Food and Drug Law Commons^™

Criminal Responsibility And The Disappearing Person, Stephen J. Morse

Cardozo Law Review

No abstract provided.

Cold Comfort Pharmacy: Pharmacist Tort Liability For Conscientious Refusals To Dispense Emergency Contraception, Kristen Marttila Gast

ExpressO

The past several years have seen an increasing number of pharmacists refuse to dispense emergency contraception, an effective, post-coital form of contraception, on the grounds that the drug violates their personal beliefs. This Article addresses the impact of those pharmacist refusals under existing principles of tort law. The Article draws on existing pharmacy case law, state-specific refusal clauses, and ethics statements promulgated by professional pharmacy associations to investigate whether pharmacists have a legal duty to dispense emergency contraception, notwithstanding religious or ethical objections. Concluding that in most states, such a legal duty does exist, the Article develops a “wrongful conception” …

Improving The Pharmaceutical Industry:Optimality Inside The Framework Of The Current Legal System Provides Access To Medicines For Hiv/Aids Patients In Sub-Saharan Africa, Gourav N. Mukherjee

Florida State University Journal of Transnational Law & Policy

No abstract provided.

Banning Smoking In Chicago's Social Scene: Protecting Labor And Broadening Public Health Policy, 40 J. Marshall L. Rev. 1063 (2007), Adrienne Detanico

UIC Law Review

No abstract provided.

The Fda Preamble: A Backdoor To Federalization Of Prescription Warning Labels?, 41 J. Marshall L. Rev. 161 (2007), Cristina Rodríguez

UIC Law Review

No abstract provided.

Tax And Economic Policy Responses To The Medicaid Long-Term Care Financing Crisis: A Behavioral Economics Approach, Diane Lourdes Dick

Cardozo Public Law, Policy & Ethics Journal

The article examines the escalating strain on Medicaid due to rising long-term care costs and an aging population, emphasizing the ineffectiveness of current policies promoting private insurance. It critiques traditional economic models for neglecting behavioral factors like emotional resistance to planning for aging and underestimating future care needs. The analysis concludes that voluntary measures, such as tax incentives and partnership programs, are insufficient and advocates for a universal compulsory program to ensure adequate preparation for long-term care, thereby reducing Medicaid reliance.

Obesity, Public Health, And The Food Supply, Barbara L. Atwell

Elisabeth Haub School of Law Faculty Publications

This Article proposes a three-part approach to improve the food supply. Specifically, it explores government taxing and spending, two traditional public health tools, and suggests that both of these governmental powers can be used to make healthier foods more readily reasonable prices, while increasing the cost of less healthy alternatives. Finally, it proposes that we promote a true “food democracy” through the creation of an education and awareness campaign. This campaign would not only better educate Americans about proper nutrition but would also focus on how we can change our entire relationship with food. It would encourage consumption of locally …

Enhancing Drug Effectiveness And Efficacy Through Personal Injury Litigation, Anita Bernstein

Faculty Scholarship

No abstract provided.

The First Amendment And Diet Industry Advertising: How Puffery In Weight-Loss Advertisements Has Gone Too Far, Jennifer E. Gross

Journal of Law and Health

Stricter government regulations regarding commercial speech that promotes weight-loss or diet products should be considered for three reasons. First, studies have shown that diet industry advertising often makes weight loss claims that are scientifically impossible. Second, consumers have suffered adverse health effects as a result of trying weight-loss programs or diet products. Third, current FTC regulations are not curbing the problem. Part II of this note outlines the history of commercial speech and its protections under the First Amendment, along with the history of the rapidly expanding diet industry and its regulatory framework. Part II examines the three arguments in …

Restricting Access To Unapproved Drugs: A Compelling Government Interest , Peter M. Currie

Journal of Law and Health

The prospective review and approval of drugs is central to the public health mission of the United States Food and Drug Administration (FDA). Requiring pharmaceutical manufacturers to generate information about their products' safety and efficacy enables the agency to evaluate the risks and benefits associated with their use, thereby preventing overly harmful products from reaching the market. The majority of consumers benefit from this intervention by gaining access to an array of drugs that are proven to be safe and effective. Thus, governmental regulation in this area is arguably justified because the aggregate social welfare is substantially improved. However, this …

Secondhand Smoke Signals From Prison, Scott C. Wilcox

Michigan Law Review

This Note argues that courts should acknowledge current societal and medical perspectives on second hand smoke (SHS) and afford real protection to prisoners against SHS through injunctive relief. Part I examines evidence that conclusively demonstrates the serious risk of harm posed by SHS to the health of inmates. It reports that inmates' long-term exposure to SHS increases their risk of contracting lung cancer, heart disease, and other potentially life threatening conditions. Part II argues that, as required by the Helling standard, contemporary society does not tolerate involuntary, long-term exposure to SHS and that prison officials exhibit deliberate indifference by allowing …

Attack Of The Balloon People, Keith E. Sealing

Vanderbilt Journal of Transnational Law

Any discussion of food security would, at first blush, seem to focus primarily on world hunger and other threats to the safety of the food supply, whether intentionally man-made (e.g., terrorism), inadvertently man-made (e.g., global warming), made-for-profit by industrial agriculture (referred to as "industrial food" throughout this Article), or "natural" although arguably man-abetted (such as bovine spongiform encephalopathy, or mad cow disease). And hunger is indeed a problem and likely to become more of a problem. However, this Article focuses on the long term threat to world health and world food security caused by the American way of eating; the …

A Penny For Your Thoughts: Private And Collective Contracting For Traditional Medicinal Knowledge Modeled On Bioprospecting Contracts In Costa Rica, Katie Bates

Georgia Law Review

For decades, pharmaceutical companies have prospected biologically diverse developing countries for plants and molecules that may form the foundations of groundbreaking medicines. In many cases, native populations have aided researchers by directing them to the plants used in their traditional medicines. Only recently, however, have native peoples pushed for compensation for this valuable contribution. The governments of developing countries, too, have begun to assert legal and physical control over their natural resources, making access to these resources by pharmaceutical companies more difficult and costly. Simultaneously, scientific developments have made drug discovery through alternative methods more feasible. Despite these changes, it …

The Plan B For Plan B: The New Dual Over-The-Counter And Prescription Status Of Plan B And Its Impact Upon Pharmacists, Consumers, And Conscience Clauses, Brittany L. Grimes

Georgia Law Review

On August 24,2006, the U.S. Food and Drug Administration decided to approve Plan B, the "morning-after"contraceptive pill, as an over-the-counter drug for women ages eighteen and older only. Individuals aged seventeen years and younger must still obtain a prescription in order to purchase Plan B, resulting in confusion and complications in implementing the age limitation. Additionally, the dual status of Plan B as both a prescription and over-the-counter drug might still be undermined by pharmacists choosing to refuse sale of contraceptives under various state protective conscience clauses. This Note explores the impact of the FDA's novel decision to create a …

Trans Fat: Can New York City Save Its Citizens From This "Metabolic Poison"?, Elizabeth Y. Spivey

Georgia Law Review

Trans fat was developed by chemists at the turn of the century and became an increasingly large part of the American diet. Trans fat in the form of partially hydrogenated vegetable oil now makes up 2% of all calories consumed in the United States. In the past two decades, studies have shown that artificially created trans fat increases cholesterol and increases the risk of coronary heart disease, heart attack, and type II diabetes. In response to these health concerns, New York City's Board of Health voted to ban trans fat from restaurant fare in December 2006. Other cities and local …

European Union Food Law Update, Nicole Coutrelis

Journal of Food Law & Policy

On March 31, 2006, the European Commission published Council Regulation (EC) No. 510/2006 On the Protection of Geographical Indications and Designations of Origin for Agricultural Products and Foodstuffs. This new regulation repealed Council Regulation (EEC) No. 2081/92 On the Protection of Geographical Indications and Designations of Origin for Agricultural Products and Foodstuffs mainly to bring Community law into conformity with the World Trade Organization (WTO) agreements and the findings of a recent WTO panel. Under the new Regulation, persons in third countries (non-European Union members) are entitled to address applications for the protection of geographic names and statements of objection …

United States Food Law Update, Michael Tingey Roberts, Margie Alsbrook

Journal of Food Law & Policy

This update summarizes some of the significant changes and developments in food law over the first half of 2006. Not every change in food law is included; instead, this update provides a starting point for scholars, practitioners, food industry members, and policymakers determined to understand the shaping of food law in modern society. Tracing the development of food law through these updates, which appear in each issue of the Journal of Food Law & Policy, also provides historical context for the development of significant food law issues over time. New developments in state law, while certainly important and deserving in …

Creating Balance: Problems Within Dshea And Suggestions For Reform, Jennifer Akre Hill

Journal of Food Law & Policy

The Dietary Supplement Health and Education Act of 1994 (DSHEA) was signed into law on October 25, 1994. At the signing, President Clinton endorsed the "intense efforts" of manufacturers and legislators to change the "treatment of dietary supplements under regulation and law." Further, the bill was signed with the hope that it would benefit consumers by permitting more access to dietary supplements and more choices for consumer directed healthcare. In support, politicians on both sides of the aisle claimed the DSHEA as a victory for consumer freedom, populist protection, and preventative medicine.

A Complete Property Right Amendment, John H. Ryskamp

ExpressO

The trend of the eminent domain reform and "Kelo plus" initiatives is toward a comprehensive Constitutional property right incorporating the elements of level of review, nature of government action, and extent of compensation. This article contains a draft amendment which reflects these concerns.

A Tough Pill To Swallow: Does The First Amendment Prohibit Wv From Regulating Pharmaceutical Companies' Advertising Expenses To Lower The Cost Of Prescription Drugs?, Brienne Taylor Greiner

West Virginia Law Review

No abstract provided.

In Sickness, Health, And Cyberspace: Protecting The Security Of Electronic Private Health Information, Sharona Hoffman, Andy Podgurski

ExpressO

The electronic processing of health information provides considerable benefits to patients and health care providers at the same time that it creates serious risks to the confidentiality, integrity, and availability of the data. The Internet provides a conduit for rapid and uncontrolled dispersion and trafficking of illicitly-obtained private health information, with far-reaching consequences to the unsuspecting victims. In order to address such threats to electronic private health information, the U.S. Department of Health and Human Services enacted the HIPAA Security Rule, which thus far has received little attention in the legal literature. This article presents a critique of the Security …

Why It Is Time To Eliminate Genomic Patents, Together With Natural Extracts Doctrine That Have Supported Such Patents, Allen K. Yu

ExpressO

The constitutional purpose of intellectual property is to “promote the progress of science and useful arts.” Given the utilitarian basis of patents, it is critical that policies and laws must be continually adjusted to reflect the needs of new technologies. When the law tries to shield itself from rather than confront the realities of underlying technologies, patents end up actually subverting rather than promote technological progress. This paper explores why the natural extracts doctrine belongs to the class of doctrines that subvert progress. The doctrine, established over a century ago to enable the patenting of purified compounds for use as …

Drugged, Carl E. Schneider

Articles

The Supreme Court's recent decision in Gonzales v. Oregon, like its decision last year in Gonzales v. Raich (the "medical marijuana" case), again raises questions about the bioethical consequences of the Controlled Substances Act. When, in 1970, Congress passed that act, it placed problematic drugs in one of five "schedules," and it authorized the U.S. attorney general to add or subtract drugs from the schedules. Drugs in schedule II have both a medical use and a high potential for abuse. Doctors may prescribe such drugs if they "obtain from the Attorney General a registration issued in accordance with the …

Bond Repudiation, Tax Codes, The Appropriations Process And Restitution Post-Eminent Domain Reform, John H. Ryskamp

ExpressO

This brief comment suggests where the anti-eminent domain movement might be heading next.

Caveat Venditor: Products Liability And Genetically Modified Foods, Kristopher A. Isham

Journal of Food Law & Policy

Genetically modified organisms (GMOs) have become a lightning rod for conflict between farmers, corporations, shareholders, government agencies, and other concerned groups. Supporters tout GMOs as a solution to the problems of diminishing returns from traditional crop plants and the rising demand for greater quantities of food. Opponents criticize GMOs for potential toxic and allergic reactions in humans, loss of biodiversity, and pesticide and antibiotic resistance in other plants and insects. As the understanding of potential applications of biotechnology broadens, the risks and benefits of such products are being scrutinized more closely.

Global Pharmaceutical Patent Law In Developing Countries- Amending Trips To Promote Access For All, Angela J. Anderson

ExpressO

This comment will analyze the need to amend and revise the current global pharmaceutical patent system under TRIPS to take into account the needs of developing countries and overall public health. This comment will emphasize that the current international trade rules, which although administered by the WTO, are dictated by developed country governments and powerful pharmaceutical companies, and therefore, without reform will further diminish the access of poor people in developing countries to vital medicines. Part II of this comment will provide a general overview of the international trade law governing patents on pharmaceuticals focusing specifically on the development of …

Global Pharmaceutical Patent Law In Developing Countries- Amending Trips To Promote Access For All, Angela J. Anderson

ExpressO

This comment will analyze the need to amend and revise the current global pharmaceutical patent system under TRIPS to take into account the needs of developing countries and overall public health. This comment will emphasize that the current international trade rules, which although administered by the WTO, are dictated by developed country governments and powerful pharmaceutical companies, and therefore, without reform will further diminish the access of poor people in developing countries to vital medicines. Part II of this comment will provide a general overview of the international trade law governing patents on pharmaceuticals focusing specifically on the development of …

Getting It Right By Getting It Wrong: How The Supreme Court Helped Healthcare Reform By Incorrectly Applying The Standard Of Review In Pharmaceutical Research And Manufacturers Of America V. Walsh, Brian Y. Furuya

Brigham Young University Journal of Public Law

No abstract provided.

Volume 6 Issue 3, Sustainable Development Law & Policy

Sustainable Development Law & Policy

No abstract provided.

Book Review: Michele Goodwin's Black Markets: The Supply And Demand Of Body Parts, Barbara A. Noah

Faculty Scholarship

The Author reviews Michele Goodwin’s book BLACK MARKETS: THE SUPPLY AND DEMAND OF BODY PARTS, published by Cambridge University Press, 2006. The book discusses the shortage of cadaveric organs available for transplantation. It argues that the shortage disproportionately impacts racial minorities. It then analyzes existing organ procurement laws and proposed alternatives, with a focus on market solutions.

BLACK MARKETS is impeccably researched and persuasively argued, though some of its points are certainly controversial. The book is aimed at and very accessible to a general audience, but it will also prove interesting and informative to legal, medical and public health academic …