Health Law and Policy Commons^™

“Pay To Prescribe”: A Case For Strengthened Enforced Of The Fcpa In The Global Pharmaceutical Industry In 2017 And Beyond, John T. Jessee Jr.

Law Student Publications

This paper will use recent Foreign Corrupt Practices Act (FCPA) enforcement actions to argue that a revamped and increased enforcement of the FCPA’s anti-bribery provisions in the pharmaceutical industry will be an absolutely critical task in 2017 and beyond, as there is much work to be done in cleaning up the industry. The paper will begin by outlining a brief history of the FCPA and examining its basic enforcement provisions. It will then examine the nature of the pharmaceutical industry’s bribery through a detailed analysis of several recent high profile enforcement cases within the industry. Lastly, the paper will propose …

The Triage And Treatment Of Healthcare Institutions In Distress: How To Involve State Regulators In Healthcare Bankruptcies And Receiverships, Brian P. Stern, Christopher J. Fragomeni

Roger Williams University Law Review

No abstract provided.

Exploitation In Medical Research: The Enduring Legacy Of The Tuskegee Syphilis Study, Ruqaiijah A. Yearby

All Faculty Scholarship

For forty years, the United States government allowed economically disadvantaged African American men to be exploited in the name of research, although the research could not generate any benefit to society. Specifically, from 1932 until 1972, government funded researchers enrolled economically disadvantaged African American men in the Tuskegee Syphilis Study to document the already known course of syphilis, which led to the men suffering sores, fever, hair loss, weight loss, headaches, paralysis, blindness, dementia, and death. In exchange for free meals, medical exams, and burial insurance, the researchers promised the men that they would provide treatment for their “bad blood,” …

The Priority Review Voucher Program At The Fda: From Neglected Tropical Diseases To The 21st Century Cures Act, Ana Santos Rutschman

All Faculty Scholarship

The priority review voucher program at the Food and Drug Administration (FDA) was established in 2007 to incentivize research and development (R&D) in traditionally underfunded diseases.1 While shrouded in controversy and criticism, the program has recently been bolstered by the passage of the 21st Century Cures Act,2 which prevented the vouchers from sunsetting in late 2016 and furthered the overall scope of the program.3 As it reaches the end of its first decade, this Article discusses the impact of the program, with a focus on recent developments. The Article builds on literature suggesting that the voucher program has been ineffective …

Lessons From Ferguson And Beyond: Bias, Health, And Justice, Sidney D. Watson

All Faculty Scholarship

August 9, 2014, Michael Brown, an 18-year-old African American teen, killed by police in Ferguson, Missouri.

November 22, 2014, Tamir Rice, a 12-year-old African American child, killed by police in Cleveland, Ohio.

April 4, 2015, Walter Scott, a 50-year-old African American man, killed by police in Charlotte, North Carolina.

November 15, 2015, Jamar Clark, a 24-year-old African American man, killed by police in Minneapolis, Minnesota.

July 6, 2016, Philando Castile, a 32-year-old African American man, killed by police in Falcon Heights, Minnesota.

The list of Black men and women killed by police goes on and seems to grow by the …

Global Health Security In An Era Of Explosive Pandemic Potential, Lawrence O. Gostin, Ana Ayala

Georgetown Law Faculty Publications and Other Works

Pandemics pose a significant risk to security, economic stability, and development. Annualized expected losses from pandemics are estimated at $60 billion per year. Despite the certainty and magnitude of the threat, the global community has significantly underestimated and underinvested in avoidance of pandemic threats.

We cannot wait or continue with the status quo, in which we pay attention to infectious disease threats only when they are at their peak and then are complacent and remain vulnerable until the next major outbreak. To reinforce and sustain international focus, funding, and action, it is crucial that pandemics rise to the level of …

Special Issue "Health Care Law And The Rights Of Individuals With Disabilities", Elizabeth Pendo, Guest Editor

All Faculty Scholarship

People with disabilities are vulnerable. They carry high risk for poor health and health outcomes. As a group, they experience social disadvantages such as poverty, underemployment and unemployment, isolation, and discrimination at a higher rate than the general population. They also face multiple barriers to quality health care and report poorer health status than people without disabilities. This Special Issue will explore the key health disparities and barriers to health care experienced by people with disabilities, and explore the legal, ethical, and social issues they raise. It will investigate the legal requirements of the Americans with Disabilities and other antidiscrimination …

Editor, "Health Care Law And The Rights Of Individuals With Disabilities", Elizabeth Pendo

All Faculty Scholarship

People with disabilities are vulnerable. They carry high risk for poor health and health outcomes. As a group, they experience social disadvantages such as poverty, underemployment and unemployment, isolation, and discrimination at a higher rate than the general population. They also face multiple barriers to quality health care and report poorer health status than people without disabilities. This Special Issue will explore the key health disparities and barriers to health care experienced by people with disabilities, and explore the legal, ethical, and social issues they raise. It will investigate the legal requirements of the Americans with Disabilities and other antidiscrimination …

Preventing Neonatal Abstinence Syndrome Within The Opioid Epidemic: A Uniform Facilitative Policy, Jeremiah A. Ho, Alexander Rovzar

All Faculty Scholarship

The United States is currently in the midst of an opioid epidemic that has hit states in the southern New England regions particularly hard — with Massachusetts as one primary example. One of the many unfortunate results of the epidemic is a dramatic upsurge in cases of opioid dependency by expectant women that result in children born with Neonatal Abstinence Syndrome (NAS). NAS is a clinical syndrome that occurs when a newborn suffers withdrawal symptoms as a consequence of abrupt discontinuation of prenatal substance exposure. The expenses of treating and rehabilitating these drug-dependent newborns, predominantly shouldered by state taxpayers, are …

The English Rule - It Ain't English, And Ought Not Be American., Timothy M. Mulligan

St. Mary's Law Journal

Abstract Forthcoming.

The Demise Of Anti-Panhandling Laws In America., Natie Pilgram Neidig

St. Mary's Law Journal

Abstract Forthcoming.

The Exclusionary Rule And The Dueling Legacies Of Utah V. Streiff: Which Will Be Suppressed., Marcos Herrera

St. Mary's Law Journal

Abstract Forthcoming.

Force Majeure: How Lessees Can Save Their Leases While The War On Fracking Rages On., Allison R. Ebanks

St. Mary's Law Journal

Abstract Forthcoming.

Entrepreneurial Administration, Philip J. Weiser

Publications

A core failing of today’s administrative state and modern administrative law scholarship is the lack of imagination as to how agencies should operate. On the conventional telling, public agencies follow specific grants of regulatory authority, use the traditional tools of notice-and-comment rulemaking and adjudication, and are checked by judicial review. In reality, however, effective administration depends on entrepreneurial leadership that spearheads policy experimentation and trial-and-error problem-solving, including the development of regulatory programs that use non-traditional tools.

Entrepreneurial administration takes place both at public agencies and private entities, each of which can address regulatory challenges and earn regulatory authority as a …

Macra And Stark: Strange Bedfellows At The Heart Of Health Care Reform, Rebecca Olavarria

Journal Publications

The enactment of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) was well-received by all as it repealed Medicare’s Sustainable Growth Rate and, in its place, mandates the implementation of a new system for health care delivery and payment. Under MACRA, health care providers are expected to work together and coordinate their efforts with the goal of improving patient outcomes and controlling costs. For the first time ever, federal reimbursements will be tied to quality of care and improved cost efficiencies. However, as a new law, MACRA’s potential for success needs to be measured in terms of its …

What Is That Hamburger Doing To My Child's Grades? Childhood Obesity And Its Effects On A Student's Academic Performance, Cheryl Page

Journal Publications

This paper addresses childhood obesity and its correlating effects on an obese child's academic development. The terms and studies outlined in this paper specifically address the issue of obesity in children. It is important to state this distinction because obesity among children is defined and measured differently than it is among adults. Before discussing the differences in the academic development of non-obese children and obese children, I will begin by defining the following terms: "Body Mass Index (BMI)," "BMI-for-age," "Overweight," "Percentile Rates," and "Childhood Obesity."

Dr. Hoffman Among Nation's Most-Cited Health Law Scholars, Case Western Reserve University School Of Law, Law-Medicine Center

Case Law-Med

• Welcome from our Law-Medicine Center leaders
• Cleveland: A top city for health care
• Professor Sharona Hoffman among most cited health law scholars in the nation
• Law-Medicine conference explores legal challenges in Precision Medicine
• Renowned healthcare journalist, Elisabeth Rosenthal, gives talk on how healthcare became a big business
• The Law-Medicine Center’s fall events take on Medicaid, healthcare privacy and reproductive rights
• Reproductive Rights Lab: Student teams conduct legal research on abortion clinics and women in prison…
• 3L wins national health law writing competition
• CJ Sandley: Advocate for at-risk prisoners
• Seth Jacobs: Revolutionizing healthcare from within 
• Q&A: Defending pharmaceuticals and medical facilities …

Introduction: Four Views On Healthism

Marquette Benefits and Social Welfare Law Review

None

On Health, Law, And Religion, Stacey A. Tovino

Faculty Articles

The Supreme Court recently decided a number of cases involving health, law, and religion, including Whole Woman's Health v. Hellerstedt, Zubik v. Burwell, and Burwell v. Hobby Lobby Stores, Inc. These cases were important for understanding constitutional undue burden limitations and the boundaries of religious exercise during the Obama Administration. Unfortunately, the Supreme Court's recent opinions addressing health, law, and religion have little value for many health law professors and most practicing health care attorneys. These individuals, tasked with teaching and applying the thousands of federal and state statutes, regulations, and government guidance documents that address a wide …

Teaching The Hipaa Privacy Rule: Illustrative Comparisons, Stacey A. Tovino

Faculty Articles

Twenty years ago, President Clinton signed the Health Insurance Portability and Accountability Act of 1996 (HIPAA) into law. Over the past two decades, the federal Department of Health and Human Services (HHS) has published several sets of rules implementing the Administrative Simplification provisions within HIPAA as well as the Health Information Technology for Economic and Clinical (HITECH) Act within the American Recovery and Reinvestment Act (ARRA). These rules include, but certainly are not limited to, a final rule published on January 25, 2013, governing the use and disclosure of protected health information by covered entities and their business associates (the …