Health Law and Policy Commons^™

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.

The “Fowl” Practice Of Humane Labeling: Proposed Amendments To Federal Standards Governing Chicken Welfare And Poultry Labeling Practices, Latravia Smith

Sustainable Development Law & Policy

Chickens raised specifically for meat production are the world’s most intensively farmed land animals. Yet, the existing legal frameworks that regulate the production and labeling of poultry products in the United States allow poultry producers to mistreat chickens, falsely distinguish poultry products, and defraud conscious consumers. This article proposes unique opportunities to improve poultry welfare in the United States’ agricultural industry and offers methods to ensure the accurate labeling of poultry products.

Cafos: Plaguing North Carolina Communities Of Color, Christine Ball-Blakely

Sustainable Development Law & Policy

No abstract provided.

About Sdlp

Sustainable Development Law & Policy

No abstract provided.

Editor's Note, Luke Trompeter, Ingrid Lesemann

Sustainable Development Law & Policy

No abstract provided.

Don’T Let The Bed Bugs Bill: Landlord Liability For Bed Bug Infestations In Georgia, Megan M. Harrison

Georgia State University Law Review

Although the historical relationship between bed bugs and humans dates back to ancient Egypt, the common bed bug, or Cimex lectularius, vanished from the beds of Americans around World War II. In the late 1990s, however, our bloodsucking bedfellows returned. Bed bug infestations are a growing public health issue. Bed bugs are now found in all fifty states, with populations in five states reaching epidemic levels. Both the Environmental Protection Agency (EPA) and the Center for Disease Control and Prevention(CDC) consider bed bugs a “pest of significant public health importance."

Despite their name, bed bugs are not limited to …

The Biologics Price Competition And Innovation Act: Is A Generic Market For Biologics Attainable?, Kasey E. Koballa

William & Mary Business Law Review

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) provides an abbreviated approval pathway for biological therapeutic products shown to be biosimilar to an FDA-approved biological reference product. The BPCIA purported to reduce the price of biologics while promoting innovation. In two recent cases, the Federal Circuit interpreted a key provision of the BPCIA requiring an applicant to provide the reference product sponsor with notice 180 days before marketing the product. The Federal Circuit’s interpretation extends the exclusivity period already provided for the reference product sponsor, deterring innovation and price reduction. Thus, the Supreme Court granted certiorari in one …

Can They Do That?: The Limits Of Governmental Power Over Medical Treatment, Paul Jerome Mclaughlin Jr.

Library Faculty Publications

The government’s power over health care is strongest when health care treatments and precautions to protect the public welfare, such as quarantines and vaccinations, are at issue. Governmental power over health care decisions weakens when an individual’s health care decisions are in question. When health care decisions would only affect the individual making them, the government’s power is even less. This article argues that government agents must be cautious in making health care determinations for others and that they should aim to protect an individual’s right to self-determination so long as those choices do not pose a threat to the …

Can They Do That? : The Limits Of Governmental Power Over Medical Treatment, Paul Mclaughlin

Law Library Faculty Scholarship

Recommended citation: Paul Jerome McLaughlin Jr. (2017) Can They Do That?: The Limits of Governmental Power over Medical Treatment, Journal of Legal Medicine, 37:3-4, 371-388, DOI: 10.1080/01947648.2017.1385039

Update On Fda Regulation Of Mhealth And Wellness Devices, Barbara Zabawa

Faculty Works

This article provides an update on the evolving regulatory landscape of mobile health (mHealth) and wellness devices, focusing on changes introduced by the Food and Drug Administration (FDA) through its 2017 Draft Guidance. These updates aim to clarify inconsistencies in the definitions and regulatory status of various categories of devices, such as mobile medical apps, general mobile apps, and low-risk wellness devices. The Draft Guidance redefines certain wellness devices, emphasizing that those related to chronic diseases or conditions may now be recognized as medical devices but remain under FDA's enforcement discretion if they pose minimal safety risks. Additionally, the article …

Innovative Contracting For Pharmaceuticals And Medicaid’S Best-Price Rule, Nicholas Bagley

Articles

In recent years, drug manufacturers and private payers have expressed interest in novel pricing models that more closely link a drug’s price to its value. Indication-based pricing, outcome-based pricing, drug licenses, and drug mortgages have all been discussed as alternatives to paying strictly for volume. Manufacturers and payers have complained, however, that Medicaid’s “best-price rule” inhibits their ability to enter into these newpricing arrangements. This article examines the best-price rule and assesses to what extent, if any, it might frustrate the goal of paying for value. We conclude that the best-price rule is not as serious a problem as it …

Legal Capacities Required For Prevention And Control Of Noncommunicable Diseases, Roger S. Magnusson, Benn Mcgrady, Lawrence O. Gostin, David Patterson, Hala Abou Taleb

Georgetown Law Faculty Publications and Other Works

Law lies at the centre of successful national strategies for prevention and control of noncommunicable diseases. By law we mean international agreements, national and subnational legislation, regulations and other executive instruments, and decisions of courts and tribunals. However, the vital role of law in global health development is often poorly understood, and eclipsed by other disciplines such as medicine, public health and economics. This paper identifies key areas of intersection between law and noncommunicable diseases, beginning with the role of law as a tool for implementing policies for prevention and control of leading risk factors. We identify actions that the …

Zika, Pregnancy, And The Law, Sam F. Halabi

Arkansas Law Review

The public health emergency surrounding the spread of the Zika virus has resurrected and brought into sharp relief some of the most vexing questions surrounding the relationship between pregnancy and law: the appropriate circumstances, if any, in which fetal tissue research is permissible; when and how the government may sponsor statements intended to influence reproductive decisions; and how to balance the health and rights of both women and their unborn children when health threats target both.

Vaccine Licensure In The Public Interest: Lessons From The Development Of The U.S. Army Zika Vaccine, Ana Santos Rutschman

All Faculty Scholarship

Vaccines developed by the public sector are key to preventing future outbreaks of infectious diseases. However, the licensure of these vaccines to private-sector companies under terms that do not ensure both their availability and affordability compromises their development. This Essay analyzes the recent attempted licensing deal for a Zika vaccine between the U.S. Army and Sanofi, a French pharmaceutical company. The proposed grant of an exclusive license to Sanofi triggered widespread concern because none of its substantive terms were disclosed. While § 209 of the Patent Act imposes limitations on exclusive licensure, the Army released no information supporting its finding …

Sb 201 - Sick Leave, Mary Elizabeth D. Steinhaus, Chadwick L. Williams

Georgia State University Law Review

The Act amends Georgia’s general provisions relating to labor and industrial relations by adding a new provision that requires qualifying employers to allow their employees to use sick leave to care for immediate family members.

Hb 359 - Power Of Attorney, Roma A. Amin, Catherine V. Schutz

Georgia State University Law Review

The bill would have repealed and replaced Georgia’s Power of Attorney for the Care of a Minor Child Act. The category of people who could be given power of attorney for the care of a minor child would have expanded from only grandparents and great-grandparents to a broad category of the child’s relatives, and anyone associated with a non-profit organization focused on child or family services or a licensed child-placing agency.

Hb 249 - Controlled Substances And Prescription Drug Monitoring Database, Emily R. Polk, Brandon M. Reed

Georgia State University Law Review

The Act amends Georgia’s controlled-substances statutes to expand medical provider requirements to record prescription drug information in an electronic prescription drug monitoring program database (PDMP). Medical providers are now required to use the PDMP to enter information about their prescription of certain types and quantities of opioids. The purpose of the act is to fight Schedule II opioid abuse throughout the state of Georgia. A medical provider’s failure to report required information is reported to his or her respective state regulatory board for possible reprimand. In addition to mandatory reporting, the Act includes various other provisions related to regulating opioid …

Sb 104 - Carjacking, Fentanyl And "Upskirting", Katherine H. Krouse, Lauren R. Light

Georgia State University Law Review

The Act includes various amendments to Georgia’s criminal code. Three changes are most notable. First, the Act designates the offense of hijacking a motor vehicle as hijacking a motor vehicle in the first degree and creates the offense of hijacking a motor vehicle in the second degree. Second, the Act criminalizes the use of a device to film underneath or through an individual’s clothing. Lastly, the Act adds the drug Fentanyl and its various analogs to the list of controlled substances.

Localism, Labels, And Animal Welfare, Samuel R. Wiseman

Northwestern Journal of Law & Social Policy

The law does relatively little to improve the welfare of animals raised for food. In the short term, at least, market-based solutions appear to have more promise as a means of promoting farm animal welfare, as consumers increasingly seek out local and humanely-raised meat and eggs. To aid consumers in identifying these products, certification systems of varying degrees of rigor exist, but even these are of little use to consumers in the restaurant context, which accounts for a large percentage of meat consumption. Patrons see only finished meals, making fraud difficult to detect, and a recent newspaper investigation suggests that …

Will The Zika Virus Enable A Transplant Of Roe V. Wade To Brazil?, Amanda Greenberg

University of Miami Inter-American Law Review

No abstract provided.

2018 Legal Update: Npdb Reporting, Retaliation, Physician Well Being, And Medical Staff Litigation, Preparing For A Successful Judicial Review Hearing, Rick D. Barton, Natalie V. Mueller

Center for Health Law Policy and Bioethics

No abstract provided.

Structured Settlement Sales And Lead-Poisoned Sellers: Just Say No, Karen Czapanskiy

Faculty Scholarship

No abstract provided.

Healthcare, Privacy, Big Data And Cybercrime: Which One Is The Weakest Link?, Marin Mrcela, Igor Vuletic

Annals of Health Law and Life Sciences

No abstract provided.

Severe Brain Injury, Disability, And The Law: Achieving Justice For A Marginalized Population, Megan S. Wright, Nina Varsava, Joel Ramirez, Kyle Edwards, Nathan Guevremont, Tamar Ezer, Joseph Fins

Florida State University Law Review

Thousands of persons with severe brain injury who are minimally conscious or "locked in" are wrongly treated as if they are unconscious. Such individuals are unable to advocate for themselves and are typically segregated from society in hospitals or nursing homes. As a result, they constitute a class of persons who often lack access to adequate medical care, rehabilitation, and assistive devices that could aid them in communication and recovery. While this problem is often approached from a medical or scientific point of view, here we frame it as a legal issue amenable to legal remedies. This Article comprehensively explores …

Regulation Of Radioactive Fracking Waste, Elizabeth Ann Glass Geltman, Nichole Leclair

Publications and Research

Natural gas extracted form shale reached record production totals in 2015 in the United States and the US Energy Information Administration (EIA) forecasts natural gas production will continue to increase. Wastes from shale gas extraction can contain the radioactive isotopes radium-226 (Ra-226) and radium-228 (Ra-228), which decay further into radon (Rn). Exposure to radon, a form of naturally occurring radioactive materials (NORM), is the leading cause of lung cancer in the United States, after smoking. This article explores how states handle the disposal of technologically enhanced naturally occurring radioactive materials (TENORM) and/or NORM waste from oil and gas operations to …

Privacy Of Information And Dna Testing Kits, Shanna Raye Mason

Catholic University Journal of Law and Technology

In modern times, consumers desire for more control over their own health and healthcare. With this growing interest of control, direct to consumer DNA testing kits have never been more popular. However, many consumers are unaware of the potential privacy concerns associated with such use. This comment examines the popularity and privacy risks that are likely unknown to the individual consumer. This comment also addresses the shortcomings of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as well as the Genetic Information Nondiscrimination Act of 2008 (GINA) in regard to protecting individual’s genetic information from misuse. This comment …

Step Therapy: Legal And Ethical Implications Of A Cost-Cutting Measure, Sharona Hoffman

Faculty Publications

The very high and ever-increasing costs of medical care in the United States are well-recognized and much discussed. Health insurers have employed a variety of strategies in an effort to control their expenditures, including one that is common but has received relatively little attention: step therapy. Step therapy programs require patients to try less expensive treatments and find them to be ineffective or otherwise problematic before the insurer will approve a more high-priced option. This Article is the first law journal piece dedicated to analyzing this important cost control measure.

The Article explores the strengths and weaknesses of step therapy …

Foreword, Adrienne A. Testa

Annals of Health Law and Life Sciences

No abstract provided.

You Can’T Save Dead People: The Emerging Battles Over Supervised Consumption Sites, James Satterberg

Washington Law Review Online

The United States is experiencing a drug overdose epidemic of historic proportions. As fatal overdose rates continue to increase, some jurisdictions have sought evidence-based solutions to this public health issue. This Comment concerns one proposed remedy in particular: supervised consumption sites. In a supervised consumption site, drug users are encouraged to consume their own drugs at the facility. Facility staff give drug users clean equipment, teach safe injection techniques, and, most importantly, monitor drug users for symptoms of overdose. If a staff member witnesses an overdose, they act to prevent the overdose from becoming fatal. Research conducted on supervised consumption …

Table Of Contents, Annals Of Health Law

Annals of Health Law and Life Sciences

No abstract provided.