Food and Drug Administration (FDA) in 2007, the lowest rate in 24 years. This disappointing output occurred despite steady clinical trial and regulatory review times, the FDA maintaining high approval rates, and the pharmaceutical industry consistently reporting increasing revenues. A government report suggests that fewer new drug applications have been submitted to the FDA by the pharmaceutical industry in recent years. These data have rekindled the debate as to the origins of pharmaceutical innovation and the comparative importance of public and private sources in contributing to drug discovery. The pharmaceutical industry contends that its research is responsible for most new medicines, and that the primary public institution supporting U.S. biomedical research, the National Institutes of Health (NIH), supports medical innovation “distinct from the process of drug development.”

The Centers for Disease Control and Prevention (CDC) has focused its obesity prevention and control efforts on improving population-level health. A recent Institute of Medicine report identified systems that affect population health, to include health care delivery systems, schools, businesses and employers, communities, and governmental public health infrastructure. CDC uses the public health model to engage these systems, and this process coordinates multiple settings, sectors, and jurisdictions to develop an integrated approach to identify, prevent, and control obesity. The public health approach goes beyond medical care to prioritize policy and environmental strategies that can be implemented across jurisdictional levels, in collaboration with traditional and nontraditional partners. The process ultimately produces tools, guidelines, and interventions that can be used to prevent and control obesity. In this manuscript, we provide an overview of the public health perspective on obesity, outline the public health framework for addressing obesity, and discuss the rationale for leveraging law-based efforts as a tool to accomplish the public health mission.

Vulnerability in research is often understood as a diminished ability to protect one's own interests, manifested by a compromised capacity to give informed or voluntary consent. Certain groups of people are thought to be more vulnerable than others and therefore are at risk of being exploited or mistreated in research. Accordingly, the federal regulations call for additional safeguards to protect vulnerable groups.

There remains some ambiguity and contradiction, however, regarding what groups are vulnerable in research and why,3 since the available codes of research ethics and regulations describe many groups as vulnerable. When so many groups are considered vulnerable, but no specification is offered as to how they are vulnerable or what particular protections are appropriate, the possibility of meaningful safeguards is diminished. In addition, current concepts of vulnerability are usually applied to whole groups of people, without distinguishing between individuals in a group who might truly have a compromised capacity to protect their own interests from those who do not.

Presidential power has provoked increasingly vigorous debate since the turn of this century. In recent years, scholars and lawyers have been grappling with how Congress’s dictates may limit the president’s Commander-in-Chief power to detain enemy combatants at Guantanamo Bay, to fight wars abroad, and to conduct intelligence activities at home. But policymakers have not yet explored the many possibilities for invoking the president’s “Take Care” power to change health care policy.

This article explores the scope and limits of President Barack Obama’s ability to invoke his executive authority to reform health care. Specifically, it identifies ways the Obama Administration can use directives to: (1) expand Medicaid and State Children’s Health Insurance Program (SCHIP) coverage through section 1115 waivers; (2) test quality initiatives through Medicare demonstration authority; (3) expand health information technology; (4) allow drug reimportation and experiment with contracting power under Medicare; (5) enhance patient protections and private coverage requirements; (6) lift coverage restrictions on Medicaid and SCHIP; and (7) build on the health insurance program for federal employees. Consistent with the mission of the Legal Solutions in Health Reform project, this article does not endorse a particular policy. Instead of recommending “what,” it explains “how.”

Not all intellectual property rights grant the right to exclude that is indicative of “property rules,” as that term was used by Guido Calabresi and A. Douglas Melamed in their seminal article. Some intellectual property rights are “liability rules,” in which the right holder has an entitlement to compensation for use of the protected invention, not a right to preclude the use. Although patent laws normally grant a right to exclude others from use of the protected invention as a default, most countries’ laws allow the government to convert the patent property rule into a liability rule through a compulsory license. It has been noted, for example, that by the end of the 1950s, the U.S. had issued compulsory licenses covering 40 to 50 thousand patents, including substantial portions of the patent portfolios of AT&T, General Electric, IBM, and Xerox. The U.S. Supreme Court recently expressed a willingness to accept liability rules over injunctions in some patent infringement cases.

There is an old saw in health policy that everyone wants health care that is good, fast, and cheap — but it’s impossible to have more than two of these at one time.

A similar bit of folk wisdom seems intuitively true for the development and testing of new pharmaceutical products. The public is in a bind. We want breakthrough drugs, and fast. But we also want these drugs to be affordable, thoroughly tested, safe, and effective. It seems we can’t have it all.

In this paper, we will not claim that one can have it all — but that we can do far better than we are at present. First, we review extensive data on contemporary problems in the design, conduct, and analysis of industry-sponsored clinical trials. Finding major issues that have been solidly documented over more than a decade, we provide many examples of the multifarious ways in which industry-funded trials have been manipulated to raise the likelihood of producing industry-friendly results.

The Proceedings of the National Summit on Legal Preparedness for Obesity Prevention and Control is based on a two-part conceptual framework composed of public health and legal perspectives. The public health perspective comprises the six target areas and intervention settings that are the focus of the obesity prevention and control efforts of the Centers for Disease Control and Prevention (CDC).

This paper presents the legal perspective. Legal preparedness in public health is the underpinning of the framework for the four “assessment” papers and the four “action” papers that are integral to the application of public health law to any particular health issue. In addition, this paper gives real-world grounding to the legal framework through examples that illustrate the four core elements of legal preparedness in public health that are at work in obesity prevention and control.

There is no doubt that industry-sponsored biomedical research is under the microscope. Unfortunately, this new era of skepticism prematurely rushes in doubts of the ethos of science. Skepticism can lead to positive changes, but only when timely and supported by sound reasoning. Snapshot views and theories, especially those that result in costly new regulations and inefficient policies often do more harm than good. Many critics would have the reader doubt scientific integrity because they believe that the relationship between the pharmaceutical industry and biomedical research poses an unavoidable and dangerous conflict of interest. However, these conflicts are neither unavoidable nor dangerous per se.