Law Commons^™

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 Decade’S Quest For Safer Drugs: Congressional Committee Green Lights Regulation Of Drug Supply Chains And Compounding Manufacturers, Mary Ann Chirba, Alice Noble

Mary Ann Chirba

On May 22. 2013, the Senate Health, Education, Labor and Pensions (HELP) Committee unanimously approved S.959, “The Pharmaceutical Compounding Quality and Accountability Act,” and S.957, “The Drug Supply and Security Act,” (now incorporated into S. 959 as an amendment). Congressional efforts to enact comprehensive legislation to improve drug safety and secure the nation’s drug supply chain have lingered for over a decade. The lack of federal uniformity has allowed a patchwork of state legislation to emerge, attracting the less scrupulous to those states with the lowest security. The issue finally gained traction among HELP Committee members when 55 people died …

Visual Gut Punch: Persuasion, Emotion, And The Constitutional Meaning Of Graphic Disclosure, Ellen P. Goodman

ellen p. goodman

The ability of government to “nudge” with information mandates, or merely to inform consumers of risks, is circumscribed by First Amendment interests that have been poorly articulated in the relevant law and commentary. New graphic cigarette warning labels supplied courts with the first opportunity to assess the informational interests attending novel forms of product disclosures. The D.C. Circuit enjoined them as unconstitutional, compelled by a narrative that the graphic labels converted government from objective informer to ideological persuader, shouting its warning to manipulate consumer decisions. This interpretation will leave little room for graphic disclosure and is already being used to …

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 …

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 …

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 …