Health Law and Policy Commons^™

Kidney, Money, And The Shī‘Ah Implementation Of The Rule Of Necessity, Zahra Takhshid

Sturm College of Law: Faculty Scholarship

In the U.S., over 43,000 people die every year waiting for a kidney. In Iran, however, monetary incentives have eliminated such a waitlist. Iran is the only country in the world with an unrelated living kidney donor program that has allowed for monetary incentives in the form of an altruistic gift, which has become known as “the Iranian Model.” Nevertheless, the legal details of the system remain vague and scholars both in and outside of Iran continue to debate the nature of the system. Does the Iranian system consider kidneys a commodity? Can you legally buy a kidney in Iran? …

Tobacco Reborn: The Rise Of E-Cigarettes And Regulatory Approaches, Daniel G. Aaron

Utah Law Faculty Scholarship

This paper examines e-cigarettes, FDA-regulated products which heat nicotine-containing fluid into an aerosol to be breathed into the lungs. Recent data show that e-cigarettes are used by about one-fifth of U.S. high schoolers. Given that we have, in the Surgeon General’s words, reached an epidemic of youth e-cigarette use, it is worth asking how a product within FDA jurisdiction became a serious threat to to 3.6 million youth.

This article will review the law surrounding e-cigarettes and the history of FDA’s attempts to regulate them. Administrative law doctrines instruct us that increased presidential control will rein in misbehaving agencies by …

Public Health In The Opioid Litigation, Daniel G. Aaron

Utah Law Faculty Scholarship

Today, the opioid crisis is playing out in the nation’s courts. Litigants have taken a microscope to defendant opioid companies whose misconduct ignited and exacerbated the opioid crisis. As the litigation continues, one could imagine numerous ways its resolution could contribute to the end of a multi-decade overdose crisis and prevent future ones. Options include holding defendant companies accountable, releasing previously secret information for research on root causes of the epidemic, and prohibiting future misconduct through injunctive relief. Unfortunately, to date, the litigation has not been so capacious. Rather, the participants—judge included—have been preoccupied with rapid monetary settlement. Though understandable, …

The New Eugenics, Samuel R. Bagenstos

Articles

During the first third of the Twentieth Century, the eugenics movement played a powerful role in the politics, law, and culture of the United States. The fear of “the menace of the feebleminded,” the notion that those with supposedly poor genes “sap the strength of the State,” and other similar ideas drove the enthusiastic implementation of the practices of excluding disabled individuals from the country, incarcerating them in ostensibly beneficent institutions, and sterilizing them. By the 1930s, with the rise of Adolf Hitler in Germany, eugenic ideas had begun to be discredited in American public discourse. And after the Holocaust, …

Social Media Self-Regulation And The Rise Of Vaccine Misinformation, Ana Santos Rutschman

All Faculty Scholarship

This essay examines the main characteristics and shortcomings of mainstream social media responses to vaccine misinformation and disinformation. Parts I and II contextualize the recent expansion of vaccine information and disinformation in the online environment. Part III provides a survey and taxonomy of ongoing responses to vaccine misinformation adopted by mainstream social media. It further notes the limitations of current self-regulatory modes and illustrates these limitations by presenting a short case study on Facebook—the largest social media vehicle for vaccine-specific misinformation, currently estimated to harbor approximately half of the social media accounts linked to vaccine misinformation. Part IV examines potential …

Taxes As Pandemic Controls, Ashley C. Craig, James R. Hines Jr.

Articles

Tax policy can play important roles in limiting the spread of communicable disease and in managing the economic fallout of a pandemic. Taxes on business activities that bring workers or customers into close contact with each other offer efficient alternatives to broad regulatory measures, such as shutdowns, that have been effective but enormously costly. Corrective taxation also helps raise the revenue required to cover elevated government expenditure during a pandemic. Moreover, the restricted consumer choice that accompanies a pandemic reduces the welfare cost of raising tax revenue from higher-income taxpayers, making it a good time for deficit closure. Current U.S. …

FacebookʼS Latest Attempt To Address Vaccine Misinformation — And Why ItʼS Not Enough, Ana Santos Rutschman

All Faculty Scholarship

On October 13, 2020 Facebook announced the adoption of a series of measures to promote vaccine trust “while prohibiting ads with misinformation that could harm public health efforts.” In the post written by Kang-Xing Jin (head of health) and Rob Leathern (director of product management), the company explained that the new measures were designed with an emphasis on encouraging widespread use of this yearʼs flu vaccine, as well as in anticipation of potential COVID-19 vaccines becoming available in the near future.

The changes focus mainly on the establishment of a multiprong informational campaign about the seasonal flu vaccine, which includes …

Medical Marijuana: Implications Of Evolving Trends In Regulation, Florence Shu-Acquaye

Faculty Scholarship

No abstract provided.

Telehealth For An Aging Population: How Can Law Influence Adoption Among Providers, Payors, And Patients?, Tara Sklar, Christopher Robertson

Faculty Scholarship

Telehealth continues to experience substantial investment, innovation, and unprecedented growth. However, telehealth has been slow to transform healthcare. Recent developments in telehealth technologies suggest great potential for chronic care management, mental health services, and care delivery in the home—all of which should be particularly impactful for an aging population with physical and cognitive limitations. While this alignment of technological capacity and market demand is promising, legal barriers remain for telehealth operators to scale up across large geographic areas. To better understand how federal and state law can be reformed to enable greater telehealth utilization, we review and extract lessons from …

Reflections On The Effects Of Federalism On Opioid Policy, Matthew B. Lawrence

Dickinson Law Review (2017-Present)

No abstract provided.

The Opioid Litigation: The Fda Is Mia, Catherine M. Sharkey

Dickinson Law Review (2017-Present)

It is readily agreed that federal preemption of state tort law alters the balance between federal and state power. Federal preemption is a high-profile defense in almost all modern products liability cases. It is thus surprising to see how little attention has been given to federal preemption by courts and commentators in the opioid litigation. Opioid litigation provides a lens through which I explore the role of state and federal courts and the Food and Drug Administration (FDA) in striking the right balance of power. My purpose here is not to resolve the divide among the few courts that have …

Safe Consumption Sites And The Perverse Dynamics Of Federalism In The Aftermath Of The War On Drugs, Deborah Ahrens

Dickinson Law Review (2017-Present)

In this Article, I explore the complicated regulatory and federalism issues posed by creating safe consumption sites for drug users—an effort which would regulate drugs through use of a public health paradigm. This Article details the difficulties that localities pursuing such sites and other non-criminal-law responses have faced as a result of both federal and state interference. It contrasts those difficulties with the carte blanche local and state officials typically receive from federal regulators when creatively adopting new punitive policies to combat drugs. In so doing, this Article identifies systemic asymmetries of federalism that threaten drug policy reform. While traditional …

Fda In The Time Of Covid-19, Elizabeth Mccuskey

Faculty Scholarship

Over the past century, Congress has made the Food & Drug Administration (FDA) responsible for regulating the safety and efficacy of drugs and devices being deployed in the fight against the COVID-19 pandemic. The FDA’s regulatory infrastructure was built for public health threats and to combat manufacturers' misinformation about treatments.

This article spotlights the ways in which FDA has been adapting to a new challenge during the COVID-19 pandemic: combating misinformation emanating from within the executive branch.

Chain Restaurant Calorie Posting Laws, Obesity, And Consumer Welfare, Charles J. Courtemanche, David Frisvold, David Jimenez-Gomez, Mariétou H. Ouayogodé, Michael Price

Institute for the Study of Free Enterprise Working Papers

The 2010 Patient Protection and Affordable Care Act (ACA) introduced a mandate requiring chain restaurants to post calorie counts on menus and menu boards. This paper investigates whether and why calorie posting laws work. To do so, we develop a model of calories consumed that highlights two potential channels through which mandates influence choice and outlines an empirical strategy to disentangle these alternatives. We test the predictions of our model using data from the Behavioral Risk Factor Surveillance System to compare changes in body mass index (BMI), obesity, and consumer well-being in locations that implemented calorie-posting laws between 2008 and …

Is Medicare For All The Answer? Assessing The Health Reform Gestalt As The Aca Turns 10, Nicole Huberfeld

Faculty Scholarship

As presidential candidates debate health reform, the expression “Medicare for All” (“M4A”) is on repeat, yet few appear to understand precisely what Medicare is or what M4A would mean. Even more striking is that Americans are vigorously debating health reform when the ACA – President Obama’s signature legislation and a health reform effort on a scale not seen in decades – turns 10 on March 23.

The ACA pioneered universal coverage, but it also ratcheted up health care complexity by building new scaffolding around an old foundation. This fragmented landscape has been exacerbated by a crazy quilt of implementation crafted …

The Pharma Perspective: The Double-Edged Sword Of Direct-To-Consumer Advertising, Ela H. Yalcin

Health Law Outlook

No abstract provided.

Covid-19, Telehealth, And Substance Use Disorders, Stacey A. Tovino

Faculty Articles

No abstract provided.

Cannabis Legalization In State Legislatures: Public Health Opportunity And Risk, Daniel G. Orenstein, Stanton A. Glantz

Marquette Law Review

Cannabis is widely used in the United States and internationally despite its illicit status, but that illicit status is changing. In the United States, thirty-three states and the District of Columbia have legalized medical cannabis, and eleven states and D.C. have legalized adult use cannabis. A majority of state medical cannabis laws and all but two state adult use laws are the result of citizen ballot initiatives, but state legislatures are beginning to seriously consider adult use legislation. From a public health perspective, cannabis legalization presents a mix of potential risks and benefits, but a legislative approach offers an opportunity …

Canada's Assisted Human Reproduction Act: Pragmatic Reforms In Support Of Research, Tania M. Bubela, Erika Kleiderman, Zubin Master, Ubaka Ogbogu, Vardit Ravitsky, Amy Zarzeczny, Bartha Maria Knoppers

Office of the Provost

Canada's Assisted Human Reproduction Act is long overdue for Parliamentary review. We argue that the current regulation of research using human reproductive materials is not proportionate, not responsive to the uncertain threats posed to human and environmental health and safety, and is not considerate of diverse values in a democratic society. We propose tailored regulatory carve-outs for in vitro research for currently prohibited activities, such as gene editing, and for the exercise of Ministerial Discretion for access by Canadians to experimental in vivo interventions that are currently prohibited, such as mitochondrial replacement therapy. Our recommendations are bounded by constitutional constraints …

Money That Costs Too Much: Regulating Financial Incentives, Kristen Underhill

Indiana Law Journal

Money may not corrupt. But should we worry if it corrodes? Legal scholars in a range of fields have expressed concern about “motivational crowding-out,” a process by which offering financial rewards for good behavior may undermine laudable social motivations, like professionalism or civic duty. Disquiet about the motivational impacts of incentives has now extended to health law, employment law, tax, torts, contracts, criminal law, property, and beyond. In some cases, the fear of crowding-out has inspired concrete opposition to innovative policies that marshal incentives to change individual behavior. But to date, our fears about crowding-out have been unfocused and amorphous; …

The Impact Of H.B. 214: A Critical Analysis Of The Texas "Rape Insurance" Bill, Lucie Arvallo

St. Mary's Law Journal

Texas House Bill 214 (H.B. 214) is subject to challenge under the Supreme Court precedent protecting a woman’s right to choose. Passed in 2017, H.B. 214 regulates Texas insurance markets by prohibiting coverage for an elective abortion unless a woman affirmatively opts into such coverage through a separate contract and pays a separate premium. Similar restrictions on insurance coverage for elective abortion in other states have been met with mixed results in the courts. What sets H.B. 214 apart from other regulations of insurance coverage for abortion is that it does not include any exceptions for abortions in cases of …

21st Century Cures Act: The Problem With Preemption In Light Of Deregulation, Megan C. Andersen

University of Michigan Journal of Law Reform

The 21st Century Cures Act introduced innovative changes to the Food and Drug Administration’s regulatory processes. In an effort to address the slow, costly, and burdensome approval process for high-risk devices, the Cures Act modernized clinical trial data by allowing reviewers to determine whether devices merit expedited review and to consider post-market surveillance data in the premarket approval process. These changes will get life-saving devices to the people who need them faster than ever before. But the tradeoff is a greater risk of injury to the patient. The 2008 Supreme Court decision Riegel v. Medtronic, Inc., held that any …

Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg

Marquette Intellectual Property Law Review

This article examines the intersection of patent law, FDA regulation, and Medicare coverage in a particularly promising field of biomedical innovation: genetic diagnostic testing. First, I will discuss current clinical uses of genetic testing and directions for further research, with a focus on cancer, the field in which genetic testing has had the greatest impact to date. Second, I will turn to patent law and address two recent Supreme Court decisions that called into question the patentability of many of the most important advances in genetic testing. Third, I will step outside patent law to take a broader view of …

Drugs' Other Side Effects, Craig J. Konnoth

Publications

Drugs often induce unintended, adverse physiological reactions in those that take them—what we commonly refer to as “side-effects.” However, drugs can produce other, broader, unintended, even non-physiological harms. For example, some argue that taking Truvada, a drug that prevents HIV transmission, increases promiscuity and decreases condom use. Expensive Hepatitis C treatments threaten to bankrupt state Medicaid programs. BiDil, which purported to treat heart conditions for self-identified African-Americans, has been criticized for reifying racial categories. Although the Food & Drug Administration (“FDA”) has broad discretion under the Food, Drugs, and Cosmetics Act (“FDCA”) to regulate drugs, it generally considers only traditional …

Pharmaceutical Drugs Of Uncertain Value, Lifecycle Regulation At The Us Food And Drug Administration, And Institutional Incumbency, Matthew Herder

Articles, Book Chapters, & Popular Press

Policy Points

• The US Food and Drug Administration (FDA) has in recent years allowed onto the market several drugs with limited evidence of safety and effectiveness, provided that manufacturers agree to carry out additional studies while the drugs are in clinical use.
• Studies suggest that these postmarketing requirements (PMRs) frequently lack transparency, are subject to delays, and fail to answer the questions of greatest clinical importance. Yet, none of the literature speaks directly to the challenges that the FDA—as a regulatory institution—encounters in enforcing PMRs.
• Through a series of interviews with FDA leadership, this article analyzes and situates those challenges …

Revisionist History? Responding To Gun Violence Under Historical Limitations, Michael Ulrich

Faculty Scholarship

In the D.C. Circuit case Heller v. District of Columbia (Heller II), Judge Kavanaugh wrote that “Heller and McDonald leave little doubt that courts are to assess gun bans and regulations based on text, history, and tradition, not by a balancing test such as strict or intermediate scrutiny.” Now Justice Kavanaugh, will he find support on the highest court for what was then a dissenting view? Chief Justice Roberts, during oral arguments for Heller I, asked “Isn’t it enough to…look at the various regulations that were available at the time…and determine how these—how this restriction and the scope of this …

Practice-Based Research Networks Ceding To A Single Institutional Review Board, Jeanette M. Daly, Tabria Weiner Harrod, Kate Judge, Leann C. Michaels, Barcey T. Levy, David L. Hahn, Lyle J. Fagnan, Donald E. Nease Jr.

Journal of Patient-Centered Research and Reviews

Historically, a single research project involving numerous practice-based research networks (PBRNs) required multiple institutional review boards (IRBs) to be involved in approval of the project. However, to avoid redundancies, federal IRB regulations now allow cooperative research projects that involve more than one institution to use reasonable methods of cooperative IRB review and to cede authority for review and oversight of the project to a single lead IRB. Through ceding, a lead IRB has the authority for review and oversight of the project delegated by all participating sites’ IRBs and becomes the IRB of record for the ceded sites. In the …

Will Courts Allow States To Regulate Drug Prices?, Christopher Robertson

Faculty Scholarship

Pharmaceuticals are consuming increasingly large portions of U.S. state budgets, and high prices are preventing patients from getting, and adhering to, essential medicines. In mid-May 2018, President Donald Trump announced a heavily hyped but relatively modest federal plan to bring down drug prices. Meanwhile, several states are moving forward with their own solutions, and Maryland’s approach is particularly ambitious. In 2017, responding to notorious cases such as the 5000% increase in the cost of Daraprim (pyrimethamine) and the 10-fold increase in the cost of EpiPens (epinephrine auto-injectors), Maryland enacted a statute that prohibits manufacturers from “price gouging” on any “essential …

Too Little Too Late: The Infeasibility Of Osha's Silica Standards In The Oil Industry, Cali M. Franks

St. Mary's Law Journal

Abstract forthcoming

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 examines the federal agency initiatives undertaken in …