Law Commons^™

Throwing Dirt On Doctor Frankenstein's Grave: Accesss To Experimental Treatments At The End Of Life, Michael J. Malinowski

Michael J. Malinowski

Abstract

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 …

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 …

The Internet As The World's Biggest Copy Machine, And How Plaintiff's Bar Seeks To Monetize It, Daniel Lyons

Daniel Lyons

On February 23, 2013, Professor Lyons presented at the First Circuit Spring Meeting of the American Bar Association Student Division.

The Implausibility Of Secrecy, Mark Fenster

Mark Fenster

Government secrecy frequently fails. Despite the executive branch’s obsessive hoarding of certain kinds of documents and its constitutional authority to do so, recent high-profile events—among them the WikiLeaks episode, the Obama administration’s celebrated leak prosecutions, and the widespread disclosure by high-level officials of flattering confidential information to sympathetic reporters—undercut the image of a state that can classify and control its information. The effort to control government information requires human, bureaucratic, technological, and textual mechanisms that regularly founder or collapse in an administrative state, sometimes immediately and sometimes after an interval. Leaks, mistakes, open sources—each of these constitutes a path out …

How Safe Is That Shrimp? The Food Safety Modernization Act, David Wirth

David A. Wirth

No abstract provided.

Padilla Postconviction Claims In Florida: Squaring Chaidez, Hernandez And Castaño, Rebecca Sharpless, Andrew Stanton

Rebecca Sharpless

In Padilla v. Kentucky, the U.S. Supreme Court ruled that the Sixth Amendment requires defense attorneys to counsel their noncitizen clients about the immigration consequences of a plea. Padilla had pled guilty in state court to a drug crime and, after his conviction became final, filed a state postconviction motion alleging that his attorney rendered ineffective assistance of counsel by failing to advise him that his plea would trigger deportation. In holding that Padilla was entitled to competent advice regarding the consequences of his plea, the Court recognized what professional norms have required for at least the last two decades. …

Usage-Based Pricing And Net Neutrality, Daniel Lyons

Daniel Lyons

No abstract provided.

The Impact Of Data Caps And Other Forms Of Usage Based Pricing For Broadband Access, Daniel Lyons

Daniel Lyons

No abstract provided.

The Illusion Of Interchangeability: The Benefits And Dangers Of Guidance-Plus Rulemaking In The Fda's Biosimilar Approval Process, Jonathan Stroud

Jonathan R. K. Stroud

On March 23, 2010, President Obama signed into law the ambitious Patient Protection and Affordable Care Act. While media attention focused largely on the sweeping changes the bill makes to the nation’s healthcare system, there was also a less-noticed rider to the bill, the Biologics Price Competition and Innovation Act of 2009 (Biosimilars Act). The Biosimilars Act grants the Food and Drug Administration (FDA) broad new authority to create an accelerated premarket approval pathway for generic competition to biologics in an attempt to drive biologic drug prices down and reduce the overall costs of health care. Traditionally, inventors of medical …

Reforming The Universal Service Fund For The Digital Age, Daniel Lyons

Daniel Lyons

No abstract provided.

Bureaucratic Leadership, Agency Mission, And The Political Calculus Of Budgetary Investment Decisions For U.S. Federal Government Agencies, 1977-2009, Anne O'Connell, George Krause

Anne Joseph O'Connell

No abstract provided.

Administering Disasters, Anne O'Connell

Anne Joseph O'Connell

No abstract provided.

Adaptive Selection And Presidential Appointments To Leadership Positions In U.S. Federal Government Agencies, 1977-2009, Anne O'Connell, George Krause

Anne Joseph O'Connell

No abstract provided.

Who Walks The Watchdog? Bureaucratic Oversight And The Governement Accountability Office, Anne O'Connell

Anne Joseph O'Connell

No abstract provided.

Qualifications: Law And Practice Of Selecting Agency Leaders, Anne O'Connell

Anne Joseph O'Connell

No abstract provided.

A Measurement Model Of Loyalty And Competence For Presidential Appointees In U.S. Goverment Agencies, 1977-2009: A Hierarchical Generalized Latent Trait Analysis, Anne O'Connell, George Krause

Anne Joseph O'Connell

No abstract provided.

The Adoption Of Transparency Policies In Global Governance Institutions: Justifications, Effects, And Implications, Megan Donaldson, Benedict Kingsbury

Megan A Donaldson

Formal transparency policies are increasingly prevalent in global governance institutions, partially attenuating the influence in these institutions of practices of secrecy inherited from interstate diplomacy. This article assesses the incidence and specific characteristics of formal transparency policies across a select group of institutions and outlines some of the justifications given for these policies - including justifications based on the publicness of these institutions - and for the more controversial exceptions to transparency, such as the exception for deliberative materials. It examines three drivers affecting the adoption, form, and content of transparency policies and other transparency measures in these institutions: spillover …

Auditing Politics Or Political Auditing?, Anne O'Connell

Anne Joseph O'Connell

No abstract provided.

The Inefficiencies Of Legislative Centralization: Evidence From Chinese Provincial Tax Rate Setting, Wei Cui

Wei Cui

Legislative power in China is centralized to an unusual degree, both in comparison to other countries and relative to the country’s high degree of administrative decentralization. Given its a priori inefficiencies, this arrangement should be significant from both positive and normative perspectives, but, surprisingly, has received little attention in legal and social scientific scholarship. We devise a novel method for analyzing the inefficiencies of centralization through studying provincial government behavior, examining provincial rate setting for the vehicle and vessel tax (VVT) in 2007 and 2011. Because all provinces have assigned VVT revenue and VVT administration to sub-provincial governments, provincial rate-setting …