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Full-Text Articles in Law

Defining Health Affordability, Govind C. Persad Nov 2023

Defining Health Affordability, Govind C. Persad

Sturm College of Law: Faculty Scholarship

Affordable health care, insurance, and prescription drugs are priorities for the public and for policymakers. Yet the lack of a consensus definition of health affordability is increasingly recognized as a roadblock to health reform efforts. This Article explains how and why American health law invokes health affordability and attempts, or fails, to define the concept. It then evaluates potential affordability definitions and proposes strategies for defining affordability more clearly and consistently in health law.

Part I examines the role health affordability plays in American health policy, in part by contrasting the United States’s health system with systems elsewhere. Part II …


Comment: Online And Off-Label: Closing The Regulatory Gap In Online Direct-To-Consumer Drug Promotion And Prescribing, Kristina L. Bitzer Nov 2021

Comment: Online And Off-Label: Closing The Regulatory Gap In Online Direct-To-Consumer Drug Promotion And Prescribing, Kristina L. Bitzer

Northern Illinois University Law Review

The advent of telemedicine led to an evolution in healthcare delivery, making it possible for healthcare professionals to provide remote patient care, thus minimizing or eliminating the need for the patient to visit a physician’s office. Recently, online telemedicine has gained significant popularity, especially in light of the COVID-19 pandemic. This Comment focuses upon online direct-to-consumer telemedicine platforms and their modern usage as one-stop-shops for acquisition of medical advice and medication. Specifically, this Comment explores prescription promotion and prescribing as done through these platforms with a special examination of off-label prescriptions. Several modern online direct-to-consumer telemedicine platforms offer prescription medications …


Reputation And Authority: The Fda And The Fight Over U.S. Prescription Drug Importation, Thomas J. Bollyky, Aaron S. Kesselheim Oct 2020

Reputation And Authority: The Fda And The Fight Over U.S. Prescription Drug Importation, Thomas J. Bollyky, Aaron S. Kesselheim

Vanderbilt Law Review

There is popular and bipartisan support for legalizing the importation of lower-cost medicines from Canada to help reduce the high prescription drug costs that Americans pay. Despite the wide interest in this policy, attempts over the last sixteen years to create a formal system for large-scale prescription drug importation in the United States have failed. The Trump Administration recently issued a final rule to enable the legal importation of prescription drugs from Canada, but the rule has important design flaws and seems destined to suffer a similar fate as previous efforts.

In this Article, we argue that prescription drug importation …


(Almost) No Bad Drugs: Near-Total Products Liability Immunity For Pharmaceuticals Explained, Anita Bernstein Mar 2020

(Almost) No Bad Drugs: Near-Total Products Liability Immunity For Pharmaceuticals Explained, Anita Bernstein

Washington and Lee Law Review

This Article explores four beliefs about supposed pharma-benevolence that appear to be shared by more than the industry, reaching the level almost of conventional wisdom. These figurative pillars help support one-sided results in court. However, each of the pillars on examination turns out at least a bit shaky. This Article puts them forward for review to start a necessary discussion.

The locus of this Article is products liability, where a court concludes that a manufactured object is defective or could be called defective by a factfinder following a trial. Drug manufacturers enjoy near-immunity from this consequence. Modern products liability identifies …


Fighting America’S Best-Selling Product: An Analysis Of And Solution To The Opioid Crisis, Ashley Duckworth Jan 2020

Fighting America’S Best-Selling Product: An Analysis Of And Solution To The Opioid Crisis, Ashley Duckworth

Washington and Lee Journal of Civil Rights and Social Justice

Deaths from drug overdoses have doubled over the last ten years and are now the leading cause of accidental death in the United States. Although some overdoses may have involved more than one drug, prescription and/or illicit opioids were involved in many of these drug overdose fatalities. The Food and Drug Administration (FDA), Center for Disease Control and Prevention (CDC), and Congress have enacted a string of regulations, statutes, and programs since the early 1990s, but nothing has seriously improved the opioid epidemic as it stands. If anything, the use of opioids has persisted. Many people want pharmaceutical companies to …


Wrong Price, Wrong Prescription: Why Maryland’S Generic Drug Law Was Not Enough To Effect Change In Rising Prescription Drug Prices, Mario B. Davis Jan 2019

Wrong Price, Wrong Prescription: Why Maryland’S Generic Drug Law Was Not Enough To Effect Change In Rising Prescription Drug Prices, Mario B. Davis

University of Baltimore Law Forum

No abstract provided.


On Drugs: Preemption, Presumption, And Remedy, Elizabeth Mccuskey May 2018

On Drugs: Preemption, Presumption, And Remedy, Elizabeth Mccuskey

Faculty Scholarship

This essay explores the role of litigation in drug safety regulation and the role of drug safety regulation in litigation, exemplified by the 2017 National Health Law Moot Court Problem. Using the example of failure-to-update claims against generic drug manufacturers, this essay argues that pharmaceutical preemption doctrine would benefit from a tailored application of the presumption against preemption. It proposes a presumption that Congress does not intend to displace historic state remedies for injury without clearly saying so, focusing on the role of remedy to account for the evolving overlap in federal and state police powers over health and to …


An Examination Of Product Hopping By Brand-Name Prescription Drug Manufacturers: The Problem And A Proposed Solution, Daniel Burke Apr 2018

An Examination Of Product Hopping By Brand-Name Prescription Drug Manufacturers: The Problem And A Proposed Solution, Daniel Burke

Cleveland State Law Review

The balance between incentivizing innovation through exclusivity protection and maintaining competitive market conditions—including prices for consumers—is a difficult line to toe. Product hopping has characteristics that constitute a violation of the Sherman Antitrust Act because companies can maintain monopoly power in the pharmaceutical market. While some monopoly power is justified as an incentive for incredibly costly innovation, extended periods of exclusivity harms consumers by keeping prescription drug prices artificially inflated. Allowing generic drug manufacturers to compete sooner in the prescription drug market by disallowing product hopping by name-brand pharmaceutical drug companies will aid in driving down prices. Courts should adopt …


The Prescription Drug Pricing Moment: Using Public Health Analysis To Clarify The Fair Competition Debate On Prescription Drug Pricing And Consumer Welfare, Ann Marie Marciarille Apr 2017

The Prescription Drug Pricing Moment: Using Public Health Analysis To Clarify The Fair Competition Debate On Prescription Drug Pricing And Consumer Welfare, Ann Marie Marciarille

Faculty Works

Fair competition law and public health law talk past each other when discussing pharmaceutical pricing and distribution. The former cannot agree on the relevant definition of consumer welfare. The latter does not fully comprehend the highly complex but inherently collective nature of pharmaceutical drug acquisition in the United States. This essay proposes to inject public health discourse into this debate to enrich it, focus it, and render it more accessible to those who must live by its outcome.


The Health Impact Fund Proposal: Application In The United States' Era Of Comparative Effectiveness, Katherine Jeanne Racz Mar 2016

The Health Impact Fund Proposal: Application In The United States' Era Of Comparative Effectiveness, Katherine Jeanne Racz

Journal of Intellectual Property Law

No abstract provided.


A Profile Of Bio-Pharma Consolidation Activity, Jordan Paradise Jan 2016

A Profile Of Bio-Pharma Consolidation Activity, Jordan Paradise

Faculty Publications & Other Works

No abstract provided.


Buyer Power And Healthcare Prices, John B. Kirkwood Jan 2015

Buyer Power And Healthcare Prices, John B. Kirkwood

Faculty Articles

One major reason why healthcare costs are much higher in America than in other countries in that our prices are exceptionally high. In this article, I address whether we ought to rely more heavily on buyer power to reduce those prices, as other nations do. I focus on two sectors where greater buyer could easily be exercised: prescription drugs covered by Medicare and hospital and physician services covered by private insurance. I conclude that the biggest buyer of all, the federal government, should be allowed to negotiate Medicare prescription drug prices. That would substantially reduce the prices of many branded …


“Danger Is My Business”: The Right To Manufacture Unsafe Products, Richard C. Ausness Dec 2014

“Danger Is My Business”: The Right To Manufacture Unsafe Products, Richard C. Ausness

Law Faculty Scholarly Articles

While no one would dispute that safety is a desirable objective, it may not always be an absolute priority. Rather, in some cases, other societal interests such as personal autonomy, consumer choice, product cost, and performance may trump legitimate safety goals. This is reflected in some of the doctrines and defenses that have evolved to protect the producers of unsafe products against tort liability. Some of these doctrines, such as those determining liability for the producers of optional safety equipment, inherently dangerous products, products with obvious hazards, and prescription drugs and medical devices, are part of the law of products …


A Prescription Warning, Carlton Lee Harpst May 2013

A Prescription Warning, Carlton Lee Harpst

Pepperdine Law Review

No abstract provided.


Pharmageddon: A Statutory Solution To Curb Ohio's Prescription Abuse Problem, Ed Woodworth Jan 2013

Pharmageddon: A Statutory Solution To Curb Ohio's Prescription Abuse Problem, Ed Woodworth

Journal of Law and Health

Prescription abuse in Ohio continues to be a serious and complex issue that should be addressed. Accordingly, Part II of this Note examines the background of prescription drug abuse generally. It identifies the dangers of prescription drug abuse, the cost drug abuse places on society, some reasons for prescription drug abuse, sources of prescription drugs, and discusses the current state and federal laws regarding prescription drug abuse and prescription reporting. Part III discusses the positive and negative aspects of H.B. 93 and Medical Rule 4731-11-11 and then offers proposals to more effectively prevent prescription drug abuse. Part IV discusses various …


Is More Information Always Better? Mandatory Disclosure Regulations In The Prescription Drug Market, Joanna Shepherd Jan 2013

Is More Information Always Better? Mandatory Disclosure Regulations In The Prescription Drug Market, Joanna Shepherd

Faculty Articles

This Article proceeds as follows. In Section I, I describe the structure of the PBM industry. I also describe the business model PBMs employ to administer prescription drug coverage and the methods they use to reduce prescription drug spending. In Section II, I discuss mandatory disclosure regulations enacted in several states and at the federal level under the Affordable Care Act. In Section III, I explain why mandatory disclosure regulations are not needed to ensure that health plan sponsors pay a competitive price for PBM services. In Section IV, I discuss the various costs that mandatory disclosure regulations will impose …


Reducing Unlawful Prescription Drug Promotion: Is The Public Health Being Served By An Enforcement Approach That Focuses On Punishment?, Vicki W. Girard Oct 2012

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

Vicki W Girard

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.

This article argues that …


The Medicare Part D Prescription Drug Benefit: Who Wins And Who Loses? , Enrich Andreas Drotleff Aug 2012

The Medicare Part D Prescription Drug Benefit: Who Wins And Who Loses? , Enrich Andreas Drotleff

Marquette Elder's Advisor

The author examines the new Medicare Part D Program, discusses first the background history which led to its enactment, and then explains how enrollment decisions affect different classes of beneficiaries. The politics involved in the passage of this legislation are explored. Transitioning dual eligibles (those covered by both Medicare and Medicaid) into the new drug program has often resulted in reduced benefits.


The Informational And Institutional Theories Of Off-Label Promotion, Miguel A. Lopez Aug 2012

The Informational And Institutional Theories Of Off-Label Promotion, Miguel A. Lopez

San Diego Law Review

This Article contends that there are two distinct theories of the offense of off-label promotion—the informational theory and the institutional theory. One is concerned with controlling the flow of medical knowledge and the other is concerned with protecting regulatory legitimacy. Different kinds of evidence are key under each theory. I argue that although the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its accompanying regulations emphasize the informational theory, federal prosecutors rely more heavily on the legal arguments that underpin the institutional theory of enforcement. A corollary to this contention is that the informational theory of off-label promotion does …


A Health Care Autopsy, Marc Gans Dec 2011

A Health Care Autopsy, Marc Gans

Marc Gans

This paper analyzes each of the factors responsible for the rapid rise in health care spending in this country. This includes an in-depth analysis of prescription drug expenditures, which has been the fastest growing component of health care costs. Lastly, this paper will address whether there is anything particularly unique about health care spending in California.


Is It Time To Shed A "Tier" For Four-Tier Prescription Drug Formularies? Specialty Drug Tiers May Violate Hipaa's Anti-Discrimination Provisions And Statutory Goals, Joseph J. Hylak-Reinholtz, Jay R. Naftzger Nov 2011

Is It Time To Shed A "Tier" For Four-Tier Prescription Drug Formularies? Specialty Drug Tiers May Violate Hipaa's Anti-Discrimination Provisions And Statutory Goals, Joseph J. Hylak-Reinholtz, Jay R. Naftzger

Northern Illinois University Law Review

This Article will analyze whether specialty drug tiers violate HIPAA. This is a question of first impression—no federal or state court decision provides an answer. Part II of this Article provides relevant background material. We begin with a discussion about the development of prescription drug coverage in the United States and the emergence of drug tiers as a cost-saving mechanism. In Part III of this Article, we begin with an historical overview of accepted discrimination and risk classification within insurance. Next, we discuss HIPAA's statutory language, legislative history, and key parts of the Final Rule implementing the law. We also …


Reducing Mass Incarceration: Lessons From The Deinstitutionalization Of Mental Hospitals In The 1960s, Bernard Harcourt Jan 2011

Reducing Mass Incarceration: Lessons From The Deinstitutionalization Of Mental Hospitals In The 1960s, Bernard Harcourt

Faculty Scholarship

In a message to Congress in 1963, President John F. Kennedy outlined a federal program designed to reduce by half the number of persons in custody. The institutions at issue were state hospitals and asylums for the mentally ill, and the number of such persons in custody was staggeringly large, in fact comparable to contemporary levels of mass incarceration in prisons and jails. President Kennedy's message to Congress – the first and perhaps only presidential message to Congress that dealt exclusively with the issue of institutionalization in this country – proposed replacing state mental hospitals with community mental health centers, …


Dangers In Prescription Drugs: Filling A Private Law Gap In The Healthcare Debate, David G. Owen Feb 2010

Dangers In Prescription Drugs: Filling A Private Law Gap In The Healthcare Debate, David G. Owen

Faculty Publications

No abstract provided.


These Statements Have Not Been Approved By The Fda: Improving The Post-Approval Regulation Of Prescription Drugs, Christopher R. Page Jan 2010

These Statements Have Not Been Approved By The Fda: Improving The Post-Approval Regulation Of Prescription Drugs, Christopher R. Page

Christopher R. Page

The American public’s confidence in the FDA is waning in the midst of increased reporting of inefficiencies in the agency. The missteps by the FDA in the post-approval regulation of prescription drugs are magnified by the pervasive use of prescription drugs in the market. This article identifies these missteps. It also chronicles the response of the state attorneys general to this void in regulation, from the famous class action suit against the tobacco industry to the Oxycontin litigation to the recent Vioxx settlement.

This response to the public’s lack of confidence is accomplished through lawsuits against pharmaceutical companies under state …


Reduced Discretion In Corporate Governance As Applied To The Pharmaceutical Industry In Nevada, Timothy Koval Jan 2010

Reduced Discretion In Corporate Governance As Applied To The Pharmaceutical Industry In Nevada, Timothy Koval

Nevada Law Journal

This Note focuses on an education-based alternative to promote effective interactions between pharmaceutical corporations and physicians that benefit patients while allowing these corporations to exercise business discretion. Specifically, educational programs that teach physicians how to interact with pharmaceutical corporations most effectively may maximize the benefits for all parties involved. Although many of the arguments presented may be extended to corporations that sell or market medical devices or appliances, their application in that context is beyond the scope of this Note. In Part II, this Note discusses the background of corporate decision-making and its application in the pharmaceutical industry in Nevada. …


Drug Safety And Commercial Speech: Television Advertisements And Reprints On Off-Label Uses, Margaret Gilhooley Dec 2009

Drug Safety And Commercial Speech: Television Advertisements And Reprints On Off-Label Uses, Margaret Gilhooley

Margaret Gilhooley

1/11/10

PREPUBLICATION VERSION

DRUG SAFETY AND COMMERCIAL SPEECH:

TELEVISION ADVERTISEMENTS AND REPRINTS ON OFF-LABEL USES

By Margaret Gilhooley©

ABSTRACT

This paper examines how the constitutional protections for commercial speech have limited the ability of Congress and FDA to regulate prescription drugs in ways that can affect safety. In Thompson v. Western States, the Supreme Court struck down a Congressional restriction on advertisements for unapproved “compound” drugs because a disclosure that FDA had not approved the compound was considered a constitutionally adequate alternative. While drug compounds are a relatively obscure category, the decision influenced Congress in deciding not to require a …


Delayed Access To Generic Medicine: A Comment On The Hatch-Waxman Act And The "Approval Bottleneck, Ankur N. Patel Jan 2009

Delayed Access To Generic Medicine: A Comment On The Hatch-Waxman Act And The "Approval Bottleneck, Ankur N. Patel

Fordham Law Review

Prescription drug costs can be astronomical. The advent of generic drugs, which sell at substantially lower prices than their brand-name counterparts, can save consumers billions of dollars per year. The Hatch-Waxman Act, which governs the introduction of generic pharmaceuticals into the marketplace, produces an undesired side effect-the "approval bottleneck." This Comment examines the "approval bottleneck"-a potential roadbolock to the generic drug approval process, and comments on attempts to alleviate the problem. This comment suggest that developments in statutes and case law have made leaps in attempting to alleviate the "approval bottleneck" problem. The Comment evaluate these developments, which include (1) …


“There's Danger Here, Cherie!”: Liability For The Promotion And Marketing Of Drugs And Medical Devices For Off-Label Uses, Richard C. Ausness Jan 2008

“There's Danger Here, Cherie!”: Liability For The Promotion And Marketing Of Drugs And Medical Devices For Off-Label Uses, Richard C. Ausness

Law Faculty Scholarly Articles

Physicians often prescribe prescription drugs and other medications for uses that are not approved by the Food and Drug Administration ("FDA"), and such "off label" prescription is widely accepted within the medical community as a legitimate form of treatment. However, the federal government discourages off-label prescription and use in various ways. For example, the FDA restricts the dissemination of information by drug companies about potential off-label therapies. In addition, federally funded health insurance programs such as Medicaid do not reimburse health care providers for off-label uses. Because drug companies make large profits from off-label prescriptions, they are often tempted to …


The Battle Over Implied Preemption: Products Liability And The Fda, Mary J. Davis Nov 2007

The Battle Over Implied Preemption: Products Liability And The Fda, Mary J. Davis

Law Faculty Scholarly Articles

A mere five years ago, the Food and Drug Administration (the "FDA") began, for the first time in its 100-year history, to take the position that its prescription drug labeling regulations defeated the ability of injured plaintiffs to pursue common law tort claims based on the adequacy of the labeling. This position, radical to many and rational to others, places federal preemption of prescription drug labeling actions directly in the center of the debate over the proper roles of federal regulation and state tort laws in promoting product safety. The U.S. Supreme Court has contributed to this debate with several …


A Tough Pill To Swallow: Does The First Amendment Prohibit Wv From Regulating Pharmaceutical Companies' Advertising Expenses To Lower The Cost Of Prescription Drugs?, Brienne Taylor Greiner Sep 2006

A Tough Pill To Swallow: Does The First Amendment Prohibit Wv From Regulating Pharmaceutical Companies' Advertising Expenses To Lower The Cost Of Prescription Drugs?, Brienne Taylor Greiner

West Virginia Law Review

No abstract provided.