Food and Drug Law Commons^™

Keep Out Fda: Food Manufacturers' Ability To Effectively Self-Regulate Front-Of-Package Food Labeling, Ellen A. Black

DePaul Journal of Health Care Law

No abstract provided.

The Medicine Shoppe V. Loretta Lynch: Pharmacists’ Corresponding Responsibility With Physicians Under Dea Interpretation Of The “Legitimate Medical Purpose” Standard, Jeffrey C. Grass Jd, Ms, Aclm

Jeffrey C Grass Esq.

The Medicine Shoppe v. Loretta Lynch et al. 14-1223 will assist pharmacists and pharmacy owners in understanding their duties “corresponding responsibility to assure that its prescriptions for controlled substances are issued for a legitimate medical purpose” and “in the practitioner's usual course of professional practice.” In the meantime, pharmacists need to know that they are not immune from administrative, regulatory or criminal prosecution under the CSA solely due to their status. Rather, they are expected to dispense drugs for the bona fide treatment of a patient's disease. Under this regime, he or she must exercise sound professional judgment when evaluating …

Defining The "Defined"—Problem Gambling, Pathological Gambling, And Gambling Disorder: Impact On Policy And Legislation, Sarah A. Hinchliffe

Barry Law Review

No abstract provided.

Regulatory Competitive Shelters In The Area Of Personalized Medicine, Yaniv Heled

Yaniv Heled

No abstract provided.

Exploring The Link Between Food Security And Climate Change, Kaitlin Y. Cordes

Columbia Center on Sustainable Investment Staff Publications

Our growing global population is demanding a more resource-intensive and so-called “Western” diet. And that change in demand has drastic impact on how we must change our supply.

Culinary Jurisprudence And National Identity: Penny Pether On The Taste Of Country Cooking, Nan Seuffert

Villanova Law Review

No abstract provided.

Drugs For The Indigent: A Proposal To Revise The 340b Drug Pricing Program, Connor J. Baer

William & Mary Law Review

No abstract provided.

Regulating Drug Promotion To Promote The Public Health: A Response To Bennett, Et Al., Patricia J. Zettler

Faculty Publications By Year

No abstract provided.

European Court Of Justice Rules In Favour Of Greater Transparency In Accessing Efsa Data, Luis González Vaqué

Luis González Vaqué

This commentary looks at an interesting judgment by the European Court of Justice (ECJ) on 16 July. The judgment relates to plant protection products, but as it seeks to achieve levels of transparency capable of overcoming the lack of trust towards the European Food Safety Authority (EFSA) - often accused of being biased for using experts with vested interests because of their industry associations - it may also be relevant to the food sector, given that the EFSA deals with many authorization procedures, opinions, etc. related to food products.

Resumen de la conferencia pronunciada el 10.11.2015 en San Cugat del …

Legal Risk Management In Online Sales Of Food And Wine, Dan Svantesson

Dan Svantesson

Most businesses have an online presence, but an online presence brings a legal risk exposure. The extent and type of risks that businesses expose themselves to vary depending on the industry as well as how they structure their online presence. This article examines a selection of legal risks facing businesses engaging in online sales and marketing of food and wine products. It also presents strategies for managing those risks.

The Safe Drinking Water / Food Law Nexus, Margot J. Pollans

Pace Environmental Law Review

At 2 AM on August 2, 2014, the Ohio Environmental Protection Agency issued the following warning to the citizens of Toledo: “Do Not Drink.” The Ohio City's tap water was contaminated with microcystin, a toxin that can cause diarrhea, vomiting, and abnormal liver function. The source was an algal bloom in Lake Erie resulting from high levels of agricultural fertilizers and animal waste. For three days, Toledo residents drank only bottled water.

This is just one of many similar examples of agricultural contamination of urban drinking water supplies. Creating a physical connection between urban and rural communities, this pollution highlights …

The Cost Of Confusion: The Paradox Of Trademarked Pharmaceuticals, Hannah Brennan

Michigan Telecommunications & Technology Law Review

The United States spends nearly $1,000 per person annually on drugs—forty percent more than the next highest spender, Canada, and more than twice the amount France and Germany spend. Although myriad factors contribute to high drug spending in the United States, intellectual property law plays a crucial and well-documented role in inhibiting access to cheaper, generic medications. Yet, for the most part, the discussion of the relationship between intellectual property law and drug spending has centered on patent protection. Recently, however, a few researchers have turned their attention to a different avenue of exclusivity—trademark law. New studies suggest that pharmaceutical …

An Administrative Meter Maid: Using Inter Partes Review And Post-Grant Review To Curb Exclusivity Parking Via The "Failure To Market" Provision Of The Hatch-Waxman Act, Brian T. Apel

Michigan Law Review

Congress created the unique Hatch-Waxman framework in 1984 to increase the availability of low-cost generic drugs while preserving patent incentives for new drug development. The Hatch-Waxman Act rewards generic drug companies that successfully challenge a pharmaceutical patent: 180 days of market exclusivity before any other generic firm can enter the market. When a generic firm obtains this reward, sometimes drug developers agree to pay generic firms to delay entering the market. These pay-for-delay agreements give rise to exclusivity parking and run counter to congressional intent by delaying full generic drug competition. The Medicare Prescription Drug, Improvement, and Modernization Act created …

The Jurisprudence Of Nature: The Importance Of Defining What Is "Natural", Jill M. Fraley

Jill M. Fraley

Informal regulations defining nature, natural, and organic have proliferated across diverse fields of law from patents to agriculture, from taxation to gemstones. The unwritten jurisprudence of defining nature is primarily a story of the struggle to isolate mankind’s manipulations and interventions, creating a man-nature dichotomy that frustrates more than it explicates. This failure to define nature continues with the Supreme Court’s recent Myriad decision, which struggles to define the law of nature exception to patentability, highlighting the challenge of measuring levels of human intervention and manipulation. Our dichotomous definitions do not generate neat, binary answers, but rather complicated scales of …

The Minty Taste Of Death: State And Local Options To Regulate Menthol In Tobacco Products, Michael Freiberg

Catholic University Law Review

Explaining why the additive menthol in tobacco products creates major public health risks, this article advocates for restricting the addition of menthol in cigarettes as a way to reduce smoking-related disease and death. Author Michael Freiberg describes how the decision to regulate menthol in tobacco products, on a federal level, was historically delegated by Congress to the discretion of the U.S. FDA, outlines the U.S. FDA’s subsequent failure to regulate menthol, and surveys state and local government efforts to regulate menthol in response to the FDA’s inaction. The article proposes additional actions that these state and local governments could take …

Regulatory Competitive Shelters, Yaniv Heled

Yaniv Heled

This Article identifies an array of seemingly disparate federal exclusivity regimes as belonging to an increasingly prevalent and relatively new class of highly valuable government benefits, which it names “regulatory competitive shelters” (RCSs). It characterizes RCSs and distinguishes them from other, more traditional kinds of government-instituted properties. The Article then proceeds to describe a particular brand of RCSs established in federal statutory frameworks whose aim—much like patents—is to create incentives for technological innovation. Identifying several common motifs of such RCS regimes, the Article offers a taxonomy of these RCSs and describes the mechanisms by which RCSs instituted under such regimes …

New Dtca Guidance — Enough To Empower Consumers?, Christopher Robertson

Faculty Scholarship

As one of only two countries that permit direct-to-consumer advertising (DTCA) of pharmaceuticals, the United States tasks the Food and Drug Administration (FDA) with regulating that advertising to ensure that it doesn't mislead consumers. When a drug maker publishes or broadcasts a claim that its drug has benefits in a particular disease, the FDA requires it to include information on the product's risks as well. Since it's not feasible for companies to include all the important information about their products in a television ad, the FDA requires them to refer viewers to more complete information, such as that in a …

Consuming Identities: Law, School Lunches, And What It Means To Be American, Melissa Mortazavi

Melissa Mortazavi

No abstract provided.

Are Food Subsidies Making Our Kids Fat? Tensions Between The Healthy Hunger-Free Kids Act And The Farm Bill, Melissa D. Mortazavi

Melissa Mortazavi

On December 15, 2010, President Obama signed the Healthy Hunger- Free Kids Act of 2010 (HHFKA)1 into law. It was hailed as a bipartisan success and a significant reform of childhood nutrition policy. Indeed, on its surface the law appears to make a significant shift away from the food paradigm of the past. However, upon closer examination, it fails to unwind the tangled connections between domestic eating habits and longstanding farm subsidies. This Article breaks new ground in several ways: First, it is one of the first essays in the emerging and underexplored field of food law, a crosssection of …

The Treatment For Malpractice – Physician, Enhance Thyself: The Impact Of Neuroenhancements For Medical Malpractice, Harvey L. Fiser

Harvey L. Fiser

Coming to a hospital near you, the medically enhanced doctor - a doctor who thinks faster, is better with short and long term memory, is calmer during surgery, can work double shifts with little cognitive fatigue, and one day may have the memories of years of experience without actually having had them. With the expanded use of cognitive enhancing pharmaceuticals such as Adderall, Provigil, and more on the way, we are already seeing changes in education and the corporate world. From reaching a “normal” status for a person with an ADHD diagnosis to creating the “supernormal” employee with cognitive enhancers, …

Private Regulation And Foreign Conduct, Adam I. Muchmore

Adam I. Muchmore

Current U.S. policy on safety regulation for imported food is based largely on ex post measures. Several reform proposals seek to strengthen the ex ante component of this regulatory program. These proposals rely on one or more of three basic strategies: direct extraterritorial regulation; delegation of regulatory authority to private entities; and delegation of regulatory authority to foreign government agencies. This paper explores the ability of each strategy to respond to several principal-agent problems relevant to imported-food safety: the regulatory license problem; interest group capture; and the reality of bribery and threats in many food-exporting countries. Through the lens of …

Food And Drug Law: The Infant Formula Act Of 1980, Randal D. Shields

Akron Law Review

The Infant Formula Act of 19802 (hereinafter the Act) was a culmination of the efforts of mothers, physicians, reporters, administrators, businessmen and congressmen to provide regulations and guidelines to prevent similar tragic episodes in the future. This comment will focus on the Act, as well as the events leading up to its promulgation. The examination will begin with the remarkable discovery in infants of the rare affliction known as metabolic alkalosis and the subsequent research which has established a direct correlation between the defective formulas and the infants' conditions. Despite an expedient voluntary recall of the formulas, controversy raged in …

Protecting Patients: A Proposal For Codifying The Reasonable Innovation Rule, Stephanie M. Mehle

Akron Law Review

Part II of this Comment will examine the history of human experimentation and how the current regime of experimenting developed then explore the gap between experimentation approved by an Institutional Review Board (“IRB”) and FDA oversight. Part III will consider the competing interests of individual patient protection and medical innovation in general and whether informed consent appropriately balances those interests. Part IV will evaluate the inadequacies of current reliance on informed consent by using two case studies, both involving novel microbial procedures, and discuss how codification of the reasonable innovation rule would address those inadequacies. Ultimately, this Comment will argue …

Compassionate Use Of Experimental Therapies: Who Should Decide?, Patricia J. Zettler

Faculty Publications By Year

In addition to being an example of unsubstantiated hype about regenerative medicine, the controversy around the Italy-based Stamina Foundation's unproven stem cell therapy represents another chapter in a continuing debate about how to balance patients' requests for early access to experimental medicines with requirements for demonstrating safety and effectiveness. Compassionate use of the Stamina therapy arguably should not have been permitted under Italy's laws, but public pressure was intense and judges ultimately granted access. One lesson from these events is that expert regulatory agencies may be the institutions most competent to make compassionate use decisions and that policies should include …

It’S The End Of The Biological Patent World As We Know It, And Consumer Watchdog Feels Fine: How Consumer Watchdog Is Attempting To Kill The Future Of Horticultural Research, George R. Holton

George R Holton

No abstract provided.

The Pharmaceutical Access And Prudent Purchasing Act Of 1990: Federal Law Shifts The Duty To Warn From The Physician To The Pharmacist, Michael J. Holleran R.Ph.

Akron Law Review

This article will first discuss the legislation recently enacted as part of the budget reduction package passed by Congress in late 1990 and how that legislation will affect pharmacists' liability. Second, the article will address the applicable statutes of limitation regarding pharmacists in particular and within the general area of malpractice. Third, the applicable standard of care will be explored as it pertains to pharmacists as well as physicians. Coupled with the standard of care discussion is an overview of the various theories of liability which physicians and pharmacists currently face and how these may change under the Act. Finally, …

An International Sos (Save Our Sharks): How The International Legal Framework Should Be Used To Save Our Sharks, Crystal Green

Pace International Law Review

The purpose of this Article is to shed light on the plight on sharks in international and domestic waters. An estimated 100 million sharks are killed every year. The cruel and wasteful practice of shark finning is responsible for a large portion of those killings. Shark fins are the most valuable part of the shark, because they are used as the key ingredient – and namesake – in an Asian delicacy known as “shark fin soup.” This Article opens with background information on the dire situation sharks are facing in our oceans, and how the depletion of these top predators …

Book Review: Aids In The World, 16 Hous. J. Int'l L. 709 (1994), Mark E. Wojcik

Mark E. Wojcik

No abstract provided.

Keynote Remarks: Re-Tooling Law And Legal Education For Food System Reform: Food Law And Policy In Practice, Emily M. Broad Leib

Seattle University Law Review

Thank you for the opportunity to be with you today and to take part in this symposium on the important role law schools and lawyers can play in changing our food system. Food preferences and food choices are incredibly personal, but the way we produce and consume food, and its impacts on our environment, public health, and the safety of ourselves and others, make it a pressing societal issue as well.

Scuttling Iuu Fishing And Rewarding Sustainable Fishing: Enhancing The Effectiveness Of The Port State Measures Agreement With Trade-Related Measures, Anastasia Telesetsky

Seattle University Law Review

Illegal, unreported, and unregulated fishing (IUU fishing) is a substantial threat to global food security and a recurring problem for global fishery managers already facing difficult baseline situations exacerbated by climate change, including warming oceans and increasing acidification. There is nothing historically new about IUU fishing; there have always been poachers who take advantage of operating in the shadows of legal commercial fishing. What is new is the extent to which marine poaching has industrialized. It is estimated that 19% of the worldwide value of marine catches are unlawful. The problem is not limited to developing states. For example, even …