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Articles 1 - 30 of 50
Full-Text Articles in Health Law and Policy
Ethical Cannabis Lawyering In California, Francis J. Mootz Iii
Ethical Cannabis Lawyering In California, Francis J. Mootz Iii
St. Mary's Journal on Legal Malpractice & Ethics
Cannabis has a long history in the United States. Originally, doctors and pharmacists used cannabis for a variety of purposes. After the Mexican Revolution led to widespread migration from Mexico to the United States, many Americans responded by associating this influx of foreigners with the use of cannabis, and thereby racializing and stigmatizing the drug. After the collapse of prohibition, the federal government repurposed its enormous enforcement bureaucracy to address the perceived problem of cannabis, despite the opposition of the American Medical Association to this new prohibition. Ultimately, both the states and the federal government classified cannabis as a dangerous …
Sb 17 - Alcoholic Beverages, Lauren A. Newman, Erin N. Winn
Sb 17 - Alcoholic Beverages, Lauren A. Newman, Erin N. Winn
Georgia State University Law Review
Georgia law previously allowed counties and municipalities to permit the sale of alcoholic beverages on Sundays from 12:30 P.M. until 11:30 P.M. This Act, deemed “the Brunch Bill,” authorizes the counties and municipalities that have affirmatively voted by referendum to sell alcoholic beverages on Sundays to sell them earlier, at 11:00 A.M., if approved by a second referendum vote. This change applies to restaurants that make at least 50% of their revenue from the sale of food and hotels, and Georgia wineries.
Agricultural Investments Under International Investment Law, Jesse Coleman, Sarah Brewin, Thierry Berger
Agricultural Investments Under International Investment Law, Jesse Coleman, Sarah Brewin, Thierry Berger
Columbia Center on Sustainable Investment Staff Publications
International investment law, based primarily on international investment treaties, plays an important role in the governance of investment in agriculture, forestry, and fishing. The obligations established by these treaties, and enforced by means of investor–state arbitration, can present challenges for policy-makers and others seeking to ensure that investments are sustainable, including by affecting the ways in which the costs and benefits of investments are distributed among different actors.
CCSI partnered with the International Institute for Environment and Development (IIED) and the International Institute for Sustainable Development (IISD) to produce a briefing note on agricultural investments under international investment law. The …
Limiting State Flexibility In Drug Pricing, Nicholas Bagley, Rachel E. Sachs
Limiting State Flexibility In Drug Pricing, Nicholas Bagley, Rachel E. Sachs
Articles
Throughout the United States, escalating drug prices are putting immense pressure on state budgets. Several states are looking for ways to push back. Last year, Massachusetts asked the Trump administration for a waiver that would, among other things, allow its Medicaid program to decline to cover costly drugs for which there is limited or inadequate evidence of clinical efficacy. By credibly threatening to exclude such drugs from coverage, Massachusetts hoped to extract price concessions and constrain the fastest-growing part of its Medicaid budget.
The Overdose/Homicide Epidemic, Valena E. Beety
The Overdose/Homicide Epidemic, Valena E. Beety
Georgia State University Law Review
This Article explores the lack of regulation of coroners, concerns within the forensic science community on the reliability of coroner determinations, and ultimately, how elected laypeople serving as coroners may influence the rise in drug-induced homicide prosecutions in the midst of the opioid epidemic.
This Article proposes that the manner of death determination contributes to overdoses being differently prosecuted; that coroners in rural counties are more likely to determine the manner of death for an illicit substance overdose is homicide; and that coroners are provided with insufficient training on interacting with the criminal justice system, particularly on overdose deaths. Death …
Drug Approval In A Learning Health System, W. Nicholson Price
Drug Approval In A Learning Health System, W. Nicholson Price
Articles
The current system of FDA approval seems to make few happy. Some argue FDA approves drugs too slowly; others too quickly. Many agree that FDA—and the health system generally—should gather information after drugs are approved to learn how well they work and how safe they are. This is hard to do. FDA has its own surveillance systems, but those systems face substantial limitations in practical use. Drug companies can also conduct their own studies, but have little incentive to do so, and often fail to fulfil study commitments made to FDA. Proposals to improve this dynamic often suggest gathering more …
Dying To Be Fresh And Clean? Toxicants In Personal Care Products, The Impact On Cancer Risk, And Epigenetic Damage, Katherine Drabiak
Dying To Be Fresh And Clean? Toxicants In Personal Care Products, The Impact On Cancer Risk, And Epigenetic Damage, Katherine Drabiak
Pace Environmental Law Review
The FDA does not conduct pre-market review of chemicals contained in cosmetics—which encompasses not only makeup but also numerous personal care products including shampoo, lotion, perfume, aftershave, and shaving cream. Every day, consumers use cosmetic products that contain a variety of synthetic ingredients, none of which the FDA has approved for safety but each of which are being ingested, absorbed, and inhaled into our bodies and accumulating in our tissue. Many of these products contain endocrine disrupting chemicals (“EDCs”), which emerging research links to an increased risk of cancer as well as immune and neurological dysfunction. This Article examines how …
The Drug Debate: Data Exclusivity Is The New Way To Delay Generics, Srividhya Ragavan
The Drug Debate: Data Exclusivity Is The New Way To Delay Generics, Srividhya Ragavan
Srividhya Ragavan
The article discusses the protection regime for clinical trial data internationally and outlines the applicable protection regime. In doing so, this article outlines how the data exclusivity regime can operate in parallel with the patent regime to add a layer of protection for the data. Such protection operates at a regulatory level to delay the entry of generic medications. Internationally, the data exclusivity regime, which has become an important contemporary tool in trade negotiations with poorer nations, works to detrimentally affect access to medication
Passing The Baton: The Effect Of The International Olympic Committee's Weak Anti-Doping Laws In Dealing With The 2016 Russian Olympic Team, Saroja Cuffey
Brooklyn Journal of International Law
Following the investigation of a Russian state-sponsored doping ploy prior to the Olympic Games in Rio 2016; the International Olympic Committee (IOC) decided against a blanket ban of the Russian Olympic team. Instead; it allowed athletes’ individual international federations to decide whether Russian athletes could compete. In following the various anti-doping laws in place; the IOC sought to protect and give justice to clean athletes around the world. This Note argues that they did not achieve this result; due to the anti-doping laws in place and the actors applying these laws. It suggests that there should be a universal anti-doping …
Integration Of Complementary And Alternative Medicine Into The Healthcare System In The United States, Nikki Lu
Global Honors Theses
Chronic diseases are a prevalent issue around the world and chronic diseases are hard to prevent due to various systemic factors in the healthcare system. This paper mainly focused on socioeconomic issues and highlighted a few systemic factors in the US healthcare system. These factors have created various health disparities, inequities among socially constructed groups, and financial expenditures in the US healthcare system. Socioeconomic factors significantly impact the health and healthcare among socially constructed groups. Additionally, in this paper there are current approaches in addressing these healthcare factors such as social determinants of health and precision medicine as well as …
Fda Flip-Flops On Antibiotic Hazard, David A. Wirth
Fda Flip-Flops On Antibiotic Hazard, David A. Wirth
David A. Wirth
No abstract provided.
Fda On Food Additives And Salt, David A. Wirth
Regulatory Response To E-Cigarettes, Morgan Johnson
Regulatory Response To E-Cigarettes, Morgan Johnson
Georgia Journal of International & Comparative Law
No abstract provided.
Suggestions For State Laws On Biosimilar Substitution, Gary M. Fox
Suggestions For State Laws On Biosimilar Substitution, Gary M. Fox
Michigan Telecommunications & Technology Law Review
Biologic drugs offer major advancements over small-molecule drugs when it comes to treating serious diseases. Biosimilars, which mimic innovative biologic drugs, have the potential to further revolutionize the practice of medicine. States now have decades of experience regulating the substitution of generic, small-molecule drugs for their brand-name equivalents. But the complexities of biologic drugs and biosimilars force states to confront novel scientific and legal issues. Many states have begun tackling those issues by passing laws that regulate when pharmacists may substitute biosimilars for their corresponding biologic drugs. Other states have yet to do so. This Note surveys five provisions common …
A Surging Drug Epidemic: Time For Congress To Enact A Mandate On Insurance Companies And Rehabilitation Facilities For Opioid And Opiate Addiction, Alanna Guy
Journal of Law and Health
This Note begins with a discussion of both the national opioid problem as well as the specific epidemic in Ohio as an example of how it has grown within all of the states. Part II discusses the differences between prescription opioids and opiates, how they can be obtained, what effects they have on the human body, and why the government has an interest in this growing problem. Next, this Note explains how and why there was an increase in access and addiction to prescription opioid pain medication. Following this explanation, the steps the government has taken to try to rectify …
Big Food And Soda Versus Public Health: Industry Litigation Against Local Government Regulations To Promote Healthy Diets, Sarah A. Roache, Charles Platkin, Lawrence O. Gostin, Cara Kaplan
Big Food And Soda Versus Public Health: Industry Litigation Against Local Government Regulations To Promote Healthy Diets, Sarah A. Roache, Charles Platkin, Lawrence O. Gostin, Cara Kaplan
Georgetown Law Faculty Publications and Other Works
Diets high in fats, sugars, and sodium are contributing to alarming levels of obesity, cardiovascular disease, type 2 diabetes, and certain cancers throughout the United States. Sugary drinks, which include beverages that contain added caloric sweeteners such as flavored milks, fruit drinks, sports drinks, and sodas, are the largest source of added sugar in the American diet and an important causative factor for obesity and other diet-related diseases.
City and county governments have emerged as key innovators to promote healthier diets, adopting menu labeling laws to facilitate informed choices and soda taxes, warnings labels, and a soda portion cap to …
Improving Generic Drug Approval At The Fda, Kathleen Craddock
Improving Generic Drug Approval At The Fda, Kathleen Craddock
Michigan Journal of Environmental & Administrative Law
Generic drugs are the store-brand cereal of the drug world. While they lack the vibrant colors of and exciting commercials behind name brands, generics are still effective. Most importantly, for some people, they make the difference between accessing essential treatment and going without. Getting generics to market as quickly as possible means fewer people will cut pills in half or skip doses to save money, which also saves billions of dollars across the U.S. health system. Because a new generic does not offer lifesaving changes for people with rare or complicated diseases, generics lack the “cultural capture of rhetoric about …
Reforming Regenerative Medicine Regulation, Sarah Duranske
Reforming Regenerative Medicine Regulation, Sarah Duranske
Georgia State University Law Review
Regenerative medicine is defined as the branch of medicine that develops methods to regrow, repair, or replace damaged or diseased cells or tissues. It includes a variety of approaches, such as transplanting cells to promote healing, editing genes in cells to attack cancer, and even building organs from biological materials. Regulating regenerative medicine therapies is no easy task. Finding a balance between competing interests–enabling timely access for needy patients while simultaneously ensuring a positive benefit/risk profile and promoting the development of beneficial innovations–is hard enough at any given point in time. But add in constantly advancing scientific knowledge and increasing …
Fighting For Your Life In America: A Study Of "Right To Try" Laws Throughout The Country, Danielle Delgrosso
Fighting For Your Life In America: A Study Of "Right To Try" Laws Throughout The Country, Danielle Delgrosso
St. John's Law Review
(Excerpt)
This Note argues that there should be a federal statute granting terminally ill patients access to experimental drugs, but that the Trickett Wendler Act, as written is not the proper vehicle for change. An ideal congressional “Right to Try” statute should be crafted to make experimental drugs realistically obtainable for terminally ill patients while protecting those patients and their quality of life. The Trickett Wendler Act’s weaknesses prevent it from reaching this objective because it is too deferential to already unclear state Right to Try laws. Part I explores the right to try movement generally, explaining what a “right …
Marijuana Agriculture Law: Regulation At The Root Of An Industry, Ryan Stoa
Marijuana Agriculture Law: Regulation At The Root Of An Industry, Ryan Stoa
Ryan B. Stoa
Marijuana legalization is sweeping the nation. Recreational marijuana use is legal in eight states. Medical marijuana use is legal in thirteen states. Only three states maintain an absolute criminal prohibition on marijuana use. Many of these legalization initiatives propose to regulate marijuana in a manner similar to alcohol, and many titles are variations of the "Regulate Marijuana Like Alcohol Act." For political and public health reasons the analogy makes sense, but it also reveals a regulatory blind spot. States may be using alcohol as a model for regulating the distribution, retail, and consumption of marijuana, but marijuana is much more …
Comparative Cannabis: Approaches To Marijuana Agriculture Regulation In The United States And Canada, Ryan Stoa
Comparative Cannabis: Approaches To Marijuana Agriculture Regulation In The United States And Canada, Ryan Stoa
Ryan B. Stoa
The United States and Canada may be friends and allies, but the two countries' approaches to the regulation of marijuana agriculture have not evolved in tandem. On the contrary, their respective paths toward legalization and regulation of marijuana agriculture are remarkably divergent. In the United States, where marijuana remains a federally prohibited and tightly-controlled substance, legalization and regulation have remained the province of state legislatures and their administrative agencies for decades. In Canada, a succession of court cases paving the way toward medicinal marijuana use has prompted the federal government to develop a national framework committed to "legalize, regulate, and …
Consumers In Shock: How Federal Government Overregulation Led Mylan To Acquire A Monopoly Over Epinephrine Autoinjectors, Nicole O'Toole
Consumers In Shock: How Federal Government Overregulation Led Mylan To Acquire A Monopoly Over Epinephrine Autoinjectors, Nicole O'Toole
DePaul Business & Commercial Law Journal
The philosophy that federal government intervention increases costs and decreases options and values available to consumers can be analyzed across a plethora of markets. This Note will focus on the epinephrine autoinjector market, specifically looking at Mylan's epinephrine autoinjector known as the EpiPen. Today, the EpiPen is considered the “Kleenex” of epinephrine autoinjectors as it is estimated to control over ninety percent of the market share. From a Darwinist perspective it would appear that because the EpiPen controls most of the market, it must be the most superior product available to consumers. However, as this note will cover, this is …
The Growing Consumer Exposure To Nanotechnology In Everyday Products: Regulating Innovative Technologies In Light Of Lessons From The Past, Katharine Van Tassel
The Growing Consumer Exposure To Nanotechnology In Everyday Products: Regulating Innovative Technologies In Light Of Lessons From The Past, Katharine Van Tassel
Katharine Van Tassel
This Article discusses the public health, regulatory, legal, and ethical issues raised by the developing appreciation of the negative physical effects and potential health risks associated with nanotech products, and is arranged as follows. After this Introduction, this Article describes the present scientific understanding of the health risks associated with the consumption of nanoparticles. Next, a summary of the existing FDA regulatory structure that governs food, dietary supplements, cosmetics, and sunscreens is provided along with an explanation of why these regulations fail to protect public health when applied to regulate the nanotech versions of these products. The Article goes on …
Genetically Modified Plants Used For Food, Risk Assessment And Uncertainty Principles: Does The Transition From Ignorance To Indeterminacy Trigger The Need For Post-Market Surveillance?, Katharine Van Tassel
Genetically Modified Plants Used For Food, Risk Assessment And Uncertainty Principles: Does The Transition From Ignorance To Indeterminacy Trigger The Need For Post-Market Surveillance?, Katharine Van Tassel
Katharine Van Tassel
In the context of GM foods, a genetic modification changes the biochemical cross-talk between genes, creating genetic material that has never existed before in nature. This novel genetic material can create unintended health risks, as seen with the case of the GM peas that contained a novel and unexpected allergenic protein and primed test mice to react to other allergens.6 The bottom line is that the scientific acceptance of the existence of the networked gene establishes that the FDA’s presumption that GM plant food is bioequivalent to traditional plant food is no longer scientifically supportable and that a new system …
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
Katharine Van Tassel
This Article will use nanotechnology as an example that highlights how regulation based on novelty rather than hazard achieves the proper balance between protecting public health while encouraging innovation through the animation of the public health product safety net. In Part II, this Article starts by explaining what nanotechnology is and the remarkable growth of its use in everyday consumer products. It then summarizes the steadily increasing number of studies that suggest that there are likely to be serious health risks associated with the use of nanotech consumer products. Next, it explains how the FDA [Food and Drug Administration] is …
The Introduction Of Biotech Foods To The Tort System: Creating A New Duty To Identify, Katharine Van Tassel
The Introduction Of Biotech Foods To The Tort System: Creating A New Duty To Identify, Katharine Van Tassel
Katharine Van Tassel
This Article examines the question of whether an unsuspecting consumer who dies from an allergic or toxic reaction to an undisclosed biotech ingredient in food can recover damages through the tort system. The surprising answer is that recovery is very unlikely. This Article outlines why this is the case, then evaluates the merits of several potential solutions to this problem including the possible creation of a common law 'duty to identify' biotech ingredients in food.
This Article is arranged as follows. First, a brief primer on the nature of biotech foods is provided. For the reader unfamiliar with the regulatory …
The Drug Debate: Data Exclusivity Is The New Way To Delay Generics, Srividhya Ragavan
The Drug Debate: Data Exclusivity Is The New Way To Delay Generics, Srividhya Ragavan
Faculty Scholarship
The article discusses the protection regime for clinical trial data internationally and outlines the applicable protection regime. In doing so, this article outlines how the data exclusivity regime can operate in parallel with the patent regime to add a layer of protection for the data. Such protection operates at a regulatory level to delay the entry of generic medications. Internationally, the data exclusivity regime, which has become an important contemporary tool in trade negotiations with poorer nations, works to detrimentally affect access to medication
How Commonsense Consumption Acts Are Preventing “Big Food” Litigation, Grace Thompson
How Commonsense Consumption Acts Are Preventing “Big Food” Litigation, Grace Thompson
Seattle University Law Review
This Note takes a critical look at Commonsense Consumption Acts and how they are detrimental to the possibility of “Big Food” litigation. The tobacco industry was held accountable through the effective use of tort litigation (commonly referred to as “Big Tobacco” litigation), and the food industry could theoretically be held similarly accountable, but CCAs are preventing the possibility of similar reform. Therefore, in order for health reform to be as effective as tobacco reform, CCAs must be repealed in the states where they exist. Part I of this Note discusses why the food industry needs tort reform. Specifically, it argues …
Serving Pets In Poverty: A New Frontier For The Animal Welfare Movement, Amanda Arrington, Michael Markarian
Serving Pets In Poverty: A New Frontier For The Animal Welfare Movement, Amanda Arrington, Michael Markarian
Sustainable Development Law & Policy
No abstract provided.
How Fast Is Too Fast? Osha’S Regulation Of The Meat Industry’S Line Speed And The Price Paid By Humans And Animals, Israel Cook
How Fast Is Too Fast? Osha’S Regulation Of The Meat Industry’S Line Speed And The Price Paid By Humans And Animals, Israel Cook
Sustainable Development Law & Policy
No abstract provided.