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Articles 1 - 30 of 494

Full-Text Articles in Health Law and Policy

Table Of Contents, Seattle University Law Review Sep 2019

Table Of Contents, Seattle University Law Review

Seattle University Law Review

No abstract provided.


Using And Misusing Legal Decisions: Why Anti-Vaccine Claims About Nvicp Cases Are Wrong, Dorit Rubinstein Reiss, Rachel Heap Aug 2019

Using And Misusing Legal Decisions: Why Anti-Vaccine Claims About Nvicp Cases Are Wrong, Dorit Rubinstein Reiss, Rachel Heap

Minnesota Journal of Law, Science & Technology

No abstract provided.


Board Of Pharmacy, John Lacrosse, John Mysliwiec, Bridget Fogarty Gramme Jul 2019

Board Of Pharmacy, John Lacrosse, John Mysliwiec, Bridget Fogarty Gramme

California Regulatory Law Reporter

No abstract provided.


Dental Board Of California, Helene E. Mayer, Bridget Fogarty Gramme Jul 2019

Dental Board Of California, Helene E. Mayer, Bridget Fogarty Gramme

California Regulatory Law Reporter

No abstract provided.


Department Of Managed Health Care, Kaitlyn Enticknap, Monet Mccord, J. D. Fellmeth Jul 2019

Department Of Managed Health Care, Kaitlyn Enticknap, Monet Mccord, J. D. Fellmeth

California Regulatory Law Reporter

No abstract provided.


Medical Board Of California, Mason Bettencourt, Betsy Gopinath Jul 2019

Medical Board Of California, Mason Bettencourt, Betsy Gopinath

California Regulatory Law Reporter

No abstract provided.


Board Of Registered Nursing, Heather Morse, Bridget Fogarty Gramme Jul 2019

Board Of Registered Nursing, Heather Morse, Bridget Fogarty Gramme

California Regulatory Law Reporter

No abstract provided.


Public Health Preparedness & Response: An Exercise In Administrative Law, John D. Blum, Jordan Paradise Jun 2019

Public Health Preparedness & Response: An Exercise In Administrative Law, John D. Blum, Jordan Paradise

DePaul Journal of Health Care Law

No abstract provided.


Narrowing In On The Problem: A Component-Level Analysis Of "Hybrid" Medical Devices, Jillian Friedmann Apr 2019

Narrowing In On The Problem: A Component-Level Analysis Of "Hybrid" Medical Devices, Jillian Friedmann

Boston College Law Review

The Medical Device Amendments of 1976 (“MDA”) classify medical devices into three categories, each of which represents a different level of risk, and requires a different level of federal oversight. Class III devices, which pose the most risk, are subject to the highest level of oversight. Those devices are protected from any claims based on state laws that differ from or add to the requirements imposed by the MDA. On March 1, 2018, the United States Court of Appeals for the Third Circuit, in Shuker v. Smith & Nephew, PLC, considered the application of preemption under the MDA to a “hybrid ...


Table Of Contents, Seattle University Law Review Feb 2019

Table Of Contents, Seattle University Law Review

Seattle University Law Review

No abstract provided.


A “Natural” Stand Off Between The Food And Drug Administration And The Courts: The Rise In Food-Labeling Litigation & The Need For Regulatory Reform, Amy-Lee Goodman Jan 2019

A “Natural” Stand Off Between The Food And Drug Administration And The Courts: The Rise In Food-Labeling Litigation & The Need For Regulatory Reform, Amy-Lee Goodman

Boston College Law Review

Faced with the health and financial toll from escalating rates of chronic disease, consumers are demanding healthier food products and increased transparency regarding the ingredients in their food. Food labels provide the primary means for businesses to communicate with customers about their food products. In response to consumer demand, food companies are stocking grocery store shelves with products claiming to be wholesome, “natural” and healthy. Yet, many of these products are not as healthy or natural as purported. Although both consumers and food manufacturers place importance on the term “natural,” the Food and Drug Administration has refused to define the ...


Billion Dollar Orphans: Tension Between The Legal Intent And Social Purpose Of The Orphan Drug Act, John Sheridan Jan 2019

Billion Dollar Orphans: Tension Between The Legal Intent And Social Purpose Of The Orphan Drug Act, John Sheridan

Texas A&M Law Review

This Comment examines the extent to which Congress empowered the FDA to address the increase in petitions and the general accessibility of orphan drug remedies. Specifically, this Comment seeks to understand why the FDA’s interpretation of the purpose of the ODA seems to conflict with the statutory intent as interpreted by federal courts. This Comment considers a statute’s ultimate goal or social purpose to be the purpose of the statute, whereas the express mechanisms by which Congress seeks to bring about these goals is best understood as the statute’s intent. To understand the FDA and judiciary’s ...


The Vaccine Race In The 21st Century, Ana Santos Rutschman Jan 2019

The Vaccine Race In The 21st Century, Ana Santos Rutschman

All Faculty Scholarship

In a world in which infectious diseases are spreading increasingly faster, the development of new human vaccines remains a priority in biopharmaceutical innovation. Legal scholars have addressed different aspects of vaccine regulation and administration, but less attention has been paid to the role of laws governing innovation during the stages of research and development (R&D) of vaccines.

This Article explores the race to develop new vaccines from its beginnings through the early 21st century, with a particular focus on the progressively pervasive role of intellectual property in governing vaccine innovation. It describes the insufficiencies of current innovation regimes in ...


The Opioid Crisis: The States' And Local Governments' Response To Bigpharma's Deception And Why The Supremacy Clause May Provide A Cloak For Opioid Manufacturers To Hide Behind, Tracie Childers Jan 2019

The Opioid Crisis: The States' And Local Governments' Response To Bigpharma's Deception And Why The Supremacy Clause May Provide A Cloak For Opioid Manufacturers To Hide Behind, Tracie Childers

Barry Law Review

No abstract provided.


Unlocking Access To Health Care: A Federalist Approach To Reforming Occupational Licensing, Gabriel Scheffler Jan 2019

Unlocking Access To Health Care: A Federalist Approach To Reforming Occupational Licensing, Gabriel Scheffler

Faculty Scholarship at Penn Law

Several features of the existing occupational licensing system impede access to health care without providing appreciable protections for patients. Licensing restrictions prevent health care providers from offering services to the full extent of their competency, obstruct the adoption of telehealth, and deter foreign-trained providers from practicing in the United States. Scholars and policymakers have proposed a number of reforms to this system over the years, but these proposals have had a limited impact for political and institutional reasons.

Still, there are grounds for optimism. In recent years, the federal government has taken a range of initial steps to reform licensing ...


Principles Of Risk Imposition And The Priority Of Avoiding Harm, Gregory C. Keating Nov 2018

Principles Of Risk Imposition And The Priority Of Avoiding Harm, Gregory C. Keating

University of Southern California Legal Studies Working Paper Series

Standards which prescribe more than efficient precaution against physical harm and health injury are commonplace in American environmental, health and safety regulation. The “safe level” standard, for example, requires the elimination of all significant risks. The “feasibility” standard requires the elimination of significant risks to the extent insofar as it is possible to do so without impairing the long run survival of the activities which give rise to the risks. These standards reach back more than a generation to the founding of the Environmental Protection and Occupational Health and Safety Agencies. You might expect them to be too well-entrenched to ...


Renovations Needed: The Fda's Floor/Ceiling Framework, Preemption, And The Opioid Epidemic, Michael R. Abrams Oct 2018

Renovations Needed: The Fda's Floor/Ceiling Framework, Preemption, And The Opioid Epidemic, Michael R. Abrams

Michigan Law Review

The FDA’s regulatory framework for pharmaceuticals uses a “floor/ceiling” model: administrative rules set a “floor” of minimum safety, while state tort liability sets a “ceiling” of maximum protection. This model emphasizes premarket scrutiny but largely relies on the state common law “ceiling” to police the postapproval drug market. As the Supreme Court increasingly holds state tort law preempted by federal administrative standards, the FDA’s framework becomes increasingly imbalanced. In the face of a historic prescription medication overdose crisis, the Opioid Epidemic, this imbalance allows the pharmaceutical industry to avoid internalizing the public health costs of their opioid ...


Keeping The Healthcare Industry Accountable, Yoori Chung Sep 2018

Keeping The Healthcare Industry Accountable, Yoori Chung

Journal of the National Association of Administrative Law Judiciary

No abstract provided.


Board Of Pharmacy, Mariam J. Saleh, Bridget Fogarty Gramme Aug 2018

Board Of Pharmacy, Mariam J. Saleh, Bridget Fogarty Gramme

California Regulatory Law Reporter

No abstract provided.


Medical Board Of California, Kayla Watson, J. D. Fellmeth Aug 2018

Medical Board Of California, Kayla Watson, J. D. Fellmeth

California Regulatory Law Reporter

No abstract provided.


Department Of Managed Health Care, Jennifer Pardue, J. D. Fellmeth Aug 2018

Department Of Managed Health Care, Jennifer Pardue, J. D. Fellmeth

California Regulatory Law Reporter

No abstract provided.


Board Of Registered Nursing, Ashkan Hayatdavoudi, Bridget Fogarty Gramme Aug 2018

Board Of Registered Nursing, Ashkan Hayatdavoudi, Bridget Fogarty Gramme

California Regulatory Law Reporter

No abstract provided.


Veterinary Medical Board, Bryan Yerger, Bridget Fogarty Gramme Aug 2018

Veterinary Medical Board, Bryan Yerger, Bridget Fogarty Gramme

California Regulatory Law Reporter

No abstract provided.


Drug Approval In A Learning Health System, W. Nicholson Price Jul 2018

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 ...


Closing The Regulatory Gap For Synthetic Nicotine Products, Patricia J. Zettler, Natalie Hemmerich, Micah L. Berman Jul 2018

Closing The Regulatory Gap For Synthetic Nicotine Products, Patricia J. Zettler, Natalie Hemmerich, Micah L. Berman

Boston College Law Review

In July 2017 the U.S. Food and Drug Administration announced a new “comprehensive plan for tobacco and nicotine regulation.” This plan focuses on making cigarettes less addictive while facilitating the development of alternative, and less-harmful, nicotine-containing products. This approach holds promise, and the public health stakes could not be higher—smoking is the leading cause of preventable death in the United States, resulting in roughly 480,000 deaths per year. But a new consumer product is emerging that could upset the FDA’s plans for a well-balanced regulatory scheme: synthetic nicotine. Synthetic nicotine products currently fall into a regulatory ...


Environmental Health Regulation In The Trump Era: How President Trump’S Two-For-One Regulatory Plan Impacts Environmental Regulation, Elizabeth Ann Glass Geltman Jun 2018

Environmental Health Regulation In The Trump Era: How President Trump’S Two-For-One Regulatory Plan Impacts Environmental Regulation, Elizabeth Ann Glass Geltman

University of Michigan Journal of Law Reform

This Article explores the Trump regulatory reform agenda and its potential impact on environmental determinants of health. The Article begins with a discussion of the Department of Commerce’s (DOC or Commerce) initial fact-finding investigation to evaluate the impact of federal regulations on domestic manufacturing. The Article next presents an overview of the Trump administration’s regulatory reform formula as announced in E.O. 13771 and the interim guidance explaining E.O. 13771 and E.O. 13777 (the executive order announcing the Trump administration’s plans to enforce the regulatory reform plan announced in E.O. 13771). The Article then ...


The Burgeoning “Biorights Movement”: Its Legal Basis, What’S At Stake, And How To Respond, Mark A. Hayden May 2018

The Burgeoning “Biorights Movement”: Its Legal Basis, What’S At Stake, And How To Respond, Mark A. Hayden

Boston College Law Review

The advent of genetic and genomic technologies has the power to transform the understanding, prevention, and treatment of disease on a scale unprecedented in modern medicine. The promise of the era of precision medicine risks being tempered by the emergence of what is increasingly being referred to as the “biorights movement.” Of particular concern is the growing trend of individuals refusing to contribute their biological material to research studies absent some form of monetary compensation. Recently announced, but yet to be implemented, regulations seek to mitigate some of the potentially harmful and progress-impeding positions advanced by the biorights movement. The ...


Fda Flip-Flops On Antibiotic Hazard, David A. Wirth May 2018

Fda Flip-Flops On Antibiotic Hazard, David A. Wirth

David A. Wirth

No abstract provided.


Fda On Food Additives And Salt, David A. Wirth May 2018

Fda On Food Additives And Salt, David A. Wirth

David A. Wirth

No abstract provided.


Reform At Risk — Mandating Participation In Alternative Payment Plans, Scott Levy, Nicholas Bagley, Rahul Rajkumar May 2018

Reform At Risk — Mandating Participation In Alternative Payment Plans, Scott Levy, Nicholas Bagley, Rahul Rajkumar

Articles

In an ambitious effort to slow the growth of health care costs, the Affordable Care Act created the Center for Medicare and Medicaid Innovation (CMMI) and armed it with broad authority to test new approaches to reimbursement for health care (payment models) and delivery-system reforms. CMMI was meant to be the government’s innovation laboratory for health care: an entity with the independence to break with past practices and the power to experiment with bold new approaches. Over the past year, however, the Department of Health and Human Services (HHS) has quietly hobbled CMMI, imperiling its ability to generate meaningful ...