Administrative Law Commons^™

Influencing Nih Policy Over Embryonic Stem-Cell Research: An Administrative Tug-Of-War Between Congress And The President, Scott Davison

Journal of the National Association of Administrative Law Judiciary

No abstract provided.

Maine's Battle In America's Other Drug War: Pharmaceutical Research And Manufacturers Of America V. Walsh, Lynsey Mitchel

Journal of the National Association of Administrative Law Judiciary

No abstract provided.

Tobacco Abuse And Disability Benefits: Response To The 2003 Meisburg Analysis, Kathryn A. Kroggel

Journal of the National Association of Administrative Law Judiciary

No abstract provided.

Taxation Without Representation: The Illegal Irs Rule To Expand Tax Credits Under The Ppaca, Jonathan H. Adler, Michael F. Cannon

Faculty Publications

The Patient Protection and Affordable Care Act (PPACA) provides tax credits and subsidies for the purchase of qualifying health insurance plans on state-run insurance exchanges. Contrary to expectations, many states are refusing or otherwise failing to create such exchanges. An Internal Revenue Service (IRS) rule purports to extend these tax credits and subsidies to the purchase of health insurance in federal exchanges created in states without exchanges of their own. This rule lacks statutory authority. The text, structure, and history of the Act show that tax credits and subsidies are not available in federally run exchanges. The IRS rule is …

The Independent Medicare Advisory Committee: Death Panel Or Smart Governing?, Robert Coleman

Journal of the National Association of Administrative Law Judiciary

No abstract provided.

California And Uncle Sam's Tug-Of-War Over Mary Jane Is Really Harshing The Mellow, Daniel Mortensen

Journal of the National Association of Administrative Law Judiciary

No abstract provided.

Christopher V. Smithkline Beecham Corporation: An Unsurprising Loss For Pharmaceutical Sales Representatives And An Erosion Of Power For Administrative Agencies, Anna Johnston

Proxy

No abstract provided.

The Mobile Health Revolution?, Nathan Cortez

Faculty Journal Articles and Book Chapters

Rarely does a class of technologies excite physicians, patients, financeers, gadgeteers, and policymakers alike. But mobile health — the use of mobile devices like smartphones and tablets for health or medical purposes — has captured our collective imagination. Observers predict that mobile health, also referred to as “mHealth” or “medical apps,” can save millions of lives, billions in spending, and democratize access to health care. Proponents argue that mobile health technologies will transform the ways in which we deliver, consume, measure, and pay for care; disrupting our sclerotic health care system.

This Article evaluates mobile health and its many ambitions. …

Do Graphic Tobacco Warnings Violate The First Amendment?, Nathan Cortez

Faculty Journal Articles and Book Chapters

When Congress passed the nation’s first comprehensive tobacco bill in 2009, it replaced the familiar Surgeon General’s warnings, last updated in 1984, with nine blunter warnings. The law also directed the U.S. Food and Drug Administration ('FDA') to require color graphics to accompany the textual warnings. By law, the warnings would cover the top fifty percent of the front and back of tobacco packaging and the top twenty percent of print advertisements, bringing the United States closer to many peer countries that now require graphic warnings. Tobacco companies challenged the requirement on First Amendment grounds, arguing that the compelled disclosures …

Bedside Bureaucrats: Why Medicare Reform Hasn't Worked, Nicholas Bagley

Articles

Notwithstanding its obvious importance, Medicare is almost invisible in the legal literature. Part of the reason is that administrative law scholars typically train their attention on the sources of external control over agencies’ exercise of the vast discretion that Congress so often delegates to them. Medicare’s administrators, however, wield considerably less policy discretion than the agencies that feature prominently in the legal commentary. Traditional administrative law thus yields slim insight into Medicare’s operation. But questions about external control do not—or at least they should not—exhaust the field. An old and often disregarded tradition in administrative law focuses not on external …

Beyond Abortion: Human Genetics And The New Eugenics, John R. Harding Jr.

Pepperdine Law Review

No abstract provided.

The Fda Sends Smoke Signals To Big Tobacco: Will The Fda Suffer Backlash, Will Alcohol Be Regulated Next, And Will The Health Of Americans Prevail?, Angela Turriciano

Pepperdine Law Review

No abstract provided.

Reducing Unlawful Prescription Drug Promotion: Is The Public Health Being Served By An Enforcement Approach That Focuses On Punishment?, Vicki W. Girard

Georgetown Law Faculty Publications and Other Works

Despite the imposition of increasingly substantial fines and recently successful efforts to impose individual liability on corporate executives under the Park doctrine, punishing pharmaceutical companies and their executives for unlawful promotional activities has not been as successful in achieving compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) as the protection of the public health demands. Over the past decade, the Food and Drug Administration (FDA) and the Department of Justice (DOJ) have shifted their focus from correction and compliance to a more punitive model when it comes to allegedly unlawful promotion of pharmaceuticals. The shift initially focused …

The Disappearing Provision: Medical Liability Reform Vanishes From The Patient Protection And Affordable Care Act Despite State Court Split, Rafael Andre Roberti

Legislation and Policy Brief

The legal and medical communities have debated the impact and necessity of medical liability reform for over twenty years. At the heart of the debate is the question of how to strike a balance between compensating patients and their families for the thousands of deaths and injuries resulting from medical errors that occur annually, and encouraging physicians to continue to care for patients across America. While several states have passed medical liability reform laws previously, on March 23, 2010, President Obama signed the Patient Protection and Affordable Care Act (ACA)—colloquially known as the “health care bill”—that contains provisions on medical …

Government Tan Lines: Examining The Reach And Effectiveness Of Federal And State Efforts To Protect Consumers From The Dangers Of Indoor Tanning, Michelle Kay Pulley

Pepperdine Law Review

No abstract provided.

Medicaid Governance In The Wake Of National Federation Of Independent Business V. Sebelius: Finding Federalism's Middle Pathway, From Administrative Law To State Compacts, 45 J. Marshall L. Rev. 601 (2012), John D. Blum, Gayland O. Hethcoat Ii

UIC Law Review

No abstract provided.

How The Supreme Court And The Department Of Labor May Dispel Myths About Erisa's Family Law Provisions And Protect The Benefit Entitlements That Arise Thereunder, 45 J. Marshall L. Rev. 635 (2012), Albert Feuer

UIC Law Review

No abstract provided.

Medicaid Governance In The Wake Of National Federation Of Independent Business V. Sebelius: Finding Federalism's Middle Pathway, From Administrative Law To State Compacts., John D. Blum, Gayland O. Hethcoat Ii

Faculty Publications & Other Works

No abstract provided.

Genealogies Of Risk: Searching For Safety, 1930s-1970s, William Boyd

Publications

Health, safety, and environmental regulation in the United States are saturated with risk thinking. It was not always so, and it may not be so in the future. But today, the formal, quantitative approach to risk provides much of the basis for regulation in these fields, a development that seems quite natural, even necessary. This particular approach, while it drew on conceptual and technical developments that had been underway for decades, achieved prominence during a relatively short timeframe; roughly, between the mid-1970s and the early 1980s--a time of hard looks and regulatory reform. Prior to this time, formal conceptions of …

Off-Label Promotion Reform: A Legislative Proposal Addressing Vulnerable Patient Drug Access And Limiting Inappropriate Pharmaceutical Marketing, Tim Mackey, Bryan A. Liang

University of Michigan Journal of Law Reform

Off-label promotion occurs when pharmaceutical manufacturers engage in promotion of unapproved or "off-label" uses of their drugs. These off label uses may lack adequate clinical data to substantiate marketing claims, have led to corporate investigations and penalties, and can endanger public health. However there is adequate evidence to suggest that off-label uses are entirely appropriate for some vulnerable patient populations, and that physicians have accepted such uses as standard. Historically, U.S. law has prohibited direct off-label promotion to physicians and patients. However, failed government guidance, industry-based litigation, and the diminished capacity of regulators to police illegal practices have had dire …

Food And Drug Administration Regulation Of Food Safety, Lawrence O. Gostin, Katie F. Stewart

Georgetown Law Faculty Publications and Other Works

Food-borne illness remains a major public health challenge in the United States, causing an estimated 48 million illness episodes and 3000 deaths annually. The FDA Food Safety Modernization Act (FSMA), enacted in 2011, gives the Food and Drug Administration (FDA) new tools to regulate food safety. The act emphasizes prevention, enhanced recall authority, and oversight of imported food.

The FSMA brings the FDA’s food safety regulation in line with core tenets of public health by focusing on preventing outbreaks, rather than reacting to them, and differentiating between foods and food producers based on the degree of risk they pose. The …

Brand New Law! The Need To Market Health Care Reform, William M. Sage

Faculty Scholarship

The most serious problem with the Patient Protection and Affordable Care Act (ACA) is not its contents but its packaging. Because it requires significant departures from business as usual in health insurance, health care delivery, and health behavior, the ACA is unlikely to succeed unless Americans feel a shared stake in its success. Unfortunately, the new law has been branded only by its opponents. Neither the Obama administration nor its congressional allies have effectively communicated the law’s key elements to the public. Most surprisingly, the groundbreaking program of near-universal health coverage the ACA creates does not even have a name. …

United States Food Law Update: The Fda Food Safety Modernization Act, Obesity And Deceptive Labeling Enforcement, A. Bryan Endres, Nicholas R. Johnson

Journal of Food Law & Policy

The long-awaited enactment of the FDA Food Safety Modernization Act (FSMA), the most significant amendment to the Federal Food, Drug, and Cosmetic Act in several decades, provides the Food and Drug Administration (FDA) with significantly enhanced jurisdiction to close some of the gaps in the domestic food safety system. The enhanced FDA authority, however, will have little impact on the shared governance system at the federal level that involves multiple agencies, as the Act does not address the U.S. General Accounting Office's (GAO) repeated calls for consolidation of the fragmented federal food safety system. Rather, the Act perpetuates the division …

Cooperation, Commandeering, Or Crowding Out?: Federal Intervention And State Choices In Health Care Policy, Jonathan H. Adler

Faculty Publications

This Article's analysis proceeds in three parts. Part II of this article outlines the policy considerations in determining the proper federal and state balance in health care policy. There are strong arguments for state primacy in health care policy, but also substantial justifications for federal intervention. Part III discusses the concept of "cooperative federalism," under which the federal government encourages state governments to implement policies in accord with federal priorities, and identifies constitutional limitations on the federal government's ability to direct or even influence state policy choices. Even if the constitutional challenges to the individual mandate fails, federalism-based challenges to …

Political Factors And Enforcement Of The Nursing Home Regulatory Regime, Philip C. Aka, Lucinda M. Deason, Augustine Hammond

Journal of Law and Health

This study analyzes the influence of political factors, oversight, and nursing home affiliation or ownership status on the enforcement of the nursing home regulatory regime, signified by the Nursing Home Reform Act ("NHRA") and its progeny. Specifically speaking, it measures, using the statistical technique of regression analysis, factors that account for variations across states in the number of deficiencies (or violations of quality standards) cited by nursing home inspectors across the states. This work is a first of its kind, an analysis not government-related, by a set of public administration scholars that systematically studies the influence of political forces on …

Nursing The Primary Care Shortage Back To Health: How Expanding Nurse Practitioner Autonomy Can Safely And Economically Meet The Growing Demand For Basic Health Care , Michael B. Zand

Journal of Law and Health

This article first discusses the history and educational requirements of the Nurse Practitioner profession. It then discusses the policy reasons why Nurse Practitioners should, and do, play an important role in the country's health care delivery system. The core of the article deals with the legal issues surrounding the NP's scope of practice including the need for collaborative agreements with physicians, authority to prescribe drugs, and identification. Finally the article discusses how NPs fit into the health insurance scheme and their liability for malpractice.

Shifting The Conversation: Disability, Disparities And Health Care Reform, Elizabeth Pendo

Articles

In keeping with the theme of this symposium, I would like to invite you to consider health care reform as a political shift in our thinking about the barriers and inequalities experienced by people with disabilities in our health care system. Traditionally, when these issues have been addressed, the predominant approach has been through a civil rights framework, specifically the Rehabilitation Act of 1973' and the American with Disabilities Act of 1990 (ADA).2 Now, the Patient Protection and Affordable Care Act of 2010 (PPACA) offers a new approach. This essay will outline the barriers to health and health care experienced …

Symposium On Commercial Speech And Public Health, Jonathan H. Adler

Faculty Publications

Does the constitutional protection of commercial speech impair the government's ability to protect and promote public health? Or does the commercial speech doctrine itself enhance consumer education and harness market competition to advance public health? Do First Amendment limitations on regulation of commercial messages unduly retard governmental efforts to safeguard consumers? Or do they properly constrain illiberal paternalism? If the Court has been over-protective of health-related commercial speech, is there a principled place to redraw the line? And how should those governmental agencies entrusted with the power to protect public health and welfare respond to these constitutional constraints?

The editors …

Informed Consent: No Longer Just What The Doctor Ordered - The Contributions Of Medical Associations And Courts To A More Patient Friendly Doctrine, 15 Mich. St. U. J. Med. & L. 17 (2010), Marc Ginsberg

UIC Law Open Access Faculty Scholarship

No abstract provided.

From A Constitutional Right To A Policy Of Exceptions: Abigail Alliance And The Future Of Access To Experimental Therapy, Patricia J. Zettler, Seema K. Shah

Faculty Publications By Year

Although there has been considerable attention to the plight of terminally ill patients with highly sympathetic constitutional and contractual claims that they should be permitted access to unapproved drugs, courts have been appropriately reluctant to grant such claims. Congress and administrative agencies have the requisite institutional competence to decide complex policy issues related to science and health care such as those involved in establishing an expanded access program. Congress and FDA should allow only limited access to unapproved therapies because there are significant concerns about the safety and efficacy of unapproved drugs. Moreover, many of the proposals to widen access …