Food and Drug Law Commons^™

Acting Differently: How Science On The Social Brain Can Inform Antidiscrimination Law, Susan Carle

Scholarly Articles in Law Reviews & Journals

Legal scholars are becoming increasingly interested in how the literature on implicit bias helps explain illegal discrimination. However, these scholars have not yet mined all of the insights that science on the social brain can offer antidiscrimination law. That science, which researchers refer to as social neuroscience, involves a broadly interdisciplinary approach anchored in experimental natural science methodologies. Social neuroscience shows that the brain tends to evaluate others by distinguishing between "us" versus "them" on the basis of often insignificant characteristics, such as how people dress, sing, joke, or otherwise behave. Subtle behavioral markers signal social identity and group membership, …

Drugs' Other Side Effects, Craig J. Konnoth

Publications

Drugs often induce unintended, adverse physiological reactions in those that take them—what we commonly refer to as “side-effects.” However, drugs can produce other, broader, unintended, even non-physiological harms. For example, some argue that taking Truvada, a drug that prevents HIV transmission, increases promiscuity and decreases condom use. Expensive Hepatitis C treatments threaten to bankrupt state Medicaid programs. BiDil, which purported to treat heart conditions for self-identified African-Americans, has been criticized for reifying racial categories. Although the Food & Drug Administration (“FDA”) has broad discretion under the Food, Drugs, and Cosmetics Act (“FDCA”) to regulate drugs, it generally considers only traditional …

Super Unleaded Malbec? A Case Study In Flawed International Standard Setting At The Codex Alimentarius, Justin Schwegel

Journal of Food Law & Policy

The World Trade Organization’s (WTO) Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) provides rules on the adoption and enforcement of SPS measures. It also presumes that food safety regulations adopted by WTO Members that conform to relevant international standards are consistent with the SPS Agreement. The relevant international standard setting body for food safety is the Codex Alimentarius Commission, which conducts most of its food safety risk management work through subsidiary bodies such as the Codex Committee on Contaminants in Food (CCCF). CCCF establishes maximum limits for food contaminants and codes of practice for reducing food …

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

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

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

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

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 …

Administering Health Innovation, Rachel E. Sachs

Cardozo Law Review

Scholars and policymakers have recently begun to focus on the role federal agencies charged with health-related missions can play in the development of innovative health technologies and promotion of access to those technologies. Appreciating the expertise of agencies like the National Institutes of Health, Food and Drug Administration, and Centers for Medicare and Medicaid Services has expanded the range of tools contemplated by scholars who had previously focused largely on the United States Patent and Trademark Office.

Yet much of this attention has so far focused on the capacities of single agencies, acting alone. This Article expands the existing scholarly …

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

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 …

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 …

Regulatory Response To E-Cigarettes, Morgan Johnson

Georgia Journal of International & Comparative Law

No abstract provided.

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 …

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 …

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

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 …

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 …

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 …

How Subterranean Regulation Hinders Innovation In Assisted Reproductive Technology, Myrisha S. Lewis

Cardozo Law Review

Most scholars believe assisted reproductive technology is subject only to minimal regulation, especially by the federal government. This belief I contend, is wrong. In this Article, I examine agency documents, statements by officials, and letters that the U.S. Food and Drug Administration (FDA) has sent to physicians and researchers over the past fifteen years to reveal an overlooked regulatory program. The FDA has been targeting new forms of assisted reproductive technology that involve small genetic modifications (advanced assisted reproductive technologies or AARTs) through regulatory actions that receive little public, media, or scholarly attention. I term this method of regulation "subterranean …

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 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

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

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

Sustainable Development Law & Policy

No abstract provided.

The Farts Heard ‘Round The World: Where Cow-Tapping Falls On The International Agenda Of Sustainable Development, Alexandra C. Nolan

Sustainable Development Law & Policy

No abstract provided.

This Is Not The Bee’S Knees: A Critical View Of The Government’S Lack Of Policy To Conserve The Pollinators, Savannah Pugh

Sustainable Development Law & Policy

No abstract provided.

Legislative Efforts To Increase State Management For Imperiled Species Should Be Rejected, Stephanie Kurose

Sustainable Development Law & Policy

No abstract provided.

Anthropogenic Noise And The Endangered Species Act, Carolyn Larcom

Sustainable Development Law & Policy

No abstract provided.

Cruelty To Human And Nonhuman Animals In The Wild-Caught Fishing Industry, Kathy Hessler, Rebecca Jenkins, Kelly Levenda

Sustainable Development Law & Policy

No abstract provided.