The Public\u27s Right to Health: When Patient Rights Threaten the Commons

This Article offers a contemporary examination of traditional public health objectives to address social problems not amenable to individual resolution. Taking the tradition a step further, it defines a “public health right” that may justify certain government actions that otherwise appear to impair individual rights. For example, lawmakers are considering whether current regulations on prescription drugs should be loosened to allow terminally ill patients to access drugs before they have been tested and approved for the general public. This Article concludes that expanding access to experimental drugs would violate the public health right to scientific knowledge and new drug development. The choice of a few patients to avail themselves of untested drugs depletes the “commons” of biomedical research. The Article concludes by briefly testing the public health right against other contemporary laws intended to promote public health and welfare, finding some but not all are justified

The Fragility of the Affordable Care Act\u27s Universal Coverage Strategy

This paper was presented at DePaul University in March 2006, as part of a Symposium on Shaping a New Direction for Law and Medicine: An International Debate on Culture, Disaster, Biotechnology & Public Health. Following the catastrophic events of 2005, including Hurricane Katrina, Pakistani Earthquakes, bird flu transmission to human populations, and the real threat of bioterrorism, government struggled in the aftermath to make sense of the devastation and human displacement. Medical teams, try as they might, are not always prepared and alerted as to how best investigate and quickly render assistance. The Symposium addressed the role of government, policy-makers, community organizations, the World Health Organization and other key players in properly situating and providing relief to respond to these issues. My paper describes both the immediate and lasting impact of Hurricane Katrina on the Gulf Region\u27s health care infrastructure and recommends approaches to prevent similar devastating effects in future disasters

Failure to Connect: The Massachusetts Plan for Individual Health Insurance

This article briefly describes the key features of the Massachusetts Health Care Reform Act, focusing particularly on the Connector. It then offers preliminary thoughts on the expected effect of that mechanism for creating quality, affordable health insurance products for individuals. Observers anticipate that commercial insurers will offer scant coverage and high-premium, high-deductible plans through the Connector, which coverage ultimately may be neither more affordable than products currently or more helpful to covering the cost of health care than no coverage at all. If the Connector fails to facilitate the individual insurance mandate, Massachusetts's promise of universal coverage may begin to unravel. Moreover, its usefulness as a model for other states proposing or considering similar risk-pooling mechanisms will be greatly diminished

Is it Worth the Trouble? The New Policy on Dissemination of Information on Off-Label Use Under the Food And Drug Administration Modernization Act of 1997

On January 14, 1998 the Food and Drug Administration (FDA) approved the use of a product previously marketed as Excedrin Extra Strength® for use in treating migraine headaches. As part of the approval for the new use of the product, FDA required the pharmaceutical manufacturer of Excedrin®, Bristol-Myers Squibb, to relabel and repackage the product. The new product is called “Excedrin Migraine®” and is sold side-by-side with Excedrin Extra Strength®. Both over-the-counter (OTC) products contain the same active ingredients: 250 milligrams of acetaminophen, 250 milligrams of aspirin, and sixty-five milligrams of caffeine. Many consumers expressed outrage and confusion that Bristol-Myers Squibb was engaging in such “deceptive” advertising practices. What gives the drug manufacturing giant the right to sell two distinctive products from a single formula? FDA does. Not only does FDA give Bristol-Myers the right to do so, but the agency actually compels such a practice. Under the Federal Food, Drug, and Cosmetic Act (FDCA) a drug manufacturer may not promote a product for any use other than the ones for which the company received FDA approval. Recent amendments to the FDCA relax this prohibition by allowing drug manufacturers to provide physicians with information about unapproved uses under certain restrictions. The new provisions for dissemination of treatment information on unapproved uses of drugs and devices went into effect on November 20, 1998 when FDA issued a Final Rule. Some commentators had urged FDA to adopt such a policy as a long-awaited reform to FDA\u27s arduous new drug approval (NDA) process. Under the rigorous requirements of the new statute, however, it is unlikely that the new policy will significantly impact on manufacturers\u27 operations or the availability of information to doctors

The Public’s Right to Health: When Patient Rights Threaten the Commons

This Article offers a contemporary examination of traditional public health objectives to address social problems not amenable to individual resolution. Taking the tradition a step further, it defines a public health right that may justify certain government actions that otherwise appear to impair individual rights. For example, lawmakers are considering whether current regulations on prescription drugs should be loosened to allow terminally ill patients to access drugs before they have been tested and approved for the general public. This Article concludes that expanding access to experimental drugs would violate the public health right to scientific knowledge and new drug development. The choice of a few patients to avail themselves of untested drugs depletes the commons of biomedical research. The Article concludes by briefly testing the public health right against other contemporary laws intended to promote public health and welfare, finding some but not all justified

Gauging the Cost of Loopholes: Health Care Pricing and Medicare Regulation in the Post-Enron Era

This article explores the problem of risk perception and regulatory loopholes in the unique era of corporate governance that followed Enron and other high-profile corporate scandals. The article draws on behavioral law and economics theory to examine pressing issues in U.S. welfare policy reform. The current Administration\u27s domestic agenda features proposals to privatize traditional government welfare programs, including Social Security and Medicare. Those proposals rely on market competition and other profit incentives to improve quality and reduce program costs. The article traces a detailed case study of a prominent for-profit hospital corporation, the impact of public perceptions of corporate wrongdoing, and the regulatory response that followed. The piece then offers key insights for upcoming policy debates over health care delivery, specifically, and regulation of private markets, generally

Public Health Law for a Brave New World; Book Review: Lawrence O. Gostin, Public Health Law: Power, Duty, Restraint

This is book review of Lawrence O. Gostin\u27s new edition of Public Health Law: Power, Duty, Restraint (University of California Press, Berkeley, California, 2d ed., 2008). A review of a second edition of a book may be somewhat unusual as subsequent editions of already published works typically do not break new ground. But this book is different. Gostin\u27s first edition, published in 2000, established and defined the modern field of public health law. The revised and expanded second edition emerges in the post-9/11, post-Katrina, post-Bush world. Gostin now seeks to apply public health paradigms to social problems beyond the field\u27s traditional realm, offering a comprehensive, encyclopedic source of public health laws and a sound prescription for health care refor