Browsing HLS Student Papers by Title
Now showing items 1-20 of 593
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The 100-plus-Year Old Case For a Minimalist Criminal Law (Sketch of a General Theory of Substantive Criminal Law)
(2015)Criminal law defines the system of government of which it is the political expression; thus having a normative theory of substantive criminal law is paramount. U.S. criminal law has developed in the absence of such overarching ... -
Access to Medicine: Pharmaceutical Patents and Public Health Needs Under the WTO Framework
(2008)Many people, particularly in developing countries, die from curable or manageable diseases without access to medicine. After the TRIPS Agreement was brought into force, access to medicine in developing countries became ... -
Accomodating Pharmacogenomics: Fulfilling the Promise of Individualized Medicine
(2005)Pharmacogenomic technologies promise to usher in an era of individualized medicine, but also pose challenges to a regulatory regime without experience dealing with the sorts of data produced by these techniques. Pharmacogenomics ... -
Accounting for Prescription Drugs’ Unforeseen Risks: A Regulatory Alternative to Tort Liability
(2009)In the context of prescription drugs, tort law is traditionally understood to providing added incentive for drug manufacturers to adhere to regulations of the Food and Drug Administration (FDA) and to account for risks ... -
ACCUTANE: POST-APPROVAL DRUG REGULATION IN A RISK MANAGEMENT FRAMEWORK
(2002)The acne drug Accutane lies at the center of a movement to expand post-approval controls on drug regulation in an effort to effectively manage drug risks. Accutane’s regulatory history tracks a trend ... -
Achieving Equilibrium: An Examination of the FDA’s Attempt to Balance Patient Safety with Access to Innovative Treatments Through the Off-Label Marketing Regulations
(2008)The FDA maintains almost complete control over the approval, labeling, and marketing of prescription drugs. Pharmaceutical companies are generally prohibited from promoting their products to doctors for any use other than ... -
Achieving Nationhood Through Health Care Delivery: A History of the Relationship between the Indian Health Service and Indian Tribes
(2005)By the measure of its mission, the Indian Health Service is one of the most successful and productive government agencies. At the same time, it is an agency often criticized for not achieving enough. Part of this criticism ... -
Adding Shades of Gray to Black and White: Proposal for a Tiered Pharmaceutical Labeling Scheme
(2011)In the United States, $26-54 billions are spent every year on the marketing of pharmaceuticals. This article focuses on the scope and pros and cons of off-label use and marketing of pharmaceuticals, and proposes a new FDA ... -
Adequacy of FDA's Response to Mad Cow Disease
(1999)This paper will attempt to analyze the history of FDA’s response to the emergence of BSE and whether FDA’s actions were adequate to protect the American public and its food supply. -
Adopting the Therapeutic Orphan: An Examination of FDA and Congress: Efforts to Promote the Inclusion of Children in Clinical Drug Studies
(2001)This paper examines both the Food and Drug Administration’s Final Rule, which mandates drug sponsors to conduct pediatric research on their products prior to FDA approval and Section 111 of the Food and ... -
Adopting the Therapeutic Orphan? A Legal and Regulatory Assessment of the FDA's Pediatric Testing Rule
(2000)This paper explores the legality and the proper limits of the FDA's rule. Part I lays out the background for the rest of the paper by exploring the complicated policy and ethical problems posed by inadequate pediatric ... -
ADVERTISING, THE FDA, AND THE TOBACCO SETTLEMENT: AS HOPES FOR SETTLEMENT DIM, CHALLENGES OF FDA AUTHORITY AND FIRST AMENDMENT CONCERNS ARE REKINDLED
(1998)This discussion will attempt to explore the controversy and dynamics of FDA authority over tobacco advertising and the constitutionality of the existing (although unapproved) restrictions on tobacco advertising, the two ... -
Agents Unchained: The Determinants of Takeover Defenses in IPO Firms
(2013)Many companies continue to go public with takeover defenses even though institutional investors zealously oppose defenses in public companies. In this Article, I analyze the determinants of takeover defenses at IPO firms ... -
Aiding AIDS: Hurdling the Obstacles to the Development of an Effective AIDS Vaccine
(2002)This paper explores the various impediments to the development of a safe and effective AIDS vaccine, and offers suggestions to help overcome these obstacles. I begin by discussing the FDA approval process and the current ... -
AIDS HOME TEST KITS
(1994)Given the emphasis on private, confidential and voluntary testing, the idea of an AIDS home test kit was inevitable. What could be more private, confidential and voluntary (and profitable) than buying a test kit at a drug ... -
Ain't Misbehavin'? An Analysis of Prescription Drug Promotions by Pharmaceutical Manufacturers and the Regulatory Response of the Food and Drug Administration
(2003)In evaluating the United States drug regulatory system in 1978, Richard J. Crout posed a choice between competing good values: "Do we want scientific rationality or personal freedom? And if we want the latter, are we willing ... -
Algorithms in the Criminal Justice System: Assessing the Use of Risk Assessments in Sentencing
(Berkman Klein Center for Internet & Society, 2017)Risk assessment tools are increasingly being incorporated into all aspects of the criminal justice system. This paper focuses on the use of these tools in the sentencing process, a relatively recent development which raises ... -
ALICE AND THE FRANKENFOODS: A WELL REGULATED WONDERLAND?
(2003)This paper uses fiction to illuminate anxieties associated with the substances that sustain, nourish and transform us, and to consider the impact of consumer perceptions on the regulatory balances that must be struck between ... -
Allergies in America after the FALCPA: Obstacles Still Facing Allergic Individuals
(2008)Allergies affect over 12 million Americans; that number is increasing and children are disproportionately affected. Four years ago, Congress enacted the Food Allergen Labeling and Consumer Protection Act of 2004, mandating ... -
ALTERNATE ROUTES OF REFORMIST ACTIVISM: MEDICAL MARIJUANA AS A CASE STUDY OF INITIATIVES WITHIN AND BEYOND STATUTORILY PRESCRIBED CHANNELS
(1996)This essay discusses the various legal and political initiatives undertaken by reformers seeking change in the laws on medical marijuana use. Part I reviews the provisions of the Controlled Substances Act, and marijuana's ...