Food and Drug Law Commons^™

Protecting Scientific Integrity: The Commercial Speech Doctrine Applied To Industry Publications, Joanna K. Sax

Faculty Scholarship

Pharmaceutical companies face increasing pressure to bring new treatments to market in order to survive. The economic reality of survival and profits may distort a company’s decision-making process regarding full disclosure on a particular new drug.

Part II of this article analyzes the publication tactics employed by some members of the pharmaceutical industry (hereinafter “industry”) and explains how some of the publications promote misleading information. Part III proposes policy recommendations to require accurate dissemination of the results of clinical trials in order to protect scientific integrity and the public welfare. Part IV of this article addresses whether industry publications are …

Teva V. Eisai: What's The Real Controversy, Grace Wang

Michigan Telecommunications & Technology Law Review

This Note examines the changing role of declaratory judgment actions in challenging patents upon generic entry and evaluates alternative regulatory schemes to the FDA's current system of patent enforcement in the drug approval setting. Part I reviews the Federal Circuit's recent decisions regarding generic drug entry, focusing on how the courts justify declaratory judgments in the current system and when a "controversy" exists to create Article III jurisdiction. Part II examines the complex system of regulating generic drug entry and how attempts to stop the exploitation of loopholes have resulted in a patchwork of regulation by various parties. It challenges …

Unpredictability In Patent Law And Its Effect On Pharmaceutical Innovation, Christopher M. Holman

Faculty Works

In recent years, the major innovator pharmaceutical companies have experienced two pronounced and significant trends: a decreasing output of innovative new drugs and cutbacks in research and development (R&D) investment. The two phenomena probably are not unrelated and raise significant concerns for a society intent upon providing affordable health care for an aging population. While the root causes of these trends are complex and diverse, we should not overlook the critical role patents play in creating the necessary incentives for the substantial investment required to develop pharmaceutically-interesting chemical compounds into actual drugs and to take them through the clinical trials …

The Food Safety Modernization Act: Keeping Dinner Safe And Farmers In The Fields, Sarah K. Baker

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

The Commerical Speech Doctrine In Health Regulation: The Clash Between The Public Interest In A Robust First Amendment And The Public Interest In Effective Protection From Harm, David Orentlicher

Scholarly Works

No abstract provided.

Warning, This Decision Will Increase The Cost Of Prescription Drugs: How The Supreme Court’S Misapplication Of Preemption Doctrine In Wyeth V. Levine Portends Devastating Consequences For Oklahoma, Tyler R. Barrett

Oklahoma Law Review

No abstract provided.

Provigil: A Commentary, Daniel A. Crane

Articles

Michael Carrier's case study on Provigil' offers new support for the view that Big Pharma is to blame for stymieing competition, retarding innovation, and inflating prices in the drug industry. Carrier argues that Cephalon was able to thwart generic entry by a combination of anticompetitive strategies. It entered into a reverse payment settlement agreement with generics seeking to enter the market. These settlements purported to allow generic entry before the expiration of the patent period, but, according to Carrier, the promise of early entry was negated by the second prong of Cephalon's anticompetitive strategy. During the time that it had …

Patent Office As Biosecurity Gatekeeper: Fostering Responsible Science And Building Public Trust In Diy Science, 10 J. Marshall Rev. Intell. Prop. L. 423 (2011), Brian J. Gorman

UIC Review of Intellectual Property Law

When the fields of intellectual property law and biotechnology intersect, most analysis is driven byeconomic and ethical issues. This article examines these factors, but in relation to the emerging security threat posed by biohackers, or do-it-yourself (“DIY”) scientists, who operate free from oversight and industry norms at the fringes of the biotechnology community. Public health risks are poised to grow as these citizen-scientists race for lucrative discoveries in the new frontier of syntheticbiology. This article proposes that the existing paradigm adjust accordingly to leverage regulatory compliance from the most ambitious biohackers looking to benefit from patent protection. The U.S. government …

Small, Slow, And Local: Essays On Building A More Sustainable And Local Food System, Mary Jane Angelo, Amelia Timbers, Matthew J. Walker, Joshua B. Donabedian, Devon Van Noble, Erik Phillips-Nania, Emily Parish, Jennifer L. Perez

UF Law Faculty Publications

A collection of essays that have strong arguments in favor of shifting from our existing centralized industrial agricultural system to a more localized system. This shift will reduce reliance on fossils fuels, which are used to make pesticide and fertilizer inputs and to transport foods long distances, thereby reducing contributions to climate change and decreasing environmental impacts. The shift will also provide social and economic benefits to local communities, improved health and a more sustainable, secure, and resilient food supply. To achieve such a shift, however, it will be necessary to overcome existing legal, economic, and social barriers and to …

Symposium On Commercial Speech And Public Health, Jonathan H. Adler

Faculty Publications

Does the constitutional protection of commercial speech impair the government's ability to protect and promote public health? Or does the commercial speech doctrine itself enhance consumer education and harness market competition to advance public health? Do First Amendment limitations on regulation of commercial messages unduly retard governmental efforts to safeguard consumers? Or do they properly constrain illiberal paternalism? If the Court has been over-protective of health-related commercial speech, is there a principled place to redraw the line? And how should those governmental agencies entrusted with the power to protect public health and welfare respond to these constitutional constraints?

The editors …

The Case For Legal Regulation Of Physicians’ Off-Label Prescribing, Doriane Lambelet Coleman, Philip M. Rosoff

Faculty Scholarship

No abstract provided.

Is There A Doctor In The (Station) House?: Reassessing The Constitutionality Of Compelled Dwi Blood Draws Forty-Five Years After Schmerber, Michael A. Correll

West Virginia Law Review

The vast majority of Fourth Amendment jurisprudence of the last century has been dedicated to parsing the physical and in- tangible boundaries of the home, developing the expectation of privacy, and, as of late, exploring the constitutional implica- tions of an increasingly electronic society. In the midst of this development, one major area has quietly fallen by the wayside - the preservation of bodily integrity. As technology has ren- dered the human body an ever-increasing source of crucial evi- dence, the Supreme Court has remained largely silent on the government's power to harvest information through medical procedures. Since the Court's …

Whipping A Game On Fellons: The Atf "Stash House" Cases, Tom Mcgettrick

Public Interest Law Reporter

No abstract provided.

Drug Tests For Welfare: Saving Taxpayer Money Or Flushing It Down The Drain?, Michelle Yoder

Public Interest Law Reporter

No abstract provided.

Combating Hunger Home And Away: Tracing America's $600 Million Price Tag For Safeguarding The Right To Food In The Horn Of Africa, Natnael Moges

Public Interest Law Reporter

No abstract provided.

Rethinking Addiction: Drugs, Deterrence, And The Neuroscience Revolution, Linda C. Fentiman

Elisabeth Haub School of Law Faculty Publications

This article connects the debate about addiction with the fundamental criminal law principle of deterrence. It seeks to bridge the gap between the competing medical and criminal justice approaches by exploring addiction in light of recent research about the brain, gender differences, and what works best from both a treatment and justice perspective. To sharpen the issues, the article deliberately focuses on the emotionally freighted subject of pregnant drug users. This approach will illuminate prevailing assumptions about how biological, genetic, cultural, and other environmental factors shape human behavior and challenge conventional understandings of deterrence in light of new research on …

Did The Fda Properly Assess The Safety Of Olestra As A Food Additive?, Leah Lebel

The Science Journal of the Lander College of Arts and Sciences

The following is an excerpt of the introduction to this article: Olestra, a fat-substitute comprised of sucrose that has been esterified with fatty acids (Blume 1995), has been the subject of much controversy ever since its creation. Olestra is not absorbed (Mattson and Nolen 1972) because it cannot be hydrolyzed by pancreatic lipases (Mattson and Volpenhein 1972) or taken up across the enterocyte microvillus membrane (Freston et al. 1997), and thus, cannot be utilized for energy. Olestra has physical and organoleptic properties similar to those of traditional triglycerides (Jandacek and Webb 1978) and is emulsified together with triglyceride (Freston et …

Winter 2011 Utton Center Newsletter, Utton Center, University Of New Mexico - School Of Law

Publications

No abstract provided.

Food-Borne Ultimatum: Proposing Federal Legislation To Create Humane Living Conditions For Animals Raised For Food In Order To Improve Human Health, The, Lynn M. Boris

Journal of Law and Health

In order to reduce the large number of human health risks associated with reckless farming practices, Congress must enact federal legislation that requires humane living conditions for farm animals and declares a moratorium on the routine use of unnecessary antibiotics. Part II of this Note will briefly review traditional farming and animal husbandry practices and examine the shift to the modern practices used by producers of animal products today. Part II will also present several farming practices utilized today that are particularly dangerous to human health. Part III of this Note will explore the immense human suffering that is occurring …

Did The Mlbpa Strike Out? An Analysis Of Union Liability In Major League Baseball's Anonymous 2003 Steroid Testing, David Adelsberg

Cardozo Arts & Entertainment Law Journal

No abstract provided.