Digital Commons Network^™

The Promise Of Telehealth For Abortion, Greer Donley, Rachel Rebouché

Book Chapters

The COVID-19 pandemic catalyzed a transformation of abortion care. For most of the last half century, abortion was provided in clinics outside of the traditional healthcare setting. Though a medication regimen was approved in 2000 that would terminate a pregnancy without a surgical procedure, the Food & Drug Administration required, among other things, that the drug be dispensed in person. This requirement dramatically limited the medication’s promise to revolutionize abortion because it subjected medication abortion to the same physical barriers of procedural care.

Over the course of the COVID-19 pandemic, however, that changed. The pandemic’s early days exposed how the …

The Fall Of Fda Review, Daniel G. Aaron

Utah Law Faculty Scholarship

The U.S. Food and Drug Administration (FDA) is in crisis. FDA can hardly go a single day without an investigation, negative news story, or scholarly critique of the agency’s work. We have increasingly entrusted FDA—today, to the tune of 25% of the U.S. economy—with vetting the products we put in and on our bodies. But the array of problems facing the agency raises questions about whether it is equipped to succeed in the 21st century.

FDA’s core function is to oversee a special legal regime called “premarket review.” Congress has prohibited all marketing of certain types of products (like drugs) …

Table Of Contents

Seattle University Law Review

Table of Contents

Medication Abortion Exceptionalism, Greer Donley

Articles

Restrictive state abortion laws garner a large amount of attention in the national conversation and legal scholarship, but less known is a federal abortion policy that significantly curtails access to early abortion in all fifty states. The policy limits the distribution of mifepristone, the only drug approved to terminate a pregnancy so long as it is within the first ten weeks. Unlike most drugs, which can be prescribed by licensed healthcare providers and picked up at most pharmacies, the Food and Drug Administration only allows certified providers to prescribe mifepristone, and only allows those providers to distribute the drug to …

Murray Energy Corporation V. Mccarthy, Sarah M. Danno

Public Land & Resources Law Review

Holding that the widespread effects of environmental regulation on the coal industry constituted sufficient importance, the Northern District of West Virginia ordered the Environmental Protection Agency to conduct analysis on employment loss and plant reduction resulting from regulatory effects. In admonishing the EPA’s inaction, the court ruled that the Agency had a non-discretionary duty to evaluate employment and plant reduction. Furthermore, the court held that the EPA’s attempt to put forth general reports in place of required evaluations was an invalid attempt to circumvent its statutory duty.

Enlightened Regulatory Capture, David Thaw

Articles

Regulatory capture generally evokes negative images of private interests exerting excessive influence on government action to advance their own agendas at the expense of the public interest. There are some cases, however, where this conventional wisdom is exactly backwards. This Article explores the first verifiable case, taken from healthcare cybersecurity, where regulatory capture enabled regulators to harness private expertise to advance exclusively public goals. Comparing this example to other attempts at harnessing industry expertise reveals a set of characteristics under which regulatory capture can be used in the public interest. These include: 1) legislatively-mandated adoption of recommendations by an advisory …

Throwing Dirt On Doctor Frankenstein’S Grave: Access To Experimental Treatments At The End Of Life, Michael J. Malinowski

Michael J. Malinowski

All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research and …

Where Babies And Death-Row Inmates Intersect: Is Arbitrary Agency Decision-Making Supported Under Existing Law?, Lisa C. Blanton Bs., Mj.

Lisa C. Blanton BS., MJ.

The Food and Drug Administration (FDA) is the executive branch regulatory agency primarily responsible for protecting the nation’s drug products.^[1] The FDA recently made highly inconsistent decisions surrounding a new drug for the prevention of pre-term birth, Makena™ (hydroxyprogesterone caproate). During a lengthy approval process, FDA made laudatory public announcements and demonstrated high programmatic preference to expedite approval of Makena by assigning orphan status^[2] and granting accelerated “fast-track” approval time-frames.^[3] Despite these actions, within weeks of the approval, the FDA issued aggressive public statements against the product’s efficacy and safety and made supportive comments about a non-FDA …

A Discourse On The Public Nature Of Research In Contemporary Life Science: A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski

Michael J. Malinowski

This article addresses the impact of integration of academia, industry, and government on the public nature of research. The article concludes that, while the integration has benefited science immensely, regulatory measures should be taken to restore the public nature of research in an age of integration.

A Failure To Consider: Why Lawmakers Create Risk By Ignoring Trade Obligations, David R. Kocan Professor

David R. Kocan Professor

The U.S. Congress frequently passes laws facially unrelated to trade that significantly impact U.S. trade relations. These impacts are often harmful, significant, and long-lasting. Despite this fact, these bills rarely receive adequate consideration of how they will impact trade. Without this consideration, Congress cannot properly conduct a cost-benefit analysis necessary to pass effective laws. To remedy this problem, the U.S. Trade Representative should evaluate U.S. domestic law to determine whether it is consistent with international trade obligations. Moreover, the U.S. Congress committee structure should be amended so that laws that might impact trade are considered within that light. In the …

Functional Government In 3-D, Robert L. Glicksman, Alejandro E. Camacho

Robert L. Glicksman

The creation of new administrative agencies and the realignment of existing governmental authority are commonplace and high-stakes events, as illustrated by the recent creation of the Department of Homeland Security after 9/11 and of new financial regulatory agencies after the global recession of 2009. Scholars and policymakers have not devoted sufficient attention to this subject, failing to clearly identify the different dimensions along which government authority may be structured or to consider the relationships among them. Analysis of these institutional design issues typically also gives short shrift to whether authority should be allocated differently based on agency function. These failures …

Health Law And Administrative Law: A Marriage Most Convenient, Timothy Stoltzfus Jost

Timothy S. Jost

This symposium explores the complex relationship between health law and administrative law. It is based on the observation that these two fields of law are peculiarly intertwined. It attempts to understand why this is so, as well as whether it is necessary and whether it is desirable. Would we as a society, that is, be better off if health law were less permeated by administrative law? Even if we would be better off, is it indeed possible to extricate health law from administrative law? This essay begins by defining health law and administrative law. It then proceeds to describe the …

What It Is-What It Should Be: An Empirical Analysis Of The Effect Of Procedures And Substantive Arguments On Adjudicative Tribunal Resource Allocation Decisions, Lydia Christine Stewart Ferreira

PhD Dissertations

Our current understanding of tribunal resource allocation decision-making is via judicial review of tribunal decisions and/or the capacity, independence and appointment process of tribunal members. This analysis of tribunals provides incomplete information. This qualitative five year case study, however, asked the three following questions: Research Question #1: Do procedures statistically affect the resource allocation decisions of the Board? If so, what elements of the procedures create this statistical effect? The author analyzed the quantitative research results relative to the A4R theory’s four procedural conditions of transparency and concluded that the A4R theory it was not ‘fine grain’ enough to identify …

Local Health Agencies, The Bloomberg Soda Rule, And The Ghost Of Woodrow Wilson, Paul A. Diller

Paul Diller

Local health agencies are often leaders in public health regulation. Despite the significance of this phenomenon, scant scholarship has assessed the interesting doctrinal and normative questions that local agency rulemaking raises. This paper uses local health agency rulemaking, and the New York City portion-cap rule for sugar-sweetened beverages ("the Bloomberg soda rule"), in particular, as a prism through which to analyze local agency rulemaking. The article first explains why it is important -- both doctrinally and practically -- to determine whence local agency power flows. If agencies are created directly by state law, then their powers should be circumscribed by …

Caremark's Irrelevance, Mercer E. Bullard

Mercer E Bullard

In re Caremark Int’l Inc. Derivative Litig. is commonly held out as the iconic corporate law case on liability for a failure of legal compliance, but the true source of corporate law as to legal compliance is the higher standard established by other sources of law. The expected cost of liability, both criminal and civil, for violations of federal healthcare regulations, for example, is a far stronger determinant of corporate compliance systems than potential liability under Caremark. Other areas of industry-specific regulation, such as for financial services, telecommunications and energy, similarly play a greater role than state corporate law in …

Prescription For Change: Third Circuit Diagnoses Pharmaceutical Sales Representatives As Exempt From Overtime Pay In Smith V. Johnson & Johnson, Brooke Burns

Brooke Burns

This Casebrief recognizes the current division developing among courts concerning whether PSRs have been wrongly misclassified as exempt from overtime pay since the World War II era. Despite the Second Circuit’s more recent decision in In re Novartis Wage and Hour Litigation, this Casebrief identifies the Third Circuit’s jurisprudence in Smith v. Johnson & Johnson as providing controlling guidance for practitioners navigating the current legal landscape.

" 'How's My Doctoring? Patient Feedback's Role In Physician Assessment", Ann Marie Marciarille

Ann Marie Marciarille

A society-wide consumer revolution is underway with the rise of online user-generated review websites such as Yelp, Angie’s List, and Zagat. Service provider reviews are now available with an intensity and scope that attracts increasing numbers of reviewers and readers. Health care providers are not exempt from this new consumer generated scrutiny though they have arrived relatively late to the party and as somewhat unwilling guests.

The thesis of this article is that online patient feedback on physicians is relevant and valuable even though it is also uncomfortable for health care providers. This is because the modern physician-patient relationship is …

Bending The Health Cost Curve: The Promise And Peril Of The Independent Payment Advisory Board, Ann Marie Marciarille, James Bradford Delong

Ann Marie Marciarille

Underlying today’s and the future’s health-care reform debate is a consensus that America’s health-care financing system is in a slow-moving but deep crisis: care appears substandard in comparison with other advanced industrial countries, and relative costs are exploding beyond all reasonable measures. The Obama Administration’s Patient Protection and Affordable Care Act (“ACA”) attempts to grapple with both of these problems. One of ACA’s key instrumentalities is the Independent Payment Advisory Board—the IPAB, designed to discover and authorize ways to reduce the rate of growth of Medicare and other categories of health spending. The IPAB is a peril. Expert boards to …

Interests In The Balance: Fda Regulations Under The Biologics Price Competition And Innovation Act, Parker Tresemer

Parker Tresemer

Recent biotechnology advances are yielding potentially life-saving therapies, but without FDA regulations designed to minimize product costs, patients will continue to be unable to afford these expensive biologic products. Many believe that these prohibitive costs stem from weak competition from generic biologic products, also known as follow-on biologics. To correct this deficiency, and to address the often conflicting regulatory and policy concerns associated with biologic products, Congress enacted the Biologics Price Competition and Innovation Act. The Act created an abbreviated approval pathway for biologic products and, if effective, could increase competition while driving down product costs. But legislation alone is …

Fda Accelerated Approval Program: Why Brake When You Can Get A Mandate?, Keren Frumkin

Keren F. Bisnauth

The FDA approval process is designed to ensure that the drugs released for public consumption are safe and effective. In 1992, the FDA implemented the Accelerated Approval process in order to expedite the approval of drugs to aid patients with life-threatening illnesses, who have little to gain from lengthy approval processes, and who cannot risk worsening health conditions. However, the questionable post-approval practices of drug manufacturers, coupled with the lax FDA enforcement of its required follow-up protocols have raised doubts as to the true value of expedited approval procedures, as well as an influx of drug recalls and lawsuits. In …

A Discourse On The Public Nature Of Research In Contemporary Life Science: A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski

Journal Articles

This article addresses the impact of integration of academia, industry, and government on the public nature of research. The article concludes that, while the integration has benefited science immensely, regulatory measures should be taken to restore the public nature of research in an age of integration.

The Deregulatory State, Lawrence O. Gostin

O'Neill Institute Papers

Public health can be achieved only through collective action, not through individual endeavor. Collective goods are essential conditions for health, but can be secured only through a well-regulated society. Yet, successive governments have eroded health and safety protections, with serious consequences. Think about the death of miners, lead in children’s toys, industrial solvents in toothpaste, salmonella in peanut butter, e-coli in spinach, and unsafe or ineffective pharmaceuticals such as COX-2 inhibitors or non-statin cholesterol medications.

Conservatives have waged a campaign against the administrative state that has created and reinforced deep-seated concerns about over-bearing government, particularly at the national level. The …

A Complete Property Right Amendment, John H. Ryskamp

ExpressO

The trend of the eminent domain reform and "Kelo plus" initiatives is toward a comprehensive Constitutional property right incorporating the elements of level of review, nature of government action, and extent of compensation. This article contains a draft amendment which reflects these concerns.

Bond Repudiation, Tax Codes, The Appropriations Process And Restitution Post-Eminent Domain Reform, John H. Ryskamp

ExpressO

This brief comment suggests where the anti-eminent domain movement might be heading next.

Zoning And Eminent Domain Under The New Minimum Scrutiny, John H. Ryskamp

ExpressO

Recently the Supreme Court has made it clearer that minimum scrutiny is a factual analysis. Whether in any government action there is a rational relation to a legitimate interest is a matter of determining whether there is a policy maintaining important facts. This has come about in the Court’s emerging emphasis on developing fact-based criteria for determining government purpose. Thus, those who want to affect zoning and eminent domain outcomes should look to what the Court sees as important facts, and whether government action is maintaining those facts with its proposed land use or eminent domain action.

Breaking The Bank: Revisiting Central Bank Of Denver After Enron And Sarbanes-Oxley, Celia Taylor

ExpressO

No abstract provided.

A Right To No Meaningful Review: The Aftermath Of Shalala V. Illinois Council On Long Term Care, Inc., Ruqaiijah Ayanna Yearby

ExpressO

A RIGHT TO NO MEANINGFUL REVIEW: THE AFTERMATH OF SHALALA v. ILLINOIS COUNCIL ON LONG TERM CARE, INC. Ruqaiijah A. Yearby

The Due Process Clause of the Fifth Amendment has been perverted in the federal administrative system. Federal agencies, such as the U.S. Department of Health and Human Services (HHS), regularly deprive individuals of liberty and property with little to no review. In its regulation of the health care industry through the Medicare program, HHS often turns a blind eye to procedural Due Process protections, such as providing individuals an opportunity to challenge the deprivation of property at a hearing, …

Organizational Misconduct: Beyond The Principal-Agent Model, Kimberly D. Krawiec

ExpressO

This article demonstrates that, at least since the adoption of the Organizational Sentencing Guidelines in 1991, the United States legal regime has been moving away from a system of strict vicarious liability toward a system of duty-based organizational liability. Under this system, organizational liability for agent misconduct is dependant on whether or not the organization has exercised due care to avoid the harm in question, rather than under traditional agency principles of respondeat superior. Courts and agencies typically evaluate the level of care exercised by the organization by inquiring whether the organization had in place internal compliance structures ostensibly designed …

Health Law And Administrative Law: A Marriage Most Convenient, Timothy Stoltzfus Jost

Scholarly Articles

This symposium explores the complex relationship between health law and administrative law. It is based on the observation that these two fields of law are peculiarly intertwined. It attempts to understand why this is so, as well as whether it is necessary and whether it is desirable. Would we as a society, that is, be better off if health law were less permeated by administrative law? Even if we would be better off, is it indeed possible to extricate health law from administrative law? This essay begins by defining health law and administrative law. It then proceeds to describe the …

The Dialectics Of Change: The New York City Health And Hospitals Corporation At A Crossroad, Edna Wells Handy

Fordham Urban Law Journal

New York City Mayors have long struggled with what to do with the New York City Health and Hospital Corporation ("HHC"). HHC is neither a city agency nor a department; nor is it a true public benefit corporation or authority. Given recent problems faced by HHC, like the AIDS crisis, evaporating public funding, a shrinking pool from which to hire employees, the movement to make HHC more accountable and connected with city government has grown. This article argues that to fully take advantage of the potential that HHC has, the opposite should be done: HHC should be allowed to vest …