Food and Drug Law Commons^™

No Duty To Warn Of Drug Interactions: A Dangerous Prescription, 46 J. Marshall L. Rev. 533 (2013), Ryanne Bush Dent

UIC Law Review

No abstract provided.

Do You Know What's On Your Plate?: The Importance Of Regulating The Processes Of Food Production, Martha Dragich

Faculty Publications

This article argues that the current regulatory approach-focusing on the supposed equivalence of new foods to traditional ones-is unduly narrow, particularly given the characteristics of the modem food system. To achieve the broad objectives of the FDCA in the context of the industrialized, highly processed, and global food supply of the twenty-first century requires adopting a broader understanding of consumer protection needs with respect to food. The FDCA itself is written in very broad terms and provides much of the authority needed today. The FDA's enforcement capacity, however, already is severely strained.52 Moreover, the scientific basis for some process- oriented …

Pharmageddon: A Statutory Solution To Curb Ohio's Prescription Abuse Problem, Ed Woodworth

Journal of Law and Health

Prescription abuse in Ohio continues to be a serious and complex issue that should be addressed. Accordingly, Part II of this Note examines the background of prescription drug abuse generally. It identifies the dangers of prescription drug abuse, the cost drug abuse places on society, some reasons for prescription drug abuse, sources of prescription drugs, and discusses the current state and federal laws regarding prescription drug abuse and prescription reporting. Part III discusses the positive and negative aspects of H.B. 93 and Medical Rule 4731-11-11 and then offers proposals to more effectively prevent prescription drug abuse. Part IV discusses various …

Finding A Cure: Incentivizing Partnerships Between Disease Advocacy Groups And Academic Commercial Researchers , Anne M. Readel

Journal of Law and Health

Collaborations between for-profit drug companies and not-for-profit disease advocacy groups have risen in recent years in an effort to find cures for orphan diseases. These unique and beneficial collaborations are a result of disease advocacy groups assuming a more active role in drug development through the use of “venture philanthropy,” which employs concepts and techniques from venture capitalism and applies them to achieving philanthropic goals. While these collaborations have found remarkable success, such as the discovery of the first known cure for cystic fibrosis in 2012, venture philanthropy for drug discovery presents numerous legal and social challenges. This Article examines …

Investing In Cannabis: Inconsistent Government Regulation And Constraints On Capital, Adrian A. Ohmer

Michigan Business & Entrepreneurial Law Review

This note’s focus is on the future of investing in the growing legalized cannabis industry. In Part II, it will provide a brief history of federal and state regulation of cannabis. Part III will discuss the current role of the federal government in regulating the cannabis industry. Part IV will explore the current avenues of access to capital for the cannabis industry. Lastly, Part V will provide suggestions for the federal government and state governments to reduce investment risk that exists in the cannabis industry.

Winter 2013 Utton Center Newsletter, Utton Center, University Of New Mexico - School Of Law

Publications

No abstract provided.

Regulating In Uncertainty: Animating The Public Health Product Safety Net To Capture Consumer Products Regulated By The Fda That Use Innovative Technologies, Including Nanotechnologies, Genetic Modification, Cloning, And Lab Grown Meat, Katharine A. Van Tassel

Faculty Publications

The past several decades have seen the creation of transformative new technologies that are being used to design innovative consumer product ingredients never seen before in nature. Examples include the use of nanotechnology and genetic modification, and, right around the corner, cloning and lab grown meat. These innovative technologies are harbingers of more pioneering consumer product ingredients to come. The remarkable pace of the development of ground-breaking new technologies means that the population is being steadily exposed to novel ingredients with unknown health risks.

Optimally, the Food & Drug Administration ("FDA") should be regulating these innovative, novel ingredients in consumer …

In Re K-Dur Antitrust Litigation: The Third Circuit's Controversial Pay-For-Delay Antitrust Decision Splits With Other Circuit Courts, Carl W. Hittinger, Lesli C. Esposito

Villanova Law Review (1956 - )

No abstract provided.

California's Proposition 37: Will Its Failure Forecast The Fate Of The Gm Food Labeling Movement In The United States Once And For All?, Meredith K. Schuh

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

From “Food Miles” To “Moneyball”: How We Should Be Thinking About Food And Climate, Bret C. Birdsong

Scholarly Works

Since Michael Pollan popularized the push to eat local food in his bestseller, The Omnivore’s Dilemma, the concept of “food miles” has been something of a rallying cry and an organizing principle in the marketing of the local food movement. Among locavores and their sympathizers, the term seems to encapsulate all that is wrong with the food system. Fresh grapes from Chile make their way to supermarkets from Maine to Minnesota, and even California. Major food conglomerates process commodity ingredients like corn, soy, and wheat into packaged food that travels across the country and across oceans before landing on …

Insights In Enforcement, Litigation & Compliance For Pharmaceutical And Medical Device Manufacturers At Fdli's Enforcement, Litigation And Compliance Conference, December 12-13, 2012, Thomas Sullivan, Abraham Gitterman

Student Articles and Papers

No abstract provided.

Taxing The Platypygous, James J. White

Articles

This Article maintains that obesity in the United States is an enormous public health issue that causes the health care costs of the obese Americans greatly to exceed those of citizens of normal weight. Recognizing that that much of that cost will be born by publicly financed programs and that the taxes supporting those programs will constitute an externality that the fat impose on the thin, the Article proposes a tax on high calorie food-but only when that food is purchased by the obese. The Article addresses many of the administrative, moral and other objections to a tax aimed at …

The American Public’S Perception Of Illegal Steroid Use: A National Survey, 2013, Gary Siperstein, Neil Romano, Gizem Iskenderoglu, Anthony Roman, Floyd J. Fowler Jr., Max Drascher

Center for Social Development and Education Publications

Through the surge of news about doping scandals in the media, it is expected that the public is aware of the magnitude of the problem among professional athletes; however, it is uncertain whether the public is aware that the problem often starts when athletes are younger. To this end, the National Baseball Hall of Fame and Museum, the Taylor Hooton Foundation, and the Professional Baseball Athletic Trainers Society partnered with the Center for Social Development and Education and the Center for Survey Research at the University of Massachusetts Boston to conduct the most comprehensive national opinion survey to date to …

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 …

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 …

A National "Natural" Standard For Food Labeling, Nicole E. Negowetti

Law Faculty Publications

No abstract provided.

Reconciling American Marijuana Policy In A Federal System, Catherine Morton

Global Tides

The recent successful ballot initiatives in Colorado and Washington to legalize recreational marijuana despite restrictive federal law continue to demonstrate the disconnect between national and state marijuana policy. In order to understand how many of these national policies were enacted, an investigation will be presented of the discriminatory history of marijuana legislation, indicating the inconsistent nature of past regulation. Thus following will be an examination of relevant Supreme Court cases depicting the Supreme Court’s ultimate hesitation to prevent the states from circumventing federal marijuana law. Finally, a discussion will be held on the ramifications of inconsistent state and national policies, …

Up To Our Ears: Corn Overproduction, Its Environmental Toll, And Using The 2012 U.S. Farm Bill To Limit Corn Subsidies, Increase Environmental Protection Incentives, And Place Accountability On Crop Operations, Christopher Frump

Florida A & M University Law Review

No abstract provided.

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.

Good Policy, Good Food: Bringing A Just And Sustainable Food System To All, Mark Winne

Florida A & M University Law Review

No abstract provided.

The Crisis Of Over-Medicating Children In Foster Care: Legal Reform Recommendations For New York, Jessica Setless

Cardozo Journal of Equal Rights & Social Justice

No abstract provided.

Front-Of-Package Nutrition Claims: Trustworthy Facts Or Deceptive Marketing? Closing The Loopholes In Labeling, Kathryn E. Hayes

Cardozo Journal of Equal Rights & Social Justice

The note argues that front-of-package (FOP) labeling on children's food products is insufficient and often misleading, failing to meet basic nutritional standards. It advocates for the adoption of uniform, science-based labeling standards developed by an objective body like the Institute of Medicine (IOM) to help parents make healthier choices. The analysis highlights the limitations of self-regulation by manufacturers and the need for stronger governmental oversight to address deceptive practices and improve public health outcomes.

Preemption Under The Controlled Substances Act, Robert A. Mikos

Vanderbilt Law School Faculty Publications

States are conducting increasingly bold experiments with their marijuana laws, but questions linger over their authority to deviate from the federal Controlled Substances Act. The CSA bans marijuana outright, and commentators have assumed that Congress sought to preempt all state laws that might somehow conflict with the CSA. Under the preemption rule now in vogue, state marijuana reforms are preempted if they either require someone to violate the CSA or, more controversially, if they pose an obstacle to Congress’s objective of eradicating marijuana. Seeking to avoid such conflicts, government officials have scuttled a number of important state marijuana reforms. This …

The Paradox Of Legal Equivalents And Scientific Equivalence: Reconciling Patent Law's Doctrine Of Equivalents With The Fda's Bioequivalence Requirement, Janet Freilich

Faculty Scholarship

Contrary to popular perception, generic drugs often enter the market before the patents covering their brand name counterparts have expired by making slight changes to the drug to avoid the brand name patent. These generics face a paradox: the U.S. Food and Drug Administration (FDA) requires that the generic "not show a significant difference" from the reference product, while patent law requires that the generic have "substantial differences" as compared to the reference product. The generic must be bioequivalent, but not legally equivalent, to the brand name drug. This paradox occurs frequently in the courts but has never been discussed …

Do Graphic Tobacco Warnings Violate The First Amendment?, Nathan Cortez

Faculty Journal Articles and Book Chapters

When Congress passed the nation’s first comprehensive tobacco bill in 2009, it replaced the familiar Surgeon General’s warnings, last updated in 1984, with nine blunter warnings. The law also directed the U.S. Food and Drug Administration ('FDA') to require color graphics to accompany the textual warnings. By law, the warnings would cover the top fifty percent of the front and back of tobacco packaging and the top twenty percent of print advertisements, bringing the United States closer to many peer countries that now require graphic warnings. Tobacco companies challenged the requirement on First Amendment grounds, arguing that the compelled disclosures …

The Future Of Gene Patents And The Implications For Medicine, Jacob S. Sherkow, Henry Greely

Other Publications

The Supreme Court decision in Myriad Genetics struck down the patenting of human genomic DNA. What will this mean for genetic testing and medicine, more broadly?

Pay-To-Play: The Impact Of Group Purchasing Organizations On Drug Shortages, Christian Deroo

American University Business Law Review

No abstract provided.

Adjustments, Extensions, Disclaimers, And Continuations: When Do Patent Term Adjustments Make Sense?, Stephanie Plamondon Bair

Faculty Scholarship

The United States patent system represents a measured trade-off between two competing policy considerations: providing sufficient incentives to encourage the innovation and development of new and socially useful inventions; and ensuring that such inventions are readily available to the public at an affordable price. Although the default patent term is now twenty years from filing, various features of, and changes to, the patent system over the years have allowed patent owners to extend the duration of their patent monopolies, sometimes for several years. Such extensions, though seemingly insignificant when compared to the full patent term, have an enormous impact on …

The U.S. Department Of Agriculture As A Public Health Agency, Lindsay Wiley

Scholarly Articles in Law Reviews & Journals

Introduction: 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.

Who’S Your Nanny, Lindsay Wiley

Scholarly Articles in Law Reviews & Journals

INTRODUCTION: In June 2012, New York City Mayor Michael Bloomberg announced his plans for a ban on the sale of sugary beverages in containers larger than 16 ounces. Shortly thereafter, the Center for Consumer Freedom took out a full-page ad in the New York Times featuring Bloomberg photo-shopped into a matronly dress with the tag line "New Yorkers need a Mayor, not a Nanny."1 On television, the CATO Institute's Michael Cannon declared, "This is the most ridiculous sort of nanny state-ism; [ilt's none of the mayor's business how much soda people are drinking." And in news- papers around the country, …