Food and Drug Law Commons^™

The Mhealth Conundrum: Smartphones & Mobile Medical Apps – How Much Fda Medical Device Regulation Is Required?, Vincent J. Roth Esq

Vincent J Roth Esq

Smartphones and tablets have provided a plethora of new business opportunities for a number of industries including healthcare. Technology, however, appears to have outpaced the regulatory environment, which has spawned criticism over the current guidance of the Food and Drug Administration (“FDA”) with regard to software and what level of regulation is required for mobile medical applications. Commentators have remarked that the FDA’s guidance in this area is complex and unclear. This article explores the current FDA regulatory scheme for mobile medical applications and adapters for mobile devices designed to provide mobile healthcare, or “mHealth.” Attention is given to further …

The Mhealth Conundrum: Smartphones & Mobile Medical Apps – How Much Fda Medical Device Regulation Is Required?, Vincent J. Roth Esq

Vincent J Roth Esq

Smartphones and tablets have provided a plethora of new business opportunities for a number of industries including healthcare. Technology, however, appears to have outpaced the regulatory environment, which has spawned criticism over the current guidance of the Food and Drug Administration (“FDA”) with regard to software and what level of regulation is required for mobile medical applications. Commentators have remarked that the FDA’s guidance in this area is complex and unclear. This article explores the current FDA regulatory scheme for mobile medical applications and adapters for mobile devices designed to provide mobile healthcare, or “mHealth.” Attention is given to further …

Visual Gut Punch: Persuasion, Emotion, And The Constitutional Meaning Of Graphic Disclosure, Ellen P. Goodman

ellen p. goodman

The ability of government to “nudge” with information mandates, or merely to inform consumers of risks, is circumscribed by First Amendment interests that have been poorly articulated in the relevant law and commentary. New graphic cigarette warning labels supplied courts with the first opportunity to assess the informational interests attending novel forms of product disclosures. The D.C. Circuit enjoined them as unconstitutional, compelled by a narrative that the graphic labels converted government from objective informer to ideological persuader, shouting its warning to manipulate consumer decisions. This interpretation will leave little room for graphic disclosure and is already being used to …

Reports Of Its Death Are Greatly Exaggerated: Ebay, Bosch, And The Presumption Of Irreparable Harm In Hatch-Waxman Litgation, Kenneth C. Louis

Kenneth C. Louis

No abstract provided.

Throwing Dirt On Doctor Frankenstein's Grave: Accesss To Experimental Treatments At The End Of Life, Michael J. Malinowski

Michael J. Malinowski

Abstract

All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research …

Throwing Dirt On Doctor Frankenstein’S Grave: Access To Experimental Treatments At The End Of Life, Michael J. Malinowski

Michael J. Malinowski

All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research and …

Repairing The Antibiotic Pipeline: Can The Gain Act Do It?, Caitlin Forsyth

Washington Journal of Law, Technology & Arts

Antibiotic resistance, according to the World Health Organization, is one of the greatest threats to public health. To combat the problem, new antibiotics need to be developed. However, antibiotic research and development is fraught with scientific and economic problems. Recognizing these problems and the public health threat posed by antibiotic resistance, Congress passed the GAIN Act, which President Obama signed into law in June 2012. The GAIN Act (Act) incentivizes pharmaceutical companies to invest in antibiotic research and development. This Article will outline the incentives in the Act and suggest why the Act may not solve the growing antibiotic resistance …

What's In A Name?: Geographical Indicators, Legal Protection, And The Vulnerability Of Zinfandel, Stephen M. Jurca

Indiana Journal of Global Legal Studies

This note explores the issues countries face when one party allegedly takes unfair economic advantage of foreign competitors in an increasingly global market by broadly interpreting international product labeling laws in its favor. The United States' widespread use of the term "champagne" in its domestic sparkling wine industry is just one example of how "genericide"-the process by which a popular brand name becomes so commonly used that the term is no longer protected by intellectual property law-negatively affects trade relations and hampers economic growth. This note focuses on the dangers of genericide in the marketplace, most specifically, the international wine …

Food Court, Jason J. Czarnezki

Elisabeth Haub School of Law Faculty Publications

This article, focusing on produce and grain, discusses the environmental and climate change impacts of food production, processing, packaging, and distribution, which ultimately contribute to both economic and social costs. The article addresses environmental energy costs in the food supply. Figure 1 shows, for example, the significant amount of energy used in various aspects of food production, transportation, and processing.

Much of this article's focus will be on commodity crops. Along with wheat and rice, corn and soybeans constitute the world's most popular planted and consumed crops. The United States is the leading producer of corn, growing nearly 40 percent …

Application Of Responsive Regulation In The Food Safety Regulations Of Bangladesh, Abu Noman M. Atahar Ali

Abu Noman Mohammad Atahar Ali

Application of responsive regulation in the food safety regulations of Bangladesh - Abstract Bangladesh, a developing country of the South Asian region, has been suffering from rampant food adulteration for the last few decades. Recent studies revealed that numerous deaths along with countless physical illnesses are occurring as the consequences of this ongoing food adulteration. Several attempts have been made through to change the food safety regulations [FSR] of Bangladesh to combat this alarming issue. Unfortunately, the situation has hardly been changed. Rather it is getting worse day by day. However, Bangladesh has never changed the regulatory enforcement philosophy of …

The Perfect Pairing: Protecting U.S. Geographical Indications With A Sino-American Wine Registry, Laura Zanzig

Washington Law Review

Chinese counterfeiters have infiltrated the wine world, falsely labeling products and using fraudulent geographical indications (GIs). GIs, which function as a type of brand, are internationally protected designations of a product’s origin and characteristics. Recently, United States GIs, such as Napa or Walla Walla, have appeared on bottles of wine composed of Chinese grapes. By misappropriating U.S. brands, Chinese counterfeiters deceive and confuse consumers, disadvantage legitimate businesses, and causes health concerns. Unlike other brands, GIs protect regions, rather than individual producers. This creates a particular void: no single winery can register a GI and no single winery is harmed by …

Waging War On Specialty Pharmaceutical Tiering In Pharmacy Benefit Design, Chad I. Brooker

Chad I Brooker

Specialty drugs represent a growing concern for both health insurance issuers and beneficiaries given their exceedingly high (and growing) costs—representing almost half of all drug spend by 2017. Payers have sought to reduce their specialty drug spend by sharing more of the cost of these drugs with the beneficiaries who depend on them through the creation of specialty drug tiers. This has forced some patients to choose between forgoing other needs to pay for their medications or not take them at all. While several states have sought to outlaw the use of specialty drug tiers or limit pharmaceutical OOP cost-sharing, …

Responsive Regulation And Application Of Grading Systems In The Food Safety Regulatory Regimes Of Developing Countries, Abu Noman M. Atahar Ali

Abu Noman Mohammad Atahar Ali

The traditional tit-for-tat philosophy in the food safety regulatory regime in most developing countries has been proven ineffective in most cases. Rather, starting with persuasion, advice, and then escalating to more severe punishments for the continuing non-compliance as suggested in the responsive regulation by Ayres and Braithwaite has been proved more effective in the food safety regulatory regime of some jurisdictions. Responsive regulation aims to increase responsibility among corporations. So, if a corporation shows responsibility, it should be rewarded, and if a corporation shows irresponsibility, it should be reprimanded (if necessary). There is no logic in seeing and treating every …

Fair Or Foul: When Does Media Accusation Of Performance Enhancing Drug Use Become Tortious?, Richard T. Ward Iii

Pace Intellectual Property, Sports & Entertainment Law Forum

The Steroids Era in baseball refers to the recent period in the MLB where many players and trainers have been found guilty or been implicated in the use of performance enhancing drugs which leads to sharp increases in player talent. The stigma associated with PED use, and also any other form of cheating, has proven to be a fast track to shame in the world of Major League Baseball. This article addresses the current state of defamation law in New York and the Federal Courts by analyzing the recent statement made by Skip Bayless concerning use of Performance Enhancing Drugs …

Drug Induced Insanity And Unconsciousness - A Clarification Of California Law, Jerome Bleiweis

Pepperdine Law Review

No abstract provided.

Respecting, Rather Than Reacting To, Race In Biomedical Research: A Response To Professors Caulfield And Mwaria, Michael J. Malinowski

Michael J. Malinowski

This Commentary is part of a colloquy on race-based genetics research.

A Discourse On The Public Nature Of Research In Contemporary Life Science: A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski

Michael J. Malinowski

This article addresses the impact of integration of academia, industry, and government on the public nature of research. The article concludes that, while the integration has benefited science immensely, regulatory measures should be taken to restore the public nature of research in an age of integration.

United States Regulation Of Stem Cell Research: Recasting Government's Role And Questions To Be Resolved, Owen C. B. Hughes, Alan L. Jakimo, Michael J. Malinowski

Michael J. Malinowski

This article directly addresses the stem cell controversy, but also the broader history and norms regarding the roles of federal and state government in U.S. science research funding.

A Prescription Warning, Carlton Lee Harpst

Pepperdine Law Review

No abstract provided.

Fda And The Rise Of The Empowered Consumer, Lewis Grossman

Articles in Law Reviews & Other Academic Journals

This Article traces the still-evolving view of consumers of FDA-regulated products as capable, rational, and rights-bearing decision makers. It also examines the corresponding diminution of FDA’s role as a paternalistic gatekeeper collaborating with medical and scientific experts to prevent products and manufacturer-provided information from reaching the public. Compared with their 1960s counterparts, today’s consumers of food and drugs have far greater freedom to make unmediated choices among a wider variety of products, guided by a relative deluge of labeling and advertising information. Moreover, food and drug regulation, once the exclusive domain of bureaucrats and experts, has become a focus of …