Food and Drug Law Commons^™

Un-Fair Trade As Friendly Fire: The Australia-Usa Free Trade Agreement, Benedict Sheehy

ExpressO

Trade, economists and trade theorists advise, is a mutually beneficial exercise. Among this group, a particular set of advocates, claim that “Free Trade” is in the interest of all parties. As will be demonstrated, Free Trade is not truly “free” but an exercise of foreign policy and the implementation of policies favouring wealthy corporate interest groups. Free Trade is controlled by wealthy nations who have stacked the rules in favour of themselves, and in particular their corporate interests, and against the poor producers in poor nations. This control is used contrary to fairness, economic and ecological logic. Fair trade, by …

On The Legal Consequence Of Sauces: Should Thomas Keller's Recipes Be Per Se Copyrightable, Christopher J. Buccafusco

ExpressO

This article is devoted to copyright protection for one of the restaurant industry’s most valuable assets – original recipes. The two most recent appellate courts to consider the issue have been hostile to the notion that recipes are copyrightable, but given the enormous amount of money at stake, litigation in this area is likely about to expand. The article begins by critiquing the courts’ conclusions. Following an analogy to musical composition, I argue that recipes are simply the means of fixation for culinary works of authorship, i.e, dishes. Next, based on interviews with some of America’s leading chefs, including Thomas …

The Final Battle For Preemption: The Fda And Prescription Drug Labeling Product Liability Actions, Mary J. Davis

ExpressO

The Food and Drug Administration (FDA) has promulgated a new regulation which revises the format for prescription drug labeling, and, in the process, has taken the position that the regulation displaces, or preempts, state products liability laws that seek to assess liability on the manufacturer for a label’s warning adequacy. In the FDA’s 100 year history, it has not taken the position that federal prescription drug labeling regulations preempt common law tort claims until the last few years, beginning with Motus v. Pfizer in 2002. This position, radical to many and rational to others, places federal preemption of prescription drug …

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 …

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.

Discovering The Boundaries: Federal Preemption Of Pharmaceutical Labeling Product Liability Actions, Mary J. Davis

ExpressO

Federally approved prescription drug labeling has not been considered conclusive on the reasonableness or adequacy of the label for assessing tort liability on the manufacturer because federal regulations in this field set a minimum standard rather than an optimal one. That fundamental statement of black-letter tort law is under attack. The Food and Drug Administration (FDA) has promulgated a regulation which revises the format for prescription drug labeling, and, in the process, has taken the position that the regulation displaces, or preempts, state products liability laws that seek to assess liability on the manufacturer for a label’s warning adequacy. In …

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 …

From Harm To Robustness: A Principled Approach To Vice Regulation, Jim Leitzel

ExpressO

John Stuart Mill’s harm principle maintains that adult behavior cannot justifiably be subject to social coercion unless the behavior involves harm or a significant risk of harm to non-consenting others. The absence of harms to others, however, is one of the distinguishing features of many manifestations of “vices” such as the consumption of alcohol, nicotine, recreational drugs, prostitution, pornography, and gambling. It is with respect to vice policy, then, that the harm principle tends to be most constraining, and some current vice controls, such as prohibitions on drug possession and prostitution, violate Mill’s precept. In the vice arena, we seem …

Deadly Discounts: How Reimportation Jeopardizes The Safety Of The U.S. Pharmaceutical Drug Supply Under The Federal Trade Commission Amendment, Nicole C. Bates

ExpressO

The amendment to a Federal Trade Commission (FTC) reauthorization bill, previously introduced as Senate Bill 334 (S.334) Pharmaceutical Market Access and Drug Safety Act of 2005 allows for the reimportation of prescription drugs into the United States from approximately 25 countries, including Canada via Internet pharmacies. There are no guarantees that the internet websites advertising as Canadian pharmacies are legitimate. The shipping of pharmaceutical drugs occurs through importation, which refers to drugs produced abroad then later shipped to the U.S., or re-importation, a term applied when drugs are produced in the U.S. and exported for sale to foreign countries and …

Blame Canada (And The Rest Of The World): The Twenty-Year War On Imported Prescription Drugs, Daniel L. Pollock

ExpressO

Rising budget deficits and sticker shock over the new Medicare drug benefit have put the issue of prescription drug costs back into the spotlight. The growth in the cost of prescription drugs continues to represent a staggering burden for taxpayer-funded health care programs, even while costs of non-drug health care services have slowed or even decreased. Among the many proposals for cutting prescription drug costs, drug importation is unique. Although bipartisan support for drug importation has existed in Congress for over five years, the federal government continues to maintain that a system of safe and effective drug importation is impossible. …

Project Bioshield, More Than Meets The Eye: A Critique Of The U.S.’S Proposed Silver Bullet For Responding To Bio-Terrorism, Jodi A. Phillipo

ExpressO

No abstract provided.

Breaking The Bank: Revisiting Central Bank Of Denver After Enron And Sarbanes-Oxley, Celia Taylor

ExpressO

No abstract provided.

“Racially-Tailored” Medicine Unraveled, Sharona Hoffman

ExpressO

In June 2005, the FDA approved BiDil, a heart failure medication that is labeled for use only by African-Americans and thus, is the first treatment of its kind. The drug likely portends a future of growing interest in “race-based” medicine. This phenomenon is emerging at the same time that scientists, in light of the Human Genome Project, are reaching an understanding that “race” has no biological meaning, and consequently, “racially-tailored” medicine is both puzzling and troubling.

This Article explores the reasons for the new focus on “racial-profiling” in medicine. It analyzes the risks and dangers of this approach, including medical …

Learning The Wrong Lessons From "An American Tragedy": A Critique Of The Berger-Twerski Informed Choice Proposal, David E. Bernstein

George Mason University School of Law Working Papers Series

This paper is a critique of Margaret Berger and Aaron Twerski, “Uncertainty and Informed Choice: Unmasking Daubert”, forthcoming the Michigan Law Review. Berger and Twerski propose that courts recognize a cause of action that would allow plaintiffs who claim injury from pharmaceutical products, but who do not have sufficient evidence to prove causation, to recover damages for deprivation of informed choice. Berger and Twerski claim inspiration from the litigation over allegations that the morning sickness drug Bendectin caused birth defects. Considering the criteria Berger and Twerski suggest for their proposed cause of action in the context of Bendectin, it appears …

Protecting Protected Speech: First Amendment Taxonomy And The Food And Drug Administration's Regulation Of "Enduring Materials", Daniel J. Gilman

Faculty Scholarship

Numerous comments have called upon the Food and Drug Administration (FDA) to exercise restraint in its treatment of the dissemination of “enduring materials” (e.g., textbooks, journal articles, etc.) that address off-label uses of drug or biological products. This article considers the constitutional protections that apply to enduring materials as examples of commercial speech, and questions whether such materials—even though distributed by manufacturers—might be viewed more properly as scientific speech. Four conclusions will be set forth: 1) enduring materials regarding off-label uses deserve at least as much protection as the Constitution affords commercial speech; 2) there are good reasons to think …

Modern Bootlegging And The Prohibition On Fair Prices: Last Call For The Repeal Of Pharmaceutical Price Gouging, Luke W. Cleland

ExpressO

This article discusses the recent passage of the Medicare Prescription Drug, Modernization and Improvement Act of 2003, and the executive and judicial decisions affecting the ability of the general public to access foreign pharmaceutical markets. The article examines the recent actions taken by the U.S. government, explore various state movements within the United States aimed at reducing pharmaceutical drug prices, outline the process of pharmaceutical drug prices in foreign countries, and advocate for a workable integration of all available mechanisms to feasibly reduce prescription drug prices for the benefit of both U.S. consumers and U.S. drug companies. As avenues to …

Mandatory Recall Authority: A Sensible And Minimalist Approach To Improving Food Safety, Michael T. Roberts

ExpressO

No abstract provided.

Securing Truth For Power: Informational Strategy And Regulatory Policy Making, Cary Coglianese

ExpressO

No abstract provided.

The Cocaine Vaccine, Dru Stevenson

ExpressO

The controversial new cocaine vaccine (TA-CD) has the potential to be an extremely effective treatment tool for recovering addicts, but it also presents opportunities for non-therapeutic uses, such as preventing cocaine use in the first place. It is foreseeable that the cocaine vaccine could become a condition of parole or probation, or receiving welfare payments, or for employment in certain occupations. Universal vaccination is also a possibility but less likely for political reasons. This article investigates each of these areas of potential use. Any setting where mandatory drug testing is currently in place could become a venue for the vaccination. …

Internet Pharmacies And The Need For A New Federalism: Protecting Consumers While Increasing Access To Prescription Drugs, Linda C. Fentiman

Elisabeth Haub School of Law Faculty Publications

In this article I will argue that Internet pharmacies pose a significant public health problem, as they raise the classic eternal triangle of health care issues--access, quality, and financing--in a new technological context. Part II describes the phenomena of Internet pharmacies, and Part III reviews the present regulatory scheme. Part IV explains why the current legal framework is inadequate to address the public health and safety problems posed by Internet pharmacies, focusing particularly on the jurisdictional, constitutional, and practical obstacles to effective state oversight of Internet pharmacies. Part V argues that comprehensive federal oversight of Internet prescribing and dispensing is …

Rulemaking, Michael Herz

Articles

No abstract provided.

Food And Drug Law Summer Internship Program: Issues In Food And Drug Law, Melinda Michelle Moss

All Graduate Theses and Dissertations, Spring 1920 to Summer 2023

In recent years, the main food regulatory agency, the Food and Drug Administration, has faced a number of diverse and complicated issues. The impact of these issues has resonated throughout the entire food community. The coarse of action that regulators decide to take in coming years will change how the nation relates to food. Regulators and industry leaders must deal with the increased amount of responsibility they hold, the changing face of food products, contention between industry and consumers, and administrative shortcomings. Both the Food and Drug Administration and industry leaders are working to maintain the high level of food …

Judicial Review Of Fda Preemption Determinations, Amanda Frost

Scholarly Articles in Law Reviews & Journals

No abstract provided.

Introduction: Three Contributions To Three Important Problems In Evidence Scholarship, Peter Tillers

Cardozo Law Review

This issue of the Cardozo Law Review is graced with original contributions about three fundamental problems in evidence scholarship and the law of evidence. First, in an exchange of views about legal remedies for the wrongful infliction of "evidential damage," Professors Ariel Porat and Alex Stein, on the one hand, and Professor Richard Friedman, on the other, touch on some of the difficulties that are associated with the nearly oxymoronic task of measuring the harm done by the destruction or loss of unknown evidence. Second, in an article about the relationship between estimation of drug quantities and burdens of proof, …

Des Third-Generation Liability: A Proximate Cause, Tracey I. Batt

Cardozo Law Review

The drug DES has been associated with multigenerational injuries. Although courts in a number of states have allowed many second-generation DES victims to recover from the drug's manufacturers, this remedy, to date, has not been extended to thirdgeneration DES casualties. A number of reasons have been cited for this refusal, but the fear of requiring a drug manufacturer to be perpetually liable to descendants of those who ingested DES as well as the tricky issue of proximate causation predominate. This Note argues that at least some third-generation DES victims could (and should) be allowed to recover, without changing any laws …

Assembling A Theory Of Infringement: Third Party Liability Based On In Vivo Production Of Patented Pharmaceuticals, Eitan Alexander Ogen

Cardozo Law Review

This Note addresses the novel and still unresolved issues raised by the facts underlying Zenith. Part I describes the patent law system and its importance to the pharmaceutical industry. Part II discusses statutory interpretation issues raised by Zenith, relating to direct infringement and associated third party liability, as they pertain to the metabolic processes of living beings. Part III analyzes these issues in light of the existing case law. Part IV integrates the discussion by proposing a set of factors to be weighed in analyzing infringement actions against third parties that is consistent with the prevailing jurisprudence, the …

Anatomy Of A Regulatory Program: Comment On 'Strategic Regulators And The Choice Of Rulemaking Procedures', Jeffrey Lubbers

Scholarly Articles in Law Reviews & Journals

Besides being a very interesting, cogent, and even a tidy study, "Strategic Regulators" sheds some bright light on agency behavior and on the important issue of whether agency rulemaking may be "ossifying."

The study design employed by Hamilton and Schroeder is attractively simple. They started with all of the Environmental Protection Agency's ("EPA's") hazardous waste regulations under the Resource Conservation and Recovery Act ("RCRA") appearing in the Code of Federal Regulations ("CFR"), counting each decimal point CFR number as a separate rule. This yielded 697 rules. They then examined all EPA/RCRA guidance documents issued since the inception of the program …

Strict Products Liability: The Original Intent, George L. Priest

Cardozo Law Review

No abstract provided.