Digital Commons Network^™

Not So Juris-Prudent: The Misguided Movement To Abandon Chevron Deference Through The Lens Of Mifepristone And The Attacks On Fda Autonomy, Ella Seltzer

Upper Level Writing Requirement Research Papers

No abstract provided.

The Promise Of Telehealth For Abortion, Greer Donley, Rachel Rebouché

Book Chapters

The COVID-19 pandemic catalyzed a transformation of abortion care. For most of the last half century, abortion was provided in clinics outside of the traditional healthcare setting. Though a medication regimen was approved in 2000 that would terminate a pregnancy without a surgical procedure, the Food & Drug Administration required, among other things, that the drug be dispensed in person. This requirement dramatically limited the medication’s promise to revolutionize abortion because it subjected medication abortion to the same physical barriers of procedural care.

Over the course of the COVID-19 pandemic, however, that changed. The pandemic’s early days exposed how the …

Table Of Contents

Seattle University Law Review

Table of Contents

Medication Abortion Exceptionalism, Greer Donley

Articles

Restrictive state abortion laws garner a large amount of attention in the national conversation and legal scholarship, but less known is a federal abortion policy that significantly curtails access to early abortion in all fifty states. The policy limits the distribution of mifepristone, the only drug approved to terminate a pregnancy so long as it is within the first ten weeks. Unlike most drugs, which can be prescribed by licensed healthcare providers and picked up at most pharmacies, the Food and Drug Administration only allows certified providers to prescribe mifepristone, and only allows those providers to distribute the drug to …

"Not For Human Consumption": Prison Food's Absent Regulatory Regime, Amanda Chan, Anna Nathanson

William & Mary Bill of Rights Journal

Prison food is poor quality. The regulations which govern prison food are subpar and unenforceable by prisoners, due in large part to Sandin v. Conner and the Prison Litigation Reform Act. This Article aims to draw attention to the dire food conditions in prisons, explain the lax federal administrative law that permits these conditions, highlight the role of Sandin v. Conner and the Prison Litigation Reform Act in curtailing prisoners’ rights, and criticize the role of the private entity American Correctional Association in enabling mass neglect of prison food. The authors recommend that the Prison Litigation Reform Act be repealed, …

Making Executioners Out Of Pharmacists: Why South Carolina Should Not Adopt A Lethal Injection Secrecy Statute, Elizabeth T. French

South Carolina Law Review

No abstract provided.

Antiquated Relics Or Misunderstood Mess, Why South Carolina Liquor Laws Are Ripe For Restructuring, Annie Day Bame

South Carolina Law Review

No abstract provided.

Don't Feel Like Going To The Store, I'Ll Drink To That, How To Govern The Direct Shipment Of Alcohol In South Carolina, Frederick N. Hanna

South Carolina Law Review

No abstract provided.

How Chevron Deference Is Inappropriate In U.S. Fishery Management And Conservation, Charles T. Jordan

Seattle Journal of Environmental Law

Well managed fisheries represent an excellent source of sustainable food making the management of which incredibly important. The management of fisheries in the United States is governed by The Magnuson-Stevens Fishery Conservation and Management Act (MSFCMA). While the Act creates strong goals and mandates to ensure the best management of fisheries as an important natural resource, there are issues of delegation within the act. The MSFCMA ultimately delegates authority to eight regional councils which are made up of unelected and un-appointed members. The membership of these councils is at risk of industry influence with little legal protections. Critical in how …

Gandhi’S Prophecy: Corporate Violence And A Mindful Law For Bhopal, Nehal A. Patel

Nehal A. Patel

AbstractOver thirty years have passed since the Bhopal chemical disaster began,and in that time scholars of corporate social responsibility (CSR) havediscussed and debated several frameworks for improving corporate responseto social and environmental problems. However, CSR discourse rarelydelves into the fundamental architecture of legal thought that oftenbuttresses corporate dominance in the global economy. Moreover, CSRdiscourse does little to challenge the ontological and epistemologicalassumptions that form the foundation for modern economics and the role ofcorporations in the world.I explore methods of transforming CSR by employing the thought ofMohandas Gandhi. I pay particular attention to Gandhi’s critique ofindustrialization and principle of swadeshi (self-sufficiency) …

Closing The Door To Lost Earnings Under The National Childhood Vaccine Injury Act Of 1986, Aaron M. Levin

Aaron M Levin

After a wave of lawsuits against vaccine manufacturers hindered the profitability and production of life-saving vaccines, Congress enacted The National Childhood Vaccine Injury Act of 1986. The Act offers an incentive for individuals to get vaccinated in order to mitigate the population’s exposure to disease, while encouraging the continued production of these serums by pharmaceutical companies. Although imperfect, the Vaccine Act fosters promise in filtering out frivolous claims and provides a central route for due process to the individuals who suffer from a vaccine-related injury. By removing a potential state tort issue to the Federal Circuit, Congress created a reasonably …

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 …

Where Babies And Death-Row Inmates Intersect: Is Arbitrary Agency Decision-Making Supported Under Existing Law?, Lisa C. Blanton Bs., Mj.

Lisa C. Blanton BS., MJ.

The Food and Drug Administration (FDA) is the executive branch regulatory agency primarily responsible for protecting the nation’s drug products.^[1] The FDA recently made highly inconsistent decisions surrounding a new drug for the prevention of pre-term birth, Makena™ (hydroxyprogesterone caproate). During a lengthy approval process, FDA made laudatory public announcements and demonstrated high programmatic preference to expedite approval of Makena by assigning orphan status^[2] and granting accelerated “fast-track” approval time-frames.^[3] Despite these actions, within weeks of the approval, the FDA issued aggressive public statements against the product’s efficacy and safety and made supportive comments about a non-FDA …

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 …

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 …

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.

A Failure To Consider: Why Lawmakers Create Risk By Ignoring Trade Obligations, David R. Kocan Professor

David R. Kocan Professor

The U.S. Congress frequently passes laws facially unrelated to trade that significantly impact U.S. trade relations. These impacts are often harmful, significant, and long-lasting. Despite this fact, these bills rarely receive adequate consideration of how they will impact trade. Without this consideration, Congress cannot properly conduct a cost-benefit analysis necessary to pass effective laws. To remedy this problem, the U.S. Trade Representative should evaluate U.S. domestic law to determine whether it is consistent with international trade obligations. Moreover, the U.S. Congress committee structure should be amended so that laws that might impact trade are considered within that light. In the …

Caremark's Irrelevance, Mercer E. Bullard

Mercer E Bullard

In re Caremark Int’l Inc. Derivative Litig. is commonly held out as the iconic corporate law case on liability for a failure of legal compliance, but the true source of corporate law as to legal compliance is the higher standard established by other sources of law. The expected cost of liability, both criminal and civil, for violations of federal healthcare regulations, for example, is a far stronger determinant of corporate compliance systems than potential liability under Caremark. Other areas of industry-specific regulation, such as for financial services, telecommunications and energy, similarly play a greater role than state corporate law in …

Prescription For Change: Third Circuit Diagnoses Pharmaceutical Sales Representatives As Exempt From Overtime Pay In Smith V. Johnson & Johnson, Brooke Burns

Brooke Burns

This Casebrief recognizes the current division developing among courts concerning whether PSRs have been wrongly misclassified as exempt from overtime pay since the World War II era. Despite the Second Circuit’s more recent decision in In re Novartis Wage and Hour Litigation, this Casebrief identifies the Third Circuit’s jurisprudence in Smith v. Johnson & Johnson as providing controlling guidance for practitioners navigating the current legal landscape.

Fda Accelerated Approval Program: Why Brake When You Can Get A Mandate?, Keren Frumkin

Keren F. Bisnauth

The FDA approval process is designed to ensure that the drugs released for public consumption are safe and effective. In 1992, the FDA implemented the Accelerated Approval process in order to expedite the approval of drugs to aid patients with life-threatening illnesses, who have little to gain from lengthy approval processes, and who cannot risk worsening health conditions. However, the questionable post-approval practices of drug manufacturers, coupled with the lax FDA enforcement of its required follow-up protocols have raised doubts as to the true value of expedited approval procedures, as well as an influx of drug recalls and lawsuits. In …

The Transatlantic Gmo Dispute Against The European Communities: Some Preliminary Thoughts, David A. Wirth

David A. Wirth

Any day now, a World Trade Organization panel is expected to rule in a dispute between the U.S. and the EU concerning market access for genetically-engineered foods and crops. This piece, written before the release of the WTO panel's report, analyzes novel systemic issues concerning the impact of WTO law on regulatory design, at both the national and international levels, that are raised by this dispute. These include (1) the application of WTO disciplines to regulatory schemes that require prior governmental approval to protect the environment and public health from newly-introduced products and substances; (2) the role of precaution as …

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.

The “California Effect” & The Future Of American Food: How California’S Growing Crackdown On Food & Agriculture Harms The State & The Nation, Baylen J. Linnekin

Baylen J. Linnekin

For several decades, California has served as the epicenter of the American food scene. California produces one-third of the nation’s food, is home to one in eight American consumers, and boasts a staggering 90,000 restaurants. California is also where eating trends are born, and where fast food, organic food, and Napa Valley wines became durable icons of American culinary culture.

The state’s place atop the national food chain, though, is in jeopardy. In recent years, California legislators have pursued regulations that negatively impact many important agricultural and culinary trends. State and local governments have banned or severely regulated a veritable …

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

Journal Articles

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.

The Deregulatory State, Lawrence O. Gostin

O'Neill Institute Papers

Public health can be achieved only through collective action, not through individual endeavor. Collective goods are essential conditions for health, but can be secured only through a well-regulated society. Yet, successive governments have eroded health and safety protections, with serious consequences. Think about the death of miners, lead in children’s toys, industrial solvents in toothpaste, salmonella in peanut butter, e-coli in spinach, and unsafe or ineffective pharmaceuticals such as COX-2 inhibitors or non-statin cholesterol medications.

Conservatives have waged a campaign against the administrative state that has created and reinforced deep-seated concerns about over-bearing government, particularly at the national level. The …

Hemp ... Why Not?, Jared B. Kahn

ExpressO

Hemp ... Why Not?

By: Jared Kahn

(Abstract)

Industrial hemp has been utilized as a commodity crop for centuries in the United States, and for millennia throughout the world. Today, the crop is cultivated for industrial uses in thirty countries, but not the United States. United States citizens may import hemp, eat hemp, wear hemp, and do whatever they please with a manufactured hemp product, but nobody grows the valuable crop in the U.S. Several states have legalized industrial hemp cultivation, however, the federal Drug Enforcement Agency (DEA) interprets the Controlled Substances Act (CSA) to prohibit the growing of hemp …

A Complete Property Right Amendment, John H. Ryskamp

ExpressO

The trend of the eminent domain reform and "Kelo plus" initiatives is toward a comprehensive Constitutional property right incorporating the elements of level of review, nature of government action, and extent of compensation. This article contains a draft amendment which reflects these concerns.

Bond Repudiation, Tax Codes, The Appropriations Process And Restitution Post-Eminent Domain Reform, John H. Ryskamp

ExpressO

This brief comment suggests where the anti-eminent domain movement might be heading next.

Breaking The Bank: Revisiting Central Bank Of Denver After Enron And Sarbanes-Oxley, Celia Taylor

ExpressO

No abstract provided.