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Articles 271 - 300 of 413
Full-Text Articles in Food and Drug Law
Side Effects: State Anti-Fraud Statutes, Off-Label Marketing, And The Solvable Challenge Of Causation, Isaac D. Buck
Side Effects: State Anti-Fraud Statutes, Off-Label Marketing, And The Solvable Challenge Of Causation, Isaac D. Buck
Cardozo Law Review
While the American public remains preoccupied with the lurching implementation of the Affordable Care Act, the regulation of pharmaceutical companies for their off-label marketing and promotion of drugs features a regulatory environment within the health industry that seems to be in wild flux. Following the Second Circuit's decision in United States v. Caronia, commentators and providers are unsure about the future of federal regulation in this area, with the FDA seeking to minimize the opinion and pharmaceutical companies celebrating its impact. Much of the understandably spirited reaction to the Caronia case has omitted a discussion of the relevant and …
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.
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, …
Keynote Remarks: Re-Tooling Law And Legal Education For Food System Reform: Food Law And Policy In Practice, Emily M. Broad Leib
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.
The Dangerous Right To Food Choice, Samuel R. Wiseman
The Dangerous Right To Food Choice, Samuel R. Wiseman
Seattle University Law Review
Scholars, advocates, and interest groups have grown increasingly concerned with the ways in which government regulations—from agricultural subsidies to food safety regulations to licensing restrictions on food trucks—affect access to local food. One argument emerging from the interest in recent years is that choosing what foods to eat, what I have previously called “liberty of palate,” is a fundamental right. The attraction is obvious: infringements of fundamental rights trigger strict scrutiny, which few statutes survive. As argued elsewhere, the doctrinal case for the existence of such a right is very weak. This Essay does not revisit those arguments, but instead …
On The Permanence Of Permanent Law: An Argument For The Continued Presence Of The Permanent Law Provisions In The Farm Bill, Kate Giessel
On The Permanence Of Permanent Law: An Argument For The Continued Presence Of The Permanent Law Provisions In The Farm Bill, Kate Giessel
Cardozo Public Law, Policy & Ethics Journal
No abstract provided.
Putting A Gag On Farm Whistleblowers: The Right To Lie And The Right To Remain Silent Confront State Agricultural Protectionism, Rita-Marie Cain Reid, Amber L. Kingery
Putting A Gag On Farm Whistleblowers: The Right To Lie And The Right To Remain Silent Confront State Agricultural Protectionism, Rita-Marie Cain Reid, Amber L. Kingery
Journal of Food Law & Policy
Whistleblowers play an important role in filling gaps in government food safety systems. Unfortunately, several dominant food-producing states have pursued legislative initiatives that punish farm whistleblowers and silence investigative tactics. First, this research describes various state legislative initiatives that curb criticism of agriculture. The work analyzes the federal food safety system and how these protections limiting agricultural criticism contravene that food safety net. Further, the research analyzes the free speech concerns in the newest protectionist laws. The analysis recommends strategies and future research to improve agriculture safety and protect free speech in an evolving food safety landscape.
Keeping The Farm And Farmer In Food Policy And Law, Neil D. Hamilton
Keeping The Farm And Farmer In Food Policy And Law, Neil D. Hamilton
Journal of Food Law & Policy
Thank you for the opportunity to be with you, it is always a pleasure to return to the University of Arkansas Law School where I began my teaching career in the fall of 1981. We are pleased Drake University Law School and the University of Arkansas College of Law have built and maintained a partnership on teaching and research that stretches back over three decades. I am especially pleased to be with you as we celebrate the 10th Anniversary of the Journal of Food Law and Policy, another part of the University's pioneering work in the area of food policy …
Patent Punting: How Fda And Antitrust Courts Undermine The Hatch-Waxman Act To Avoid Dealing With Patents, Rebecca S. Eisenberg, Daniel A. Crane
Patent Punting: How Fda And Antitrust Courts Undermine The Hatch-Waxman Act To Avoid Dealing With Patents, Rebecca S. Eisenberg, Daniel A. Crane
Michigan Telecommunications & Technology Law Review
Under the Hatch-Waxman Act, patent law and FDA regulation work together to determine the timing of generic entry in the market for drugs. But FDA has sought to avoid any responsibility for reading patents, insisting that its role in administering the patent provisions of the Hatch-Waxman Act is purely ministerial. This gap in regulatory oversight has allowed innovators to use irrelevant patents to defer generic competition. Meanwhile, patent litigation has set the stage for anticompetitive settlements rather than adjudication of the patent issues in the courts. As these settlements have provoked antitrust litigation, antitrust courts have proven no more willing …
Michigan Craft Beer Legislation, Kincaid C. Brown
Michigan Craft Beer Legislation, Kincaid C. Brown
Law Librarian Scholarship
Michigan is currently in the midst of a craft beer boom. The Michigan Brewers Guild’s member list includes more than 150 breweries and brewpubs brewing craft beer. Michigan’s craft beer industry is boosting the state’s economy. According to an analysis by the Brewers Association customized by the Michigan Brewers Guild, the craft beer industry is directly responsible for more than 5,000 Michigan jobs and contributes more than $277 million to the state’s economy and more than $144 million in wages.
The Hamburglar, Friend Or Foe: What Is The Best Solution For Lawsuits Alleging Obesity Caused By Fast Food Outlets When No Causal Link Between Consumption And Obesity Can Be Found?, Mary Hoshall Hodges
The Hamburglar, Friend Or Foe: What Is The Best Solution For Lawsuits Alleging Obesity Caused By Fast Food Outlets When No Causal Link Between Consumption And Obesity Can Be Found?, Mary Hoshall Hodges
Journal of Food Law & Policy
When is the last time you ventured through the drive-thru of a fast food establishment? Maybe last night when it was just easier than taking the time to cook dinner, or maybe last weekend on your way home from vacation, or maybe when you were running low on funds and needed a cheap meal? Given the busy, fast-paced lives Americans lead, it is no wonder that many rely on the fast food industry, even though most would not care to admit it.
Restructuring Local School Wellness Policies: Amending The Kids Act To Fight Childhood Obesity, Rebecca Edwalds
Restructuring Local School Wellness Policies: Amending The Kids Act To Fight Childhood Obesity, Rebecca Edwalds
University of Michigan Journal of Law Reform
Childhood obesity is a major problem plaguing the United States. Over one-third of children are overweight, and there is little indication that this trend will reverse in the near future. The federal government has attempted to combat childhood obesity through the National School Lunch Act, which regulates the quality of foods federally subsidized schools may serve to children, and provides broad goals for physical activity. These basic goals leave extensive room for states to implement different standards, and they are not sufficient to effectively confront the childhood obesity problem. This Note proposes amendments to the National School Lunch Act that …
Let My Brewers Go! A Look At Home Brewing In The U.S., Hannah Jeppsen
Let My Brewers Go! A Look At Home Brewing In The U.S., Hannah Jeppsen
Journal of Food Law & Policy
In mid-August of 2012, a group of Americans stormed the White House, demanding transparency on a subject many Americans may find surprising: beer. More specifically, Americans requested White House home brew recipes, a presidential secret until Barack Obama's administration released them on September 1, 2012. Not only does Obama enjoy a good home brew, he is also the first president to brew in the White House and even take beer on the campaign trail. However, it was the August petition that garnered home brewing national media attention.
Health And Welfare Preempted: How National Meat Association V. Harris Undermines Federalism, Food Safety, And Animal Protection, Marya Torrez
Journal of Food Law & Policy
In 2008, the Humane Society of the United States (HSUS) released an undercover video filmed at the Hallmark Meat Packing Company and Westland Meat Company (Hallmark/Westland) in Chino, California. "The footage depicted nonambulatory cows being kicked, dragged, electrocuted, jammed with forklifts and sprayed in the nostrils with water to simulate drowning - in an effort to get them to stand up and walk to their slaughter." At least five inspectors from the U.S. Department of Agriculture (USDA) - the federal agency tasked with ensuring that food safety and animal welfare guidelines are followed - were present at the time. The …
Vape Away: Why A Minimalist Regulatory Structure Is The Best Option For Fda E-Cigarette Regulation, Nick Dantino
Vape Away: Why A Minimalist Regulatory Structure Is The Best Option For Fda E-Cigarette Regulation, Nick Dantino
University of Richmond Law Review
No abstract provided.
The Grapes Of Wrath: Encouraging Fruitful Collaborations Between Local Governments And Farm Wineries In The Commonwealth, Philip Carter Strother, Andrew E. Tarney
The Grapes Of Wrath: Encouraging Fruitful Collaborations Between Local Governments And Farm Wineries In The Commonwealth, Philip Carter Strother, Andrew E. Tarney
University of Richmond Law Review
No abstract provided.
The Forgotten Half Of Food System Reform: Using Food And Agricultural Law To Foster Healthy Food Production, Emily Broad Leib
The Forgotten Half Of Food System Reform: Using Food And Agricultural Law To Foster Healthy Food Production, Emily Broad Leib
Journal of Food Law & Policy
America is facing widespread problems with its food system, including environmental harms due to externalities from industrial farms; the increasing amount of "food _miles" traveled by the products that make up our daily meals; and the growing size and complexity of recent outbreaks of foodborne illnesses. Indeed, the entire system that covers the life cycle of food, through production, processing, distribution, consumption, and food waste management, is in crisis. One of the most disturbing of these well-documented problems with the industrial food system is the increase in rates of obesity and diet-related illnesses. Obesity rates in the U.S. have more …
An Overview Of Arkansas' Right-To-Farm-Law, L. Paul Goeringer, H. L. Goodwin
An Overview Of Arkansas' Right-To-Farm-Law, L. Paul Goeringer, H. L. Goodwin
Journal of Food Law & Policy
In the 1980s, state legislatures in all fifty states enacted statutes commonly referred to as "right-to-farm" laws. Arkansas enacted its right-to-farm law ("the Act") in 1981. While there are similarities, these laws differ from state-to-state. All right-to-farm laws provide agricultural producers with statutory defenses to nuisance challenges, subject to certain conditions. As one scholar has noted, right-to-farm laws are designed "to protect existing farm investments by reducing actions under nuisance law that enjoined agricultural activities." These laws also work to preserve farmland and protect established farmland from the pressures of urbanization, allowing "farmers to continue with their husbandry pursuits rather …
United States Food Law Update: Shrouded By Election-Year Politics, State Initiatives And Private Lawsuits Fill In The Gaps Created By Congressional And Agency Ossification, A. Bryan Endres, Lisa R. Schlessinger, Rachel Armstrong
United States Food Law Update: Shrouded By Election-Year Politics, State Initiatives And Private Lawsuits Fill In The Gaps Created By Congressional And Agency Ossification, A. Bryan Endres, Lisa R. Schlessinger, Rachel Armstrong
Journal of Food Law & Policy
Observers of food law in the 2012 presidential election year witnessed a dramatic slowing of federal initiatives-perhaps arising from a desire by both Congress and the administration to avoid upsetting critical constituent groups during a year seemingly dominated by campaigns and endless talking points. For example, Congress failed to take action on a unique compromise between what some had considered mortal enemies-the Humane Society of the United States and United Egg Producers-that would implement a federal animal welfare standard for laying hens in return for abandoning ballot measures in various states. Similarly, the FDA waited until the early days of …
The U.S. Department Of Agriculture As A Public Health Agency? A "Health In All Policies" Case Study, Lindsay F. Wiley
The U.S. Department Of Agriculture As A Public Health Agency? A "Health In All Policies" Case Study, Lindsay F. Wiley
Journal of Food Law & Policy
The "war on obesity" is now well into its second decade. What began as an effort to encourage medical doctors to screen and treat patients whose weight put them at risk for health problems has transformed into a much broader public health campaign to address the root causes of obesity. A growing number of state, territorial and local health departments are currently exploring new ways to promote healthy eating and physical activity. At the federal level, the U.S. Centers for Disease Control and Prevention (CDC) has made "nutrition, physical activity and obesity" a top priority.
Locally Grown Food: Examining The Ambiguity Of The Term 'Local' In Food Marketing, Brad Rose
Locally Grown Food: Examining The Ambiguity Of The Term 'Local' In Food Marketing, Brad Rose
Journal of Food Law & Policy
Locally grown food products are becoming increasingly popular among consumers. In response, many food retailers are devoting more space to locally grown products. The locally grown label is part of a marketing strategy designed to take advantage of consumer desires for fresh and safe products that support local farmers and help the environment. Many consumers believe that locally grown food is "fresher, has fewer chemicals, and comes from smaller, less corporate farms.' This increased demand from consumers has led to an "explosion of the use of the word 'local' in food marketing." However, there is no single definition of "local" …
California And Uncle Sam's Tug-Of-War Over Mary Jane Is Really Harshing The Mellow, Daniel Mortensen
California And Uncle Sam's Tug-Of-War Over Mary Jane Is Really Harshing The Mellow, Daniel Mortensen
Journal of the National Association of Administrative Law Judiciary
No abstract provided.
Chapter 415: Big Help For Small Businesses, Matthew Read
Chapter 415: Big Help For Small Businesses, Matthew Read
McGeorge Law Review
No abstract provided.
Interpreting Biological Similarity: Ongoing Challenges For Diverse Decision Makers, Sarah M. Cork
Interpreting Biological Similarity: Ongoing Challenges For Diverse Decision Makers, Sarah M. Cork
Michigan Telecommunications & Technology Law Review
Similarity is an elusive and complicated concept facing comparisons of biological molecules, as even minute changes to a molecule's structure can dramatically affect its function in the body. Yet the flood of biologic drugs on the market will increasingly force these similarity comparisons. These concerns are particularly relevant to two groups of drugs: families of biologic drugs that closely resemble each other in structure and function, here termed "similar-impact biologics," and the biosimilars, which are intended to closely approximate generic forms of biologic drugs. In bringing biologic drugs to the market, manufacturers are likely to face dual obstacles: FDA approval …
A Fresher Law: Amending The Florida Right To Farm Act To Include Urban Micro Farming As A Key Initiative To Promote Sustainability, Food Access, And Environmental Justice For Low-Income Communities, Cameryn Rivera
Florida A & M University Law Review
No abstract provided.
When Everyone Is An Orphan: Against Adopting A Us-Styled Orphan Drug Policy In Canada, Matthew Herder
When Everyone Is An Orphan: Against Adopting A Us-Styled Orphan Drug Policy In Canada, Matthew Herder
Articles, Book Chapters, & Popular Press
Putting aside whether diseases that affect only small numbers of people ("rare diseases") should be prioritized over diseases that are otherwise orphaned, in this paper I argue that a new approach to rare, orphan diseases is needed. The current model, first signaled by the United States’ Orphan Drug Act and subsequently emulated by several other jurisdictions, relies on a set of open-ended criteria and market-based incentives in order to define and encourage drug therapies for rare, orphan diseases. Given a) the biopharmaceutical industries’ growing interest in orphan diseases, b) progress in the sphere of personalized medicines enabling more and more …
Regulating Prescription Drugs For Patient Safety: Does Bill C-17 Go Far Enough?, Matthew Herder, Elaine Gibson, Janice Graham, Joel Lexchin, Barbara Mintzes
Regulating Prescription Drugs For Patient Safety: Does Bill C-17 Go Far Enough?, Matthew Herder, Elaine Gibson, Janice Graham, Joel Lexchin, Barbara Mintzes
Articles, Book Chapters, & Popular Press
Canada was the last developed country in the world to remove thalidomide from the market, and doing so required an Act of Parliament. At the request of Health Canada’s then Food and Drug Directorate, thalidomide’s two manufacturers voluntarily withdrew the drug from the market on Mar. 2, 1962. However, most of the drug’s distribution was in the form of free samples to medical professionals, which the directorate had no legal authority to control. Therefore, to avoid similar situations in the future and to stop sales of thalidomide, on Dec. 4, 1962, the Parliament of Canada amended the Food and Drugs …
The Special Supplemental Nutrition Program For Women, Infants, And Children (Wic) And The Supplemental Nutrition Assistance Program (Snap): Comparing Policies And Suggesting Changes, Regina T. Cucurullo
The Special Supplemental Nutrition Program For Women, Infants, And Children (Wic) And The Supplemental Nutrition Assistance Program (Snap): Comparing Policies And Suggesting Changes, Regina T. Cucurullo
Journal of Food Law & Policy
National concerns, such as obesity, should be addressed through national efforts. Considering the national reach of the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) and the Supplemental Nutrition Assistance Program (SNAP) and their ability to influence the diets of a significant amount of the nation's population, changes to these programs should be made to encourage healthy nutrition.
Food And Agricultural Security Strategy And Its Implementation Under Public Health Security And Bioterrorism Preparedness And Response Act Of 2002, Vivek V. Nemane
Food And Agricultural Security Strategy And Its Implementation Under Public Health Security And Bioterrorism Preparedness And Response Act Of 2002, Vivek V. Nemane
Journal of Food Law & Policy
The U.S. agricultural system can be described as concentrated, specialized and industrialized. A typical food chain generally involves agricultural production, storage, processing and distribution. In the U.S. agricultural and food system, most production, distribution and processing is done in a consolidated and centralized manner.
Food Sovereignty In The United States: Supporting Local And Regional Food Systems, Allison Condra
Food Sovereignty In The United States: Supporting Local And Regional Food Systems, Allison Condra
Journal of Food Law & Policy
Today, perhaps more than ever, an increasing portion of U.S. society is paying attention to and asking questions about our food and agricultural system. We are recognizing the immense consequences of the agricultural "efficiencies" we valued and wrote into our policies in the seventies-for example, growing corn "fence row to fence row" and the ease of microwaved meals and prepackaged foods. 3 The increasingly global nature of our food system and its consequences are becoming more apparent. Food safety concerns-prompted by a growing number of foodborne illness outbreaks and the government's response in the 2009 Food Safety Modernization Act-loom large …
The Real Toy Story: The San Francisco Board Of Supervisors Healthy Food Incentives Ordinance, Cortney Price
The Real Toy Story: The San Francisco Board Of Supervisors Healthy Food Incentives Ordinance, Cortney Price
Journal of Food Law & Policy
Obesity among children in the United States has tripled over the last thirty years. Incidentally, the world's largest fast food restaurant, McDonald's, first introduced its children's Happy Meal thirty-two years ago. Shortly thereafter, the first Disney inspired toy found its way into Happy Meals and the hearts of the "billions and billions served." Although the iconic Happy Meal and accompanying toy have become "a staple of Americana akin to baseball and apple pie," the continued existence of the practice is being threatened in light of the powerful influence toys have on children's food choices, thus contributing to the current obesity …