Federal intervention in food labeling is often proposed with the aim of achieving a social goal such as improving human health and safety, mitigating environmental hazards, averting international trade disputes, or supporting domestic agricultural and food manufacturing industries Economic theory suggests, however, that mandatory food-labeling requirements are best suited to alleviating problems of asymmetric information and are rarely effective in redressing environmental or other spillovers associated with food production and consumption Theory also suggests that the appropriate role for government in labeling depends on the type of information involved and the level and distribution of the costs and benefits of providing that information This report traces the economic theory behind food labeling and presents three case studies in which the government has intervened in labeling and two examples in which government intervention has been proposed

/pdf/economics-of-food-labeling-1so2nvroo9.pdf

Economics of Food Labeling

https://www.gastrojournal.org/article/S0016-5085(07)01115-8/pdf

AGA Institute Review of Endoscopic Sedation

Most people in the developed world will sooner or later be given prescription drugs to treat common diseases or to reduce the risk of getting them. Almost everyone who takes medicines will, at some stage, encounter those that do not work as well as they do in other people or even that cause an adverse reaction. Pharmacogenetics seeks to reduce the variation in how people respond to medicines by tailoring therapy to individual genetic make-up. It seems increasingly likely that investment in this field might be the most effective strategy for rapidly delivering the public health benefits that are promised by the Human Genome Project and related endeavours.

Pharmacogenetics goes genomic

In law, with rare exception such as legislative action, change is evolutionary and methodical Unlike biomedical science where a breakthrough can quickly lead to dramatic changes in medical practice, legal precedent is more adherent and must evolve either through the legislative process or on a court by court basis in case law Nevertheless, compelling evidence will pave the road to change within the law Health care research conducted over the last three decades has produced a body of empirical evidence that suggests an overhaul of our current legal standards of informed consent is overdue
 This article uses health services research to examine the fundamental assumptions of our current informed consent laws and propose legal reform Much has been written on how to bring the law to bear on medical practice in order to improve patient rights and protect physicians, but far less has been done to bring the practice of medicine to inform our legal standards Prior legal scholarship on informed consent has made arguments regarding reform from both ethical and legal perspectives; however, only a small few have incorporated clinical and health services research as well as ethical and legal principles to analyze informed consent

/pdf/rethinking-informed-consent-the-case-for-shared-medical-pmhi3idbpc.pdf

Rethinking informed consent: the case for shared medical decision-making.

The growing prevalence of obesity among adults and children has prompted legal initiatives designed to combat this public health problem. The authors describe litigation and legislation that target obesity and discuss the potential for public health law to reduce obesity in the United States.

http://www.nptinternal.org/productions/chcv2/prevention/pdf/NEJM%20Obesity%20and%20Public%20health%20law.pdf

Obesity — The New Frontier of Public Health Law

A rich academic literature exists about issues of informed consent in medical care, and, to a lesser extent, about a variety of issues posed by human experimentation. Most commentators regard patient autonomy as a desirable— though in practice often unattainable—goal, and near unanimity exists about the necessity for even fuller disclosure before experimenting on subjects. Although this Article intentionally side-steps the broader debate about informed consent, it challenges the conventional wisdom that special disclosure rules should apply in the experimental context.
 Clinical trials have become big business. Estimates suggest that as many as twenty million Americans have enrolled in formal biomedical studies, though, as a measure of the full scope of medical experimentation on humans, that figure may represent only the proverbial tip of the iceberg. Historically, sponsors of clinical trials recruited subjects informally, counting on word of mouth among physicians and also perhaps posting flyers around college campuses.

Informed consent and the elusive dichotomy between standard and experimental therapy.

In the last decade, "evidence-based medicine" (EBM) has become all the rage. Just as the Supreme Court instructed the federal judiciary to take a more critical approach to the assessment of expert testimony, proponents of EBM call on health care professionals to apply the best available evidence when making treatment decisions. Instead of relying on what they may remember from medical school or have learned from their personal experiences (or from drug company sales-persons), EBM insists that physicians consult the biomedical literature for the latest clinical research findings. The fact that the medical profession views such an idea as novel offers a startling picture of traditional ("opinion-based") medical practice, one quite different from that imagined by courts and regulatory agencies when they blithely assume that physicians can effectively assimilate tremendous quantities of complex information. EBM may, however, embody some naive assumptions about the character of the available scientific evidence, failing to appreciate shortcomings such as the extent to which conflicts of interest have affected the biomedical literature. Nevertheless, the debate surrounding evidence-based medicine offers important insights for various decisionmakers when they address health care quality issues. In turn, legal institutions may help to facilitate EBM by addressing conflicts of interest in biomedical research and by encouraging physicians to rely on rigorous research rather than largely anecdotal information when treating their patients.

Medicine's Epistemology: Mapping the Haphazard Diffusion of Knowledge in the Biomedical Community

This article evaluates an important but rarely discussed type of informal agency activity denominated "arm-twisting," defined as the use of threats by an administrative agency to impose a sanction or withhold a benefit in hopes of encouraging voluntary compliance with a request that the agency could not impose directly on a regulated entity. The article first describes the variety of arm-twisting techniques available to federal regulators, in contexts ranging from licensing and government contracting to product recalls and settlements of enforcement actions. In each of these settings, agencies enjoy significant leverage overregulated entities, allowing federal officials to extract nominally voluntary concessions. Agencies may threaten to deny licenses, refuse to enter into procurement agreements, disseminate adverse publicity, or impose other sanctions against uncooperative parties, and, in at least some cases, such threats allow agencies to pursue extrastatutory goals, seemingly incontravention of the limits on their delegated authority. The article then draws comparisons to arm-twisting in other contexts, including land use exactions and criminal plea bargaining. Finally, after considering the unconstitutional conditions doctrine as well as judicial constraints on plea bargaining and administrative consent decrees, the article suggests a series of possible substantive and procedural safeguards aimed at minimizing the risk of overreaching by federal regulatory officials. Because the problem often is not amenable to judicial control, greater agency self-restraint and congressional oversight may offer the only realistic prospects for curbing improper uses of administrative arm-twisting.

Administrative Arm-Twisting in the Shadow of Congressional Delegations of Authority

This paper catalogues several types of missteps made in loss-of-a-chance cases. Whether a court has decided to endorse or to reject proportional recoveries for the loss of less-than-even odds of a favorable outcome, more careful consideration of the mathematical and other concepts involved in such cases should promote greater clarity in the analysis. Unfortunately, a number of judges, lawyers, and commentators have made errors in dealing with loss-of-a-chance claims, including mistakes related to comparisons across stages of a disease, flawed assumptions about background mortality rates, and faulty calculations related to changes in the chance of survival. This paper recommends that courts adopt an attributable risk equation when resolving these cases.

https://papers.ssrn.com/sol3/Delivery.cfm/SSRN_ID646084_code46201.pdf?abstractid=646084&mirid=1

An Inventory of Mathematical Blunders in Applying the Loss-of-a-Chance Doctrine

Those who write about pain management have focused almost entirely on delivery issues, paying essentially no attention to the federal regulatory challenges that affect the development of pain relief technologies — namely, pharmaceuticals and medical devices indicated for analgesic uses. The academic literature is strangely devoid of any sophisticated discussion of the difficulties that attend, first, the product approval decisions of the Food and Drug Administration (FDA) and, second, the scheduling decisions made by the Drug Enforcement Administration (DEA). If a “bottleneck” develops upstream, it could have serious repercussions downstream — without pain relief technologies, the issues of access that have preoccupied previous commentators would have little practical consequence.
 The modern pharmaceutical industry traces its origins back more than a century, around the time that the German company Bayer first synthesized aspirin (acetylsalicylic acid) and began marketing it as an analgesic.

Lars Noah

Papers

Informed consent and the elusive dichotomy between standard and experimental therapy.

Medicine's Epistemology: Mapping the Haphazard Diffusion of Knowledge in the Biomedical Community

Administrative Arm-Twisting in the Shadow of Congressional Delegations of Authority

An Inventory of Mathematical Blunders in Applying the Loss-of-a-Chance Doctrine

Challenges in the Federal Regulation of Pain Management Technologies