Food and Drug Law Commons^™

Food Ordinances: Encouraging Eating Local, Mia Shirley

William & Mary Environmental Law and Policy Review

No abstract provided.

What Is The Best Way For Manufacturers And Physicians To Apply Sunscreen To Avoid Being Burned By The Final Sunshine Act Regulations?, Abraham Gitterman

Student Articles and Papers

This [article] explains the requirements under the Patient Protection and Affordable Health Care Act’s Physician Payment Sunshine Act that all medical product manufacturers report to Health and Human Services (HHS) any payment or transfer of value made to physicians and teaching hospitals. Author Abraham Gitterman ... warns that manufacturers may face adverse consequences of public access to payment data, including fraud and abuse investigations and private litigation actions. He recommends that manufacturers begin training employees to ensure compliance with the statute and reduce the likelihood of further investigations. He further suggests that the Center for Medicare & Medicaid Services (CMS) …

California Expands Tort Liability Under The Novel Market Share Theory: Sindell V. Abbott Laboratories, N. Denise Taylor

Pepperdine Law Review

The California Supreme Court, in the novel and unprecedented case of Sindell v. Abbott Laboratories, eliminated the plaintiffs burden of identification of a negligent party, and thus the causation requirement, in a multiple party tort action. In the course of this decision, the court adopted the "market share" theory of liability which dictated in Sindell that nonidentifiable defendant-manufacturers of the generic drug DES would be liable for the damages in proportion to their share of business in the market. The author thoroughly examines various theories of recovery, such as "alternative liability," "concert of action" and "enterprise liability," which the court …

Fixing The Vaccine Act's Structural Moral Hazard, Brandon L. Boxler

Pepperdine Dispute Resolution Law Journal

The article presents information on the Vaccine Injury Compensation Program. It discusses the U.S. Federal circuit case Hazlehurst v. Sec'y of Health & Human Servs., in which lawsuit against the defendant was filed by the plaintiff who sought claims against the liability of product to recover damages for alleged injuries which his son had received from vaccines. It also provides information on the structural moral hazard of the program which devolves it into a litigious adjudicatory process.

The Illusion Of Interchangeability: The Benefits And Dangers Of Guidance-Plus Rulemaking In The Fda's Biosimilar Approval Process, Jonathan Stroud

Jonathan R. K. Stroud

On March 23, 2010, President Obama signed into law the ambitious Patient Protection and Affordable Care Act. While media attention focused largely on the sweeping changes the bill makes to the nation’s healthcare system, there was also a less-noticed rider to the bill, the Biologics Price Competition and Innovation Act of 2009 (Biosimilars Act). The Biosimilars Act grants the Food and Drug Administration (FDA) broad new authority to create an accelerated premarket approval pathway for generic competition to biologics in an attempt to drive biologic drug prices down and reduce the overall costs of health care. Traditionally, inventors of medical …

A Thousand Tiny Pieces: The Federal Circuit’S Fractured Myriad Ruling, Lessons To Be Learned, And The Way Forward, Jonathan R. K. Stroud

Jonathan R. K. Stroud

No abstract provided.

Mandatory Drug Testing Of College Athletes: Are Athletes Being Denied Their Constitutional Rights? , Allison Rose

Pepperdine Law Review

No abstract provided.

Chapter 415: Big Help For Small Businesses, Matthew Read

McGeorge Law Review

No abstract provided.

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

Publications

No abstract provided.

Frameworks For Amending Reservoir Water Management, Ethan Mower, Leandro E. Miranda

Publications

Managing water storage and withdrawals in many reservoirs requires establishing seasonal targets for water levels (i.e., rule curves) that are influenced by regional precipitation and diverse water demands. Rule curves are established as an attempt to balance various water needs such as flood control, irrigation, and environmental benefits such as fish and wildlife management. The processes and challenges associated with amending rule curves to balance multiuse needs are complicated and mostly unfamiliar to non-US Army Corps of Engineers (USACE) natural resource managers and to the public. To inform natural resource managers and the public we describe the policies and process …

A Water Rights Manual For Mutual Domestic Water Consumers Associations, Utton Center, University Of New Mexico - School Of Law, Zachary Carpenter, Gregory Chakalian, Darcy S. Bushnell

Publications

The Utton Center prepared this Water Rights Manual to assist Mutual Domestic Water Consumers Associations (MDWCAs) with the development, protection and management of their water rights.

This manual provides an introduction to and defines Water Rights in New Mexico, as well as to acquire and have recognized Water Rights. This document also covers water management and planning, and provides additional resources.

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.

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 …

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.

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

Florida A & M University Law Review

No abstract provided.

Rights And Roles: Alaska Natives And Ocean And Coastal Subsistence Resources, Jordan Diamond, Greta Swanson, Kathryn Mengerink

Florida A & M University Law Review

This article explores the strengths and weaknesses of the two pillars of the framework for managing marine subsistence resources in Alaska: the pillar that protects Alaska Native rights to marine subsistence resources, and the pillar that protects the resources themselves. It focuses on how well the pillars support subsistence practices and Alaska Native leadership in the management framework. Part I summarizes the management challenge posed by the effects rapid climate change is causing in the Arctic, including impacts to the marine subsistence resources upon which Alaska Natives depend. Part II explores the laws and doctrines related to Alaska Native subsistence …

The Unconstitutional Prosecution Of Controlled Substance Metabolites Under Utah Code § 41-6a-517, Joshua C. Snow

Utah OnLaw: The Utah Law Review Online Supplement

This Article achieves three main goals. First, it explains and explores Utah’s per se metabolite laws against the backdrop of the national landscape of metabolite laws. Second, this Article provides a concise explanation regarding the science of drug metabolites. Finally, this Article presents two constitutional challenges to Utah Code section 41-6a-517. The first challenge argues that the statute creates an impermissible status offense in violation of the Eighth Amendment to the U.S. Constitution. The second challenge argues that the statute violates Utah’s Uniform Operation of Laws Clause found in the Utah Constitution. This Article concludes by asking Utah state courts …

Public-Private Regime Interactions In Global Food Safety Governance, Ching-Fu Lin

Transnational Business Governance Interactions Working Papers

In response to an apparent decline in global food safety, numerous public and private regulatory initiatives have emerged to restore public confidence. This trend has been particularly marked by the growing influence of private regulators such as multinational food companies, supermarket chains and non-governmental organizations (NGOs), who employ private standards, certification protocols, third-party auditing, and transnational contracting practices. This paper explores how the structure and processes of private food safety governance interact with traditional public governance regimes, focusing on Global Good Agricultural Practices (GlobalGAP) as a primary example of the former. Due to the inefficiency and ineffectiveness of public regulation …

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

American University Business Law Review

No abstract provided.

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

Law Faculty Publications

No abstract provided.