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Full-Text Articles in Law
Where Babies And Death-Row Inmates Intersect: Is Arbitrary Agency Decision-Making Supported Under Existing Law?, Lisa C. Blanton Bs., Mj.
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 …
Erisa Preemption Of State “Play Or Pay” Mandates: How Ppaca Clouds An Already Confusing Picture, Mary Ann Chirba
Erisa Preemption Of State “Play Or Pay” Mandates: How Ppaca Clouds An Already Confusing Picture, Mary Ann Chirba
Mary Ann Chirba
From the introduction: Although ERISA preemption was ranked among the top "eight pertinent issues" that needed to be addressed in order to achieve comprehensive health care reform, Congress opted to avoid it when it passed the Patient Protection and Affordable Health Care Act on March 23, 2010, and the Health Care and Education Reconciliation Act just one week later ("PPACA" or the "Act", collectively). Currently 180 million Americans receive employer-sponsored health benefits, and millions more will do so once PPACA takes full effect over the next few years. This expansion of employer based coverage, coupled with what the Act does …
Our Bodies, Our Cells: Fda Regulation Of Autologous Adult Stem Cell Therapies, Mary Ann Chirba, Alice Noble
Our Bodies, Our Cells: Fda Regulation Of Autologous Adult Stem Cell Therapies, Mary Ann Chirba, Alice Noble
Mary Ann Chirba
Stem cells have been an endless source of fascination and controversy since Dolly the sheep was cloned in 1996. This month’s announcement of a cloned human embryo from a single skin cell came on the heels of Sir John B. Gurdon and Dr. Shinya Yamanaka’s receipt of the 2012 Nobel for Physiology and Medicine for their work with induced pluripotent stem cells. Pluripotent stem cells can be embryonic or induced. Embryonic stem cells (ESCs) can generally be obtained from human embryos or by cloning embryos through somatic cell nuclear transfer (SCNT), as was done for Dolly. Gurdon and Yamanaka demonstrated …
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
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
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
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 Courts And Malpractice Claims Adjudication Through Medicare: Some Questions, Timothy Stoltzfus Jost
Health Courts And Malpractice Claims Adjudication Through Medicare: Some Questions, Timothy Stoltzfus Jost
Timothy S. Jost
No abstract provided.
Health Law And Administrative Law: A Marriage Most Convenient, Timothy Stoltzfus Jost
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 …
Local Health Agencies, The Bloomberg Soda Rule, And The Ghost Of Woodrow Wilson, Paul A. Diller
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 …