A Drug by Any Other Name ... ? Paradoxes in Dietary Supplement Risk Regulation

Dietary supplements present vexing regulatory challenges for the Food and Drug Administration (FDA). Although several observers have called for reform or repeal of Dietary Supplement Health and Education Act (DSHEA), and the FDA often has lamented its lack of meaningful authority over dietary supplements, this Author suggests that the agency actually possesses the regulatory muscle to adopt a more aggressive risk identification and risk management strategy within the confines of DSHEA, and that it need not ask Congress to amend the statute

A Drug by Any Other Name ... ? Paradoxes in Dietary Supplement Risk Regulation

Dietary supplements present vexing regulatory challenges for the Food and Drug Administration (FDA). Although several observers have called for reform or repeal of Dietary Supplement Health and Education Act (DSHEA), and the FDA often has lamented its lack of meaningful authority over dietary supplements, this Author suggests that the agency actually possesses the regulatory muscle to adopt a more aggressive risk identification and risk management strategy within the confines of DSHEA, and that it need not ask Congress to amend the statute

Nicotine Withdrawal: Assessing the FDA\u27s Effort to Regulate Tobacco Products

At a press conference held on August 23, 1996, just one year after initially revealing his plans, President Clinton announced sweeping federal regulations to combat the underage use of tobacco products. The Food and Drug Administration (FDA) subsequently published a lengthy preamble to accompany the final regulations, detailing the Agency\u27s assessment of the problem and responding to numerous public comments to its notice of proposed rulemaking (NPRM). Characterizing the growing use of tobacco products as a pediatric disease, FDA Commissioner David Kessler previously had vowed to alter the smoking habits of the newest generation of tobacco users in order to radically reduce the incidence of smoking-related death and disease. This Article critically evaluates claims that the FDA has exceeded statutory and constitutional limitations on its power. The tobacco regulations deal with both cigarettes and smokeless tobacco products, and they focus primarily on the advertising, sale, and distribution of these products to children and adolescents. Among other things, the regulations establish a federal minimum age for the purchase of tobacco products, prohibit some vending machine sales, and limit the format and content of, as well as the conditions under which minors are exposed to, tobacco product advertising. The Agency also plans to require that the tobacco industry undertake a substantial educational program aimed at minors to provide information about the harmful consequences of using tobacco products and to counteract the appealing images associated with tobacco use in recent advertising campaigns. Part II focuses on objections to the Agency\u27s claim that it can regulate the advertising of tobacco products using the special statutory provisions applicable to restricted medical devices. The FDA argues that nicotine qualifies as a drug because tobacco companies intend that consumers become addicted to nicotine containing products. Even if true, the Agency still must justify the assertion of authority over products traditionally regulated by another agency, and then it must explain the counterintuitive classification of tobacco products as medical devices, and also as restricted devices, rather than as drugs. Part III canvasses some of the apparently unanticipated consequences of this device classification, including the possibility that cigarette manufacturers may enjoy a broader preemption defense in tort lawsuits. Finally, Part IV addresses the relative strength of some of the various constitutional objections raised by the industry, particularly with regard to the advertising restrictions and the proposed industry-financed educational campaign. Ultimately, this Article concludes that the FDA regulations exceed the Agency\u27s delegated authority and that the proposed educational campaign contravenes the First Amendment

The Role of Race in End-of-Life Care

This essay focuses on one important aspect of racial disparities that has received comparatively little attention in the legal literature--the existence and causes of racial differences in end-of-life decision making and in the utilization of palliative and hospice care. African Americans and other racial minorities in the United States utilize palliative care and hospice less frequently than white Americans. These minority populations also tend to resist advance care planning and instead opt to receive more life-prolonging care at the end of life, even when quality of life and prognosis are poor. After a lifetime of limited access to health care compared with whites and, in some cases limited treatment options (because of lack of insurance coverage or biased clinical judgment by physicians), African Americans and other racial and ethnic minorities utilize strikingly higher levels of aggressive, life-prolonging care at the end of life. Much of the explanation for these disparities in end-of-life care appears to lie in problems with communication and trust between physician and patient, although broader influences of culture and religious belief also play a role. The complexities of communication between minority patients and their physicians run in two directions, creating a destructive synergy that can dampen empathy in the relationship and negatively impact care at the end of life. Although many cultural factors play a role in the decision making of African American patients regarding end-of-life care, this essay focuses primarily on issues of trust and communication because these impact African Americans most directly

Bioethical Malpractice: Risk and Responsibility in Human Research

This Article provides an overview of Institutional Review Board (IRB) operations, reviews the sources of regulatory guidance, and examines the weaknesses of the existing system for the protection of human research subjects. It then discusses the scant case law relating to IRB negligence in the protection of human research subjects and explores some hypothetical circumstances under which it may be appropriate to hold a board accountable for injuries to clinical trial participants. Finally, this Article considers the potential consequences of expanded IRB liability, concluding that tort lawsometimes may serve an important function as a catalyst to regulatory reform when professional self-regulation and governmental supervision fail

Teaching Bioethics: The Role of Empathy & Humility in the Teaching and Practice of Law

The article discusses how bioethics education integrates ideas from ethics, law, science, and public policy with the goal of solving problems associated with the delivery of medical care. Topics discussed include Torts and various health law courses; American legal education\u27s multi-tiered approach to teach students about law; and role of empathy and humility in the teaching and practice of law

Race and Healthcare in America: Foreword

In all four of the articles that form this Symposium, the authors identify troubling disparities and injustices in our healthcare system and suggest strategies to ameliorate these problems. Sadly, the reforms of the Obama administration will probably do little to address these issues directly. The mandated insurance coverage requirement, for example, applies to U.S. citizens and legal residents, but not, unsurprisingly, to undocumented immigrants? Similarly, the legislation expands public programs but does nothing directly to support the burden of EMT ALA\u27s unfunded mandate on hospitals. And, as the evidence has long demonstrated, insurance coverage alone fails to guarantee equal medical treatment. The problem of racial disparities in healthcare remain systemically part of the larger problem of race relations in the United States-politically charged, difficult to isolate from the surrounding complexities of our woefully inefficient healthcare payment and delivery system, underappreciated in significance, and often lost in favor of the latest media blitz about a cutting edge cure for a rare disease or a miracle recovery from a devastating injury. The authors of these symposium articles very effectively draw attention to these racial disparities

The Inclusion of Pregnant Women in Clinical Research

In the past three decades, there has been unprecedented growth in medical research utilizing human subjects, with much promise for new treatments that extend life, improve quality of life, and prevent disease and disability. Safe prescribing of drug therapies requires that researchers design clinical trials to test products for the benefit of all persons who are likely to utilize them, not just a limited population. For this reason, it is essential that clinical trials include women, pregnant women, children, and racial minorities, as appropriate, because these populations sometimes exhibit different patterns of response or adverse reactions. Despite some significant progress in including women in clinical research, there is a dearth of sound research data on the safety and efficacy of already approved and commonly used medications for pregnant women. At this point, nearly all medications used to treat illness in pregnant women, including common chronic conditions such as hypertension, depression, diabetes, epilepsy, and cancer, are used off-label; that is, outside of the FDA-approved uses based on clinical trial and post-marketing data. Physicians must make prescribing decisions for their pregnant patients without the benefit of randomized, controlled clinical trials testing the safety and efficacy of drugs in pregnant women or the impact of these products on the health of the fetus. This problem of prescribing in the dark is receiving some attention in the medical and scientific community, but progress appears slow. Meanwhile, pregnant women face the difficult choice between taking untested drugs or foregoing necessary pharmacotherapy during pregnancy, potentially to the detriment of both woman and fetus. The default position — to exclude pregnant women from clinical research — is untenable. Although serious challenges in study design, institutional review board (IRB) oversight, and research participant safety make the thought of research in pregnant women daunting, it is important to find ways to test commonly used drugs in pregnant patients. Postponing action until consensus on the ethical and regulatory issues can be achieved is no solution. Women get ill while pregnant or become pregnant while suffering from chronic illness, and therefore must sometimes take prescription and non-prescription medications. Researchers must, therefore, design and implement clinical trials and other types of data collection techniques for both new and already-approved drugs and therapies that will generate data for the safe use of these drugs for pregnant women and their fetuses. This article will describe the current status of inclusion of pregnant women in research, and will discuss some of the FDA-related regulatory barriers to collecting safety and efficacy information and approaches to improve the availability of data to support safe drug prescribing during pregnancy. Finally, although pro-life constituencies have significant influence on health policy, efforts to improve the quality and quantity of safety data should not bow to external, non-science-based attempts at interference with these goals